NATIONAL INSTITUTES OF HEALTH

MATERIALS COOPERATIVE RESEARCH
AND DEVELOPMENT AGREEMENT

This Materials Cooperative Research and Development Agreement (“M-CRADA”) has been adopted for use by the Institutes and Centers (“ICs”) of the National Institutes of Health (“NIH”) for transfers of essential research material(s) from collaborators (hereinafter “Collaborator Research Material”) not otherwise reasonably available for NIH research. It consists of a copy of the NIH Model M-CRADA, a Signature Page, a Contacts Page, and a Summary Page. The research plan (“Research Plan”) is attached as Appendix A and all changes to this model agreement are collected in Appendix B. Appendices A and B are incorporated herein by reference. This M-CRADA involves no exchange of personnel or of any resources other than as described in Appendix A. This M-CRADA is made under authority of the Federal Technology Transfer Act, 15 U.S.C. § 3710a, and is governed by its terms.

¨ Yes

x No

¨ Yes (Please provide Assurance Number:                         )

¨ No

NIH may publish or otherwise publicly disclose the results of the research, but if Collaborator has given confidential information to NIH such public disclosure may be made only after Collaborator has had thirty (30) days to review the proposed disclosure to determine if it contains any confidential information, except when a shortened time period under court order or the Freedom of Information Act pertains.

SIGNATURES BEGIN ON THE NEXT PAGE

SIGNATURE PAGE

ACCEPTED AND AGREED

By executing this M-CRADA, each Party represents that all statements made herein are true, complete, and accurate to the best of its knowledge. Collaborator acknowledges that it may be subject to criminal, civil, or administrative penalties for knowingly making a false, fictitious, or fraudulent statement or claim.

CONTACTS PAGE

M-CRADA Notices

Patenting and Licensing

Delivery of Materials Identified In Article 1

For IC: 

IC Contact: Richard J. Youle, Ph.D.

IC Address: SNB, Bldg 35, Room 2C-917, 35 Convent Drive, MSC 3704, Bethesda, MD 20892-3704

IC Phone Number: 301-496-6628

IC Fax: 301-402-0380

IC contact e-mail YouleR@ninds.nih.gov

For Collaborator:  same as for M-CRADA notices

Collaborator Contact:

Collaborator Address:

Collaborator Phone Number:

Collaborator Fax:

Collaborator contact e-mail:

SUMMARY PAGE

Either party may, without further consultation or permission,

release this summary page to the public.

ABSTRACT OF THE RESEARCH PLAN:

The Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke of the National Institutes of Health will conduct research characterizing a variety of compounds proprietary to Lixte Biotechnology Holdings, Inc., under a Materials Cooperative Research and Development Agreement. The research will examine the compounds’ potential for anti-cancer activity, reducing neurologic deficit due to ischemia and brain injury, and stabilizing catalytic function of misfolded proteins for inborn brain diseases.

APPENDIX A

RESEARCH PLAN

Background

Lixte Biotechnology Holdings, Inc.’s primary emphasis is on developing drugs for cancer but its proprietary compounds also have potential for treating a variety of other diseases. The Surgical Neurology Branch (SNB) has experience in researching brain tumors, neurological brain injury, and inborn diseases affecting the brain, such as Gaucher’s disease, von Hippel-Lindau, and neurofibromatosis type II.

Overall Goal. The SNB would like to examine the Collaborator’s compounds’ potential for anti-cancer activity, reduction of neurologic deficit due to ischemia and brain injury, and stabilization of the catalytic function of misfolded proteins for inborn brain diseases.

Research

The SNB will characterize proprietary compounds from the Collaborator, including but not limited to the following seven:

LB-100, LB-102, LB-113, LB-153, LB-157, LB-201, and LB-205.

Collaborator may provide additional proprietary compounds to the SNB if the parties mutually agree in advance and the transfer is documented in writing.

The SNB may study one or more of the above compounds in in vitro and in vivo (animal models) for the following effects:

APPENDIX B

EXCEPTIONS OR MODIFICATIONS TO THIS M-CRADA

Additions are noted as underline and deletions are noted as strikeout.

Modify Article 20 as follows: