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

License Grant

Assignee re-grants the Assignor certain rights in and to the IP by a License Agreement and Royalty Agreement.

Licensee grants to Licensor an exclusive perpetual license of the IP

(a)
to make, use, and practice the IP for research, clinical, teaching, or other non-commercial purposes, but not for purposes of commercial development, use, manufacture, or distribution of any product in the field of the detection of microbial pathogens other than as authorized with the written consent of Licensee; and

(b)
to make, use, and practice the IP for research, clinical, teaching, or other non-commercial purposes as well as for any commercial purposes including but not limited to commercial development, use, manufacture, or distribution of any product in any field save and except for the field of the detection of microbial pathogens. Licensor covenants not to use the IP for all of the licensed IP rights granted to Licensor.

License Property

The Technology A portable instrument and associated software for measuring fluorescence resonance energy transfer (FRET) between pairs of fluorophores. The instrument, software, and methods developed can be used to measure FRET between any fluorophore pair and can make simultaneous measurements of multiple fluorophore pairs. The present instrument, software, and methods have been developed specifically for measurement of BAI-2 concentrations with single proteins containing FRET pairs and a BAI-2 binding domain. BAI-2 is a quorum-sensing molecule synthesized by bacterial pathogens. By measuring BAI-2, the instrument provides a method for detection of pathogenic bacteria and has applications in several industries including healthcare (the said invented portable instrument and associated software are, collectively, the Technology).

Fluorescence Resonance Energy Transfer or “FRET” is a physical phenomenon that is increasingly being used in biomedical research and drug discovery. It is the distance-dependent transfer of energy from one fluorescent molecule (the donor) to another fluorescent molecule (the acceptor). The transfer of energy leads to a reduction in the donor’s fluorescence intensity and an increase in the acceptor’s emission intensity. Due to its sensitivity to distance, FRET has been used to investigate molecular interactions.

Product means a device for detecting bacteria in bio-samples whereby such device is produced using any of the IP.

Field of Use

The instrument provides a method for detection of pathogenic bacteria and has applications in several industries including healthcare.

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

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.

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).

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

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Assisted Living and Nursing Homes

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Home Health Care

·
Physician’s offices

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.