Royalty Report: Diagnostic, Medical, Device – Collection: 6962

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

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 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 Company has the rights to use certain raw materials in the manufacture of Vitamin D diagnostic tests.

License Property

Vitamin D diagnostic tests are for reagents that are used in its FastPack Vitamin D Assay.

The FastPack System is for the treatment of cancer and infectious diseases using nanoparticle coating technology similar to the core nanoparticle coating technology.

The FastPack System is a proprietary diagnostics platform launched in 2001. This novel, rapid and highly accurate immunoassay testing system consists of the FastPack Analyzer and the FastPack test pouch; a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Since the initial conception of the system, the Company has developed two versions of its analyzer and test pouch (1.0 and IP) and has expanded its assay menu to 10, including tests for prostate cancer, thyroid function, metabolic disorders and research applications.

Field of Use

FastPack® IP Vitamin D Immunoassay
Vitamin D, known as the sunshine vitamin, is part of a group of fat-soluble prohormones which encourage the metabolism of calcium and phosphorus in the body. Increasing research is now uncovering evidence illustrating the importance of vitamin D in the protection against a whole host of health issues. It is also estimated that as much as half the population in the world is deficient in vitamin D. The FastPack® IP Vitamin D immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. This assay is designed for use with the FastPack® IP System which is designed specifically for use in the practice laboratory setting.

License Grant

The Licensor hereby grant to Licensee and its Affiliates an irrevocable license, without the right to sublicense, to make, use, sell, offer to sell, and/or import, products utilizing or incorporating the inventions claimed in the valid and enforceable claims of the Licensor's Portfolio of Lateral Flow Patents, including continuations, continuations in part and divisionals thereof.

License Property

The settlement agreement provides for a license to the Licensee of all current and future patents of the Licensor and its affiliates which embody lateral flow technology for all diagnostic products other than for cardiology testing and for consumer/over-the-counter women's health (except that diagnostics for women's infectious diseases are within the licensed field of use).

The suit was filed in the U.S. District Court, Southern District of California alleged infringement of our U.S. Patent No. 4,943,522.

Lateral flow test devices include our tests for pregnancy, strep, H pylori, and Chlamydia.

Field of Use

The Licensor is a leading global developer of advanced diagnostic devices and is presently exploring new opportunities for its proprietary electrochemical and other technologies in a variety of professional diagnostic and consumer-oriented applications including immuno-diagnostics with a focus on women's health, cardiology and infectious disease.

License Grant

The Licensor of England grants to the Licensee a non-exclusive license under the Patent Rights in the Territory to make, use and sell Licensed Products.

Licensor grants to the Licensee a non-exclusive option to a license to make, use and sell Products Under Option. This option may be exercised on a per analyte basis at any time within the two (2) year period subsequent to the Effective Date of the Agreement, whereupon it will cease on a per analyte basis.

License Property

Licensed Product shall mean any device for qualitative or quantitative detection of the analytes Fetal Fibronectin, and, Interleukin 6 for Group B Strep and Chlamydia.

Products Under Option shall mean any device for qualitative or quantitative detection of the analytes Fetal Fibronectin, and, Interleukin 6 for Group B Strep and Chlamydia.

Fetal fibronectin (fFN) is a fibronectin protein produced by fetal cells. It is found at the interface of the chorion and the decidua (between the fetal sac and the uterine lining). It can be thought of as an adhesive or 'biological glue' that binds the fetal sac to the uterine lining.

Field of Use

Fetal fibronectin (fFN) is used to test pregnant women who are between 22 weeks and 35 weeks of gestation and are having symptoms of premature labor. The test helps predict the likelihood of premature delivery. Many pregnant women experience symptoms that suggest preterm labor.

Licensee designs, develops, manufactures and markets innovative products for women’s health, with focus on reproductive healthcare, using proprietary technologies to predict preterm birth and assess infertility.

License Grant

The parties agree to amend and extend the Original LOI and agree to replace the Original LOI in its entirety by this Letter of Intent (“LOI”), which LOI shall supersede and replace the Original LOI in its entirety relating to a potential worldwide license between Licensor and Licensee relating to  the FastPack 2.0 System.

