Royalty Report: Cancer, Drugs, cell therapy – Collection: 336303

License Grant

The Institute hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement, an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Field of Use and to practice and have practiced any Licensed Processes in the Licensed Field of Use.

License Property

Licensed Patent Rights shall mean
U.S. Provisional Patent Application No. 61/535,086 filed September 15, 2011 entitled 'T Cell
Receptors Recognizing HLA-Al- or HLA-CW7-Restricted Mage' (HHS Ref No. E-266-2011/0-US-01)
U.S. Patent Application No. 14/344,354 filed March 12, 2011 entitled 'T Cell Receptors Recognizing
HLA-A1- or HLA-CW7-Restricted Mage' (HHS Ref No. E-266-2011/0-US-07)
U.S. Provisional Patent Application No. 61/701,056 filed September 14, 2012 entitled 'T Cell
Receptors Recognizing MCH Class II-Restricted Mage-A3' (HHS Ref No. E-230-2012/0-US-01)

Field of Use

Licensed Field of Use is for the treatment of MAGE-expressing cancers by the development, manufacture and commercialization of melanoma antigen family (MAGE) A3 and A6 T cell receptor (TCR)-based autologous and allogenic peripheral blood, T cell therapy products.

Autologous peripheral blood T cell therapy products shall mean T cell or precursor products and compositions derived from blood, bone marrow, lymph nodes and thymus and, for the avoidance of doubt, shall exclude tumor-infiltrating lymphocytes (TILs).

License Grant

The Licensor, government public health organization, grants an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Field of Use and to practice and have practiced any Licensed Processes in the Licensed Field of Use.

License Property

The property relates to New York Esophageal Antigen-1 (NY-ESO-1) T cell receptor (TCR)-based autologous peripheral blood T cell therapy product.

Field of Use

Licensed Field of Use is
–  Development, manufacture and commercialization of New York Esophageal Antigen-1 (NY-ESO-1) T cell receptor (TCR)-based autologous peripheral blood T cell therapy product as set forth in the Licensed Patent Rights for the treatment of NY–ESO–1-expressing cancers.
–  For purposes of this Agreement, autologous peripheral blood T cell therapy products shall mean T cell or precursor products and compositions derived from blood, bone marrow, lymph nodes and thymus and, for the avoidance of doubt, shall exclude tumor-infiltrating lymphocytes (TILs).

License Grant

In the original agreement Licensor, government public health organization, grants an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

The Licensor grants a co-exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use. For purposes of this Agreement co-exclusive shall mean that at any time only the Licensee and its Affiliates, on the one hand, and one other Licensee and its Affiliates, on the other hand, shall at any time have a license or other right from the Licensor under the Licensed Patent Rights in the Licensed Territory in the Licensed Fields of Use.

License Property

The agreement is for a specified constructs, formulations and doses of specified Licensed Products in a specified cancer indication, the statistical demonstration in a pivotal Phase 3 Clinical Study of safety and efficacy, sufficient to support a BLA submission by the Licensee for such specified construct, formulation and dose of such specified Licensed Product for the treatment of such specified cancer indication.

Field of Use

Licensed Fields of Use, defined in the original agreeement is
–  Development and manufacture of synovial sarcoma breakpoint X-2 (SSX-2) T cell receptor (TCR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of head and neck cancer, hepatocellular carcinoma, melanoma, prostate cancer, and sarcoma.
–  Development and manufacture of epidermal growth factor receptor variant III (EGFRvIII) chimeric antigen receptor (CAR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of brain cancer, head and neck cancer, and melanoma.
–  Development and manufacture of synovial sarcoma breakpoint X-2 (SSX-2) T cell receptor (TCR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of breast cancer, ovarian cancer, and colorectal cancer.
–  Development and manufacture of epidermal growth factor receptor variant III (EGFRvIII) chimeric antigen receptor (CAR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of breast cancer, ovarian cancer, and colorectal cancer.
For purposes of the Agreement, autologous peripheral blood T cell therapy products shall mean T cell or precursor products and compositions derived from blood, bone marrow, lymph nodes and thymus and, for the avoidance of doubt, shall exclude tumor-infiltrating lymphocytes (TILs).

