Royalty Report: Drugs, Pain, Pharmaceuticals – Collection: 256269

License Grant

Licensor grants an exclusive license, with the right to grant sublicenses under the Licensor Licensed Patents and Patents within the Licensor Improvements to make, have made, develop, use, sell, offer for sale, have sold, and import Licensed Products in and for the Field throughout the Territory.

License Property

Licensor has certain patent rights relating to methods and compositions for use in the topical treatment of back pain, muscle tensions and myo-fascial pain, where such methods and compositions feature a topical carrier system containing a local anesthetic agent and are intended for use on intact mammalian skin and/or outer synovial membranes, and certain additional patent rights relating to methods and compositions that include the use of certain intradermal pharmaceutical penetration enhancing excipients.

“Licensed Product” means a transdermal pharmaceutical patch product for sale only by prescription containing bupivacaine as the only active ingredient, indicated and approved by a Regulatory Authority for use in the Field, wherein such product and/or indication is covered by a Valid Claim of the EpiCept Licensed Patents or a Valid Claim of a Patent under the EpiCept Improvements.

Field of Use

The Field shall mean all pharmaceutical applications for the palliative, prophylactic and/or therapeutic treatment of Back Pain in humans.

License Grant

Licensor grants a royalty-bearing, exclusive right and license, with the right to grant sublicenses under the Licensor Intellectual Property and Licensor Product Registration Data to develop, market, use, sell, offer for sale and import the LidoPAIN® BP Product within the Territory and develop, make, have made, manufacture, market, use, sell, offer for sale and import the Licensee BP Product in the Territory.

License Property

Licensor is currently developing a topical lidocaine patch product currently known as LidoPAIN® BP.

Licensed Products means, collectively, the Licensee BP Product and the LidoPAIN® BP Product.

LidoPAIN® BP Product means a non-sterile adhesive backed topical patch, for sale by prescription only, containing lidocaine as the only active ingredient and indicated, and approved by the FDA, for the treatment of acute low back pain or a substantially similar indication.

Licensee BP Product means a non-sterile adhesive backed topical patch, for sale by prescription only, containing lidocaine as the only active ingredient.

Field of Use

The field of use is for the treatment of acute low back pain and owns patents covering the use of a topical lidocaine patch product for the treatment of low back pain.

License Grant

The Licensors grant, jointly and severally, to the Licensee an exclusive, worldwide and perpetual license to use, license or otherwise exploit the Licensed Technology in the Field pain management, for any human or non-human diagnostic, prophylactic or therapeutic use to develop, have developed, make, have made, use, import and sell, have sold and offer for sale Licensed Products and perform Licensed Services, with the right to sublicense with respect to any or all of such recited purposes, provided that such rights as to know-how, proprietary knowledge, information and expertise contained within the Licensed Technology that does not relate solely to the Licensed Patents is licensed hereunder on a nonexclusive basis.

License Property

Methods and compositions for treating pain at a specific site with an effective concentration of capsaicin or analogues thereof.

Field of Use

The Licensee specializes in topical products with pain management applications.

License Grant

Licensee desires to acquire certain assets and rights pertaining to Eladur® and obtain a license to Licensor's proprietary TRANSDUR® transdermal delivery technology and other intellectual property to develop and commercialize Eladur®, and Licensor desires to transfer such assets and grant such a license to Licensee.

For the  License to Product, Licensor grants an exclusive license under the Licensed Technology, other than specific third party patents, solely to make, have made, use, import, sell, offer for sale and otherwise develop and Commercialize Products in the Field in the Territory, and, as permitted, an exclusive sublicense under Licensors license to Licensee Patents solely to make, have made, use, import, sell, offer for sale and otherwise Develop and Commercialize Products that contain bupivacaine, and no other Bupivacaine compound as the sole active ingredient, in the Field in the Territory.

Licensor grants to a limited right to use the trademark 'TRANSDUR®' solely in connection with the sale and marketing of Products in the Field within the Territory in accordance with this Agreement.

License Property

Licensor owns and controls rights in and to its product known as Eladur®, which is a transdermal bupivacaine patch based on Licensors proprietary TRANSDUR® transdermal delivery technology.

Bupivacaine shall mean bupivacaine, or any enantiomer, polymorph, salt form, racemate, isomer, diastereomer, tautomer, solvate, hydrate, or ester of bupivacaine.

Product shall mean any transdermal patch containing Bupivacaine as the sole active ingredient, including Eladur® as further described in IND No. 75,436.

TRANSDUR® Technology is defined as pharmaceutical transdermal patch drug delivery systems for use with a range of pharmaceutical preparations for sustained release of medication into the body, wherein the transdermal patch comprises: a backing layer; a pressure-sensitive adhesive layer; and a release liner, wherein the pressure-sensitive adhesive layer comprises: active agent, polyisobutylene, and plasticizer.

ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.
Bupivacaine is an anesthetic (numbing medicine) that blocks nerve impulses in your body. Bupivacaine is used as a local (in only one area) anesthetic. Bupivacaine is given as an epidural injection into the spinal column to produce numbness during labor, surgery, or certain medical procedures.

Field of Use

The agreement is for the rights to develop and commercialize ELADUR®, Licensor's investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN).

Postherpetic neuralgia s the most common complication of shingles. The condition affects nerve fibers and skin, causing burning pain that lasts long after the rash and blisters of shingles disappear. The chickenpox (herpes zoster) virus causes shingles.  Postherpetic neuralgia is a painful condition that affects your nerves and skin. It is a complication of herpes zoster, commonly called shingles. When the pain caused by shingles doesn't go away after the rash and blisters clear up, the condition is called postherpetic neuralgia.

License Grant

Pursuant to this agreement, Licensor, an individual, has assigned his entire right, title and interest in, to and under the inventions described in the 925 application to Licensee.

Licensee is hereby granted and shall have a non-exclusive, perpetual, irrevocable, worldwide license to make, have made, modify, reproduce, display, use and sell such Item as part or in connection with such inventions.

Licensor grants to Licensee an exclusive option to obtain an exclusive, worldwide license to any Licensor Technology.

License Property

Licensor has assigned his entire right, title and interest in, to and under the inventions described in U.S. patent application. Serial No. 09/425,925 (the ''925 application'), entitled, 'Local Prevention or Amelioration of Pain from Surgically Closed Wounds,' which issued as U.S. Patent No. 6,383,511 (the ''511 Patent') to Cassel, as the inventor.

The term Licensors Technology means all copyrightable material, notes, records, inventions, improvements, developments, discoveries and trade secrets conceived, made by or discovered by Licensor outside of the performances of his services.

The Product means any composition of matter, material, device, apparatus, or system developed by Licensee for the treatment of pain from surgically closed wounds, which the making, using, offering for sale, sale or importation by an unlicensed third party, would infringe one or more issued claims of a Patent.

Field of Use

This agreement is for the field of surgical wound pain management.
LidoPAIN SP is a sterile prescription analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wound while also providing a sterile protective covering for the wound.

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.

License Grant

We entered into a non-exclusive, worldwide license agreement with Licensor, an individual,  for U.S. Provisional Patent Application No. 60/006,385 and U.S. Utility Patent Application No. 08/746,207 (U.S. Patent No. 6,248,788) directed to methods of treating neuropathic pain using capsaicin anesthetic, and all applications and patents relating thereto. The licensed technology relates to the use of capsaicin for pain relief. The primary patent underlying the license expires on November 6, 2016. This license agreement makes reference to the August 2001 license agreement between us and Drs. Campbell and Licensor and Mr. Meyer and provides that if Dr. Licensor develops or has any right to any technology under U.S. Patent No. 6,248,788 relating to an injectable product or service using capsaicin and its analogues for pain relief, the technology will be licensed to us pursuant to the terms of the August 2001 license agreement with Drs. Campbell and Licensor and Mr. Meyer.

Field of Use

Field of Use means any human or non-human diagnostic, prophylactic or therapeutic use of the Licensed Patents and Licensed Technology.

License Grant

Licensor hereby grants to Licensee an exclusive license, with the right to grant sublicenses.

License Property

The license is for the development and commercialization of non-injectable Dex (Dexmedetomidine) for use in the treatment of pain (including post-operative pain) in humans in any dosage form for transdermal, transmucosal (including sublingual and intranasal), topical, enteral or pulmonary (inhalational) delivery, the Licensed Dosage Forms, but specifically excluding delivery vehicles for administration by injection or infusion.

Dex is in a class of drugs called alpha-2 adrenergic agonists, which produce their effects by selectively activating the alpha-2 adrenergic receptors in the body and produce a broad range of effects depending on the specific drug and the alpha-receptors it activates, including anti-hypertensive, analgesic and sedative effects. In particular, Dex has demonstrated sedative, analgesic and anxiolytic properties in multiple preclinical and clinical studies, including the new drug application, or NDA, studies for Precedex®.

5217718 & 5124157: TRANSDERMAL ADMINISTRATION OF DEXMEDETOMIDINE – Method and device for administering dexmedetomidine transdermally

Field of Use

Under the Dexmedetomidine License Agreement, they were granted an exclusive license under Licensor Know-How and certain Patents to commercialize products in the territory.

“Field” means the treatment of pain in humans, including mild, moderate, or severe acute and chronic pain, alone or as an adjunct.