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EXHIBIT 10.21B
[Xxxxxx Diagnostics Division Letterhead]
December 22, 1997
Xxxx Xxxxxxx
President & CEO
SpectRx, Inc.
Dear Xxxx:
This letter serves three purposes with respect to the ongoing Abbott/SpectRx
research program for the extraction of interstitial fluid for glucose
monitoring: summarizes our mutual understanding of the current state of the
feasibility phase, outlines the key next steps the parties will take and serves
to amend certain terms (the "Amendment") of our Research & Development and
License agreement dated October 10, 1996 (the "Agreement").
1. The state of the feasibility phase at this time is best summarized as
follows:
A. SpectRx has made progress in the [ * ] extraction of
[ * ] of interstitial fluid, [ * ] in the
Agreement.
B. The Research Program has made progress in the extraction of
interstitial fluid by using [ * ] (the "Current Technology").
C. The Current Technology [ * ] at this time and [ * ] to
understand the best [ * ] of technology options and whether
this [ * ] provides acceptable performance, both from a
technical and user acceptability perspective, while meeting
[ * ] for a possible commercial product (the "Optimization").
D. SpectRx has [ * ] in an effort to [ * ] as described in the
Agreement and will [ * ].
2. The parties acknowledge the Research Program is not complete and to best
deal with the current situation, they will proceed in the following
manner and accordingly, the Agreement shall be amended as follows:
A. As part of the Optimization, user studies will be performed to 1)
get additional interstitial fluid extraction performance data on
the various technology permutations of the Current Technology,
and 2) understand the user acceptance of the Current Technology
alternatives from a [ * ] over current finger stick technology.
These studies, as well as additional steps necessary to complete
the Optimization including research, drafting protocols,
internal studies, additional clinicals, focus panels and
resource assignments [ * ]
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[ * ] will be decided on and executed under the direction of
Abbott with input from SpectRx. In addition, ongoing [ * ] will
be completed by [ * ] [ * ] and sections of the [ * ]
considered appropriate by Abbott will be shared with SpectRx.
[ * ]
B. [ * ] of the Optimization, [ * ] the parties may decide to
re-direct the Research Program, as defined in the Agreement,
based on the results of the Optimization. If a re-direction is
mutually agreed to, the parties will negotiate in good faith to
restructure the Research Program Plan, milestones and other
terms of the Agreement which must be re-structured as
necessitated by the revised Research Program Plan, and all
terms necessary for any new business relationship desired by
the parties. Notwithstanding the foregoing, in no event will
the total funds for the research milestones, the total project
milestones or royalties be increased and there will be no
payment due from Abbott for the restructuring itself.
3. In recognition of the progress SpectRx has made in the [ * ]
extraction of [ * ] of interstitial fluid, the parties agree:
X. Xxxxxx will make a one time $500,000 progress payment to SpectRx
within fifteen (15) days of execution of this Amendment. This
payment is not a Research Program milestone payment under the
Agreement and this payment is not to be construed as evidencing
achievement of any milestone under the Agreement.
B. [ * ].
C. The provisions of this Amendment are hereby made a part of the
Agreement; any conflict between the provisions of this Amendment
and the Agreement shall be resolved in favor of the provisions of
this Amendment. All capitalized terms used in this Amendment and
not defined herein shall have the same meanings as given to them
in the Agreement. Except as specifically set forth in this
Amendment, nothing herein shall be construed as a modification or
waiver by Abbott or SpectRx of any rights or remedies that Abbott
or SpectRx may have under the Agreement, including without
limitation, any rights to terminate the Agreement.
Please countersign and return one copy of this letter as confirmation of
SpectRx's agreement to all statements and amended terms herein.
Sincerely, Agreed and accepted,
/s/ XXX XXXXXXX /s/ XXXX X. XXXXXXX
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Xxx Xxxxxxx Xxxx Xxxxxxx
Corporate Vice President President & CEO
Diagnostics Products R&D SpectRx, Inc.
Xxxxxx Laboratories
12/23/97 12/25/97
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Date Date
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[ * ] Certain information of this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with respect to
the omitted portions.