License Grant

The Licensor, government public health organization, hereby grants and Licensee accepts a nonexclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import or have imported any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

Pursuant to the License Agreement, licensor granted to the Company a non-exclusive worldwide right and license to develop and manufacture certain proprietary autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, ovarian cancer, breast cancer, and colorectal cancer.

The intellectual property subject to the License Agreement is covered by 43 patents and patent applications, consisting of nine issued United States patents, 13 pending patent applications in the United States, and 21 foreign patents and patent applications as counterparts of U.S. patents/patent applications. The Company also has limited rights to sublicense the intellectual property subject to the License Agreement. The License Agreement will expire on a product-by-product basis upon the expiration of the subject patent rights.

Tumor infiltrating lymphocytes (TIL) are a subset of T lymphocytes (T cells) that migrate and are located within a tumor site. TIL isolated from these tumor sites exhibit natural anti-tumor activity without genetic modifications. For the avoidance of doubt, cell therapy products involving genetically modified tumor infiltrating lymphocytes are excluded from Licensed Fields of Use.

Patent(s) or Patent Application(s)
1.
United States Patent No. 5,399,346 issued March 21, 1995 [HHS Ref. No. E-189-1989/3-US-02]

2.
United States Patent No. RE39788 issued August 21, 2007 [HHS Ref. No. E-189-1989/3-US-04]

3.
United States Patent No. 5,830,755 issued November 3, 1998 [HHS Ref. No. E-093-1995/0-US-01]

4.
Australian Patent No. 709122 issued December 2, 1999 [HHS Ref. No. E-093-1995/0-AU-03]

5.
United States Patent No. 6,734,014 issued May 11, 2004 [HHS Ref. No. E-040-1996/0-US-07]

6.
United States Patent No. 7,378,277 issued May 27, 2008 [HHS Ref. No. E-040-1996/0-US-08]

7.
United States Patent No. 7,723,111 issued May 25, 2010 [HHS Ref. No. E-323-2000/0-US-01]

8.
European Patent No. 1379670 issued August 6, 2008 [HHS Ref. No. E-323-2000/0-EP-03]

9.
United States Patent Application No. 12/715,829 filed March 2, 2010 [HHS Ref. No. E-323-2000/0-US-09]

10.
United States Patent Application No. 10/526,697 filed May 5, 2005 [HHS Ref. No. E-275-2002/1-US-02]

11.
European Patent Application No. 3794636.5 filed April 4, 2005 [HHS Ref. No. E-275-2002/1-EP-03]

12.
Canadian Patent Application No. 2,497,552 filed March 2, 2005 [HHS Ref. No. E-275-2002/1-CA-04]

13.
Australian Patent Application No. 2003265948 filed September 5, 2003 [HHS Ref. No. E-275-2002/1-AU-05]

14.
United States Patent Application No. 13/178,644 filed July 8, 2011 [HHS Ref. No. E-275-2002/1-US-06]

15.
United States Patent No. 7,381,405 issued June 3, 2008 [HHS Ref. No. E-297-2002/0-US-02]

16.
Canadian Patent Application No. 2,501,087 filed April 1, 2005 [HHS Ref. No. E-297-2002/0-CA-03]

17.
Australian Patent No. 2002353822 issued February 23, 2009 [HHS Ref. No. E-297-2002/0-AU-04]

18.
United States Patent No. 7,915,036 issued March 29, 2011 [HHS Ref. No. E-106-2004/0-US-02]

19.
United States Patent Application No. 11/576,621 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-US-02]

20.
Canadian Patent Application No. 2,590,401 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-CA-03]

21.
Australian Patent No. 2005336093 issued June 9, 2011 [HHS Ref. No. E-340-2004/2-AU-04]

22.
European Patent Application No. 05858553.0 filed April 5, 2007 [HHS Ref. No. E-340-2004/2-EP-05]

23.
Australian Patent Application No. 2007248019 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-AU-03]

24.
Canadian Patent Application No. 2,651,174 filed November 3, 2008 [HHS Ref. No. E-086-2006/0-CA-04]

25.
European Patent Application No. 07797329 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-EP-05]

26.
United States Patent Application No. 12/298,927 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-US-06]

27.
United States Patent No. 7,820,174 issued October 26, 2010 [HHS Ref. No. E-106-2006/3-US-01]

28.
United States Patent Application No. 12/870,941 filed August 30, 2010 [HHS Ref. No. E-106-2006/3-US-03]

29.
Australian Patent Application No. 2009282886 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-AU-04]

30.
Canadian Patent Application No. 2,734,838 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-CA-05]

31.
European Patent Application No. 09791694.4 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-EP-06]

32.
Australian Patent Application No. 2008206442 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-AU-02]

33.
Canadian Patent Application No. 2,674,445 filed July 3, 2009 [HHS Ref. No. E-059-2007/2-CA-03]

34.
European Patent Application No. 08727582.2 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-EP-04]

35.
United States Patent Application No. 12/522,321 filed July 7, 2009 [HHS Ref. No. E-059-2007/2-US-05]

36.
PCT Patent Application No. PCT/US2010/021909 filed January 25, 2010 [HHS Ref. No. E-043-2009/0-PCT-02]

37.
PCT Patent Application No. PCT/US2010/031988 filed April 22, 2010 [HHS Ref. No. E-170-2009/0-PCT-02]

38.
PCT Patent Application No. PCT/US2010/048701 filed September 14, 2010 [HHS Ref. No. E-205-2009/0-PCT-02]

39.
United States Patent Application No. 12/869,390 filed August 26, 2010 [HHS Ref. No. E-273-2009/0-US-02]

40.
United States Provisional Patent Application No. 61/405,668 filed October 22, 2010 [HHS Ref. No. E-236-2010/0-US-01]

41.
United States Provisional Patent Application No. 61/384,931 filed September 21, 2010 [HHS Ref. No. E-269-2010/0-US-01]

42.
United States Provisional Patent Application No. 61/466,200 filed March 22, 2011 [HHS Ref. No. E-114-2011/0-US-01]

43.
United States Provisional Patent Application No. 61/473,409 filed April 8, 2011 [HHS Ref. No. E-148-2011/0-US-01]

Field of Use

Licensed Fields of Use

(a) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma.

(b) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of ovarian cancer.

(c) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of breast cancer.

(d) The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of colorectal cancer.

License Grant

The Licensor, government organization, hereby grants and Licensee accepts, a nonexclusive, worldwide License under the Patent Rights any of the Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of ovarian cancer, breast cancer and colorectal cancer.

Tumor infiltrating lymphocytes (TIL) are a subset of T lymphocytes (T cells) that migrate and are located within a tumor site. TIL isolated from these tumor sites exhibit natural anti-tumor activity without genetic modifications.

For the avoidance of doubt, cell therapy products involving genetically modified tumor infiltrating lymphocytes are excluded from Licensed Fields of Use.

Upon written approval, which shall include prior review of any subLicense Agreement by PHS and which shall not be unreasonably withheld, Licensee may enter into sublicensing Agreements.

United States Patent No. 5,399,346 issued March 21, 1995 [HHS Ref. No. E-189-1989/3-US-02]

United States Patent No. RE39788 issued August 21, 2007 [HHS Ref. No. E-189-1989/3-US-04]

United States Patent No. 5,830,755 issued November 3, 1998 [HHS Ref. No. E-093-1995/0-US-01]

Australian Patent No. 709122 issued December 2, 1999 [HHS Ref. No. E-093-1995/0-AU-03]

United States Patent No. 6,734,014 issued May 11, 2004 [HHS Ref. No. E-040-1996/0-US-07]

United States Patent No. 7,378,277 issued May 27, 2008 [HHS Ref. No. E-040-1996/0-US-08]

United States Patent No. 7,723,111 issued May 25, 2010 [HHS Ref. No. E-323-2000/0-US-01]

European Patent No. 1379670 issued August 6, 2008 [HHS Ref. No. E-323-2000/0-EP-03]

United States Patent Application No. 12/715,829 filed March 2, 2010 [HHS Ref. No. E-323-2000/0-US-09]

