Royalty Report: Medical, Nerve, Supply – Collection: 372628

License Grant

These Parties have entered into a certain Asset Purchase Agreement.

For the License, Licensor grants a worldwide license under the Licensed Technology to make, have made, use, offer to sell, sell, and otherwise commercialize Licensed Products, solely within the Field of Use.

For the Right to Grant Sublicenses, Licensor grants the right to grant sublicenses under the Licensed Technology to make, have made, use, offer to sell, sell, and otherwise commercialize Licensed Products within the Field of Use.

License Property

The patents include
Platelet-Derived Growth Factor Compositions and Methods of Use Thereof;
Maxillofacial Bone Augmentation Using rhPDGF-BB and a Biocompatible Matrix;
Compositions and Methods for Repairing Cartilage Defects;
Compositions and Methods for Treating Bone;
Prevention and Treatment for Osteonecrosis and Osteonecrosis of the Jaw;
Methods and Compositions for Treating the Vertebral Column; and,
Compositions and Methods for Treating Rotator Cuff Injuries.

Licensor has certain assets related to the orofacial therapeutic business.

rhPDGF means recombinant human platelet derived growth factor.

Licensed Products means any product with application within the Field of Use that Licensor and/or Licensee develops or has developed which is covered by the Licensed Technology, developed through the use of a process which is covered by the Licensed Technology, or could not be manufactured, used or sold without the incorporation or use in whole or in part of some or all of the Licensed Technology, including, but not limited to
—  any Growth Factor product, including GEM 21S, GEM ONJ, GEM 22A, and a GEM OS2-like product for application within the Field of Use, including Growth Factors alone, combinations of Growth Factors, and combinations of Growth Factors with non-Growth Factor products, and any component thereof, for which commercialization thereof is not subject to a third party license agreement that Licensor enters into after the Closing of the Asset Purchase Agreement;
—  any device, e.g., bone matrix material, implant and/or related product, for which the commercialization thereof is not subject to a third party license agreement that Licensor enters into after the Closing of the Asset Purchase Agreement.

Field of Use

The Field of Use means all applications above the neck in humans and all veterinary applications. For the avoidance of doubt, Field of Use in humans does not include central nervous system diseases such as multiple sclerosis, nerve regeneration or extraoral dermal or epidermal tissue, except that oral indications, such as cleft lip and palate, that traverse the intraoral-extraoral boundary, are not excluded.

License Grant

By the 2003 agreement, Licensor granted an exclusive worldwide sublicense for the Licensed Technology in the Field of Use and the Field of Extended Use.  This amended and restated agreement is to continue the Exclusive Sublicense with the amendments.

Licensor grants an exclusive worldwide license under the Licensed Technology to use, offer to sell, sell, and otherwise commercialize, solely in the Field of Use and the Field of Extended Use, Licensed Products which include rhPDGF-BB purchased from Licensor.

For the Sublicenses, Licensor grants the right to grant sublicenses under the Licensed Technology to Distributors to use, offer to sell and sell, in the Field of Use and the Field of Extended Use, Licensed Products purchased from Licensor.

License Property

Licensed Products means any product consisting essentially of rhPDGF-BB in the absence of other growth-promoting proteins and in combination with a synthetic or natural matrix, or any part thereof i.e., any product consisting essentially of rhPDGF-BB in the absence of other growth-promoting proteins without a matrix, or a synthetic or natural matrix alone, that is covered by the Licensed Patents; is developed through the use of a process that is covered by the Licensed Patents or could not be manufactured, used or sold without the incorporation or use in whole or in part of some or all of the Licensed Patents.

Proven rhPDGF technology is FDA approval of GEM 21S for periodontal bone regeneration suggests potential for efficacy in other bone and musculoskeletal applications.

Field of Use

GEM 21S was approved by the U.S. Food and Drug Administration the treatment of periodontal bone defects and gum tissue recession associated with periodontal disease.

GEM 21S® growth-factor enhanced matrix is indicated to treat the following periodontally related defects intrabony periodontal defects; furcation periodontal defects; and gingival recession associated with periodontal defects.

GEM 21S® growth-factor enhanced matrix combines a bioactive protein – highly purified rhPDGF-BB – with an osteoconductive matrix, ß-TCP.

GEM 21S® is the only dental therapy containing rhPDGF-BB, one of the main growth factors found in the human body and well known for its stimulatory role in wound healing.

This completely synthetic grafting system is engineered to stimulate wound healing and bone regeneration when implanted in the body by triggering a cascade of molecular events that continues on even after the implanted rhPDGF-BB is gone.

The Field of Use means all uses related to the treatment, cure, or relief of mammals for periodontal diseases and/or the repair, restoration or reconstruction of oral and cranio• maxillofacial osseous defects.

The Field of Extended Use shall mean all uses outside the Field of Use that are related to the treatment and healing of bone, cartilage, tendon and ligaments of the skeletal tissue system in animals, excluding humans, excluding the treatment and healing of soft tissue wounds.

License Grant

The Licensee entered into an exclusive license agreement with the Licensors for the use of their patent application for the method of producing autologous PRP to treat neuropathy.

License Property

The patent application is for a method of producing autologous PRP to treat neuropathy.  Neuropathy is a nerve disease causing numbness and pain.  Our products utilize Platelet rich plasma (PRP), a blood plasma derived product, which typically contains an elevated level of platelets and growth factors (at least four to eight times) than normal blood concentration. PRP appears to have beneficial effects for tendon, ligament or muscle injuries, maxillofacial therapies, dentistry, cosmetics, wound healing, cardiothoracic surgery, ear–nose–throat surgery, neurosurgery, urology, and ophthalmology.

Platelet-rich plasma (PRP) is blood plasma that has been enriched with platelets.

Field of Use

The Licensee will have exclusive rights to utilize this application in connection with the manufacture and sale of its neuropathy treatment products. The Licensee is currently developing products for treating peripheral neuropathy, hair loss and facial rejuvenation using platelet-rich plasma. As a concentrated source of autologous platelets, PRP contains (and releases through degranulation) several different growth factors and other cytokines that stimulate healing of bone and soft tissue, and can also be used as a treatment for hair regrowth. These products are not yet commercially available.