Royalty Report: Device, Respiratory, Medical – Collection: 256986

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 18

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 18

Primary Industries

  • Device
  • Respiratory
  • Medical
  • Delivery
  • Drugs
  • Therapeutic
  • cardiac
  • Viral Infection
  • Disease
  • Fibrosis
  • Supply
  • Generators
  • Cancer
  • Gastrointestinal
  • Scientific & Technical Instruments
  • Diagnostic

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 256986

License Grant
The Company grants an exclusive license to an undisclosed Licensee for the commercialization of the GeNOvent for the treatment of persistent pulmonary hypertension of the newborn (PPHN) and future related indications at concentrations of <80 ppm in the hospital setting in the United States and another country.
License Property
GeNOvent is a novel cylinder free ventilator compatible nitric oxide (NO) generator and phasic-flow delivery system.

GeNOvent is a cylinder free, phasic flow nitric oxide delivery system and has been designated as a medical device by the US Food and Drug Administration (FDA). The device can generate NO on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. A disposable smart filter is used to remove nitrogen dioxide (NO2), a toxic gas. The elimination of the need for large, high-pressure cylinders for NO is a significant advantage in the hospital setting by greatly reducing inventory and storage requirements, and improving overall safety with the elimination of NO2 purging steps, among other benefits.

The Licensor is a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension.

Nitric oxide (NO) is a crucially important molecule proven to play a critical role in a broad array of biological functions. Inhaled nitric oxide is currently approved for treating term and near-term neonates with Persistent Pulmonary Hypertension of the Newborn (PPHN) in the United States of America and most major markets. In Europe, Japan and Australia, inhaled NO is approved to treat PPHN as well as pulmonary hypertension during the peri-operative cardiac surgery period in neonates, children, and adults. In the airways, NO is believed to play a key role in the innate immune system at concentrations of approximately 200 ppm. In vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, both gram-positive and gram-negative, but also against other diverse organisms including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate their multi-drug resistant strains.

Persistent pulmonary hypertension of the newborn (PPHN) is a life-threatening condition secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a pulmonary vasodilator and is approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.

Field of Use
This agreement pertains to the medical device industry.

IPSCIO Record ID: 353499

License Grant
Under the terms of the Settlement Agreement, the Licensee retains United States and China commercialization rights to LungFit® PH from United Kingdom Licensor.
License Property
LungFit® PH is an NO generator and delivery system (the LungFit™ system) that is capable of generating NO from ambient air. The LungFit™ system can generate NO up to 400 parts per million (ppm) for delivery to a patient’s lungs directly or via a ventilator. The LungFit™ system can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose.
Field of Use
Field of use is for the treatment of persistent pulmonary hypertension of the newborn (PPHN), severe acute respiratory syndrome coronavirus 2 (“SARS CoV-2”)/acute viral pneumonia (“AVP”), bronchiolitis (BRO) and nontuberculous mycobacteria (“NTM”) lung infection.

Licensee current areas of focus with LungFit® are persistent pulmonary hypertension of the newborn (“PPHN”), acute viral pneumonia (“AVP”) including COVID-19, bronchiolitis (“BRO”) and nontuberculous mycobacteria (“NTM”) lung infection.

IPSCIO Record ID: 376522

License Grant
The parties collaborated to advance the clinical development of high concentration Nitric oxide for the treatment of Nontuberculous Mycobacteria, or NTM pulmonary disease with Licensor providing grant money to be allocated to the ongoing LungFit® GO NTM pilot study.
License Property
Nitric oxide (“NO”) generator and delivery system (the “LungFit® system”) is capable of generating NO from ambient air. The LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s lungs directly or via a ventilator. LungFit® can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. LungFit® can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus.
Field of Use
Field of use is for the treatment of Nontuberculous Mycobacteria, or NTM pulmonary disease.

Nontuberculous mycobacteria, also known as environmental mycobacteria, atypical mycobacteria and mycobacteria other than tuberculosis, are mycobacteria which do not cause tuberculosis or leprosy. NTM do cause pulmonary diseases that resemble tuberculosis. Nontuberculous mycobacterial (NTM) lung disease is a serious infection caused by bacteria that are common in the environment and can cause lung damage.

