Royalty Report: Diagnostic, Medical, nucleic acid – Collection: 227280

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 13

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.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 13

Primary Industries

  • Diagnostic
  • Medical
  • nucleic acid
  • Test/Monitoring
  • Drugs
  • Assay
  • Cancer
  • Scientific & Technical Instruments
  • Device
  • DNA
  • ribonucleic acid
  • Genome
  • Research
  • HIV / AIDs
  • Disease
  • Drug Discovery

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: 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.

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: 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: 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: 240484

License Grant
Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, a royalty-bearing, non-exclusive immunity from suit under PCR Technology solely to use Licensed Technology to perform Licensed Services within the United States and its possessions and the Commonwealth of Puerto Rico. The Parties understand and agree that no rights are hereby granted, expressly or by implication, under U.S. Patent No. 4,965,188.
License Property
PCR Technology shall mean polymerase chain reaction technology covered by United States Patent Nos. B1 4,683,195 and B1 4,683,202 and any reissue or reexamination patents thereof.
4,683,195 – Process for amplifying, detecting, and/or-cloning nucleic acid sequences
4,683,202 – Process for amplifying nucleic acid sequences

Licensed Services shall mean the performance of an Assay by Specialty Labs to detect nucleic acid sequences associated with a human disease or condition within the Licensed Field. Licensed Services include but are not limited to, any combination of the steps of collecting a sample for analysis, isolating nucleic acid sequences therein, amplifying one or more desired sequences, analyzing the amplified material and reporting the results.

Diagnostic Product shall mean an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing an Assay.

Assay shall mean an IN VITRO diagnostic procedure utilizing PCR Technology to detect the presence, absence or quantity of a nucleic acid sequence associated with a specific human disease or condition.

Field of Use
Licensed Field shall mean the field of human IN VITRO diagnostics solely for the detection of genetic diseases, genetic pre-disposition to disease, cancer, tissue transplant typing, Parentage, and microorganisms associated with infectious diseases.

IPSCIO Record ID: 291929

License Grant
Licensor hereby grants Licensee a, worldwide, non-transferable, non-exclusive license under Licensor Licensed Technology, to, (1) develop Generic Kits and Standard Kits as authorized in this Agreement, (2) make, have made, and use (which use includes the right to modify) Licensor OEM Kits and (3) distribute, market and sell such Licensor OEM Kits (OEM License) pursuant to the license granted to Licensee as set forth in this Agreement. Licensee agrees to forbear from the use and exercise of the OEM License otherwise a royalty payment will be due.  If Licensee grants any Third Party a license to exploit the TAG Improvements, Licensee shall pay Licensor a royalty.

The purpose of the Collaboration is to develop, manufacture, market and sell (i) Products, and (ii) software applications for Approved Instruments all as set forth in this agreement. The purpose of the Collaboration may be modified and/or extended upon mutual agreement of the Parties in writing.

License Property
Licensor Licensed Technology means Technology Controlled by Licensor and its Affiliates as of the Effective Date that is useful in the Field of Use, as listed or described hereto. Licensor represents and warrants that the items listed hereto comprise all of the Licensor Licensed Technology as of the Effective Date of this agreement. As of the Effective Date the Licensor Licensed Technology does not require payment of royalties to third parties. Licensor and its Affiliates will amend this from time to time to keep it current. Licensor and its Affiliates warrant that all Controlled Technology for carrying out the marketing, sale, and other disposition of Products will be included in the Licensor Licensed Technology.

US Patent 5,888,819 – Method for determining nucleotide identity through primer extension

Product means any of a Standard Kit, a Custom Kit and/or a Generic Kit.

Combination Kit means any Custom Kit that contains Primers more than 50% of which are identical to Primers contained in any part of any Standard Kits existing at the time of launch of such Custom Kit, or any combination of Standard Kits existing at the time of launch of such Custom Kit.

Custom Kit means a kit consisting of certain Reagents, certain Primers that have been customized by Licensor or Licensors subcontractors for use in the Field of Use and an End User License, and shall not include use of or refer to any use of TAG Arrays other than for genotyping with GBA.

Standard Kit means a kit consisting of Reagents, CMC Approved Primers for use in the Field of Use and an End User License.

Generic Kit means a kit consisting of Reagents and an End User License.

Primer means GBA primers (a synthetic oligonucleotide of a sequence known to be complementary with the oligonucleotide sequence immediately adjacent, 5, to a SNP) or either PCR primers or information to generate PCR primers.

