Royalty Report: Diagnostic, Medical, Cancer – Collection: 324667

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 14

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: 14

Primary Industries

  • Diagnostic
  • Medical
  • Cancer
  • Disease
  • Device
  • Drugs
  • Test/Monitoring
  • Biotechnology
  • Veterinary
  • Diagnostic Substances
  • DNA
  • Tissue
  • Therapeutic
  • Genome
  • Proteins
  • nucleic 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: 324667

License Grant
German Licensor grants to Licensee and its Affiliates a worldwide, non-exclusive license (without the right to sublicense) under the Licensed Patents (i) to make, to have made, to use, to have used, to import, to have imported, to offer to sell, to have offered to sell, and to sell and to have sold Licensed Products and to pass on to direct and indirect purchasers of Licensed Products the right to use such purchased Licensed Products and (ii) to perform Licensed Services.
License Property
The term Licensed Patent(s) shall mean those patents and patent applications which are listed below as well as any reexamination certificate, reissue, substitution, renewal, extension, addition, utility model or other patent right, U.S. or foreign, which has now issued or in the future may issue from any continuation, continuation in part or divisional application of such patents and patent applications.
US Patent #5,185,243 – Method for detection of specific nucleic acid sequences
US Patent #5,516,641 – Method for detection of specific nucleic acid sequences

The term Licensed Product(s) shall mean any human vitro diagnostic testing product and any other product whose manufacture, use, or sale would, but for the license granted under this Agreement, infringe any claim of a Licensed Patent which claim has not been held unpatentable, invalid or unenforceable by a decision of a  competent tribunal from which no appeal has or can be taken or which claim has not been admitted by the patentee to be invalid or unenforceable.

The term Licensed Services shall mean any services performed by using Licensed Products and any services the performance of which would in the absence of the license granted herein infringe any claim of a Licensed Patent which claim has not been held unpatentable, invalid or unenforceable by a decision of a competent tribunal from which no appeal has or can be taken, or which claim has not been admitted by the patentee to be invalid or unenforceable.

Licensor is a leading manufacturer and distributor of in vitro diagnostics, or IVD, products worldwide with a strong market position in each of the core product markets, which include chemistry/immunochemistry, hemostasis, microbiology and infectious disease diagnostics.

Field of Use
Field of Use is for human vitro diagnostic testing.

In Vitro diagnostics (IVDs) are diagnostic tests that that can detect diseases, conditions, or infections. In vitro diagnostics test a sample of tissue or bodily fluids, as opposed to testing inside the body

Licensee develops products for applications in the life sciences, oncology, reproductive health and other segments.

IPSCIO Record ID: 223141

License Grant
The German Licensor hereby grants to Licensee an exclusive license (including the right to grant sublicenses) under the Licensed Patent Rights to conduct research and to develop, make, use, offer for sale, sell and import Licensed Products and to provide Services in the Territory.
License Property
Licensed Patent Rights shall mean (a) those certain patent applications and patents listed hereto; (b) all patents that have issued or in the future issue from such foregoing patent applications, including utility, model and design patents and certificates of invention; (c) all patents that have issued or in the future issue from any patent application that claims priority from, or common priority with, any of the foregoing patent applications, including utility, model and design patents and certificates of invention; and (d) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such foregoing patent
applications and patents.

W003023057 (PCT /EP02/05489) – Method and Diagnosis Kit for Selection and/or for Qualitative and/or Quantitative Detection of Cells

Licensed Products shall mean in-vitro diagnostic assays to isolate, detect, identify, quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of prostate cancer and/or bladder cancer, for the purpose of research, diagnosis or medical care, the  manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the AdnaGen Patent Rights.

Field of Use
This agreement pertains to the medical industry relating to certain technology concerning the qualitative and quantitative detection of cells which may be useful in connection with nucleic acid diagnostic assays. The diagnostic indicators are used for the presence of prostate cancer and/or bladder cancer, for the purpose of research, diagnosis or medical care.

'Group 1 Additional Products' shall mean in-vitro diagnostic assays to isolate, detect, identify or quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of kidney cancer, cervical cancer, and/or ovarian cancer, for the purpose of research, diagnosis or medical care, the manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent Rights.

'Group 2 Additional Products' shall mean in-vitro diagnostic assays to isolate, detect, identify or quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of lung cancer, colon cancer, and/or breast cancer, for the purpose of research, diagnosis or medical care, the manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent Rights.

IPSCIO Record ID: 29416

License Grant
We entered into a settlement and mutual release agreement with the Company pursuant to which we received a non-exclusive, perpetual, non-transferable worldwide license to the patent rights in exchange for a product royalty based on sales.
License Property
Licensed Product(s) shall mean, on a country-by-country basis (i) Licensee’s INRatio™ test strip product(s), when made, used, sold, offered for sale or imported to a country for which there is a Valid Claim, and (ii) any other product(s) related to testing for blood coagulation, the manufacture, sale or use of would, but for the license granted herein, directly infringe a Valid Claim in the country of sale. For purposes of this definition of Licensed Product(s), “Valid Claim” means a claim of an issued and unexpired patent included within the Licensed Patents that has not been held invalid by a court of competent jurisdiction and that has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise.
Field of Use
The rights granted apply to the medical industry.

IPSCIO Record ID: 605

License Grant
Swiss Licensor grants to Licensee and its Affiliates, a non-exclusive worldwide right and license under the Licensed Patents as follows to perform in vitro human and/or animal diagnostic testing procedures on a sample of material obtained from a human or animal, as applicable, solely to detect the presence, absence or quantity of a nucleic acid sequence associated with a disease or condition in the Licensed Fields.
License Property
Other Technology shall mean the processes covered by the method claims (if they are Valid Claims) of United States Patent Nos. 5,008,182, 5,677,152, 5,773,258 and 5,176,995, and any reissue or reexamination patents thereof, and the claims (if they are Valid Claims) of United States Patent No. 5,110, 920, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

PCR Technology shall mean polymerase chain reaction technology covered by Valid Claims of United States Patent Nos. B1 4,683,195, B1 4,683,202, and 4,965,188 and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

Quantitation Technology shall mean the method claims (if they are Valid Claims) of United States Patent Nos. 5,389,512 and 5,219,727, and any reissue or reexamination patents thereof, and claims 1-4, 8, 9 and 15-18 (if they are Valid Claims) of United States Patent No. 5, 476,774, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

RT and RT-PCR  Technology shall mean the reverse transcription process covered by the method claims (if they are Valid Claims) of United States Patent Nos. 5,407,800, 5,310,652, 5,561,058, 5,618,703 and 5,322,770, and any reissue or reexamination patents thereof, and the claims (if they are Valid Claims) of United States Patent No. 5,693,517, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

'5' Nuclease Technology' shall mean only the processes defined by the method claims (if they are Valid Claims) of United States Patent Nos. 5,210,015 and 5,487,972 and any reissue or reexamination patents thereof and the reaction mixture claims (if they are Valid Claims) of United States Patent No. 5,804,375 and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

Field of Use
Diagnostic Services Field means the field of human in vitro diagnostics for the detection, quantitation, monitoring, genotyping, or phenotyping, of genetic and infectious diseases, disease susceptibility, genetic pre-disposition to disease or cancer; analyzing specimens taken from a human being for the purpose of testing, with respect to that human being, for a physiological or pathological state, for a congenital abnormality, for safety and compatibility of a treatment or to monitor therapeutic measures; or any use of PCR as a testing service to provide to a person data, results or interpretations of any application of PCR for purposes of therapy or diagnosis of a human being, including, without limitation, clinical laboratory services, whether or not a fee is charged for such services; tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation; Parentage Determination; diagnosis, disease management; and clinical trials, whether or not a patient result is provided directly or indirectly to a patient.  Licensed Field shall specifically exclude any services performed for screening of blood and/or blood products.

IPSCIO Record ID: 203305

License Grant
The Licensor of England grants to the Licensee a non-exclusive, non-sublicensable license within the Field and the Territory to use the Patents and the Know-How, to develop and have developed, make and have made, to Supply and have Supplied, either directly or through distributors, to import and have imported and to use and have used the Products within the Field.
License Property
The Scorpions technology is the means, methods and compositions used to detect nucleic acid amplification based on compositions that have one or more amplification primer portions linked to one or more nucleic acid probe portions and that are detectable as a result of the extension of one of the primers without concomitant amplification of the probe portion as described.

The products are any assay kit or other composition manufactured for use within the Field, the manufacture, use, sale, or import of which would, but for the license, infringe one or more valid claims of one or more of the issued Patents.