IPSCIO Record ID: 263060

License Grant
In this Agreement, the Licensee expanded the scope of the license agreement with the Licensor, who prior to 2015 was Parent of Licensee, for rights to develop and commercialize pulsed nitric oxide for idiopathic pulmonary fibrosis to include patients with Pulmonary Fibrosis (PH-PF).
License Property
The Licensor manufactures and markets pharmaceutical drugs and devices, based on proprietary pulsatile nitric oxide delivery.

INOpulse program is an extension of the technology used in hospitals to deliver continuous-flow inhaled nitric oxide.

Field of Use
The clinical-stage therapeutics company focused on developing innovative products that address significant unmet medical needs in the treatment of cardiopulmonary diseases,  expanded the scope of the license from PH-IPF to PH in patients with Pulmonary Fibrosis (PH-PF), which includes idiopathic interstitial pneumonias, chronic hypersensitivity pneumonitis, occupational and environmental lung disease, with a royalty on net sales of any commercial products for PH-PF.  Pulmonary fibrosis is a lung disease that occurs when lung tissue becomes damaged and scarred.

IPSCIO Record ID: 28235

License Grant
The Amendment expands the scope of the Licensee's license from the Licensor. Under the Cross-License Amendment, the Licensee will continue to develop the pulse program in the field of cardiopulmonary disease.
License Property
The Licensor manufactures and markets pharmaceutical drugs and devices.

INOpulse is based on the Company’s proprietary pulsatile nitric oxide delivery device. The Company is currently developing two product candidates under its INOpulse program one for the treatment of pulmonary arterial hypertension, or PAH, for which the Company intends to commence Phase 3 clinical trials in the second half of 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease, or PH COPD, which is in Phase 2 development.

The INOpulse device is designed to be portable for use by ambulatory patients on a daily basis inside or outside their homes. The device is programmed to automatically adjust based on a patient’s breathing pattern to deliver a constant and appropriate dose of the inhaled nitric oxide over time, independent of the patient’s activity level, thus ensuring more consistent dosing in the alveoli of the lungs. In addition, we have developed a proprietary triple-lumen nasal cannula which enables more accurate delivery of the dose to the patient. The INOpulse device is also compatible with many long-term oxygen therapy systems that operate via a nasal cannula.

Field of Use
The Licensee will develop its Licensor pulse program for the treatment of three additional cardiopulmonary diseases chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension associated with sarcoidosis and pulmonary hypertension associated with pulmonary edema from high altitude sickness.

IPSCIO Record ID: 32979

License Grant
Licensor hereby grants to Israelis Licensee a non-exclusive, non-sublicensable license, under CareFusion’s interest in the CareFusion Patents, to develop, make, have made, use, have used, sell, offer for sale, have sold, and import Licensed Products throughout the world solely within the Field (the “License”).
License Property
The intellectual property licensed covers devices and methods for delivering nitric oxide (NO) formulations to a patient at steady and alternating concentrations, including intermittent delivery of NO. The license also covers patents relating to devices and methods for delivering alternating concentrations of NO topically, nasally and to an upper respiratory tract.

“NO Gas” means nitric oxide gas.
“NO Gas Container” means a storage vessel for NO Gas.
“NO Gas Delivery Device(s)” means devices used for the delivery of NO Gas that contain Intellectual Property Licensed by CareFusion to Licensee.

Nitric Oxide (NO) possesses broad-spectrum anti-microbial activity acting against bacteria, fungi and viruses. NO is produced at high output as part of the innate immune response. NO and its by-products (for example, Reactive Nitrogen Species, RNS) are responsible for the process of killing microorganisms within white blood cells called macrophages and in organs such as the lungs and other mucolytic tissues.

Field of Use
“Field” means the application of NO Gas for the treatment of diseases or conditions in humans (expressly excluding veterinary applications).

