EXHIBIT NO. 10.57
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
TRAINING & LICENSE AGREEMENT
This License Agreement (hereinafter referred to as the "Agreement"),
effective as of the 18th day of December, 2002 (hereinafter referred to as the
"Effective Date") is by and between Becton, Xxxxxxxxx and Company, having a
place of business at 0 Xxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxx 00000-0000 (hereinafter
referred to as "BD"), and Genaissance Pharmaceuticals, Inc. (GNSC), having a
place of business at Xxxx Xxxxxxx Xxxx, Xxx Xxxxx, XX 00000 (hereinafter
referred to as "GNSC").
WITNESSETH
WHEREAS, GNSC is interested in researching and developing certain
diagnostic technologies by utilizing BD's proprietary BDProbeTec(TM) ET platform
and BD's proprietary SDA Technology;
WHEREAS, BD is interested in entering into an agreement with GNSC to train
GNSC in the utilization of BD's proprietary BDProbeTec(TM) ET platform; and to
grant GNSC a non-exclusive license to BD's proprietary SDA technology and BD's
proprietary Intellectual Property necessary for operation of the BDProbeTec ET.
NOW, THEREFORE, in consideration of the premises and the mutual promises
and covenants herein contained, BD and GNSC agree as follows:
1. DEFINITIONS
a) "Licensed Patents" shall mean the U.S. patents and pending U.S. patent
applications listed in Appendix A to this Agreement, and any re-issues,
divisionals, continuations, re-examinations and foreign counter-parts
thereof.
b) "Licensed Know-How" shall mean BD's know-how related to Licensed Patents,
the BDProbeTec(TM) ET, and custom software for the BDProbeTec(TM) ET.
Licensed Know-How shall also include, upon written request from GNSC,
BD's know-how necessary in the design and development of assays that
utilize BDProbeTec(TM) ET. Licensed Know-How shall further include
methods to conduct research to design and develop assays for qualitative
detection of nucleic acids through SDA Technology and homogeneous nucleic
acid detection. Licensed Know-How shall additionally include any and all
information and discussions under Section 2.
c) "Licensed Products" shall mean any device, instrument, service, kit,
composition of matter, material, product or component thereof that
utilizes Licensed Know-How, or the making, using, selling or importing of
which would, in the absence of the license granted hereunder, infringe,
contribute to the infringement of, or induce the infringement of any
claim to a Licensed Patent. For purposes of this Agreement, the
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term "Licensed Product" shall include products listed in Appendix C to be
added thereto upon initiation of development of each product covered by
this Agreement.
d) "HAP(TM) Marker" shall mean a polymorphism or any ordered combination of
two or more polymorphisms present at a locus on a single chromosome [**].
e) "Predictive HAP(TM) Marker" shall mean a HAP(TM) Marker that is
associated with a clinical endpoint [**].
f) "HAP(TM) Partner(s)" shall mean a Third Party, other than a diagnostic
company, with whom GNSC agrees to provide genotype data or genetic
testing services tied to a specific product development program.
g) "BDProbeTec(TM) ET" shall mean the clinical platform for infectious
disease testing owned by BD using SDA Technology and real time detection
means.
h) "Strand Displacement Amplification Technology" or "SDA Technology" shall
mean an isothermal method of amplifying DNA using a restriction enzyme
with the capability to nick a recognition site and a polymerase to
initiate synthesis of a new strand of DNA and displace a strand of DNA
that has annealed to the target and which is described in further detail
in the patents set forth in Appendix A.
i) "Instrument" shall mean the BDProbeTec(TM) ET installed in GNSC's HAP(TM)
Typing facility in New Haven, CT.
j) "Net Sales" shall mean a Licensed Product which is sold, leased, put into
use or otherwise placed in commerce by GNSC. No deduction shall be made
for taxes, duties, levies and similar charges (and any related interest
and penalties), however designated, imposed as a result of the existence
or operation of this Agreement.
k) "Intellectual Property" shall mean any new patentable and unpatentable
inventions, discoveries, improvements, biological materials, software,
know-how, copyrightable material and any equivalents thereof.
l) "Confidential Information" shall mean any information which is deemed to
be proprietary and confidential to the Party which owns that information.
m) "Quarter" shall mean any period of three consecutive calendar months
beginning January 1, April 1, July 1, and October 1, occurring during the
term of this Agreement.
n) "Party" shall mean BD or GNSC.
o) "Third Party" shall mean any party other than BD or GNSC.
p) "Test" shall mean one or more HAP(TM) Marker(s) that collectively give a
phenotypic result.
