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| 8-K - SCIVANTA MEDICAL CORP | v164258_8k.htm |
EXHIBIT 10.31
Fourth
Addendum to the Technology License Agreement
between
The
Research Foundation of State University of New York
for
and on behalf of University at Buffalo
and
Donald
D. Hickey, M.D.
and
Clas
E. Lundgren, M.D., Ph.D.
and
Scivanta
Medical Corporation
This
Fourth Addendum (this “Fourth Addendum”) to the Technology License Agreement (as
such term is defined below), entered into as of the 29th day of October, 2009
(the “Fourth Addendum Effective Date”), is by and among The Research Foundation
of State University of New York, for and on behalf of University at Buffalo, a
non-profit corporation organized and existing under the laws of the State of New
York (the “Foundation”), Donald D. Hickey, M.D. (“Hickey”) and Clas E. Lundgren,
M.D., Ph.D. (a/k/a Claes Lundgren and referenced herein as “Lundgren”) and
Scivanta Medical Corporation (formerly Medi-Hut Co., Inc.), a corporation duly
organized under the laws of the State of Nevada, and having its principal place
of business at 215 Morris Avenue, Spring Lake, New Jersey 07762
(“Licensee”). Foundation, Hickey and Lundgren will be collectively
referenced herein as “Licensor.” Capitalized terms used herein, but
not otherwise defined herein, shall have such meanings as given to such terms in
the Technology License Agreement.
WHEREAS,
Licensor and Licensee entered into an exclusive Technology License Agreement on
November 10, 2006, as amended on each of June 29, 2007, October 24, 2008 and
January 6, 2009 (the “Technology License Agreement”), to facilitate the
development and commercialization of certain technology owned by Licensor so
that this technology may be utilized to the fullest extent for the benefit of
Licensee, Licensor, the inventor(s) and the public; and
WHEREAS,
Licensor and Licensee desire to modify the aforementioned Technology License
Agreement for the mutual benefit of both parties;
NOW,
THEREFORE, in consideration of the mutual promises and covenants contained
herein, and for other good and valuable consideration, the receipt of which is
hereby acknowledged, the parties agree as follows:
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1.
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The
modifications of the Technology License Agreement herein will be effective
as of the Fourth Addendum Effective Date and will remain in effect for the
duration of the Technology License Agreement unless further modified in
writing by the parties hereto.
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2.
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In
consideration for Licensor’s agreement to the terms of this Fourth
Addendum, Section 1.16 will be deleted in its entirety and replaced with
the following:
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1.16
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“Term”
means the period of time beginning on the Effective Date and ending on the
later of (i) the expiration date of the last to expire Patent Right, or
(ii) thirteen (13) years from the sale of the first Licensed Product on a
country by country basis.
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3.
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Section
3.10 Cash Payment will be deleted in its entirety and replaced with the
following:
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3.10 Cash
Payment. Licensee will pay
Hickey a cash payment of $50,000 on or before February 28,
2010. Licensee will pay Hickey a second cash payment of
$108,438 on or before the date that is thirty (30) days after the first
commercial sale of a Licensed Product by the Licensee. If the
Licensee fails to make the second payment pursuant to this Section 3.10 on
or before the due date, then interest shall accrue on any outstanding
balance at a rate that is equal to the lesser of the maximum rate allowed
by law or 1.5% per month, but in any case each cash payment and any
accrued interest must be paid in full no later than October 31,
2010.
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4.
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Section
4.2(b) will be deleted in its entirety and replaced with the
following:
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(b)
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On
or before February 28, 2010, Licensee will commence a clinical trial in
the U.S.
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5.
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Section
4.2(c) will be deleted in its entirety and replaced with the
following:
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(c)
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On
or before July 31, 2010, Licensee
will:
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i.
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make
application for 510(k) pre-market notification with the FDA for approval
to market the Licensed Product in the U.S. and take the equivalent action
within the EU;
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ii.
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make
contact with and engage in an initial meeting with the governing agencies
in Japan, India and China to seek guidance on obtaining approval to market
the Licensed Product in each of said countries;
and
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iii.
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negotiate
a manufacturing contract for the production of the Licensed Product to be
marketed commercially.
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6.
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Section
4.2(d) will be deleted in its entirety and replaced with the
following:
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(d)
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On
or before November 30, 2010, Licensee
will:
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i.
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gain
approval to market the Licensed Product in the U.S. However,
this deadline will be extended for any time in which the application for
510(k) pre-market notification has been filed with the FDA and is under
review;
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ii.
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be
capable of manufacturing, or having manufactured, commercial versions of
the Licensed Product for sale;
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iii.