U.S.A. Patent 5,525,494 – Non-amplifiable Tails Patents

Scorpions(TM) probes are highly sensitive, sequence-specific, bi-functional molecules containing a PCR primer covalently linked to a probe. Scorpions probes provide strong fluorescent signals, excellent sequence discrimination, short reaction times, and predictable probe design. The interaction of the probe and the desired target occurs very rapidly and in advance of any competing side reactions such as the formation of internal secondary structures or re-annealing. The unique intra-molecular nature of the Scorpions reaction means that it is ideally suited for fast, quantitative, real-time PCR analysis.

Field of Use
This agreement is for the human in vitro diagnostics field.

Scorpions(TM) technology will provide benefits in speed and in developing highly multiplexed tests.  The first commercial products expected to use the Scorpions probes for Licensee will be in the recreational water testing area.

IPSCIO Record ID: 352725

License Grant
The Parties and others have entered into the Settlement Agreement dated as of the Effective Date.   Both of the Parties desire to continue their current businesses related to the sale of services in the NIPT LDT Field.

The Parties desire for Licensee to have the exclusive right to Exploit the Pooled Patents in the NIPT IVD Field.

Licensee will have
– the exclusive, worldwide, sublicensable right under the Pooled Patents to Exploit NIPT IVD Products in the NIPT IVD Field,
– the exclusive, worldwide, sublicensable right under the Pooled Patents, excluding the Isis Patents, to Exploit NIPT LDT Tests in the NIPT LDT Field, subject to the non-exclusive rights granted to, or reserved by, the Licensor Parties, and
– the nonexclusive, worldwide, sublicensable right under the Isis Patents to Exploit NIPT LDT Tests in the NIPT LDT Field.

Licensor on behalf of itself and its Affiliates, grants to Licensee and its Affiliates an exclusive, irrevocable and perpetual, non-transferable and non-assignable, worldwide license, with the exclusive right to grant sub licenses, under the Licensor Owned Patents and Isis Patents, to Exploit NIPT LDT Tests in the NIPT LDT Field and to Exploit NIPT IVD Products in the NIPT IVD Field, provided that the license is Royalty bearing with respect to NIPT IVD Products and the license is Test Fee-bearing with respect to NIPT LDT Tests.

License Property
Pooled Patents means patents owned or controlled by Licensee and the Licensor.

NIPT IVD Product means a distributable in vitro diagnostic device that has either received applicable Regulatory Approval for sale and use to conduct or perform, in whole or in part, NIPT or is otherwise particularly labeled and marketed for use to conduct or perform NIPT, in whole or in part, excluding general purpose products and components labeled for research use only.

Licensor noninvasive prenatal testing (NIPT) is a chromosome counting method that analyzes genetic information in fetal cell-free DNA in maternal blood to determine risk for specific fetal chromosomal and subchromosomal abnormalities.

Field of Use
Licensed NIPT Field means, collectively, the NIPT IVD Field and NIPT LDT Field.  NIPT means in vitro cell-free nucleic acid-based non-invasive prenatal testing, including, without limitation, testing by massively parallel sequencing or digital PCR, of a biological sample, including but not limited to plasma, serum, whole blood, and urine, obtained from a pregnant woman, excluding oncology testing.

IPSCIO Record ID: 28762

License Grant
The Finnish Licensor grants Licensee an exclusive License to make, use, develop, have developed, manufacture, have manufactured, offer to sell, sell and have sold Licensed Products utilizing urine or oral fluid as the sample material under the Licensee brand name or the brand name of a Third Party.

Licensor grants Licensee a non-exclusive License to make, use, develop, have developed, manufacture, have manufactured, offer to sell, sell and have sold Licensed Products utilizing blood, serum, plasma, or urogenital swab as the sample material under the Licensee brand name.

License Property
Licensed Products shall mean human in vitro clinical diagnosticand non-therapy screening tests incorporating Licensed Technology which are designed by Licensee to detect Analytes in human blood, serum, plasma, urine, oral fluids, or urogenital swabs.

Licensed Technology shall mean human in vitro clinical diagnostic and non-therapy screening rapid test and sample applicator device technology described in European Patent Application 04003603.0 and corresponding foreign counterparts thereof; Finnish Patent Application FI200040825 and all issues, reissues, amendments divisions, continuations, continuations-in-part, and corresponding foreign counterparts thereof; and all confidential  know-how  proprietary to Licensor needed to assist Licensee in developing and manufacturing Licensed Products.

