Royalty Report: Diagnostic, Medical, DNA – Collection: 227281

$150.00

Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 9

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Created On: 2020-07-15
Record Count: 9

Primary Industries

  • Diagnostic
  • Medical
  • DNA
  • Scientific & Technical Instruments
  • Device
  • Drugs
  • Test/Monitoring
  • nucleic acid
  • Assay
  • Drug Discovery
  • Therapeutic
  • Cancer
  • Disease
  • Biotechnology
  • Diagnostic Substances
  • ribonucleic acid

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 227281

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.

IPSCIO Record ID: 227280

License Grant
Nonexclusive License:  The Canadian Licensor hereby grants to Licensee a nonexclusive, nontransferable, worldwide, license under Licensor’s Intellectual Property Rights to develop, have developed, register, make, have made, use, offer for sale, have sold, import and sell Licensee Sourced Products for sale and use in connection with the GeneXpert® Instruments.

Sublicenses:  Licensee may only sublicense the license rights granted by Licensor to Licensee to its Affiliates as expressly set forth in this agreement and in accordance with the terms and conditions hereof.

License Property
GeneXpert Instrument means Licensee’s family of instruments which incorporate GeneXpert Cartridges to carry out integrated sample preparation, molecular amplification, and detection methods and which are manufactured and sold by Licensee.

GeneXpert Cartridge means a closed or substantially closed device that contains, among other things, pelletized or dried reagents intended for single or multiple use sample preparation and nucleic acid analysis and that is suitable for insertion into, or use as a part of, a GeneXpert Instrument.

Licensor Intellectual Property means all Intellectual Property Rights that are owned, either partially or wholly, by Licensor, or are licensed to and sub-licensable by, or otherwise controlled by, Licensor and which is related to Target Assays and Licensor Materials.

Licensee Sourced Products means Target Assays that are designed, developed, manufactured and sold by Licensee pursuant to the license from Licensor set forth in this agreement that but for such license grant from Licensor would infringe valid claims of Licensor’s Intellectual Property Rights.

Licensor Materials means Licensor produced probes, primers, for the Target Assays, and related components that Licensor may supply to Licensee pursuant to this Agreement.

Target Assays means the assays for identified infectious disease targets and more fully set forth below.  Target Assays include Licensee Sourced Products.

Target Assays:
Organism or Syndrome
Group B Streptococci
MRSA (Methicillin Resistant
Staphylococcus Aureus)
VRE (Vancomycin Resistant
Enterococci)

Licensee Intellectual Property means all Intellectual Property Rights that are owned, either partially or wholly, by Licensee, or are licensed to and sub-licensable by, or otherwise controlled by, Licensee, and which are related to GeneXpert Instrument, GeneXpert Cartridge, Smart Cycler Instruments and disposables.

Field of Use
This agreement pertains to the analytical instrument market relating to nucleic acid based analysis.

IPSCIO Record ID: 243464

License Grant
For the Conditional Non-Exclusive License to Licensee for Instruments, Licensor grants to a nonexclusive, world-wide license under Licensors interest in the Intellectual Property to make, have made, and import, Instruments outside of the Collaboration Field.

For the Non-Exclusive License to Licensee for Instruments Developed Outside the Joint Development Program, Licensor grants a non-exclusive, world-wide license under Licensors interest in Collaboration Licensors Intellectual Property to make, have made, use, import, offer to sell, and sell instruments outside the Collaboration Field.

For the Non-Exclusive License to Licensee for Instruments,  Licensor grants to a non-exclusive world-wide license under Licensors interest in the Intellectual Property to use, offer to sell, and sell Instruments outside of the Collaboration Field.

This agreement also includes exclusive grants from Licensee to Licensor.

License Property
Licensee has certain skills, proprietary technology and know-how related to the manufacture, design and use of Assembled Arrays.

Licensor has certain skills, proprietary technology and know-how related to the development of bioanalytical instrumentation systems and associated reagents and the marketing, sales and support of products incorporating such systems.

Licensor has DNA Synthesis and Purification Patents  referred to as the Caruthers Process and Caruthers Reagents, and related patents.

Field of Use
Collaboration Field means the field of Zip Code Chemistry used in combination with Assembled Arrays.

Nucleic Acid Analysis Field means the field of characterization of a nucleic acid sample including but not limited to the determination of the relative abundance of the nucleic acid, all or part of a sequence of the nucleic acid, or variations in the sequence of the nucleic acid. The Nucleic Acid Analysis Field excludes the Collaboration Field.

The Parties are designing product based on the Array of Arrays for SNP genotyping. The first SNP genotyping assay format that Licensee intend to commercialize will be PE Biosystems' proprietary OLA ZipCode assay format. This assay format enables the creation of a universal Array of Arrays that can be used to analyze any set of SNPs.

IPSCIO Record ID: 237263

License Grant
Licensor grants a non-exclusive, non-transferable license, without the right to sublicense, to Licensed Patents and Licensed Know-How to use the Instrument solely for the internal research and development activities.

Licensor grants a world-wide, non-exclusive, nontransferable license, without the right to sublicense, to make, use, sell, off er for sale and import Licensed Products for genotyping HAPâ„¢ Markers in all fields other than human and animal infectious diseases. Excluded from this grant is the right to make, sell, offer for sale or import the Licensors ProbeTecâ„¢ ET.

License Property
Licensed Know-How shall mean Licensors know-how related to Licensed Patents, the ProbeTecâ„¢ ET, and custom software for the ProbeTecâ„¢ ET. Licensed KnowHow shall also include, upon written request from Licensee, Licensors know-how necessary in the design and development of assays that utilize ProbeTecâ„¢ ET.

The patents include, but are not limited to, Nucleic Acid Target Generation,  Oligonucleotides for amplification and detection of hemochromatosis, and, Methods for detecting nucleic acid sequence variations.

Licensed Products shall mean any device, instrument, service, kit, composition of matter, material, product or component thereof that utilizes Licensed Know-How.

Instrument shall mean the Licensors ProbeTecâ„¢ ET installed in Licensees HAPâ„¢ Typing facility in New Haven, CT.

HAPâ„¢ Marker shall mean a polymorphism or any ordered combination of two or more polymorphisms present at a locus on a single chromosome that is contained in the Licensee HAPâ„¢ Database during the term of this Agreement or that is discovered from any gene where such discovery was made solely by employees of Licensee or others acting on behalf of Licensee, or, jointly by employees of Licensees or others acting on its behalf and employees of a HAPâ„¢ Partner or others acting on its behalf or for which a HAPâ„¢ Partner requests Licensee to develop genotyping assays or provide genotype data.

Licensor ProbeTecâ„¢ ET shall mean the clinical platform for infectious disease testing owned by Licensor using Strand Displacement Amplification Technology or SDA Technology and real time detection means.

LICENSED PATENTS

1. US Patent No. 5,270,184, entitled 'Nucleic Acid Target Generation'

2. US Patent No. 5,422,252, entitled 'Simultaneous Amplification of Multiple Targets'

3. US Patent No. 5,455,166, entitled 'Strand Displacement Amplification'

4. US Patent No. 5,536,649, entitled 'Decontamination of Nucleic Acid Amplification Reactions'

5. US Patent No. 5,547,861, entitled 'Detection of nucleic acid amplification'

6. US Patent No. 5,648,211, entitled 'Strand Displacement Amplifcation Using Thermophilic Enzymes'

7. US Patent No. 5,624,825, entitled 'Simultaneous Amplification of Multiple Targets'

8. US Patent No. 5,691,145, entitled 'Detection of nucleic acids using G-quartets'

9. US Patent No. 5,712,124, entitled 'Strand Displacement Amplification'

10. US Patent No. 5,736,365 entitled 'Multiplex nucleic acid amplification'

11. US Patent No. 5,744,311 entitled 'Strand displacement amplification using thermophilic enzymes'

12. US Patent No. 5,840,487, entitled 'Internal controls for isothermal nucleic acid amplification reactions'

13. US Patent No. 5,863,736, entitled 'Method, apparatus and computer program products for determining quantities of nucleic acid sequences in samples'

14. US Patent No. 5,888,739, entitled 'Detection of nucleic acids using G-quartets and Itetraplexes'

15. US Patent No. 5,916,779, entitled 'Strand displacement amplification of RNA
targets'

16. US Patent No. 5,919,630, entitled 'Detection of nucleic acids by fluorescence quenching'

17. US Patent No. 5,928,869, entitled 'Detection of nucleic acids by fluorescence quenching'

18. US Patent No. 5,935,791, entitled 'Detection of nucleic acids by fluorescence quenching'

Field of Use
Licensee creates personalized medicines through the integration of pharmacogenomics into drug development and marketing.  The fields of human and animal infectious diseases are excluded from this license.

