Royalty Report: Cancer, Medical, Device – Collection: 264174

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

The Institute, a private nonprofit applied science and technology development company, has granted the Company an exclusive license to patents covering the manufacturing, processing and applications of RadioGelâ„¢.

As a result of this Amendment, the Company has agreed to revised terms regarding the license fee and royalty rate.

License Property

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

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.

License Grant

Licensor, a private nonprofit applied science and technology development company, hereby grants to Licensee to the extent of the Licensed Field and Licensed Territory, an exclusive license to make, have made, use and sell Licensed Products.

The license granted shall be subject to any rights the Government of the United States of America may presently have or may assert in the future for any reason including, but not limited to, those rights set forth.

Licensor reserves the right to (i) practice the Patents for research, development and demonstration purposes for itself and others, (ii) nonexclusively license the Patents to nonprofit institutions that collaborate with Licensee for research, development, and demonstration purposes only, and (iii) license the Patents in fields not exclusively licensed herein.

License Property

Licensed Products means any and all products incorporating or services utilizing one or more claims of the licensed Patents.

Patent or Patents means the following patents, and all reissues, reexaminations, substitutes, and extensions thereof:
Issued Patents

Title: Stimulus Sensitive Gel with Radioisotope and Methods of Making (Licensee IPID 11505-E
Master Patent ID 1201)*  
Country

Patent Number
  
Date Granted
U.S.

6,296,831

October 2, 2001

Title: Stimulus Sensitive Gel with Radioisotope and Methods of Making (Licensee IPID 11505-E
CON Master Patent ID 1204)*
Country

Patent Number

Date Granted
U.S.

6,869,588

March 22, 2005

Title: Stimulus Sensitive Gel with Radioisotope and Methods of Making (Licensee IPID 11505-E
Master Patent ID 1197)*
Country

Patent Number

Date Granted
Canada

2,327,325

January 24, 2006

Title: Thermogelling Biodegradable Aqueous Polymer Solution (Licensee IPID 12483-B Master Patent ID 1892)†

Country

Patent Number

Date Granted
U.S.

6,841,617

January 11, 2005

Title: Thermogelling Oligopeptide Polymers (Licensee IPID 12483- B CIP Master Patent ID 1893) †
Country

Patent Number

Date Granted

U.S.

7,087,244

August 8, 2006

Title: Thermogelling Biodegradable Aqueous Polymer Solution (Licensee IPID 12483-B Master Patent ID 1889) †

Country

Patent Number

Date Granted
Canada

2,423,488

July 13, 2010

Title: Multiple Stimulus Reversible Hydrogels (Licensee IPID 12575-E Master Patent ID 1963)*
Country

Patent Number

Date Granted

U.S.

6,660,247

December 9, 2003

Title: Multiple Stimulus Reversible Hydrogels (Licensee IPID 12575-E CON Master Patent ID 4425)*

Country

Patent Number
  
Date Granted
U.S.

7,033,571

April 25, 2006

RadioGelâ„¢ device 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.

Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area.

Field of Use

Licensed Field means, and is limited to, medical and veterinary therapeutic radioisotope delivery.

License Grant

The Company acquired exclusive worldwide rights to the GliaSite® Radiation Therapy System.

Licensor is willing to grant Licensee rights to the Licensor IP in the Territory with a limited field of use of intracavity radiation therapy (brachytherapy) of the brain (“Exclusive Field of Use”).

License Property

the GliaSite® Radiation Therapy System, the only FDA-cleared balloon catheter device used in the treatment of brain cancer.

GliaSite® Radiation Therapy System (RTS) is for the treatment of brain cancer, i.e. primary and recurrent gliomas and metastic brain tumors.  Specifically, the intended use of GliaSite® RTS is the management of surgically resectable brain tumors where adjuvant radiation therapy of the post-resection tissue bed is indicated.

