Exhibit 10.1

Timothy T. Soncrant, M.D.

President

CURE, LLC

1300 Atwood Road

Silver Spring, MD 20906

 

May 27,2002

 

Re:          Axonyx Inc. (“Axonyx”) with CURE LLC (“Cure”)

 

Dear Mr. Soncrant,

 

Thank you for taking the time to meet with me today to discuss, among other
things, the status of the Phenserine project.  This letter agreement (the
“Letter Agreement”) sets forth our recent understandings with respect to the
Phenserine Development Program governed by the February 27,1997 License
Agreement between Cure and Axonyx (the “License Agreement”).  Accordingly, and
intending to be mutually bound, Axonyx and Cure hereby agree as follows:

 

1.    Amendment of License Agreement.  The License Agreement is hereby amended
and supplemented as follows:

 

1.1  Section 10.  The first sentence of Section 10 of the License Agreement is
hereby deleted in its entirety and replaced with the following:

 

In the event that LICENSEE fails either to:  (a) commence Phase I testing within
three (3) months after the date of approval of an IND, (b) Phase II testing
within fourteen (14) months of the date of such approval, (c) Phase III testing
within forty-two (42) months of the date of such approval, or (d) submit an NDA
for approval in the United States, Japan, the U.K., Germany, France, Belgium, or
Canada within six and one half (6.5) years of the date of the IND approval, then
CURE may make a written demand that LICENSEE begin such phase of testing or
submit such NDA for approval, it being understood, however that if the delay in
commencing such phase of testing or obtaining such approval is a result of
difficulties in recruiting clinical research subjects for Phase III clinical
trials, or the result of other similar technical or logistical difficulties with
respect to factors outside of LICENSEE’s or its sub-licensee’s control, then
CURE shall refrain from making the aforementioned written demand so long as, in
CURE’s reasonable judgment, LICENSEE and/or its sub-licensee is acting in good
faith and using its best efforts to recruit such clinical research subjects, or
to address such other difficulties.

 

2.    Amendment of PHS Agreement.  The parties acknowledge that (i) The
intellectual property sublicensed to Axonyx pursuant to the License Agreement
was licensed to Cure from The National Institutes of Health, the Centers for
Disease Control and Prevention or the Food and Drug Administration
(collectively, “PHS”); (ii) Section 10 of the PHS Agreement, which obligates
Cure or its sublicensee to comply with Appendix E and Appendix F, is
incorporated into Section 3 of the License Agreement (entitled “Pass Through
Obligations from PHS Agreement”); and (iii) Section 10 of the PHS Agreement
provides that Appendix E and Appendix F may be modified by the parties.  The
parties hereby agrees that in the event Appendix E and/or Appendix F (or any
other provisions) of the PHS Agreement are modified, such modified Appendices or
provisions shall, upon their modification, be deemed to automatically replace
the original appendices or provisions in the License Agreement.

 

This Letter Agreement constitutes our entire understanding with respect to the
subject matter hereof and may not be amended without a writing signed by both
parties.  Unless specifically modified herein, all terms and conditions of the
License Agreement shall remain in full force and effect.  This Letter Agreement
may be executed in counterparts and shall be governed by the laws of the State
of New York.

 

I would be grateful if you would please indicate your consent to the above
agreements by signing below and returning an executed copy of this letter to me.

1

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Sincerely,

 

 

 

/s/ Gosse Bruinsma, M.D.

Gosse Bruinsma, M.D.

 

 

 

AGREED TO AND ACCEPTED

 

 

 

/s/ Timothy Soncrant, M.D.

By:

Timothy T. Soncrant, M.D.

 

President

 

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