Royalty Report: Drugs, Delivery, Respiratory – Collection: 266845

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Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 20

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: 20

Primary Industries

  • Drugs
  • Delivery
  • Respiratory
  • Device
  • Disease
  • Medical
  • Therapeutic
  • Fibrosis
  • Viral Infection
  • Pharmaceuticals
  • Drug Discovery

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: 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: 273406

License Grant
Licensor hereby grants to Licensee an exclusive right and royalty-bearing license or sublicense, as applicable, with the right to grant sublicenses solely as set forth under the Licensor Technology and Joint Patents to make and have made, to use and have used, 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.
License Property
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 Pulmonary Surfactant(s) or other pharmacological agent(s), together with any excipients or inactive ingredients, formulated for use in a Licensed Product.

Licensor Technology means (a) Licensors proprietary Aerosol Technology (including without limitation the technologies, devices, processes, equipment, materials and know-how relating to the aerosolization of liquid forms of drug products and the Aerosol Devices and Disposable Dose Packs therefor) and (b) all Intellectual Property owned by or licensed to Licensor relating to such Aerosol Technology, including, without limitation, the Licensor Patents.

Licensor Patents means all Patents owned by Licensor or to which Licensor otherwise has rights that claim or are directed to the Licensor Technology.

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.

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.

IPSCIO Record ID: 273263

License Grant
Licensor hereby grants to Licensee an exclusive right and royalty-bearing license or sublicense, as applicable, in the Territory, with the right to grant sublicenses solely as set forth, 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.
License Property
Licensed Product means a combination drug-device product using or otherwise practicing the Licensor Technology and delivering Pulmonary Surfactants or other pharmaceutical compounds (each alone or in combination with other pharmaceutical compounds).

Licensor Technology means (a) Licensors proprietary Aerosol Technology owned or controlled by Licensor in the Territory as of June 30, 2008 (including without limitation the technologies, devices, processes, equipment, materials and know-how relating to the aerosolization of liquid forms of drug products and the Aerosol Devices and Disposable Dose Packs therefor) and (b) all Intellectual Property owned by or licensed to Licensor in the Territory as of June 30, 2008 relating to such Aerosol Technology, including, without limitation, the Licensor Patents.

Licensor Patents means all Patents owned by Licensor in the Territory or to which Licensor otherwise has rights in the Territory, as of June 30, 2008, that claim or are directed to the Licensor Technology.in each case which Inventions relate primarily to the Licensor Technology.

Field of Use
Exclusive Field means (i) 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, and (ii) the therapeutic or preventative use in humans of Aerosol Technology to deliver other pharmaceutical compound(s) as an active ingredient for the prevention or treatment of a Target Indication in the Target Populations.

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: 166969

License Grant
Under this agreement, Licensor granted to the exclusive license to manufacture and market Licensors products in the U.S.
License Property
Licensor has a proprietary pulmonary dry powder drug delivery system that is designed to aerosolize pharmaceuticals in dry powder formulations for delivery to the lungs.
Field of Use
Licensee is a specialty respiratory pharmaceutical and pulmonary drug delivery company.

IPSCIO Record ID: 311005

License Grant
Under this agreement the parties will collaborate to develop and commercialize once-daily LABA products for the treatment of chronic obstructive pulmonary disease (“COPD”) and asthma.
License Property
Products consist of Laba, a Long-Acting Beta2 Agonist, as well as the respiratory assets listed below.

Laba, a Long-Acting Beta2 Agonist, is a type of bronchodilator medicine. Bronchodilator medicine opens the airways in the lungs by relaxing smooth muscle around the airways. LABA are also long-term control medicines.

RELVAR®/BREO® is a once-a-day combination inhaled respiratory medicine consisting of vilanterol (VI), a long-acting beta2-agonist (LABA), and fluticasone furoate (FF), an inhaled corticosteroid (FF/VI), delivered via the ELLIPTA® dry powder inhaler.

