Cooperative Research And Development With The Fda

EXHIBIT 10.12


CRADA # 26 - 97


FEDERAL TECHNOLOGY TRANSFER ACT
FDA/CBER COOPERATIVE RESEARCH & DEVELOPMENT AGREEMENT


1. SUMMARY OF PROPOSED AGREEMENT WITH NEOPHARM, INC.


Laboratory: Center for Biologics Evaluation and Research
Project Title: Development and Commercialization of Interleukin-13
Pesudomonas Exotoxin as anticancer agent
Project Description: SEE TAB 1 - RESEARCH PLAN
FDA Project Officer: RAJ K. PURI, M.D., PH.D.


Proposed Effective Dates From: August 1997 To: August 2001


Resource Summary: $ Estimated # Estimated Estimated
Designated FTEs Equipment Materials
---------- ----------- --------- ---------

FDA 0 0.05 ($45,000/yr)
Collaborator $100,000/yr 0.10
Total $400,000 0.15 ($180,000)


2. REVIEWS BY FDA ORGANIZATIONS - TAB 2


A. Possible Organizational Conflict -- Revisions Requested:
None


B. Comments on Individual Conflict of Interest:
DEPI AND CBER - SEE TAB 3


3. Center action in response to reviews


[ ] Summary of Comments
[X] No Revisions Made To Agreement


4. FDA Review Board Recommendation to the Commissioner

[X] Accept [ ] Disapprove [ ] Modify (Explanation
Attached)


/s/ Elizabeth D. Jacobson 8/6/97 - ------------------------------------------ ---------------
Review Board Chairperson Date


5. LEAD DEPUTY COMMISSIONER'S DECISION


[ ] Accepted [ ] Disapproved [ ] Modification(s)
(Explanation
Attached)


/s/ Masira 8/12/97 - ------------------------------------------ --------------- Lead Deputy Commissioner of Food and Drugs Date


2


CRADA SIGNATURE PAGE
--------------------


FOR FDA:


/s/ 8/27/97 - ------------------------------------------ ------- Name/Signature Date


Acting Deputy Director - ------------------------------------------ Title


Mailing Address for Notices: - ------------------------------------------ Center for Biologics Evaluation - ------------------------------------------ and Research - ------------------------------------------ Food and Drug Administration - ------------------------------------------ 5600 Fishers Lane, HFM-44 - ------------------------------------------ Rockville, MD 20857 - ------------------------------------------ Attn: Mary Meyer


FOR THE COLLABORATOR: (The undersigned expressly certifies or affirms that the contents of any statements made or reflected in this document are truthful and accurate.)


Aguilur Rahman / /s/ Aguilur Rahman 7/21/97 - ------------------------------------------ ------- Name/Signature Date


Chief Scientific Officer - ------------------------------------------ Title


Mailing Address for Notices:


NeoPharm Inc. - ------------------------------------------ 225, East Deerpath, Suite 250 - ------------------------------------------ Lake Forest, IL 60045 - ------------------------------------------


- ------------------------------------------


- ------------------------------------------


[Include additional signature and address blocks as necessary for all Parties to this CRADA]


33


3


[LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service


------------------------------------------------------------------------


Food and Drug Administration
Rockville MD 20857


[STAMPED AUG 6 1997]


NOTE TO: Lead Deputy Commissioner


Through: Executive Secretariat on 8/7/97


SUBJECT: Proposed Cooperative Research and Development
Agreements under the Federal Technology Transfer
Act of 1986 -- ACTION


During its August 4, 1997 meeting, the FDA CRADA Review Board
considered one proposed Cooperative Research and Development
Agreement (CRADA). The proposed collaboration is between


CBER and Neopharm, Inc. to "Develop and
Commercialize Interleukin-13 Pseudomonas
Exotoxin as Anticancer Agent."


The CRADA proposal has been reviewed by other FDA Centers for
organizational conflict of interest; by the Division of Ethics and
Program Integrity for any individual and organizational conflict of
interest, and by other offices for any issues which might need
resolution. The reviews were favorable and all issues that were
raised have been addressed.


The Board then conducted its review and recommends your acceptance
of this CRADA. An Executive Summary is attached. Please indicate
your decision and sign the Summary. Under the Federal Technology
Transfer Act, Agencies are required to make their decision within 30
calendar days or, in this case, by September 4, 1997.


Please let me know if I can provide anything further on this.


/s/ Elizabeth D. Jacobson

Elizabeth D. Jacobson, Ph.D.
Chairperson,
FDA CRADA Review Board


Attachment
Executive Summary and
FDA CRADA 26-97

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