Reagent means buffers, enzymes and terminators (but not Primers) useful in GBA.

GBA means Genetic Bit Analysis, or single nucleotide primer extension methods designed to detect the identity of a single nucleotide at a predetermined location in the DNA of a sample.

SNP means Single Nucleotide Polymorphism.

Technology means and includes all inventions, discoveries, improvements, trade secrets and proprietary methods and materials, whether or not patentable, including but not limited to, samples of, methods of production or use of, and structural and functional information pertaining to, chemical compounds, proteins or other biological substances; other data; formulations; techniques; and know-how; including any negative results.

TAG Array means a tag array GeneChip probe array. Each set of probes consists of four probes with the following relationship to a defined target sequence — a perfect match to target sequence, a single base mismatch to target sequence, a perfect match to the complement of target sequence, and, a single base mismatch to the complement of target sequence. For the avoidance of doubt, TAG Arrays include no license (express or implied) authorizing use for any purpose except genotyping with GBA.

TAG Assay means any assays for hybridization to a TAG Array.

TAG improvement is any improvements to TAG Assays.

Field of Use
These new assays will allow researchers to customize high density SNP analyses solely by designing GBA primers for use on a standard GeneChip array.

The first products to be commercialized by the alliance will include reagent kits for use with Licensee's new universal array designed to perform thousands of user-defined SNP analyses.  Licensee has developed and intends to establish its GeneChip® system as the platform of choice for acquiring, analyzing and managing complex genetic information in order to improve the diagnosis, monitoring and treatment of disease.

Field of Use means the use of Product to practice GBA in Tag Array format in Approved Instruments for Research Purposes and clinical reference laboratories where work is performed under the Clinical Laboratory Improvements Act and explicitly excludes Products that have received marketing approval from the FDA.

GeneChip system is a commercial microarray platform that allows whole genome gene expression analysis for a wide variety of experimental organisms.

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
Licensee has received a license from Licensor for thermal cycling limited to the fields of life sciences research, industrial testing, aspects of identity testing and forensics. Licensee will require a license for thermal cycling in additional fields, such as clinical diagnostics.

Licensee's I-CORE module is a low-cost, self-contained instrument for performing and continuously monitoring chemical reactions such as PCR. Each module can optically measure up to four separate reactions. The I-CORE module rapidly and accurately controls the heating and cooling of the sample, which allows for fast reactions and accurate results. I-CORE modules can be configured into a variety of DNA analysis instruments or can be sold to manufacturers of large clinical and research instruments for incorporation into their instrument platforms. The I-CORE module is a key component in both our Smart Cycler and GeneXpert families of products.

The discovery of PCR and other amplification techniques dramatically improved the turnaround and time sensitivity of DNA probe assays. PCR acts on a target molecule to generate a million or more copies of the target nucleic acid sequence through repeated cycles of heating and cooling. Originally, this thermal cycling was accomplished by manually moving the sample between hot and cold water baths. Detection is typically accomplished by tagging the DNA with fluorescent dyes and manually placing the amplified sample on a gel to read it. Later, thermal cyclers were developed to automate the heating and cooling functions, and fluorimeters were developed to read the fluorescent signal.

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.

IPSCIO Record ID: 291130

License Grant
Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, a royalty-bearing, non exclusive, personal, non-transferable license under the Licensed Technology solely to perform Licensed Services within the Territory.

Licensor hereby grants to Licensee the right and Licensee accepts and agrees to credit Licensor as the source of its Licensed Technology rights in Licensees promotional materials and any other materials intended for distribution to Third Parties as follows

License Property
Licensor owns and has the right to grant licenses to practice under certain United States Patents describing and claiming, inter alia, nucleic acid amplification processes known as polymerase chain reaction ('PCR'), homogeneous PCR, and RT-PCR ('reverse transcription PCR').