ANORO® ELLIPTA® is a dual bronchodilator consisting of umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2-agonist (LABA) for the treatment of chronic obstructive pulmonary diseases (COPD). This once-a-day combination inhaled respiratory medicine is delivered via the ELLIPTA® dry powder inhaler.

TRELEGY® ELLIPTA® is a combination of fluticasone furoate (FF), an inhaled corticosteroid (ICS); umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD in patients with a history of exacerbations. This three-way combination inhaled respiratory medicine is self-administered by patients through the ELLIPTA® dry powder inhaler.

Field of Use
The field of use is for COPD/Asthma patients. Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing.

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: 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: 315809

License Grant
Licensor grants under the Licensor Technology in the U.S.
–   an exclusive license, with the right to sublicense, to research, develop, import, use, market, sell, have sold, offer for sale and otherwise commercialize the Product in the Field in the U.S., and
–   a co-exclusive license, with the right to sublicense, to manufacture and have manufactured the Product for the purposes of researching, developing, importing, using, marketing, selling, having sold, offering for sale and otherwise commercializing the Product in the Field in the U.S.; and,
–   a non-exclusive license, with the right to sublicense, solely and to the extent needed to conduct clinical and non-clinical development activities with respect to the Product in the Field outside the U.S.
License Property
Licensor is a pharmaceutical development company focused on the research, development, manufacturing and commercialization of novel proprietary products for the acute treatment of central nervous system disorders based on its proprietary technology, the Staccato® system, and has developed and obtained FDA approval for a drug-device combination product that is comprised of Loxapine (as defined hereinafter) delivered by a Staccato Device, and approved under the trade name Adasuve. Licensor owns or controls certain patents, know-how and other intellectual property relating to the Staccato Device and Product.

Product shall mean the drug-device combination product that is comprised of Loxapinc delivered by the Staccato Device, which has been or is during the Term approved by the FDA in the U.S., which form of product is currently designated as Adasuve®.

Staccato Device shall mean any hand-held, fixed-dosage device for the administration of API(s), which relies on Licensors proprietary heat package and stainless steel substrate to rapidly heat and create a condensation vaporized aerosol of APl(s) that allows the delivery of API(s) through deep lung inhalation, where the device is known as or based on, but may or may not be referred to, as the Staccato® system.

The patents relate to the Delivery of antipsychotics through an inhalation route.

Field of Use
ADASUVE (loxapine) is an inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

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: 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: 1165

License Grant
The license agreement assigns to the Licensee, Viratek’s exclusive license from a University covering the aerosol device used to deliver ribavirin (Virazole(R)) to the lungs.
License Property
VIRAZOLE® is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to Respiratory Syncytial Virus (RSV). Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy.
Field of Use
Ribavirin is an anti-viral drug indicated for severe RSV infection (individually), hepatitis C infection (used in conjunction with peginterferon alfa-2b or peginterferon alfa-2a), and other viral infections.

IPSCIO Record ID: 286068

License Grant
Licensors hereby grant to Licensee

(i) an exclusive (even as to Licensor, Licensor and their Affiliates), royalty-bearing license, with the right to grant sublicenses, under the Licensor Know-How and Licensor Patent Rights, to make, have made, use, have used, promote, develop, offer to sell, sell, have sold, import, have imported, export, have exported, and market Formulated Amikacin and Product in the Field throughout the Royalty Territory solely in connection with Exploitation of the Product in the Field throughout the Royalty Territory, provided that the foregoing license is subject to Licensor’s right to Manufacture as set forth in Agreement;

(ii) a non-exclusive, royalty-free license, under the Licensor Trademarks, with the right to grant sublicenses, throughout the Royalty Territory, to use and display the Licensor Trademarks in connection with the Commercialization of the Product in the Field throughout the Royalty Territory, as provided under and in accordance with this agreement; and

(iii) a non-exclusive, royalty-bearing license, under the Licensor Know-How and Licensor Patent Rights, with the right to grant sublicenses, in the Field throughout the Royalty Territory, to use, have used, promote, offer to sell, sell, have sold, import, have imported, export, have exported, and market the Device solely in connection with Exploitation of the Product in the Field throughout the Royalty Territory.

