Royalty Report: Drugs, Wound Care, Pharmaceuticals – Collection: 3465

License Grant

The Licensor receives royalties on the Licensee's sales.

License Property

The Licensor is a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, which significantly reduces the need for antibiotics while reducing infections and accelerating healing.

Microcyn Technology is a unique shelf-stable pH-neutral oxychlorine compound. Microcyn has been studied for its clinical benefits and safety, a number of these findings peer-reviewed and published. These studies demonstrate that the Microcyn Technology delivers wound healing benefits, reduction of inflammation, cure or improvement of infection and antimicrobial activity; all while remaining safe and biocompatible as evidenced in a 2007 study published in the International Wound Journal. The reason for this safety is that mammalian cells have evolved with special pumps to regulate the active ingredients in Microcyn Technology while viruses, spores and bacteria, including drug-resistant bacteria, lack this ability.  The technology behind the Microcyn® Technology-based family of products involves a unique, patented electrochemical treatment of dilute saltwater. A pH neutral solution of hypochlorous acid, and its sodium salt, hypochlorite, is generated. Hypochlorous acid is a natural product the human body produces in response to injury.

Several solutions derived from this platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores; increase blood flow to the wound site; and reduce both inflammation and pain while assisting in faster wound closure.

Field of Use

The Microcyn Technology addresses the need for improved solutions in multiple markets including dermatology, oral care, cosmeceutical, wound care and others.

License Grant

Licensor grants Licensee of the Cayman Islands an exclusive license under the Licensed Patents and Licensed Technology in both cases to make, have made, use, sell, offer to sell, import, and otherwise distribute and dispose of Products in each case solely in the Field throughout the Territory.

Licensor grants a non-exclusive license to use the Licensor Marks solely in connection with the marketing, promotion and sale of the Product(s) in the Field.

License Property

Licensor is the sole owner of Patent entitled Use of physiologically balanced, ionized, acidic solution in wound healing.

Product shall mean any product comprising any formulation containing hypochlorous acid as its principal active ingredient including that product known as NVC-101.

NVC-101 is a topical antimicrobial that can decrease the bacterial bioburden of chronic wounds.

Field of Use

The Field shall mean, with respect to Products, all commercial uses of the Products for wound care, wound healing, wound cleaning, wound debridement, wound disinfection, wound inflammation, wound exudate management, wound granulation, wound reepithelialization and any other form of wound treatment or wound management including use in surgical wounds and associated disinfection as well as any other treatments that may be adapted to be assisted by reduced pressure, all in humans, but shall exclude for all purposes any products or uses intended for the eye, ear or nose, including the prevention or treatment of any infection thereof.

License Grant

The University gave the Company exclusive sub-license rights to the use of its patents and patent applications.

License Property

The Company holds exclusive worldwide rights for the manufacturing, marketing, and distribution of its Nimbus(TM) and topical MultiStat(TM) technologies.

Patent applications relate to the new projects treatment of mustard gas, Nimbus treatment of lumber, and antimicrobial and antiproteolytic wound dressing and method. Nimbus (Nimbus or 'Nimbus technology'), a family of polymers that are bio-engineered to have antimicrobial, super-absorbent, and other properties that can be used in a wide range of applications, such as wound dressings and apparel.

MultiStat (MutltiStat),is a family of patented matrix metalloproteinase inhibitors (MMPIs) that are believe to have significant benefit in the maintenance, healing and repair of skin and eyes. Independent laboratories as well as in-house research show that MultiStat is effective in medical (wound care) and consumer (cosmetic) applications. MultiStat is currently being sold as a performance ingredient to several cosmetics companies.

Field of Use

Licensee is seeking to use our Nimbus technology in (a) advanced wound care products and other medical devices; and (b) consumer products, including apparel and personal care. Licensee believes that the size and growth characteristics of the antimicrobial market represent an attractive opportunity for the Nimbus technology.  

