Royalty Report: Medical, Delivery, Device – Collection: 6811

License Grant

The Company sold all of its assets related to the Intraject needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to the Buyer, a privately-held pharmaceutical company. The Buyer is responsible for further development and commercialization efforts of Intraject (now rebranded under the name DosePro). In December 2007, the Buyer submitted a New Drug Application for the migraine drug sumatriptan using the needle-free injector DosePro – Sumavel* DosePro. The NDA was accepted for filing by the FDA in March 2008. The same month, the Buyer entered into a License Agreement to grant exclusive rights in the European Union to Desitin Pharmaceuticals, GmbH to develop and commercialize Sumavel DosePro in the European Union.

License Property

On July 16, 2009, the Buyer announced that it had received approval from the FDA for its NDA for Sumavel DosePro needle-free delivery system. On August 3, 2009, The Buyer and Astellas Pharma US, Inc. announced that they had entered into an exclusive co-promotion Agreement in the U.S. for the Sumavel DosePro needle-free delivery system. Under the announced terms of the Agreement, the companies will collaborate on the promotion and marketing of Sumavel DosePro with Licensee focusing their sales activities primarily on the neurology market while Astellas will focus mostly on primary care physicians. Licensee will have responsibility for manufacturing and distribution of the product. On January 13, 2010, Licensee announced the U.S. commercial launch of its Sumavel DosePro product.

Field of Use

Sumavel DosePro is a pre-filled, single-use disposable, needle-free drug delivery system that subcutaneously delivers 6 mg of sumatriptan in 0.5 ml of sterile liquid.  Sumavel DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

License Grant

The Licensor hereby grants to Licensee the Exclusive and sublicensable right in the Field in the Territory, under the Patent Rights and Medi-Ject Know How and Improvements only for the Field, to use, have used, sell and have sold, but not manufacture, the Device(s) in the Territory for the Term of this Agreement.

License Property

The Licensor owns valuable Medi-Ject Know How (hereinafter defined) and has been granted patent protection relating to the disposable front-end chamber and adaptor for such needle-free injector devices and Licensor is desirous of developing, Exclusively licensing and supplying such devices in the Territory to Licensee for use in the treatment of human growth disorders and further indications in the Field.  The Licensor has acquired the rights to an improved Device(s) which is a needle-free injector device system capable of delivering drugs through the skin in a controlled manner.

'Disposable Front End Chamber(s)' means a system which is filled with medicant at the time of administration and used to hold and administer the medicant needle-free.

Device(s) means those Medi-Ject needle-free injector devices.

The MJ7 is a needle-free drug delivery system composed of a power pack, a needle-free syringe assembly, an adapter assembly for drawing drug from a traditional glass vial and an adapter cap to serve as a container closure for the drug vial. The power pack is reusable and is connected with the needle-free syringe when injecting or aspirating drug. The device is hand-held and spring powered. The delivered dose can be varied by the user up to the maximum of 0.5 ml in 0.01 ml increments. The needle-free syringe, adapter assembly and adapter cap are the only drug or injection site contacting materials, and these parts and assemblies are provided to the end user as sterile. The device is readied for use, or armed, by manually compressing a spring using a rotating or twisting motion. A similar but opposite twisting motion is used to dose the needle-free syringe when it is attached to the power pack. The drug to be delivered is injected by holding the device against the injection site with slight pressure and in a fashion that the needle-free syringe is in intimate contact with the injection site. Pushing a button which releases the energy stored in the spring triggers the injection. This device includes a safety mechanism that prevents inadvertent firing of the device. The safety is automatically set in the safe or non-firing mode when the device is armed. The safety prevents device actuation by preventing the button from being pushed. The device is primarily cylindrical in shape with a maximum diameter of approximately 1-inch. The length of the device is approximately 6 inches when the spring is fully compressed and the needle-free syringe is not attached. The device is approximately 7 3/4 inches when the device is fully extended at a dosage setting of 0.5 ml and the needle-free syringe is attached. The weight of the device is approximately 1/3 lbs. (135 grams) without the disposable components.

APPENDIX B – PATENTS

U. S. PATENTS – ISSUED

4,507,113               HYPODERMIC JET INJECTOR
Des.304,616           MEDICAMENT INJECTOR
5,062,830               DRY DISPOSABLE NOZZLE ASSEMBLY FOR MEDICAL JET INJECTOR
5,697,917               NOZZLE ASSEMBLY WITH ADJUSTABLE PLUNGER TRAVEL GAP
5,722,953               NOZZLE ASSEMBLY FOR INJECTION DEVICE
5,769,138               NOZZLE AND ADAPTER FOR LOADING MEDICAMENT INTO AN INJECTOR            
5,800,388               PLUNGER/RAM ASSEMBLY ADAPTED FOR A FLUID INJECTOR

5,836,911               INJECTION DEVICE HAVING POSITIONING
5,846,233               COUPLING DEVICE FOR MEDICAL INJECTION SYSTEM
5,865,795               SAFETY MECHANISM FOR INJECTION DEVICES
5,891,085               NOZZLE ASSEMBLY WITH LOST MOTION CONNECTION FOR MEDICAL                                                     INJECTOR ASSEMBLY
5,921,967               PLUNGER FOR NOZZLE ASSEMBLY
5,875,976               LOCKING MECHANISM FOR NOZZLE ASSEMBLY

APPLICATIONS – FILED

60/094,163             LOADING MECHANISM FOR MEDICAL INJECTOR ASSEMBLY
60/094,167             INJECTION-ASSISTING PROBE FOR MEDICAL INJECTOR

Field of Use

Field means using hGH to treat any human ailment.

License Grant

The Parties are collaborating in the development and commercialization of the Device.

Licensor grants an exclusive license, with the right to sublicense, under the Licensor Patent Rights and Know How to use the Device in the Product and to sell, offer for sale, import and distribute the Product in the Field in the Territory.

For the Additional License in the Event of Failure to Supply,  in the event that Licensor is unable to supply conforming Devices to Licensee in connection with an accepted purchase order, then Licensor grants to Licensee a royalty-bearing right and license in the Territory to make and have made the Device for use in the Product in the Field in the Territory, and use and reference the necessary regulatory documentation, and any and all data or information included or referenced therein, to make or have made the Device.

License Property

Licensor owns or has rights to certain technology which may be used in the manufacture of a fixed-dose, single-dose disposable mini-needle injector for the delivery of sumatriptan.

The device is a fixed-dose, single-dose disposable mini-needle injector for the delivery that accommodates a Becton Dickinson 1 ml long glass Hypak syringe.

Field of Use

The Field means the delivery of the drug for the treatment of migraines in humans.

License Grant

The parties entered an agreement to acquire the U.S rights to Treximet®(sumatriptan / naproxen sodium) for the acute treatment of migraine attacks with or without aura in adults.

License Property

Treximet is a tablet containing a combination of sumatriptan and naproxen.

Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain.