Document:

kite-ex1013_300.htm

Exhibit 10.13 

 

 

 

 

December 16, 2015

 

Ms. Shawn Tomasello

3508 Burnt Pine Lane

Miramar Beach, FL 32550-1836

 

Re:Employment Letter

 

Dear Ms. Tomasello:

 

Kite Pharma, Inc. (“Kite” or the “Company”) is pleased to offer you the position of Chief Commercial Officer, on the following terms and conditions:

 

	
 
	
1.
	
Title; Reporting; Duties.  

 

	
 
	
(a)
	
As Chief Commercial Officer, you will perform such duties as are customarily provided by the Chief Commercial Officer of a similarly situated company in the United States and shall have such other responsibilities and duties as may be from time to time directed by the Company.  You shall report directly to Kite’s Chief Executive Officer and Chief Operating Officer.

 

	
 
	
(b)
	
You shall devote substantially all of your business time, attention and energies to the business and affairs of Kite and shall not during the term of your employment be actively engaged in any other business activity, whether or not such business activity is pursued for gain, profit or other pecuniary advantage, that will materially interfere with the performance of your duties or your availability to perform such duties or that will adversely affect, or negatively reflect upon, Kite. 

 

	
 
	
(c)
	
Your duties shall be performed primarily out of or in the vicinity of Destin, Florida with the definitive address to be determined. Any duties needed to take place at Kite’s office, which is currently located at 2225 Colorado Avenue, Santa Monica, CA 90404 will be for a pre-defined period of one week per month or as required by the CEO or COO.

 

	
 
	
(d)
	
Notwithstanding the foregoing, the Company may change your title, position, duties, supervisor and work location from time to time as it deems appropriate. 

 

	
 
	
2.
	
Start Date.  Your employment shall commence on December 17, 2015, or such other date as may be agreed to by you and Kite.

 

	
 
	
3.
	
Compensation.  

 

	
 
	
(a)
	
Base Salary. You shall receive an annual base salary equal to Four Hundred Twenty Five Thousand ($425,000), which shall be payable in accordance with Kite’s payroll practices. 

 

	
 
	
(b)
	
Performance Bonus.  You shall be eligible to receive an annual performance bonus payable in cash at a target amount equal to 50% of your Base Salary, subject to the successful achievement of agreed upon individual and corporate performance goals

 

	
 
	
(c)
	
Corporate Accommodations.  Your primary residence will be in Florida. In connection with your employment with the Company, the Company shall reimburse you for reasonable costs associated with travel and hotel accommodations during periods in which you are working at the Company’s principal place of business. You may also elect to use first or business class travel while traveling to and from the Company’s principal place of business or for any business related travel.

 

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.com      

 

 

 

 

	
 
	
(d)
	
Withholding. Kite shall withhold all applicable federal, state and local taxes and social security and such other amounts as may be required by law from all amounts payable under this Section 3 consistent with Florida resident tax withholding. 

 

	
 
	
4.
	
Equity Awards.   

 

	
 
	
(a)
	
Subject to the approval of the Board of Directors of Kite (the “Board”), or an authorized committee thereof, you shall be granted a stock option (the “Option”) to purchase One Hundred Sixty Thousand (160,000) shares of Kite’s common stock (the “Option Shares”) pursuant to Kite’s 2014 Equity Incentive Plan (the “Plan”).  Such grant shall be evidenced by an option agreement (the “Option Agreement”) to be entered into by and between you and the Company.  In the event of a conflict between this Agreement and the Option Agreement, the terms of the Option Agreement shall control. The exercise price per Option Share will be equal to closing price per share of the Company’s common stock as reported on the NASDAQ Global Select Market on the such Option is granted by the Board, or an authorized committee thereof.  The Option shall have a 10 year term and shall vest and become exercisable as follows: (i) 33% upon the first anniversary date of your Start Date (the “Initial Vesting Date”); and thereafter (ii) the remaining unvested Options Shares shall vest in 24 equal monthly installments as of the last calendar day of each month following the Initial Vesting Date.

 

	
 
	
(b)
	
Subject to the approval of the Board, or an authorized committee thereof, you shall be granted a restricted stock unit (“RSU”) in the amount of 44,000 shares of Kite’s common stock (the “Restricted Stock”) pursuant to the Plan.  Such grant shall be evidenced by a Restricted Stock Unit Agreement (the “Award Agreement”) to be entered into by and between you and the Company.  In the event of a conflict between this Agreement and the Award Agreement, the terms of the Award Agreement shall control. Subject to your continuous Services to the Company, the RSU shall vest in three (3) equal annual installments upon each anniversary of your Start Date.  

