Description
Created On: 2020-07-15
Record Count: 11
Primary Industries
- Diagnostic
- Medical
- Device
- Drugs
- Biotechnology
- Disease
- Assay
- Surgical
- Diagnostic Substances
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
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.
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.
IPSCIO Record ID: 266
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.
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
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.
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
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
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.
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 Pendingâ€: means U.S. Patent Application No. 11/924,033 (“Portable Apparatus for Improved Sample Analysisâ€), No. 11/856,925 (“Method for Determining the Immune Status of a Subjectâ€), No. 11/221,252 (“Method of Producing a Plurality of Isolated Antibodies to a Plurality of Cognate Antigensâ€), No. 11/221/ 038 (“Method of Identifying drugs, targeting moieties or Diagnosticsâ€).
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: 28762
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.
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.
The use is the worldwide professional and OTC human in vitro clinical diagnostic markets.
IPSCIO Record ID: 300607
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.
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: 2634
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.
IPSCIO Record ID: 203464
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.
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.
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: 297544
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 “1.0â€/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.
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.
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: 26919
IPSCIO Record ID: 28713
The Company entered into a definitive Agreement pursuant to which the Licensor agreed to assign its ownership of 11 patents to the Company which protect the Licensor's infectious disease diagnostic test kit technology. The Licensor also granted the Company a License to utilize 18 additional patents related to the diagnostic test kits.
#5,981,210 Method for determining a presence or absence of a nonparaffinophilic hydrophobic microorganism in a body specimen by using a DNA extraction procedure and a novel DNA extraction procedure
#5,935,806 Method and apparatus for speciating and identifying MAI (Mycobacterium Avium Intracellulare) and testing the same for antibiotic sensitivity
#5,882,920 Apparatus for determining the presence or absence of a paraffinophilic microorganism
#5,854,014 Apparatus for testing paraffinophilic microorganisms for antimicrobial sensitivity
#5,846,760 Method for determining a presence or absence of a nonparaffinophilic hydrophobic microorganism in a body specimen and an associated kit
#5,776,722 Method of testing a body specimen taken from a patient for the presence or absence of a microorganism a further associated method and associated apparatus
#5,569,592 Apparatus for testing MAI (Mycobacterium Avium Intracellulare) for antimicrobial agent sensitivity
#5,472,877 Apparatus for determining the presence or absence of MAI (Mycobacterium Avium Intracellulare)
#5,316,918 Method and apparatus for testing MAI (Mycobacterium Avium Intracellulare) for antimicrobial agent sensitivity
#5,153,119 Method for speciating and identifying MAI (Mycobacterium Avium Intracellulare)
Realm of Use or Assignor’s Use with regard to the Assignor’s use of the Assigned Patents means the Assigned Patents and use of the technology and intellectual property associated with the Assigned Patents for all uses, including but not limited to (a) hydrogen production applications (b) augmenting growth of microorganisms to collect any microbial by-products, including but not limited to hydrogen, antibiotics, or any chemical synthesis (c) bioremediation (d) apoptosis (e) nanotechnology, (f) biomems for all uses, including but not limited to medical uses, (g) microfluidic devices for all uses, including but not limited to medical uses, and (h) identification and detection of over 32 different paraffin-eating and non-paraffin-eating microorganisms, other than for the identification of Atypical Mycobacteria, Tuberculosis, Mycobacterium Avium Intracellulare (MAI), Mycobacteria, Paratuberculosis, Nocardia and Pseudomonas for disease diagnosis (unless associated with biomems, microfluidic devices, or nanotechnology), (i) testing for antimicrobial agent sensitivity of microorganisms including but not limited to using such technology for controlling growth of undesirable microorganisms in a bioreactor and using such technology to test the efficacy of antibiotic compounds or other compounds which may be collected as by-products from using the Assigned Patents to identify and grow microorganisms, (j) any industrial use whatsoever; but excludes using the Assigned Patents and associated technology and intellectual property for (1) the detection and identification of human and veterinary identification of Atypical Mycobacteria, Tuberculosis, Mycobacterium Avium Intracellulare (MAI), Mycobacteria, Paratuberculosis, Nocardia and Pseudomonas for disease identification test kits (unless associated with biomems, microfluidic devices, or nanotechnology) and (2) selling test kits or providing diagnostic services in the field of health for determining the antimicrobial agent sensitivity of microorganisms to ascertain which antibiotics are efficacious against microorganisms in the field of health (unless associated with biomems, microfluidic devices, or nanotechnology). Whereas the Field of Use and the Realm of Use both provide for certain uses within the area of health, the Assignee, with regard to the Assigned Patents and all technology and intellectual property associated with the Assigned Patents is limited to only the uses within the areas of health that are specified in the Field of Use.