IPSCIO Record ID: 228775

License Grant
The Licensee entered into a non-exclusive worldwide license agreement with the Licensor to license seven issued U.S. patents, and one U.S. patent application, including corresponding foreign counterparts – including patents granted in Australia, Mexico and China. The intellectual property licensed covers devices and methods for delivering NO (nitric oxide) formulations to a patient at steady and alternating concentrations, including intermittent delivery of NO and also covers patents relating to devices and methods for delivering alternating concentrations of NO topically, nasally and to an upper respiratory tract to potentially eliminate bacteria, viruses, fungi and other microbes from the lungs and may also be effective against antibiotic-resistant bacteria.
License Property
The Licensor has granted the use of certain patents that relate to methods and devices for delivering 80-400 PPM NO formulations to patients.
Field of Use
The Licensee is a medical device company developing a nitric oxide (NO) delivery system, that is capable of generating NO from ambient air.  The Licensee believes that they are meeting a medical need for patients suffering from certain severe lung infections for which the system can be used.

IPSCIO Record ID: 266845

License Grant
For the Exclusive License,  the Swiss Licensor grants an exclusive right and license or sublicense, as applicable, in the Territory, with the right to grant sublicenses, under the Licensor Technology and Licensor Technology Improvements to make and have made, to use and have used, to develop and have developed, to sell and have sold, to offer for sale and have offered for sale, to import and export and have imported and exported Licensed Products in the Exclusive Field in the Territory during the Term.

For the Non-Exclusive, Research License, Licensor grants a nonexclusive, research only license or sublicense, as applicable, in the Territory, with the right to grant sublicenses, under the Licensor Technology and Licensor Technology Improvements to conduct non-human studies for the development of Other Products, solely for the prevention or treatment of a Target Indication in the Target Populations.

License Property
Licensors technology is relating to the aerosolization of liquid forms of drug products and the Aerosol Devices and Disposable Dose Packs.

Licensed Product means a combination drug-device product using or otherwise practicing the Licensor Technology and delivering Pulmonary Surfactants (alone or in combination with other pharmaceutical compounds).

Drug Product means a pharmacological agent(s), including Pulmonary Surfactants, together with any excipients or inactive ingredients, formulated for use in connection with an Aerosol Device or Disposable Dose Packet.

Aerosol Device means a device to aerosolize a pharmaceutical compound for administration to humans. It is contemplated that the Aerosol Device shall consist of permanent (e.g., nondisposable) components that control power and electronics (e.g., control unit) and a physical mechanism (e.g., pump) to provide a means for dispensing the Drug Product from the container closure system.

Aerosol Technology means any technology related to the aerosolization of a liquid form of a pharmaceutical compound. Aerosol Technology does not include technology that is related to the delivery of aerosols as dry powders.

An Other Product means a combination drug-device product using or otherwise practicing the Licensor Technology and delivering pharmaceutical compounds other than Pulmonary Surfactants as an active ingredient in humans, alone or in combination with other pharmaceutical compounds, that are other than Pulmonary Surfactants.

Field of Use
Exclusive Field means the therapeutic or preventative use in humans of Aerosol Technology to deliver Pulmonary Surfactants (alone or in combination with any other pharmaceutical compound(s)) as an active ingredient for the prevention or treatment of Respiratory Indications.

Target Indications means the following Respiratory Indications Respiratory Distress Syndrome (RDS); Chronic Lung Disease (BPD); Transient Tachypnea; Hypoxemia; Pulmonary Hypertension; Pneumonia; Bronchiolitis; Diaphragmatic Hernia; Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS); Lung Transplantation; Respiratory Syncitial Virus (RSV); Cystic Fibrosis; Chronic Obstructive Pulmonary Disease (COPD); and Emphysema.

Target Populations means human patients in a Hospital Setting receiving forms of treatment for the applicable Respiratory Indication that are typically and principally provided within a Hospital Setting.

The restructure strategic alliance agreement is to unite two complementary respiratory technologies – Licensee peptide-containing synthetic surfactant technology with Licensor’ novel capillary aerosolization technology – to deliver therapeutics to the deep lung.

IPSCIO Record ID: 286077

License Grant
Licensor grants an exclusive license for the Licensor Technology in the Territory to research, Develop, Commercialize, use, import, register, sell, have sold, and distribute Products in the Field within the Territory.

Licensor grants a non-exclusive license for the Licensor Technology in the Territory to make and have made Products in the Field in the Territory.

This agreement includes a non-exclusive grant back from Licensee to Licensor.

License Property
Licensor has certain proprietary rights related to a pulmonary drug delivery technology known as AERx® technology, as well as expertise and know-how relating to the use and manufacture of such technology.

The licensed Technology means, only if it relates to the AERx pulmonary drug delivery system and collectively, the Licensor Patents, Licensor Know-How, Licensor New Intellectual Property, all Information relating to the Licensor Patents, Know-How, and New Intellectual Property in the course of any work conducted pursuant to this Agreement, and Licensor Improvements.

The patents include, but are not limited to, Disposable package for intrapulmonary delivery of aerosolized formulations; Methos of fabricating porous membrane with unique pore structure for aerosolized delivery of drugs;  Aerosol-forming porous membrane with certain pore structure;  Device and method of creating aerosolized mist of respiratory drug; Lockout device for controlled release of drug from patient-activated dispenser; and, Method of administration of insulin.

Field of Use
Field means pulmonary delivery of prostacyclin drugs for the treatment of pulmonary arterial hypertension and any and all other therapeutic indications and uses other than control of glucose levels in humans.

IPSCIO Record ID: 388300

License Grant
Licensee entered into an Agreement with an undisclosed third party for a perpetual, exclusive, world-wide license to certain intellectual property related to the Oxygen Assist Module for the delivery of non-invasive ventilatory support.
License Property
Oxygen Assist Module is designed to automatically maintain SPO2 levels within a specified range for a defined period of time. The device solution is focused on High Velocity Nasal Insufflation (“HVNI”, or “High Velocity Therapy”), which delivers non-invasive ventilatory support to patients by providing heated, humidified, oxygenated air at high velocities through a small-bore nasal interface, and on closed loop control systems.

This license is for the delivery of non-invasive ventilatory support relating to the Oxygen Assist Module focused on at home patient monitoring.

Field of Use
High Velocity Therapy is an advanced form of high flow therapy that is differentiated due to its ability to deliver breathing gases, including oxygen, at a high velocity, for the treatment of spontaneously breathing patients with either Type 1 hypoxic respiratory distress, like that experienced by patients with pneumonia or COVID-19, or Type 2 hypercapnic respiratory distress, like that experienced by patients with COPD. Licensee's Precision Flow systems, which use High Velocity Therapy technology, are clinically validated alternatives to, and address many limitations of, the current standard of care for the treatment of respiratory distress in a hospital setting.

IPSCIO Record ID: 28731

License Grant
Licensor hereby grants unto Licensee a worldwide, royalty-bearing, exclusive license, limited to the Licensed Field, under the Licensed Patents and know-how, to exclusively manufacture, have made, develop, engineer or modify, use, lease, import, export, offer to sell, Licensed Products and/or Licensed Processes; and a worldwide, royalty-bearing, non-exclusive license, to purchase, manufacture, have made, develop, engineer or modify, use, lease, import, export, sell, and have sold items (i.e., analyzer devices, delivery devices, or others items) that are used in relation to the Licensed Field.

Licensor hereby further grants the right to sublicense the Licenses granted herein.

License Property
Licensor represents that it is the sole owner and inventor of certain inventions and know-how relating to endothermic generators that produce nitric oxide, described in the “Licensed Patents”.
Field of Use
Licensed Field shall include all uses related to an endothermic generator system, including all components capable of producing nitric oxide and filling cylinders or other containers, as well as any accessory or replacement parts that may be associated with said generator.

What is required is a nitric oxide generator which is capable of producing nitric oxide and diluting the pure nitric oxide into concentrations that have utility.
Presently nitric oxide is successfully being used with FDA approval in the treatment of newborns with respiratory illness. Ongoing medical research shows promise in the use of NO for the treatment of a myriad of diseases and illnesses partially due to its antiviral and bactericidal properties.

IPSCIO Record ID: 49323

License Grant
The parties wish to amend certain provisions of the Supply Agreement to, among other things, change the pricing terms; and the parties wish to amend certain provisions of the License Agreement to, among other things, add royalty terms, as additional consideration for the Products to be supplied under the Supply Agreement.
License Property
INOpulse is based on the Company’s proprietary pulsatile nitric oxide delivery device and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease, or PH COPD.  The INOpulse device is designed to be portable for use by ambulatory patients on a daily basis inside or outside their homes. The device is programmed to automatically adjust based on a patient’s breathing pattern to deliver a constant and appropriate dose of the inhaled nitric oxide over time, independent of the patient’s activity level, thus ensuring more consistent dosing in the alveoli of the lungs.
Field of Use
This agreement pertains to the drug industry.

