Royalty Report: Drugs, Delivery, Respiratory – Collection: 294022

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 16

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: 16

Primary Industries

  • Drugs
  • Delivery
  • Respiratory
  • Device
  • Pain
  • Disease
  • Therapeutic

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: 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: 294023

License Grant
English Licensor hereby grants Licensee an exclusive royalty-bearing license in the Territory, for the term of this Agreement, with the right to grant sublicenses, to and under the Compound-Inclusive Claims and the Licensor Know-How, to manufacture, use, import, export, offer for sale, sell and otherwise develop and commercialize the Product within the Field.

Licensor hereby grants Licensee a worldwide, exclusive, perpetual, irrevocable, royalty free, fully-paid up license, with the right to grant sublicenses through multiple tiers without restriction, to and under the Licensor Patent Rights that are Compound-Limited Claims. The license grant shall survive termination or expiration of this Agreement for any reason.

License Property
Licensor has been engaged in the research and development of engineered particles to enhance the therapeutic performance of compounds (to be administered by pulmonary or aerosol delivery) using its proprietary supercritical fluid particle formation technology, including but not limited to solution enhancement dispersion of supercritical fluid particles

Device means any device designated by Licensee for use for inhalation by means of nasal delivery or pulmonary delivery of the Formulation that is suitable for use in clinical trials for the Product and commercialization of the Product, including devices for which Licensee owns an exclusive license in the Field for such purpose. Unless otherwise noted, the use of the term “Device” in this Agreement is not intended to indicate thereby the definition of “device” in the Federal Food, Drug and Cosmetic Act, as amended. Notwithstanding any other provision of this Agreement, Licensor does not grant to Licensee any license or other right in or to any device Controlled by Licensor other than those rights granted or in or to any device Controlled by any Affiliate of Licensor.

Compound means dihydroergotamine mesylate salt or isomorphs or isomers thereof.

Compound-Inclusive Claims means all claims of Licensor Patent Rights that are not Compound-Limited Claims.

Licensor Patent Rights means the rights granted by any governmental authority under any Patents and Patent Applications Controlled by Licensor that, assuming such Patent Applications were issued Patents, but for the grant of the license, would be infringed by the manufacture, use, import, export, offer for sale or sale of a Particulate Formation of Compound, including without limitation a Particulate Formation of Compound or Product by or on behalf of Licensee (other than by Licensor), including without limitation those Patents and Patent Applications listed. Licensor Patent Rights do not include Licensor Know-How. Licensor represents that it has used good faith efforts to include all Licensor Patent Rights existing as of the Effective Date. Once per calendar year or as reasonably requested by Licensee, the Parties will update the list as applicable.

US 6,063,138 – Method and apparatus for the formation of particles

Product means the combination of the Formulation, produced through processing of the Particulate Formation of Compound, and a Device, the manufacture, use, import, export, offer for sale or sale of which by or on behalf of Licensee would, but for the grant of the licenses in this agreement, infringe any Licensor Patent Rights or exploit any Licensor Know-How.

Patent means (i) letters patent and utility models including any extension, substitution, registration, confirmation, reissue, re-examination, renewal, or foreign corresponding rights thereof and (ii) to the extent rights are granted by a governmental authority thereunder, a Patent Application.

Compound-Limited Claims means all claims of those Licensor Patent Rights listed or that are not listed that claim Compound, formulations of Compound, compositions of matter, methods of manufacture or methods of using Compound or formulations of Compound, including without limitation the Particulate Formation of Compound and Formulation, whether or not such claims claim any compositions of matter, methods of manufacture of methods of using other compounds or formulations of such other compounds.

Field of Use
The patents and know-how is to develop and commercialize any formulation of a form of dihydroergotamine for administration by inhalation using a device.

Field means administration of the Formulation by nasal or pulmonary delivery to patients by means of a Device.

MAP0004 is our proprietary inhaled version of dihydroergotamine, or DHE, intended to treat migraine.

