Royalty Report: Medical, Delivery, Device – Collection: 29433

License Grant

As part of a strategic partnership, technology for a small device that sticks to the body and injects a dose of insulin was transferred for commercialization.  Licensee will acquire a majority interest in Licensor's subsidiary.

License Property

The Licensor is a privately held business who has been developing the h-Patch as a simple, unobtrusive tool to help people with type 2 diabetes control their injections of insulin.

The h-Patch is a small, flat plastic pod with a sticky side that adheres to a patient's skin. A tiny micro-needle in the device injects insulin into the patient's skin when the patient hits a start button. When the device has emptied all its insulin, the needle retracts and the entire device is discarded.

Field of Use

The Licensee is an investment company that is also taking a major ownership interest in the Licensor.

License Grant

The Licensor hereby grants to a Denmark Company a world-wide, exclusive, royalty-bearing license under the Aradigm Patent Rights (including applicable Aradigm Background IPR), Aradigm Selected Pulmonary Delivery Patent Rights, Aradigm New IPR and Aradigm Know-How (including applicable Aradigm Background IPR) to (a) develop, manufacture, use, market, distribute, sell, offer for sale, have made, import and/or export any Packaged Product and the Device in and from the Territory for use within the Field, with the right to sublicense its customers and Joint Marketing Partners pursuant and (b) otherwise exercise and perform its rights and obligations under this Agreement.

License Property

AERx iDMS insulin diabetes management system (iDMS uses a unique liquid human insulin strip to deliver an aerosol of insulin to the lungs. AERx iDMS enables 1-unit increment dosing, and the device ensures that the insulin dose is released at the optimal point of inhalation for delivery to the lungs.  The device was used for dosing fast-acting human insulin immediately before main meals, in combination with bedtime NPH insulin. The AERx iDMS device recorded the date and time of each insulin inhalation, insulin units used, and inhalation technique during aerosol delivery.

The AERx iDMS is being designed as a painless and convenient alternative to insulin injection. This should enable patients with diabetes to comply more effectively with their insulin therapy, thereby reducing the risk of long-term complications.  AERx iDMS is being developed to control blood glucose levels in patients with diabetes.

Field of Use

Field shall mean pulmonary administration of insulin, insulin analogs and any other compounds whose principal therapeutic effect is to control blood glucose levels in humans, including but not limited to glucagon-like peptide (GLP), GLP-1 and analogs of GLP.

License Grant

The Company executed a development and commercialization agreement with the Denmark Licensee to jointly develop a pulmonary delivery system for administering insulin by inhalation.

Under the terms of the agreement, Licensee has been granted exclusive rights to worldwide sales and marketing rights for any products developed under the terms of the agreement.

License Property

Through December 31, 2005, the Company received from Licensee $150.1 million in product development and milestone payments. Under the terms of the development agreement in effect at December 31, 2005 between the Company and Licensee, prior to completion of the restructuring transaction, Licensee was to fund all product development costs incurred by the Company under the terms of the agreement, and the Company was to be the initial manufacturer of the product and was to receive a share of the overall gross profits resulting from Licensee's sales of the product while Licensee and the Company agreed to co-fund final development of the AERx device.

Field of Use

The most advanced program using our AERx technology platform is AERx iDMS for the treatment of diabetes with inhaled insulin, asan alternative to injectable insulin, which is being developed by Novo Nordisk and is now in Phase 3 clinical trials. We have shown in the development program with AERx iDMS that the system is capable of delivering insulin into the blood streamfaster than by subcutaneous injection of regular insulin, thus providing a more convenient, patient-friendly approach to controlling meal-time glucose levels. Our patented breath control methods and technologies guide patients into the optimal breathing pattern for effective insulin deposition in and absorption from the lung. Pursuant to our agreement with Licensee, Licensee is responsible for and is funding all development, manufacturing and commercialization activities, and we will be entitled to receive a royalty on net sales.

License Grant

The Company has exclusive right to manufacture, market and distribute products utilizing automated retraction technology.