IPSCIO Record ID: 369388

License Grant
This amendment updates the compensation, territory, this term and trademarks, among other details and definitions.

During the Term, Licensee shall have a right of first negotiation to obtain rights to distribute the Product in a country that is not in the current territory; provided that Licensor has not previously granted to a Third Party distribution rights in such country or is not itself distributing in such country.

In the original agreement, Licensor appoints Licensee as its distributor during the Term to market, promote, distribute and sell the Product in the Territory  on an exclusive basis solely for use in the home-based, open-cup, continuous-flow, general-purpose nebulizer market, not for use in hospitals; and on a non-exclusive basis solely for use in alternate care facilities.

License Property
The trademarks are Aerogen®; Aeroneb® Go, and, OnQ® Aerosol Generator.

The Aeroneb Go is a fast, efficient, simple-to-use nebulizer developed for the millions of patients worldwide who require respiratory therapy in and away from home. The product was designed to eliminate many of the problems associated with current methods of medication delivery when using nebulizers. Unlike many compressor, ultrasonic, or mesh-based nebulizers, the Aeroneb Go allows patients to complete their treatments quickly, and delivers a high-quality respirable aerosol.

A nebulizer or nebuliser is a drug delivery device used to administer medication in the form of a mist inhaled into the lungs. Nebulizers are commonly used for the treatment of asthma, cystic fibrosis, COPD and other respiratory diseases or disorders. They use oxygen, compressed air or ultrasonic power to break up solutions and suspensions into small aerosol droplets that are inhaled from the mouthpiece of the device. An aerosol is a mixture of gas and solid or liquid particles.

Field of Use
By the original agreement, the field of use is the respiratory field.

IPSCIO Record ID: 314125

License Grant
Pursuant to the agreement, the companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection.  The Licensee will receive the exclusive European rights to the new drug. Licensee will become the exclusive worldwide manufacturer for the novel next-generation therapy for the eradication of H. pylori infection, Movantik® (naloxegol) and RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections.
License Property
H. pylori infection is a type of bacteria. These germs enter your body and live in your digestive tract which may cause sores, called ulcers or stomach cancer.

Movantik® is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids.

Movantik® is a proprietary once-daily oral PAMORA approved by the U.S. Food and Drug Administration for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation

RHB-204 is used for pulmonary nontuberculous mycobacteria (NTM) infections. Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria, found in the soil as well as natural and engineered water systems.

Licensor is a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases.

Field of Use
The companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection and RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections.

IPSCIO Record ID: 383543

License Grant
Licensor of Germany grants to Licensee of Israel an exclusive, perpetual, license in the Field, subject only to AKITA rights, non-exclusive with respect to AKITA rights, including the right to sublicense, to use the Device and utilize the Device Related IP and the Device Data
— in and for the development of Drug Products; and/or
— in pre-clinical and clinical trials of Drug Products; and/or
— in and for the registration, marketing, distribution and sale of Drug Products; and,

to advertise, market, distribute and sell the Device and any replacement parts thereof, worldwide, for use together with the Drug Product, including, without limitation, in pre-registration sale of Products for use by individual patients on a compassionate use basis.

Licensor grants an exclusive sublicense under TTPs IP Rights to exploit the Device in the Field in the Territory; provided that Licensee shall not make or have made the Device or any portion thereof.

License Property
This collaboration is for the development of an aerosolized form of Licensees injectible API drug product for administration through inhalation (the Drug Product), using the Device that is based on the eFlow®.

The Device shall mean the inhalation device proprietary to Licensor that
—  is based on the Present Device and perforated vibrating membrane technology and that shall include the eKeyTM System and other modifications and Improvements as may be necessary in order to meet the Specifications, to the extent accepted by Competent Regulatory Authorities; and
—  is customized for use with the Drug Product; and,
—  complies with the Specifications, including any Improvements.

The Device Related IP is any and all intellectual property rights, including, without limitations, the Licensor Patents, Know-How, technology, trade secrets and Improvements on the foregoing, covering and/or related to the Device.

The eFlow shall mean the nebulizer proprietary to Licensor that is based on perforated vibrating membrane technology and includes the mixing chamber and valve system associated with the device that is currently sold under the trade name EFLOW®.

The eKey System shall mean a method or system to discourage and/or prevent use of the Device with unauthorized medications, the initial specifications and performance features.

Licensees API is Alpha 1 Antitrypsin liquid drug produced through Licensee’s proprietary process from Fraction IV-1 or of any other source.

The Present Device shall mean the present model no. 78G1013 (configuration 30) of eFlow,

Collectively the AKITA Rights are the intellectual properly licensed by Licensor lo Activaero GmbH is limited to use with Activaeros AKITA 2 inhalation system, which system does not include the mixing chamber and the valve system associated with the Device, and which license
– only allows use of a very specific configuration of the nebulizer handset, incorporating TouchSpray Technology, licensed from TTP, in connection with the AKITA Controlled Breathing System,
– may be commercialized by either Activaero GmbH, in accordance with its agreement with Licensor, and,
– does not allow the use of the nebulizer handset without a controlled breathing system.

Field of Use
The strategic Collaboration Agreement to develop Licensee's Alpha-1 Antitrypsin (AAT) liquid drug candidate for inhalation through Licensor's eFlow for the treatment of patients suffering from Alpha-1 Antitrypsin deficiency.

The eFlow®rapid nebuliser system provides you with an efficient device for the treatment of respiratory diseases.  The eFlow Inline nebulizer system enables efficient aerosol delivery to mechanically ventilated patients in intensive medical care.

Alpha-1 antitrypsin deficiency (A1AD or AATD) is a genetic disorder that may result in lung disease or liver disease.

The Field of use is pulmonary delivery of the Drug Product for any indication whatsoever.

IPSCIO Record ID: 262807

License Grant
The Company entered into an agreement with a manufacturer of the nebulizer for the use to administer Molgradex.
License Property
Molgradex (an inhalation formulation of recombinant human GM-CSF for the treatment of aPAP) for the treatment of severe pulmonary conditions.  Molgradex is administered to the lungs using the investigational eFlow® Nebulizer System.

Molgradex, is a sterile nebulizer solution in a vial containing 300 µg of molgramostim, designed to be administered once daily by inhalation via a high efficiency Investigational eFlow Nebulizer System. The PARI eFlow Nebulizer system for use with investigational drug products is a reusable electronic inhalation system that has been optimized for administration of Molgradex.

“aPAP” – autoimmune pulmonary alveolar proteinosis

“CF” –  nontuberculous mycobacterial (“NTM”) lung infection n individuals living with cystic fibrosis

AeroVanc, a Phase 3 stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (“MRSA”) lung infection in individuals living with CF.

Field of Use
This agreement pertains to the drug industry.

IPSCIO Record ID: 27802

License Grant
Assignor, our chairman and chief executive officer, does hereby sell, assign, transfer and convey unto the Assignee the entire right, title and interest (a) in and to the Patents; (b) in and to all rights to apply for foreign patents on the Patents pursuant to the International Convention for the Protection of Industrial Property or otherwise; (c) in and to any and all applications filed and any and all patents granted on the Patents in the United States or any foreign country, including each and every application filed and each and every patent granted on any application which is a divisional, substitution, continuation, or continuation-in-part of any of said applications; and (d) in and to each and every reissue or extensions of any of said patents.
License Property
The agreement covers patents and applications for Metabolic Gas Exchange and Non-invasive Cardiac Output Monitor, Respiratory Calorimeter, Metabolic Calorimeter Employing Respiratory Gas Analysis, Oxygen Consumption Meter, Respiratory Calorimeter with Bidirectional Flow Monitors for Calculating of Oxygen Consumption and Carbon Dioxide Production, Respiratory Calorimeter with Bidirectional Flow Monitors, Method and Apparatus for Respiratory Gas Analysis Employing Measurement of Expired Gas Mass, Method and Apparatus for the Non-invasive Determination of Cardiac Output, Airway-based Cardiac Output Monitor and Methods for using same, O2 Consumpt. Meter, A System and Method of Metabolic Rate Measurement, Health Improvement System and Method, Improved Systems and Methods for Drug Administration.
Field of Use
Assignee designs, develop and market technologically advanced and proprietary handheld medical devices and software for the measurement and monitoring of important health parameters. Assignee's current health monitoring devices measure oxygen consumption to calculate resting metabolic rate, or RMR. The accurate measurement of resting metabolic rate, which establishes how many calories a person burns per day at rest and represents up to 75% of the total calories burned by a healthy individual per day, can be important to the success of medical therapy and to achieving weight management and fitness goals. However, an accurate, cost-effective and practical device for measuring and monitoring metabolism has not previously been available.

IPSCIO Record ID: 230775

License Grant
Licensor appoints Licensee as its distributor during the Term to market, promote, distribute and sell the Product in the Territory  on an exclusive basis solely for use in the home-based, open-cup, continuous-flow, general-purpose nebulizer market, not for use in hospitals; and on a non-exclusive basis solely for use in alternate care facilities.

For the Product Manufacturing License, Licensor grants the non-transferable license, without the right to grant sublicenses, except to subcontractors and/or vendors that fabricate and/or supply components of the Product on behalf of Licensee as shall be mutually agreed to from time to time, under the Licensor Licensed Rights and the Manufacturing Improvements to manufacture and assemble components of the Product, excluding the OnQ Aerosol Generator, and to assemble final Product for distribution and sale in the Territory.

For the distribution rights, Licensor grants to Licensee a non-transferable right and license under the Licensor Licensed Rights to import, export, offer for sale and sell the Product in the Territory solely for use by end users in the home-based, open-cup, continuous flow, general purpose nebulizer market and in alternate care facilities.

For the OnQ Aerosol Generator Manufacturing License, Licensor grants a non-exclusive, non-transferable license, without the right to grant sublicenses, under the Licensor Technology to manufacture and assemble the OnQ Aerosol Generator at the OnQ Aerosol Generator Manufacturing Facility solely during the OnQ Manufacturing Period, and solely for use in assembling the Product that Licensor is permitted to distribute and sell and for use by Licensor.

For the Back~Up Manufacturing Right, under certain conditions,  Licensor shall grant a non-exclusive, non-transferable license, without the right to grant sublicenses, under the Licensor Technology to manufacture and assemble the OnQ Aerosol Generator solely for Licensees use in assembling the Product for sale and distribution.

For the Trademark License, Licensor grants a non-exclusive, nontransferable license, with no right to sublicense, to use the Trademarks in each country of the Territory in connection with the marketing, sale and distribution of Product in the Territory.

License Property
Trademarks  Aerogen® ,  Aeroneb® Go ,  OnQâ„¢ Aerosol Generator

Product means Licensors proprietary Aeroneb® Go open-cup, continuous flow, general-purpose portable nebulizer, incorporating the OnQ Aerosol Generator, and including any Product Improvement incorporated therein.

OnQ Aerosol Generator means Licensors proprietary aerosol generator.

The Aeroneb Go, a proprietary product of Licensor, is an open-cup nebulizer intended for use by pediatric and adult patients, for continuous aerosolization of physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

The Aeroneb Go is a fast, efficient, simple-to-use nebulizer developed for the millions of patients worldwide who require respiratory therapy in and away from home. The product was designed to eliminate many of the problems associated with current methods of medication delivery when using nebulizers. Unlike many compressor, ultrasonic, or mesh-based nebulizers, the Aeroneb Go allows patients to complete their treatments quickly, and delivers a high-quality respirable aerosol.

a nebulizer or nebuliser is a drug delivery device used to administer medication in the form of a mist inhaled into the lungs. Nebulizers are commonly used for the treatment of asthma, cystic fibrosis, COPD and other respiratory diseases or disorders. They use oxygen, compressed air or ultrasonic power to break up solutions and suspensions into small aerosol droplets that are inhaled from the mouthpiece of the device. An aerosol is a mixture of gas and solid or liquid particles.

Field of Use
The field of use is the respiratory field.   This manufacture and distribution is for use by customers solely in the home or in alternate care facilities.
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