Royalty Report: Drugs, Cancer, Pharmaceuticals – Collection: 27804

License Grant

Licensor hereby grants to Licensee and its Affiliates a sole and exclusive worldwide sublicense in all fields of use to practice under the Patent Rights and to utilize the Know-how, and to make, have made, use, lease and/or sell the Licensed Products and to practice the Licensed Processes, to the full end of the term for which the Patent Rights are granted, unless sooner terminated as hereinafter provided.

License Property

Patent(s) or Patent Application(s):

U.S. Application Serial No. 07/492,468 filed 3/13/90; “06-Substituted Guanine Compounds And Methods For Depleting 06-Alkylguanine-DNA Alkyltransferase Levels” Issued 2/25/92 U.S. Pat. 5,091,430

U.S. Application Serial No. 07/616,913 filed 11/21/90; “06-Benzylated Guanine, Guanosine and 2’-Deoxyguanosine Compounds Possessing 06-Alkylguanine-DNA Alkyltransferase Depleting Activity” CIP of ‘468 issued 10/4/94 U.S. Pat. 5,352,669

U.S. Application Serial No. 07/805,634 filed 12/21/91; “06-Substituted Guanine Compounds And Methods For Depleting 06-Alkylguanine-DNA Alkyltransferase Levels” DIV of ‘468, issued 10/25/94 U.S. Pat. 5,358,952

U.S. Application Serial No. 07/875,438 filed 4/29/92; “06-Substituted Guanine Compounds and Methods for Depleting Derivatives 06 Alkylguanine-DNA Alkyltransferase Levels” CIP of ‘634 Abandoned 8/19/94

U.S. Application Serial No. 08/255,190 filed 6/7/94; “06-Substituted Guanine Compounds And Methods For Depleting 06-Alkylguanine-DNA Alkyltransferase” CIP of ‘438, and ‘913 issued 11/25/97 U.S. Pat. 5691,307.

U.S. Application Serial No. 08/283,953 filed 8/1/94; “Substituted 06-Benzylguanines And 6(4) – Benzyloxpyrimidines” issued 6/11/96 U.S. Pat. 5,525,606, and PCT/US95/09702 filed 7/31/95 (based on parent application 08/283.953.  National Stage filed in Europe (EPO Application No. 9592837.7.  Validated in all countries, except Finland, under the European Patent Convention), Canada (Canadian Application No. 2,195,856), Japan (Japanese Application No. 506694/1996), Australia (Australian Serial No. 32079/95, Issued Patent No. 702711) and U.S. Application No. 08/849,223, Issued 9/28/99 as U.S. Patent No. 5,958,932).  Divisional of EP ‘837.7, Application No. 01108585.9 filed 4/5/01.

U.S. Application Serial No. 08/661,923 filed 6/11/96, issued 5/19/98 as 5,753,668; “Substituted  Benzyloxpyrimidines and Their Inactivation of 06-Alkylguanine-DNA Alkyltransferase” DIV of parent application 08/283.953.

U.S. Application Serial No. 08/927, 846 filed 9/11/97. Issued 6/29/99 as 5,916,894; “Substituted O6-Benzylguanines And 6(4) – Benzyloxpyrimidines” DIV of parent application 08/283,953.

U.S. Application Serial No. 08/318,238 filed 5/25/99. Issued 1/9/01 as 6,172,070; “Substituted O6-Benzylguanines And 6(4) – Benzyloxpyrimidines” DIV of parent application 08/283.953.

U.S. Application Serial No. 08/849,223 filed 7/31/95. Issued  9/28/99 as 5,958,932; “Substituted O6-Benzylguanines And 6(4) – Benzyloxpyrimidines” CIP of parent application 08/283,953.

U.S. Application  No. 09/590,187, filed 6/9/00, U.S Patent 6,303,604, issued 10/16/01U.S. Application Serial No. 09/333,047 filed 6/15/99 (Allowed) “Pharmaceutical Composition Comprising 2,4-Diamino-6-Benzyloxy-Triazine And Inactivation of O6-Alkylguanine-DNA-Alkyltransferase.”

U.S. Application No. 09/333,047, filed 6/15/99, U.S Patent 6,333,331, issued 12/25/01 “Substituted 06-Benzylguanines.”

U.S. Application No. 09/928,410; filed 8/14/01 “Substituted 06 Benzyl-8-Aza-Guanines” Pending.

Field of Use

The following will serve to outline License’s (the 'Sublicensee') plans for development of O6-Benzylguanine ('BG') as an intravenous chemotherapeutic potentiating agent used in combination with alkylating agents such as BCNU or Temozolomide (the 'Agent' or 'Agents') for the treatment of cancer.