 

	
 
	
(c)
	
In the event that your employment with Kite is terminated without Cause at any time beginning on the date that is 90 days prior to the effective date of a Change of Control (as defined in the Plan) and ending on the date that is 12 months following the Change of Control, then (i) all unvested Restricted Stock and Option Shares shall immediately vest in full, and (ii) the Option will remain exercisable for a period of 90 calendar days following the date of such termination, after which time the Option shall expire; provided, however, that no such Option shall be exercisable after the expiration of its maximum term.   

 

	
 
	
5.
	
Expenses.  Kite will reimburse you for all normal, usual and necessary expenses incurred in furtherance of the business and affairs of Kite upon timely receipt by Kite of appropriate vouchers or other proof of your expenditures and otherwise in accordance with any expense reimbursement and approval policy as may from time to time be adopted by Kite.

	
 
	
6.
	
Benefits.  As a regular full-time employee, you shall be entitled to participate in the employee benefits made available to similarly-situated employees, in accordance with the terms of such benefits plans and programs.  Information regarding these employee benefits is available in the official plan documents, summary plan descriptions, and applicable summaries.  Details on each plan will be provided at the time of hire.  The Company, in its sole discretion, has the right to amend or terminate any benefit plan or program at any time and without prior notice.  Your health benefits would be effective on the first day of the month of employment following the effective date of your hire if you timely enroll when you commence employment with Kite.  The benefits package currently includes medical, dental and disability benefits.  

 

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.com      

 

 

 

 

	
 
	
7.
	
Vacation.  During each year of your employment you shall be entitled to fifteen (15) days of paid time off in addition to company recognized holidays.  Notwithstanding the foregoing, you shall not be entitled to take more than two (2) consecutive weeks of vacation without the prior written consent of the Company.   

 

	
 
	
8.
	
Paid Sick Leave.  Upon hire, you will be credited with five (5) days of paid sick leave, which you may use during calendar year 2015 for yourself or a family member for the diagnosis, care or treatment of an existing health condition or preventive care, or specified purposes set forth in the Company’s policy if you are a victim of domestic violence, sexual assault, or stalking.  

 

	
 
	
9.
	
Representations and Warranties.  You hereby represent and warrant as follows:

 

	
 
	
(a)
	
By accepting the Company’s offer of employment, you represent that you have no agreements, relationships, or commitments with any other person or entity that conflict with your obligations to the Company. 

 

	
 
	
(b)
	
You have the full right, power and legal capacity to enter and deliver this Agreement and to perform your duties and other obligations hereunder.  This Agreement constitutes the legal, valid and binding obligation of the parties, enforceable against each in accordance with its terms.  No approvals or consents of any persons or entities are required for you to execute and deliver this Agreement or perform your duties and other obligations hereunder.

 

	
 
	
(c)
	
You represent and warrant to the Company that you have not brought and shall not bring with you to the Company, or use in the performance of your duties, any materials or documents of any former employer that are not generally available to the public, unless you have obtained written authorization from the former employer for their possession and use and provided the Company with a copy thereof.

 

	
 
	
10.
	
Conditions to Employment.  This offer of employment is contingent upon, and your employment shall be subject to:

 

	
 
	
(a)
	
execution of Kite’s form of Proprietary Information and Invention Assignment Agreement attached hereto as Exhibit A, which prohibits unauthorized use or disclosure of Kite’s proprietary information;

 

	
 
	
(b)
	
completion of a background examination to the reasonable satisfaction of Kite; and 

 

	
 
	
(c)
	
satisfying the requirements of the Immigration Control and Reform Act, which may be accomplished by showing your proof of right to work in the U.S. within three days of commencing employment (see http://www.uscis.gov/i-9 for a list of acceptable proof, such as (i) an original drivers license and social security card, or (ii) a passport).

 

	
 
	
(d)
	
Notwithstanding the foregoing, this offer may be withdrawn by Kite at any time prior to its execution by the Company. 

 

	
 
	
11.
	
Employment-at-will and Termination.  Your employment shall be at-will.  Accordingly, you may terminate your employment with Kite at any time and for any reason whatsoever, without or without advance notice, simply by notifying Kite in writing.  Similarly, Kite may terminate your employment at any time and for any reason whatsoever, with or without cause or advance notice.  This at-will relationship cannot be changed except in a writing signed by the Company’s Chief Financial Officer and you.  The employment terms contained in this Agreement supersede any other agreements and promises made to you by Kite or any representative on its behalf, whether oral, written or implied.