The Licensee's four core technologies are Novel Intrinsically Micro-Bonded Utility Substrate (NIMBUS®), a family of advanced polymers bio-engineered to have antimicrobial, hemostatic, and other properties that can be used in a wide range of applications; Stay Fresh® is a unique chemical formulation for textiles with a durable antimicrobial agent effective against an array of bacteria even after numerous laundering cycles; NimbuDerm® is a novel copolymer for application as a persistent hand sanitizer with long lasting protection against germs; and MultiStat, a family of advanced patented methods and compounds shown to be effective in skin therapy applications.

License Grant

For the License to Finished Products,  Licensor grants the Licensee of Portugal, only in the Territory, the sole and exclusive, transferable, sub-licensable right in the Field of Use under the Know-How, the Documentation, the Licensor Improvements, Joint Improvements and the Patents
– to use Bulk Active Material to produce or have produced Finished Products only for making Sales in the Field of Use, either directly, through its Affiliates or through Distributors or Sub-Licensees, in the Territory; – and, to use Bulk Active Material to conduct internal research and development activities relative to and for the benefit of making Joint Improvements or Licensee Improvements to Finished Products.

For the License to Trademark for the Bulk Active Material, Licensor grants, only in the Territory, to Licensee a non-exclusive, transferable, sub-licensable right in the Field of Use to use, copy, publish, display, distribute and disseminate, on or in any tangible form or electronic media, the Trademark for the Bulk Active Material only in connection with the Sale of Finished Products in the Field of Use and associated marketing collaterals and packaging in accordance with the Trademark Style Guide and Requirements.

License Property

Thymosin beta 4 (TB4) is a novel drug undergoing human clinical trials for chronic wounds.

TB4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. TB4 represents a new class of wound healing drug and is different from other wound repair factors, such as growth factors, in that it promotes endothelial cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and has a very low molecular weight, allowing it to diffuse relatively long distances through tissues. A key mechanism of action is TB4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. It has been the subject of a significant amount of research at the NIH and a number of other academic institutions, and has been reported to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of conditions.

Patents are for Methods of treating Epidennolysis Bullosa and Other similar Dermatological Indications with Thymosin Beta 4, Analogues, isoforms and Other Derivatives, Treatment of Infections and Other Disorders, Thymosin B4 Promotes Wound Repair,  Methods of Treating and Preventing Anthrax Induced Pathologies with Thymosin Beta 4 Analogs, isoforms and Other Derivatives incorporated into 2600-108, Methods of Healing or Preventing Inflammation, Damage and Other Changes that Occur prior to, During or Immediately after a Myocardial Event with Thymosin Beta 4, Analogues, isoforms, and other Derivatives, Methods of Healing, Treating and/ or Reversal of Stenosis or ·Restenosis of the Myocardium and Coronary Vessels, Heart Valves and Septa Injuries or Defects Using Thymosin Beta 4, or TB4 Analogues, isoforms, Antibodies or anti-sense Peptides, and, Methods of Treating and Preventing Physical, Cognitive and Biological Damage Due to Ionizing Radiation Exposure by Administering LKKTET Peptides, TB4, analogues, isoforms and Other Derivatives.

Finished Product means any prescription or over-the-counter pharmaceutical product, or a medical device, in the Field of Use containing the Bulk Active Material.

The trademark will be determined by Licensee and approved by Licensor.

Field of Use

The field of use means the availability and use of the Finished Products formulated for the prevention and/or treatment of any indication for external wounds and internal wounds. For the sake of clarity, such indications shall include, but not be limited to, the gastrointestinal tract and burns; and shall not include ocular wounds. It is understood that any treatment or use of the Finished Products may not be incorporated into the form of any type of cosmetic product.

License Grant

The Licensee entered into an agreement with a national blood bank, under which the blood bank supplies the blood that serves as the raw material for, and manufactures, the Licensee's CureXcell product in Israel. Under the agreement, the blood bank produces CureXcell based on the Licensed Technology and based on the Licensee’s needs.