License Grant

Licensor, government organization, hereby grants and 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 Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

Patent(s) or Patent Application(s):

U.S. Application Serial No. 07/492,468 filed 3/13/90; “06-Substituted Guanine Compounds And Methods For Depleting 06-Alkylguanine-DNA Alkyltransferase Levels” Issued 2/25/92 U.S. Pat. 5,091,430

U.S. Application Serial No. 07/616,913 filed 11/21/90; “06-Benzylated Guanine, Guanosine and 2’-Deoxyguanosine Compounds Possessing 06-Alkylguanine-DNA Alkyltransferase Depleting Activity” CIP of ‘468 issued 10/4/94 U.S. Pat. 5,352,669

U.S. Application Serial No. 07/805,634 filed 12/21/91; “06-Substituted Guanine Compounds And Methods For Depleting 06-Alkylguanine-DNA Alkyltransferase Levels” DIV of ‘468, issued 10/25/94 U.S. Pat. 5,358,952

U.S. Application Serial No. 07/875,438 filed 4/29/92; “06-Substituted Guanine Compounds and Methods for Depleting Derivatives 06 Alkylguanine-DNA Alkyltransferase Levels” CIP of ‘634 Abandoned 8/19/94

U.S. Application Serial No. 08/255,190 filed 6/7/94; “06-Substituted Guanine Compounds And Methods For Depleting 06-Alkylguanine-DNA Alkyltransferase” CIP of ‘438, and ‘913 issued 11/25/97 U.S. Pat. 5691,307.

U.S. Application Serial No. 08/283,953 filed 8/1/94; “Substituted 06-Benzylguanines And 6(4) – Benzyloxpyrimidines” issued 6/11/96 U.S. Pat. 5,525,606, and PCT/US95/09702 filed 7/31/95 (based on parent application 08/283.953.  National Stage filed in Europe (EPO Application No. 9592837.7.  Validated in all countries, except Finland, under the European Patent Convention), Canada (Canadian Application No. 2,195,856), Japan (Japanese Application No. 506694/1996), Australia (Australian Serial No. 32079/95, Issued Patent No. 702711) and U.S. Application No. 08/849,223, Issued 9/28/99 as U.S. Patent No. 5,958,932).  Divisional of EP ‘837.7, Application No. 01108585.9 filed 4/5/01.

U.S. Application Serial No. 08/661,923 filed 6/11/96, issued 5/19/98 as 5,753,668; “Substituted  Benzyloxpyrimidines and Their Inactivation of 06-Alkylguanine-DNA Alkyltransferase” DIV of parent application 08/283.953.

U.S. Application Serial No. 08/927, 846 filed 9/11/97. Issued 6/29/99 as 5,916,894; “Substituted O6-Benzylguanines And 6(4) – Benzyloxpyrimidines” DIV of parent application 08/283,953.

U.S. Application Serial No. 08/318,238 filed 5/25/99. Issued 1/9/01 as 6,172,070; “Substituted O6-Benzylguanines And 6(4) – Benzyloxpyrimidines” DIV of parent application 08/283.953.

U.S. Application Serial No. 08/849,223 filed 7/31/95. Issued  9/28/99 as 5,958,932; “Substituted O6-Benzylguanines And 6(4) – Benzyloxpyrimidines” CIP of parent application 08/283,953.

U.S. Application  No. 09/590,187, filed 6/9/00, U.S Patent 6,303,604, issued 10/16/01U.S. Application Serial No. 09/333,047 filed 6/15/99 (Allowed) “Pharmaceutical Composition Comprising 2,4-Diamino-6-Benzyloxy-Triazine And Inactivation of O6-Alkylguanine-DNA-Alkyltransferase.”

U.S. Application No. 09/333,047, filed 6/15/99, U.S Patent 6,333,331, issued 12/25/01 “Substituted 06-Benzylguanines.”

U.S. Application No. 09/928,410; filed 8/14/01 “Substituted 06 Benzyl-8-Aza-Guanines” Pending.

Field of Use

Licensed Fields of Use: Development and administration of 06-Benzylated Guanine and Derivatives thereof to enhance chemotherapy treatments of tumor cells.

License Grant

The Licensor, a University, and the Co-owners hereby grant to the Company a sole and exclusive, worldwide license in all fields of use to practice under the Patent Rights and to utilize the Know-how, and to make, have made, use, lease and/or sell the Licensed Products and to practice the Licensed Processes, to the full end of the term for which the Patent Rights are granted, unless sooner terminated as hereinafter provided.