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2. TRAINING OF GNSC
a) Within six (6) weeks of the Effective Date of this Agreement, BD shall
provide a training program to GNSC personnel for utilization of the
BDProbeTec(TM) ET and the Licensed Know-How and technology relating to
the Licensed Patents. The training shall involve direct contact between
BD and GNSC scientists to discuss the Licensed Know-How and technology
relating to the Licensed Patents. The BD and GNSC personnel shall
discuss, generally, methods of assay discovery and development. However,
the training shall not suggest specific areas of research. The training
plan is set forth in Appendix B.
b) GNSC hereby acknowledges and agrees that:
i) BD is a manufacturer of in-vitro diagnostic (IVD) devices and assays,
ii) BD is strictly prohibited from collaborating or participating in the
design and development of tests except in compliance with the
requirements of the Food and Drug Administration, and
iii) none of the assays discussed during the training may be used for
diagnostic purposes unless such assays are submitted to the FDA for
clearance or are otherwise in compliance with FDA requirements.
c) Following the training under this Section 2, GNSC shall have full
responsibility for its activities under this Agreement without any
further training assistance from BD.
3. TESTING OF BDPROBETEC(TM) ET BY GNSC
a) Within [**] of the Effective Date of this Agreement, BD shall install the
Instrument at GNSC's facility in New Haven, CT, [**]. This installation
shall include field service of the Instrument. The Instrument shall
remain the property of BD. An additional Instrument may also be
installed, [**] upon mutual written agreement between BD and GNSC.
b) Upon written request by GNSC, BD shall provide information on existing
software code and communication code to aid GNSC in their development of
external applications for processing and analysis of data from
BDProbeTec(TM) ET. Such information shall be treated as Confidential
Information as set forth in Section 9.
c) GNSC shall test the ability of the BDProbeTec(TM) ET to meet certain
performance requirements as defined by GNSC.
d) Within [**] of installation of the BDProbeTec(TM) ET, GNSC shall provide
BD with a written report detailing the test resultS, as well as any
suggestions for improving the operation or performance of the
BDProbeTec(TM) ET.
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e) If the test results meet GNSC's performance requirements, GNSC shall
adopt the BDProbeTec(TM) ET as a platform for the purpose of internal
research and development of assays and for commercialization consistent
with Section 4 of this Agreement.
f) If GNSC's test results do not meet its performance requirements, then
[**], shall either (i) [**] and GNSC shall repeat the test described in
this paragraph 3, or (ii) remove the Instrument from GNSC. If BD chooses
to remove Instrument, this Agreement shall terminate and GNSC may seek
other alternative technologies of its own choosing at its own cost and
GNSC shall return all reagents to BD.
g) BD shall provide, [**] to GNSC, reagents and supplies that are sold by BD
for GNSC's use with the BDProbeTec(TM) ET, [**] fOr GNSC to develop,
design, optimize and validate assays for internal research and
development purposes of GNSC or HAP(TM) Partners, [**]. GNSC shall
provide or obtain all other needed reagents and supplies [**].
h) BD shall also install at GNSC's facility in New Haven, CT updates to the
Instrument and associated software within [**] after they become
commercially available during the Term, [**].
4. LICENSE GRANT
a) BD hereby grants to GNSC a non-exclusive, fully paid-up, non-transferable
license, without the right to sublicense, to Licensed Patents and
Licensed Know-How to use the Instrument solely for the internal research
and development activities stated in Sections 2 and 3 above. This license
is limited to the territory of the United States of America. The fields
of [**] from this license.
b) BD hereby grants to GNSC a world-wide, non-exclusive, royalty-bearing,
non-transferable license, without the right to sublicense, to make, use,
sell, offer for sale and import Licensed Products for genotyping HAP(TM)
Markers in all fields [**]. Excluded from this grant is the right to
make, sell, offer for sale or import the BD ProbeTec(TM) ET.
c) GNSC shall restrict the knowledge and use of the the Licensed Know-How
granted under this Section 4 to only GNSC employees who are on a
need-to-know basis and such GNSC employees shall maintain the
confidentiality of the Licensed Know-How pursuant to Section 9.
