Royalty Report: Medical, Device, Delivery – Collection: 1686

License Grant

Inventors, two of whom are former officers and directors of the Licensee hereby grant and Licensees hereby accept exclusive licenses for the entire world to make, use and sell Products. Such licenses are perpetual, subject to the payment of royalties as provided herein.

License Property

'Gel Patents' shall refer to United States Patent No. 5,067,965, Bio-Oncotic Gel for Implant Protheses
'Micro Implant Patents and Patent Applications' refers to United States patent Application Serial Number 07/232,671, an Application, allowed in part and issued on November 2, l993, as Patent No. 5,258,028, United States Patent for Textured Micro Implants

'Reflux Disorders Patent Application' refers to United States Patent Application Serial Number 07/863,848, entitled Treatment of Urologic and Gastric Fluid Reflux Disorders by Injection of Micro Particles

Field of Use

Multiple patents Macroplastique(r) Implants are an injectable medical device implant designed to treat certain forms of urinary / in a minimally invasive procedure involving injection of the product material through a needle into the soft tissue at the bladder neck to act as a tissue bulking agent.

License Grant

Under the terms of an agreement with several undisclosed related Licensors the Licensee pays royalties on sales of certain Macroplastique products.

License Property

Macroplastique® Implants is an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence that is primarily due to intrinsic sphincter deficiency. Macroplastique is a soft-textured, permanent implant injected, under endoscopic visualization, around the urethra distal to the bladder neck. It is a proprietary composition of heat vulcanized, solid, soft, irregularly shaped polydimethylsiloxane (solid silicone elastomer) implants suspended in a biocompatible excretable carrier gel.

Field of Use

The Licensee is a global medical device company.

License Grant

Licensor hereby grants to Licensee a nonexclusive, nontransferable license, without the right to sublicense, under the Patent Rights to make, have made, use and sell Licensed Products and to practice and have practiced the Licensed Methods within the United States.

License Property

Collagen is the owner of United States Patent No. 4,803,075, entitled 'Injectable Implant Composition Having Improved Intrudability'

Macroplastique® is a minimally invasive, implantable soft tissue bulking agent for the treatment of urinary incontinence.

Field of Use

'Licensed Products' means (I) any injectable aqueous suspension of a particulate biocompatible material which contains a lubricant, and (ii) any other product, apparatus, kit or component part thereof.

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 Licensee entered into an agreement as licensee to obtain exclusive patent rights covering certain injection-related instrumentation.  The Licensor is undisclosed.

Field of Use

The Licensee's business is the manufacture, distribution and sale of an injectable medical device implant used to treat certain forms of urinary incontinence.

License Grant

Licensor hereby grants to Licensee an exclusive, worldwide, royalty-bearing license of the Patent Rights, with the right to grant and authorize sublicenses, to develop, make, have made, use, sell and otherwise distribute and exploit the Licensed Products.

License Property

Licensor is the sole and exclusive owner of certain intellectual property rights, including patent rights in chemical compounds relating to a polymer hydrogel formulation based on a copolymer of three chemicals; i) polyvinylpyrrolidinone (PVP), ii) a derivative of PVP, and iii) an acrylic for the use in dermatological applications.

Licensed Product means any product or material distributed solely for use in the field of dermatology for application in the epidermis, dermis, or subcutaneous fatty tissue, urology, and gastroenterology the manufacture, use or sale of which by an unlicensed third party would constitute an infringement of a Valid Claim if such claim is or were to be included in an issued patent.

Patent Rights means all rights in U.S. patents 5,116,371 and 5,713,960.

The bulking agent that comprises our products involves the use of a polymeric component from the poly-n-vinyl pyrrolidinone (PVP) family, which is recognized for its biocompatibility and extensive clinical use in other Class III (permanent implantable) medical devices.

PVP is a non-toxic, non-metabolized hydrogel that has been approved for use as a plasma volume expander, a plasma detoxifying agent, an orally-ingested diagnostic aid (complex of PVP and iodine), a component of soft contact lenses, a variety of dental applications, a filler for a permanent implantable urological device and as an excipient in the manufacturing of tablets containing a variety of drugs.  The dose of PVP used in our products is minimal; approximately 95% of the injected volume is water contained in the polymer matrix. We are developing the following products designed for use in dermatology, urology, and gastroenterology. Dermatology AquaDerm is targeted at the long-term corrective effects of skin treatment.  AquaDerm addresses conditions of tissue atrophy due to aging, facial wrinkles and depressed scars, as well as soft tissue defects resulting from surgery and inflammatory skin diseases.  PVP has infinite molecular weight as a base polymer matrix, which impedes absorption and migration of polymer substrate into the surrounding tissue, thus lengthening the cosmetic effect. Most other injectable materials are suspensions (leading to the absorption of suspension media and migration of suspended particles) or biological in nature (such as Collagen, which the body digests).

