AMENDMENT THREE To LIMITED EXCLUSIVE PATENT LICENSE AGREEMENT For OPTICAL COHERENCE TOMOGRAPHY For Human and Animal Dentistry Between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA and LANTIS LASER, INC. LLNL Case No. TL01640-0.3 Lawrence Livermore...
AMENDMENT
THREE
To
For
OPTICAL
COHERENCE TOMOGRAPHY
For
Human and Animal Dentistry
Between
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
and
XXXXXX
LASER, INC.
LLNL
Case No. TL01640-0.3
Xxxxxxxx
Livermore National Laboratory
University
of California
X.X.
Xxx 000, X-000, Xxxxxxxxx, XX 00000
Industrial
Partnerships and Commercialization
December
18, 2006
AMENDMENT
THREE
December
2006
To
License
Agreement - LLNL Case Number TL01640-0.0
For
Optical Coherence Tomography for Human and Animal Dentistry
between
Xxxxxx Laser, Inc. and
The
Regents of the University of California
effective
September 14, 2001
This
Amendment Three to the License Agreement by and between The Regents of the
University of California (“THE REGENTS”) and Xxxxxx Laser, Inc. (“LICENSEE”)
will be effective as of the date of execution of this Amendment by the last
signing Party. This Amendment and the associated License Agreement are subject
to overriding obligations to the Federal Government pursuant to the provisions
of THE REGENTS’ Contract No. W-7405-ENG-48 with the United States Department of
Energy (“DOE”) for the operation of the Xxxxxxxx Livermore National Laboratory
(“LLNL”).
This
Amendment Three will modify the payment schedule and performance obligations.
All other terms and conditions remain the same.
Therefore,
in consideration of the mutual covenants and obligations recited herein, THE
REGENTS and LICENSEE hereby amend the License Agreement as follows:
1.
EXHIBIT
B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS)
Delete
Section B.4 (Performance Obligations) in its entirety and replace with the
following:
B.4 |
Performance
Obligations
|
B.4.1 |
LICENSEE
will build five (5) beta systems for clinical evaluation by leading
clinicians and universities to provide feedback for the final
specification of the pre-productions System and to perform
characterization and validation studies. Software will be developed
further to accommodate high speed scanning that will allow images
to be
shown on screen in real time. It will also be expanded for clinical
use to
allow the capture, manipulation and storage of image data. Refinement
of
the probe will be an ongoing effort to meet the clinical needs of
the
dental practitioners. The design of the hand-held scanner mechanism
will
be finalized in consultation with clinicians. These tasks will be
completed by December 31, 2007.
|
B.4.2 |
LICENSEE
will (1) build two commercial configurations of the pre-production
system
that incorporate OCDR - one for integration with other digital modalities
and the other as a stand-alone system, and (2) complete the development
of
the electronic interface with the OCT System, by December 31, 2008.
FDA
510(k) clearance for Licensed Products that incorporate OCDR will
be
applied for simultaneous to the last stages of
development.
|
B.4.3 |
LICENSEE
will achieve the first of Sales of Licensed Products at the close
of
LICENSEE’s business on December 31, 2008.
|
B.4.4 |
LICENSEE
will achieve accumulative gross sales revenues from the Sales of
Licensed
Products of at least Ten Million Dollar ($10,000,000) at the close
of
LICENSEE’s business on December 31, 2009.
|
B.4.5 |
LICENSEE
will achieve accumulative gross sales revenues from the Sales of
Licensed
Products of at least Twenty Million Dollar ($20,000,000) at the close
of
LICENSEE’s business on December 31, 2010.
|
B.4.6 |
LICENSEE
will achieve gross sales revenues from the Sales of Licensed Products
of
at least Thirty Million Dollars ($30,000,000) per calendar year commencing
with calendar year 2011 as measured at the close of LICENSEE’s
business
on December 31 of the relevant
year.
|
2
B.4.7 |
Progress
reports will be due annually on every February 28. The next progress
report is due on February 28, 2007.
|
B.4.8 |
LICENSEE
will
proceed commercially diligently to develop, file relevant regulatory
applications for and attempt to obtain relevant regulatory
commercialization approvals with respect to the manufacturing, marketing,
and sale of Licensed Products for at least one use in the Field of
Use.
