Royalty Report: Medical, Device, Packaging & Containers – Collection: 4410

License Grant

Swiss Licensor hereby grants to Licensee and its Affiliates, solely in the Field of Use:
  (a) an exclusive (even as to Baxter) royalty-bearing right and license under the Licensed Patents and Licensed Know-How to make, have made, assemble, use, sell, offer for sale, distribute, import and export:  
  (i) Platelet Products solely for sale in the Platelet Territory;  
  (ii) Plasma Products solely for sale in the Plasma Territory;  
  (iii) RBC Products solely for sale in the RBC Territory; and  
  (iv) Residual Products solely for sale in the Residual Territory.

License Property

Licensor, owns or has rights in certain proprietary Licensed Materials, Licensed Patents and Licensed Know-How (all as hereafter defined) relating to the INTERCEPT Blood System.
Parties have developed technology for the inactivation of pathogens in blood and blood components (the “INTERCEPT Blood System”).

“INTERCEPT Illuminator” means a proprietary illumination device, including operating software and data management system including source code for each, developed for use with Platelet Sets and Plasma Sets.

“ESOL Solution” means a proprietary red blood cell storage solution, also known as erythrosol in all formulations thereof.

“Conversion Kit” means a disposable set having Intersol Solution which permits the preparation of single donor platelets collected on a non-Baxter apheresis collection platform to interface with the Platelet System.

“Plasma Sets” means disposable processing sets, including without limitation, single unit and jumbo configurations, for inactivation of pathogens in plasma components of blood, containing the raw material amotosalen (“S-59”) or other psoralen compounds.

“Platelet Product” means Platelet Systems, Conversion Kits and Storage Solution Containers.
“Platelet Sets” means disposable processing sets for the inactivation of pathogens in platelet components of blood, containing the raw material amotosalen (“S-59”) or other psoralen compounds

Field of Use

“Field of Use” means (a) the inactivation or reduction of pathogens for the decontamination of all blood cells and blood components, including inactivation of pathogens in whole blood, and (b) the inactivation of leukocytes or reduction of leukocyte activity through nucleic acid binding.

License Grant

Licensor hereby grants to Licensee and its Affiliates, solely in the Field of Use:

(a)
an exclusive (even as to Baxter) royalty-bearing right and license under the Licensed Patents and Licensed Know-How to make, have made, assemble, use, sell, offer for sale, distribute, import and export:

(i)
Platelet Products solely for sale in the Platelet Territory;

(ii)
Plasma Products solely for sale in the Plasma Territory;

(iii)
RBC Products solely for sale in the RBC Territory; and

(iv)
Residual Products solely for sale in the Residual Territory; and

(b) a nonexclusive, royalty-bearing right and license to use, reproduce, display, translate, distribute copies of, and to modify and create derivative works of the Licensed Materials within the respective parts of the Territory set forth.

License Property

Parties have developed technology for the inactivation of pathogens in blood and blood components (the “INTERCEPT Blood System”).

The Intercept Blood System, which is based on our proprietary Helinx technology for controlling biological replication, is designed to enhance the safety of donated blood components by inactivating viruses, bacteria, parasites and other pathogens, as well as potentially harmful white blood cells.

Field of Use

“Field of Use” means (a) the inactivation or reduction of pathogens for the decontamination of all blood cells and blood components, including inactivation of pathogens in whole blood, and (b) the inactivation of leukocytes or reduction of leukocyte activity through nucleic acid binding.

The rights granted apply for blood safety, cancer and infectious disease.

License Grant

Dated: 2007

As a result of Baxter International Inc.'s sale of its transfusion therapies division to the Licensor, the Licensee has certain Agreements with the Licensor.

License Property

The INTERCEPT Blood System is designed for three blood components.  The INTERCEPT Blood System for platelets, or platelet system, and our INTERCEPT Blood System for plasma, or plasma system, have received CE marks and are being marketed and sold in a number of countries in Europe, The Commonwealth of Independent States, or CIS, the Middle East and selected countries in other regions around the world.

Field of Use

The Licensee will pay royalties on future Intercept Blood System product sales, including the platelet system, the plasma system, the red blood cell system, illuminators.

License Grant

Licensor and Licensee shall collaborate to develop a Cell Washing System that can be utilized with the Viral Inactivation Agent to inactivate pathogens in red cells and then to remove or neutralize the inactivation agent.

Licensee agrees to purchase Cell Washing Technology for use in viral inactivation of red blood cell concentrates only from Licensor.  Licensee shall have the exclusive worldwide right to buy Licensors Cell Washing Technology in the field of viral inactivation of red blood cell concentrates, except that Licensees rights become nonexclusive if Licensee, for reasons not due to Licensor, fails to gain FDA approval for viral inactivation of red blood cells with its Viral Inactivation Agent together with the Cell Washing System by December 31, 2005, or, if Licensee s purchases of Cell Washing Systems from Licensor in calendar year 2006 are less than $3,000,000.

License Property

The system is the only “closed” cell washing system approved by the FDA. This closed system allows the cells to be either immediately transfused or stored for later transfusion, similar to untreated red blood cells.

Licensor develops and commercializes, among other things, automated blood processing systems, consisting of equipment and disposables, including the Equipment.

The term Viral Inactivation Agent shall refer to Licensees proprietary materials for pathogen inactivation, including materials designed to inactivate viruses and other microorganisms, developed or being developed by Licensee.

The term Cell Washing System shall refer to Equipment and Disposables and does not include leukoreduction, delivery and incubation of the Viral Inactivation Agent.

Field of Use

The field is viral inactivation of red blood cell concentrates.  Licensee is developing Viral Inactivation Agent, including associated processes, among them a joint development effort involving a Licensors Cell Washing System.

License Grant

The Licensor of Australia grants an exclusive license under the Licensed Patents, and to the Licensed Invention, to make, use, import, offer to sell, and sell compositions of matter, methods and processes which are covered under the Licensed Patents, and/or which are encompassed by the Licensed Invention, in any and all Fields of Use, with the right to grant sublicenses.

License Property

The license pertains to patents, know-how and other intellectual property relating to our foundation technology for removal of lipids from proteins and our continued operations at present are dependent upon such license.

Licensed Invention means any composition of matter, method or process relating to alterations in the lipid structure of biological material; e.g., including, but not limited to, delipidization of soft tissue, e.g., atheroma, inactivation of lipid-enveloped organisms, e.g., viruses, as well as know-how, materials, trademarks, copyrights and technology which has or may be acquired by or on behalf of either or both of the Licensor, and which is useful in or necessary toward the development, optimization and/or commercialization of any composition of matter, method or process defined by the claims of the Licensed Patents.

Technology is based on a process of selective, systemic removal of lipids from plasma, or blood without red cells. This process is known as plasma delipidation. The process is designed to provide therapeutic benefit by enhancing the body's natural ability to heal itself. We believe that through the use of this system a patient's risk of such common disorders as heart attack and stroke will be reduced, and circulation throughout the body will be improved with numerous attendant benefits.

– United States Patent No. 5,911,698, entitled 'Treatment for Cardiovascular and Related Diseases';

– United States Patent No. 5,744,038, entitled 'Solvent Extraction Methods for Delipidating Plasma';

– United States Patent No. 4,895,558, entitled 'Autologous Plasma Delipidation Using a Continuous Flow System';

– Australian Patent Counterparts to the United States Patents: Australian Patent Nos. 594964, 693458 and 695826, respectively, as well as six pending foreign patent applications related thereto;

– Pending PCT application entitled: A Method of Treating Infectious Diseases;

– Pending PCT application entitled: A Viral Vaccine

Field of Use

The Field of Use means any activity, research or endeavor to which the Licensed Invention and Licensed Patents may be applied.

License Grant

Licensor grants to Licensee (A) an exclusive, irrevocable, worldwide, sub-licensable, transferable license to the Patents used in the Technology to research, develop, make, have made, use, sell, offer for sale, have sold, distribute and have distributed, import and have imported, the Products and New Products within the Exclusive Field of Use and (B) a non-exclusive, irrevocable, worldwide, sub-licensable, transferable license to the Patents used in the Technology to research, develop, make, have made, use, sell, offer for sale, have sold, distribute and have distributed, import and have imported, the Products and New Products within the Non-Exclusive Field of Use.

License Property

Technology means the Intellectual Property Rights and Product Registration Rights required to make, use, and sell the Product Line.  Product Line means the Angel® Concentrated Platelet System product line.  The product line represents point of care technologies for the safe and efficient separation of autologous blood and bone marrow to produce platelet based therapies or cell concentrates. The Company currently has two distinct platelet rich plasma (“PRP”) devices, one of which is the Angel® concentrated Platelet Rich Plasma (“cPRP”) System for orthopedics markets.

Field of Use

This agreements relates to the separation of autologous blood and bone marrow to produce platelet based therapies or cell concentrates for orthopedics markets.

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 Kit:SB101 / W

SafeBlood Graft Kit

SBG Kit:SB101 / W 1

SafeBlood Graft Kit

SBG Kit:SB102 / W

SafeBlood Graft Kit

SBG Kit:SB201 / W

SafeBlood Graft Kit

SBG Kit: SB 103

SafeBlood Graft Kit 800-1001A(1)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A(2)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A(3)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A(4)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A(5)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A(6)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A(7)

BIOMET:GPS 800-1001A

SafeBlood Graft Kit 800-1001A

BIOMET:GPS 800-1001A

GPS Counter Balance

BIOMET:GPS 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