License Property

CureXcell is an injectable suspension of living human white blood cells, including macrophages, neutrophils and lymphocytes, that are crucial to initiating, promoting and completing the process of cellular regeneration and wound healing. The Licensee uses proprietary cell activation technology to trigger these cells to release growth factors and other biochemical factors that improve the healing environment in the wound bed and stimulate wound closure.

Field of Use

The CureXcell product is sold to health care professionals in Israel for clinical purposes as part of the Licensee’s research and development activities. The Licensee is a regenerative medicine company focused on developing, manufacturing and commercializing novel cell therapy products to address unmet needs in the treatment of chronic and other hard-to-heal wounds. Their product candidate, CureXcell, is an advanced wound care, or AWC, therapy to treat such wounds by injecting living human white blood cells that have been activated to facilitate the healing process. CureXcell is currently in two pivotal, Phase 3, double-blind clinical trials targeting a broad indication for the treatment of diabetic foot ulcers, or DFUs, and venous leg ulcers, or VLUs. The Licensee anticipates results from their DFU clinical trial and interim data from their VLU clinical trial in the second half of 2015. They already hold product approval for CureXcell as a medical device in Israel for the treatment of chronic and other hard-to-heal wounds, and have effectively and safely treated more than 5,000 patients in commercial or clinical study settings in Israel.

License Grant

The Licensors grants the Licensee a non-revocable, exclusive, sub-licensable, transferable right in and to the Licensed IP to make, have made, use, sell, export, reproduce, market and distribute Products for External Wound Care in the field of use.

License Property

External Wound Care means the treatment of external, tunneled or undermined wounds (including, without limitation, pressure ulcers (Stages I – IV), venous stasis ulcers, diabetic ulcers, ulcers resulting from arterial insufficiency, surgical wounds, traumatic wounds, first and second degree burns, superficial wounds, cuts scrapes, skin tears, skin flaps and skin grafts.

Patent means – United States Patent No. 6,136,341.

The patented technologies and processes related to CellerateRxTM, an advanced collagen based wound care product formulation.  These new licenses are limited to the human health care market for external wound care, and include any new product developments based on the licensed patent and processes.

Field of Use

The Field of Use means the worldwide human health care market, (excluding the veterinary, nutritional and injectable markets as well as all other uses) and subject to certain exceptions.

License Grant

The Licensor and the Licensee of an India entered into a Patent and Technology License Agreement to License the Nimbus® intellectual property.

Under the Agreement, the Licensor grants the Licensee exclusive rights to use the Nimbus intellectual property in hydrophilic polyurethane foam for wound care applications and for securing intravenous tubings and catheters on products sold in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, Russia and their territories and possessions.

License Property

The antimicrobial technology that has been custom designed for wound care and other medical applications. NIMBUS® received de Novo FDA clearance in June 2009 and has been commercialized in traditional wound care applications.  Additional applications under development include advanced wound dressings, medical adhesives, and catheters.

NIMBUS® is based on non-toxic, long chain polymers with high charge density that provide superior efficacy via a physical action on microbes. By destroying bacteria at the cellular level, NIMBUS® eliminates the risk of developing drug resistance. The technology is highly effective against a multitude of bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE), two of the most significant antibiotic-resistant organisms responsible for hospital infections.

The Marks and Trademarks of Licensor include without limitation Quick-Med Technologies, QMT, Quick-Med, NIMBUS, and accompanying logos and trade dress, including the QMT Cross Official Logo

Patent
Intrinsically Bactericidal Absorbent Dressing and Method of Fabrication – IN/PCT/2001/00776/MUM
Method of Attaching An Antimicrobial Cationic Electrolyte To The Surface of A Substrate – PCT/US2006/32955
Polyelectrolyte Complex for Imparting Antimicrobial Properties to a Substrate – PCT/US2009/051163

Field of Use

Field means hydrophilic polyurethane foam in various shapes and sizes, used solely for wound care applications as primary or secondary dressings and for securing intravenous tubings and catheters.