Field of Use
Licensee develops, manufactures, markets and sells human in vitro clinical diagnostic tests for the detection of human infectious agents in the worldwide professional clinical diagnostic markets.

The use is the worldwide professional and OTC human in vitro clinical diagnostic markets.

IPSCIO Record ID: 279313

License Grant
University hereby grants and Licensee hereby accepts an Exclusive license under the Licensed Patents and Licensed Materials to make, have made, import, use, lease, sell and offer for sale and otherwise commercialize and exploit Licensed Products in the Licensed Territory, and practice any method process or procedure within the Licensed Patents in the Licensed Territory.  Said license is Exclusive, including the right to sublicense  in the Licensed Field of Use for a term commencing as of July 1, 1997 and ending on the expiration of the last to expire of the Licensed Patent(s).  University shall have the right to practice the Invention(s) and use the Technology for its own bona fide research, including sponsored research and collaborations. University shall have the right to publish any information included in Licensed Materials and Licensed Patent(s).
License Property
Licensed Product(s) means any product or part thereof in the Licensed Field of Use, the manufacture, use, or sale of which

(a)I s covered by a valid claim of an issued, unexpired Licensed Patent(s) directed to the Invention(s). A claim of an issued, unexpired Licensed Patent(s) shall be presumed to be valid unless and until it has been held to be invalid or unenforceable by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken or is disclaimed, or rejected or found invalid or unenforceable in a reissue application or re- examination proceeding or otherwise;
  
(b) Is covered by any claim being prosecuted in a pending application directed to the Invention(s); or

(c) Incorporates any of the Licensed Materials.

Licensed Patent(s) means any (i) U.S. patent application Serial Number 270,631 filed July 1, 1994 (issued on July 22, 1997 as U.S. Patent Number 5,650,135), (ii) all divisions, substitutions, and continuations in whole or part of any of the preceding, (iii) all foreign patent applications corresponding to or claiming priority from (including International Application Number PCT/US95/15040 and all national applications claiming priority therefrom), and (iv) all U.S. and foreign patents issuing on any of the preceding, including patents of addition, reexaminations, reissues and extensions.

5,650,135 – Non-invasive localization of a light-emitting conjugate in a mammal

Licensed Materials means those biological materials listed, and such other agreed materials as University may provide to Licensee during the term of this Agreement, which shall be added.
– Individual components of light systems (Vectors, genes and gene fragments)
– Bacteria
– Tumor cells
– Indicator cells for HIV
– Transgenic mouse lines

Field of Use
Licensed Field of Use means all uses.

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: 122373

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 perform licensed services within the United States and its possessions and the Commonwealth of Puerto Rico.
License Property
PCR technology shall mean polymerase chain reaction technology covered by United States Patent Nos. B2 4,683,195, B1 4,683,202 and 4,965,188 and any reissue or reexamination patents thereof. The performance of 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 within the licensed field.

It is understood by the parties that Licensor may, from time to time, come into possession or control of additional patents or claims of patents relating to PCR technology rights to which Licensor may decide to offer to add to the Diagnostic Services Agreement and which Licensee may desire to accept.

Additional Patents
U.S. Patent Number 5,008,182
U.S. Patent Number 5,176,995
U.S. Patent Number 5,219,727
U.S. Patent Number 5,110,920

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: 260378

License Grant
Licensor grants a non-exclusive license, without the right to grant or authorize sublicenses, under the Licensed Patent Rights to develop and perform the Services solely at the Facilities, and to use, and offer for sale and sell the Services to Third Parties solely in the Territory.
License Property
Licensed Patent Rights shall mean, collectively, Licensors rights in all patent applications, including provisional patent applications, heretofore or hereafter filed in the Territory;  all patents that have issued or in the future issue in the Territory from any of such patent applications, including without limitation utility models, design patents and certificates of invention; and,  all divisionals, continuations, continuations-in-part, substitutions, reissues, renewals, extensions, restorations or additions to any such patent applications and patents, in each case that claim, and only to the extent they claim, compositions, uses, methods, equipment, devices and other technology for the use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women for prenatal diagnostic testing by whole genome massively parallel sequencing, used in the performance of the MaterniT21 PLUS Test by Licensors Laboratories as of the Effective Date, or any improvements to such test; provided, however, that the Licensed Patent Rights shall exclude any of the foregoing licensed by a University to Licensor under another agreement.

MatemiT21 PLUS Test shall mean the laboratory-developed test for the non-invasive testing of a plasma sample from a pregnant woman for the detection and diagnosis of prenatal aneuploidy and/or fetal abnormalities by use of cell-free fetal nucleic acids, currently known as the MatemiT21 PLUS test, as performed by Licensors Laboratories.

Field of Use
The Field shall mean the non-invasive detection and diagnosis of prenatal aneuploidy and fetal abnormalities by use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women.
The MaterniT® 21 PLUS test analyzes genetic information that enters your bloodstream from the placenta.  It analyzes the amount of chromosome 21 in fetal DNA picked up from the maternal blood sample. It can detect an increased amount of chromosome 21 material which is associated with trisomy 21 (Down syndrome). It is completely non-invasive as it only involves a blood sample from the mother.

IPSCIO Record ID: 203343

License Grant
The parties previously entered a Clinical Diagnostics Agreement and Blood Screening Agreement.

Pursuant to the settlement, the parties hereby irrevocably stipulate the Licensor Licensed Patents in the Territory are valid and enforceable; and, the making, use, offer for sale, sale, or importation of any Licensee Product in the Territory, where a Licensor Licensed Patent has issued and prior to the expiration of such Licensor Licensed Patent, would, in the absence of the licenses granted in the Agreements, as applicable, constitute infringement of one or more claims of such Licensor Licensed Patent.

Per the original agreement, the Parties entered a nonexclusive license in the Territory, without the right to sublicense, under the Licensor Licensed Patents to make, import, use, offer for sale and sell Licensor Licensed Products for use in Blood Screening solely for sale to or use by or on behalf of Existing Customers under the Existing Agreements and Existing Offers.

License Property
The Licensee Products means all assays sold by Licensee for the detection, quantitation, genotyping or other analyses of nucleic acid sequences Directed to HIV for use in in vitro diagnostics and/or Blood Screening, including without limitation the following products of Licensee Amplicor HIV-1 test, v. 1.0; Amplicor HIV-1 Monitor test, v. 1.0; Amplicor HIV-1 Monitor test, v. 1.5; COBAS Amplicor HIV-1 Monitor test, v. 1.5; Ampliscreen HIV-1 test, v. 1.5; and COBAS Ampliscreen HIV-1 test, v. 1.5; and all versions and successors and substitutes therefor.

Blood Screening means the commercial use of products that detect nucleic acid sequence(s) for the screening of blood, plasma or blood components intended for transfusion or for use in blood products (e.g., without limitation, immunoglobulins); or confirmatory or supplemental testing of the same samples otherwise screened for purposes described.

Directed to HIV means that the claim or technology in question is directed to methods, compositions, reagents or kits specifically for use in nucleic acid-based diagnostic assays for the detection of HIV nucleic acid sequence(s), or specifically for use in the manufacture of any compositions or reagents for use in, or manufacture of nucleic acid-based diagnostic assays for detection of HIV nucleic acid sequence(s) (excluding, for example, polymerase chain reaction claims and technology and other methods for detection of nucleic acid sequence(s) generally which involve nucleic acid amplification).

HIV means any viral isolate of the human immunodeficiency virus classified as HIV by the International Committee on the Taxonomy of Viruses (or any body that replaces such Committee) or any subtype of such isolate and further includes any isolate that is at least forty percent (40%) homologous to any such isolate and of the same genomic type and substantially the same genomic organization, any isolate that has a genome that either hybridizes to or is substantially identical to any such isolate or its compliment, and any defective or modified form of any of the above isolates.

''Patent' means U.S. Patent No. 6,531,276 Bl

Field of Use
This agreement is for the HIV Qualitative Assay field.

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: 362520

License Grant
Israeli Licensor on behalf of itself and its Affiliates hereby grants to Licensee and Licensee’s Affiliates, a Limited Exclusive, sublicensable, royalty-bearing license under the Licensed Patents to Exploit the Licensed Products in the Field in the Licensee Territory during the Term through any and all means and channels of distribution now known or hereinafter discovered.

