Royalty Report: Drugs, Biotechnology, Therapeutic – Collection: 195

License Grant

The Canadian Licensee acquired all rights, title and interest to technology rights for specific additional antibodies to treat coronary heart disease and chronic viral diseases from the Licensor, which subsequently became an owner of Licensor.

License Property

Licensor acquired certain rights in the technology and know-how of Licensee relating to its Super-Antibody Technology known as 'SAT'.  Licensor now wishes to acquire the remaining antibody assets held by Licensee that were not previously acquired by Licensor.

The antibodies are in the late pre-clinical stage and have demonstrated efficacy in animal models of human disease.  The companies plan to jointly develop a Super-Antibody version of an antibody with the ability to reduce plaque formation that causes narrowing of the arteries and the occurrence of coronary heart disease.  Licensee is also acquiring further rights to the monoclonal antibody 1F7, targeted to treat chronic viral diseases.

IF7 Patent Rights (owned by Immpheron)
1) 'Variable heavy and light chain regions of murine monoclonal antibody 1F7.' U.S. Pat. No. 6,057,421
Issued May 2, 2000; inventors S. Muller and H. Kohler. (No further U.S. or international patent applications related to this one were sought.)
2) 'Nucleotide sequences encoding variable regions of heavy and light chains of monoclonal antibody 1 F7. and anti-idiotypic antibody reactive with anti-HIV antibodies' (inventors S. Muller and H. Kohler).  U.S. Pat. No. 6,768,004, issued July 27, 2004.
International patent applications 1F7 nucleotide sequence
a)  Atty docket 200-014CA Canada App. No. 2,434,209  APPLICATION PENDING.
b) Atty docket 200-014EP Europe App. No. 02 70 7461.6  APPLICATION PENDING.
T15 antibody  Invention and clone for commercialization (owned by Heinz Kohler; held in trust for ImmPheron)

F6-3 antibody Invention and clone for commercialization (owned by Heinz Kohler held in trust for ImmPheron)

Other Intellectual Property Rights
Any antibodies held by Immpheron as at June 30, 2002 or developed thereafter.
Material Limitations or Third Party Rights (section 6.1(g)
mAb 1F7 (AS/gene sequence mAb 1F7)

Two mAb 1F7 USA -patents are issued; the Canada and European patent applications on the DNA 1F7 are pending.

License Grant

Assignor (from France) hereby irrevocably sells, conveys, assigns and will assign, transfers and relinquishes solely and exclusively to Assignee (from Israel), Assignor’s entire right, title and interest in and to the Patent Rights, Technology and Deliverables. Assignee shall pay Assignor royalties based on Net Sales of Products.

License Property

The Licensee obtained all rights, titles and interests in and to the patent rights, technology and deliverables related to the anti-Ferritin mAb, AMB8LK, including its nucleotide and protein sequences, its ability to recognize human acid and basic ferritins,  or a part of its ability to recognize human acid and basic ferritins.

Technology means the data including electronic data, documents, information (including electronic information), records discoveries, improvements, know-how, trade secrets, methods, materials and compositions, and processes including synthesis, developed by or otherwise acquired by Assignor as of the Effective Date and relating to (i) Use of anti-ferritin monoclonal antibodies in the treatment of some cancers or (ii) Nucleotide and protein sequences of an antibody directed against an epitope common to human acidic and basic ferritins, monoclonal antibodies or antibody-like molecules comprising these sequences or the Deliverables or the uses thereof as described in the Patent Rights.

Products or Product means a product containing AMB8LK or the manufacture, use, sale, offering for sale, or importation of which would infringe a Valid Claim of the Patent Rights.

AMB8LK means a monoclonal antibody, as described in applications WO2009/037525 and US20090074657, including its nucleotide and protein sequences, recognizing human acid and basic ferritins, or a part of this antibody able to recognize human acid and basic ferritins. AMB8LK includes the variable heavy chain of this monoclonal antibody, the variable light chain of this monoclonal antibody as well as variants of these chains, a chimeric or humanized anti-ferritin monoclonal antibody comprising the variable heavy chain, the variable light chain and/or their variants and functional fragment of these antibodies (Fv, Fab, scFv, bis-scFv or diabody).