LICENSEE will file with the U.S. Food and Drug Administration (FDA)
at
least one Premarket Notification (510k Notification) or Premarket
Application for clearance/approval of Licensed Products that incorporate
OCDR and obtain clearance from the FDA no later than December 31,
2008.
Notwithstanding any other term of this Agreement, for the purposes
of (a)
invoking/complying with the Xxxxx-Xxxxxx Act (35 U.S.C. § 156) and any
corresponding rules and regulations of the U.S. Patent & Trademark
Office regarding patent term extension, and (b) seeking regulatory
approval of LICENSEE’s Licensed Products and Licensed Methods, LICENSEE
shall act as THE REGENTS’ agent. To the extent deemed necessary by
LICENSEE, in good faith, the Parties will cooperate to secure regulatory
approval of LICENSEE’s Licensed Products and Licensed
Methods.
|
2.
EXHIBIT
C (FEES AND ROYALTIES) is deleted in its entirety and replaced with the
following:
[This
space left intentionally blank]
3
AMENDMENT
TO
EXHIBIT
C - FEES AND ROYALTIES
NOTICE
LICENSEE
considers information in this Exhibit C to be Proprietary.
C.1 |
License
Issue Fee
|
C.1.1 |
As
partial consideration for this Agreement, LICENSEE owes and will
pay to
LICENSOR a nonrefundable issue fee of One Hundred Seventy-Five Thousand
Dollars ($175,000) (License Issue Fee) to be paid as
follows:
|
C.1.1.1 |
Fifteen
Thousand Dollars ($15,000) was paid when LICENSEE executed the
Agreement.
|
C.1.1.2 |
Seventy-Six
Thousand Dollars ($76,000) was paid by October 6,
2006.
|
C.1.1.3 |
Eighty-Four
Thousand Dollars ($84,000) to be paid on or before July 28,
2007.
|
C.1.2 |
THE
REGENTS executed the Agreement after receipt of LICENSEE’s executed copies
of the Agreement and payment of the first installment of the License
Issue
Fee specified in C.1.1.1 above.
|
C.1.3 |
The
License Issue Fee will not be credited against any other royalty
or fee
due from LICENSEE to LICENSOR.
|
C.1.4 |
In
the event that LICENSEE grants sublicenses, LICENSEE will collect
an issue
fee greater than or equal to Fifty Thousand Dollars ($50,000). LICENSEE
will pay to LICENSOR Fifty Percent (50%) of any issue fee from
sublicensing.
|
C.2 |
Earned
Royalties
|
C.2.1 |
In
addition to the License Issue Fee, LICENSEE will pay LICENSOR an
earned
royalty of Six Percent (6%) on its Net Sales and on Net Sales of
its
sublicensees. Payments of earned royalties will be in accordance
with the
requirements of Article 5 (FEES, ROYALTIES AND PAYMENTS), Article
7
(PROGRESS AND ROYALTY REPORTS), and Article 20 (NOTICES) of this
Agreement.
|
4
C.2.2 |
THE
REGENTS will decrease the earned royalty on Net Sales of Licensed
Products
that implement scanning applications of OCDR (Scanning Products)
in the
event that LICENSEE must also pay earned royalties on sales of Scanning
Products under a license(s) with a third party(ies) for rights to
patents
that dominate that part of THE REGENTS’ Patent Rights pertaining to
Scanning Products. The earned royalty due LICENSOR will be decreased
by
the actual earned royalty paid to such third parties up to a maximum
of
Two and One-Half (2.5) percentage points. In no case will the earned
royalty due LICENSOR be less than Three and One-Half Percent (3.5%)
of Net
Sales. THE REGENTS will decrease the earned royalty from Net Sales
of
Scanning Products only if 1) LICENSEE
provides
THE REGENTS with a copy of the relevant third party license agreements
including any amendments thereof, and 2) LICENSEE sells Scanning
Products
only separately from other Licensed Products and accounts for such
sales
separately, and 3) LICENSEE reports to THE REGENTS actual royalty
payments
made to third parties under the relevant license agreements. Any
information disclosed under the reporting requirements can be marked
PROPRIETARY and will not be disclosed to third parties, except as
required
by law.
|
C.2.3 |
The
earned royalty on sales of Licensed Products that implement OCDR
(OCDR
Products) that are sold as part of a larger product system shall
be based
on the average Net Sales of that OCDR Product sold separately on
a non-OEM
basis over the relevant royalty reporting period. In cases where
LICENSEE
integrates OCDR Products with one or more Authorized Technologies
(Integrated Products), and LICENSEE
does not sell OCDR Products separately and therefore cannot determine
earned royalties based on separate sales of OCDR, then LICENSEE
shall pay an earned royalty of Six Percent (6%) on a fraction of
Net Sales
of Integrated Products as follows:
|
Number
of Authorized Technologies
integrated
with OCDR Product
|
Fraction
of Net Sales of
Integrated
Products
|
|
1
|
1/2
|
|
2
or more
|
1/3
|
5
In
no
case will LICENSEE pay an earned royalty on less than one-third (1/3) of the
Net
Sales of an Integrated Product.
Each
of
digital x-ray technology and laser technology for ablating biological material
is an Authorized Technology. The Parties may agree to amend this Agreement,
in
writing, to include other technologies as Authorized Technologies.
C.3 |
Maintenance
Fee
|
C.3.1 |
Beginning
in calendar year 2002, LICENSEE will pay LICENSOR a license maintenance
fee of Ten Thousand Dollars ($10,000) per calendar year, due on February
28 of each year. The maintenance fee will be waived once the minimum
annual royalty requirement is met.
|
C.3.2 |
LICENSEE
will pay to THE REGENTS Fifty Thousand Dollars ($50,000) for past
due
maintenance fees for calendar years 2002 through 2006 by December
31,
2007. In addition LICENSEE must pay the 2007 maintenance fee of Ten
Thousand Dollar ($10,000) due February 28, 2007. THE REGENTS must
receive
both payments from the LICENSEE on time to maintain
exclusivity.
|
6
C.4 |
Minimum
Annual Royalties
|
C.4.1 |
LICENSEE
will
pay
to LICENSOR a minimum annual royalty according to the requirements
of
Article 5 (FEES ROYALTIES AND PAYMENTS) and the schedule below. The
minimum annual royalty paid to LICENSOR during a calendar year will
be
credited against the earned royalty due and owing for the calendar
year in
which the minimum payment was made.
|
Calendar
Year
|
Minimum
Annual Royalty
|
Due
Date
|
|||||
2008
|
$
|
20,000
|
February
28, 2008
|
||||
2009
|
$
|
60,000
|
February
28, 2009
|
||||
2010
|
$
|
100,000
|
February
28, 2010
|
||||
2011
and thereafter for the life of this Agreement
|
$
|
250,000
|
February
28, 2011 and every February 28 thereafter for the life of the
Agreement
|
C.5 |
Distribution
of Payments
|
LICENSEE
will pay ninety-five and six-tenths percent (95.6%) of all fees and royalties
due to LICENSOR under this Agreement directly to THE REGENTS and will pay four
and four-tenths percent (4.4%) of such fees and royalties directly to Optiphase,
Inc. Payment shall have been considered to be made to Optiphase, Inc. by
depositing appropriate money into an account designated by
Optiphase.
C.6 |
Assignment
Fee
|
LICENSEE
will pay THE REGENTS an Assignment Fee of One Hundred Thousand Dollars
($100,000) prior to such assignment being approved by THE REGENTS as per Article
18 (ASSIGNABILITY).
THE
REGENTS and LICENSEE execute this Amendment, in duplicate originals, by their
respective officers who are duly authorized on the day and year that is
written.
7
XXXXXX LASER, INC. |
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA XXXXXXXX LIVERMORE NATIONAL
LABORATORY
|
||
By: | By: | ||
|
|
||
Title:
|
Title:
Director, IPAC
Date
Signed:
|
||
Date Signed:
|
8