Licensor shall grant to Licensee  and its affiliates an exclusive (including with respect to Licensor), all-fields, worldwide, assignable license, including the rights to sublicense through multiple tiers of sublicense, under all Licensor FastPack 2.0 Patent Rights and Licensor Know-How (except for Licensor intellectual property that pertains to FastPack “1.0”/IP as well as to the FastPack 2.0 System). Licensor FastPack 2.0 Patent Rights include without limitation the patents and pending patent applications listed and any patent or patent application claiming priority thereto; and an exclusive (including with respect to Licensor), worldwide, assignable license, including the rights to sublicense through multiple tiers of sublicense, under all Licensor Patent Rights and Licensor Know-How not included in the license grant described in this Agreement, limited to the field of use consisting of developing, making, having made, using, manufacturing, offering for sale, selling, having sold, exporting and importing all products (Licensed Products) related to the FastPack 2.0 System.

License Property

FastPack 2.0 System is a certain point of care, rapid quantitative immunoassay analyzer, as well as all associated intellectual property and technology, including, but not limited to, any assays, plasma separation devices, dispensers, and pouches related thereto.  Vitamin D assays are included in the FastPack 2.0 analyzer.

The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescent technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button.

Field of Use

The FastPack IP System is a state of the art, near-patient blood analyzer that provides quantitative immunoassay results, at the push of a button, for important biomarkers in the areas of cancer, metabolic disorders, hormone regulation and pregnancy management.

The FastPack® IP System is an established, point of care immunoassay system designed to enable physician office laboratories (POLs) to offer key quantitative test results where there is immediate clinical value. The test menu includes Vitamin D, Testosterone, TSH, Free T4, PSA, and hCG.

License Grant

The Company has taken a license to two U.S. patents, which expire in the financial years 2004 and 2014 respectively, covering the format of Uni-Gold(TM) rapid test device i.e. the visual result given by its one step strip test.

License Property

The Company 's Uni-Gold one step assays detect antibodies to various infectious diseases and conditions in serum and plasma or whole blood based on the principle of an immuno-chromatographic assay.  The Company currently markets four products based on this technology, Uni-Gold HIV, Uni-Gold Hepatitis B, Uni-Gold hCG (pregnancy) and Uni-Gold H. pylori.

License Grant

Assignee desires to acquire said patents for use within the Field of Use, both domestically and internationally.The Assignee is a stockholder of the Assignor/ Licensor.

The Company entered into a definitive Agreement pursuant to which the Licensor agreed to assign its ownership of 11 patents to the Company which protect the Licensor's infectious disease diagnostic test kit technology. The Licensor also granted the Company a License to utilize 18 additional patents related to the diagnostic test kits.

License Property

#5,989,902 Method for determining the antimicrobial agent sensitivity of a nonparaffinophilic hydrophobic microorganism and an associated apparatus
#5,981,210 Method for determining a presence or absence of a nonparaffinophilic hydrophobic microorganism in a body specimen by using a DNA extraction procedure and a novel DNA extraction procedure
#5,935,806 Method and apparatus for speciating and identifying MAI (Mycobacterium Avium Intracellulare) and testing the same for antibiotic sensitivity
#5,882,920 Apparatus for determining the presence or absence of a paraffinophilic microorganism
#5,854,014 Apparatus for testing paraffinophilic microorganisms for antimicrobial sensitivity
#5,846,760 Method for determining a presence or absence of a nonparaffinophilic hydrophobic microorganism in a body specimen and an associated kit
#5,776,722 Method of testing a body specimen taken from a patient for the presence or absence of a microorganism a further associated method and associated apparatus
#5,569,592 Apparatus for testing MAI (Mycobacterium Avium Intracellulare) for antimicrobial agent sensitivity
#5,472,877 Apparatus for determining the presence or absence of MAI (Mycobacterium Avium Intracellulare)
#5,316,918 Method and apparatus for testing MAI (Mycobacterium Avium Intracellulare) for antimicrobial agent sensitivity
#5,153,119 Method for speciating and identifying MAI (Mycobacterium Avium Intracellulare)

