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

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.

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

License Grant

An undisclosed third party granted the Company an exclusive, worldwide, sublicenseable license under certain patent rights to make, use, import and commercialize products and processes for diagnostic, industrial and research and development purposes.

License Property

The products and processes for diagnostic, industrial and research and development purposes target the detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum, cerebral spinal fluid and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter (“CFU/mL”) and target sepsis and Lyme disease.

Field of Use

This agreement pertains to the medical industry.  

The Company is an in vitro diagnostics company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. The Company is using its T2 Magnetic Resonance technology (“T2MR”) to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.