Royalty Report: Drugs, Therapeutic, Biotechnology – Collection: 29101

License Grant

A University hereby grants to the Licensee an exclusive License under Patent Rights, including the right to grant sublicenses.

License Property

The licensed field is for the diagnosis, treatment and prevention of autoimmune disease and includes inventions disclosed in Disclosure Docket No. SD1993-268  â€œMethod and Reagents for the Treatment of Rheumatoid Arthritis'/ 'Vaccine Compositions and Methods Useful in Inducing Immune Protection Against Arthritogenic Peptides Involved in the Pathogenesis of Rheumatoid Arthritis'; SD2000-133, 'Pan HLA DR Binding Heat Shock Protein Peptides as Immunomodulatory Tools'; SD2001-901, 'Pan HLA DR Binding Heat Shock Proteins as Immunomodulatory Tools'; SD2002-051 'Methods of Epitope-Specific and Cytokine/Anticytokine Immunotherapy for Modulation of Pathogenic Immune Responses in Mediated Diseases'; and SD2006-256 'Methods and Formulations for Epitope Specific Immunotherapy.'

Field of Use

'Field' means diagnosis, treatment and prevention of autoimmune disease.

License Grant

Licensor grants to the Licensee of Denmark a non-exclusive, non-transferable, worldwide, royalty-bearing license, with the right to grant sublicenses, under the Licensed Technology to make, have made, sell, have sold and import Products in the Field during the Term. For avoidance of doubt, Licensee shall only have the right under the license granted to use PADRE® as part of a Product.

Licensee shall have the right to grant sublicenses.

License Property

Licensed Technology shall mean, to the extent necessary or useful for research, development, manufacture, use, sale or import of Products in the Field, all Patent Rights and Know-How, including all PADRE® Improvements.

PADRE® shall mean a peptide capable of binding antigen binding sites on major histocompatibility complex (MHC) molecules encoded by substantially all alleles of a DR locus, including, without limitation, a composition comprising a peptide recited in the claims of United States Patent Application Serial No. 08/121,101 and any patent applications, U.S., international and foreign, that derive priority from such patent application, such as continuing applications and any patents issuing therefrom. Such peptides are also referred to as pan DR binding peptides and include, without limitation, AKXV AA WTLKAAA,using the single letter designation for amino acids, wherein X is cyclohexylalanine or phenylalanine, and other peptides claimed and/or disclosed in the patent applications.

Product shall mean any product that contains, is comprised of or uses PADRE® in combination or association with any AutoVac™ Molecule.

Field of Use

Field shall mean the prevention and/or treatment of diseases or disorders in humans.

The license is to use PADRE technology for use in connection with their AutoVacâ„¢ technology for controlling autoimmune diseases.
The PADRE technology consists of a family of small (13 amino acid), synthetic proprietary molecules that are potent immunostimulants, meaning that they stimulate the immune response.

License Grant

Therefore the Licensor, a University, grants an exclusive license to the Licensed Patents, and an exclusive license to the Know How, to make, have made, use, import, offer to sell and sell Licensed Products and to practice the Licensed Process(es) in the Field of Use and Territory to the Licensee
Licensee may sublicense the rights granted.

License Property

The invention relates to methods for modulating the immune function through targeting of CLIP molecules.

Invention Disclosures
CU1760C- Selective Modulation of Gamma Delta T Cells to Treat Autoimmune Diseases, HIV, and Cancer
CU1969C – Competitive inhibitors of Invariant Chain expression and/or ectopic CLIP binding
CU1971C- Use of soluble H-2M (HLA-DM) as a CLIP displacement therapy (combined with CU1969C and patents filed under CU1969C)
CU2131C- Topical HIV prevention cream/gel (provisional application was abandoned as it was covered under applications filed in CU1760C and CU1969C)
CU2253C – The use of non-specific CLIP displacing peptides to treat or prevent chronic disease mediated by infectious organisms (no patents filed yet)
CU2254C – The use of peptides derived from an infectious organism that displace CLIP in order to treat or prevent chronic conditions mediated by those very organisms (no patents filed yet)

Patent Applications
Country
Serial No
File Date
Title
lnternal ID

United States
60/886,852
01/26/2007
Methods of Modulating Immune Function Through Targeting of Invariant Chain/CD74 and Clip
CU1760C- PPA1

United States
60/906,731
03/13/2007
Immune Mechanism For The Depletion of CD4+ T Cells
CU1760H- PPA2

PCT
PCT/US2008/001097
01/28/2008
Methods of Modulating Immune Function
CU1760C- PCT1

United States
12/011,643
01/28/2008
Methods of Modulating Immune Function
CU1760C-US2

United States
12/021'118
01/28/2008
Methods of Modulating Immune Function
CU1760C-US1

United States
61/191,740
09/11/2008
The Immune Response to HIV
CU1760C- PPA3

Country
Serial No
File Date
Title
lnternal ID

United States
61/000,152
10/23/2007
Competitive Inhibitors of Invariant Chain Expression and/or Ectopic Clip Binding
CU1969C- PPA1

United States
61/135,942
07/25/2008
Clip Inhibitors and Methods of Modulating Immune Function
CU1969C- PPA2

United States
61/135,964
07/25/2008
Competitive Inhibitors of Invariant Chain Expression and/or Ectopic Clip Binding
CU1996C- PPA3

United States
61/137,150
07/25/2008
Methods for Treating Viral Disorders
CU1969C-PPA4

PCT
PCT/US2008/012078
10/23/2008
Competitive Inhibitors of Invariant Chain Expression and/or Ectopic Clip Binding
CU1969C-PCT1

United States
15/508,554
07/23/2009
Methods for Treating Viral Disorders
CU1969C- US1

PCT
Pending
7/23/2009
Methods For Treating Viral Disorders
CU1969C-PCT3

PCT
Pending
7/23/2009
Clip Inhibitors and Methods of Modulating Immune Function
CU1969C-PCT2

United States
12/508,543
7/23/2009
Clip Inhibitors and Methods of Modulating Immune Function
CU1969C-US2

United States
61/135,922
7/25/2008
Proteins for Use in Diagnosing and Treating Infection and Disease
CU2421H-PPA1

United States
12/508,532
7/23/2009
Proteins for Use in Diagnosing and Treating Infection and Disease
CU2421H-US1

PCT
Unknown
7/23/2009
Proteins for Use in Diagnosing and Treating Infection and Disease
CU2421H-PCT1

Field of Use

Field of Use means the diagnosis, detection, prevention, and treatment of any disease.

License Grant

The ‘941 patent was issued in February 2004, covering the use of CTLA4-Ig to treat specific autoimmune disorders including rheumatoid arthritis and multiple sclerosis. The patent is assigned to the Licensor and the U.S. Navy and is exclusively Licensed to Repligen.

Field of Use

The rights granted in the field relating to the healthcare industry.

License Grant

With this amendment, the Parties revise and amend the Agreement to add the Collaboration Compound known as GI-6300 as a Drug Candidate under the Agreement and to remove the Collaboration Compound known as GI-10000 as a Drug Candidate under the Agreement.

License Property

GI-6300 means the series of Tarmogen products that express brachyury. GI-6301 is part of the GI-6300 series and means the single Tarmogen product that may become the subject of [an IND filing under CRADA #02264] and that expresses a human brachyury protein.

Field of Use

The focus of the compound in this agreement is for the treatment of cancer.