5. INTELLECTUAL PROPERTY
a) BD shall own:
i) all BD Intellectual Property created before the Effective Date, and
ii) all Intellectual Property created pursuant to activities under this
Agreement that relates to Licensed Patents, Licensed Know-How, SDA
Technology or BD ProbeTec(TM) ET .
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b) GNSC shall own:
i) all GNSC Intellectual Property created before the Effective Date, and
ii) all Intellectual Property created pursuant to activities under this
Agreement that relates to HAP(TM) Markers and Predictive HAP(TM)
Markers including assays, subject to the terms of GNSC's agreements
with its HAP(TM) Partners.
c) Any Intellectual Property created under Sections 5.a.ii or 5.b.ii shall
be treated as Confidential Information by the non-owning party as set
forth in Section 9. Each party shall promptly give notice under Section
14 to the other party of any Intellectual Property subject to Sections
5.a.ii or 5.b.ii.
6. ROYALTIES
a) In consideration of the license granted hereunder, GNSC shall pay BD a
royalty rate of [**] ([**]%) percent on Net Sales of Licensed Products on
or subsequent to the Effective Date, [**].
7. REPORTS AND PAYMENTS
a) GNSC shall submit to BD within [**] days after the end of each Quarter
during the term of this Agreement, and upon the termination of this
Agreement, separate written reports for the preceding three month period
identifying Net Sales of Licensed Products, and the amount of royalty due
BD together with payment of such royalty amount or any other payments. If
no royalties or payments are due to BD for any reporting period, the
report shall so state.
b) All royalties or other payments due hereunder shall be payable in US
dollars. Any conversion to US dollars shall be converted monthly at the
prevailing rate as quoted in the Wall Street Journal for the last day of
each month.
c) GNSC shall keep full, clear and accurate records showing all sales of
Licensed Products and all Net Sales of Licensed Products. GNSC shall
retain such records for at least seven (7) years from the date Net Sales
occurred. BD shall have the right, through independent certified public
accountants acceptable to GNSC, to make an examination, during normal
business hours, of all records and accounts bearing upon the amount of
royalty payable to BD hereunder. In the event such examination shows any
underreporting or underpayment by GNSC in excess of [**] ([**]%) for any
reporting period, then GNSC shall pay the cost of such examination, the
amount of any underpaid royalty as well as late payment charges.
d) Late payments hereunder shall be subject to a late payment charge
calculated at an annual rate of [**] percent ([**]%) over the prime rate
as quoted in the Wall Street Journal on the day payment was due. If the
amount of such charge exceeds the maximum permitted by law, such charge
shall be reduced to such maximum.
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8. CONFIDENTIALITY
a) Each party, using the same degree of care used by it to protect its own
Confidential Information of like character, shall, during the term of
this Agreement and for a period of five (5) years thereafter, keep
confidential and not use or disclose, except for the purposes of this
Agreement, any information relating to the subject matter of this
Agreement marked conspicuously as "CONFIDENTIAL" at the time of receipt
from the provider or, if transmitted orally or visually by the provider,
reduced to writing, marked confidential and provided to recipient within
thirty (30) days of said oral or visual transfer.
b) The foregoing obligations of confidentiality shall not apply to any
information which:
i) Was in the recipients possession prior to acquisition from the
provider; or
ii) Subsequent to receipt by the recipient, is independently developed by
an employee or agent of recipient who did not have access to such
information; or
iii) Is lawfully obtained after the date of this Agreement by the recipient
from a source other than the provider; or
iv) Is generally available to the public or which becomes generally
lawfully available to the public through sources other than the
recipient; or
v) Is approved for release by written authorization of the provider.
c) The terms, but not the existence, of this Agreement shall be treated as
Confidential Information by the parties, and neither party shall disclose
the terms or conditions of this Agreement to any third party without the
prior written permission of the other party. Each party, however, shall
have the right to make disclosures to the extent required by an order of
court, regulation of another governmental body, or otherwise by law or by
a stock exchange, provided that the party shall promptly provide written
notice to the non-disclosing party of the intended disclosure and of the
court order or regulation prior to such disclosure and that the party
takes all reasonable steps to minimize such disclosure by, for example,
obtaining a protective order and/or appropriate confidentiality
provisions requiring that such information to be disclosed be used only
for the purpose for which such law, order, regulation or requirement was
issued. Additionally, each party may disclose this Agreement or its
contents to the extent reasonably necessary, under a suitable
confidentiality agreement, to its accountants, attorneys and financial
advisors.
