Royalty Report: Medical, Device, Diagnostic – Collection: 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

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

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

Licensor grants to Licensee and its Affiliates a limited non-exclusive, personal and non-transferable, right and subLicense under the Licensed Patents, to make, have made for its own use and sale, use, offer to sell, sell and import product within the field and within the territory, and to practice the methods claimed in the Licensed Patents in connection with such product, and to extend to its customers purchasing product the right to use and sell the product purchased and to practice the methods claimed in the Licensed Patents in connection with such product.

License Property

Licensed Patent shall mean United States Patent Nos. 5,073,484, 5,654,162 and 6,020,147 and any patents resulting from a re-examination or reissue from any of the foregoing patents.

The patents are for a device for detecting the presence of an analyte in a carrier liquid suspected of containing said analyte, which device comprises a liquid permeable solid medium which defines a path for fluid flow capable of supporting capillary flow, along which are a site for application of the carrier liquid, a diffusively bound labeled reactant specific for the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety, said labeled reactant being capable of flow along the flow path, wherein said diffusively bound labeled reactant and said analyte or chemical moiety are of a specific ligand-anti ligand pair, and one or more zones spaced along said flow path, each zone having a predetermined amount of a reactant bound to it which is specific for either the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety.

Wherein said device can be used by contacting a carrier liquid with said application site in such a manner that permits said liquid to pass along the flow path by capillary flow such that analyte or reaction product of the analyte with another chemical moiety becomes bound to both the labeled reactant and the reactant bound to the solid medium;  and wherein the labeled reactant, with the reactant bound to the solid medium, sandwiches the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety.

Lateral flow tests also known as lateral flow immunochromatographic assays, are simple devices intended to detect the presence (or absence) of a target analyte in sample (matrix) without the need for specialized and costly equipment, though many lab based applications exist that are supported by reading equipment.[2] Typically, these tests are used for medical diagnostics either for home testing, point of care testing, or laboratory use.