Licensor hereby grants to Licensee and Licensee’s Affiliates, a Limited Exclusive, sublicensable, royalty-bearing license under Licensor’s intellectual property rights in the Product Technical Information to Exploit the Licensed Products in the Field in the Licensee Territory during the Term through any and all means and channels of distribution now known or hereinafter discovered.

License Property
Licensed Product shall mean any Diagnostic Test (a) the Exploitation of which, or of any process, method, material, composition or assay used therein or for the performance thereof, would infringe a Valid Claim but for the licenses granted herein, (b) which was developed or manufactured using a Licensed Process, or (c) which incorporates or is developed using Royalty-Bearing Technical Information.

Product Patent(s) shall mean all Patents in the Licensee Territory now or in the future owned or Controlled by Licensor and/or its Affiliates that are necessary or useful for any of the Diagnostic Tests and are specifically directed to one or more elements of any of the Diagnostic Tests that are unique to such Diagnostic Test (as contrasted to methods of performance in general of tests based on microRNAs or composition of matter claims that are relevant to multiple indications), including but not limited to (a) the Patents listed as may be amended from time to time by the Parties; and (b) all Patents in the Licensee Territory (i) to which any of the Patents set forth claim priority or (ii) for which any of the Patents listed a basis for priority, including any divisionals, continuations, substitutions, continuations-in-part, extensions, renewals, re-examinations or reissues of such Patents listed, provided that Product Patents(s) shall not include the Excluded Acquisition Patents or the Platform Patents. For the avoidance of doubt, (e), the Product Patents include all methods of use claims directed to the use of microRNAs for the indications that are the targets of the Diagnostic Tests, but exclude all composition of matter claims directed to microRNAs.

Platform Patent(s) shall mean all Patents in the Licensee Territory now or in the future owned or Controlled by Licensor and/or its Affiliates that are necessary or useful for the Exploitation of a Licensed Product and cover one or more compositions of matter or technologies which can be used across two or more products, including but not limited to (a) the Patents listed as may be amended from time to time by the Parties; and (b) all Patents in the Licensee Territory (i) to which any of the Patents set forth claim priority or (ii) for which any of the Patents listed a basis for priority, including any divisionals, continuations, substitutions, continuations-in-part, extensions, renewals, re-examinations or reissues of such Patents listed, provided that Platform Patents(s) shall not include the Excluded Acquisition Patents.  For the avoidance of doubt, the Platform Patents include all composition of matter claims directed to microRNAs within the Licensed Patents.

Licensed Patents shall mean the Platform Patents and the Product Patents.

Product Technical Information shall mean any Technical Information which is necessary or useful to Exploit the Licensed Products in the Licensee Territory and owned or otherwise Controlled by Licensor or any of its Affiliates as of the Effective Date or during the Term, including Licensor Improvements incorporated into the Licensed Products, if any, but excluding any Excluded Acquisition Technical Information and any Technical Information that is claimed or disclosed in the Licensed Patents.

Mets Software shall mean the source code and object code forms of a certain software application which contains, among other things, an algorithm created by or on behalf of Licensor for the purpose of processing the results of the Mets Test, in the forms that such software exists as of the Effective Date, and any updates and Improvements adopted by Licensor for the Mets Test and distributed by Licensor to Licensee during the Term.

Licensed Intellectual Property shall mean the Licensed Patents, the Product Technical Information and the Mets Software.

Field of Use
Field shall mean the diagnosis of any disease or any human condition. For the purposes of this definition, diagnosis shall mean use (a) where the medical management of a human  is involved, for (i) the measurement, observation or determination of (x) the presence of a human disease, (y) the stage, progression or severity of a human disease, (z) the risk of contracting a human disease, and/or (ii) the selection of patients for a particular treatment with respect to a disease; and/or (b) in a clinical laboratory for tracking, testing or quality controlling of human body fluids or tissue samples; and/or (c) designated and regulated by the FDA as a diagnostic test or analyte specific reagent, to the extent used according to (a) and/or (b) above.

Licensee has the exclusive right to develop and commercialize miRviewâ„¢ mets, miRviewâ„¢ meso and miRviewâ„¢ squamous tests in the United States.

Licensor has initiated microRNA-based diagnostic programs for various cancers
1.      miRviewTM mets For identification of  the origin of the primary tumor of metastases;
2.      miRviewTM squamous For differentiating squamous from non squamous non-small cell lung cancer; and
3.      miRviewTM meso For differentiating mesothelioma from other carcinomas in the lung and pleura.

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