Royalty Report: Drugs, Disease, Therapeutic – Collection: 28716

License Grant

Licensor is willing to grant certain rights to patents and technology that may result from the research collaboration.

Licensor and Licensee are each pursuing various aspects of research in the field of Apheresis Selective Depletion of Small Reactive Molecules and Pathogens that Involves a Novel Treatment of the Pathophysiologic Basis of Diseases such as Alzheimer's Disease, Traumatic Brain Injury (TBI), Chronic Pain Syndrome, Fibromyalgia, Multiple Sclerosis, Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease), Blood Sepsis, Cancer, Heart Attacks and Strokes.

License Property

Technology involved is in the area of sequential-dialysis.  Intellectual property developed as a result of the projects will be owned jointly by the Licensor and Licensee.

License Grant

Under the terms of the Asset Purchase Agreement with Party A, the Danish Licensee became party to a royalty agreement with the Trust for worldwide net sales of Arimoclomol for the treatment of Amyotrophic Lateral Sclerosis (ALS). Pursuant to this Asset Agreement, Party A sold and transferred certain preclinical and clinical data, patents and other intellectual property rights, and other assets, including contractual rights and obligations relating to a portfolio of chemical compounds, including arimoclomol, to Licensee.

License Property

Arimoclomol is an orally- or naso/gastrically-administered small molecule that crosses the blood-brain barrier and is designed to selectively amplify the natural role of endogenous Heat Shock Proteins (HSPs), which protect against cellular toxicity caused by protein misfolding, aggregation and lysosomal dysfunction.

The Trust is the charitable remainder beneficiary that generates a potential income stream from donors, or other beneficiaries, to benefit the research of ALS.

Amyotrophic lateral sclerosis or ALS, is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. ALS is often called Lou Gehrig's disease.

Field of Use

The Field of Use is for the treatment or prevention of Amyotrophic Lateral Sclerosis (ALS).  ALS, commonly referred to as Lou Gehrig’s disease, is a rapidly progressing neurological disease with the onset of symptoms typically occurring between 40 to 70 years of age, with patient mortality occurring in most patients within three to five years of disease onset. ALS attacks neurons responsible for controlling voluntary muscles, resulting in muscle weakness in limbs, and impacts speaking, chewing, swallowing and breathing, leading to progressive disability and eventually death, typically from respiratory failure and aspiration pneumonia.

Licensee is biopharmaceutical company harnessing the amplification of Heat Shock Proteins, or HSPs, in order to develop and commercialize novel therapeutics for the treatment of neurodegenerative orphan diseases that includes Amyotrophic Lateral Sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

License Grant

Owner grants to Licensee exclusive, nontransferable licenses for

a.
the Applications and the Patents; and

b.
the Trademarks.

The Technology is owned by two entities that are under the control of the Chairman of our Board of Directors.

License Property

The pending PCT patent application relates to the treatment of auto-immune diseases.

Licensor shall have sole discretion to select other countries into which exclusive rights in the Licensed technology may be pursued, and if we decline to pay those expenses, then licensor may pay said expenses and our Licensed rights in those countries will revert to the Licensor.

“Applications” means PCT/US2009/062895, entitled Medication and Treatment for Disease.

“Trademarks” mean Feldetrex™, including US Trademark Application

Field of Use

Feldetrexâ„¢ is a potential treatment for  Multiple Sclerosis, Fibromyalgia, and Traumatic Brain Injury.

License Grant

The Licensor grants the Licensee exclusive, nontransferable Licenses for the Applications and the Patents; and the Trademarks, until the Patents expire.

The grant of each License hereunder includes the right to grant subLicenses to Related Companies.

License Property

Applications means PCT/US2009/062895, entitled Medication and Treatment for Disease.

Trademarks mean Feldetrexâ„¢, including US Trademark Application No. 77/601,101 and any identical marks later filed in countries other than the United States of America.

Feldetrexâ„¢ drug is a proprietary combination of generic medications which is believed to reduce the symptomatology of Multiple Sclerosis, Fibromyalgia, and Traumatic Brain Injury.
Multiple Sclerosis is a chronic, progressive illness that affects the nerves in the brain, spinal cord, and other parts of the central nervous system.
Fibromyalgia (FM or FMS) is characterized by chronic widespread pain and allodynia (a heightened and painful response to pressure).[1] Its exact cause is unknown but is believed to involve psychological, genetic, neurobiological and environmental factors.

Field of Use

Trial usage of Feldetrex â„¢ has been used in patients with Multiple Sclerosis.

Licensee shall prominently use the Trademark on Licensed Products.

License Grant

The Licensor grants the UK Licensee an exclusive, royalty-bearing license for the Patent Rights, to make, have made, use, have used, Sell and have Sold Products and Processes; and the right to grant sublicenses.

License Property

The investigational new drug will suppress neuroinflammation.  US Provisional Patent Application 62/515,711. Filed June 6th 2017.

Field of Use

The IP includes the nasal administration of foralumab, a fully human anti-CD3 mAb, for treatment of neurodegenerative diseases such as Lou Gehrig’s disease (ALS), progressive multiple sclerosis and traumatic brain injury.

'Nasal administration of foralumab is an innovative immunotherapy which has potential for treatment of neurodegenerative diseases such ALS and progressive MS'.

License Grant

Canadian Licensor hereby grants to Licensee a license to Licensor’s intellectual property rights in the Reagents and the POC Rapid Assays to manufacture the POC Rapid Assays in accordance with the POC Rapid Assay Specifications, subject to the terms and conditions of this Agreement, for the sole and exclusive purpose of incorporating the Reagents into P~C Rapid Assays.

License Property

Licensor has developed, and is in the process of further developing, certain unique, proprietary biomarkers and protein targets for the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke.

Reagents shall mean biomarkers and protein targets developed and produced by Licensor for the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke. The term “Reagents” shall also include all other biomarkers and protein targets developed and produced by Licensor (other than for stroke) for which there shall be application in the point of care diagnostic products.

POC Rapid Assays shall mean rapid assay diagnostic point of care products, utilizing Reagents; provided, however, that “POC Rapid Assays” shall not include devices for test procedures performed in a hospital’s central clinical laboratory or in a reference laboratory setting. In addition, “POC Rapid Assays” shall not include any assay that can be used on any instrument with random access capability and/or any instrument with the ability to analyze multiple samples.

POC Rapid Assay Specifications shall mean the standards and specifications for the manufacture of the POC Rapid Assays, as developed and agreed to by the Parties, as amended from time to time, and shall be appended to and form part of this Agreement.

Reagent Specifications shall mean the standards and specifications for the manufacture of the Reagents, as developed and agreed to by the Parties, as amended from time to time, and shall be appended to and form part of this Agreement.

Field of Use

The biomarkers are used to determine the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke.  Biomarkers can be measured through a blood sample.