License Property
Product means the combination of (a) Formulated Amikacin and (b) the Device for use in the Pulmonary Delivery of Formulated Amikacin, which Product is developed in accordance with and pursuant to this Agreement. Product shall not include any products including nebulizer devices based upon the PDDS Platform Technology for use or sale with any active ingredients other than Amikacin, or any products including devices that are not based upon the PDDS Platform Technology.

Formulated Amikacin means Amikacin in a liquid formulation existing as of the Effective Date or developed pursuant to this Agreement for use in Pulmonary Delivery by means of the Device.

Device means a nebulizer device compnsmg at least an aerosol generator (which, as of the Effective Date, has the configuration designated by Licensor as the 'OnO' or 'OnO2'), housing and a medicine cup.

Licensor Patent Rights means (a) the Patents listed, (b) any Patents that issue from the Patent Applications, (c) any Patents and/or Patent Applications that claim priority to a Patent or Patent Application listed
7108197 – Droplet ejector with oscillating tapered aperture
7083112 – Method and apparatus for dispensing liquids as an atomized spray
7040549 – Systems and methods for controlling fluid feed to an aerosol generator

Licensor Trademarks means the trademarks and any Trademarks of Licensor or Licensor that are developed during the term of this Agreement for use with the Product.  Trademark means NEKTAR(R).

PODS Platform Technology means any technology, article of manufacture, component, system, discovery, or invention that relates to the Device, Device components (including without limitation controller, circuitry, software code, algorithm, electrical connections and fluid connections) and methods of making or using the Device (including without limitation methods of treatment or administration).

Field of Use
Field means the amelioration, treatment and/or prevention in humans of respiratory infections, including without limitation pneumonia*.

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: 233445

License Grant
The University grants an exclusive license under the Licensed Patents to develop, manufacture, have made, use, sell, have sold, distribute, rent or lease Licensed Products/Services throughout the Territory, together with a right to grant sublicenses, and, an exclusive license to use Licensed Technical Information to develop, manufacture, have made, use, sell, have sold, distribute, rent or lease Licensed Products/Services in the Field of Use throughout the Territory
License Property
Licensed Product/Licensed Service shall mean any product or service the development, manufacture, use, sale, distribution, rental or lease of which cannot be developed, manufactured, used, sold, distributed, rented or leased without infringing, in the relevant jurisdiction, a claim of a Licensed Patent that has neither expired nor has been declared invalid by a court from which no appeal has been or can be taken.

Licensed Technical Information shall mean know-how, formulations, confidential information, and physical materials existing as of the Effective Date and conveyed by Licensor to the Licensee relating to the Licensed Patents.  The patents are for Use of lntratracheally Administered Hyaluronic Acid to ameliorate Emphysema,  and, Method For The Prevention of Tissue Elastic Fiber Injury.

United States Patent #5,633,003, Use of Intratracheally Administered Hyaluronic Acid to Ameliorate Emphysema
United States Patent Application serial #09/079,209, Method For The Prevention of Tissue Elastic Fiber Injury

Field of Use
The intended use or application is for Defining the optimum Molecular Weight of Hyaluronic Acid (HA), and, Use of additional Compounds in Conjunction with HA, such as chondroitin sulfate, HA binding proteins, CD 44 receptor, and, Use of HA for drug delivery.

Patents relate to the use of intratracheally administered hyaluronic acid to treat certain respiratory diseases.

