Royalty Report: Diagnostic, Medical, Device – Collection: 266

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 17

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: 17

Primary Industries

  • Diagnostic
  • Medical
  • Device
  • Disease
  • Drugs
  • Biotechnology
  • Assay
  • Surgical
  • Bacterial Infection
  • HIV / AIDs
  • Diagnostic Substances
  • Test/Monitoring

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: 6962

License Grant
The Assignor hereby assigns, conveys and delivers to the Assignee, and the Assignee hereby acquires from the Assignor, all right, title and interest of the Assignor in and to the following; (i) certain inventions, formulae, manufacturing secrets, processes and know-how with respect to the manufacture of certain bio-medical products and (ii) certain intellectual property and inventions used in connection with said products.
Assignor hereby grants Assignee the right to use and display Assignor's trademarks, service marks, and trademarks and trade names that are applicable to Assignor Product(s) under this private labeling agreement. Assignee may use any of Assignor's Marks as part of its corporate, trade or other business name.
License Property
FDA 510K Cleared tests means that the following tests have been giving approval by the U.S. Food & Drug Administration to market the tests and testing device.

FDA 510K Numbers and Approved Tests
Device Name
510(K) Number

Rubella-Cube
K892051

CMV-Cube
K884842

Rotacube (Rotavirus)
K884017

Blue Dot Test for Pregnancy
K882588

First Sign (Pregnancy, HCG)
K973208

V-Trend Target IM Test (Infectious Mononucleosis)
K890041

Target Strep A
K880460

Target HCG Enzyme Immunoassay Reagents
K862247

Target ASO Test
K910073

Target HCG Test
K914303

Target HCG One-Step
K903937

V-Trend Target RF Test
K904105

Target Quantitative HCG
K890131

V-Trend Target CRP Test
K890423

Target Reader
K885254

510(K) Approved Platform Products
HCG Human chorionic gonadotropin (Pregnancy Test) Rapid enzyme immunoassay test for qualitative detection of HCG in urine, serum and plasma. HCG is a hormone produced by the developing placenta. Serum and urine levels of HCG climb rapidly, starting as soon as the week following implantation, reaching peak levels near the end of the first trimester. One-step technology offers superior speed and simplicity without sacrificing sensitive and specific results.

Strep A Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.

Rubella Rapid enzyme immunoassay test for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage to the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects. Therefore, all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.

CMV Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections pose a very significant risk in infants and immunocomprised patients.

Rotavirus Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenterics in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocmial infection.

Mono Qualitative and quantitative detection of heterophile antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient’s serum, usually 1 to3 weeks after the onset of symptoms Common symptoms include fatigue, pharyngitis, fever, lymphadenopatherapy and splenomegaly.

CRP C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if monitored on a daily basis. CRP is also predictive of clinical cardiovascular disease.

Reader The Target System Reader is designed to interpret selected membrane enzyme immunoassays. The instrument is designed for laboratory, emergency room or field use and requires only a few minutes to learn to operate. The reader permits more precise, accurate readings of test results than visual interpretation.

Field of Use
Field of Use means diagnostic testing for any disease or medical condition that can be transmitted by one human to another within the diagnostic health care industry, mobile and non-mobile, which industry focuses on providing healthcare and diagnostic solutions and services, but not limited to Hospitals, Emergency Medical Vehicle Care, Mobile Health Clinics, Schools, Government Agencies, retail drug stores, corporations, Hospices, Assisted Living and Nursing Homes, Home Health Care, and Physician’s offices. The Field of Use herewith does not include diagnostic or analytical testing within the Veterinary and Livestock, Environmental Testing or any military, law enforcement, bioterrorism or homeland security related industries.

IPSCIO Record ID: 266

License Grant
The Assignor hereby assigns, conveys and delivers to the Assignee, and the Assignee hereby acquires from the Assignor, all right, title and interest of the Assignor in and to the following; (i) certain inventions, formulae, manufacturing secrets, processes and know-how with respect to the manufacture of certain bio-medical products and (ii) certain intellectual property and inventions used in connection with said products.
License Property
FDA 510K Cleared tests means that the following tests have been giving approval by the U.S. Food & Drug Administration to market the tests and testing device.