The Licensor grants to the Company the right to grant sublicenses to third- parties.

License Property

The Licensor is the owners of Patents and U.S. Patent Applications 08/620/969, 08/255/190, and 08/661/923.

Field of Use

The patents relate to chemotherapy and the agreement is for all fields of use.

License Grant

Licensor hereby grants Licensee, and Licensee hereby accepts, the world-wide, non-exclusive right and license to use and practice under the Patents in the Licensed Field, to research, develop, manufacture, use, market, distribute, and sell Licensed Products during the term of this Agreement.

License Property

Licensor has certain intellectual property rights, including patents, covering the cancer and anti-inflammatory properties of benzamides and nicotinamides.

Licensed Products means any product whose manufacture, sale or use would infringe a valid claim or claims in the Patents.

US patent 6,028,111
US patent 6,100,299
US CIP application Serial No. 09/584,821 filed May 31, 2000 of co-pending
US patent application Serial No. 09/093,474 filed June 8, 1998
US patent 5,561,161
US patent application Serial No. 08/673,341

Field of Use

Licensed Field means all subject matter, applications and diseases or indications excluding declopramide (3-chloropracainamide) in cancer or anti-inflammatory indications.

License Grant

University grant to Licensee, and Licensee hereby accepts, a royalty-bearing, exclusive license under Licensed Subject Matter to make, have made, manufacture, have manufactured, use, import, offer to sell, sell and/or have sold products within Licensed Territory for use within Licensed Field. This grant is subject herein below, the payment by Licensee to University of all consideration as provided herein, and is further subject to the following rights retained by University to:
(a) publish the general scientific findings from research related to Licensed Subject Matter, subject to the terms of Article XI-Confidential Information and Publication; and
(b) use Licensed Subject matter solely for its own internal, non-commercial research, teaching, and other educationally-related purposes; and
(c) request that the Licensee transfer Licensed Subject Matter to academic or research institutions for non-commercial research use or for purposes of collaboration upon terms reasonably acceptable to the Licensee and such third party; provided, however, that Licensee will not unreasonably withhold consent to University’s use of the Licensed Subject Matter in collaborations between University, and/or the National Cancer Institute (NCI).

License Property

Licensed Subject Matter means Patent Rights, Improvements and Technology Rights within Licensed Field.

Patent Rights means University’s rights in information or discoveries described in invention disclosures below or in the subsequent reductions to practice of such information or discoveries (so long as such subsequent reductions to practice are not obligated to a third party), or claimed in any patents, and/or patent applications, whether domestic or foreign, based on such invention disclosures and such reductions to practice (that are not obligated to a third party) and all domestic and foreign divisionals, continuations, continuations-in-part, reissues, reexaminations or extensions thereof, including any foreign counterparts thereto and any letters patent that issue thereon, including but not limited to: (a) Provisional Application entitled, “Compounds and Methods for the Treatment of Cancer” filed July 16, 2004; (b) U.S. Application Serial Number 60/346,492 filed January 7, 2002; (c) WO 2003/057012 filed January 7, 2003; (d) U.S. Application Serial Number 10/337,969 filed January 7, 2003; and (e) national stage filings for MDA01-063 in Europe, Japan, Canada and Australia.

MDA01-063 “New Organic Arsenic Derivatives as a Treatment for Cancer,” Srdan Verstovsek, M.D., Ph.D., Ralph A. Zingaro Ph.D., Emil J. Freireich, M.D., Hatice Duzkale, M.D., Hagop M. Kantarjian, M.D.

MDA04-076 “Arsenic-Lipid Derivatives as a Treatment for Cancer,” Srdan Verstovsek, M.D., Ph.D., Ralph A. Zingaro Ph.D., Hagop M. Kantarjian, M.D., M. Gao

Licensed Products means any product or service that is covered in whole or in part by a valid claim contained in the Patent Rights in the country in which the product is made, used, leased or sold.

Field of Use

Patent applications and related improvements and know-how) are for the manufacture and commercialization of two classes of organic arsenicals (water- and lipid-based) for human and animal use. The class of water-based organic arsenicals includes ZIO-101.

ZIO-101 is an organic arsenic compound covered by an issued U.S. patent and applications internationally. A form of commercially available inorganic arsenic (arsenic trioxide (Trisenox®) or ATO) has been approved for the treatment of acute promyelocytic leukemia (APL), a precancerous condition, and is on the compendia listing for the therapy of multiple myeloma as well as having been studied for the treatment of various other cancers.

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.