Royalty Report: Diagnostic, Medical, Device – Collection: 289227

$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
  • Device
  • Cancer
  • Drugs
  • DNA
  • Test/Monitoring
  • Disease
  • ribonucleic acid
  • Proteins
  • Imaging

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: 289227

License Grant
University hereby grants Licensee the exclusive right to conduct various technical, pre-clinical, marketing, patent, and other studies on Products in the field of use during a six (6) month period commencing on the effective date of this Agreement (the option period). The option period may be extended by mutual written agreement of the parties.

In consideration of the royalties, and subject to the terms and conditions, as set forth in this Agreement and effective upon the earlier to occur of (i) written notification to University during the option period that Licensee desires to license the Patent(s), or (ii) expiration of the option period with no written notification given, University hereby grants to Licensee i. the exclusive worldwide license in the field of use to use the Patent to make, have made, use distribute, and sell the Product(s); and ii. the right to grant sublicenses to any Patent licensed hereunder, provided that any sublicensee agrees to be bound by the terms and conditions of this Agreement applicable to sublicensees.

License Property
The term Patent or Patents shall mean any and all patent applications listed while, and to the extent, said applications remain pending, and any and all pending or unexpired patents issued thereon and any continuation, division, extension or reissue thereof, and any and all pending or unexpired foreign patents issuing from any application filed which corresponds to claims contained in any of the foregoing patents or applications.
USC#2860, filing date 12/15/1999

Product or Products shall mean any article, composition, apparatus, substance, chemical, material, method or service which is made, used, distributed or sold by Licensee which
i. is covered in whole or in part by one or more pending or unexpired claims contained in a Patent in the country in which the Product(s) is made, used, distributed or sold;
ii. is manufactured using a method or process which is covered in whole or in part by one or more pending or unexpired claims contained in a Patent in the country in which (a) the Product(s) is made, use, distributed or sold, or (b) the method or process is used or sold;
iii. the use of which is covered in whole or in part by one or more pending or unexpired claims contained in a Patent in the country in which (a) the Product(s) is made, used, distributed or sold, or (b) the method or process is used or sold; or
iv. incorporates Information transferred to Licensee pursuant to the confidential disclosure agreement dated January 7, 2000 between University and Licensee (as the term Information is defined in said agreement).

Field of Use
The agreement is a  license with the right to sublicense, the patents for RGI-1 and related technology, for use in human and veterinary diagnostic laboratory services, the sale of clinical diagnostic products, and the sale of research products to the research community.

Field of Use shall mean (i) human and veterinary diagnostic laboratory services or (ii) the sale of clinical diagnostic products, and (iii) the sale of research products to the research community.

RGI-1 enables Licensee to rapidly and reliably isolate RNA and DNA from FFPE tissues.  The technology involves heating the sample in specific solutions at high temperatures for a period of time. Heating the specimens at high temperatures rapidly reverses the cross-links which previously created problems in analyzing RNA from paraffin tissues by polymerase chain reaction technology (PCR). The yield of RNA is also increased by use of this patented technology.
The technology involves heating the sample in specific solutions at high temperatures for a period of time. Heating the specimens at high temperatures rapidly reverses the cross-links which previously created problems in analyzing RNA from paraffin tissues by polymerase chain reaction technology (PCR). The yield of RNA is also increased by use of this patented technology.

Diagnostic tests for cancer recurrence or chemotherapy response are based on the genetic analysis of RNA extracted from tumor tissue. Until recently, this type of genetic analysis was only possible using a large quantity of nearly full-length RNA recovered from fresh-frozen clinical specimens. However, fresh-frozen tissue specimens from patients are not generally available because the standard process for handling biopsy specimens is to fix tissues in formalin and then embed them in paraffin. Fixation in paraffin preserves the tissue and allows easy examination of the sample by pathologists. Additionally, the majority of hospitals and clinics worldwide lack the infrastructure to store and archive frozen tissues. As a result, hospitals today have accumulated enormous libraries of archived FFPE tissue specimens taken from the majority of cancer patients, rather than fresh-frozen specimens. Although such FFPE specimens are extensively available and easily accessible, existing methods of RNA extraction from FFPE specimens of tumor tissue have not been considered useable for genetic profiling studies. The isolation of RNA from FFPE tissue with methods that have been published in the past is also unreliable and inconsistent in terms of RNA yield.

IPSCIO Record ID: 290553

License Grant
The parties amend certain terms of the License Agreement that includes but not limited to royalty description, sublicense section, address for notices, field of use, and the warranties section.

University furthermore grants to Licensee the right to make, have made, distribute and sell clinical diagnostic products. Licensee shall continue to have the right to commercially exploit the licensed inventions as related to diagnostic laboratory services.

The original agreement states
University hereby grants Licensee the exclusive right to conduct various technical, pre-clinical, marketing, patent, and other studies on Products in the field of use during a six (6) month period commencing on the effective date of this Agreement (the option period). The option period may be extended by mutual written agreement of the parties.

In consideration of the royalties, and subject to the terms and conditions, as set forth in this Agreement and effective upon the earlier to occur of (i) written notification to University during the option period that Licensee desires to license the Patent(s), or (ii) expiration of the option period with no written notification given, University hereby grants to Licensee i. the exclusive worldwide license in the field of use to use the Patent to make, have made, use distribute, and sell the Product(s); and ii. the right to grant sublicenses to any Patent licensed hereunder, provided that any sublicensee agrees to be bound by the terms and conditions of this Agreement applicable to sublicensees.

License Property
The term Patent or Patents shall mean any and all patent applications listed while, and to the extent, said applications remain pending, and any and all pending or unexpired patents issued thereon and any continuation, division, extension or reissue thereof, and any and all pending or unexpired foreign patents issuing from any application filed which corresponds to claims contained in any of the foregoing patents or applications.
USC#2860, filing date 12/15/1999

Product or Products shall mean any article, composition, apparatus, substance, chemical, material, method or service which is made, used, distributed or sold by Licensee which
i. is covered in whole or in part by one or more pending or unexpired claims contained in a Patent in the country in which the Product(s) is made, used, distributed or sold;
ii. is manufactured using a method or process which is covered in whole or in part by one or more pending or unexpired claims contained in a Patent in the country in which (a) the Product(s) is made, use, distributed or sold, or (b) the method or process is used or sold;
iii. the use of which is covered in whole or in part by one or more pending or unexpired claims contained in a Patent in the country in which (a) the Product(s) is made, used, distributed or sold, or (b) the method or process is used or sold; or
iv. incorporates Information transferred to Licensee pursuant to the confidential disclosure agreement dated January 7, 2000 between University and Licensee (as the term Information is defined in said agreement).

Field of Use
The patents are for RGI-1 and related technology, for use in human and veterinary diagnostic laboratory services, the sale of clinical diagnostic products, and the sale of research products to the research community.

RGI-1 enables Licensee to rapidly and reliably isolate RNA and DNA from FFPE tissues.  RGI-1 generates molecular-based tumor analyses for use in guiding chemotherapy treatment for cancer patients.

IPSCIO Record ID: 290552

License Grant
The parties amend the royalty section of the original agreement; in all other respects, the License Agreement is hereby ratified and confirmed.

The original License Agreement grant is as stated
University hereby grants Licensee the exclusive right to conduct various technical, pre-clinical, marketing, patent, and other studies on Products in the field of use during a six (6) month period commencing on the effective date of this Agreement (the option period). The option period may be extended by mutual written agreement of the parties.