Field of Use

The Licensee is a clinical stage biopharmaceutical company specializing in the development and commercialization of targeted therapeutics, including mAbs, nanotherapeutics and antibody drug conjugates, for the treatment of inflammatory diseases and cancer. AMB8LK is a monoclonal antibody.

License Grant

The Canadian University hereby grants to the Canadian Licensee an exclusive world-wide license, in respect of the Type I Technology and a non-exclusive world-wide license in respect of the Type II Technology, to make use of, or caused to be used, sell and/or sublicense the Technology and any know how associated therewith or which forms a basis thereof whether it is the Scientist's know how, and to manufacture, commercialize, distribute, market, import, export, offer to sell, sell, lease and/or license or sublicense Products on the terms and conditions hereinafter set forth (the License).

License Property

The Scientist of  the University has been engaged in research during the course of which he has developed certain recombinant viral antigens, murine antibody clones and an animal model.

Type I Technology shall mean the recombinant viral antigens and murine antibody clones and Type II Technology shall mean the animal model.

1. Antigens cloned, expressed and purified in the Tyrrell University laboratory as follows

·
Human Hepatitis B(HBV) Core Antigen (short)

·
Duck Hepatitis B(DHBV) Surface Antigen

·
Duck Hepatitis B(DHBV) Polymerase Protein

·
Duck Hepatitis B(DHBV) Core Protein

2. Murine antibody clones developed in the Tyrrell University laboratory as follows

·
Monoclonal Antibody 1D12 to HBV core antigen

·
Monoclonal antibodies 2C12, 2D12, 2C11, 2A12, 4A10, 1F9, 2G11 to HBV surface antigen

·
Monoclonal Antibody 3A8, 2C4 to HBV Polymerase

·
Monoclonal Antibody 1F4 to DHBV Surface Antigen

·
Monoclonal Antibodies 9A8, 8D6, 7G4, 7G5, 7G10, 9F2, 9G8, 1A9, 4A9, 1H5 to DHBV Core Antigen.

3. Animal model as follows

·
Hepatitis B Duck Model

Including any replications of progeny of the above made by the Licensee and, if that which is made by the Licensee, constitutes cells or DNA molecules. Type II Technology includes all modifications, improvements and variants thereof and any data or information in relating thereto including sequence information.

Field of Use

Licensee will be commercializing novel therapeutic approaches to treat diseases, excluding cancer, in humans created by identifiable microbial pathogens.

License Grant

Licensor hereby grants, and Licensee hereby accepts, the following licenses

(a) an exclusive, worldwide license, including the right to grant sublicenses, to develop, make, have made, import, use, sell, offer to sell or have sold Licensed Products and related cell lines, including the Sp2/0 Cell Line.

License Property

Licensor has developed a murine monoclonal antibody directed against the CCR5 antigen and designated by Licensee's as “PRO 140”

“Humanized Antibody(ies)” means the humanized form of the Murine Antibody.

“Licensed Product(s)” means products, for any use, incorporating substantially all of the Humanized Antibody or any modification, variant or fragment of the Humanized Antibody containing at least one variable region of the Humanized Antibody.

“Murine Antibody(ies)” means, subject to Section 2.01(b), the murine monoclonal antibody designated as “PRO 140” directed against the Target Antigen.

Field of Use

Licensee shall also evaluate the Humanized Antibody to determine whether such antibody also possesses anti-HIV activity not less than one-third (1/3) that of the Murine Antibody (“Minimum Anti-HIV Activity”) as measured according to an HIV-1 infectivity assay that measures the extent of HIV-l replication.

License Grant

Licensee desires Licensor to conduct research with the Mice to generate fully human monoclonal antibodies to certain Antigens.

For the Evaluation License, Licensor grants an exclusive, nontransferable license for the term of the applicable Evaluation Period to use the Collaboration Technology relating to such Antigen solely for the purpose of evaluating whether Licensee shall desire to acquire a commercial license to such Product(s) directed against such Antigen.

For the Option for Commercial Licenses, Licensee shall have an option to obtain a commercial license with respect to Product(s) directed against such Antigen in the Field of Use in all countries of the Territory,

For the Commercial License,  Licensor grants an exclusive, even as to Licensor, license, with the right to sublicense, under the Licensed Technology to make, have made, import, have imported, use, offer for sale and sell Product(s) directed against such Antigen in the Field of Use in the Territory.

For the Research License, Licensee shall have an irrevocable, perpetual, worldwide exclusive research license, without the right to sublicense, to make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or interest in the Antibody{ies) and Antibody Cell(s) transferred by Licensor to Licensee, and any related Collaboration Technology, including Genetic Material(s) relating specifically and solely to such Antibody(ies) and Antibody Cell(s), in each case, and an irrevocable, perpetual, worldwide non-exclusive research license, without the right to sublicense, to make and use, but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or interest in the Collaboration Technology relating specifically and solely to antibody(ies), antibody cell(s) or genetic material(s) having a binding specificity and affinity for such Antigen, in each case, which is necessary for Licensee to make and use the same for research.

License Property

The patents relate to Transgenic non-human animals capable of producing heterologous antibodies.

The Collaboration Know How shall mean, with respect to each Antigen, any parts or derivatives of the Mice prepared by Licensor in connection with the applicable Immunization and delivered to Licensee, including without limitation, Antibody(ies), Antibody Cell(s), polypeptides, Genetic Material(s) or other biological materials derived directly or indirectly from the Mice delivered to Licensee, all information relating specifically and solely to the foregoing, including without limitation, technical data, protocols and methods and processes with respect to Product(s) directed against such Antigen and, all information relating specifically and solely to antibody(ies), antibody cell(s) or genetic material(s) having a binding specificity and affinity for such Antigen, including without limitation, technical data, protocols and methods and processes.

Product(s) shall mean, with respect to an Antigen, a composition or compositions with each composition comprising one or more Antibody(ies), Antibody Cell(s) or Genetic Material(s).

Licensor is the sole and exclusive owner of certain transgenic Mice useful for the preparation of fully human monoclonal antibodies.

HuMAb -Mouse technology is a transgenic mouse system that creates high-affinity, fully human antibodies instead of mouse antibodies.  Using standard, well proven laboratory techniques, scientists can produce these antibodies in a matter of months.

Bispecific antibodies, which enhance and direct the body's own immune system to fight disease; and immunotoxin  technology.

Field of Use

The Field of Use shall mean all uses of Product(s), including all human therapeutic, prophylactic and diagnostic uses of Product(s).

License Grant

For the Patent License For Commercialization of Products, Licensor grants a worldwide, exclusive license or sublicense, in the Field, under Licensor Patents and Licensors interest in Joint Patents, with the right to grant sublicenses, to make, have made, use, import, and offer for sale and sell Products.

For the Know-how License, Licensor grants to
– an exclusive worldwide license to use Licensor Know-how within the Field, wherein such Know-how is solely related to the Collaboration Inhibitor including but not limited to the non-clinical development, process development, manufacturing, clinical development, and marketing of a Collaboration Inhibitor, in pursuance of the Research & Development Plan, during the Collaboration Term, and during the remaining Term of this Agreement.
– a non-exclusive worldwide license to use Licensor Know-how within the Field, wherein such Know-how is related to a Collaboration inhibitor including but not limited to the non-clinical development, and marketing of a Collaboration Inhibitor, in-pursuance of the Research & Development Plan, during the Collaboration Term, and during the remaining Term of this Agreement.

License Property

The patents include but are not limited to Methods and Compositions for the Treatment of  Inflammatory Diseases; Methods and Compositions for the Treatment of glomerulonephritis and other Inflammatory Diseases; Use Of C5-Specific / Antibodies For Reducing Immune And Hemostatic Dysfunctions During Extracorporeal Circulation; Recombinant DNA Products And Methods; and, Single Polypeptide Chain Molecules.

The Collaboration Inhibitor means the humanized anti-C5 monoclonal antibody coded h5G 1.1-ScFv and analogs, derivatives and formulations thereof owned or otherwise Controlled by Licensor.

Field of Use

The Field means the research, development, commercialization and use of Collaboration Inhibitor.  The field of competition is considered any pharmaceutical compound or product that specifically inhibits the production of C5a or specifically inhibits interaction with its receptor and in either case which is developed for use in acute cardiovascular conditions and/or applications and which is not a Product.