FDA 510K Numbers & Approved Tests

Device Name

                                           510(K) Number

Rubella-Cube

                                                K892051

CMV-Cube

                                                K884842

Rotacube (Rotavirus)

                                K884017

Blue Dot Test for Pregnancy
                                
K882588

First Sign (Pregnancy, HCG)

                                K973208

V-Trend Target IM Test (Infectious Mononucleosis)
K890041

Target Strep A

                                                K880460

Target HCG Enzyme Immunoassay Reagents

K862247

Target ASO Test

                                                K910073

Target HCG Test

                                                K914303

Target HCG One-Step
                                  
K903937

V-Trend Target RF Test
                                
K904105

Target Quantitative HCG
                                  
K890131

V-Trend Target CRP Test
                                        
K890423

Target Reader

                                                K885254

510(K) Approved Platform Products
HCG Human chorionic gonadotropin (Pregnancy Test) Rapid enzyme immunoassay test for qualitative detection of HCG in urine, serum and plasma. HCG is a hormone produced by the developing placenta. Serum and urine levels of HCG climb rapidly, starting as soon as the week following implantation, reaching peak levels near the end of the first trimester. One-step technology offers superior speed and simplicity without sacrificing sensitive and specific results.

Strep A Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.

Rubella Rapid enzyme immunoassay test for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage to the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects. Therefore, all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.

CMV Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections a very significant risk in infants and immunocomprised patients.

Rotavirus Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenterics in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocmial infection.

Mono Qualitative and quantitative detection of heterophile antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient’s serum, usually 1 to3 weeks after the onset of symptoms Common symptoms include fatigue, pharyngitis, fever, lymphadenopatherapy and splenomegaly.

CRP C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if monitored on a daily basis. CRP is also predictive of clinical cardiovascular disease.

Reader The Target System Reader is designed to interpret selected membrane enzyme immunoassays. The instrument is designed for laboratory, emergency room or field use and requires only a few minutes to learn to operate. The reader permits more precise, accurate readings of test results than visual interpretation.

Field of Use
Field of Use is defined as Diagnostic testing for any disease or medical condition that can be transmitted by one human to another within the diagnostic health care industry, mobile and non-mobile. The Field of Use herewith does not include diagnostic or analytical testing within the Veterinary and Livestock, Environmental Testing or any military, law enforcement, bioterrorism or homeland security related industries.
Such testing to be done at the point of care, such point of care may include but are not limited to places such as

·
Hospitals

·
Emergency Medical Vehicle Care

·
Mobile Health Clinics

·
Schools

·
Government Agencies

·
Retail Drug Stores

·
Corporations

·
Hospices

·
Assisted Living and Nursing Homes

·
Home Health Care

·
Physician’s offices

IPSCIO Record ID: 6961

License Grant
The Licensor hereby assigns, conveys and delivers to the Licensee, and the Licensee hereby acquires from the Licensor, all right, title and interest of the Licensor in and to the following; (i) certain inventions, formulae, manufacturing secrets, processes and know-how with respect to the manufacture of certain bio-medical products and processes and (ii) certain intellectual property and inventions used in connection with said products. A true and correct copy of a list of the Patent Pending Applications and associated USPTO numbers afforded the Patent Pending Applications.

Licensor hereby grants Licensee the right to use and display Licensor's trademarks, service marks, and trademarks and trade names that are applicable to Licensor Product(s) under this private labeling agreement. Licensee may use any of Licensor's Marks as part of its corporate, trade or other business name.