In consideration of the royalties, and subject to the terms and conditions, as set forth in this Agreement and effective upon the earlier to occur of (i) written notification to University during the option period that Licensee desires to license the Patent(s), or (ii) expiration of the option period with no written notification given, University hereby grants to Licensee i. the exclusive worldwide license in the field of use to use the Patent to make, have made, use distribute, and sell the Product(s); and ii. the right to grant sublicenses to any Patent licensed hereunder, provided that any sublicensee agrees to be bound by the terms and conditions of this Agreement applicable to sublicensees.

License Property
The term Patent or Patents shall mean any and all patent applications listed while, and to the extent, said applications remain pending, and any and all pending or unexpired patents issued thereon and any continuation, division, extension or reissue thereof, and any and all pending or unexpired foreign patents issuing from any application filed which corresponds to claims contained in any of the foregoing patents or applications.
USC#2860, filing date 12/15/1999
Field of Use
The patents are for RGI-1 and related technology, for use in human and veterinary diagnostic laboratory services, the sale of clinical diagnostic products, and the sale of research products to the research community.

RGI-1 enables us to rapidly and reliably isolate RNA and DNA from FFPE tissues.

IPSCIO Record ID: 289226

License Grant
Licensor hereby grants to Licensee a license to the Optimized Assays. This grant to Licensee shall be for its internal use in Licensees diagnostic service business and during the term of the collaboration shall be without royalty, but without any rights to sublicense or transfer to any third party. After the termination of the collaboration, the Optimized Assays will be licensed to Licensee for its internal diagnostic services for a royalty.

The parties collaborate so that Licensor will obtain access to the Licensor Patent Rights and the Licensor Assays so that Licensee may develop, optimize, manufacture and sell assays for research, investigational and in vitro diagnostic use (Optimized Assays).

License Property
Licensor owns certain patent rights, has developed certain technology, and possesses expertise relating to the preparation of assays;

Optimized Assays means assays for research, investigational and in vitro diagnostic use.

The phrase Licensor Patents Rights shall mean and include (i) all United States and foreign applications for patents listed, as well as all United States and foreign patents that have or may hereafter issue in respect of such applications for patents, and (ii) all applications for patents whose subject matter in whole or in part is entitled to the benefit of the filing date(s) of any of the applications for patents listed and all United States and foreign patents that have or may hereafter issue in respect of such applications for patents, including in each case of the foregoing clauses, without limitation, all continuations, continuations-in-part, divisionals, substitutions, Patent Cooperation Treaty applications, United States provisional patent applications, continued prosecution applications, utility models, supplementary protection certificates, reexaminations, renewals, extensions and reissues thereof.
6,428,963 – Isolation of RNA from formalin-fixed paraffin-embedded tissue specimens
6,248,535 – Method for isolation of RNA from formalin-fixed paraffin-embedded tissue specimens
6,610,488 – Isolation of RNA, DNA and proteins from formalin-fixed paraffin-embedded tissue specimens

Licensor Assay mean the research assays the Licensee develops.

Field of Use
The term Field shall mean the research, development, manufacture and sale of assays by Licensee, including but not limited to the Optimized Assays.

