kite-ex104_285.htm



 

Exhibit 10.4

National Institutes of Health

SECOND AMENDMENT TO L-077-2015/0

This is the second amendment (“Second Amendment”) of the agreement by and between the National Institutes of Health (“NIH”) within the Department of Health and Human Services (“HHS”), and Kite Pharma, Inc. having an effective date of December 31, 2014 and having NIH Reference Number L-077-2015/0 (“Agreement”).  This Second Amendment, having NIH Reference Number L‐077‐2015/2, is made between the NIH through the Office of Technology Transfer, NIH, having an address at 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, U.S.A., and Kite Pharma, Inc., having an office at 2225 Colorado Avenue, Santa Monica, CA 90404 (the “Licensee”).  This Second Amendment includes, in addition to the amendments made below, a Signature Page.

Whereas, the NIH and the Licensee desire that the Agreement be amended a second time as set forth below in order to clarify the NIH intellectual property subject to the terms of the Agreement and the allowance for sublicenses to Licensee Affiliates.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, the NIH and the Licensee, intending to be bound, hereby mutually agree to the following:


	
1)
	
Paragraph 1 on the cover page of the Agreement shall be replaced in its entirety with the following:




“United States provisional patent application Serial No. 61/846,167 filed on July 15, 2013 entitled “Anti-Human Papilloma Virus 16 E6 T Cell Receptors” [HHS Ref. Nos. E-495-2013/0-US-01]; and all the subsequent or related patent applications claiming priority to this application.”


	
2)
	
Paragraph 2 on the cover page of the Agreement shall be replaced in its entirety with the following:




“International patent application No. PCT/US2014/046480 filed on July 14, 2014 entitled “Anti-Human Papilloma Virus 16 E6 T Cell Receptors” [HHS Ref. Nos. E-495-2013/0-PCT-02]; and all the subsequent or related patent applications claiming priority to this application.”


	
3)
	
Paragraph 3 on the cover page of the Agreement shall be replaced in its entirety with the following:




“United States provisional patent application Serial No. 62/004,335 filed on May 29, 2014 entitled “Anti-Human Papilloma Virus 16 E7 T Cell Receptors” [HHS Ref. Nos. E-176-2014/0]; and all the subsequent or related patent applications claiming priority to this application, including but not limited to the PCT.”


	
4)
	
Paragraph 4.5 shall be added after Paragraph 4.4 on page 6 of the Agreement and shall read:




“The Licensee may enter into sublicensing agreements under Licensed Patent Rights with Affiliates of Licensee, and Paragraphs 4.1 and 4.4 of the Agreement and Paragraph V in Appendix C of the Agreement shall not apply to such Affiliate sublicense; provided that Licensee shall notify NIH in writing of the Affiliate that sublicenses any Licensed Patent Rights within thirty (30) days of effectiveness of each sublicense.”


	
5)
	
Paragraph I in Appendix A of the Agreement shall be replaced in its entirety with the following: 




“United States provisional patent application Serial No. 61/846,167 filed on July 15, 2013 entitled “Anti-Human Papilloma Virus 16 E6 T Cell Receptors” [HHS Ref. Nos. E-495-2013/0-US-01]; and all the subsequent or related patent applications claiming priority to this application.”


	
6)
	
Paragraph II in Appendix A of the Agreement shall be replaced in its entirety with the following:




“International patent application No. PCT/US2014/046480 filed on July 14, 2014 entitled “Anti-Human Papilloma Virus 16 E6 T Cell Receptors” [HHS Ref. Nos. E-495-2013/0-PCT-02]; and all the subsequent or related patent applications claiming priority to this application.”

 


			
	
CONFIDENTIAL -NIH
	
 
	
 

	
Second Amendment of L-077-2015/0
	
Final    Kite Pharma, Inc.
	
3/23/2016

	
Model 09-2006 (updated 11-2015)
	
Page 1 of 4
	
 




 



 


	
7)
	
Paragraph III in Appendix A of the Agreement shall be replaced in its entirety with the following: 




“United States provisional patent application Serial No. 62/004,335 filed on May 29, 2014 entitled “Anti-Human Papilloma Virus 16 E7 T Cell Receptors” [HHS Ref. Nos. E-176-2014/0]; and all the subsequent or related patent applications claiming priority to this application, including but not limited to the PCT.”


