Exhibit 10.6
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
COLLABORATION AGREEMENT
BETWEEN
LIPOMED INC. OF RALEIGH, NC ("LIPOMED")
AND
BRUKER INSTRUMENTS, INC. OF BILLERICA, MA ("BRUKER")
LipoMed and Bruker wish to collaborate on the adaptation, further development
and deployment of Bruker's INCA(TM) (Integrated NMR Clinical Analyzer) for
LipoMed's NMR LipoProfile(R) clinical laboratory test for blood lipoprotein
levels.
As part of this Collaboration Agreement ("Agreement"), Bruker and LipoMed agree
as follows:
1. A previously executed Confidential Disclosure Agreement, dated September
14, 1998, shall be extended for the duration of the Agreement.
2. LipoMed, including any subsidiaries or licensees of LipoMed, shall commit
to the purchase of at least [**] INCA 400 MHz systems within [**] of the
execution date of the Agreement. The systems will include Phase 1
technology, described below, and will optionally be equipped with Phase 2
technology should LipoMed so decide. Timing of the ordering and delivery of
individual INCA units will be linked to development milestones as specified
in Appendix A such that any delay in meeting or failure to meet such
milestones shall correspondingly extend the [**] for purchase of the
requisite INCA systems.
3. Bruker shall be responsible for the adaptation and further development of
its present INCA system to meet LipoMed's specifications. Bruker will not
charge LipoMed any development costs associated with these adaptations and
further developments, unless specifically stated below. LipoMed will assist
Bruker with the design and testing of the Phase 1 and Phase 2 technologies.
However, Bruker retains all commercial and patent rights (if any) for these
developments subject to any commercial and patent rights held or applied
for by LipoMed with respect to its NMR LipoProfile technology or otherwise
directly related to LipoMed's proprietary methods or technologies.
4. LipoMed and Bruker shall establish a Joint Development Team to formulate
specifics of the development plan, including, but not limited to, project
goals, specifications, milestones and testing. This Joint Development Team
will consist of Drs. ▇▇▇▇▇ ▇▇▇▇▇ and ▇▇▇▇▇ ▇▇▇▇▇▇ (LipoMed), ▇▇▇▇▇▇ ▇▇▇▇
(Bruker Project Manager for INCA), and ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (Bruker NMR Head of
R&D). As needed, other individuals may be added to address specific project
planning and execution issues.
5. LipoMed is aware that the INCA is not cleared by the U.S. FDA. LipoMed
accepts all responsibility and costs associated with obtaining FDA (or an
equivalent international organization's) clearance or adherence to its
regulations. Bruker will make available any documentation needed to pursue
this matter. It will be Bruker's responsibility to ensure that its
equipment adheres to common international safety and quality standards as
they relate to scientific equipment (Bruker is ISO 9001 certified and it's
equipment meets CE standards. Bruker will promptly notify LipoMed if
Bruker's ISO status changes or if its equipment fails to meet such CE
standards).
6. The INCA system is a fully functional NMR system and consists of the
following subunits:
. INCA protective enclosure containing all subunits.
. New UltraShield II(TM) 400 MHz 54 mm magnet with lifting mechanism for
service
. New, space-saving AVANCE 400 console [**].
. Shims, preamplifiers, [**] probe with automatic tuning capability.
. Pentium PC computer (complete) with NT operating system, [**], flat panel
external LCD Touchscreen monitor and a Touchscreen NMR Interface.
. Unit 1 will be delivered with the NMR Case(TM) sample changer with new
PLC controls.
7. Bruker shall develop in Phase 1:
. A high capacity (More than [**] samples) automated sample delivery system
capable of generating NMR LipoProfile data on plasma samples Less than or
equal to [**] ml at a rate of [**] sample/[**].
. A new sample container format suitable for high through-put operation
(container material, dimensions, and cost to be finalized during
Collaboration).
. A means of [**] samples to the [**] prior to [**] the [**] for analysis.
. A modified [**] NMR probe with [**] and [**] suitable for non-spinning
new-format samples.