IPSCIO Record ID: 294022

License Grant
Australia Licensor hereby grants Licensee an exclusive license to the Licensor Intellectual Property and the Third Party Patents in relation to the Field in the Territory, with the right to grant sublicense, to develop, use, make (subject to the terms and conditions of this Agreement and any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates), sell, offer for sale, export and import the Products. In no event shall Licensee use the Licensor Intellectual Property or the Third Party Patents for purposes not related to Licensee obligations to Licensor under this Agreement or any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates.
License Property
Licensor Intellectual Property shall mean the Licensor Know-How, the Licensor Patents and the Licensor Developed Technology. Licensor Intellectual Property excludes (a) technologies solely relating to the Compound, Formulation, or the Product; and (b) products, processes, methods, technologies and other inventions in the public domain or that are owned or made by Third Parties (other than on behalf of Licensor or its Affiliates) and not Controlled by Licensor or its Affiliates.

Licensor Developed Technology shall mean improvements to the Licesor Know-How and Licensor Patents conceived, created, developed or otherwise invented or acquired solely by an employee or agent of Licensor or one of its Affiliates or a Third Party (under contract with Licensor or one of its Affiliates) as a direct result of fulfilling obligations or exercising rights, including the sharing of Confidential Information, under this Agreement or any other agreement between the Parties.

Licensor Patents shall mean any and all rights under the Patent Applications and/or Patents as set forth as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof. In the event any additional Licensor Patent or Patent Application is necessary or useful to allow Licensee to practice the rights granted to it by Licensor herein, Licensor shall include such Patent or Patent Application as applicable.
US application 10/497715 – Method of Particle Formation
US application 10/017135 – Synthesis of small particles.

Compound shall mean (i) any beta-agonist in combination with any steroid; (ii) any steroid; and (iii) insulin, as well as any salts, isomorphs, polymorphs, cogeners or isomers of the preceding. Initial specifications for each Compound will be agreed to by the parties and after such agreement shall be considered an original part of this Agreement.

Product shall mean the Formulation comprising the Product Intermediate and, to the extent required to effect delivery to a patient, a delivery device for use in the Field.

Formulation shall mean a composition of Product Intermediate suitable for administration by inhalation via pulmonary or nasal delivery, as applicable. A Formulation may comprise a mixture, blend or solution of the Product Intermediate combined with excipients and/or adjuvants or neat Product Intermediate and a single Product Intermediate may be covered by more than one Formulation. Specifications for each Formulation will be developed by MAP and after such development shall be considered an original part of this Agreement.

Beta-agonist shall mean any short-acting beta-agonist or any long-acting beta agonist as those terms may be further defined from time to time in a generally accepted pharmacology textbook.

Field of Use
Field shall mean the administration of a Product by inhalation as follows (i) for a Product containing any Beta-agonists and any steroid, the Field shall be limited to administration via pulmonary delivery; (ii) for a Product containing a steroid as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery; and (iii) for any Product containing Insulin as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery. The parties may add additional fields to the definition of Field as the parties may mutually agree from time to time, under the terms of this Agreement.

Licensee is engaged in the research and development of proprietary drug delivery systems for inhalation therapy by pulmonary or nasal delivery, including devices and formulations suitable for those devices.

IPSCIO Record ID: 273268

License Grant
Licensor of Ireland grants an exclusive, sublicensable license to the Licensor Intellectual Property for the sole purpose of, and only to the extent necessary for, using, marketing, distributing, selling, having sold, offering for sale, importing and exporting the Product in the Field in the Territory.

Licensor grant a non-exclusive sublicensable license in the Field in the Territory to the Licensor Intellectual Property for the sole purpose of, and only to the extent necessary for, Licensee to make and have made the Product Intermediate in Canada, the United States, Ireland, UK, France, Germany, Italy, Spain, Portugal, Netherlands, Belgium, Switzerland, Sweden, Finland, Norway, Denmark, Japan, Australia and New Zealand for use in the Field or to make and have made the Product Intermediate in any other country in the Territory as agreed by EPIL at its sole discretion.

Licensor grants a worldwide, irrevocable, nonexclusive license, with the right to grant sublicenses, to all Licensor Developed Technology to the extent that such Licensor Developed Technology does not incorporate NanoCrystal® Technology.

License Property
Products shall mean sterile, aqueous formulations of Compound, regardless of stabilizer, made using Licensor Intellectual Property, alone or in combination with a currently marketed long-acting Beta agonist; a currently marketed short-acting Beta agonist; or any Beta agonist to which Licensee has proprietary rights and packaged for commercial sale.

Compound shall mean the steroid budesonide.

Device shall mean a unit dose nebulizer.

NanoCrystal® Technology shall mean EPILs proprietary technology directed to
—  nanoparticulate dispersions of compounds stabilized against particle growth or agglomeration and materials, methods and equipment used for making such dispersions; and,
—  formulations including finished formulations derived from or incorporating said dispersions and materials, methods and equipment used for making such formulations including the NanoMill® System.

NanoMill® System shall mean the milling system designed and developed by or on behalf of Licensor and its Affiliates for preparing nanoparticulate dispersions for pharmaceutical formulations, including the milling equipment and appropriate milling media and stabilizing materials, and associated manuals, protocols and know-how.

Field of Use
The Field shall mean the pulmonary delivery of Product by means of the Device for therapeutic pharmaceutical use by humans.

IPSCIO Record ID: 203566

License Grant
The parties entered into to a Research and Development Agreement dated March 10, 1997 relating to EPI-HNE4, an inhibitor of human neutrophil elastase.  The Parties now enter into this Agreement for thecommercialization of the results of the Research and Development Agreement.

Licensor grants the Swiss Licensee an exclusive license with the right to sublicense during the term of this Agreement, under the EPI-HNE Patent Rights, EPIHNE Technology, the cystic fibrosis or CF Know-How and CF Patent Rights, to develop, use, offer for sale, sell, have sold, import and export CF Product in the Territory and to make or have made or to purchase or have purchased CF Product for such purposes.

Licensor grants exclusive license with the right to sublicense during the term of this Agreement, under the EPIHNE Patent Rights, EPI-HNE Technology, the applicable CF Know-How and CF Patent Rights, to develop, use, offer for sale, sell, have sold, import and export any Other Product in the Territory and to make or have made or to purchase or have purchased such Other Products for such purposes.

License Property
The EPI-HNE Technology shall mean molecules, including EPI-HNE4, recombinant strains that produce EPI-HNE4 and methods of purifying EPI-HNE4 from recombinant organisms, and other protein molecules with anti-neutrophil elastase activity as described in the EPI-HNE Patent Rights.

The Product is for cystic fibrosis.

Field of Use
The field means human therapeutic uses solely for the treatment of cystic fibrosis, acute respiratory distress syndrome ('ARDS'), and chronic obstructive pulmonary diseases (COPD), such as emphysema and chronic bronchitis.

IPSCIO Record ID: 291187

License Grant
Licensor grants the Licensee of Barbados;
– a license under the Licensor Technology to research, develop, import, use, sell, have sold and offer for sale the Product in the Field in the Territory, with such license being exclusive under the Licensor Product Patents and Licensor Know-How and non-exclusive under the Licensor Background Patents.

– a worldwide license under the Licensor Technology to manufacture and have manufactured the Product for use and sale in the Field in the Territory, with such license being co-exclusive with Licensor under the Licensor Product Patents and Licensor Know-How and non-exclusive under the Licensor Background Patents;

– a non-exclusive license solely to conduct clinical and non-clinical development activities with respect to .the Product outside the Territory, solely for the purpose of researching, developing, importing, using, selling, having sold and offering for sale the Product in the Field in the Territory;

For the Trademark and Copyright License, Licensor grants and causes its Affiliates to grant to Licensee, under the Licensor Trademarks and Copyrights an exclusive license to research, develop, manufacture, have manufactured, import, use, sell, have sold and offer for sale Product in the Field in the Territory and a non-exclusive license solely to conduct clinical and non-clinical development activities with respect to the Product outside the Territory, solely for the purpose of researching, developing, importing, using, selling having sold and offering for sale the Product in the Field in the Territory.