United States Patent Application No. 10/526,697 filed May 5, 2005 [HHS Ref. No. E-275-2002/1-US-02]

European Patent Application No. 3794636.5 filed April 4, 2005 [HHS Ref. No. E-275-2002/1-EP-03]

Canadian Patent Application No. 2,497,552 filed March 2, 2005 [HHS Ref. No. E-275-2002/1-CA-04]

Australian Patent Application No. 2003265948 filed September 5, 2003 [HHS Ref. No. E-275-2002/1-AU-05]

United States Patent Application No. 13/178,644 filed July 8, 2011 [HHS Ref. No. E-275-2002/1-US-06]

United States Patent No. 7,381,405 issued June 3, 2008 [HHS Ref. No. E-297-2002/0-US-02]

Canadian Patent Application No. 2,501,087 filed April 1, 2005 [HHS Ref. No. E-297-2002/0-CA-03]

Australian Patent No. 2002353822 issued February 23, 2009 [HHS Ref. No. E-297-2002/0-AU-04]

United States Patent No. 7,915,036 issued March 29, 2011 [HHS Ref. No. E-106-2004/0-US-02]

United States Patent Application No. 11/576,621 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-US-02]

Canadian Patent Application No. 2,590,401 filed April 4, 2007 [HHS Ref. No. E-340-2004/2-CA-03]

Australian Patent No. 2005336093 issued June 9, 2011 [HHS Ref. No. E-340-2004/2-AU-04]

European Patent Application No. 05858553.0 filed April 5, 2007 [HHS Ref. No. E-340-2004/2-EP-05]

Australian Patent Application No. 2007248019 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-AU-03]

Canadian Patent Application No. 2,651,174 filed November 3, 2008 [HHS Ref. No. E-086-2006/0-CA-04]

European Patent Application No. 07797329 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-EP-05]

United States Patent Application No. 12/298,927 filed May 3, 2007 [HHS Ref. No. E-086-2006/0-US-06]

United States Patent No. 7,820,174 issued October 26, 2010 [HHS Ref. No. E-106-2006/3-US-01]

United States Patent Application No. 12/870,941 filed August 30, 2010 [HHS Ref. No. E-106-2006/3-US-03]

Australian Patent Application No. 2009282886 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-AU-04]

Canadian Patent Application No. 2,734,838 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-CA-05]

European Patent Application No. 09791694.4 filed August 20, 2009 [HHS Ref. No. E-106-2006/3-EP-06]

Australian Patent Application No. 2008206442 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-AU-02]

Canadian Patent Application No. 2,674,445 filed July 3, 2009 [HHS Ref. No. E-059-2007/2-CA-03]

European Patent Application No. 08727582.2 filed January 11, 2008 [HHS Ref. No. E-059-2007/2-EP-04]

United States Patent Application No. 12/522,321 filed July 7, 2009 [HHS Ref. No. E-059-2007/2-US-05]

PCT Patent Application No. PCT/US2010/021909 filed January 25, 2010 [HHS Ref. No. E-043-2009/0-PCT-02]

PCT Patent Application No. PCT/US2010/031988 filed April 22, 2010 [HHS Ref. No. E-170-2009/0-PCT-02]

PCT Patent Application No. PCT/US2010/048701 filed September 14, 2010 [HHS Ref. No. E-205-2009/0-PCT-02]

United States Patent Application No. 12/869,390 filed August 26, 2010 [HHS Ref. No. E-273-2009/0-US-02]

United States Provisional Patent Application No. 61/405,668 filed October 22, 2010 [HHS Ref. No. E-236-2010/0-US-01]

United States Provisional Patent Application No. 61/384,931 filed September 21, 2010 [HHS Ref. No. E-269-2010/0-US-01]

United States Provisional Patent Application No. 61/466,200 filed March 22, 2011 [HHS Ref. No. E-114-2011/0-US-01]

United States Provisional Patent Application No. 61/473,409 filed April 8, 2011 [HHS Ref. No. E-148-2011/0-US-01]

Field of Use

The use of the Licensed Patent Rights to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma.