Royalty Report: Diagnostic, Drugs, Medical – Collection: 203391

License Grant

In furtherance of the settlement of the Lawsuit, Licensor is willing to license certain of its intellectual property to Licensee.

Licensor hereby grants to Licensee and its Affiliates a non-exclusive, royalty-bearing license to the Patent Rights, without the right to sublicense except as approved by Licensor in writing, to make, have made, use, sell and have sold Mab-based Licensed Products in the Territory, except products utilizing the format technology that is proprietary and that, as of today, is provided by Party A to Licensor in the test format in Licensor’s current Witness heartworm diagnostic products. For purposes of clarity, Licensor hereby acknowledges Licensee’s right to have such Mab-based Licensed Products or any component thereof manufactured by a third party. This license grant is limited only to Licensee’s own Mab-based Licensed Products whereas products which Licensee may distribute for other parties that may otherwise infringe the Patent Rights are specifically excluded, except as approved by Licensor in writing.

Licensor hereby also grants to Licensee and its Affiliates a non-exclusive, royalty-free license to the Patent Rights, without the right to sublicense except as approved by Licensor in writing, to make, have made, use, sell and have sold Di33-based Licensed Products in the Territory, except products utilizing the format technology that is proprietary and that, as of today, is provided by Party A to Licensor in the test format in Licensor’s current Witness heartworm diagnotic products. For purposes of clarity,  Licensor hereby acknowledges Licensee’s right to have such Di33-based Licensed Products or any component thereof manufactured by a third party. Furthermore, the Parties agree that, if a product qualifies as both a Mab-based Licensed Product and a Di33-based Licensed Product, it shall be subject to royalties. This license grant is limited only to Licensee’s own Di33-based Licensed Products whereas products which Licensee may distribute for other parties that may otherwise infringe the Patent Rights are specifically excluded, except as approved by Licensor in writing.

License Property

Patent Rights shall mean the ’631 Patent.  Licensor is the owner of United States Patent No. 4,789,631 issued on December 6, 1988, entitled “Immunoassay for Anti-Dirofilaria Immitis Antibody” (the ’631 Patent).

Licensed Products shall mean Mab-based Licensed Products and/or Di33-based Licensed Products.

Mab-based Licensed Products shall mean any heartworm antigen detection test product or part thereof having or using at least one monoclonal antibody that reacts with Dirofilaria immitis antigenic extract, including any said heartworm antigen detection test product or part thereof within the scope of a claim in the Patent Rights or manufactured by a process within the scope of a claim in the Patent Rights. For avoidance of doubt, the Parties agree that Licensees SOLO STEP® CH product and canine and feline reference laboratory heartworm antigen detection tests using such a monoclonal antibody are “Mab-based Licensed Products”.

Di33-based Licensed Products ” shall mean any heartworm antibody detection test product or part thereof using at least one recombinant Di33 protein, wherein a Di33 protein has properties as set forth in the ‘569 Patent, including any said heartworm antibody detection test product or part thereof within the scope of a claim in the Patent Rights or manufactured by a process within the scope of a claim in the Patent Rights.

Field of Use

This agreement pertains to health products for dogs, cats and horses relating to developing, manufacturing and marketing veterinary diagnostics, vaccines and other animal health related products worldwide.

License Grant

This amendment clarifies rights and royalties for the licensed canine heartworm test.  Licensor grants a limited, nonsublicensable, nonassignable, nonexclusive license under U.S. Patent No. 4,789,631 to develop, make, sell, market, distribute and use the Binax Test.  
The FeLV Synbiotics Sublicensed Product is hereby licensed back to Binax for development, manufacture, sale and distribution anywhere in the world.

License Property

The grant is for a canine heartworm test.

Field of Use

This agreement pertains to the veterinary care industry.

License Grant

The Hospital hereby grants to Licensee a non-exclusive, royalty-bearing license. (freely sublicensable only to Licensees affiliates and manufacturing contractors) to make, use, import, market and sell Licensed Patents under the Licensed Patents, and (without either party expressing a position as to whether and to what extent such other products are actually covered within the allowed claims of the applicable Licensed Patents) a non-exclusive, non-royalty bearing license  (freely sublicensable only to Licensees affiliates and manufacturing contractors) under the Licensed Patents to make, use, import, market and sell any and all heartworm diagnostic products, other than Licensed Products.

The Hospital hereby grants to Licensee a most favored nation provision which applies only Licensees royalties for its Post-1990 Net Sales over $125 million hereunder.  If the royalty rate charged by the Hospital now or at any time in the future  (calculated based on the total consideration paid for net sales covered) to any other commercial licensee of the Licensed Patents, or any of them, is less than the royalty rates charged hereunder (calculated based on the total consideration paid for net sales covered under this license) then, on or after reaching the sixth 25 million tranche of Post – 1990 net sales Licensee may elect, at its option, to adopt prospectively the royalty rate (as calculated above) charged to such favored commercial license.  The Hospital covenants to inform Licensee of all past and future commercial licenses to the extent they contain royalty rates which would make it advantageous for Licensee to elect to so adopt.  This most favored nation provision is not retroactive.  This most favored nation provision shall not apply to any transaction with Merial covering past sales but shall apply to any future sales with Merial.