IPSCIO Record ID: 253973

License Grant
Licensee wishes to acquire rights under the patents for the purpose of developing, manufacturing, using and selling products for use in connection with its GeneXpert® and SmartCycler® platforms.

The French Licensor grants to Licensee a personal, non-transferable, irrevocable, non-exclusive, worldwide sublicense under the Patents, for the sole purpose of developing, manufacturing, having manufactured, using, selling, offering for sale, importing and/or having sold Products under Licensees own and sole label in the Field for the duration of this Agreement.

License Property
Licensor is the exclusive licensee, with the right to sub-license, of certain patents owned by a Third Party(s) relating to the diagnosis of methycillin resistant Staphylococcus aureus.

The Licensee Platforms are the GeneXpert® and the SmartCycler® platforms of Licensee, including any improvements brought by Licensee during the term hereof that do not substantially modify the technical features and characteristics of these platforms.

The Platforms are of two types: those with automated sample preparation, as in the Licensees GeneXpert® instrument, and those without automated sample preparation, as in the Licensees SmartCyler® instrument. Each of these platforms is a thermal cycler.

Field of Use
The term Field means human in-vitro diagnostics, to the exclusion of Collaboration Sepsis Products and Excluded Products, and (ii) all other diagnostic fields, including veterinary and environment testing.

The Platforms are primarily intended for use in the automated performance of the polymerase chain reaction (PCR) process.

IPSCIO Record ID: 222544

License Grant
Licensor hereby grants to Licensee under the Licensed Patents a personal, non-transferable, non-exclusive license in the Licensed Field and in the Territory, with no rights to sublicense, to sell directly or indirectly through distributors  and to otherwise exploit, in all cases under Licensee’s trademarks and trade names, Licensed Products in the form of complete Licensed Real-Time Thermal Cyclers as well as any add-on, substitute, repair and replacement components, including, without limitation, software or hardware, and not as a foundry or OEM manufacturer for Third Parties.
License Property
Licensed Patents shall mean the Algorithm and Heated Cover Patent Rights, the Amplification System Patent Rights, the Automated Method Patent Rights, the Real-Time Apparatus Patent Rights and the Thermal Cycling Instrument Patent Rights.

Licensor owns patent(s) that describe and claim automated thermal cycling apparatus capable of performing and detecting nucleic acid amplification in real time.  Licensor owns patent(s) describing and claiming automated apparatus suitable for performing the PCR process, and apparatus claims in corresponding counterpart patents and patent applications in other countries;  describing and claiming an amplification system comprising PCR reagents and a thermal cycler programmed to carry out a PCR protocol; and, automated performance of the PCR process using certain programmed thermal cyclers.

Licensed Product shall mean a Licensed Real-Time Thermal Cycler, including any components, replacement parts, upgrades, computer software or hardware for or in the foregoing, the Exploitation of which would, but for the rights granted under this Agreement, infringe at least one Valid Claim of the Real-Time Apparatus Patent Rights.

License refers to patents for nucleic acid sequencing and real time PCR thermalcycling in diagnostics market.

Field of Use
Licensed Field shall mean Licensed Products and processes for the use thereof, that are neither sold nor used in the Applied Markets, are certified to be compliant, on in vitro diagnostic medical devices (IVD-D), or when sold or used in other jurisdictions, satisfy the applicable regulatory requirements relating to in vitro human diagnostic products; are designed, configured, promoted arid intended for use with a menu of Licensee provided diagnostic kits that are approved, compliant or are otherwise cleared by the
appropriate regulatory authority in each jurisdiction where the instrument is used or sold; and in the U.S., may also be used for Licensee provided Analyte Specific Reagents.

Applied Markets shall mean quality assurance and quality control, including, without limitation, conformance with specifications, purity and batch to batch consistency; testing and monitoring of environmental and food samples; identity testing (including, without limitation, for humans, animals, plants, organisms, microbes or their remains); epidemiology; and biosecurity.

IPSCIO Record ID: 233461

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.