IPSCIO Record ID: 383582

License Grant
In the original agreement, Licensor granted
— For the Layton and Stanford Patent Rights a nonexclusive, non-transferrable, limited sub-licensable, world-wide license under the Layton Patent Rights and the Stanford Patent Rights to practice and use the subject matter within the Layton Patent Rights and the Stanford Patent Rights in the Licensee Database Field of Use, Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use.
— For the Montefiore Patent Rights, a non-transferrable, limited sub-licensable, world-wide license under the Montefiore Patent Rights to practice and use the subject matter within the Montefiore Patent Rights in the Licensee Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use.
— For the Cancer Marker Patent Rights, Licensor grants a non-transferrable, limited sub-licensable, world-wide license under the Cancer Marker Patent Rights to practice and use the subject matter within the Cancer Marker Patent Rights in the Licensee Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use, only with respect to cancer.
— For the Database Patent Rights and Seilhamer/Scott Patent Rights, Licensor grants a nonexclusive, non-transferable, non-sublicensable , world-wide license under the Database Patent Rights and Seilhamer/Scott Patent Rights to practice and use the subject matter within the Database Patent Rights and the Seilhamer/Scott Patent Rights in the Licensee Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use, and the Personalized Research Field of Use.
— For the Sublicenses, Licensee shall have the right to grant sublicenses to third parties under such Patent Rights on a Product-by-Product basis to make, use, import, sell, and offer for sale Products developed by Licensee or its Affiliates.
— For the Co-Exclusive Licenses in the Homebrew and Diagnostic Fields of Use, Co-Exclusive shall mean that each Party has the right to exercise all of the rights under the Patent Rights in question in the field of use for which the parties have co-exclusive rights, without obligation to the other except to the extent provided in this Agreement, and neither Party alone has the right to grant sublicenses to third parties under such Patent Rights without express written consent of the other Party.
License Property
Cancer Marker Patent Rights shall mean all Valid Claims listed in any of the following patents and patent applications, to the extent that they are owned by Licensor with the right to license under this Agreement, and to the extent that they claim the composition of matter or use of any nucleic acids or proteins as markers or diagnostics for cancer.

The patents include
— Processes for Genetic Manipulations Using Promoters;
— Method for Detecting Pathological Conditions;
— Comparative Gene Transcript Analysis; and,
— Methods for Fabricating Micro Arrays of Biological Samples.

Field of Use
Licensee licenses various classes of patents from Licensor pertaining to the manipulation of genes, the detection of pathological conditions, comparative gene analysis, methods for fabricating tests of biological samples and the use of proteins as markers for cancers.

IPSCIO Record ID: 378118

License Grant
The Licensee licensed certain technology from University covering inventions relating to methods to image brain and other tissues for use both in research and in the clinic.
License Property
The technology is owned and patented by University and includes US Patent 10,545,075 issued January 28, 2020.

US Patent 10,545,075 – Methods and compositions for preparing biological specimens for microscopic analysis

Technology licensed from University is a patent-protected CLARITY technology.

The CLARITY technology allows clearing of animal and human tissue so that thick tissue samples can be imaged in three dimensions (3D) with a confocal or light-sheet microscope and then analyzed by a lab scientist in a 3D dataset. CLARITY technology entails the formation of a hydrogel matrix by cross-linking biological molecules to a 3-D (three-dimensional) network of hydrophilic polymers, followed by lipid removal to generate a transparent and structurally intact tissue.

Field of Use
Field of use is for preparing a biological specimen for microscopic analysis.

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.

IPSCIO Record ID: 383575

License Grant
Licensor of Switzerland grants a non-exclusive and non-transferable license, without the right to sublicense, under the Licensed Patents in the Territory with the rights to
—  incorporate Licensed Products into Licensee’s Complete Diagnostic Kits,
—  make, offer to sell and sell such Complete Diagnostic Kits in the Licensed Field, and
—  convey with the sale of such Complete Diagnostic Kits the right to use the Complete Diagnostic Kits under the Licensed Patents in the Licensed Field. Licensee’s right to use Complete Diagnostic Kits includes the right to perform evaluations and validations of Complete Diagnostic Kits, but specifically does not include the right to use Complete Diagnostic Kits for the performance of diagnostic services or testing, except that Licensee may use Complete Diagnostic Kits as End Users.
License Property
Licensor owns or controls certain Licensed Patents relating to chemically modified thermostable DNA polymerases, also known as Hot Start Enzymes, for use in polymerase chain reaction, or PCR, technology.

Licensed Product means a chemically modified thermostable DNA polymerase, the manufacture, use or sale of which is covered by one or more Valid Claims of the Licensed Patents, sold by Licensor, directly or through its distributor, or made and sold by a supplier licensed to make and sell the same.

Complete Diagnostic Kit means a Licensee manufactured and trademarked kit covered by one or more Valid Claims of the Licensed Patents, not covered by any Licensor patents other than the Licensed Patents and dedicated for use for PCR in the Licensed Field, and which Licensee manufactured and trademarked kit is comprised of, at a minimum, the essential active reagents used in the practice of PCR for nucleic acid testing in the Licensed Field. For the avoidance of doubt and for the sake of clarification, ASRs, Analyte Specific Reagents, are not Complete Diagnostic Kits.

U.S. Patent No. 5,677,152 — Issued October 14, 1997 (process and kit claims only) Nucleic Acid Amplification Using a Reversibly Inactivated Thermostable Enzyme

U.S. Patent No. 5,773,258 — Issued June 30, 1998 (process and kit claims only) Nucleic Acid Amplification Using a Reversibly Inactivated Thermostable Enzyme

U.S. Patent No. 6,127,155—Issued October 3, 2000 (reaction mixture claims only) Stabilized Thermostable Nucleic Acid Polymerase Compositions Containing Non-Ionic Polymeric Detergents

Field of Use
The Licensed Field means the field of use consisting of products or processes for the measurement, observation or determination of a disease, disease state or genetic predisposition to a disease, by detecting, quantitating, distinguishing and/or monitoring nucleic acids in samples of material originating from a human being for the medical management for that human being, but excluding
—  human identity testing, and
—  the following human disease targets Hepatitis A Virus, Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, Human Papilloma Virus and Parvovirus B19; provided, however, that the said exclusions for the Human Papilloma Virus and Parvovirus B19 disease targets shall be limited to 3 years from the Effective Date after which time the Human Papilloma Virus and Parvovirus B19 disease targets shall be included within the Licensed Field subject to the royalty and other terms and conditions of this Agreement.

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: 372579

License Grant
This amendment updates the amendment date, territory and royalties.  The original agreement in non-exclusive.
License Property
The original license is for Licensed Real-Time Thermal Cycler shall mean an instrument, whether sold as an integrated product or as one or more components or modules, the manufacture, importation, offer for sale, sale or use of which would, but for the rights granted under this Agreement, infringe at least one Valid Claim of the Real-Time Apparatus Patent Rights.

Real-time PCR thermal cyclers/thermocyclers carry out quantitative PCR (qPCR) for experiments in gene expression, genetic variation, genotyping, and specific detection of rare targets, bacteria, and viruses.

Field of Use
The Fields shall mean research, and all applied fields, specifically including food testing. The term Fields does not include the Human In Vitro Diagnostic Field or veterinary in vitro diagnostic applications.

Product relates to Polymerase Chain Reaction (PCR) and instruments (thermal cycler) for performing PCR.
Polymerase chain reaction is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.

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: 273391

License Grant
Licensor hereby grants to Licensee, subject to all the terms and conditions of this Agreement, a worldwide, nonexclusive right and license (without the right to grant sublicenses) under the Patent Rights to (a) use, offer to sell, sell and practice Diagnostic Services in the Field; (b) make, have made, use, offer to sell, sell and import Licensed Reagents in the Field; and (c) make, have made, use, offer to sell, sell and import Kits in the Field. Notwithstanding the foregoing, Licensor hereby grants to Licensee the worldwide, non-exclusive right to convey to the end-user (purchaser) of FDA (U.S. Food and Drug Administration) Approved Kits manufactured by Licensee the right to perform Diagnostic Services solely in conjunction with the use of FDA Approved Kits manufactured by or on behalf of Licensee (without the right to grant sublicenses).
License Property
Patent Rights shall mean collectively the Gene Patent Rights and the Methodology Patent Rights.

Diagnostic Service(s) shall mean the performance of laboratory-based assays covered in whole or in part by a Valid Claim of the Patent Rights.

Gene Patent Rights shall mean the United States and foreign patents and patent applications relating to the APC (Adenomamus polyposis coli) gene and/or the p53 gene and licensed (with the right to grant sublicenses) to Licensor pursuant to the JHU (Johns Hopkins University) License Agreement together with patents arising therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent applications listed hereto (which may be updated from time to time to include such additional patents and patent application that may arise therefrom); provided, however, that Gene Patent Rights expressly excludes any claims of such patents and patent applications that fall outside of the Field, including, without limitation, claims to antibodies, to the treatment, prevention or remedying of a gene deficiency, to purified proteins, or to DNA (Deoxyribonucleic acid) sequences other than those sequences that correspond to the p53 gene and the APC (Adenomatous polyposis coli) gene; provided further that DNA sequences which are (i) immediately adjacent to the p53 or APC genes and (ii) necessary to the use of the p53 or APC genes, respectively, in the Field shall be considered within the Gene Patent Rights.

US Patent No.  5,352,775 – APC gene and nucleic acid probes derived therefrom
US Patent No.  5,527,676 – Detection of loss of the wild-type P53 gene and kits therefor

Methodology Patent Rights shall mean the United States and foreign patents and patent applications relating to methods of detecting mammalian nucleic acids isolated from stool specimens and reagents therefor and licensed (with the right to grant sublicenses) to Licensor pursuant to the JHU (Johns Hopkins University) License Agreement together with patents resulting therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent application listed hereto (which may be updated from time to time to include such additional patents and patent applications that may arise therefrom).

US Patent Application No. W093/20235 and 08/861,910 (detecting mammalian nucleic acids from stool)

Licensed Reagent shall mean any Reagent covered in whole or in part by a Valid Claim of the Patent Rights.

Kit shall mean a collection of one or more Reagents, including at least one Licensed Reagent, packaged in the form of a kit (including an FDA Approved kit).

Field of Use
Field shall mean (a) stool-based detection of any disease or condition (including pre-cancers, staging and monitoring of the foregoing, and therapeutic response) for research and development, Clinical Laboratory Improvement Amendments (CLIA) testing services (and their foreign equivalents), and FDA Approved Kits; and (b) a screening assay (regardless of other uses to which such assay is put) for colorectal cancer in any type of patient samples, excluding tests solely for staging and/or monitoring of colorectal cancer which do not obsolete or adversely impact such screening assay.

IPSCIO Record ID: 28487

License Grant
The Licensor granted the Licensee a non-exclusive license agreement for the use of the patent rights and technology as they relate to cervical and ovarian cancer.
License Property
The Company agreed to settle an arbitration proceeding instituted by anther party against the Company through the transfer to the other party of certain patents, patent applications and other intellectual property rights relating to the AcCell technology.

The AcCell product is a computer-aided automated microscopy instrument designed to help medical specialists examine and diagnose specimens of human cells.

U.S. Patent 6,535,626; 6,430,309; 6,285,498; 6,148,096; 6,151,161; 6,118,581; 6,091,842; 6,081,740; 5,999,844; 5,963,368; 5,930,732; 5,833,794; 5,690,892; 5,077,806; 5,073,857

Field of Use
Licensed Field shall mean the field of products designed, developed, tested, manufactured, distributed, marketed, approved, sold, provided, and/or used exclusively for the screening of cervical or ovarian cancer which require the incorporation of  a fluorescent probe as its primary probe,  or which may incorporate other fluorescent or non-fluorescent probes, and in which the assay itself (a procedure employing one or more reagents which determines the biological state of a clinical specimen comprised of cells or tissues) is primarily fluorescent.

Licensee have designed and manufactured the AcCell(TM) computer-aided automated microscopy instrument and the AcCell Savant(TM), an instrument that includes an AcCell instrument and software and which collects quantitative cellular information used in support of a diagnostic process.

Licensee is a life sciences company engaged in the design, development and commercialization of cost-effective screening systems to assist in the early detection of cancer.

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