Royalty Report: Medical, Supply, Wound Care – Collection: 4049

License Grant

We signed an exclusive license and supply agreement with Licensor for its poly-4-hydroxybutyrate polymer for certain fields of use, which we have branded Biofiber.

License Property

Biofiber is a high-strength biodegradable polymer that we have used in suture applications and in several soft tissue repair development projects.  Biofiber is an advanced high-strength resorbable polymer fiber produced using recombinant DNA technology as well as our F2A peptide, a synthetic version of the natural human FGF-2 growth factor.

Field of Use

The Licensee is global medical device company focused on surgeons that treat musculoskeletal injuries and disorders of the shoulder, elbow, wrist, hand, ankle and foot.  The Field of Use apply to an extremity specialist customer base a broad line of joint replacement, trauma, sports medicine and orthobiologic products to treat extremity joints

License Grant

The Licensee entered into a five-year license agreement with Licensor relative to a technology known as OPLA. The Licensee and Licensor are committed to research and development of specified uses of the OPLA technology.

License Property

The Open-cell Polylactic Acid or OPLA is a porous polymer foam technology, and to our biomaterials technology platform in the orthopedics drug and delivery markets.  This porous tissue matrix technology facilitates wound healing in both bone and soft tissue and is bio absorbable at controlled rates for specific functions and tissues.  This technology adds a series of products, development programs and intellectual property related to porous biodegradable regeneration matrices.  Specifically, we are researching applications for articular cartilage regeneration, bone growth scaffolds for spinal and trauma applications and for the delivery of drugs and growth factors.

License Grant

We signed an agreement with Licensor to develop, commercialize and distribute products incorporating  Licensor's F2A synthetic growth factor technology in the field of orthopaedic and podiatric soft tissue repair. As amended on February 10, 2010, this agreement granted us an option to purchase an exclusive, worldwide license for such products. We exercised this option on February 10, 2010.

License Grant

The company entered into an agreement with a Doctor to purchase rights to patents, ideas and designs related to the 'MultiLock' design for an anterior cervical plating system.  The Doctor agreed to provide exclusive continuing services as a developer, product lecturer and general consultant for anterior cervical plating.

License Property

The MultiLock design is for an anterior cervical plating system.

Field of Use

This agreement pertains to the medical industry relating to an anterior cervical plating system.  The Licensee is a designer, manufacturer and worldwide distributor of orthopaedic implant devices and   instrumentation for reconstruction and fixation.  Reconstructive devices are for joint arthroplasty that involve the replacement with mechanical substitutes of impaired skeletal joints such as knees, hips, shoulders, and the small joints of the elbow, hands and feet. The Company also offers devices for 1) fracture fixation due to trauma 2) arthroscopic surgery of the knee, shoulder and extremities,  and 3) the spine to aid in correction of deformity and instability.

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 company entered into an agreement with a Doctor to purchase rights to patents, ideas and designs related to the 'SingleLock'  design for an anterior cervical plating system.  The Doctor agreed to provide exclusive continuing services as a developer, product lecturer and general consultant for anterior cervical plating.

License Property

The SingleLock design is for an anterior cervical plating system.

The plates is used to help fuse the cervical vertebrae, are designed to be more anatomically correct than current plate options. The system will utilize self tapping screws, eliminating the need for drilling or tapping.

Field of Use

This agreement pertains to the medical industry relating to an anterior cervical plating system.  The Licensee is a designer, manufacturer and worldwide distributor of orthopaedic implant devices and instrumentation for reconstruction and fixation.  Reconstructive devices are for joint arthroplasty that involve the replacement with mechanical substitutes of impaired skeletal joints such as knees, hips, shoulders, and the small joints of the elbow, hands and feet. The Company also offers devices for 1) fracture fixation due to trauma 2) arthroscopic surgery of the knee, shoulder and extremities,  and 3) the spine to aid in correction of deformity and instability.

License Grant

The agreement licensed certain bone wax rights to develop products in the field of bone remodeling, based on patent number 7,074,425 for use in the human skeletal system.  The license agreement excludes the fields of (1) a resorbable hemostat (resorbable bone wax), (2) a resorbable orthopedic hemostat (bone wax) and antimicrobial dressing, and (3) veterinary orthopedic applications. In January 2014, Licensee received 510k approval for their first product under the license, a bioactive bone graft putty and bone graft extender.  In February 2014, Licensor granted a Commercial License to Licensee according to the terms of the development and license agreement.

License Property

The Licensor acquired patent 7,074,425 in September 2009.  It is for a resorbable bone wax and delivery system for orthopedic bone void fillers. The patent offers innovative, safe and effective resorbable orthopedic products that are complementary to the already existing Licensor products.  The bone wax and delivery system address issues such as bone wax granuloma and the cost-effective delivery of materials that manage bone wound healing. The resorbable orthopedic products covered by the patent are (a) a resorbable orthopedic hemostat (resorbable bone wax) used to stop blood flow, (b) a delivery system for osteogenic/osteoinductive orthopedic products (bone void fillers), and (c) the formula as a delivery system for bone growth factors.

License Grant

Licensor grants to Company, an affiliate, an exclusive, worldwide, non-transferable license, with the right to sublicense, to the Intellectual Property to make, have made, modify, import, use, offer to sell, sell and have sold Products and perform and have performed processes under the Intellectual Property, solely in the Field.  The parties are entering into a Stock Purchase Agreement of even date.

License Property

The intellectual property and patents include, but are not limited to, Purification of structurally ordered recombinant protein polymers, Construction of synthetic DNA and its use in large polypeptide synthesis, High molecular weight collagen-like protein polymers, Synthetic proteins as implantables, Protein-enriched thennoplastics, and, Tissue Adhesive Using Synthetic Crosslinking.

Field of Use

The Field shall mean human or veterinary applications involving treatment, repair and/or diagnosis of conditions of the spine; provided that with respect to any Intellectual Property covering covalently crosslinked or adhesive protein polymer formulations (including without limitation, drug delivery formulations) the Field shall mean all orthopaedic applications, including treatment or diagnosis of deformities of the musculoskeletal system, which includes all of the bones and cartilages of the body and associated muscle attachments.

The Company is to develop and commercialize an injectable protein-based formulation for the repair of spinal disks damaged either by injury or aging. Based on Licensor's proprietary tissue adhesive technology, the product under development has potential to be an effective outpatient surgical treatment for chronic low back pain.