Our product will be injected into the affected areas and filled to the appropriate point, making the defect flush with the surrounding tissue, or in the case of lip augmentation plumped to the desired size. Most products in the facial aesthetics/dermatology market today have the common drawback of migration/absorption.  Animal trials and initial human clinical trials indicate longer-term maintenance of results for AquaDerm. Urology AquaGen has been developed for use as a bulking agent in the minimally invasive treatment of stress urinary incontinence (SUI), the most common form of urinary incontinence. AquaGen is injected into the urethra/bladder junction (urinary sphincter muscle), reinforcing the muscle tissues around the bladder neck, the 'bulking' of the closure mechanism that prevents accidental urine leakage. Gastroenterology AquaFlux has been designed for use as a bulking agent in the minimally invasive treatment of chronic heartburn or gastroesophageal reflux disease (GERD). AquaFlux is utilized as a bulking agent to strengthen and build the sphincter muscle at the base of the esophagus through a minimally invasive procedure, reinforcing and augmenting the closure mechanism that prevents reflux or gastric heartburn.

Field of Use

Licensee desires to continue and expand its licenses from Partners in Biomaterials relating to such device in the fields of dermatology, urology, and gastroenterology.

License Grant

The Licensee entered into an exclusive License and development Agreement with an Australian University, granting the Company a worldwide exclusive (even as to the university) License, with rights to subLicense, to all the Company’s product candidates and associated know-how based on the University's technology, including the exclusive right to manufacture, use and sell the product candidates. The Company agreed to invest towards development of any Licensed product.

License Property

The University Intellectual Resources Management is focused on developing the key surgical devices that would make noninvasive procedures a reality.  The Licensee is a developmental stage medical device company focused on the development of medical devices that manipulate tissues for endoscopic and minimally invasive surgery for the treatment of obesity, gastroesophageal reflux disease, Barrett's Esophagus, esophageal obstructions, upper gastrointestinal bleeding, hernia formation and other intraperitoneal abnormalities.  The Company’s product portfolio includes a device for endoscopic bariatric surgery (obesity surgery) and endoscopic repair of gastroesophageal reflux disorder (GERD), as well as an endoscopic device for excision and diagnosis of Barrett’s esophagus.

Licensed Patent Rights and Licensed Patents shall mean (1) United States Provisional Patent Application No. 60/698,748 filed July 13, 2005, and titled Suturing System for Transoral Gastroplasty and United States Provisional Patent Application No. 60/742,826 filed December 6, 2005, and titled Systems and Techniques for Transoral Gastroplasty; (2) International Patent Application No. PCT/US04/028516 entitled Suturing Devices and Methods, filed September 2, 2004 (claiming benefit of U.S. Provisional Patent Application Serial No. 60/499,539, filed September 2, 2003; U.S. Provisional Patent Application Serial No. 60/507,837, filed October 1, 2003; and U.S. Provisional Patent Application Serial No. 60/576,510, filed June 3, 2004); (3) any and all Patent Rights under the patents or patent applications for any Additional Technologies and associated Know-How licensed by the Company.

License Grant

The Licensors hereby grant to the Licensee, and the Licensee hereby accepts, an exclusive license worldwide to make use and sell Product (hereinafter referred to as the 'License').  Such license is perpetual, subject to the payment of royalties and other obligations of the Licensee herein.

License Property

The Licensors have developed a material used in and around implantable prosthetic devices (called Bio-Oncotic Gel (United States Patent No. 5,067,965)), and have invented certain breast implant products, along with methods and materials to manufacture the breast implants.

U.S. Patent 4,955,909 September 11, 1190 (S.N. 07/496,234)
U.S. Patent 5,260,965 November 26, 1191 (S.N. 07/304,764)
U.S. Patent 5,997,574 and any corresponding foreign patent applications U.S. Patent 5,630,844 and any corresponding foreign patent applications U.S. Patent 6,162,251 and any corresponding foreign patent applications U.S. Patent 09/452,656 and any corresponding foreign patent applications.