License Property
Product shall mean any combination product consisting of Loxapine and the Device which delivers Loxapine.

Device shall mean any hand-held, single-use, fixed-dosage device for the administration of API( s) which device relies on Licensors proprietary heat package and stainless steel substrate to rapidly heat and create a condensation vaporized aerosol of APl(s) that allows the delivery of APl(s) through deep lung inhalation, which device is known as or based on, but may or may not be referred to, as the Staccato® system.

Loxapine shall mean the compound or any metabolite, salt, polymorphic form, free base form or prodrug form of such compound.   Loxapine is for the treatment of psychiatric and/or neurological indications and the symptoms associated therewith, including the rapid treatment of agitation associated with schizophrenia or bipolar disorder.  The Product shall be sold in the Territory under the Trademark Adasuveâ„¢

The products will display both trademarks Adasuve and Staccato.

Field of Use
Loxapine is a typical antipsychotic medication used primarily in the treatment of schizophrenia. The drug is a member of the dibenzoxazepine class and structurally related to clozapine.

Field shall mean the prevention or treatment of any psychiatric and/or neurological indication and the symptoms associated with these indications.

IPSCIO Record ID: 279592

License Grant
For the exclusive Patent Rights, Licensor, an university,  grants to Licensee an exclusive license under such Patent Rights to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Exclusive Field in the Territory and to perform Licensed Services in the Exclusive Field in the Territory.

For the Limited Patent Rights, Licensor grants to Licensee

an exclusive license to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Limited Exclusive Field in the Territory and to perform Licensed Services in the Limited Exclusive Field in the Territory, and

a non-exclusive license to manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the field of vaccines the Territory and to perform Licensed Services in the field of vaccines the Territory. Both parties agree that Licensor can further license the Patent Rights listed in Exhibit C in the field of vaccines.

License Property
Exclusive Patent rights are for
—  Enhanced Delivery of Immunosuppressive Drug Compositions for Pulmonary Delivery
—  Compositions and Methods of Making Brittle-Matrix Particles Through Blister Pack Freezing
—  Process for Production of Nanoparticles and Microparticles by Spray Freezing Into Liquid
—  Drug Particles From Freezing onto a Surface
—  Multidrug Brittle Matrix Compositions
—  Templated Open Flocs of Anisotropic Particles for Enhanced Pulmonary Delivery
—  Non-Settling Flocs for Surfactant-Free Enhanced Pulmonary Delivery with Pressurized Metered Dose Inhalers
—  Tern plated Open Flocs of Anisotropic Particles for Enhanced Pulmonary Delivery

Limited patent rights are for
—  Formation of Stable Submicron Peptide or Protein Particles by Thin Film Freezing

Field of Use
The field of use relates to particle formation, and more particularly, to the formation of stable submicron protein particles.  The specific fields are as applicable in the Exclusive patents or Limited Exclusive patents.

Thin Film Freezing (TFF) platform can significantly improve the solubility of poorly water-soluble drugs, a class of drugs that makes up approximately 33% of the major pharmaceuticals worldwide, thereby improving the pharmacokinetic effect of those drugs. We believe that in the case of some new drugs that cannot be developed due to poor water-solubility, our TFF platform has the potential to improve the pharmacokinetic effect of the drug to a level allowing for its development and commercialization. While our TFF platform was designed to improve solubility of poorly water-soluble drugs generally, we have found that the technology is particularly useful in generating dry powder particles with properties that allow for superior inhalation delivery, especially to the deep lung, which is an area of extreme interest in respiratory medicine.

Disclaimer: The information gathered from RoyaltySource® database was sourced from the U.S. Securities and Exchange Commission EDGAR Filings and other public records. While we believe the sources to be reliable, this does not guarantee the accuracy or completeness of the information provided. Further, the information is supplied as general guidance and is not intended to represent or be a substitute for a detailed analysis or professional judgment. This information is for private use only and may not be resold or reproduced without permission.