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: 291110

License Grant
Canadian Licensor hereby grants to Licensee an exclusive license for the Field in the Territory under the Licensed Patents; and an exclusive license for the Field in the Territory under the Know-How; for the sole purpose of developing, making, having made, importing, using, offering for sale and selling Licensed Product in the Territory, including the right to grant sublicenses under these rights as set out in this Agreement.
License Property
Licensed Product means Ciprofloxacin encapsulated in the Licensor Liposome Technology and which is intended for pulmonary delivery.

Ciprofloxacin means the chemical compound known as ciprofloxacin, whose more specified chemical name is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid and all pharmaceutically active salts thereof.

AERx Device means the durable hand-held device developed by Licensee for the delivery of Ciprofloxacin by inhalation and known as the AERx Device, as such device may be modified pursuant to the Agreement.

Loading Patents means the patents owned by University and exclusively licensed to Licensor and set out in Agreement.
5,800,833 – Method for loading lipid vesicles
5,785,987 – Method for loading lipid vesicles

Sphingosome Patents means the Patents owned by Licensor and set out in this Agreement.
5,543,152 – Sphingosomes for enhanced drug delivery

Licensed Patents means the Loading Patents and the Sphingosome Patents.

Patent means (a) all patent applications filed or having legal force in any country owned or controlled by Licensor as of the Effective Date; (b) all patents that have issued or in the future issue therefrom owned or controlled by Licensor as of the Effective Date, including without limitation utility, model and design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions (including supplemental protection certificates), additions, registrations or confirmations to or of any such patent applications and patents.

Licensor Liposome Technology means Licensor’s proprietary liposomal drug delivery system that encapsulates drugs in sphingomyelin/cholesterol liposomes using a proton gradient generated by either an ionophore or methylammonium sulfate.

Field of Use
This agreement pertains to patented liposomal formulation technology for the pulmonary delivery of ciprofloxacin

Ciprofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. It is used to treat different types of bacterial infections, including skin infections, bone and joint infections, respiratory or sinus infections, urinary tract infections, and certain types of diarrhea.

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: 344505

License Grant
By this agreement, the German Licensor grants Exclusive rights under the Licensor Technology and the Licensor Trademarks to Distribute, Commercialize and Develop Products incorporating the Compound in the Territory and in the Field.

Licensor grants the following rights in the Territory and in the applicable Field
— For the Appointment as Exclusive Distributor for Original Products.    Licensor appoints  Licensee as the Exclusive Distributor of the Original Products in the Territory, with the sole and exclusive right, exclusive even as to Licensor, to Commercialize these Products in the Territory.
— For the Grant of Rights under Licensor Technology to Develop and Commercialize Products,  An Exclusive right under the Licensor Technology in the Territory to Develop and Commercialize Products in the Field.
— For the Grant of Rights under the Teijin Patents to Develop and Commercialize Products, subject to the payments to be made pursuant to this Agreement, a right and irrevocable during the Term, fully paid up sublicense under the Teijin Patents to Develop and Commercialize Products in the Field.
— For the Grant of Rights under the 3M Patents to Develop and Commercialize Products, a right and irrevocable during the Term, fully paid up non-exclusive license under the 3M Patents to Develop and Commercialize Products in the Field.
— For the Grant of Rights under Licensor Trademarks to Commercialize Product, an Exclusive right and license under the Licensor Trademarks, to Commercialize Products in the Territory and in the Field exclusively under such Trademarks, as assigned by Licensor through the Steering Committee to each Product.

License Property
The pharmaceutical compound is ciclesonide.

The compound specifications are
B9207-015 INN Ciclesonide Chemical Abstracts Name 16.17-[(Cyclohexylmethylene)bis(oxy})-11-hydroxy-21-(2-methyl-1-oxopropoxy} pregna-1.4-diene-3.20-dione (( 11 beta, 16alpha/R}) as more specifically laid out in Licensors Specifications of Ciclesonide un-micronized (Version 23 0} and Ciclesonide micronized (Version 14,0}. both dating 10 August 2007,

The trademarks are Omnaris and Alvesco.

Licensor controls certain Licensor Technology relating to its proprietary Compound (INN) and certain products incorporating such Compound including, without limitation, the Alvesco® MDI Product, an innovative inhaled corticosteroid (ICS) providing asthma control in all patient groups regardless of asthma severity, and the Omnaris® AQ Product, an innovative intranasal steroid formulation exhibiting significant therapeutic effects in seasonal as well as perennial allergic rhinitis (SAR/PAR).

Licensee acknowledges that Licensees rights to any 3M Technology and Teijin Technology forming part of the Licensor Technology are only provided to the extent Controlled by Licensor.

Field of Use
The Field means all prophylactic and therapeutic uses in humans in any formulation or dosage form for any and all indications including, without limitation, the Nasal Field and the Respiratory Field.

Alvesco® MDI Product, an innovative inhaled corticosteroid (ICS) providing asthma control in all patient groups regardless of asthma severity, and the Omnaris® AQ Product, an innovative intranasal steroid formulation exhibiting significant therapeutic effects in seasonal as well as perennial allergic rhinitis (SAR/PAR).

Omnaris is used to treat symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing) caused by seasonal and year-round nasal allergies. Ciclesonide works by reducing the swelling (inflammation) of the nasal passages.

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.

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: 369286

License Grant
Japanese Licensor hereby grants to Licensee an exclusive, royalty-bearing license (with the right to sublicense in accordance with this agreement, under the Licensed Technology to (i) develop, use, sell, offer for sale, import or otherwise commercialize the Product, and (ii), make or have made the Product (using the Device supplied by Licensor or a Third Party permitted under this Agreement); in each case of (i) and (ii) solely for the Field within the Territory.

Licensee has the right to grant sublicenses under the license granted to any Affiliate or Third Party, other than a Licensor Competitor, to commercialize the Product in EU, Japan, Australia, New Zealand, Canada, the United States and/or the Territory in its entirety without Licensor’s prior written approval.

License Property
Licensed Patents
8,337,817 – Preparation for transnasal application

Product means the product consisting of (i) a pharmaceutical product containing the Compound, as the only active pharmaceutical ingredient, formulated using the Formulation Technology and (ii) the Device that contains such pharmaceutical product.

Device means the single-use version of Licensor’s proprietary nasal delivery device (Fit-lizer™).

Compound means the compound known as Dihydroergotamine or DHE, and any complex, chelate, salt, hydrate, polymorph, isomer, diastereomer, prodrug, congener, metabolite or ion pair thereof.

Formulation Technology means Licensor’s proprietary nasal drug delivery formulation technology as further described below, including its powdery drug carrier (µco™ System carrier).
– Licensors proprietary inhalable dry powder pharmaceutical formulations designed to enhance drug absorption, comprising of one or more physiologically active substance and muco-adhesive powder drug carrier (µcoâ„¢ Carrier) including Microcrystalline cellulose Ceolus® PH-F20JP (Manufacturer Asahi Kasei Corporation), microcrystalline cellulose Ceolus® PH-301; (Manufacturer Asahi Kasei Corporation) and tribasic calcium phosphate.

Field of Use
The licensing agreement is for a novel, rapidly absorbed treatment for acute migraine incorporating dihydroergotamine (DHE) as the active drug.

TO-2070 is expected to offer a new and potentially improved approach to the treatment of acute migraine.  Preclinical data suggest that TO-2070 may offer significant migraine treatment benefits beyond those provided by less convenient and more invasive DHE drug delivery methods, such as injection, liquid nasal sprays or pulmonary inhalation.  TO-2070 is designed to provide these benefits at a relatively low cost via a unique and proprietary nasal powder drug delivery system that can be easily self-administered by patients.

TO-2070 is based on a novel nasal powder drug delivery technology created by SNBL that combines a muco-adhesive drug carrier with a proprietary nasal powder drug delivery device.  This system is the product of a decade-long SNBL internal development program with the objective of unlocking the significant market potential for nasal drug delivery by overcoming many of the obstacles that have limited its application to date.  Unlike previous nasal drug delivery technologies, the SNBL system is able to consistently deliver drug into the nasal cavity with each administration and hold it in place on the nasal mucosa to enable enhanced absorption into the bloodstream. Delivery of the dry powder drug formulation to the nasal mucosa via the specially designed device nozzle is achieved by simply squeezing the device.

IPSCIO Record ID: 344507

License Grant
Licensor of Malta grants the exclusive right and license under the Licensor Patents and Licensor Know-How to Develop, have Developed, market, have marketed, use, have used, Commercialize, have Commercialized, distribute, have distributed, offer for sale, sell and have sold the Products in the Territory and to package, distribute, sell, market and promote the Products in and throughout the Territory, including the right to grant sub-licenses, subject to all of the terms and conditions of this Agreement.
License Property
Licensor controls certain Licensor Know-How and Licensor Patents relating to the Products, including technology essential to the Development of stable and acceptable preparations, suspensions, or other chemical mixtures of ingredient required to Develop a product containing a corticosteriod, including Ciclesonide.

Ciclesonide, alone is the Standalone Product.
Arformoterol is the Combination Product.

Ciclesonide means the compound ciclesonide including all its isomers, titrates, hydrates, metabolites, polymorphs, prodrugs, epimers, and salts.

Field of Use
Ciclesonide is an inhaled corticosteroid that is intended for the treatment of asthma symptoms, regardless of asthma severity.

The  license and development agreement is for know-how and intellectual property rights related to stable sterile suspension formulations, for use in the development, commercialization, marketing, sale and distribution of an inhalation pharmaceutical product containing ciclesonide as its only active ingredient and an inhalation pharmaceutical product containing both ciclesonide and arformoterol as its active ingredients, throughout the world, collectively referred to as the Ciclesonide Products.

Competing Products means any nasal or inhaled corticosteroid formulations, arformoterol or formoterol, whether containing a single or two or more active ingredients, in the Territory, other than products currently marketed by Licensor as of the Effective Date and products containing budesonide, fluticasone or salmeterol, alone or in combination with any other active pharmaceutical ingredient other than Ciclesonide, arformoterol, or formoterol,

Licensee has material capabilities, resources and experience in the development, clinical testing, regulatory approvals, commercialization, marketing and distribution of branded inhalation pharmaceutical products.

IPSCIO Record ID: 344506

License Grant
Licensor of Malta grants the exclusive right and license under the Licensor Patents and Licensor Know-How to Develop, have Developed, market, have marketed, use, have used, Commercialize, have Commercialized, distribute, have distributed, offer for sale, sell and have sold the Product in the Territory and to package, distribute, sell, market and promote the Product in and throughout the Territory, including the right to grant sub-licenses, subject to all of the terms and conditions of this Agreement.
License Property
Licensor has material capabilities, resources and experience in the development and analytical testing of inhalation pharmaceutical products, and has made substantial progress in development of the Product.

Product means Licensors levalbuterol/ipratropium combination inhalation solution product in current and all future formulations and delivery modes, any Additional Product and any Improvement.

Field of Use
The Levalbuterol/ipratropium Product candidate is  an inhalation solution with the potential to treat chronic obstructive pulmonary disease, or COPD.

Competing Products means any nasal or inhaled formulations, whether containing a single or two or more active ingredients, for the treatment of asthma or COPD, in the Territory, other than products currently marketed by Licensor as of the Effective Date and products containing budesonide, fluticasone or salmeterol, alone or in combination with any other active pharmaceutical ingredient other than levalbuterol.

IPSCIO Record ID: 367578

License Grant
Israeli Licensor hereby grants to the Licensee an exclusive worldwide through multiple tier license, in the Territory, to 1) the Intellectual Property Rights resulting from and/or arising under the Development Plan and/or Development Results including Resulting Patents, and/or the Drug Formulation and/or Product ; and 2) to make, have made, use, have used and/or license the Drug Formulation and/or the Development Results, and 3) to make, have made, sell, have sold, use, have used, license, and/or import Product; and 4) an exclusive license in the Territory to any Patents covering the Drug Formulation and Product to enable the Licensee to make, have made, sell, have sold, and/or use Products. The Licensee shall not use the Drug Formulation and/or the Development Results for any purpose other than exercise of the License. Licensor hereby grants to the Licensee a non-exclusive license, in the Territory under the Licensor Patents, to use the Licensor Formulation Technology to 1) develop, make, have made, and use, the Drug Formulation, and 2) develop, make, have made, sell, have sold, and use, Product.
License Property
Licensor Patents shall mean the patents and/or patent applications covering or disclosing Licensor Formulation Technology; and including but not limited to,  U.S. Patent No. 5,540,934, U.S. Patent No. 5,716,638 and PCT International Application No. PCT/EP95/02397 and any continuations, continuations-in-part, extensions, divisions, substitutions or additions to such applications and all patents which are reissues thereof, re-validations and registrations based thereon, and any and all foreign patents and patent applications corresponding thereto.

5,540,934 – Compositions for applying active substances to or through the skin
5,716,638 – Composition for applying active substances to or through the skin

Product means a pharmaceutical preparation or composition containing the Drug Formulation which is covered by a Valid Patent Claim.

Drug means the Licensees organoselenium drug or materials, as specified in this Agreement, and its racemate, metabolite, derivatives, isomers, polymorphs, crystals.

Drug Formulation means the formulation of the Drug utilizing Licensors Formulation Technology.

Field of Use
Field of use is for Ethosome, a non-invasive, transdermal drug delivery technology.

Ethosomes are phospholipid nanovesicles used for dermal and transdermal delivery of molecules.

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: 294017

License Grant
The English Licensor hereby grants, on behalf of itself and its Affiliates, to the English Licensee, effective on the Effective Date, a royalty-bearing, exclusive (even as to Licensor (except to the extent necessary for Licensor to perform the Licensor Development Activities)) worldwide license, with the right to sublicense, under the Licensor Technology to Manufacture, Develop and Commercialize the Products in the Field in the Territory.

Licensee hereby grants, on behalf of itself and its Affiliates, to Licensor, effective on the Effective Date, a royalty-free, non-exclusive license, with the right to sublicense, (i) under the Licensee Technology to the extent necessary for Licensor to perform the Licensor Development Activities and (ii) under any Licensee Improvement Manufacturing Patent Rights for use other than for the Manufacture, Development and/or Commercialization of the Products in the Field in the Territory.

License Property
Xodol means the product currently marketed under the brand name 'Xodol', which is a combination of 5, 7.5 or 10 milligrams (mg) ofhydrocodone, in each case, combined with 300 mg of acetaminophen (it being understood that (x) Licensors existing sublicensee currently markets such product under a different name and (y) such product, whether marketed under such different name or any other name in the future, shall be deemed to be 'Xodol' for the purposes of this Agreement).

Product means any Hydrocodone Product or Combination Product.

Hydrocodone Product means any pharmaceutical product containing Hydrocodone as its sole Active Ingredient that is in a formulation containing the Licensee Technology and which is Developed, Manufactured and Commercialized pursuant to, and in accordance with, this Agreement.

Combination Product means any pharmaceutical product comprised of Hydrocodone and any non-opioid agonist drug as the Active Ingredients.  For purposes of clarity, S-297995 (also known as Naldemedine) is a non-opioid agonist drug.

S-297995 means (5R, 14S)-17-(Cyclopropylmethyl)-6, 7-didehydro-4,5-epoxy-3 ,6, 14-trihydroxy-N-[1-methyl-l-(3-phenyl-1,2,4-oxadiazol-5-yl)ethyl]morphinan-7-carboxamide Monotosylate including any metabolites, prodrugs, solvates (including hydrates), esters, salts, stereoisomers, racemates, tautomers and polymorphs (including crystal forms), of such compound.

Licensor Technology means the (a) Licensor Know-How and the Licensor Patent Rights, including Licensor Core Technology (b) the Licensor Core Technology Improvements, and (c) all intellectual property rights therein.

Licensor Patent Rights means any Patent Right that Licensor or its Affiliates Controls on the Effective Date or that comes into the Control of Licensor or its Affiliates during the Term (other than any Patent Rights which are Licensee Patent Rights), to the extent that such Patent Right is necessary or useful to Develop, Manufacture, or Commercialize in the Territory, the Products in the Field, including any method of making the Products, any composition or formulations of the Products, or any method of using or administering the Products provided that Licensee Patent Rights excludes any Patent Rights to the extent relating to an Licensee API.  The Licensor Patent Rights existing on the Effective Date are set forth.
8,298,581 – Matrix compositions for controlled delivery of drug substances
8,563,038 – Formulations and methods for the controlled release of active drug substances

Licensor Core Technology means, to the extent covered by any Licensor Patent Rights or Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date,  (i) any abuse-deterrent drug delivery system, (ii) the formulation of products for which any such abuse-deterrent drug delivery system is used and/or (iii) manufacturing of products containing any such abuse-deterrent drug delivery system.  

Licensor Core Technology includes the Licensor Patent Rights and Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date to the extent covered by clause (i), (ii) and/or (iii) above.  Notwithstanding anything herein to the contrary, in the event there is a dispute as to whether anything in clause (i), (ii) and/or (iii) above was covered by any such Licensor Know-How as of the Effective Date, Licensor shall have the burden of proof with respect to establishing that it was so covered.

Generic Product means, on a country-by-country basis, any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or Sublicensee of Licensee under a marketing authorization granted by a Regulatory Authority to a Third Party and (b) results from (i) an abbreviated new drug application including any amended or successor abbreviated route of approval thereof in the United States (ANDA) or (ii) abbreviated routes of approval in any other countries in the Territory that are comparable to ANDA, which in the case of clause (i) and/or (ii), references the applicable Product, provided that (x) such pharmaceutical product has the same Active Ingredient as the Product and an abuse deterrent system or (y) the Product is the primary basis for the approval of such pharmaceutical product.

Patent Right means any and all (a) patent applications filed in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon; (b) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof; and (c) any other form of government-issued right substantially similar to any of the foregoing, including certificates of invention and applications for certificates of invention.

Field of Use
The collaboration is for the development and commercialization of abuse-deterrent hydrocodone-based product candidates.  Abuse-deterrent is for the treatment of pain and in other indications.

IPSCIO Record ID: 213679

License Grant
Licensor hereby grants to English Licensee an exclusive, sub-licensable, license under the Licensor IP to research, have researched, develop, have developed, manufacture, have manufactured, import, register, market, promote, distribute, use, sell, supply and otherwise exploit Products in the Territory; and to otherwise exercise Licensee’s rights and fulfill Licensee’s obligations pursuant to and in accordance with the provisions of this Agreement.

Further, Licensor hereby grants to Licensee a non-exclusive, sub-licensable, licence under the Licensor IP to use the same with clinical comparator products and mono products or combination products solely for the purposes of the development of Products hereunder.

License Property
Licensor Technology means Licensor’s proprietary iSPERSEâ„¢ technology.  iSPERSEâ„¢, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximising local concentrations and reducing systemic side effects to improve patient outcomes.

Licensor IP means
(a)    any and all Intellectual Property owned or controlled by Licensor or its Affiliates at the Effective Date relating to the Licensor Technology and/or Formulation(s), including the Patents and such rights in the Licensor Data; and
(b)    any improvements or developments thereto developed independently of this Agreement; and
(c)    any improvements or developments thereto created or developed by or on behalf of Licensee during the course of this Agreement except to the extent such improvements or developments constitute Licensee IP.

Intellectual Property means patents, supplementary protection certificates, trademarks, service marks, registered designs, rights in designs, applications for any of the foregoing, trade or business names, copyrights, rights under licences and consents for any such thing and all rights or forms of protection of a similar nature or having equivalent or similar effect subsisting anywhere in the world.

Product means any product combining a Device with a Formulation.

Licensor Data means any data, reports or other documentation, including the data package for PUR0200, in Licensor’s possession or under its control as at the Effective Date.

Device means an inhaler device to be determined by Licensee.

Formulation means (a) any formulation of Tiotropium formulated using the Licensor Technology, including PUR0200 and/or (b) any formulation of [*****] formulated using the Licensor Technology.

“[*****]” means [*****] alone for monotherapy, and not in combination with any other active ingredient.

Licensee IP means any Intellectual Property
a)      covering a Device and any formulation of drugs for a Device and owned or controlled by Licensee or its Affiliates as of the Effective Date (which for the avoidance of doubt shall exclude the Formulations and Licensor Technology);
b)      any improvements or developments thereto developed independently of this Agreement;
c)      any improvements or developments thereto created or developed by or on behalf of Licensee during the course of this Agreement; and
d)      created or developed by or on behalf of either Licensee during the course of this Agreement relating to a Device, including without limitation any improvements thereto, and relating to the development, Manufacture and connectivity (for example, but without limitation, mHealth) thereof.

Field of Use
This agreement pertains to the drug industry relating to the field of respiratory disease.

IPSCIO Record ID: 279333

License Grant
Licensor hereby grants to Licensee for the Term of this Agreement an exclusive (even as to Licensor) license in the Field under the Licensor Intellectual Property to develop, make, have made, use, sell, offer for sale and import Licensed Product(s) in the Territory.
License Property
Licensed Product(s) means all finished pharmaceutical oral formulations for commercial sale (or, where the context so indicates, a Formulation Candidate) that (i) contain the Compound alone as a therapeutically active ingredient or in combination with any other pharmaceutically active ingredient, and (ii) utilize Licensor Intellectual Property.

Intellectual Property means the Licensed Patents, the Licensor Know-How and the Licensor Technology.

Licensed Patents means Patents owned or controlled by Licensor or which Licensor, through license or otherwise, has or acquires rights, which are necessary or useful for the manufacture, use or sale of Licensed Product, including, but not limited to, compositions, formulations, methods of their manufacture, or methods of their use, or otherwise relate to Licensor Know-How or Licensor Technology, including (i) any of the Patents set forth hereto that contain claims that cover, or which relate to, any aspect of Licensed Product, (ii) the Development Patents and (iii) such other Patents as the Parties may agree in writing from time to time.

5,447,729 – Multilamellar drug delivery systems
5,484,608 – Sustained-release drug delivery system

Licensor Technology means  Licensor’s bioavailability enhancement and/ or controlled-release delivery, formulation, process and manufacturing technologies, including but not limited to the Licensor Lead Technology and the technologies embodied in the Licensed Patents and the Licensor Know-How.

Licensor Lead Technology means Microtrol® multi particulate technology or, as subsequently agreed between the Parties, one of the Other Licensor Technologies as may be applied to the Compound pursuant to the Development Plan.

Compound means trospium chloride, the chemical compound whose specific chemical name is 3-alpha benziloyJoxynortropane-8-spiro-1-pyrrolidinium; chloride, or any other trospium salt.

Field of Use
Trospium chloride (“trospium”) is  indicated for urinary incontinence. Trospium is currently under evaluation in a Phase III clinical study.
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