 

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.com      

 

 

 

 

	
 
	
12.
	
No Reliance by You on Promise or Representation Not in this Agreement.  In accepting employment with Kite and signing this Agreement, you agree that you are not relying on any representation, promise or inducement that has been made by Kite or any representative on its behalf that is not explicitly stated in this Agreement.  Kite is not bound by and will not be liable for any representation, promise or inducement that is not explicitly stated forth in this Agreement. 

 

	
 
	
13.
	
Governing Law.  The terms of this offer letter shall be governed by, and construed and interpreted in accordance with, the laws of the State of California without regard to such State’s principles of conflict of laws, except as provided in Section 15.  

 

	
 
	
14.
	
Arbitration.  To the maximum extent permitted by law, any dispute between the parties, including but not limited to those arising out of, or relating to, this Agreement, shall be exclusively decided by binding arbitration in accordance with the terms of the Mutual Agreement to Arbitrate Claims, which is attached as Exhibit B and incorporated into this Agreement.   The Federal Arbitration Act shall govern the interpretation, enforcement and all proceedings pursuant to the Mutual Agreement to Arbitrate Claims.  To the extent that the Federal Arbitration Act is inapplicable, the terms of the Mutual Agreement to Arbitrate Claims shall be construed in accordance with California law. 

 

	
 
	
15.
	
Miscellaneous.

 

	
 
	
(a)
	
This agreement, and your rights and obligations hereunder, may not be assigned.  Kite may assign its rights, together with its obligations, hereunder in connection with any sale, transfer or other disposition of all or substantially all of its business or assets provided the assignee entity which succeeds to Kite expressly assumes the Kite’s obligations hereunder and complies with the terms of this Agreement.

	
 
	
(b)
	
This agreement cannot be amended orally, or by any course of conduct or dealing, but only by a written agreement signed by the parties hereto.

	
 
	
(c)
	
The failure of either party to insist upon the strict performance of any of the terms, conditions and provisions of this agreement shall not be construed as a waiver or relinquishment of future compliance therewith, and such terms, conditions and provisions shall remain in full force and effect.  No waiver of any term or condition of this agreement on the part of either party shall be effective for any purpose whatsoever unless such waiver is in writing and signed by such party.

	
 
	
(d)
	
This agreement sets forth the entire agreement and understanding of the parties relating to the subject matter hereof, and supersedes all prior agreements, arrangements and understandings, written or oral, relating to the subject matter hereof.  No representation, promise or inducement has been made by either party that is not embodied in this agreement, and neither party shall be bound by or liable for any alleged representation, promise or inducement not so set forth.

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.com      

 

 

 

 

If you wish to accept employment at Kite Pharma, Inc., under the terms described above, please sign and date this letter, and return it to me. 

 

We look forward to your favorable reply and to a productive and enjoyable working relationship.

 

Very truly yours, 

 

	
By:
	
/s/ Cynthia Butitta
	
 
	
By:
	
/s/ Shawn Tomasello

	
Name:
	
Cynthia Butitta
	
 
	
Name:
	
Ms. Shawn Tomasello

	
Title:
	
CFO & COO
	
 
	
Date:
	
12/20/15

	
Date:
	
1/6/16
	
 
	
 
	
 

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.com      

 

 

 

 

EXHIBIT A

 

Proprietary Information and Invention Assignment Agreement

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.com      

 

 

 

 

EXHIBIT B

MUTUAL AGREEMENT TO ARBITRATE CLAIMS

 

 

 

					
	
2225 Colorado Avenue   
	
● Santa Monica, CA 90404   
	
●   Phone 310.824.9999   
	
●   Fax 310.824.9944   
	
●   www.kitepharma.comkite-ex1021_301.htm

	
	
Exhibit 10.21

	
***Text Omitted and Filed Separately

	
Execution Copy

	
with the Securities and Exchange Commission.

	
Confidential Treatment Requested

	
Under 17 C.F.R. Sections 20080(b)(4) and Rule 406 of the Securities Act of 1933, as amended.