License Property

Licensed Products means any canine heartworm diagnostic products within the allowed claims of the applicable Licensed Patents, regardless of the end use of such product.  The Parties agree that canine heartworm kits based upon antigen-detection are covered within the allowed claims of the applicable Licensed Patents.

Licensed Patents means U.S. Patent No. 4,839,275, Canadian Patent No. 1,232,849 ad Australian Patent No. 582,129, all issued in the name of the inventor.

4,839,275 – Circulating antigens of dirofilaria immitis, monoclonal antibodies specific therefor and methods of preparing such antibodies and detecting such antigens

Field of Use

Field of use is for the treatment of canine heartworm.  

Heartworm disease is a serious disease that results in severe lung disease, heart failure, other organ damage, and death in pets, mainly dogs, cats, and ferrets. It is caused by a parasitic worm called Dirofilaria immitis. The worms are spread through the bite of a mosquito.

License Grant

Licensor grants to the Australian Licensee a non-transferable, non-exclusive, perpetual and irrevocable license under the Patent to make, have made, use, sell, offer to sell, and import canine heartworm test kit products (CHW Kits) that contain the anti-CHW monoclonal antibody from clone key DI 16 872.5 (the CHW Antibody) or any derivatives thereof created or developed by or for Licensee (the CHW Antibody Derivatives).

Licensor further grants a non-transferable, non-exclusive, perpetual and irrevocable license under the Patent to use, sell, offer to sell, and import CHW Antibody contained in CHW Kits; and, CHW Antibody Derivatives contained in CHW Kits.

Licensee shall have no right to sublicense.

Licensor grants Licensee an immunity from suit for licensed products.

Licensor grants an exclusive, non-transferable, sublicensable (only to Licensee partners) license, to use and display  Japan Witness® trademark only for ICT lateral flow veterinary test kit products sold in Japan. With regard to this license, Licensee shall not, and shall have no right to, sell outside of Japan, or authorize its distributors, resellers, and OEMs to sell outside of Japan, ICT lateral flow veterinary test kit products bearing Japan Witness® trademark.

License Property

The patent is for Immunoassay for Anti-Dirofilaria Immitis Antibody.  

The biological materials are Anti-CHW MAb, clone key DI16872.5-USDA code E118.00, Rabbit Anti-CHW PAb-USDA code E019.00, Rabbit Anti-CPV PAb-USDA code E024.01, and, Anti-CPV MAb, clone key A1C2.32-USDA code E024.01.

The products are canine heartworm test kits.

Field of Use

Licensee is in the business of developing, manufacturing and marketing veterinary diagnostics and other animal health related products worldwide, including ICT lateral flow veterinary test kit products which, for purposes of this Agreement, shall mean all veterinary diagnostic products in ICT (immunochromatography strip assay) format.

License Grant

Technology Party A hereby grants to Party B of Australia the exclusive, non-transferable, royalty-bearing sublicensable right, for the Exclusive Period, under all Technology owned or controlled by Party A which Party A, (i) to Distribute Products in the Party B Territory, and (ii) to make and manufacture Products throughout the world.

Trademarks. Party A hereby grants to Party B the exclusive, non-transferable, royalty-free, sublicensable right, for the Exclusive Period, to use and display the Trademarks in the Party B Territory in connection with the Distribution of Products.

License Property

1.   Canine Heartworm Antigen Test Kit containing typically 10 or 25 Pouches, each containing 1 test device and a packet of desiccant

  10 or 25 Pipettes

  1 Buffer Dropper Bottle, labeled

  1 Directions for Use Leaflet

Biologicals used in manufacture of the test device include Canine Heartworm antiserum (Polyclonal) – USDA registered Product code   E019.00 Canine Heartworm monoclonal antibody, clone key DI 16 872-5, USDA registered product code E118-00

2.   Feline Leukemia Virus Antigen Test Kit containing  typically 10 Pouches, each containing 1 test device, and a packet of desiccant

  10 Pipettes

  1 Buffer Dropper Bottle, labeled

  1 Directions For Use Leaflet

Biologicals used in manufacture of the test device include

Anti-Feline Leukemia Virus monoclonal antibody, clone key 24-1A2

Anti-Feline Leukemia Virus monoclonal antibody, clone key 1111B10A5

Non Specific Blocker monoclonal antibody, clone key B56.1.3A1/48

3.   Canine Parvo Virus Antigen Test Kit containing typically

5 Pouches, each containing 1 test device, and a packet of desiccant

  5 Pipettes

  1 Buffer Dropper Bottle, labeled

  1 Directions For Use Leaflet

Biologicals used in the manufacture of the test kit include

  Anti-Parvo Virus monoclonal antibody, clone key A1C2.32

  Anti-Parvo Virus antiserum (Polyclonal) with USDA registered product

  code E024.01

  Non Specific Blocker monoclonal antibody, clone key B56.1.3A1/48

Field of Use

This Agreement pertains to the medical industry relating to veterinary products.