License Property

VanishPoint(R) products invented by 80% shareholder are designed specifically to prevent needlestick injuries and to prevent reuse.  The friction ring mechanism permits the automated retraction of the syringe needle into the barrel of the syringe, directly from the patient, after delivery of the medication is completed.

U.S. Patent 5,120,310, Issued June 9, 1992, entitled Nonreusable Syringe; U.S. Patent 5,188,613, Issued February 23, 1993, entitled Nonreusable Syringe with Safety Clip; U.S. Patent 5,267,961, Issued December 7, 1993, entitled Nonreusable Syringe with Safety Clip; Foreign Counterpart Patent Applications on the Nonreusable Syringe with Safety Clip corresponding to U.S. Patents 5,120,310 and 5,188,613 for Europe (Serial No. 92910361.2), China (Serial No. 92102245.X), India (Serial No. 186/CAL/92), Mexico (Serial No. 92-01493), and Taiwan (Serial No.  82205282); U.S. Patent 5,423,758, Issued June 13, 1995, Entitled Retractable Fluid Collection Device and a Counterpart Patent Cooperation Treaty Application Serial No. 94/13953, Entitled Blood Sampler, Filed December 6, 1994 designating all PCT countries; U.S. Patent 5,385,551, Issued January 31, 1995, Entitled Nonreusable Syringe with Front Retraction and a Counterpart Patent Cooperation Treaty Application Serial No.  PCT/US94/10235, Filed September 7, 1994 designating all PCT countries; U.S. Patent 5,389,076, Issued February 14, 1995, Entitled Single Use Medical Device with Retraction Mechanism and a Counterpart Patent Cooperation Treaty Application Serial No.  PCT/US95/03953, Filed March 31, 1995 designating all PCT countries; U.S. Patent Application Serial No. 380107, Filed January 30, 1995, Entitled Syringe Plunger Seal and Locking Assembly, and the right to file Patent Applications thereon in nearly any foreign country until January 30, 1996; and A new U.S. Patent Application filed in May, 1995, Entitled Tamperproof Retractable Syringe with Serial No. 08/438,954, and the right to file Patent Applications thereon in nearly any foreign country until May, 1996.

Field of Use

The field of use shall mean the syringe technology relating to the healthcare industry.

License Grant

The Company has agreed to revised terms regarding the license fee and to increase the royalty fee on net sales as regards to the use of its patented RadioGelâ„¢ technology from a private nonprofit applied science and technology development company.

License Property

RadioGelâ„¢ is an injectable particle-gel, for brachytherapy radiation treatment of cancerous tumors in people and animals.

RadioGelâ„¢ is a brachytherapy device comprising highly insoluble Yttrium-90 particles delivered by needle injection using a water-polymer composite for high-dose treatment of non-resectable solid tumors that cannot be treated effectively by any other means. It is designed for maximum safety to deliver a high, pure-beta radiation dose to target (tumor) tissue, with comparatively small-to-negligible radiation doses to adjacent normal tissues, and with negligible radiation dose to any major organ or tissue in the body.

RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature and then gels when reaching body temperature after injection into a tumor. In the gel are small, one micron, yttrium-90 phosphate particles (“Y-90”). Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactively drops to 5% of its original value after ten days.

Field of Use

This agreement pertains to the medical industry relating to a radiation oncology medical device for the development of the yttrium-90 based brachytherapy device RadioGelâ„¢ for the treatment of non-resectable tumors.

License Grant

Licensor hereby grants to Licensee (i) an exclusive worldwide right and license, under the Patent Rights to make, have made, use and sell the Licensed Products, together with the right to grant sublicenses throughout the world; (ii) an exclusive worldwide right and license to use the Technical Information to make or have made the Licensed Products, together with the right to grant sublicenses throughout the world; to make, have made, use and sell said certain inventions relating to retractable needle assemblies.

License Property

Technology refers to certain inventions relating to retractable needle assemblies, including, including, but not limited to the Safe Step Safety Blood Collection Needle, Safe Step Safety Winged Set Blood Collection Needle, Safe Step Safety Wing Needle Set/Catheter, Safe Step Safety PICC Catheter System and Safe Step Safety I.V. Catheter Systems (U.S. Patent No. 4,900,307).