Royalty Report: Medical, Wound Care, Supply – Collection: 116250

License Grant

Licensor grants to the Japanese Licensee a royalty bearing, nontransferable, exclusive license, with limited right to sublicense, to use Licensor Technology for the development, import, use, marketing, sale, and distribution of the Product in the Field of Use in the Territory.  Licensee shall have an exclusive right, in the Field of Use in the Territory, to import, use for development, promote, market, sell and distribute the Product which Licensor manufactures or has contractor manufacture for Licensor and supply to Licensee.  Licensor shall not export, promote, or supply the Product to any third party in the Territory.  Licensor grants to Licensee a royalty free, nontransferable, exclusive license, with the right to sublicense, to use Nuo Trademark for the Product which Licensee import, develop, use, market, sell and distribute in the Field of Use in the Territory. Licensor shall register the Licensor Trademark in the Territory.

License Property

The Licensor is the owner of certain intellectual property rights pursuant to which it has commercialized a point of care cell separation device which produces a platelet based therapeutic formulation for use on chronic, hard to heal wounds and ulcers offered as the Aurix System.

Product means the combination of devices to produce a Wound Dressing from the patient’s blood. As of the Effective Date, the Product means Aurix System (formerly AutoloGel System) which consists of Centrifuge, Wound Dressing Kit, and Reagent Kit.

Product
Centrifuge II

Wound Dressing Kit Section I
S-Monovette Tubes
ACD-A, 6.0ml
Safety-MultiFly Set
21g x ¾”
Tourniquet

Alcohol Prep Pads
2-Ply Medium, Saturated with 70%
Gauze Sponges

Adhesive Bandage Strips

Foam Tub Holder

Wound Dressing Kit Section II
Alcohol Prep Pads
2-Ply Medium, Saturated with 70%
Gauze Sponges

3 mL Syringe w/Needle
20 G x 1”
5 mL Syringe w/Needle
20 G x 1”
20 mL Syringe w/Needle

3 Way Stop Lock
Discofix
Blunt Needle
Monoject 16” x 1 ½”
Skin Protection Wipe
Cavilon—No Sting Barrier Film, 1.0 ml
N-Terface Dressing
4” x 12” Strip

Reagent Kit

Ascor L 500, Ascorbic Acid Injection, USP,  500mg/mL
McGuff Pharmaceuticals, Inc.
Calcium Chloride Injection, USP, 10%
American Reagents, Inc.
Thrombin Topical (Bovine Origin) USP, Thrombin-JMI 5,000U
Kings Pharmaceuticals

Nuo Trademark
Aurix
Aurix System
Autologel
Cytomedix
Nuo Therapeutics

Nuo Patent
Nuo Patnet-1

Application No.
JP2000-555609
Patent No.
JP3993981
Nuo Patent-2

Application No.
JP2012-534244
Patent No.
JP5502207

Field of Use

This agreement pertains to the medical industry relating to a therapeutic device for all wound care and topical dermatology applications in human and veterinary medicine.

License Grant

The Licensor shall grant to the Japanese Licensee an exclusive license, with limited right to sublicense, to use Licensor Technology for manufacturing, or having third-party manufacture devices which are covered by the Licensor Patent or embodied by Licensor Know How, such as the New Devices and Centrifuge of current and future version, for the Territory. for all wound care and topical dermatology applications of the Companys Aurix® system and related intellectual property and know-how in human and veterinary medicine in Japan.

License Property

The Licensors intellectual property is for wound care and topical dermatology applications of the Licensors Aurix® system and related intellectual property and know-how in human and veterinary medicine in Japan.

The Aurix® System is used at point-of-care for the safe and rapid preparation of biodynamic hematogel from a small sample of a patient’s own blood.

Field of Use

Wound care solutions in humans and animals.

License Grant

The Parties amend the Agreement to modify the products and materials that are subject to the Agreement; extend the Agreement subject to certain conditions; and to make other material changes to the original Agreement.

License Property

Patents shall mean U.S. 7,045,673 – Intrinsically bactericidal absorbent dressing and method of fabrication

Products include the following
1. Conforming gauze bandage used as a secondary dressing to hold primary dressing in place  either 100% cotton or a blend of rayon and PET
2. Gauze sponges, gauze bandage rolls, gauze packing strips  100% cotton
3. 100% cotton, Rayon/PET blend or cotton/polyester blend nonwoven sponges
4. Dressings constructed of 100% cotton or cotton/rayon blend sandwiched between layers of PET (Mylar) or PA (Nylon) either with or without an adhesive border

Materials shall mean Polydiallyldimethyl ammonium chloride with specified substrate materials. (100% cotton and blends of rayon and PET)

Trademark shall include without limitation “Quick-Med Technologies” “QMT”, “Quick-Med”, “NIMBUS”, and accompanying logos and trade dress, including the QMT Cross Official Logo, which is subject to modification by Licensor from time to time.