IPSCIO Record ID: 1042

License Grant
The Netherlands Company hereby grants to Licensee a non-transferable, non-exclusive license, without the right to sublicense, to use the NASBA Technology and/or the Accusphere Technology and the Patent Rights for the sole purpose of manufacturing, using, selling and/or having sold by resellers Licensed Products under its own label in the Research Market, Water Testing Market and the Air Testing Market in the Territory for the life of this Agreement.
License Property
The term NASBA means isothermal transcription based enzymatic nucleic acid amplification procedure, method or system.

The term Accusphere Technology means a proprietary processing method which conveys thermal protective characteristics to enzymes and other biologically active molecules when stored at temperatures above 00C and as set out in more detail in Annex A.

The term Licensed Products shall mean any in vitro diagnostic test, assay, method or kit, the development, manufacture, use, or sale of which make use of the NASBA Technology and/or are covered by one or more claims of the Patent Rights and/or which make use of the Accusphere Technology and includes services for providing test results or other services which utilize such product(s).

The Company has begun development of products for rapid detection of biological contaminants in environment related locations (drinking water and air), as well as in food and certain samples used to identify the causative agent of certain human diseases. All of the Company’s planned environmental and clinical diagnostic products for detection of viral or bacterial pathogens are based on the Licensee’s NASBA technology.

The Company has licensed the NASBA technology from the Licensee for certain specific applications and expects to reach agreement with other unaffiliated parties to expand the scope of LSI’s NASBA related activities.

The NASBA method employs all of the Company’s internally produced enzyme products in conjunction with other substrates to cause rapid replication (amplification) of specific segments of nucleic acids.  Confirmation of the presence of large numbers of a single segment of RNA or DNA after the amplification reaction is the basis for determination of the identity of contaminating viruses or bacteria.

Field of Use
The rights granted apply in the Research Market, Water Testing Market and the Air Testing Market.

IPSCIO Record ID: 291119

License Grant
Licensor offers to the polymerase chain reaction (PCR) process users commercial and non commercial license rights under these patents and patent applications for automated
performance of the PCR process for research and certain other fields that include, inter alia, an up-front fee component based on the capacity of thermal cyclers used to perform the process.

Licensor grants to the Thermal Cycler Supplier the following personal, non-transferable, non-exclusive rights in the Territory under the Amplification Patent Rights:
—  Thermal Cycler Supplier is hereby authorized to sell and distribute to end users under Thermal Cycler Suppliers name and trademarks the specific thermal cyclers and temperature cycling instruments, i.e. the Smart Cycler(R) System, Smart Cycler(R) XC System and GeneXpert(TM) Prototype, in the configurations described) and any thermal cycler or temperature cycling instrument containing one or more I-CORE(TM) modules manufactured by Thermal Cycler Supplier, but not otherwise to sell or distribute to thermal cycler suppliers, with a label conveying to end users, including Thermal Cycler Supplier itself, in the Fields the up-front rights of PCR process licenses under the Amplification Patent Rights, that  is, with an Authorized Thermal Cycler label; and
—  Thermal Cycler Supplier may advertise and promote such thermal cyclers and temperature cycling instruments and so labeled as Authorized Thermal Cyclers for PCR.

Licensor grants to Thermal Cycler Supplier a personal, non-transferable, non-exclusive right under the Amplification System Patent Rights to convey to end-user customers, including Thermal Cycler
Supplier itself, of Thermal Cycler Suppliers Authorized Thermal Cyclers a non-exclusive license to use the same in the Fields in the Territory.

License Property
The patents include:
—  describing and claiming gene amplification processes including, among others, a process known as the polymerase chain reaction (PCR) process, which are owned by Roche Molecular Systems, Inc., and amplification process claims in corresponding counterpart patents and patent applications in other countries, and,
—  automated apparatus suitable for performing the PCR process, and apparatus claims in corresponding counterpart patents and patent applications, and,
—  improvements in thermal cycling apparatus for- PCR, including a pressing heated cover, and corresponding counterpart patents and patent applications in other countries,and,
—  describing and claiming an amplification system comprising PCR reagents and a thermal cycler programmed to carry out a PCR protocol,and,
—  claim automated performance of the PCR process using certain programmed thermal cyclers.
Field of Use
Fields shall mean research and development, quality assurance or control, environmental testing, plant diagnostics, identity testing (other than parentage testing for humans) and forensics.  The Fields specifically exclude human and veterinary diagnostics.
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