Licensed Technology shall mean, subject to the following limitations, the Valid Claims of the United States patents listed in Agreement and any reissue or reexamination patents thereof. No rights under any kit claims of such patents are included in this definition or licensed under this Agreement. With the exception of the reaction mixture claims of United States Patents Nos. 5,804,375, 5,693,517, 5,476,774 and 6,127,155, the plasmid claims of the 5,476,774 patent, the primer claims of United States Patent No. 5,573,906, and the probe claims of United States Patent No. 5,110,920, no rights under any apparatus, device, composition of matter, reagent or substance claims of such patents are included in this definition or licensed under this Agreement.
4,683,195 – Process for amplifying, detecting, and/or-cloning nucleic acid sequences
4,683,202 – Process for amplifying nucleic acid sequences
4,965,188 – Process for amplifying, detecting, and/or cloning nucleic acid sequences using a thermostable enzyme

Diagnostic Product shall mean an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

Licensed Service(s) shall mean the performance by Licensee of an in vitro procedure within the Licensed Field which utilizes the Licensed Technology. Licensed Services include, but are not limited to, any combination of the steps of collecting a sample for analysis, isolating nucleic acid sequences from the sample, amplifying one or more desired sequences, analyzing the amplified material, including sequence analysis, and reporting the results.

Field of Use
Licensed technology includes specified nucleic acid amplification processes, to perform certain polymerase chain reaction-based human in vitro clinical laboratory services.

Licensed Field shall mean the field of clinical laboratory services that detect the presence, absence and/or quantity of a nucleic acid sequence for the detection, diagnosis, confirmation, prognosis, management and/or treatment of a human disease or condition, including, but not limited to, such services to identify predisposition to disease, disease susceptibility, confirm disease, predict therapeutic effectiveness or monitor disease progress; used in the course of human clinical trials; for Parentage Determination; and for tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation. Licensed Field shall specifically exclude any services performed for the screening of blood and/or blood products.

IPSCIO Record ID: 329692

License Grant
Prior to the Effective Date of this Agreement, the Parties have been involved in collaborative efforts to jointly develop assays for the ANAIS Instrumentation.

By this agreement, the Parties shall cooperate in the Development Transition and in the transfer of any information and Know-How necessary for Licensee to assume the development of the ANAIS Products.

Licensor grants a non-exclusive, non-transferable, worldwide license in the ANAIS Field to use the Licensor Technology to develop, make and have made, use, sell, offer for sale, have sold, and import the ANAIS Products, solely and exclusively for use on the ANAIS Instrumentation.

License Property
The ANAIS Instrument shall be an automated laboratory instrument for performing nucleic acid assays utilizing High Density DNA Probe Arrays.
Key BioChemistry Components include
– All enzymes used in transcription-based amplification for use in ANAIS Assays.
– All biochemical components used for amplification of amplicon of target with TMA, which is Licensors patents and technology relating to Nucleic Acid Sequence Amplification Methods.
– All probes, primers, and oligonucleotides used in ANAIS Assays.
– Nucleic acids used for ,positive and negative controls, standards, calibrators, and for quality control of ANAIS Assay components.

ANAIS products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor and solely and exclusively for use on ANAIS Instrumentation
– Probe Assays for the detection, identification, quantification, and/or susceptibility testing for panels of microorganisms or agents (but specifically excluding single organisms) in specimens taken from humans, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken. A panel shall test for 10 or more distinct species of organisms or agents in the following groups of microorganisms
or agents  Bacteria; Viruses; Yeast/Fungi; or, Parasites.The panels shall be medically relevant.

– Probe Assays for the detection, identification, quantification, and/or susceptibility testing for an individual organism, drawn only from the groups or families listed below, in specimens taken from humans, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken Hepatitis virus; HIV virus; Herpes virus; Human papilloma virus; HTLV Virus; Yeast; Fungus; Parasite; and, Bacterium other than Neisseria gonorrhoeae or Chlamydia trachomatis.

– Probe Assays for testing of sequences encoding human leukocyte antigens in specimens taken from humans and/or

– Probe Assays to detect and /or precisely identify microorganisms or agents including bacteria, yeast, viruses and parasites for use in quality control processes of water, food products, and/or previously developed pharmaceutical or cosmetic products, and/or identify foods coming or derived from plants and/or/ animals for the purpose of confirming anticipated source(s) of the food.

Assay shall mean a diagnostic process or procedure applied to a sample, or a portion of a sample, whereby a particular chemical compound, or a collection of compounds, or a portion of a chemical compound, is detected and optionally quantified.

Field of Use
The ANAIS Field shall mean
– the detection, identification, quantification, and/or susceptibility testing of organisms or agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken;
– testing for sequences encoding human leukocyte antigens;
– testing for microorganisms or agents, including bacteria, yeast, viruses and parasites in quality control processes of water, food products, and/or previously developed pharmaceutical or cosmetic products; and/or
– testing for the purposes of identifying genetically-modified foodstuffs or identifying animal species in foodstuffs.