. A modified INCA-GUI for executing automated NMR LipoProfile blood plasma
testing, tailored for use by clinical laboratory technicians. The
detailed specifications for this GUI will be defined by the Joint
Development Team, with detailed input from LipoMed. Note: If LipoMed
requires GUI software capabilities beyond those specified in advance by
the Joint Development Team, it may develop these in-house at its own
expense. Bruker will assist in this effort by making available to LipoMed
on a confidential basis whatever documentation and source code is needed.
Alternatively, LipoMed can contract with Bruker for additional software
development services at a discounted professional services rate of $1,000
per day, or $150 per hour, not including travel and additional expenses.
Bruker and LipoMed agree that during the Phase 1 development effort the
present technical concepts could be modified substantially in order to
achieve the sample throughput, data quality and reliability required for
LipoMed's use of INCA. Since Bruker is not equipped to handle hazardous
biological materials (ie., blood plasma), all plasma testing will be
conducted at LipoMed on a prototype INCA system. Testing at Bruker shall
be restricted to suitable non-hazardous samples to be supplied by
LipoMed. Once Phase 1 is successfully completed, development of Phase 2
will begin.
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8. In the optional Phase 2, Bruker shall develop the following adaptations:
. A mechanism of transporting samples, or sample racks, to the rapid sample
changer to enable unattended analysis of at least 300 samples, either by
means of a new automated sample tray changer (ASTC) or any other method
deemed suitable by the Joint Development Team.
. A modified GUI for executing automated NMR LipoProfile blood plasma
testing on batches of at least 300 samples, tailored for use by clinical
laboratory technicians. The detailed specifications for this GUI will be
defined by the Joint Development Team, with detailed input from LipoMed.
Note: If LipoMed requires GUI software capabilities beyond those
specified in advance by the Joint Development Team, it may develop these
in-house at its own expense. Bruker will assist in this effort by making
available to LipoMed on a confidential basis whatever documentation and
source code is needed. Alternatively, LipoMed can contract with Bruker
for additional software development services at a discounted professional
services rate of $1,000 per day, or $150 per hour, not including travel
and additional expenses.
Phase 2 will begin after Phase 1 is finished, and will take approximately
twelve months.
9. It is agreed that sample collection, storage, preparation, and transfer to
the NMR measurement container, sample (or sample tray) labeling for
unambiguous identification, sample positioning in the NMR sample tray,
sample disposal after measurement, and commercial aspects of testing (e.g.
patient info, billing, etc.), as well as all consumables are the sole
responsibility of LipoMed, and are not included in the Collaboration
Agreement.
10. The price for each of the first [**] INCA systems sold to LipoMed,
including items developed or adapted in Phase 1, plus installation,
training, and a one-year warranty is $[**]. Accessory items developed or
adapted in Phase 2 are priced at $[**] for each INCA system, including
installation and a one-year warranty. Payment terms for the first [**]
systems are outlined in Appendix A.
11. The price for additional INCA systems (which include Phase 1 accessories)
beyond the first [**] sold to LipoMed shall be negotiated, but will not
exceed $[**] each. The price for the Phase 2 accessories shall not exceed
$[**].
12. In consideration for LipoMed's commitment to purchase [**] INCA systems in
accordance with paragraph 2 of this Agreement, Bruker will not knowingly
sell or utilize its INCA systems (or Phase 1 or Phase 2 accessories) for
commercial use in lipoprotein and subclass analysis in the fields of
cardiovascular disease and diabetes (the "Restricted Field") during such
initial 36-month period. Bruker further agrees that for a period of seven
years following such initial three-year period, it will not knowingly sell
or utilize its INCA system for commercial use in the Restricted Field
provided that LipoMed, including its subsidiaries, affiliates or licenses,
purchases at least [**] additional INCA systems each year.
13. The parties agree that upon development of the sample containers to be used
with the rapid sample changer and agreement on the container
specifications, they will negotiate in good
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faith a supplier agreement between LipoMed and Bruker for such sample
containers. Provided, however, that LipoMed agrees not to reverse
engineer Bruker proprietary sample formats which Bruker NMR develops for
the INCA or other high-throughput NMR systems.
14. INSTALLATION, WARRANTY AND SERVICE
Bruker NMR remains responsible for installation, warranty service and
post-warranty service of all INCA systems. The purchase of each INCA
system includes one installation and demonstration of specifications by
Bruker NMR free-of-charge. The cost of customer site preparation
according to Bruker's site planning guide, or rigging and transportation
of the system into the LipoMed or customer lab, and consumables required
for the installation are not included in the Bruker NMR OEM price.
