November 24, 1998
Xx. Xxx Xxxxxxxx
Office of Research Affairs
0000 Xxxxxx Xxxxxx
XXX Xxxx X-0
Xxxxxxxxxxxx, Xx. 00000
Dear Xxx:
By this letter, I would like to formally propose the extension of funding under
the Clinical Study and Research Agreement (the "Agreement") dated as of November
20, 1995, between AVAX Technologies, Inc. ("AVAX"), Xxxxxx Xxxxxxxxx University
("TJU"), and Xxxxx Xxxx, M.D., as Principal Investigator. I have attached
amendments to Exhibits A and B that would serve to replace those in the original
agreement and which indicate our funding intentions for the next one year
(Exhibit B) and our expectations for accomplishments under the research
initiatives (Exhibit A). Except as expressly provided in this letter, all other
terms, conditions and provisions of the Agreement shall continue in full force
and effect as provided therein.
Additionally, I would like to confirm the intention of paragraph fifteen, which
reads as follows:
"Subject to Paragraph 12 hereof and to the proviso to the immediately
succeeding sentence, title to any equipment, materials, supplies and things
of value purchased, built, manufactured or acquired either from Sponsor or
from third parties in conjunction with performance of the Study shall vest
in TJU. All such equipment shall be and remain the property of TJU."
It is our interpretation that this paragraph applies to those items purchased by
TJU and would exclude those items purchased and/or paid for by AVAX.
I would also like to confirm the intention of paragraph thirteen concerning
indemnification, which reads as follows:
o Page 2 March 29, 1999
"Sponsor agrees to indemnify, hold harmless and defend TJU, its trustees,
officers, employees, the Principal Investigator and agents from and against
any and all claims, suits, losses, damages, cost, fees, expenses (including
attorney's fees), and other liabilities asserted by third parties, both
government and non-government, resulting from or arising out of the
clinical study and research program carried out pursuant to this Agreement,
provided, however, that Sponsor shall not be liable for TJU's negligence,
intentional wrongdoing, or its failure to follow the Research Protocol."
While it appears the use of the abbreviation "TJU" in the last sentence is
intended to refer to all of the parties listed in the first sentence of the
paragraph, I believe it would be clearer and more reflective of our intent to
amend the last part of the last sentence (in bold italics above) to read as
follows:
"provided, however, that Sponsor shall not be liable for any such claims,
suits, losses, damages, costs, fees, expenses (including attorneys' fees),
and other liabilities asserted by third parties arising out of or related
to (i) the failure of any such person or entity to follow the terms of the
Research Protocol or Sponsor's written instructions concerning use of the
Study drug, (ii) failure of any such person or entity to comply with
applicable FDA or other government requirements, or (iii) the negligence
of, or intentional wrongdoing by, any such person or entity."
Finally, I would like to update paragraph 16 to replace Xxxx Xxxxx, Ph.D. and
Xxxxxxx X. Xxxxx, Esq. as the representatives who should receive notice on
behalf of AVAX, with the following:
Xxxxxxx X. Xxxxx, M.D.
President and Chief Executive Officer
AVAX Technologies, Inc.
0000 Xxxx Xxxxxx
Xxxxx 000
Xxxxxx Xxxx, Xxxxxxxx 00000
With a copy to:
Xxxxx X. Xxxxxxx
Chief Financial Officer
AVAX Technologies, Inc.
0000 Xxxx Xxxxxx
Xxxxx 000
Xxxxxx Xxxx, Xxxxxxxx 00000
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Should you agree with the new Exhibits A and B and the clarifications/amendments
described above, please have the appropriate TJU official and Xx. Xxxx sign this
letter and return it to me. Upon execution, we will immediately forward a check
for the first quarter's funding of the extension.
Should you have any questions or comments, please feel free to call me.
Sincerely,
AVAX Technologies, Inc.
By:
/s/ Xxxxxxx X. Xxxxxx
Name: Xxxxxxx X. Xxxxx, M.D.
Title: President and Chief Executive Officer
Accepted this 1st day of January, 1999
On behalf of Xxxxxx Xxxxxxxxx University
/s/ Xxxxxx Xxxxxxxx
--------------------------------------------
Name: Xxxxxx Xxxxxxxx
Title: Manager, Research Administration
Accepted this 1st day of January, 1999
/s/ Xxxxx Xxxx 1/14/99
--------------------------------------------
Name: Xxxxx Xxxx, M.D.
Title: Principal Investigator
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Exhibit A
Research Protocol
The study is to evaluate the feasibility of applying the DNP Cancer Vaccine
technology to treatment of malignancies other than melanoma. The ongoing studies
will be conducted with other human cancers such as breast, renal and colon
cancers and may include in vitro testing, cell culture studies, in vivo animal
models and human studies. It may also include studies of potential second
generation products.
Principal Investigator
The Principal Investigator of the Study is Xx. Xxxxx Xxxx of Xxxxxx Xxxxxxxxx
University.
Performance
During the next Agreement year of the Study, from 11/20/98 to 11/19/99, the
Principal Investigator will use best efforts to achieve the following
objectives:
[Redacted information has been separately filed with the Commission for
Confidential Treatment.]
o Page 5 March 29, 1999
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Exhibit B - Funding for the period from
11/20/1998 to 11/19/1999
[Redacted information has been separately filed
with the Commission for Confidential Treatment.]
Total Funding $ 279,690
Commitment
--------------------------------------------------------------------------------
Note: Except as provided in the attached letter, the funding above is to be
provided on the same terms, conditions and provisions as specified in the
Clinical Study and Research Agreement dated November 20, 1995.