The ANAIS Field specifically does not include testing for infectious agents in blood and blood products intended for transfusion, or the testing for infectious agents in blood in connection with organ transplants, or the testing of specimens from non-human animals or environmental sources except as specifically provided above, even if such testing is for the purpose of detecting or identifying organisms which are associated with infectious diseases in man.

IPSCIO Record ID: 282956

License Grant
Licensor hereby grants to Licensee under the Licensed Patents a non-exclusive license, without the right to grant sublicenses, to make, sell, offer for sale or otherwise dispose of Licensed Products in the Territory solely for use in the Licensed Field. Under this license, Licensee may use the Licensed Products only to the extent necessary for Licensee to perform quality control functions on lots of the Licensed Products, but under no circumstances may Licensee use the Licensed Products for Research Purposes or for any other purpose within or outside the License Field.
License Property
Licensed Product means a Kit and an End User License.

Licensed Patents means US Patent No. 5,888,819 and 6,004,744 and any divisionals, continuations, reissues, and foreign counterparts thereof.

5,888,819 – Method for determining nucleotide identity through primer extension
6,004,744 – Method for determining nucleotide identity through extension of immobilized primer

Instruments' mean automated electrophoresis nucleotide sequencing

'Genotype' means the detection or quantification of an individual SNP within a single sample (whether or not the genome of the sample is heterozygous for the given SNP).

Kit means a product designed for performing Primer Extension comprising one or more Reagents, the sale or offer for sale of which, without the licenses granted herein, would infringe or contribute to the infringement of at least one claim of a Licensed Patent.

Primer Extension means a nucleic acid template-dependent primer extension reaction to determine the identity of a single nucleotide base at a specific position in a nucleic acid of interest in which the reaction is performed in the presence of two or more terminators and in the absence of extendable nucleotides.

Reagent means an enzyme, buffer, primer extension chain-terminating compound or other composition useful for Primer Extension.

Field of Use
Licensed Field means the use of a Licensed Product on Approved Instruments for Research Purposes only. Practical applications of these techniques include genetic disease diagnoses, infectious disease diagnoses, forensic techniques, paternity determinations, and genome mapping.

IPSCIO Record ID: 329693

License Grant
Licensor grants a non-exclusive, non-transferable, worldwide license in the VIDAS Field to use the Licensor Technology solely to develop, make and have made, use, sell, offer for sale, have sold and import the VIDAS Products, solely and exclusively for use on the VIDAS Instrumentation.
License Property
Licensor possesses technology, knowledge, know-how and proprietary rights pertaining to nucleic acid hybridization and amplification technologies, detection and identification technologies, including specific probes targeting ribosomal RNA and specific target sequences and regions, microbiological culture collections, Probe Assay formats, specimen collection and processing, multiple analyte detection technologies and related intellectual property.

VIDAS Instrumentation shall mean, collectively, the Licensee instrument system currently known as the VIDAS system and the Licensee instrument system currently known as the mini-VIDAS system, as such systems existed on the date of the VIDAS Agreement and as hereafter modified or supplemented by additional instrumentation or devices as required to accommodate VIDAS Products, each of which modified and/or supplemented systems shall consist of instrumentation which is generally sold for processing and interpreting both Probe Assays and immunoassays, excluding, in any event, all VIDAS Products to be run on such instrumentation, provided, however, that such term may include a Probe Assay-only VIDAS system that Licensee may elect to develop at its expense, and provided, further, such modified and/or supplemented Probe Assay-only instrumentation system shall
–  be semi-automated, meaning it does not accept the sample container itself and performs all steps needed to produce the tests results.
–  use as its test format (i) a multi-well plastic cassette, currently referred to as a VIDAS strip which contains pre-dispensed reagents, tests for analytes and controls which is manually loaded into and resident in individual incubation and processing slots, and (ii) a pipette tip, currently referred to as an SPA, containing immobilized capture ligands; and
–   accommodate, on any single unit capable of stand-alone operation of such modified and/or supplemented instrument system, no more than thirty (30) test cassettes at one time.

VIDAS Products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor in this Agreement and solely and exclusively for use on VIDAS Instrumentation
–   VIDAS Initial Products, which shall mean, collectively, Probe Assays for the detection of Chlamydia trachomatis (VIDAS Probe CT); Probe Assays for the detection of Neisseria gonorrhoeae (VIDAS Probe GC), Probe
Assays for the detection of Neisseria gonorrhoeae and/or Chlamydia trachomatis in combination VIDAS CT/GC Screen and Probe Assays for the detection of Mycobacterium tuberculosis (VIDAS Probe MTB)
–   VIDAS QHIV Product, means the Probe Assay for the quantitative detection of human immunodeficiency virus which has been the subject of joint Parties development efforts prior to the Effective Date. IF Licensee elects to develop an alternative QHIV probe assay for the VIDAS Instrumentation and a new regulatory submission is required for such assay, then (i) if Licensee ceases to market the original VIDAS QHIV Product and markets only the alternative QHIV probe assay, such alternative QHIV probe assay shall thereafter be prospectively considered to be the VIDAS QHIV Product for purposes of this Agreement, but (ii) if Licensee continues to market the original VIDAS QHIV Product and also markets the alternative QHIV probe assay, such alternative QHIV probe assay shall be considered to be a VIDAS Future Infectious Disease Product for purposes of this Agreement.
–  VIDAS HLA Product, which shall mean Probe Assays for the detection and quantification of sequences encoding·human leukocyte antigens;
–  VIDAS Food Testing Products, which shall mean Probe Assays for the detection of microorganisms in any and all materials associated with the production (including quality control) of foodstuffs or beverages, including water, intended for human or animal consumption.
–  VIDAS Future Infectious Disease Products, which shall mean Probe Assays, other than the VIDAS Initial Products and VIDAS QHIV Product, for detection, identification, quantification of, and/or susceptibility testing for agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken.
–  VIDAS Other Future Products, which shall mean any Probe Assays which are directed at one or more Option Targets selected by Licensee.

Assay shall mean a diagnostic process or procedure applied to a sample, or a portion of a sample, whereby a particular chemical compound, or a collection of compounds, or a portion of a chemical compound, is detected and optionally quantified.

Probe Assay shall mean an Assay using a nucleic acid as a necessary and active reagent or which detects a set of nucleic acid sequences or a specific nucleic acid sequence, as a means of obtaining useful information relevant to the sample being assayed.

Key Biochemistry Components or KBCs shall mean (a) the lysing tubes, enzymes, nucleic acids and other biochemical compounds and reagents.  Key Biochemistry Components are
–  All enzymes used in transcription-based amplification, including TMA and variations and improvements to TMA, for use in VIDAS Assays.
–  All biochemical components used for amplification of amplicon of target with TMA.
–  All probes, primers, and oligonucleotides used in VIDAS Assays.
–  Nucleic acids used for positive and negative controls, standards, calibrators, and for quality control of VIDAS Assay components and VIDAS kits.

Field of Use
Technology covers semi-automated probe assays and advanced fully-automated, probe assays for the diagnosis of infectious diseases and detection of food pathogens.

Licensee and its Affiliates maintain and operate a worldwide network of semi-automated instruments known as VIDAS and mini-VIDAS for the diagnosis of infectious disease and other indications.

VIDAS Field shall mean
–  the detection, identification, quantification, and/or susceptibility testing of agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken;
–  testing for sequences encoding human leukocyte antigen;
–  testing for microorganisms in any and all materials associated with the production, including quality control, of foodstuffs or beverages, including water, intended for human or animal consumption;
–  testing for any analyte listed and selected by Licensee, as present in a clinical sample from the human body, solely for the purpose of diagnosis and medical care of the person from whom the tested sample was taken.

The VIDAS Field specifically does not include testing for infectious agents in blood and blood products intended for transfusion, or the testing for infectious agents in blood in connection with organ transplants, or the testing of specimens from non-human animals or environmental sources except as specifically provided above, even if such testing is for the purpose of detecting or identifying organisms which are associated with infectious diseases in man.

The target markers are
–  Cancer Markers
1. Prostase,
2. Mammaglobin,
3. Kras,
4. p53,
5. Cancer related mutations of the mitoch9ndrial RNA in the D-Loop regulatory region, the NADH (nicotinamide adenine dinucleotide) region, and the dehydrogenase subunit 4.
–  Cardiac Markers
6. Factor II (Prothrombiri) mutation (20210)
7. Factor V Leiden mGtation
–  Alzheimer Markers
8. ApoE
9. presenilin,
–  Sepsis Markers
10. Sepsis specific cytokine.