Additional installations, if any, will be billed by Bruker NMR to LipoMed
at normal posted service rates. Each system price includes a one-year
limited warranty under Bruker's standard warranty terms. The period of
warranty is one year following demonstration of specifications, but in
any event not more than 15 months after delivery. Warranty covers both
parts and labor. For those items supplied but not manufactured by Bruker,
the warranty terms of the manufacturer will be transferred to the buyer.
After the expiration of the one-year limited warranty LipoMed, or the
final customer, may purchase additional annual Maintenance Service
Agreements (MSA) or per-call service from the Bruker service organization
in each country at normal MSA or per-call service rates, posted in each
country from time to time. If a customer requires additional response
time guarantees, or 24/7 coverage, then Bruker's standard surcharges to
the normal MSA rates will apply.
LipoMed will remain responsible for service issues not related to the
automated NMR data acquisition, such as sample preparation and handling,
administration, patient billing and data tracking.
15. GENERAL TERMS AND CONDITIONS
15.1. LipoMed and Bruker will jointly and by mutual agreement develop and
release a press release and other related statements, explaining the
benefits of this Agreement to future customers.
15.2. Neither party acquires any intellectual property rights under this
Agreement except the limited rights necessary to carry out the purposes
set forth in paragraph 12.
15.3. Both parties shall adhere to all applicable laws, regulations and rules
relating to the export of technical data and equipment. LipoMed shall
not export or re-export any Bruker product or technical data to any
proscribed country listed in such applicable laws, regulations and
rules unless properly authorized. Bruker shall be solely responsible
for compliance with all applicable laws, regulations and rules relating
to the import of equipment, parts or technology for the INCA systems.
15.4 This Agreement does not create any agency or partnership relationship.
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15.5. All additions or modifications to this Agreement must be made in
writing and must be signed by both parties.
15.6. Drafts to this agreement were exchanged and drafted by both parties
hereto, and accordingly this Agreement shall be considered jointly
drafted.
15.7 This Agreement is made under, and shall be construed according to, the
laws of the Commonwealth of Massachusetts.
For LipoMed: For Bruker:
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
----------------------------------- -----------------------------------
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Ph.D.
CEO, Lipomed, Inc. President, Bruker Instruments, Inc.
Date: 3/2/00
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APPENDIX A
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Approximate Development Order/Delivery Payment
Date Milestones Schedule Schedule
-----------------------------------------------------------------------------------------------
[**] Commence Phase 1 planning [**] $[**] ([**]%)
Make [**] decision
Make [**] decision
[**] [**] and [**] at LM $[**] ([**]%)
Determine [**] via plasma
[**] at LM
Demonstrate Phase 1 [**] at
Bruker
Develop and test [**]
[**] [**] Phase 1 [**] $[**] ([**]%)
[**] Phase 1 [**] at LM
[**] software at LM
[**] [**] Phase 1 [**] and [**] $[**] ([**]%)
[**] Begin Phase 2 development [**] $[**] ([**]%)
[**] [**] and [**] [**] with $[**] ([**]%)
Phase 1 [**]
-----------------------------------------------------------------------------------------------
Approximate Development Order/Delivery Payment
Date Milestones Schedule Schedule
-----------------------------------------------------------------------------------------------
[**] [**] $[**] ([**]%)
[**] [**] $[**] ([**]%)
Demonstrate Phase 2 [**] at
Bruker
[**] Phase 2 [**] for [**] $[**]([**]%)
[**] [**] and [**] [**] with $[**]([**]%)
Phase 1 [**]
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[**] [**] $[**]([**]%)
[**] [**] Phase 2 [**] on [**] $[**]([**]%)[**]
[**] [**] of Phase 2 [**] on [**] $[**]([**]%)
[**] [**] with Phase 1 & 2 [**] $[**]([**]%)
[**] [**] and [**] $[**]([**]%)
[**] [**] $[**]([**]%)
[**] [**] with Phase 1 & 2 [**] $[**]([**]%)
[**] [**] and [**] $[**]([**]%)
[**] [**] of [**] $[**]([**]%)
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