Royalty Report: Drugs, Delivery, Pain – Collection: 233472

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 9

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: 9

Primary Industries

  • Drugs
  • Delivery
  • Pain
  • Cancer
  • Disease
  • Medical
  • Drug Discovery
  • Pharmaceuticals
  • 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: 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: 315809

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

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

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

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

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

IPSCIO Record ID: 291187

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

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

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

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

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

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

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

The products will display both trademarks Adasuve and Staccato.

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

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

IPSCIO Record ID: 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: 3004

License Grant
The Licensee from Israel  has acquired the U.S. and Canadian rights to commercialize AZ-004, a novel formulation of loxapine administered via deep lung inhalation using the  Israel Licensor's proprietary Staccato® device.
Field of Use
AZ-004 is initially targeted for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.  Staccato® loxapine combines Licensor's proprietary Staccato® single dose inhaler drug delivery system with the antipsychotic drug loxapine.

IPSCIO Record ID: 299286

License Grant
Pursuant to an agreement where a third party assigned licensed property to Licensee, Licensee receives a worldwide, exclusive license, under the Licensed Intellectual Property, solely to develop, use, offer for sale, sell, and import, but not make or have made Products.
License Property
Licensor owns or has rights in certain technology, know-how, patents and other intellectual property rights related to the design, development, manufacture and/or use of the Products.

Products means an AZ-002 Product and/or an AZ-004 Product.  Programs means the AZ-002 Program and/or the AZ-004 Program.

AZ-002 Product means a pharmaceutical product in which Alprazolam is the sole active ingredient and it is delivered using Staccato Technology.

AZ-004 Product means a pharmaceutical product in which Loxapine is the sole active ingredient and it is delivered using Staccato Technology.

Alprazolam means alprazolam and all salts, metabolites, prodrug and other physical forms thereof.

Loxapine means loxapine and all salts, metabolites, prodrug and other physical forms thereof.

Field of Use
The field of use relates to the Staccato Technology, proprietary technology for the vaporization of a pharmaceutical composition via rapid-heating to form a condensation aerosol that allows rapid systemic drug delivery to humans through lung inhalation.

AZ-002 (Staccato alprazolam). We are developing AZ-002 for the acute treatment of panic attacks associated with panic disorder. In April 2006, we initiated an in-clinic, 36 patient, multi-center, doubleblind, placebo-controlled, proof of concept Phase IIa clinical trial in patients with panic disorder.

AZ-004 (Staccato loxapine). We are developing AZ-004 for the treatment of acute agitation in patients with schizophrenia. In January 2007, we completed enrollment of an in-clinic 120 patient, multi-center, double-blind, placebo-controlled Phase IIa clinical trial in patients with schizophrenia suffering from agitation.

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: 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: 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.

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