IPSCIO Record ID: 203394

License Grant
For the Exclusive License Grant, Licensor grants an exclusive, worldwide license under the Licensed Patents in the Exclusive Field, for use , to make, have made, use, offer to sell, sell and import Licensed Products and Licensed Processes.

For the Non-Exclusive License Grant, Licensor grants a non-exclusive, worldwide license under the Licensed Patents in the Non-Exclusive Field, with the right to sublicense as herein provided to make, have made, use, offer to sell, sell and import Licensed Products or Licensed Processes.

For Sublicensing, Licensee shall have the right to sublicense the rights granted solely for use with Licensees Hybrigel Technology to a Sublicensee.

License Property
The Licensor has proprietary acrydite chemistry technology described and claimed in the Licensed Patents. The Technology expressly includes the Licensed Patents, Licensed Products, and the Licensed Process.

Hybrigel Technology shall mean Licensees proprietary electrophoretic hybridization technology that relies on gel-based capture technology and that is  useful in the isolation of nucleic acid and the diagnosis of disease as disclosed in the U.S. patents, and foreign patents relating thereto.

Field of Use
The exclusive field means nucleic acid isolation from human stool samples for the purpose of screening, detecting or diagnosing colorectal cancer.

The non-exclusive field means any field, other than the exclusive field, in which the Hybrigel Technology is employed.

IPSCIO Record ID: 203279

License Grant
Licensor grants to Licensee under the Real-Time Apparatus Patent Rights a personal, non-transferable, non-exclusive license in the Fields and in the HIVD Field, in the Territory, to make, but not have made, use and import Licensed Real-Time Thermal Cyclers, and to offer to sell, and sell the same to end users solely under Licensee’s name and trademarks but not otherwise to manufacture for, or sell or distribute to or for, thermal cycler instrument suppliers.

Licensor grants to Licensee under the Real-Time Apparatus Patent Rights a personal, non-transferable, non-exclusive license in the Fields and in the HIVD Field, in the Territory, to make, but not have made, use and import add-on and substitute components, modules, computer hardware and software for Licensed Real-Time Thermal Cyclers, and to offer to sell, sell and distribute the same only to end-user owners of Licensed Real-Time Thermal Cyclers purchased from Licensee.

Licensor grants to Licensee under the Amplification System Patent Rights a personal, non-transferable, non-exclusive right to convey to end-user customers, including Licensee itself, of Licensee’s Licensed Real-Time Thermal Cyclers a non-exclusive license to use such Licensed Real-Time Thermal Cyclers in the HIVD Field in the Territory.

License Property
The licensed property includes patents describing and claiming automated thermal cycling apparatus capable of performing nucleic acid amplification and detecting that amplification in real time, and apparatus claims in corresponding counterpart patent applications in other countries.  And a US patent describing and claiming an amplification system comprising polymerase chain reaction (PCR) reagents and a thermal cycler programmed to carry out a PCR protocol.

Licensed Real-Time Thermal Cycler shall mean a Real-Time Thermal Cycler as defined below, where the system or its manufacture, importation, offer for sale, sale or use would, except for the rights granted under this Agreement, infringe at least one Valid Claim within the Real-Time Apparatus Patent Rights.

Field of Use
The Fields shall mean research, and all applied fields other than human in vitro diagnostic applications for the clinical management of patients, which are specifically excluded.

The HIVD Field shall mean the field of human in vitro diagnostic applications for the clinical management of patients, excluding any human in vitro diagnostic applications for the clinical management of patients involving the detection, quantitation, genotyping or characterization of human immunodeficiency virus (HIV) or hepatitis C virus (HCV).

IPSCIO Record ID: 204362

License Grant
Licensor grants a non-exclusive, non-transferable license, with the limited right to sublicense, under the Licensed Patents to make, have made, import, use, distribute and sell Licensed Products solely within the Field of Use and within the Territory.
License Property
Licensor owns or has rights in certain technology regarding lyophilized beads or reagent spheres.

Freeze-drying—technically known as lyophilisation, lyophilization, or cryodesiccation—is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Freeze-drying works by freezing the material and then reducing the surrounding pressure to allow the frozen water in the material to sublime directly from the solid phase to the gas phase.

Field of Use
The Field of Use shall mean nucleic acid based amplification assays excluding for use in molecular biology research and isothermal rolling circle amplification.
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