Royalty Report: Drugs, Delivery, Pain – Collection: 26586

License Grant

Licensee shall have the exclusive right to Commercialize each of the Licensed Products in the Territory.  Saber Delivery System a patented and versatile depot injectable useful for protein and small molecule delivery that can be formulated for systemic or local administration.

License Property

The advantages of Saber may include reduced side effects, longer duration and smaller injection volume. Our first application is for controlled delivery of bupivacaine for post-operative pain relief (Saber-Bupivacaine), for which we own all worldwide rights. Saber-Bupivacaine is currently in Phase II clinical trials. We are developing Saber-Bupivacaine, a sustained-release formulation of bupivacaine, a local anesthetic, using our Saber delivery system for the treatment of post-surgical pain.

License Grant

Licensor grants to the Licensee of Ireland
– the exclusive right and license to make, have made, use, offer for sale, sell and import the Product in the Territory, including the right to record sales for its own account;
– in each case, solely for use in the Field and Territory and in connection with Licensees development and Commercialization of the Product and to otherwise exercise Licensees rights and perform its obligations under this Agreement
Know-How;
— an exclusive license under the Product Patents Rights and Product
— an exclusive license under the SAIB Patent Rights;
— an exclusive license under the Re-appliable Patent Rights; and
— an exclusive sublicense under Licensors license to the Epicept Intellectual Property; and,
– an exclusive license and right of cross-reference to all Development Data Controlled by Licensor in existence as of the Effective Date solely to exercise its rights and licenses under this Agreement with respect to the Product.

Licensor grants an exclusive license to use the Licensor Trademark in the Territory solely in connection with the Commercialization of Product in the Territory.

License Property

Licensor is the owner of a proprietary product for pain treatment consisting of a bupivacaine transdermal patch as described below and certain patents and know-how relating thereto.

Product means the product under development by Licensor currently known as ELADURâ„¢.

Bupivacaine means 1-butyl-N-(2,6-dimethylphenyl) piperidine-2-carboxamide, including any and all pharmaceutically acceptable salts, solvates, prodrugs, esters, free base forms, enantiomers (and racemic or other mixtures of said enantiomers) thereof.

Topical Bupivacaine Product means any formulation containing Bupivacaine, either alone or in combination with one or more other active ingredients. for use in the Field.

Licensor Trademark means the trademark rights to the mark ELADURâ„¢ and similar rights under the laws of any Governmental Entity, including all goodwill associated therewith, and all applications, registrations, extensions and renewals relating thereto.

Patents rights include Transdermal Delivery System, and, Methods for Transdermal Drug Administration.

Field of Use

ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.

Bupivacaine is a prescription medication used as a local anesthetic (numbing medicine). Bupivacaine blocks the nerve impulses that send pain signals to your brain.  Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work.

The Field means all pharmaceutical applications, including the treatment of pain, for human health.

License Grant

The Licensor entered into a collaboration Agreement with the Licensee, a company headquartered in of Denmark. Under the terms of the Agreement, the Licensor Licensed to Licensee the exclusive commercialization rights to Posidur for the European Union and certain other countries.  The Licensor will jointly direct and equally fund with the Licensee a development program for Posidur intended to secure regulatory approval in both the U.S. and the E.U.  In addition, the Licensor will manufacture and supply the product to the Licensee for commercial sale in the licensed territory.  The Licensor retains full commercial rights to Posidur in the U.S., Canada, Asia and other countries.

License Property

Our post-operative pain relief depot, Posidur, is a sustained release injectable using our Saber delivery system to deliver bupivacaine, an off-patent anesthetic agent.

Field of Use

The Field of Use apply to the medical industry.

License Grant

In this Agreement with Irish Licensor Subsidiary, the Licensee of Ireland is obligated to pay the Licensor a royalty on sales of XaraColl in the United States . Licensee also agreed to pay a royalty on sales of Cogenzia outside of the United States.

License Property

XaraColl® for the treatment of post-operative pain and Cogenzia® for the treatment of diabetic foot infections. These products combine proven therapeutics, including small molecules and biologics, with highly customized drug release profiles, localized drug delivery and superior handling properties.

XaraColl, is an implantable, bioresorbable collagen sponge designed to provide sustained post-operative pain relief, or analgesia, through controlled delivery of bupivacaine hydrochloride, or bupivacaine, at the surgical site. Bupivacaine is a local anesthetic drug.

Field of Use

The Licensee develops localized drug delivery technologies.

License Grant

Licensee entered into an exclusive global license and sub-license from the Israel Licensor for the rights to discover, make, sell, market, and otherwise commercialize Licensed Compound or any pharmaceutical composition or preparation (in any and all dosage forms) in final form, including any combination product, containing a Licensed Compound (Licensed Product).

License Property

Licensed Compound means bupivacaine liposome, in injectable gel or suspension.

Licensed Product means any pharmaceutical composition or preparation (in any and all dosage forms) in final form such as LBL100 or ProbudurTM.

LBL100 or ProbudurTM means Long-acting Bupivacaine Liposomal-gel 3.0% which is a drug product candidate based on a unique liposomal delivery system utilizing large multi-vesicular vesicles (“LMVVs”) encapsulating a high dose of the local anesthetic bupivacaine. These drug-loaded liposomes are composed of lecithin and cholesterol which are generally recognized as safe (“GRAS”) by the FDA. These LMVVs are embedded in hydrogel beads to form a Lipogel. The system delivers a local anesthetic/analgesic medicine from the Lipogel. This this product candidate could potentially eliminate the need for opioids for post-operative pain relief.

Probudur is the product candidate covered by US Patent No. 9,713,591. The patent contains composition claims to pharmaceutical compositions having an external storage solution containing an active pharmaceutical ingredient and particles of liposomes embedded in a polymeric matrix contained within the storage solution.

9,713,591 – Composition of matter comprising liposomes embedded in a polymeric matrix and methods of using same

Licensor develops a number of highly-potent therapeutics utilizing proprietary liposome-based nano-drugs with novel drug-loading-capabilities and drug-release mechanisms. Licensors proprietary platform implements a highly-efficient innovative approach which allows for the remote drug loading into nano-liposomes and concomitant controlled release of the drugs at the targeted site.

Field of Use

The field of use is for the treatment of pain control to be used for general surgeons, anesthesiologists, and orthopedic surgeons. Probudur may provide pain control for up to 96 hours.

LBL100 (3% bupivacaine in Lipogel), is being developed as a long-acting local anesthetic for post-operative pain.

LBL100 is a drug product based on a type of liposomal delivery system with large multi-vesicular vesicles (LMVVs) encapsulating a very high dose of the local anesthetic bupivacaine in a unique way. These drug-loaded liposomes are composed of lecithin and cholesterol; both lipids are “GRAS” (Generally Recognized As Safe). These LMVVs are embedded in hydrogel beads to form a lipogel. The system delivers a local analgesic medicine from the Lipogel that is intended to provide improved onset, duration and peak performance properties. With early studies indicating it can provide pain control for up to 96 hours, the formulation has shown the potential to reduce reliance on opioid pain management to improve quality of care and hospital economics.

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

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.