November 25,1997
Xx. Xxxx Xxxxxxx, President
MMTC, Inc.
00 Xxxxxx Xxxx, Xxxxx X-000
Xxxxxxxxx, XX 00000
RE: Amendment to the License Agreement between MMTC, Inc. ("MMTC ") and
Xxxxxx Laboratories, Inc. ("CLI") dated August 23, 1996 as extended
April 11, 1997.
Dear Xx. Xxxxxxx:
Based upon our conversations and prior negotiations, I understand that
MMTC has agreed to amend the above referenced License Agreement as follows:
a. The "Licensed Patents" listed an Appendix I shall include U.S.
Patent 5,149,198 dated September 22, 1992 (Sterzer -
Temperature-Measuring Microwave Radiometer Apparatus) and 5,688,050
dated November 17, 1997 (Sterzer - Temperarture-Measuring Microwave
Radiometer Apparatus) (the "New Patents"). The parties agree that any
CLI rights to the New Patents will be limited to the "Field", as
defined in the Agreement. In order to maintain rights to the New
Patents, CLI must fund research and development work by MMTC in an
amount of (Confidential Treatment Requested) per month commencing
December 1, 1997. Such research and development work will initially
consist of incorporating the radiometer technology into the balloon
catheter device. If such work is completed within a one year period,
then the funded research and develop work may be used, upon the mutual
agreement of MMTC and CLI, for additional phantom studies or animal
studies to demonstrate the validity of the technology. If CLI funds
such research and development activities for 12 months, its rights to
the New Patents shall be the same as its rights to other Licensed
Patents and its research and development funding obligation shall
cease.
b. Section 3.2 is amended to read as follows:
3.2 CLI shall meet the following development milestones by the specified date:
(i) to file Investigational Device Exemption(IDE) within 2 months
after completion of necessary animal safety data from the
animal study performed at Montefiore Medical Center, however
no later than June 30, 1998; or
(ii) to commence a clinical safety trial with not less than ten
(10) patients (or as required by FDA) within 60 days upon
receipt of IDE approval from the FDA and upon the
investigator receiving Internal Review Board (IRB) approval
as required by his medical facility, however no later than
July, 31, 1998; thereafter
(iii) to commence clinical efficacy trial within 60 days upon
receipt of further IDE approval to do such and approval by
the investigational site's IRB to do such, however no later
than October 31, 1998.
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c. Section 9.2(iii) is replaced in the entirety and to read as
follows:
9.2(iii) CLI shall purchase product liability insurance for the
protection of MMTC, its directors, officers, agents and employees,
that, in the absolute and unreviewable discretion of MMTC, is
satisfactory to MMTC in the amount of not less than (Confidential
Treatment Requested) for product liability. CLI shall have said product
liability coverage in effect prior to the first human patient being
treated with the herein technology of this agreement. This
representation is a condition precedent to the effectiveness of this
Agreement. Liability should cover long-term complaits by patients after
the treatment and on other personnel involved directly or indirectly
with operations of the equipment, even if the agreement is no longer in
force.
d. Section 12.6 is replaced in the entirety and to read as follows:
Section 12.6 CLI shall raise by public/or private offering of its stock
(Confidential Treatment Requested) in funds by March 31,1998. If CLI
does not realize or obtain the (Confidential Treatment Requested) in
funds by said date, MMTC shall at its option, terminate this agreement
and shall be allowed to retain any and all funds received by MMTC from
CLI. The registration statements or prospectuses or any other papers
written in connection with such public/or private offering shall not
refer by name to MMTC or any of its directors, officers, agents, or
employees unless agreed to by MMTC.
The foregoing sets forth your understanding of the extensions and amendments to
the Agreement, please countersign this letter in the space provided below.
XXXXXX LABORATORIES, INC. MMTC, INC.
By /s/Xxxxxxx X. Xxxx By /s/Xxxx Xxxxxxx
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Xxxxxxx X. Xxxx, President Xxxx Xxxxxxx, President
November 25, 1997
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