Document:

EX-10.40

   

  Exhibit 10.40

  CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE ALAUNOS THERAPEUTICS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) IS CUSTOMARILY AND ACTUALLY TREATED AS PRIVATE.

  PUBLIC HEALTH SERVICE

  Amendment

  This Agreement is based on the model Amendment Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”).

  This Cover Page identifies the Parties to this Agreement:

  The U.S. Department of Health and Human Services, as represented by

  National Cancer Institute

  an Institute or Center (hereinafter referred to as the “IC”) of the

  NIH

  and 

  Ziopharm Oncology, Inc., hereinafter referred to as the “Licensee”,

  having offices at One First Avenue, Parris Building #34, Navy Yard Plaza, Boston, MA 02129,

  created and operating under the laws of Delaware.

  Tax ID No.: 84-1475642

   

  A-239-2021

   

  			
	CONFIDENTIAL-NIH
Fifth Amendment of L-190-2019-0
Model 10-2105
	Final  Ziopharm Oncology, Inc.
Page 1 of 7
	August 11, 2021

   

  

   

  FIFTH AMENDMENT TO L-190-2019-0

  This is the fifth amendment (“Fifth Amendment”) of the agreement by and between the IC and Licensee having an effective date of May 28, 2019 and having IC Reference Number L-190-2019-0 (“Agreement”). This Fifth Amendment, having IC Reference Number L-190-2019-5 includes, in addition to the amendments made below, 1) a Signature Page, 2) Attachment 1 (Royalty Payment Information), and 3) Appendix A - Patent(s) or Patent Application(s).

  WHEREAS, the IC and the Licensee desire that the Agreement be amended a fifth time as set forth below in order to bring additional patent rights within the scope of the Agreement.

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

  1) Appendix A - Patent(s) or Patent Application(s) of the Agreement shall be deleted and replaced with Appendix A - Patent(s) or Patent Application(s) of this Fifth Amendment. This Appendix A is further incorporated by reference on the cover page of the Agreement.

  2) Within sixty (60) days of the execution of this Fifth Amendment, the Licensee shall pay the IC an amendment issue royalty in the sum of one US Dollar ($1.00). Payment options may be found in Attachment 1. The parties agree that the foregoing payment obligation shall be in lieu of the non-creditable, non-refundable amendment issue royalty set forth in Paragraph VII of Appendix C of the Agreement for all Additional T Cell Receptors added pursuant to this Fifth Amendment.

  3) In the event any provision(s) of the Agreement is/are inconsistent with Attachment 1, such provision(s) is/are hereby amended to the extent required to avoid such inconsistency and to give effect to the payment information in such Attachment 1.

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

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

  6) This Fifth Amendment is effective upon execution by all parties.

  SIGNATURES BEGIN ON NEXT PAGE

   

  A-239-2021

   

  			
	CONFIDENTIAL-NIH
Fifth Amendment of L-190-2019-0
Model 10-2105
	Final  Ziopharm Oncology, Inc.
Page 2 of 7
	August 11, 2021

   

  

   

  FIFTH AMENDMENT TO L-190-2019/0

  SIGNATURE PAGE

  In Witness Whereof, the parties have executed this Fifth 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 IC:
	 

	/s/ Richard U. Rodriguez
	8-11-21

	Richard U. Rodriguez, MBA
Associate Director
Technology Transfer Center
National Cancer Institute
	Date

  National Institutes of Health Mailing Address or E-mail Address for Agreement notices and reports:

  License Compliance and Administration
Monitoring & Enforcement
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, Maryland 20852-3804 U.S.A.

  E-mail: [***]

  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/ Jill Buck
	8-13-2021

	Signature of Authorized Official
Name:	Jill Buck
Title:	EVP
	Date

   

   

  A-239-2021

   

  			
	CONFIDENTIAL-NIH
Fifth Amendment of L-190-2019-0
Model 10-2105
	Final  Ziopharm Oncology, Inc.
Page 3 of 7
	August 11, 2021

   

  

   

  I.	Official and Mailing Address for Agreement notices:

  Michael A. Robinson

  Name 

  Senior Vice President, Intellectual Property

  Title

  Mailing Address:

  Ziopharm Ocology, Inc.

  One First Avenue, Parris Building #34

  Navy Yard Plaza

  Boston, MA 02129

  Email 	Address: [***]

  Phone:	[***]

  Fax:	[***]

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

  Christine Legal

  Name 

  Sr. Manager, Accounts Payable

  Title

  Ziopharm Oncology, Inc.

  One First Avenue, Parris Building #34

  Navy Yard Plaza

  Boston, MA 02129

  Email Address: [***]

  Phone:	[***]

  Fax:	[***] 

   

  A-239-2021

   

  			
	CONFIDENTIAL-NIH
Fifth Amendment of L-190-2019-0
Model 10-2105
	Final  Ziopharm Oncology, Inc.
Page 4 of 7
	August 11, 2021

   

  

   

  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).

  ATTACHMENT 1- ROYALTY PAYMENT INFORMATION
New Payment Options Effective March 2018

  The License Number MUST appear on payments, reports and correspondence.

  [***]

   

  A-239-2021

   

  			
	CONFIDENTIAL-NIH
Fifth Amendment of L-190-2019-0
Model 10-2105
	Final  Ziopharm Oncology, Inc.
Page 5 of 7
	August 11, 2021

   

  

   

  APPENDIX A - PATENT(S) OR PATENT APPLICATION(S)

  Patent(s) or Patent Application(s):

  Group A

  [***]

  Group B

  [***]

  Group C

  [***]

  Group D

  [***]

  Group E

  [***]

  Group F

  [***]

   

  A-239-2021

   

  			
	CONFIDENTIAL-NIH
Fifth Amendment of L-190-2019-0
Model 10-2105
	Final  Ziopharm Oncology, Inc.
Page 6 of 7
	August 11, 2021EX-10.44

  Exhibit 10.44 

  Amendment #3

  Cooperative Research and Development Agreement # 03111

  “Development and Evaluation of Alaunos Therapeutics, Inc.’s Proprietary Non-viral Sleeping Beauty Vectors for Genetic Modification of Peripheral Blood Lymphocytes with Genes Encoding Mutated Tumor Neoantigen-specific T Cell Receptors (also referred to as Mutation Reactive T Cell Receptors) that Have Been Identified Using NCI Proprietary Methods”

  IC Principal Investigator: Steven A. Rosenberg, M.D., Ph.D. 

  Collaborator: Alaunos Therapeutics, Inc. (“Alaunos”)

  The purpose of this amendment is to change certain terms of the above-referenced Cooperative Research and Development Agreement (CRADA). These changes are reflected below, and except for these changes, all other provisions of the original CRADA and Amendments #1 and 2 remain in full force and effect. Upon execution, IC and Alaunos will each retain a copy of this amendment.

  The Parties agree:

  1.Upon final signature, the term of the CRADA is extended retroactively for one (1) year, from January 9th, 2022 to January 9th, 2023.

  2.Ziopharm Oncology, Inc. is changed to Alaunos Therapeutics, Inc. Collaborator’s CRADA principal investigator is changed from Dr. Laurence Cooper to Dr. Drew Deniger effective with this Amendment. The address of Alaunos is changed to 8030 El Rio, Houston TX 77054. The Contacts Page is deleted in its entirety and replaced with the Contacts Page set forth in Exhibit 1. These changes are made throughout the CRADA including in the title.

  SIGNATURES ON THE FOLLOWING PAGE

  

  ACCEPTED AND AGREED TO:

  For the National Cancer Institute

   

  			
	/s/ James H. Doroshow, M.D.
	 
	03/15/2022

	James H. Doroshow, M.D.
	 
	Date

	Deputy Director for Clinical and Translational Research, NCI
	 
	 

   

  For Alaunos:

   

  			
	/s/ Kevin S. Boyle, Sr.
	 
	03/15/2022

	Name: Kevin S. Boyle, Sr.
	 
	Date

	Title CEO
	 
	 

   

  

  Exhibit 1:

  CONTACTS INFORMATION PAGE

  CRADA Notices

   

  			
	For NCI:
 
	 
	For Collaborators:

	Technology Transfer Specialist
National Cancer Institute
9609 Medical Center Drive
Bethesda, MD 20892-9702 MSC 9702
Rockville, MD 20850-9702 (express mail)
Tel: [***]
Fax: [***]
	 
	Chief Legal Officer
ALAUNOS THERAPEUTICS,
INC.
8030 El Rio
Houston TX 77054
email: [***]

	 
	Patenting and Licensing
 
	 

	For IC:
	 
	For Collaborator (same as above)

	 
	 
	 

	Technology Transfer Center
National Cancer Institute
9609 Medical Center Drive
Bethesda, MD 20892-9702 MSC 9702
Rockville, MD 20850-9702 (express mail)
Tel: [***]
Fax: [***]
	 
	 

	 
	Finances
 
	 

	For IC:
 
	 
	For Collaborator:

	Technology Transfer Manager for Finances
NCI, Technology Transfer Center
9609 Medical Center Dr., 1E-452, MSC
9702
Bethesda, MD 20892-9702
Tel: [***]
Email: [***]
EIN: 52-085811
	 
	Christine Legal
Sr. Manager, Accounts Payable
8030 El Rio St.
Houston TX 77054
[***]

   

  

   

  			
	Delivery of Materials Identified in Appendix B (if any)

	 
	 
	 

	For IC:
	 
	For Collaborator:

	 
	 
	 

	Steven A. Rosenberg, M.D., Ph.D.
Surgery Branch, NCI
10 Center Drive, MSC 1201
Bldg. 10, CRC Room 3-3940
Bethesda, MD 20892-1201
Tel. [***]
Fax: [***]
	 
	Drew Deniger, Ph.D.
Vice President, Research &
Development
8030 El Rio
Houston TX 77054

	Clinical Contact (as needed for Article 4.4.2)

	For IC:
	 
	For Collaborator:

	 
	 
	 

	Steven A. Rosenberg, M.D., Ph.D.
Surgery Branch, NCI
10 Center Drive, MSC 1201
Bldg. 10, CRC Room 3-3940
Bethesda, MD 20892-1201
Tel. [***]
Fax: [***]
 
and
 
[***]
	 
	Drew Deniger, Ph.D.
Vice President, Research &
Development
Alaunos Therapeutics, Inc.
8020 El Rio
Houston TX 77030
Email: [***]

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