Royalty Report: Diagnostic, Medical, Device – Collection: 287575

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

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. T2MR enables rapid 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”).

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 present Contract for the Transfer of Technology and Material calls for the scientific and technological co-operation between the Brazilian Licensee and the Licensor, for the production of the HIV ½ Stat-Pak.

License Property

The Licensor is a company having as its main purpose the production of lateral flow rapid diagnostic test kits including but not limited to Rapid test kit for HIV – HIV ½ Stat-Pak.

HIV 1/2 STAT-PAK® assay is a single use, immunochromatographic test used to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum and plasma specimens.

Field of Use

Rapid test kit for HIV ½ produced by the Licensee termed HIV ½Stat – Pak composed of tests based on immunochromatography and lateral low, adapted to rapid supports for use with serum, plasma or whole blood, sealed in individual laminated foil pouches containing also, lancets, transfer loops, band-aids and dessicants.

License Grant

Licensor grants a non-exclusive license, without the right to grant or authorize sublicenses, under the Licensed Patent Rights to develop and perform the Services solely at the Facilities, and to use, and offer for sale and sell the Services to Third Parties solely in the Territory.

License Property

Licensed Patent Rights shall mean, collectively, Licensors rights in all patent applications, including provisional patent applications, heretofore or hereafter filed in the Territory;  all patents that have issued or in the future issue in the Territory from any of such patent applications, including without limitation utility models, design patents and certificates of invention; and,  all divisionals, continuations, continuations-in-part, substitutions, reissues, renewals, extensions, restorations or additions to any such patent applications and patents, in each case that claim, and only to the extent they claim, compositions, uses, methods, equipment, devices and other technology for the use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women for prenatal diagnostic testing by whole genome massively parallel sequencing, used in the performance of the MaterniT21 PLUS Test by Licensors Laboratories as of the Effective Date, or any improvements to such test; provided, however, that the Licensed Patent Rights shall exclude any of the foregoing licensed by a University to Licensor under another agreement.

MatemiT21 PLUS Test shall mean the laboratory-developed test for the non-invasive testing of a plasma sample from a pregnant woman for the detection and diagnosis of prenatal aneuploidy and/or fetal abnormalities by use of cell-free fetal nucleic acids, currently known as the MatemiT21 PLUS test, as performed by Licensors Laboratories.

Field of Use

The Field shall mean the non-invasive detection and diagnosis of prenatal aneuploidy and fetal abnormalities by use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women.
The MaterniT® 21 PLUS test analyzes genetic information that enters your bloodstream from the placenta.  It analyzes the amount of chromosome 21 in fetal DNA picked up from the maternal blood sample. It can detect an increased amount of chromosome 21 material which is associated with trisomy 21 (Down syndrome). It is completely non-invasive as it only involves a blood sample from the mother.