Field of Use

Assignee’s Field of Use or Field of Use with regard to Assignee’s use of the Assigned Patents and use of the technology and intellectual property associated with the Assigned Patents shall mean only the uses within the areas of health described herein; specifically, the detection and identification of human and veterinary identification of Atypical Mycobacteria, Tuberculosis, Mycobacterium Avium Intracellulare (MAI), Mycobacteria, Paratuberculosis, Nocardia and Pseudomonas for disease identification, and antibiotic assaying (but such assaying does not include antibiotic assaying when those antibiotics or compounds are derived from by-products obtained through growing microorganisms using Assignor's IP) for determining the antimicrobial agent sensitivity of microorganisms to ascertain which antibiotics are efficacious against microorganisms in the field of health which may lead to drug discoveries; and excludes any other uses, including any use reserved for the Assignor as specified in the Realm of Use or Assignor’s Use, and excludes kits for any other uses, which uses or kits are reserved to Assignor, including but not limited to uses, kits, or bioreactors pertaining to bioremediation, apoptosis, nanotechnology, biomems, microfluidic devices, the production of hydrogen and the identification and growing of over 32 different paraffin-eating and non-paraffin eating microorganisms to collect any microbial by-products of any kind, including antibiotics (all of which fall under the Realm of Use of the Assignor). Further, the Assignee’s Field of Use does not include any industrial use of the Assigned Patents. Whereas the Assignee’s Field of Use and the Assignor’s Use both provide for certain uses within the area of health, the Assignee, with regard to Assignee’s use of the Assigned Patents and use of the technology and intellectual property associated with the Assigned Patents is limited to only the uses within the areas of health that are specified in the Assignee’s Field of Use.

Realm of Use or Assignor’s Use with regard to the Assignor’s use of the Assigned Patents means the Assigned Patents and use of the technology and intellectual property associated with the Assigned Patents for all uses, including but not limited to (a) hydrogen production applications (b) augmenting growth of microorganisms to collect any microbial by-products, including but not limited to hydrogen, antibiotics, or any chemical synthesis (c) bioremediation (d) apoptosis (e) nanotechnology, (f) biomems for all uses, including but not limited to medical uses, (g) microfluidic devices for all uses, including but not limited to medical uses, and (h) identification and detection of over 32 different paraffin-eating and non-paraffin-eating microorganisms, other than for the identification of Atypical Mycobacteria, Tuberculosis, Mycobacterium Avium Intracellulare (MAI), Mycobacteria, Paratuberculosis, Nocardia and Pseudomonas for disease diagnosis (unless associated with biomems, microfluidic devices, or nanotechnology), (i) testing for antimicrobial agent sensitivity of microorganisms including but not limited to using such technology for controlling growth of undesirable microorganisms in a bioreactor and using such technology to test the efficacy of antibiotic compounds or other compounds which may be collected as by-products from using the Assigned Patents to identify and grow microorganisms, (j) any industrial use whatsoever; but excludes using the Assigned Patents and associated technology and intellectual property for (1) the detection and identification of human and veterinary identification of Atypical Mycobacteria, Tuberculosis, Mycobacterium Avium Intracellulare (MAI), Mycobacteria, Paratuberculosis, Nocardia and Pseudomonas for disease identification test kits (unless associated with biomems, microfluidic devices, or nanotechnology) and (2) selling test kits or providing diagnostic services in the field of health for determining the antimicrobial agent sensitivity of microorganisms to ascertain which antibiotics are efficacious against microorganisms in the field of health (unless associated with biomems, microfluidic devices, or nanotechnology). Whereas the Field of Use and the Realm of Use both provide for certain uses within the area of health, the Assignee, with regard to the Assigned Patents and all technology and intellectual property associated with the Assigned Patents is limited to only the uses within the areas of health that are specified in the Field of Use.