	
 

 

National Institutes of Health

FIRST AMENDMENT TO L-068-2013/0

This is the first amendment (“First 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 April 11, 2013 and having NIH Reference Number L-068-2013/0 (“Agreement”).  This First Amendment, having NIH Reference Number L‐068‐2013/1, 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 First Amendment includes, in addition to the amendments made below, 1) a Signature Page, 2) Attachment 1 (Additional Defintitions), Attachment 2 (Replacement Appendix B), and 3) Attachment 3 (Replacement Appendix C).

 

Whereas, the NIH and the Licensee desire that the Agreement be amended a first time as set forth below in order to clarify and conform the license definitions and terms across multiple agreements between the NIH and the Licensee.

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 4.5 is deleted in its entirety.

	
2)
	
The Paragraphs in Attachment 1 are added to the Article 2 “Definitions” section of the agreement.

	
3)
	
Paragraphs IV and V in Appendix C are deleted in their entirety and replaced with Paragraphs IV and V in Attachment 2.

	
4)
	
All terms and conditions of the Agreement not herein amended remain binding and in effect.

	
5)
	
The terms and conditions of this First 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 First Amendment, and the First Amendment itself, to be null and void, unless this First 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.

	
6)
	
This First Amendment is effective upon the date both parties sign the First Amendment..

SIGNATURES BEGIN ON NEXT PAGE

 

 

				
	
A-411-2015
	
 
	
 

	
 
	
 
	
 

	
CONFIDENTIAL -NIH
	
 
	
 

	
First Amendment of L-068-2013/0
	
 
	
Kite Pharma, Inc
	
September 28, 2015

	
Model 09-2006 (updated 8-2012)
	
Page 1 of 3
	
 
	
 

 

 

First AMENDMENTTO L-0-2013/0

SIGNATURE PAGE

In Witness Whereof, the parties have executed this First 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 
	
 
	
9/29/15

	
Richard U. Rodriguez
	
 
	
Date

	
Director, Division of Technology Development and Transfer
	
 
	
 

	
Office of Technology Transfer
	
 
	
 

	
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
	
 
	
10/1/15

	
Signature of Authorized Official
	
 
	
Date

	
 
	
 
	
 

	
Arie Belldegrun
	
 
	
 

	
Printed Name
	
 
	
 

	
 
	
 
	
 

	
Chairman, President and Chief Executive Officer
	
 
	
 

	
Title
	
 
	
 

 

	
 
	
I.
	
Official and Mailing Address for Agreement notices:

 

	
 
	
 
	
Arie Belldegrun, MD, FACS

	
 
	
 
	
Name

	
 
	
 
	
Chairman, President and Chief Executive Officer

	
 
	
 
	
Title

 

				
	
A-411-2015
	
 
	
 

	
 
	
 
	
 

	
CONFIDENTIAL -NIH
	
 
	
 

	
First Amendment of L-068-2013/0
	
 
	
Kite Pharma, Inc
	
September 28, 2015

	
Model 09-2006 (updated 8-2012)
	
Page 2 of 6
	
 
	
 

 

 

 

	
 
	
 
	
Mailing Address
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Kite Pharma, Inc.
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
2225 Colorado Avenue
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
Santa Monica, CA 90404
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
 
	
 
	
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).

 

				
	
A-411-2015
	
 
	
 

	
 
	
 
	
 

	
CONFIDENTIAL -NIH
	
 
	
 

	
First Amendment of L-068-2013/0
	
 
	
Kite Pharma, Inc
	
September 28, 2015

	
Model 09-2006 (updated 8-2012)
	
Page 3 of 6
	
 
	
 

 

 

ATTACHMENT 1 – ADDITIONAL Definitions  

 

	
 
	
2.16
	
“Phase 1 Clinical Study” shall mean the initial introduction of an investigational new drug into humans, the principal purpose of which is to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, in compliance with 21 C.F.R. §312(a) or foreign equivalent.

 

	
 
	
2.17
	
“Phase 2 Clinical Study” shall mean controlled human clinical studies conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug in compliance with 21 C.F.R. §312(b) or foreign equivalent, and shall include any clinical study that leads to a conditional regulatory approval, that is followed by a confirmatory Phase 3 Clinical Trial.

 

	
 
	
2.18
	
“Phase 3 Clinical Study” shall mean expanded controlled and uncontrolled human clinical trials pursuant to a randomized study with endpoints agreed upon by regulatory bodies for regulatory approval performed after Phase 2 Clinical Trial evidence suggesting effectiveness of a drug has been obtained, and is intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a drug and to provide an adequate basis for regulatory approval and physician labeling, as in compliance with 21 C.F.R. §312 or foreign equivalent, and shall include a confirmatory study that is conducted following conditional regulatory approval.

 

	
 
	
2.19
	
“Sublicense Royalties” shall include all consideration, in whatever form, received from a sublicensee in connection with a sublicense of the Licensed Patents Rights resulting from: (a) up-front fees received by Licensee for the granting of a sublicense to the Licensed Patent Rights; and (b) license maintenance fees. Sublicense Royalties shall not include (1) payments received by Licensee from a sublicensee solely for a future bona fide research and development program; and (2) the purchase by a sublicensee of debt or equity securities of the Licensee at no less than fair market value. 

 

 

 

				
	
A-411-2015
	
 
	
 

	
 
	
 
	
 

	
CONFIDENTIAL -NIH
	
 
	
 

	
First Amendment of L-068-2013/0
	
 
	
Kite Pharma, Inc
	
September 28, 2015

	
Model 09-2006 (updated 8-2012)
	
Page 4 of 6
	
 
	
 

 

 

ATTACHMENT 2 – REPLACEMENT APPENDIX C, ParaGRAPHS IV and V  

	
IV.
	
The Licensee agrees to pay the NIH Benchmark royalties within [...***...] of achieving each Benchmark by Licensee or its sublicensees for each Licensed Product:  

	
 
	
(a)
	
Fifty thousand dollars ($50,000.00) upon commencement of the first Licensee-sponsored Phase 1 Clinical Study for the first indication in the Licensed Field of Use.

	
 
	
(b)
	
[...***...] dollars ($[...***...]) for [...***...]. 

	
 
	
(c)
	
[...***...] dollars ($[...***...]) for [...***...]. 

	
 
	
(d)
	
[...***...] dollars ($[...***...]) for [...***...]. 

	
 
	
(e)
	
[...***...] dollars ($[...***...]) for [...***...]. 

	
 
	
(f)
	
[...***...] dollars ($[...***...]) upon definitive FDA approval or foreign equivalent for a Licensed Product or Licensed Process for the first indication in the Licensed Field of Use. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

	
 
	
(g)
	
[...***...] dollars ($[...***...]) upon [...***...]. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

	
 
	
(h)
	
The first time the aggregate Net Sales of all Licensed Products achieve the following thresholds, the Licensee pays the following one-time Benchmark royalties:

	
 
	
(1)
	
[...***...] dollars ($[...***...]) when the aggregate Net Sales of all Licensed Products reaches [...***...] dollars ($[...***...]). 

	
 
	
(2)
	
[...***...] dollars [...***...]) when the aggregate Net Sales of all Licensed Products reaches [...***...] dollars ($[...***...]). 

	
 
	
(3)
	
[...***...] dollars ($[...***...]) when the aggregate Net Sales of all Licensed Products reaches one billion dollars ($1,000,000,000.00).

For purposes of this Agreement, “successful completion of a Licensee-sponsored Phase 3 Clinical Study” shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product 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.

 

 

				
	
A-411-2015
	
 
	
***Confidential Treatment Requested

	
 
	
 
	
 

	
CONFIDENTIAL -NIH
	
 
	
 

	
First Amendment of L-068-2013/0
	
 
	
Kite Pharma, Inc
	
September 28, 2015

	
Model 09-2006 (updated 8-2012)
	
Page 5 of 6
	
 
	
 

 

 

	
V.
	
The Licensee agrees to pay the NIH the following  Sublicense Royalties on the fair market value of any consideration received for granting each sublicense in accordance with Article 4 of this Agreement, within [...***...] of the execution of each sublicense: 

	
 
	
(a)
	
[...***...] percent ([...***...]%) for a sublicense granted [...***...].

	
 
	
(b)
	
[...***...] percent ([...***...]%) for a sublicense granted [...***...].

	
 
	
(c)
	
[...***...] percent ([...***...]%) for a sublicense granted [...***...].  A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

	
 
	
(d)
	
[...***...] percent ([...***...]%) for a sublicense granted [...***...].  A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare (India).

Notwithstanding the foregoing, Sublicensing Royalties shall not exceed [...***...] dollars ($[...***...]) per sublicense.   

 

				
	
A-411-2015
	
 
	
***Confidential Treatment Requested

	
 
	
 
	
 

	
CONFIDENTIAL -NIH
	
 
	
 

	
First Amendment of L-068-2013/0
	
 
	
Kite Pharma, Inc
	
September 28, 2015

	
Model 09-2006 (updated 8-2012)
	
Page 6 of 6

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