	
8)
	
All terms and conditions of the Agreement not herein amended remain binding and in effect.





	
9)
	
The terms and conditions of this Second Amendment shall, at the NIH’s sole option, be considered by the NIH to be withdrawn from the Licensee’s consideration and the terms and conditions of this Second Amendment, and the Second Amendment itself, to be null and void, unless this Second Amendment is executed by the Licensee and a fully executed original is received by the NIH within sixty (60) days from the date of the NIH’s signature found at the Signature Page.





	
10)
	
This Second Amendment is effective upon the date of last signature.




SIGNATURES BEGIN ON NEXT PAGE

 


			
	
CONFIDENTIAL -NIH
	
 
	
 

	
Second Amendment of L-077-2015/0
	
Final    Kite Pharma, Inc.
	
3/23/2016

	
Model 09-2006 (updated 11-2015)
	
Page 2 of 4
	
 




 



 

SECOND AMENDMENT TO L-077-2015/0

SIGNATURE PAGE

In Witness Whereof, the parties have executed this Second Amendment on the dates set forth below.  Any communication or notice to be given shall be forwarded to the respective addresses listed below.

For the NIH:

 


	
/s/ Richard U. Rodriguez
	
 
	
3/23/2016

	
Richard U. Rodriguez, MBA
	
 
	
Date

	
Associate Director
	
 
	
 

	
Technology Transfer Center
	
 
	
 

	
National Cancer Institute, National Institutes of Health
	
 
	
 




 

Mailing Address or E-mail Address for Agreement notices and reports:

Chief, Monitoring & Enforcement Branch, DTDT

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville, Maryland  20852-3804 U.S.A.

E-mail: LicenseNotices_Reports@mail.nih.gov

For the Licensee (Upon information and belief, the undersigned expressly certifies or affirms that the contents of any statements of the Licensee made or referred to in this document are truthful and accurate.):

 


	
/s/ Arie Belldegrun
	
 
	
3/24/2016

	
Signature of Authorized Official
	
 
	
Date

	
 
	
 
	
 

	
Arie Belldegrun
	
 
	
 

	
Printed Name
	
 
	
 

	
 
	
 
	
 

	
Chairman, President and Chief Executive Officer
	
 
	
 




 


			
	
 
	
I.
	
Official and Mailing Address for Agreement notices:




 


	
 
	
 
	
Arie Belldegrun, MD, FACS
	
 
	
 

	
 
	
 
	
Name
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Chairman, President and Chief Executive Officer
	
 
	
 

	
 
	
 
	
Title
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Mailing Address
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Kite Pharma, Inc.
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
2225 Colorado Avenue
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Santa Monica, CA 90404
	
 
	
 




 


			
	
CONFIDENTIAL -NIH
	
 
	
 

	
Second Amendment of L-077-2015/0
	
Final    Kite Pharma, Inc.
	
3/23/2016

	
Model 09-2006 (updated 11-2015)
	
Page 3 of 4
	
 




 



 

 


	
 
	
 
	
Email Address:
	
 
	
legal@kitepharma.com
	
 

	
 
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Phone:
	
 
	
310-824-9999
	
 

	
 
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Fax:
	
 
	
310-496-2700
	
 




 


			
	
 
	
II.
	
Official and Mailing Address for Financial notices (the Licensee’s contact person for royalty payments):




 


	
 
	
 
	
Arie Belldegrun, MD, FACS
	
 
	
 

	
 
	
 
	
Name
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Chairman, President and Chief Executive Officer
	
 
	
 

	
 
	
 
	
Title
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Mailing Address
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Kite Pharma, Inc.
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
2225 Colorado Avenue
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Santa Monica, CA 90404
	
 
	
 




 


	
 
	
 
	
Email Address:
	
 
	
invoices@kitepharma.com
	
 

	
 
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Phone:
	
 
	
310-824-9999
	
 

	
 
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Fax:
	
 
	
310-496-2700
	
 




 

Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801‐3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).

 

 


			
	
CONFIDENTIAL -NIH
	
 
	
 

	
Second Amendment of L-077-2015/0
	
Final    Kite Pharma, Inc.
	
3/23/2016

	
Model 09-2006 (updated 11-2015)
	
Page 4 of 4