Royalty Report: Drugs, Delivery, Device – Collection: 369286

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 11

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: 11

Primary Industries

  • Drugs
  • Delivery
  • Device
  • Pain
  • Medical
  • Optical
  • Surgical
  • Nanoparticles
  • Respiratory

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: 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: 248285

License Grant
The Norwegian Licensor hereby grants Licensee an exclusive (even as to Licensor) license to and under the Licensor Know-How, the Licensor Patents, the Licensor Trademarks and the Licensor Additional Intellectual Property (i) to use, sell, offer for sale, have sold and import the Product in the Licensed Territory; and (ii) to make or have made the Product anywhere in the world solely for such permitted use, sale, offer for sale and importation in the Licensed Territory.
License Property
Device means a nasal device used for the delivery of pharmaceutical products in a powder or liquid formulation and that is covered by an Licensor Patent listed below.

6,715,485 – Nasal delivery device
8,327,844 – Nasal delivery method
7,740,014 – Nasal devices

Product(s) means any products or product candidates developed by or under the authority of a Party or any of its Affiliates as of the Effective Date or during the Term consisting of a formulation that contains [as its sole active ingredient] a compound within the class of compounds [known as triptans], including any salt, polymorphic or amorphous form of such a compound, that is delivered in a nasal delivery device; [provided that, the foregoing definition of Product may be amended and expanded by the mutual agreement of the Parties, in each Partys sole discretion, to include a formulation of triptan with one or more other active ingredients]. For purposes of the foregoing, the class of compounds known as [triptans] includes the compounds known as of the Effective Date as the following Sumatriptan[, rizatriptan, naratriptan, zolmitriptan, almotriptan, frovatriptan, avitriptan and eletriptan]. Solely for the purposes of a Product shall also include products or product candidates consisting of [ a formulation that contains a compound within the class of compounds known as triptans (including any salt, polymorphic or amorphous form of such a compound) together with one or more other active ingredients, that is delivered in a nasal delivery device].  

Licensor Trademarks means, any, whether domestic or foreign, trademarks, service marks, and trade names Controlled by Licensor or any of its Affiliates as of the Effective Date or during the Term that are used (or required to be used) in connection with the Device or a Product in the Licensed Territory, including those trademarks, service marks and trade names listed (the 'Existing Licensor Trademarks').  
Service marks and trade names
Optimist, Optimose, Breath Powered, Bi-Directional

Field of Use
The rights granted apply to the healthcare industry relating to pharmaceutical products.

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: 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: 344522

License Grant
For the License to Product, Licensor grants to the Licensee of Japan, an exclusive license under the Licensor Technology to research, Develop, have Developed, make, have made, use, have used, market, distribute, import, export, lease, sell and offer for sale, promote, sell and have sold Product, in each case for use in the Field in the Territory.
License Property
Licensor owns and controls rights in and to certain technologies and compositions related to and comprising its proprietary injectable, non-polymeric, high viscosity liquid carrier known as the SABER formulation platform technology.

The Active Ingredient shall mean sirolimus.

The Existing Product shall mean those formulations of the Active Ingredient incorporating the SABER® Formulation Platform.

Product shall mean
— any pharmaceutical product incorporating (A) the Active Ingredient as its sole active pharrmaceutical ingredient and the SABER® Formulation Platform; or
— any Existing Product,
in each case formulated for local administration to the eye, including intra-ocular or peri-ocular injection.

SABER Formulation Platform shall mean, Licensors or its Affiliates proprietary (i.e. Covered by Licensor Patents or incorporating Confidential Information of Licensor) injectable non-polymeric, high viscosity liquid carrier system comprising SAIB for imparting controlled release to active ingredients.

SABER Technology is a patented technology designed to provide sustained release, bioerodible injectable depot systems.

Field of Use
The Field shall mean the treatment, mitigation or preventions of diseases, disorders or conditions of the eye.

IPSCIO Record ID: 273379

License Grant
The Irish Licensor grants to the Irish Licensee an exclusive license to the Licensor Intellectual Property to import, export, use, other than for formulation development activities, offer for sale and sell the Product in the Field in the Territory.

Licensor grants a worldwide, non-exclusive license to the Licensor Trademark, solely for the purpose of fulfilling Licensees obligations in relation to this Agreement.

License Property
Compound means the active drug substance lorazepam (7-chloro-5-(2-chlorophenyl)-3- hydroxy- l ,3-dihydro-2H-1,4..benzodiazepin-2-one) including all salts, esters, complexes, chelates, hydrates, isomers, stereoisomers, crystalline forms, amorphous forms, prodrugs (including all compounds that are metabolized or dissolve into the same active moiety in the body), solvates, metabolites/metabolic precursors, and pegylated form thereof.

Other Compound means diazepam (7-chloro-l-methyl-5-phenyl-l ,3-dihydro-2H-1 ,4- benzodiazepin-2-one). including all salts, esters, complexes, chelates, hydrates, isomers, stereoisomers, crystalline forms, amorphous forms, prodrugs (including all compounds that are metabolized or dissolve into the same active moiety in the body), solvates, metabolites/metabolic precursors, and pegylated form thereof.

Product means the nasal formulation of Product Intermediate incorporated or filled into a Device.

Buccal Formulation means formulations of Product Intermediate for administration by placing in the mouth for absorption through the cheek, the gum or the upper or lower inside lip without swallowing, achieved by means of a muco adhesive, including but not limited to any specific formulation that may be selected for commercialization.

Field of Use
The product is used or useful in the manufacture and use of products containing nanoparticles.

Field means the use as a prescription or over-the-counter pharmaceutical product in humans, specifically excluding diagnostic use.

Licensee acquired global rights to a novel nasal lorazepam formulation for the treatment of emergency seizures in epilepsy patients.

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: 372487

License Grant
For the Licensors Technology, Licensor grants an exclusive, even as against Licensor except for use pursuant to the Supply Agreement, sublicensable, worldwide license under the Licensor Technology to Exploit the Products and the exclusive right to negotiate additional licenses.
License Property
Patents include, but are not limited to
— Method of increasing nasal peptide drug delivery,
— Absorption Enhancers for Drug Administration, and
— Anti-bacterial compositions for drug administration.

Licensor has rights in certain proprietary technology regarding the chemically synthesizable delivery enhancement and stability agents that, among other things, allow noninvasive systemic delivery of potent peptide, protein, and large molecule drugs.

Compound shall mean glucagon or any glucagon analog, including any isomer, hydrates, anhydrides, solvates, esters, salt forms, free acids or bases, prodrugs, complexes or polymorphs.

Material shall mean the Licensor product known as Intravail® and/or ProTek® stabilization agents.

Product shall mean any product for use in the Field, comprising the Compound and formulated using the Enhancement Agents.

Enhancement Agents shall mean Licensors proprietary chemically synthesizable delivery enhancement agents (including without limitation the lntravail® absorption enhancement and ProTck® stabilization agents), that, among other things, allow non-invasive systemic delivery of potent peptide, protein, and small and large molecule drugs.

ProTek® protein stabilization technology comprises the use of proprietary GRAS excipients that prevent aggregation of proteins and peptides thereby improving the stability of drug product formulated with these excipients. Intravail® comprises a broad class of transmucosal absorption enhancement agents that allow non-invasive systemic delivery of potent peptide, protein, nucleotide-related, and other small and large molecule drugs.

Field of Use
The agreement will enable the development and commercialization of a wide variety of glucagon presentations, including Licensee's lead glucagon product candidate, a liquid formulation in an auto injector intended for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia. Other presentations and indications contemplated by the agreement include the use of glucagon in the treatment of hyperinsulinemia with continuous subcutaneous infusion and the treatment of hypoglycemia via intranasal administration and administration via a bi-hormonal pump.