The patent for company's proprietary NIMBUS(R) polymeric antimicrobial technology is applicable to a variety of base materials including woven and nonwoven fabrics.
The broad range of materials covered under the provisions of the patent include those that are composed of natural fibers, such as cotton and wool, as well as synthetics such as polyurethane, polyester, nylon and polypropylene. The applications included in the allowed claims are for a full spectrum of products such as medical devices including wound and burn dressings and blood transfer and storage products, surgical drapes and gowns, bedding, industrial and military protective wear and consumer apparel plus hygienic products such as wipes, diapers and feminine care.

Field of Use

NIMBUS is the first non-leaching antimicrobial available in a wound dressing. The dressings serve as a barrier to infection, kill germs absorbed into the dressing, and do not interfere with tissue healing. The NIMBUS active agent maintains effectiveness even in the presence of large amounts of proteinaceous exudates.

Field means the field of conforming gauze, gauze sponges, gauze bandage rolls, gauze packing strips, rayon/PET, cotton or cotton/polyester blend nonwoven sponges, and dressings constructed of 100% cotton or cotton/rayon blend sandwiched between layers of PET (Mylar) or PA (nylon) non-adherent perforated film used solely for wound care and sold to the institutional market not for resale as more specifically described in agreement.  The Field specifically excludes products provided to, developed for, or sold to the general, over-the-counter consumer market and, subject to the non-exclusive rights granted to DERMA pursuant hereof, the United States government, including, without limitation, the Department of Defense and/or agencies and military services thereof.

Licensor Policy on Use of Licensor Marks, Trademarks and Official Logo All Licensed Products that include Licensor technology, and related product packaging, advertising, promotional and marketing materials, shall display Licensor’s Official Logo in a size and prominence in accordance with industry standards. Use of Licensor’s Official Logo (the Logo) shall maintain the integrity of the Logo’s design. The color used is Burgundy, Black and White.  Licensor’s Marks, including but not limited to its name and Official Logo shall be displayed in a size and prominence at least equal to similar marks, names and logos for similar products or methods on any product, packaging, documentation, advertising, promotional, marketing, and related materials in accordance with industry standards.  The elements of the Licensor trade dress cannot be separated without the prior permission of Licensor.

License Grant

The Licensor agrees to grant an exclusive License to such Patent (7.045,673) Rights relating to its proprietary antimicrobial NIMBUS® technology in the Field and Exclusive territory and a non-exclusive License to such Patent Rights and Technology in the Field in the Non-exclusive territory on the terms and conditions of this Agreement.

License Property

Products
1. Conforming gauze bandage used as a secondary dressing to hold primary dressing in place either 100% cotton or a blend of rayon and PET

2. Gauze sponges, gauze bandage rolls, gauze packing strips 100% cotton

3. Oil emulsion acetate 100% acetate

4.

Unna boot 100% cotton

Field of Use

NIMBUS is the first non-leaching antimicrobial available in a wound dressing. The dressings serve as a barrier to infection, kill germs absorbed into the dressing, and do not interfere with tissue healing. The NIMBUS active agent maintains effectiveness even in the presence of large amounts of proteinaceous exudates.

Field means the field of conforming gauze, oil-emulsion acetate, gauze sponges, gauze bandage rolls, gauze packing strips and Unna Boot dressings used solely for wound care and sold to the institutional market not for resale.

License Grant

Licensor hereby grants to Licensee for the a non-exclusive, royalty-bearing license to manufacture, have made, use, import, sell, promote, market, offer for sale, or otherwise transfer Platelet Products, Activated Platelet Gel Services and Experimental Platelet Gel Therapies for use in practicing or involving the practice of processes covered by one or more claims of the Licensed Patent in any field of use.

License Property

The controversy between the Parties based upon Licensee's manufacture, use, marketing, offer to sell, and/or sale of products alleged to infringe U.S. Patent No. 5,165,938.

Activated Platelet Gel Therapies are defined as methods of treating damaged tissues and/or wounds using topical compositions containing platelets activated by adding thrombin or another biologic release agent, or containing substances released from platelets after activation by adding thrombin or another biologic release agent.

Experimental Platelet Gel Therapies are defined as methods of treating damaged tissues and/or wounds using topical compositions containing platelets activated by locally present thrombin or another biologic release agent, or containing substances released from platelets after activation by locally present thrombin or another biologic release agent, i.e., without adding thrombin or another biologic release agent.

Schedule of SafeBlood Branded Single Use Disposable Kit Products
Item Description

Manufacturer Number

SafeBlood Graft Kit
                    
SBG KitSB101 / W

SafeBlood Graft Kit

SBG KitSB101 / W 1

SafeBlood Graft Kit

SBG KitSB102 / W

SafeBlood Graft Kit

SBG KitSB201 / W

SafeBlood Graft Kit

SBG Kit SB 103

SafeBlood Graft Kit 800-1001A(1)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A(2)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A(3)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A(4)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A(5)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A(6)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A(7)

BIOMETGPS 800-1001A

SafeBlood Graft Kit 800-1001A

BIOMETGPS 800-1001A

GPS Counter Balance

BIOMETGPS 800-0508

Schedule of SafeBlood Branded Single Use Disposable Component Products

Item Description

Manufacturer Number

SBG Graft Activator
    
CD SBG-1005

Ratio Procedure kit

Micromedics SA-4400

Blending Connector

Micromedics SA-3674

Single Spray Tip

Micromedics SA-3671

Dual Spray Applicator Tip

Micromedics SA-3660

Dual Tip

Micromedics SA-0205

Schedule of SafeBlood Branded Capital Equipment Products
Item Description

Manufacturer Number

GPS Centrifuge 120 Volt 50-60HZ
    
GPS – 7426

License Grant

Licensor hereby grants to Licensees for a non-exclusive, royalty-bearing license to manufacture, have made, use, import, sell, promote, market offer for sale, or otherwise transfer PPAI Branded Platelet Products for use in practicing processes covered by one or more claims of the Licensed Patents in any field of use anywhere in the world. This grant includes the right for Licensees to grant sublicenses to Distributors, with the prior written consent of Licensor (which shall not be unreasonably withheld).

License Property

Licensor filed an action against PPAI (the 'Illinois Action'), Civil Action No. 02 C 4776, in the United States District Court for the Northern District of Illinois, which included claims for infringement of U.S. Patent No. 5,165,938 ('the '938 Patent') based upon PPAI's manufacture, use, marketing, offer to sell, and/or sale of products used to practice Platelet Therapies;

'Platelet Products' shall mean all devices, kits, applicators, reagents or other items (regardless of whether in the nature of a capital product having more than a single use or a disposable product having only a single use) manufactured, marketed, promoted, used, offered to be sold, or sold by or for PPAI and/or Transcorporeal for use in practicing Platelet Therapies, including without limitation the items. The items and all successor equipment and products that are improvements to such scheduled equipment and products, will be considered Platelet Products for purposes of this Agreement. PPAI Branded Platelet Products shall be designed in such manner that a Disposable Kit is required for each Platelet Therapy administered.

'Platelet Therapies' refers to methods of treating damaged tissues and/or wounds using topical compositions containing platelets, or substances derived from platelets, regardless of whether the patient is a human or animal.

'PPAI Brand' shall mean any trademark, trade name or brand name owned or licensed by PPAI and/or Transcorporeal (including, without limitation, the Secquire(TM) or Thrombograft(TM) brand names). 'PPAI Branded' shall mean having or bearing a PPAI Brand.

Item Description               Manufacturer Number

—————-                        ——————-

Secquire Kit (15 Kits/case)           SK50-20

Secquire Limited (24/case)            SK50-LI     DT-8405

Secquire Centrifuge Machine           CL05-1017

Secquire Centrifuge Machine           CL05-1017-220

Four Place Rotor Systems              R-52151

(20-40 ml Change Over Kit)

Aero Carrier Bucket (10-20 ml)        AC-5101

Two Place Rotor System (10-20 ml)     R-52152

Change Over Kit)

Four Place Swinging Bucket Rotor      BR-05-103B

Shield Bucket                         SB-05-170

Dual Tip Applicator 26 ga x 3'        SA-0105

Dual Tip Applicator 26 ga x 4'        SA-0106

Dual Tip Applicator 26 ga x 7'        SA-3612

Dual Tip Applicator 20 ga x 2.5'      SA-0205

Dual Tip Applicator 20 ga x 4'        SA-3618

Dual Tip Applicator 20 ga x 7'        SA-3619

Dual Tip Applicator 20 ga x 10.25'    SA-3620

Dual Tip Applicator Endoscopic        SA-3650

Dual Spray Tip Applicator             SA-3660

Ratio Applicator Procedural Kit       SA-4400

111 Ratio (No Tips)

Aerosol Applicator, 111 Ratio        SA-6111

Aerosol Regulator                     SA-6030

Table Ratio Kit                       TRK-11

License Grant

The Company has an exclusive sublicense to distribute CellerateRX® Activated Collagen® products into the wound care and surgical markets in the United States, Canada and Mexico.

License Property

CellerateRX® is a wound and skin care product for use by surgeons on surgical wounds consisting of a Surgical Powder that is a medical hydrolysate of Type I bovine collagen.  When applied to a surgical wound, the hydrolyzed collagen is ready to aid in the natural wound healing process.

Licensor manufactures the products and owns the CellerateRX registered trademark.

Field of Use

CellerateRX Surgical Powder is a medical hydrolysate of Type I bovine collagen indicated for the management of
Surgical wounds
Traumatic wounds
Partial- and full-thickness wounds
First- and second-degree burns

Licensee will utilize the wound and skin care products for external wounds, including the treatment of external, tunneled or undermined wounds.  These products are used by surgeons in the medical industry. This would include 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.

The Licensees business is developing, marketing, and distributing wound and skin care products to physicians, hospitals, clinics and post-acute care settings.