Royalty Report: Drugs, Delivery, Drug Discovery – Collection: 273266

License Grant

Pursuant to an asset purchase agreement also dated July 21, 2004, the Buyer/Licensee acquired rights granted to another, the Third Party, by Licensor of Switzerland.  With this agreement, Licensor agrees to the assignment and assumption of the license.

The Third Party hereby assigns to Buyer all of The Third Party’s rights under or pursuant to the License Agreement relating to Products and Improvements in the Territory.

License Property

The Assignment / Assumption relates to microparticulate capsule formulation of Product (the MPC Formulation), and, Zanaflex tablets. Zanaflex Capsules are manufactured using The Third Partys proprietary SODAS (spheroidal oral drug absorption system) multiparticulate drug delivery technology.

Zanaflex Capsules and Zanaflex tablets contain tizanidine hydrochloride, or tizanidine, one of the two leading treatments currently used for the management of spasticity.

This medication is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury).

Field of Use

Zanaflex is a prescription medicine used to treat the symptoms of muscle stiffness (spasticity) associated with conditions such as Cerebral palsy or other neurological disorders.

Licensee is a commercial-stage biopharmaceutical company which markets Zanaflex Capsules.  Zanaflex Capsules and Zanaflex tablets, are FDA-approved for the management of spasticity, a symptom of conditions such as MS and SCI that is commonly characterized by stiffness and rigidity, restriction of movement and painful muscle spasms.

License Grant

Licensor of Ireland grants an exclusive license under the Licensor Intellectual Property in the Territory to package, use, import, export, promote, distribute, offer for sale, sell and otherwise exploit and, solely as permitted in the Supply Agreement, to make and have made
– the Fampridine Product in the SCI Field for the SCI Term;
– the Fampridine Product in the MS Field for the MS Term; and
– without prejudice, the Product in the SCI Field, MS Field and/or Other Indication Field for the Other Indication Term, subject to any contractual obligations with respect to a formulation using Nanoformulation technology in the Other Indication Field.

Licensor grants a non-exclusive royalty free license in the Territory solely for use in connection with the sale of the Product, for the term of this Agreement to use any trademark which relates to the Licensor technology applicable to the Product.

License Property

The Compound shall mean 4-aminopyridine as well as the isomers, and the salts thereof.

Fampridine Product shall mean any finished pharmaceutical oral sustained release dosage form containing the Compound, which is in the scope of one or more Valid Claims within the Licensor Patent Rights in the country of sale, and/or incorporates Licensor Know-How in material part. The use of the pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods, clinical protocols and data developed for and on behalf of Licensor, which is included in the Licensor Know-How shall constitute incorporation of the Licensor Know-How in material part.

Licensee patents used are Treating Diseases of the Anterior Horn Cells, and, the use of  4-Aminopyridine in the treatment of a neurological condition.

Licensors patents include Matrix Formulation of Potassium Chemical Blockers (Fampridine)

Field of Use

Fampridine is a drug that has been shown to improve walking speed for some adults with multiple sclerosis.

The field of use Indication shall mean any use or indication of Product for treatment of any condition, including spinal cord injury (SCI) and multiple sclerosis (MS).

MS Field shall mean use as an oral prescription medicine fort he treatment of MS in humans.

SCI Field shall mean use as an oral prescription medicine for the treatment of SCI in humans.

Other Indication Field shall mean use as a prescription medicine for the treatment of any condition in humans, excluding the SCI Field and the MS Field, but for the avoidance of doubt including the treatment of SCI and/or MS otherwise than orally.

License Grant

Licensor of Ireland grants to the Licensee, an entity formed by the Licensor and Licensee parent, for the term of the Agreement an exclusive license, with the right to grant sublicenses, for the territory to clinically test, register, have manufactured in accordance with the terms of this Agreement, to package, use, promote, distribute and sell the product  as a prescription medicine.

Licensor grants a non-exclusive license, with the right to grant sublicenses, in the territory for the term to use the Licensor trademark upon or in relation to the product.

License Property

Product shall mean the encapsulated SODAS® drug specific dosage forms in not more than four dosage strengths not exceeding 180mg.

The drug specificed for this agreement is Once-daily oral morphine capsules, containing SODAS® beads.

The trademark shall mean SODAS®.

The Product to be supplied to Licensee by Licensor shall be in the form of bulk two-piece hard gelatin capsules containing microparticulate SODAS® particles.

SODAS® (Spheroidal Oral Drug Absorption System) is Licensor’s Multiparticulate drug delivery system. Based on the production of controlled release beads, the SODAS® technology is characterized by its inherent flexibility, enabling the production of customized dosage forms that respond directly to individual drug candidate needs.

Field of Use

The license is  for a controlled release oral morphine pain relief product.

Licensor is knowledgeable in the development of drug specific dosage forms and has developed a unique range of delivery systems designed to provide newer and better formulations of medicaments,

License Grant

Licensor grants an exclusive worldwide license, with tile right to sub-license, under Licensors Product Intellectual Property to make, have made, sell, or have sold, and otherwise commercialize, market and distribute the Product throughout the world.

License Property

Licensor has developed a proprietary drug delivery system, including drug infusion pumps, ports, catheters, programming systems and accessories.  The Product is a preservative-free injectable formulation or formulations of clonidine and all current or future analogs, modifications and improvements of clonidine.

The SynchroMed system is the only externally programmable, implantable, drug infusion system available today. Using telemetry, the clinician can program its pump to deliver precise doses of medication at specific times to provide optimum therapy for each patient. It is widely used with morphine sulfate to block pain signals traveling to the brain and is also used to treat severe spasticity associated with multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Clinical trials are expected to be initiated in 1998.

Field of Use

The Licensee will test the use of clonidine, delivered directly to the spinal fluid by the Medtronic SynchroMed(R) implantable drug infusion system, in the treatment of chronic intractable pain. Intractable pain is typically defined as constant, long-term pain that is not manageable without intervention. Clonidine delivered intrathecally (inside the sheath that surrounds the spinal cord) may be effective in patients with pain who no longer experience adequate relief with intrathecal morphine. These patients, if not already using a SynchroMed system, will require its implant to deliver intrathecal clonidine.