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have
developed a sales force or distribution capability in the U.S. for the
Licensed Product, either internally or per a third party service or
distributor. For the EU, the Licensee shall have an additional
four (4) months to meet this milestone;
and
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iv.
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have
established a service capability, either internally or per a third party
service or distributor, to provide customer service for the Licensed
Product in each jurisdiction in which the Licensed Product is approved by
the appropriate governing authority to be
marketed.
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7.
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Section
4.2(e) will be added as follows:
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(e)
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Within
eighteen (18) months from the date the Licensed Product is approved by the
FDA for marketing in the U.S., Licensee will, on its own or through a
Sublicensee, file for approval to market the Licensed Product in Japan,
India and China.
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8.
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Section
4.3 will be added as follows:
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4.3
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The
Foundation (on behalf of the Licensors) will have the right to request a
monthly teleconference meeting with the Licensee, including as appropriate
representatives from each of the catheter, software, hardware and clinical
trial vendors involved in the development and testing of Licensed
Products, to brief the Licensors on the status of product development and
related clinical trials for the Licensed Product. The meetings
will be conducted via teleconference, however, the Foundation will have
the right to request that up to six (6) of these monthly meetings be held
in-person in Buffalo, New York. Prior to any in-person meeting
being held, a mutually agreeable agenda will be developed by the
Foundation (on behalf of the Licensors) and the Licensee as well as a list
of participants required to attend the meeting in-person. The
first in-person meeting will be held within one month of the Licensee
closing on its current round of financing. This right of the
Licensors will expire upon the Licensee’s submission of an application for
approval of the Licensed Product to the FDA that contains the
contractility feature of the device or upon the Licensee’s determination
that the contractility feature is not commercially
reasonable.
In the event that the Licensee determines
that the contractility feature of the Licensed Product is not commercially
reasonable, Licensee agrees to return all rights licensed to the Licensee
under the Technology License Agreement pertaining to the contractility
feature of the Licensed Product to the Licensor, including pertinent
technology, software, know-how and developments that would allow Licensor
to develop and market a device solely for the measurement of cardiac
contractility. All details of said return of rights will be
subject to the mutual agreement of the Licensee and Licensor or in the
event that no agreement can be reached, established per the arbitration
provisions of Paragraph 17.1 of the Technology License
Agreement.
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9.
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Section
4.4 will be added as follows:
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4.4
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The
Foundation is granted the right to have one person observe the Licensee’s
board of directors meetings. The person designated by the
Foundation will be subject to the approval of the Licensee, which approval
will not be unreasonably withheld. The Licensee approves
Jeffrey A. Dunbar, or his successor at the Foundation, as the Foundation’s
designee to observe the Licensee’s board meetings. Mr. Dunbar
shall be notified of all board meetings at the same time as other Licensee
board members and will be provided the same materials for each board
meeting as the other directors of the Licensee. This right of
the Foundation will expire upon the Licensee receiving FDA approval to
market the Licensed Product in the U.S. Observer rights will
not extend to discussions or topics involving attorney-client privilege or
matters which, in the opinion of legal counsel for the Licensee, represent
a conflict of interest between Licensors and
Licensee.
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10.
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The
third sentence of Section 9.1 will be deleted in its entirety and replaced
with the following:
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Licensee
will carry product liability insurance (upon market launch) and clinical trial
insurance (upon the commencement of any clinical trial) which covers the
Licensed Product having such coverage limits appropriate to the risk involved in
marketing and testing the Licensed Product and will list Foundation, Hickey and
Lundgren each as an additional named insured.
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11.
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Other
than as specifically modified in this Fourth Addendum, all other terms,
conditions and covenants of the Technology License Agreement shall remain
in full force and effect.
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IN
WITNESS WHEREOF, the undersigned duly authorized representatives of the parties
have executed this Fourth Addendum, effective as of the Fourth Addendum
Effective Date.
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SCIVANTA
MEDICAL CORPORATION
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THE
RESEARCH FOUNDATION OF
STATE UNIVERSITY OF
NEW YORK
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| By: |
/s/
David R. LaVance
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By: |
/s/
Woodrow W. Maggard
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David
R. LaVance
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Woodrow
W. Maggard
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| Title: | President and Chief Executive Officer | Title: |
Associate
Vice Provost, STOR
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DONALD
D. HICKEY, M.D.
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CLAS E. LUNDGREN,
M.D., Ph.D.
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| By: |
/s/
Donald D. Hickey, M.D.
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By: |
/s/
Clas E. Lundgren, M.D., Ph.D.
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Donald
D. Hickey, M.D.
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Clas
E. Lundgren, M.D., Ph.D.
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