License Property
Patent Pending Applications
1. U.S. Patent Application No. 11/924,033 Portable Apparatus for Improved Sample Analysis

2. U.S. Patent Application No. 11/856,925 Method for Determining the Immune Status of a Subject

3. U.S. Patent Application No. 11/221/038 Method of Identifying Drugs, Targeting Moieties or Diagnostics

4. U.S. Patent No. 11/221,252 Method of Producing a Plurality of Isolated Antibodies to a Plurality of Cognate Antigens

Field of Use
Field of Use is defined as Diagnostic testing for any disease or medical condition that can be transmitted by one human to another. The Field of Use herewith does not include diagnostic or analytical testing within the Veterinary and Livestock, Environmental Testing or any military, law enforcement, bioterrorism or homeland security related industries.
Such testing to be done at the point of care, such point of care may include but are not limited to places such as
·
Hospitals

·
Emergency Medical Vehicle Care

·
Mobile Health Clinics

·
Schools

·
Government Agencies

·
Retail Drug Stores

·
Corporations

·
Hospices

·
Assisted Living and Nursing Homes

·
Home Health Care

·
Physician’s offices

IPSCIO Record ID: 907

License Grant
Licensor hereby grants Licensee the right to use and display Licensor's trademarks, service marks, and trademarks and trade names that are applicable to Licensor Product(s) under this private labeling agreement. Licensee may use any of Licensor's Marks as part of its corporate, trade or other business name.

The Licensor hereby assigns, conveys and delivers to the Licensee, and the Licensee hereby acquires from the Licensor, all right, title and interest of the Licensor in and to the following; (i) certain inventions, formulae, manufacturing secrets, processes and know-how with respect to the manufacture of certain bio-medical products and processes and (ii) certain intellectual property and inventions used in connection with said products.  A true and correct copy of a list of the Patent Pending Applications and associated USPTO numbers afforded the Patent Pending Applications.

License Property
Licensor is the holder of four Patent Pending Applications which are part of this License Agreement in a defined Field of Use.

Licensee is a bio-medical, development, manufacturing and marketing company that will produce, brand, develop, manage and provide sales strategy for all aspects of a full marketing program to manufacture and sell all of Licensor's Intellectual Properties.

“Patents Pending” means U.S. Patent Application No. 11/924,033 (“Portable Apparatus for Improved Sample Analysis”), No. 11/856,925 (“Method for Determining the Immune Status of a Subject”), No. 11/221,252 (“Method of Producing a Plurality of Isolated Antibodies to a Plurality of Cognate Antigens”), No. 11/221/ 038 (“Method of Identifying drugs, targeting moieties or Diagnostics”).

Field of Use
Field of Use means diagnostic testing for any disease or medical condition that can be transmitted by one human to another within the diagnostic health care industry, mobile and non-mobile, which industry focuses on providing healthcare and diagnostic solutions and services, but not limited to Hospitals, Emergency Medical Vehicle Care, Mobile Health Clinics, Schools, Government Agencies, retail drug stores and corporations.

The Field of Use herewith does not include diagnostic or analytical testing within the Veterinary and Livestock, Environmental Testing or any military, law enforcement, bioterrorism or homeland security related industries.

Such testing to be done at the point of care, such point of care may include but are not limited to places such as
  Â· Hospitals
  Â· Emergency Medical Vehicle Care
  Â· Mobile Health Clinics
  Â· Schools
  Â· Government Agencies
  Â· Retail Drug Stores
  Â· Corporations
  Â· Hospices
  Â· Assisted Living and Nursing Homes
  Â· Home Health Care
  Â· Physician’s offices

IPSCIO Record ID: 322230

License Grant
Under the terms of the worldwide licensing agreement with the Licensor, the Licensee will adapt the coronavirus test to run on its T2Dx Instrument.
License Property
T2Dx Instrument has the ability to rapidly identify COVID-19.

The COVID-19 molecular diagnostic test is designed to detect the presence of the SARS-CoV-2 virus in a nasopharyngeal swab sample.

Coronavirus disease (COVID-19) is an infectious disease caused by a coronavirus (called SARS-CoV-2), a contagious respiratory illness.

Field of Use
The field of use is for the detection of the SARS-CoV-2 virus.

SARS-CoV-2 virus is a coronavirus that causes a contagious respiratory illness.

Licensee is a diagnostics company that develops innovative and proprietary technology platforms that target treatments for early detection of a variety of diseases including COVID-19 (SARS-CoV-2 virus).

IPSCIO Record ID: 2634

License Grant
The Licensor hereby grant to Licensee and its Affiliates an irrevocable license, without the right to sublicense, to make, use, sell, offer to sell, and/or import, products utilizing or incorporating the inventions claimed in the valid and enforceable claims of the Licensor's Portfolio of Lateral Flow Patents, including continuations, continuations in part and divisionals thereof.
License Property
The settlement agreement provides for a license to the Licensee of all current and future patents of the Licensor and its affiliates which embody lateral flow technology for all diagnostic products other than for cardiology testing and for consumer/over-the-counter women's health (except that diagnostics for women's infectious diseases are within the licensed field of use).

The suit was filed in the U.S. District Court, Southern District of California alleged infringement of our U.S. Patent No. 4,943,522.

Lateral flow test devices include our tests for pregnancy, strep, H pylori, and Chlamydia.

Field of Use
The Licensor is a leading global developer of advanced diagnostic devices and is presently exploring new opportunities for its proprietary electrochemical and other technologies in a variety of professional diagnostic and consumer-oriented applications including immuno-diagnostics with a focus on women's health, cardiology and infectious disease.

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: 382626

License Grant
Licensor grants Swiss Licensee to sell Licensor woman’s licensed diagnostic product VS-Sense in Mexico.
License Property
VS-Sense is a vaginal health diagnostic medical device.

The VS-SENSEâ„¢ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms to rule out or rule in Bacterial Vaginosis and Trichomoniasis. The test indicates by color change whether a vaginal secretion has disordered acidity parameters. Results are based on combined indication of pH level and buffer capacity (watery secretion) which characterizes Bacterial Vaginosis and Trichomoniasis.

The VS-SENSEâ„¢ Test indicates abnormal vaginal discharge acidity by identifying changes in the pH level. The test cutoff is set at pH 4.7 (+0.3/-0.2 pH units; there may be variations due to sensitivity to buffer capacity). When the vaginal secretion has a pH above this cutoff, the test tip will be stained (or partially stained) green or blue. The test, when combined with clinical examination, assists the physician in diagnosing conditions which are associated with elevated pH levels.

Field of Use
The licensed product is used for diagnosing vaginal health in women.

IPSCIO Record ID: 300607

License Grant
The Company has the rights to use certain raw materials in the manufacture of Vitamin D diagnostic tests.
License Property
Vitamin D diagnostic tests are for reagents that are used in its FastPack Vitamin D Assay.

The FastPack System is for the treatment of cancer and infectious diseases using nanoparticle coating technology similar to the core nanoparticle coating technology.

The FastPack System is a proprietary diagnostics platform launched in 2001. This novel, rapid and highly accurate immunoassay testing system consists of the FastPack Analyzer and the FastPack test pouch; a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Since the initial conception of the system, the Company has developed two versions of its analyzer and test pouch (1.0 and IP) and has expanded its assay menu to 10, including tests for prostate cancer, thyroid function, metabolic disorders and research applications.

Field of Use
FastPack® IP Vitamin D Immunoassay
Vitamin D, known as the sunshine vitamin, is part of a group of fat-soluble prohormones which encourage the metabolism of calcium and phosphorus in the body. Increasing research is now uncovering evidence illustrating the importance of vitamin D in the protection against a whole host of health issues. It is also estimated that as much as half the population in the world is deficient in vitamin D. The FastPack® IP Vitamin D immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. This assay is designed for use with the FastPack® IP System which is designed specifically for use in the practice laboratory setting.

IPSCIO Record ID: 297544

License Grant
The parties agree to amend and extend the Original LOI and agree to replace the Original LOI in its entirety by this Letter of Intent (“LOI”), which LOI shall supersede and replace the Original LOI in its entirety relating to a potential worldwide license between Licensor and Licensee relating to  the FastPack 2.0 System.

Licensor shall grant to Licensee  and its affiliates an exclusive (including with respect to Licensor), all-fields, worldwide, assignable license, including the rights to sublicense through multiple tiers of sublicense, under all Licensor FastPack 2.0 Patent Rights and Licensor Know-How (except for Licensor intellectual property that pertains to FastPack “1.0”/IP as well as to the FastPack 2.0 System). Licensor FastPack 2.0 Patent Rights include without limitation the patents and pending patent applications listed and any patent or patent application claiming priority thereto; and an exclusive (including with respect to Licensor), worldwide, assignable license, including the rights to sublicense through multiple tiers of sublicense, under all Licensor Patent Rights and Licensor Know-How not included in the license grant described in this Agreement, limited to the field of use consisting of developing, making, having made, using, manufacturing, offering for sale, selling, having sold, exporting and importing all products (Licensed Products) related to the FastPack 2.0 System.

License Property
FastPack 2.0 System is a certain point of care, rapid quantitative immunoassay analyzer, as well as all associated intellectual property and technology, including, but not limited to, any assays, plasma separation devices, dispensers, and pouches related thereto.  Vitamin D assays are included in the FastPack 2.0 analyzer.

The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescent technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button.

Field of Use
The FastPack IP System is a state of the art, near-patient blood analyzer that provides quantitative immunoassay results, at the push of a button, for important biomarkers in the areas of cancer, metabolic disorders, hormone regulation and pregnancy management.

The FastPack® IP System is an established, point of care immunoassay system designed to enable physician office laboratories (POLs) to offer key quantitative test results where there is immediate clinical value. The test menu includes Vitamin D, Testosterone, TSH, Free T4, PSA, and hCG.

IPSCIO Record ID: 203464

License Grant
The Licensor of England grants to the Licensee a non-exclusive license under the Patent Rights in the Territory to make, use and sell Licensed Products.

Licensor grants to the Licensee a non-exclusive option to a license to make, use and sell Products Under Option. This option may be exercised on a per analyte basis at any time within the two (2) year period subsequent to the Effective Date of the Agreement, whereupon it will cease on a per analyte basis.

License Property
Licensed Product shall mean any device for qualitative or quantitative detection of the analytes Fetal Fibronectin, and, Interleukin 6 for Group B Strep and Chlamydia.

Products Under Option shall mean any device for qualitative or quantitative detection of the analytes Fetal Fibronectin, and, Interleukin 6 for Group B Strep and Chlamydia.

Fetal fibronectin (fFN) is a fibronectin protein produced by fetal cells. It is found at the interface of the chorion and the decidua (between the fetal sac and the uterine lining). It can be thought of as an adhesive or 'biological glue' that binds the fetal sac to the uterine lining.

Field of Use
Fetal fibronectin (fFN) is used to test pregnant women who are between 22 weeks and 35 weeks of gestation and are having symptoms of premature labor. The test helps predict the likelihood of premature delivery. Many pregnant women experience symptoms that suggest preterm labor.

Licensee designs, develops, manufactures and markets innovative products for women’s health, with focus on reproductive healthcare, using proprietary technologies to predict preterm birth and assess infertility.

IPSCIO Record ID: 306253

License Grant
University grants Licensee (a) an exclusive, non-transferable license, limited to the Territory and the Field, with the right to sublicense, under the Patent Rights to make, have made, use, sell, offer for sale and import Licensed Products; and (b) a non-exclusive, non-transferable license, limited to the Territory and the Field, to use the Technical Information to develop, manufacture and sell Licensed Products.
License Property
Invention PadLock-RCA-Nuclease Protection Lateral Flow Assay (PLAN-LFA) for the Detection of Pathogen Sequences at the Point of Care, known as University Technology # 2020-070 (including the RNA sequence of the same).

Licensed Product(s) means any product, process, or service (a) that is covered by the Patent Rights, infringes the Patent Rights, or would infringe the Patent Rights (but for a valid statutory exception in the U.S. or other countries); (b) the development, manufacture, use, sale or importation of which is, incorporates, uses, or is derived from, any Technical Information; or (c) meeting the qualifications of both (a) and (b).

Patent Rights US Provisional Application No. 62/989,592 “Padlock Probe-Based Rolling Circle Amplification Paired with Nuclease Protection for Point of Need Nucleic Acid Detection”

Field of Use
The field of use relating to this diagnostic device is used for the detection of Pathogen Sequences (infectious diseases) at the Point of Care.  These pathogens or biomarkers can occur in humans or animals, or contaminants in water supplies, foodstuffs, or animal feeds. In public health, sequence data are used to reconstruct the evolution of pathogens, to anticipate future spread, and to target interventions. Such sequence data are increasingly being used to track the spread of pathogens and to predict their phenotypic properties. Both applications have great potential to inform public health and treatment decisions if sequence data can be obtained and analyzed rapidly.

Pathogenic bacteria is a disease-causing bacteria. Pathogenic bacteria can contribute to many worldwide diseases, including tuberculosis, cholera, anthrax, leprosy, the bubonic plague, pneumonia, and food-borne illnesses. The most common fatal bacterial infectious diseases are respiratory infections.

The license certain intellectual property will allow Licensee to develop a device to detect virulent viral pathogens such as HIV, hepatitis C, dengue, Zika and severe acute respiratory syndrome coronavirus 2 (“SARS-Cov-2”), responsible for COVID-19.

Licensee has a technology platform that measures the signature of infectious bacteria, enabling real-time and rapid response in medical, veterinary, pharmaceutical and aquatic applications.

IPSCIO Record ID: 26919

License Grant
The Company has taken a license to two U.S. patents, which expire in the financial years 2004 and 2014 respectively, covering the format of Uni-Gold(TM) rapid test device i.e. the visual result given by its one step strip test.
License Property
The Company 's Uni-Gold one step assays detect antibodies to various infectious diseases and conditions in serum and plasma or whole blood based on the principle of an immuno-chromatographic assay.  The Company currently markets four products based on this technology, Uni-Gold HIV, Uni-Gold Hepatitis B, Uni-Gold hCG (pregnancy) and Uni-Gold H. pylori.

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: 3949

License Grant
We invested money into a newly formed 50/50 joint venture with another party, to bring to fruition R&D for innovative Point-of-care diagnostic tests.
License Property
The joint venture products will be focused on proprietary lateral flow and optics technologies (whereby a sample of saliva, urine, or whole blood moves across a solid platform to interact with a reagent to produce colorimetric or other changes that can be measured qualitatively or quantitatively) and Point-of-Care delivery of data through novel and inexpensive readers.
Field of Use
We intend to use lateral flow and optics intellectual property for the joint development of point of care diagnostic products for human, forensic and veterinary use.

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: 324150

License Grant
The parties terminated the agreement that provided certain patent rights and technologies related to the FISH product line.
License Property
The FISH product line includes QuickFISH and PNA FISH diagnostic test products.

QuickFISH provides rapid and accurate identification of critical bloodstream infections 1-3 days earlier than conventional identification methods. With QuickFISH, results are available within 30 minutes from the positive blood culture, enabling clinicians to optimize antibiotic therapy sooner. QuickFISH enables de-escalation of broad spectrum antimicrobials (e.g. vancomycin) for patients with contaminated blood cultures. QuickFISH products are a suite of FDA -cleared and CE-marked diagnostics for rapid molecular testing of positive blood cultures designed to assure appropriate antibiotic therapy.

PNA FISH® tests are for rapid identification of bacteria and yeast directly from positive blood cultures. These tests cover pathogens responsible for the majority of bloodstream infections. PNA is a synthetic Peptide Nucleic Acid made up of oligonucleotide bases with a peptide backbone. The PNA probe is fluorescently labeled and binds to species-specific 16S ribosomal RNA.

Field of Use
The field of use is for the testing of infections. This allows microbiologists to rapidly differentiate Stapylococcus aureus from coagulase-negative staphylococci.
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