License Grant

Licensee entered into an exclusive license with the University Research Foundation covering certain patented processes which may be used in the manufacture and distribution of a brachytherapy device to be used in the treatment of breast cancer.  The license also allows licensee to sublicense the covered processes for additional fees.

License Property

The ClearPath device is placed through a single incision and is designed to conform to the resection cavity, allowing for more conformal therapeutic radiation dose distribution following lumpectomy compared to other methods of APBI. ClearPath is designed to accommodate either high-dose, ClearPath-HDR, or low-dose rate, ClearPath-CR, treatment methods. Brachytherapy, or internal radiation therapy, makes use of radioactive sources or seeds and has emerged as one of the most common treatments of prostate cancer.

Field of Use

The rights granted apply to the medical industry relating to cancer treatments.

License Grant

For the License to the Kaminski Patent Family and Wahl Patent Family, the Licensors each each grant to the Licensor a worldwide, irrevocable, non-exclusive license to for any and all purposes.

License Property

The Kaminski Patent Family shall mean U.S. Patents No. 6,015,542, 6,090,365, 5,595,721, 5,843,398, 6,287,537, and 6,565,827, including associated derivatives.  this includes the ZevalinTM Therapeutic Regimen.  ZevalinTM Kits refer to any kit containing Ibritumomab Tiuxetan for the preparation of Indium-111 Ibritumomab Tiuxetan and Yttrium-90 Ibritumomab Tiuxetan as currently formulated and approved by the FDA.

The Wahl Patent Family shall mean U.S. Patents No. 6,251,362, and 6,022,521, including associated derivatives.

Field of Use

The field of use is all uses.  ZevalinTM Kits relate to the treatment of any B-cells malignancies.

The B-cell lymphomas are types of lymphoma affecting B cells. Lymphomas are 'blood cancers' in the lymph nodes. They develop more frequently in older adults and in immunocompromised individuals. B-cell lymphomas include both Hodgkin's lymphomas and most non-Hodgkin lymphomas.

License Grant

Licensor hereby grants an exclusive, non-transferable, sublicensable right and license, solely in the Licensed Territory and the Licensed Field of Use, (i) under the Patent Rights and the Licensee Patent Rights improvements to make, have made, sell, lease, offer for sale, and import the Licensed Products, and (ii) to use the Licensor Information solely in connection with the Licensed Products.

License Property

Patent Rights: PCT/US04/019337: Microparticles for Micro-arterial Imaging and Radiotherapy.

Its intended use is as a means of micro-arterial brachytherapy in the treatment of soft tissue cancer tumors in the liver. Soft tissue tumors are connected to the blood supply and this kind of therapy is administered through the blood supply system. Soft tissue tumors are among the most difficult forms of cancer to treat.

Field of Use

Licensed Field of Use shall mean the human healthcare field.

License Grant

The Company is negotiating, the success of which cannot be assured, for an exclusive worldwide license to manufacture, use and sell equipment in the areas of neutron and ion beam radioisotope production and gadolinium neutron capture therapy under two U.S. patents and related technical know-how.

License Property

The two patents relate to a pulsed plasma apparatus for the production of plasma-generated neutrons. Under one configuration, the pulsed plasma device is designed to produce short-lived high-intensity positron-emitting radioisotopes, including carbon-11 with a 20-minute half-life, oxygen-15 with a 122-second half-life, and nitrogen-13 with a 10-minute half-life, that are used extensively in PET cameras for the diagnosis of brain, heart and lung functions.

Under a different configuration, the device is designed as an external beam radiation treatment unit to produce thermal neutrons that are essential for gadolinium neutron capture therapy (GNCT), a type of external beam radiation therapy used to treat certain tumorous cancers located in or near critical organs. Under GNCT, the element gadolinium is transported to a patient’s cancerous tumor and irradiated with an external beam of thermal neutrons which destroys the tumor without damage to external healthy tissue.

Field of Use

The rights granted apply to the medical industry.