Royalty Report: Medical, Assay, Test/Monitoring – Collection: 294486

Licensee shall have the exclusive right to make or have made, use, have used, sell and have sold the affected System and Components designed specifically for the System for use with Oasis LabCard chips in the Field.

For the duration of the Development Phase for each Program, each Party is granted a license under the Intellectual Property Rights of the other Party to use Systems and Components to the extent reasonably necessary to satisfy its obligations under this Agreement.

For the duration of the Commercialization Phase for each Program, each Party is granted a license under the Intellectual Property Rights of the other Party to use Systems and the individual Components incorporated into such Systems to the extent reasonably necessary to exercise its rights and satisfy its obligations under this Agreement.

LOCI shall mean the technology owned or licensed by Licensor relating to luminescent oxygen channeling assays and described in U.S. Patent application Serial No. 704,569, filed May 22, 1991 and U.S. Patent application Serial No. 718,490 filed June 20, 1991.

Oasis LabCard chips shall mean any microfluidic analytical device that has one or more small reaction vessels~connected to and over a capillary channel, which is in turn connected to a source of replenishing liquid, and that does not require the use of electrical fields to facilitate the movement of fluids through the capillary channel.

For the duration of the Commercialization Phase for each Program, Licensee is granted a license under the Intellectual Property Rights of Licensor to the extent reasonably necessary to commercialize the Systems as contemplated above and to manufacture capillary pin dispensers.

Licensee shall have the exclusive right to make or have made, use, have used, sell and have sold the affected System and Components designed specifically for the System for use with Oasis LabCard chips in the Field.

For the duration of the Development Phase for each Program, each Party is granted a license under the Intellectual Property Rights of the other Party to use Systems and Components to the extent reasonably necessary to satisfy its obligations under this Agreement.

For the duration of the Commercialization Phase for each Program, each Party is granted a license under the Intellectual Property Rights of the other Party to use Systems and the individual Components incorporated into such Systems to the extent reasonably necessary to exercise its rights and satisfy its obligations under this Agreement.

LOCI shall mean the technology owned or licensed by Licensee relating to luminescent oxygen channeling assays and described in U.S. Patent application Serial No. 704,569, filed May 22, 1991 and U.S. Patent application Serial No. 718,490 filed June 20, 1991.

Oasis LabCard chips shall mean any microfluidic analytical device that has one or more small reaction vessels~connected to and over a capillary channel, which is in turn connected to a source of replenishing liquid, and that does not require the use of electrical fields to facilitate the movement of fluids through the capillary channel.

Oasis LabCard chips are for small volume homogeneous assays in both genomics and pharmaceutical drug screening applications. Oasis LabCard chips will be similar in size and format to existing microwell plates.

Licensor grants a worldwide, excluding the right to make and use non-polymeric Chips with less than sixteen electrophoretic channels in Japan, non-exclusive limited license under all of its right, title and interest in, to and under the Ramsey Patent Family solely to make and use microfluidic Chips which fall outside of  the definition of Licensee LabCards, but which Chips would meet that definition but for the fact that they  are not constructed from a polymer or any other material that is not silica based, Licensee R&D Chips, solely for the purpose of research and development of products and technologies to be commercialized by Licensee itself, or in conjunction with others, but excluding any research and development performed on behalf of, or for the benefit of, other parties, including as part of a service business or contract research and development business.

The Ramsey Patent Family shall mean, to the extent of Licensors rights under to, and under the following, United States Patent No. 6,001,229;  any  Patent that directly claims priority to the 229 Patent, e.g., as a continuation, in-whole or in-part, divisional,  reexamination, or reissue of the 229 Patent; and any Patent that directly or indirectly claims priority to the 229 Patent, e.g., any Patent claiming priority to one or more Patents that directly or indirectly claim priority to the 229 Patent, and any Foreign Counterparts to any of the foregoing. The Ramsey Patent Family shall include, without limitation, United States Patent No. 6,001,229, 5,858,195, 6,010,607, 6,010,608 and 6,033,546 and any continuations, in whole or in part, divisions, reissues, reexamination, renewals, substitutions,  confirmations, registrations, revalidations, revisions, extensions and Foreign Counterparts of any of the foregoing Patents. For clarification, a Patent shall be deemed a Patent in the Ramsey Patent Family only to the extent and only so long as Licensor has rights to sublicense rights in, to and under the Ramsey Patent Family with respect to such Patent.

Licensee Licensed Product shall mean an Licensee Licensed Instrument and/or an Licensee Licensed LabCard, as applicable.

Licensee Licensed Instrument shall mean an instrument, add-on module, software or hardware including those specifically identified in the agreement, but excluding, in any event, any microfluidic Chip, (a) the manufacture, use, in the manner intended, or sale of which, by Licensee or any third party, would infringe a Valid Claim of a Patent in the Ramsey Patent Family in the country of such manufacture, use or sale, absent a license, or (b) that is designed or used, in the manner intended, by Licensee or any third party, to perform a method that would infringe a Valid Claim of a Patent in the Ramsey Patent Family in the country where such method is performed, absent a license.

Licensee Licensed LabCard shall mean a microfluidic chip or card, regardless of its size or thickness (Chip), constructed from a polymer or any other material that is not silica based, regardless of weather such Chip contains a Double T Structure or a Cross Structure or has covered or uncovered channels including but not limited to the types of Chips illustrated, (a) the manufacture, use, in the manner intended, or sale of which, by Licensee or any third party, would infringe a Valid Claim of a Patent in the Ramsey Patent Family in the country of such manufacture, use or sale, absent a license, or (b) that is designed or used, in the manner intended,  by Licensee or any third party, to perform a method that would infringe a Valid Claim of a Patent in the Ramsey Patent Family in the country where such method is performed, absent a license.

The Parties have agreed to settle all patent litigation and cross-license their microfluidic lab-on-a-chip systems. The devices are used to speed sampling in bioanalysis and genomic and pharmaceutical research.

Licensor's LabChip technology enables experiments that ordinarily require laboratories full of equipment and people to be conducted on a chip small enough to fit in the palm of a child's hand. The chip contains a network of microscopic channels that move fluids and chemicals electrostatically in order to perform experiments.

VIDAS Instrumentation shall mean, collectively, the Licensee instrument system currently known as the VIDAS system and the Licensee instrument system currently known as the mini-VIDAS system, as such systems existed on the date of the VIDAS Agreement and as hereafter modified or supplemented by additional instrumentation or devices as required to accommodate VIDAS Products, each of which modified and/or supplemented systems shall consist of instrumentation which is generally sold for processing and interpreting both Probe Assays and immunoassays, excluding, in any event, all VIDAS Products to be run on such instrumentation, provided, however, that such term may include a Probe Assay-only VIDAS system that Licensee may elect to develop at its expense, and provided, further, such modified and/or supplemented Probe Assay-only instrumentation system shall
–  be semi-automated, meaning it does not accept the sample container itself and performs all steps needed to produce the tests results.
–  use as its test format (i) a multi-well plastic cassette, currently referred to as a VIDAS strip which contains pre-dispensed reagents, tests for analytes and controls which is manually loaded into and resident in individual incubation and processing slots, and (ii) a pipette tip, currently referred to as an SPA, containing immobilized capture ligands; and
–   accommodate, on any single unit capable of stand-alone operation of such modified and/or supplemented instrument system, no more than thirty (30) test cassettes at one time.

VIDAS Products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor in this Agreement and solely and exclusively for use on VIDAS Instrumentation
–   VIDAS Initial Products, which shall mean, collectively, Probe Assays for the detection of Chlamydia trachomatis (VIDAS Probe CT); Probe Assays for the detection of Neisseria gonorrhoeae (VIDAS Probe GC), Probe
Assays for the detection of Neisseria gonorrhoeae and/or Chlamydia trachomatis in combination VIDAS CT/GC Screen and Probe Assays for the detection of Mycobacterium tuberculosis (VIDAS Probe MTB)
–   VIDAS QHIV Product, means the Probe Assay for the quantitative detection of human immunodeficiency virus which has been the subject of joint Parties development efforts prior to the Effective Date. IF Licensee elects to develop an alternative QHIV probe assay for the VIDAS Instrumentation and a new regulatory submission is required for such assay, then (i) if Licensee ceases to market the original VIDAS QHIV Product and markets only the alternative QHIV probe assay, such alternative QHIV probe assay shall thereafter be prospectively considered to be the VIDAS QHIV Product for purposes of this Agreement, but (ii) if Licensee continues to market the original VIDAS QHIV Product and also markets the alternative QHIV probe assay, such alternative QHIV probe assay shall be considered to be a VIDAS Future Infectious Disease Product for purposes of this Agreement.
–  VIDAS HLA Product, which shall mean Probe Assays for the detection and quantification of sequences encoding·human leukocyte antigens;
–  VIDAS Food Testing Products, which shall mean Probe Assays for the detection of microorganisms in any and all materials associated with the production (including quality control) of foodstuffs or beverages, including water, intended for human or animal consumption.
–  VIDAS Future Infectious Disease Products, which shall mean Probe Assays, other than the VIDAS Initial Products and VIDAS QHIV Product, for detection, identification, quantification of, and/or susceptibility testing for 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.
–  VIDAS Other Future Products, which shall mean any Probe Assays which are directed at one or more Option Targets selected by Licensee.

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.

Probe Assay shall mean an Assay using a nucleic acid as a necessary and active reagent or which detects a set of nucleic acid sequences or a specific nucleic acid sequence, as a means of obtaining useful information relevant to the sample being assayed.

Key Biochemistry Components or KBCs shall mean (a) the lysing tubes, enzymes, nucleic acids and other biochemical compounds and reagents.  Key Biochemistry Components are
–  All enzymes used in transcription-based amplification, including TMA and variations and improvements to TMA, for use in VIDAS Assays.
–  All biochemical components used for amplification of amplicon of target with TMA.
–  All probes, primers, and oligonucleotides used in VIDAS Assays.
–  Nucleic acids used for positive and negative controls, standards, calibrators, and for quality control of VIDAS Assay components and VIDAS kits.

Licensee and its Affiliates maintain and operate a worldwide network of semi-automated instruments known as VIDAS and mini-VIDAS for the diagnosis of infectious disease and other indications.

VIDAS Field shall mean
–  the detection, identification, quantification, and/or susceptibility testing of 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 antigen;
–  testing for microorganisms in any and all materials associated with the production, including quality control, of foodstuffs or beverages, including water, intended for human or animal consumption;
–  testing for any analyte listed and selected by Licensee, as present in a clinical sample from the human body, solely for the purpose of diagnosis and medical care of the person from whom the tested sample was taken.

The VIDAS 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.

The target markers are
–  Cancer Markers
1. Prostase,
2. Mammaglobin,
3. Kras,
4. p53,
5. Cancer related mutations of the mitoch9ndrial RNA in the D-Loop regulatory region, the NADH (nicotinamide adenine dinucleotide) region, and the dehydrogenase subunit 4.
–  Cardiac Markers
6. Factor II (Prothrombiri) mutation (20210)
7. Factor V Leiden mGtation
–  Alzheimer Markers
8. ApoE
9. presenilin,
–  Sepsis Markers
10. Sepsis specific cytokine.