IPSCIO Record ID: 319229

License Grant
United Kingdom Licensor granted to the Licensee an exclusive world-wide license to develop and commercialize products, including NES100, which contain hydrophilic neuropeptide Leucin5-Enkephalin and an amphiphile compound which is quaternary ammonium palmitoyl glycol chitosan, and to engage in a collaborative program utilizing Licensors knowledge, skills and expertise in the clinical development of products and in attracting external funding for such development.
License Property
NES100 is a nanotechnology-based intranasal spray drug product candidate which enables the delivery of a metabolically labile peptide drug (Enkephalin) into the brain. NES100 is manufactured using high pressure homogenization and spray drying. The Molecular Envelope Technology (MET) nanoparticles are well tolerated via the nasal route at the dose administered. There is pharmacological evidence of activity of MET enabled enkephalin in morphine-tolerant animals.  NES100 is an intranasal device to deliver exogenous enkephalin for the management of acute and chronic pain containing hydrophilic neuropeptide Leucin5-Enkephalin and an amphiphile compound which is quaternary ammonium palmitoyl glycol chitosan.

Intellectual Property includes but not limited to the US Patent Nos. 8,278,277.  This covers lipophilic derivatives of hydrophilic drugs comprising a hydrophilic drug and a cleavable linker as well as methods of treatment using these compositions. In particular the patents relate to compositions of a lipophilic derivative of the hydrophilic neuropeptide Leucine [5]-Enkephalin and an amphiphile compound, where the derivative includes a lipophilic linker attached to the side chain oxygen of the tyrosine in the Leucine [5]-Enkephalin, and where the amphiphile compound is quaternary palmitoyl glycol chitosan (GCPQ).
8,278,277 – Delivery of hydrophilic drugs

Licensor is a leader in pharmaceutical nanotechnology. The nanomedicines know-how and proprietary technology platforms provide drug delivery solutions for poorly water soluble drugs, nucleic acids and peptides.

Field of Use
The field of use is for the management of Post-Traumatic Stress Disorder relating to pain.  NES100 is an intranasal device and using this product supports the effort among prescribers, regulators, and patients to seek non-addictive treatment options to combat the opioid epidemic.

IPSCIO Record ID: 372482

License Grant
Licensor grants an exclusive, including with respect to Licensor except as to Licensor’s performance of its obligations under this Agreement or conduct of the Existing Clinical Trials, license, with the right to sublicense, in the Field in the Territory, under the Licensor Intellectual Property, to develop, make or have made, use, offer for sale, sell, import, market and promote Product.

For the Licensor Trademarks, Licensor grants an exclusive, including with respect to Licensor except as to Licensor’s performance of its obligations under this Agreement and conduct of Existing Clinical Trials, license, with the right to sublicense, to use the Licensor Trademarks solely in connection with Product in the Territory.

License Property
The patents relate to
Transmucosal delivery devices with enhanced uptake;
Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces; and,
Transmucosal drug delivery for use in chronic pain relief.

Licensor controls certain patents and know-how relating to Product, and has initiated clinical studies with respect to the Product.

The Active Ingredient means buprenorphine.  Buprenorphine is an opioid used to treat opioid use disorder, acute pain, and chronic pain.

Product means a drug product containing buprenorphine as its sole active ingredient (and not containing naloxone or any analog or derivative thereof and using Licensors BEMA Technology in any formulation and any dosage strength.

BEMA Technology means Licensor’s proprietary BioErodible MucoAdhesive (BEMA®) Drug Delivery Technology, a buccal soluble film consisting of a small bioerodible polymer film for application to the mucosal membranes (inner lining of the cheek).

Field of Use
The Field means all uses in humans.  Buprenorphine is an opioid used to treat opioid use disorder, acute pain, and chronic pain.

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.
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