Category: Technology Licenses
Created On: 2022-04-28
Record Count: 16
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
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.
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
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.
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 â€œDeviceâ€ in this Agreement is not intended to indicate thereby the definition of â€œdeviceâ€ 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 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
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 NanoCrystalÂ® Technology.
Compound shall mean the steroid budesonide.
Device shall mean a unit dose nebulizer.
NanoCrystalÂ® 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 NanoMillÂ® System.
NanoMillÂ® 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.
IPSCIO Record ID: 291110
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 Licensorâ€™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.
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
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.
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.
IPSCIO Record ID: 344505
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.
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 AlvescoÂ® MDI Product, an innovative inhaled corticosteroid (ICS) providing asthma control in all patient groups regardless of asthma severity, and the OmnarisÂ® 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.
AlvescoÂ® MDI Product, an innovative inhaled corticosteroid (ICS) providing asthma control in all patient groups regardless of asthma severity, and the OmnarisÂ® 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
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.
— 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
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
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.
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.
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 Licensorâ€™ novel capillary aerosolization technology – to deliver therapeutics to the deep lung.
IPSCIO Record ID: 369286
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 Licensorâ€™s prior written approval.
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 Licensorâ€™s proprietary nasal delivery device (Fit-lizerâ„¢).
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 Licensorâ€™s proprietary nasal drug delivery formulation technology as further described below, including its powdery drug carrier (Âµcoâ„¢ 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 (Âµcoâ„¢ Carrier) including Microcrystalline cellulose CeolusÂ® PH-F20JP (Manufacturer Asahi Kasei Corporation), microcrystalline cellulose CeolusÂ® PH-301; (Manufacturer Asahi Kasei Corporation) and tribasic calcium phosphate.
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
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.
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
Product means Licensors levalbuterol/ipratropium combination inhalation solution product in current and all future formulations and delivery modes, any Additional Product and any Improvement.
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
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.
Ethosomes are phospholipid nanovesicles used for dermal and transdermal delivery of molecules.
IPSCIO Record ID: 273406
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.
IPSCIO Record ID: 294017
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.
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.
IPSCIO Record ID: 213679
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.
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 Licensorâ€™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.
â€œ[*****]â€ 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.
IPSCIO Record ID: 279333
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 Licensorâ€™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 MicrotrolÂ® 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.