Royalty Report: Drugs, Pain, Delivery – Collection: 372482

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 14

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: 14

Primary Industries

  • Drugs
  • Pain
  • Delivery
  • Cancer
  • Disease
  • Pharmaceuticals
  • Drug Discovery
  • Adhesive/Bonding
  • Medical
  • 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: 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: 372509

License Grant
Licensor grants to the Licensee of Sweden during the Initial Term an exclusive, sub-licensable license, under the Licensed Technology to market, advertise, promote, distribute, offer for sale, sell and import the Licensed Product in the Territory, and,
grants during the Term a non-exclusive, sub-licensable license under the Licensed Technology to, on a Licensed Product-by-Licensed Product basis and effective only with respect to the development of a Licensed Product for a particular indication following Governmental Approval of such Licensed Product for such indication, research and develop such Licensed Product in the Territory.

During the term of this Agreement, Licensor shall not sell any Licensed Product or any Competing Product with respect thereto for use in the Territory, nor grant any right or license to any Third Party with respect to the Licensed Product or any Competing Product in the Territory.

For the Trademarks, Licensor grants an exclusive, sub-licensable license to use the Marks during the Term solely in connection with the promotion, marketing, distribution, offer for sale, and sale of the Licensed Product in the Territory.

License Property
Marks means BEMA.  BEMA means the proprietary bioerodible, mucoadhesive multi-layer polymer film technology.

The Licensed Product means individually and collectively the BEMA-based product which contains fentanyl as it sole API, is currently the subject of Phase III clinical trials being conducted by Licensor, would, but for the licenses granted under this Agreement, infringe one or more claims of the Licensed Patent Rights, and does not contain naloxone as an additional ingredient.  Fentanyl Product means any Licensed Product other than the Naloxone Product.

BEMA(TM) Fentanyl consists of a small, dissolvable, polymer delivery system, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. BEMA(TM) Fentanyl has shown in Phase III clinical studies important patient advantages compared to competing products, especially fewer side effects.

BEMATM Fentanyl is a treatment for “breakthrough” cancer pain (i.e., episodes of severe pain which “break through” the medication used to control the persistent pain). BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid pain relief. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain

Field of Use
The field of use is for Breakthrough Pain In Opioid Tolerant Cancer Patients.

IPSCIO Record ID: 4069

License Grant
In connection with the Licensor's consent to our U.S. licensing transaction with Meda AB relating to ONSOLISâ„¢, we and the Licensor entered into a second Dispute Resolution Agreement pursuant to which we and the Licensor agreed to waive and dismiss with prejudice all current disputes between us, concerning each of the Clinical Development and Licensing Agreements and a securities purchase Agreement that we previously entered into which disputes had commenced during 2006.
License Property
BEMAâ„¢ (BioErodible MucoAdhesive) drug delivery system

The BEMA® drug delivery technology is a buccal soluble film consisting of a small, BioErodible polymer film for application to the mucosal membranes (inner lining of cheek). BEMA® films were designed to rapidly deliver a dose of drug across the mucous membranes for time sensitive conditions.

Field of Use
The rights apply to the healthcare industry.

IPSCIO Record ID: 282856

License Grant
Licensor hereby grants to Licensee, subsidiary, a sole and exclusive, royalty-bearing license under the BEMA Technology to use, develop, market, advertise, promote, distribute, offer for sale, sell, export and import, manufacture, and have manufactured Products in the Territory, with the right to sublicense in accordance with this agreement. Subject to the terms of this Agreement, Licensee shall have the right to assign this Agreement, on the basis set forth in this agreement. During the term of this Agreement, Licensor shall not grant any right or license to any third party with respect to the BEMA Technology in the Territory.

Licensor hereby grants to Licensee a sole and exclusive, royalty-free license to use the Marks solely in connection with the use, promotion, marketing, distribution, offer for sale, and sale of the Products, on a Product-by-Product basis, in the Territory during the Royalty Term. Licensee may grant a sublicense to the Marks in accordance with this agreement.

License Property
BEMA means Licensor’s proprietary bioerodible, mucoadhesive multi-layer polymer film.

Marks means “BEMA” or any additional trademarks owned by Licensor with respect to the BEMA Technology, alone or accompanied by any logo or design and any non-English language equivalents in figure, sound or meaning, whether registered or not.

Fentanyl Product means the first Product containing Fentanyl, used for the treatment of pain and sold in a Commercial Sale.

BEMA Patent Rights means all Patent Rights in the Territory related to the patents and patent applications listed, claiming BEMA or any Improvement, or which are necessary or appropriate to develop, manufacture and commercialize Products in the Territory, and that are under the Control of Licensor as of the Effective Date or that come under Licensors Control during the Term.
5,800,832 – Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces
6,159,498 – Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces

BEMA Technology means the BEMA Patent Rights and the BEMA Know How.

Field of Use
BEMA(TM) is an acronym for “Bioerodible Mucoadhesive”, and consists of a patented oral BEMA™ disc, which delivers the drug through the mucosal surface (inner cheek) by placing the disc between the cheek and gum.

The BEMA(TM) technology allows for the delivery of drugs across the buccal (i.e., mouth) mucosa that provides a rapid onset of therapeutic effect and a competitive advantage in such areas as pain relief and sedation.

IPSCIO Record ID: 289191

License Grant
Licensor grants the Licensee of China an exclusive license, without rights of sublicense, in the Field under the Licensed Technology to market, advertise, promote, distribute for commercial sale, offer for sale, sell, and import for commercial sale the Licensed Product in the Territory and Licensor hereby grants a non-exclusive license, without rights of sublicense, under the Licensed Technology to develop in the Territory the Licensed Product for additional human therapeutic indications following Governmental Approval of such Licensed Product in the Territory for the Initial Indication.
License Property
Licensed Product means the 200mcg, 400mcg, 600mcg, 800mcg, and 1200mcg dosage strengths of that BEMA-based product which contains fentanyl as its sole API, is the subject of MAA DCP DE-H-1660-001-006-DC and NDA 022266 and, is supplied to Licensee by Licensor.

Product means the Licensed Product, Placebos, and Demonstration Samples.

The Drug Product is BEMA rM Fentanyl, Bucco/ Soluble Film

BEMA means the proprietary bioerodible, mucoadhesive multi-layer polymer film technology Controlled by Licensor.

Field of Use
A Competing Product means a pharmaceutical product that is labeled or marketed for the indication of breakthrough pain and incorporates fentanyl as an API.

The Field means the treatment of breakthrough cancer pain in patients tolerant to opioids, the Initial Indication, and, following Governmental Approval in the Territory of the Licensed Product for the Initial Indication, any additional human therapeutic indications for which Governmental Approval is obtained.

IPSCIO Record ID: 212269

License Grant
The Company is granting the exclusive rights to develop and commercialize ONSOLIS® (fentanyl buccal soluble film) in the U.S. to Licensee.  The Company secured a new commercial partner for ONSOLIS® when a licensing agreement was completed.
License Property
ONSOLIS® a buprenorphine depot product for treatment of opioid dependence in the field of microencapsulation-based controlled/sustained release and drug delivery technologies.
Field of Use
Onsolis (fentanyl buccal soluble film) is an opioid analgesic indicated for the management of breakthrough pain in cancer.

Licensee will be responsible for the manufacturing, distribution, marketing and sales of ONSOLIS in the U.S.

IPSCIO Record ID: 203466

License Grant
Licensor grants the exclusive right and license in the Field under Licensors Intellectual Property Rights to market, offer for sale, sell and import products, including the Product, in the Territory,  the exclusive right and license in the Field under Licensors Intellectual Property Rights to use the Product in the Territory, provided that such right and license is limited to such use as is necessary for Licensee to market, offer for sale, sell, import and, Manufacture the Product in the Territory, and a non- exclusive right and license to use the Product and all information and Intellectual Property Rights with respect thereto, including, without limitation, data, studies and clinical trials, solely for the purpose of obtaining Regulatory Approvals for the Product.

Licensor grants an exclusive, non-transferable, except in accordance with a permitted assignment of this Agreement, license in the Field to use Licensors trademark.

License Property
Licensor is developing a proprietary oral mucoadhesive, erodible form of drug that contains benzocaine as the active ingredient for oral pain.

The Licensors trademark is ORADISC.

Field of Use
The Field means the treatment of oral pain utilizing anesthetics, excluding the treatment of sore throat and excluding any product containing amlexanox as an active ingredient.

IPSCIO Record ID: 256300

License Grant
The Licensor of Germany grants a non-exclusive, non-transferable, license to and under the patent to make, have made, use, have used, offer to sell, sell, have sold or import or have imported the Product.

The Parties wish to cooperate in the exclusive manufacturing of the Products and Placebos in the Territory.

License Property
The licensed property is EP O 949 925.

The Active Principle shall mean Fentanyl.

The Product shall mean Licensees transmucosal oral system containing Active Principle based on the Design of Licensee Technology.  

Licensee has bioerodable mucoadhesive transmucosal technology.

Licensor has technology and process for oral film form products and/or pharmaceutical preparations in general, their use, process development, including without limitation the mass preparation, coating, drying and compiling thereof, and, manufacturing, packaging, and labeling.

U.S. Patents Nos. 5,948,430, 6,177,096 and 6,284,264

Field of Use
Both Parties have experience with the oral film-form products industry.

The Licensee lead BEMAâ„¢ product under development is BEMAâ„¢ Fentanyl, a treatment for breakthrough cancer pain.

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: 324674

License Grant
The Licensor grants a sole and exclusive, even as to Licensor, worldwide license in the Therapeutic Areas under Licensor Technology and Licensor Know-How solely for the right to make, have made, use, offer to sell, sell and import Products with the right to grant sublicenses, in the Territory.

In addition, the Licensor hereby grants to Licensee a non-exclusive right under Additional Know-How to make, have made, use, offer to sell, sell and import Products in the Therapeutic Areas, with the right to grant sublicenses, in the Territory.

License Property
Patent means Bioadhesive hot-melt extruded film for topical and mucosal adhesion applications and drug delivery and process for preparation thereof.

Products means any and all pharmaceutical or veterinary products, combinations and compositions which contain one or more of the compounds
Buturphanol,
Fentanyl,
Meperdine,
Morphine,
Nalbuphine,
Oxymorphine,
Sumatriptan, and,
Tizandine, excluding Combination Products.

Field of Use
The field of use is in the Therapeutic Areas.  â€œTherapeutic Areas” shall mean the areas of oral mucosal delivery for prevention and treatment of all forms of pain including acute and chronic pain for both human and veterinary use.

IPSCIO Record ID: 233472

License Grant
Licensor grants an exclusive, including with respect to Licensor except as necessary for Licensor to carry out its obligations under this Agreement, license, with the right to sublicense, in the Territory, under the Licensors Intellectual Property, to develop, make or have made, use, offer for sale, sell, import, market and promote Product.
License Property
The proprietary device is AZ-003 or Staccato® fentanyl, a multiple-dose delivery system for fentanyl that permits rapid systemic delivery of fentanyl through inhalation, and Licensor has initiated clinical studies with respect to AZ-003.

The patents relate to Delivery of Opioids through an Inhalation Route.

The technology, the Staccato system, vaporizes excipient-free drugs to form condensation aerosols that, when inhaled, allows for rapid systemic drug delivery. Because of the particle size of the aerosol, the drug is quickly absorbed through the deep lung into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous, or IV, administration but with greater ease, patient comfort and convenience.

Field of Use
This product AZ-003 (Staccato fentanyl) is being developed for for the treatment of breakthrough pain in cancer and non-cancer patients.

IPSCIO Record ID: 203511

License Grant
Licensor grants the exclusive, even as to Licensor and its Affiliates, license under the Licensor Technology to develop, make or have made, use, sell, offer for sale, import, export, register, market and promote the Product in the Licensed Field in the Licensed Territory.

Licensor also grants access to and a right of cross-reference, solely to exercise its rights pursuant to the foregoing license, to the following, in each case to the extent Controlled by Licensor and its Affiliates all Development Data in existence as of the Effective Date;  all data related to the formulation or composition of the Product in existence as of or after the Effective Date; and to the extent useful for Licensee or its Sublicensees to develop, make, have made, use, sell, offer to sell, import, export, register, market and promote the Product in the Licensed Field in the Licensed Territory in accordance with Licensee’s rights under this Agreement, all Preclinical, Non-Clinical and Clinical data, including without limitation pharmacological, pharmacokinetic and toxicological data, [generated with respect to Chronogesic useful in connection with seeking Regulatory Approval for Chronogesic (Chronogesic Data) from trials commenced prior to the Effective Date.

License Property
The patents are for Transdermal Delivery Systems, Implantable Devices and Methods for Treatment of Pain by Delivery of Fentanyl and Fentanyl Congeners, and, Devices and Methods for Pain Management.

The Product means a transdermal patch for human use using the Licensor Technology containing sufentanil (including all salts thereof) and having a duration of application of (14] days or less, including all dosage strengths thereof and line extensions thereof, and including al] improvements thereto, [together with any adhesive overlay intended for use with such patch.] The term Product includes [any Authorized Generic Product] except as expressly provided herein.

The sufentanil patch, which is in early-stage clinical development employs Licensor's proprietary TRANSDUR(TM) drug-adhesive matrix formulation and is intended to provide relief of moderate-to-severe chronic pain for up to seven (7) days.  The product's weeklong duration combined with its reduced size (about 20% of the size of the on-market transdermal fentanyl patches but with a therapeutically equivalent dose) may offer improved patient convenience and compliance.'

Sufentanil is a synthetic opioid analgesic drug approximately 5 to 10 times more potent than its parent drug, fentanyl, and 500 times as potent as morphine.

United States Provisional Patent Application Number 60/621,123  for 'Transdermal Delivery Systems

United States Utility Patent Application Number 10/922,239for 'Implantable Devices and Methods for Treatment of Pain by Delivery of Fentanyl and Fentanyl Congeners

United States Utility Patent Application Number 11/044,521 for 'Devices and Methods for Pain Management'

Field of Use
Licensed Field means all fields of use in humans.  Licensee has capabilities in the development, manufacture, promotion, marketing, sales and life cycle management of pharmaceutical products in the field of pain treatment.

IPSCIO Record ID: 368511

License Grant
Licensor grants an exclusive license throughout the Territory, with the right to grant sublicenses, under the Licensor Technology, to conduct the Development and Regulatory Program and the Commercialization Program, with respect to the Products including Licensor Technology which may result from the Development and Regulatory Program and to use, market, sell, have sold and distribute such Product in the Territory; provided, however, that nothing shall alter the rights of Licensor contained in this Agreement to manufacture the Product.
License Property
Initial Platform Technology, with respect to the Initial Product, shall mean and include that certain technology that is the subject matter of US Patent Application No. 60/783, 181 for Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes, and any improvement thereto whether patentable or not.

Subsequent Platform Technology. with respect to the Subsequent Product, shall mean and include that certain technology that is the subject matter of US Patent Application No. 60/783,181 for Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes, and any improvements thereto whether patentable or not.

Compound shall mean morphine sulfate and/or morphine polystyrene.

Initial Product shall mean the pharmaceutical formulation developed under this Agreement that is demonstrated to have Bioequivalence to KADIAN® Referenced Product

KADIAN® NT shall mean the abuse deterrent form of the KADIAN® Reference Product which is presently the subject of Phase Ill trials being performed by or on behalf of Licensee.

Subsequent Product shall mean the pharmaceutical formulation developed under this Agreement that is demonstrated to have Bioequivalence to KADIAN® Referenced Product, or as to which Licensee elects to proceed hereunder without Bioequivalence) containing the Compound as its single active ingredient in a Subsequent extended-release suspension formulation with a concentration of at least 30 mg/15 ml using Licensor Subsequent Platform Technology, at one specific strength that is developed as part of the Development and Regulatory Program. In the event that the Subsequent Product is not Bioequivalent to the KADIAN® Referenced Product, Licensee shall have the option, but not the obligation, to proceed with the Development and Regulatory Program as if the Subsequent Product achieved Bioequivalence.

Kadian (morphine sulfate) is a narcotic pain reliever used to treat moderate to severe pain.

Field of Use
The field of use for KADIAN is as an extended release morphine sulfate pain medication.

Licensee will gain access to Licensor's LiquiXR(TM) technology, a novel and proprietary drug delivery platform for sustained release products in liquid form. The company plans to use this technology to develop an oral liquid product complementary to the company's KADIAN® solid dose product line.

IPSCIO Record ID: 280823

License Grant
Licensor grants a non-exclusive, worldwide license, including the right to grant sublicenses, to manufacture, use, sell, offer for sale and import, Products under all Licensor Patent Rights and Licensee Patent Rights.
License Property
Licensor has expertise in the development and manufacturing of drug delivery systems and biomaterials, and products using the same for medical, veterinary and dental applications.

Compound means any proprietary compound, its derivatives, metabolites, and intermediates, owned or controlled by Licensee, that Licensee provides pursuant to any Research Plan or any Exploratory Development Program Plan.

Area means research or development with respect to delivery systems for Licensee Compounds.

Licensor Technology means all technology, technical information, know-how, expertise and trade secrets owned or controlled by Licensor as of the Effective Date of this Agreement, that relates to and/or is useful in developing the Atrigel(R) System, the bioerodible mucoadhesive disc (BEMA(TM)) system, the mucoadhesive gel (MCA(TM)) system, the solvent microparticulate (SMP(TM)) system and/or other drug delivery technology owned or controlled by Licensor.

ATRIGEL(R) System means the biodegradable, polymeric drug delivery system in all embodiments claimed in the Licensor Patent Rights.

Field of Use
The patent is a drug-delivery systems three time-release gels that work inside and outside the body, and a disc that sends drugs such as painkillers through the lining of the mouth for immediate absorption.
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