9. TRANSFERABILITY OF RIGHTS AND OBLIGATIONS
a) This Agreement and the license granted under it may not be assigned,
transferred or sold by GNSC.
b) BD may freely assign this Agreement in whole or in any part.
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10. DURATION AND TERMINATION
a) The term of this Agreement shall be for two years from the Effective
Date, unless events occur as set forth in Section 3(f)(ii). This
Agreement shall automatically renew on an annual basis provided that GNSC
has Net Sales and has paid to BD royalties due on Net Sales in the
preceding year.
b) BD may terminate this Agreement in the event of a material breach of an
obligation under this Agreement and GNSC's failure to remedy such breach
fourteen (14) days after having received notice of such breach.
c) In the event that GNSC shall be adjudicated bankrupt, go into
liquidation, receivership or trusteeship, make an assignment for the
benefit of its creditors or enter into any similar proceeding of the same
nature, then BD shall have the right without liability therefore to
terminate this Agreement forthwith by notice in writing to GNSC. Nothing
herein shall limit any other remedies to which BD may be entitled to
under law or equity.
11. DISCLAIMER AND HOLD HARMLESS
a) GNSC agrees to hold BD harmless against judgments, fees, expenses, or
other costs arising from or incidental to any liability or lawsuit
brought as a consequence of GNSC's activities under this Agreement,
whether or not GNSC or any one or more of the employees or agents of GNSC
is named as a party defendant in any such lawsuit.
b) GNSC expressly indemnifies and holds BD, its affiliates, successors and
assigns and its officers, directors and employees harmless from and
against any and all claims, liabilities, damages, costs, expenses, and/or
actions of any kind whatsoever which arise from or are connected with
GNSC's activities under this Agreement.
c) BD makes no representations or warranties of any kind as to the
merchantability, non-infringement, suitability or safety of Instrument,
SDA Technology, Licensed Patents, Licensed Know-How or the training
provided under this Agreement. GNSC shall conduct its own analyses and
train its own personnel. BD does not confer any right by implication,
estoppel or otherwise, other than the licenses and rights expressly
granted herein.
12. NOTICES
a) Any notice or other communication required or permitted by this AGREEMENT
shall be deemed to have been validly delivered on the date mailed if the
same shall be mailed by registered or certified mail, postage prepaid,
return receipt requested, or faxed with confirmation, addressed as
follows:
i) To BD:
Becton, Xxxxxxxxx and Company
0 Xxxxxxx Xxxxxx
0
Xxxxxx, XX 00000-0000
Attention: Vice President, Business Development
Fax No.: (000) 000-0000
With copy to:
Becton, Xxxxxxxxx and Company
0 Xxxxxx Xxxxx, XX000
Xxxxxxxx Xxxxx, XX 00000-0000
Attention: Vice President and Chief Intellectual Property Counsel
Fax No.: (000) 000-0000
ii) To GNSC:
Attention:
13. GOVERNING LAW
a) This Agreement shall be construed, interpreted and applied in accordance
with and governed by the laws of the state of New Jersey, United States
of America and the parties hereby submit to the jurisdiction of the
courts of that state.
14. SEVERABILITY
a) Should any part or provision of this Agreement be held unenforceable or
in conflict with the law of any jurisdiction, the validity of the
remaining part or provisions shall not be affected by such holdings.
15. INFRINGEMENT
a) GNSC shall promptly notify BD in writing if GNSC becomes aware of any
infringement or suspected infringement of any Licensed Patent.
16. MEDIATION OF DISPUTES
a) Either party may give the other party written notice of any dispute
hereunder not resolved in the normal course of business. If the matter
has not been resolved within sixty (60) days following such notice, or if
the parties fail to discuss or meet within twenty-one (21) days following
such notice, either party may, but shall not be obligated to, initiate
mediation of the controversy or claim under the then current Center for
Public Resources Procedure for Mediation of Business Disputes. Once
mediation is initiated by one party, the other party agrees to
participate in and conduct the mediation procedures in good faith.
If a negotiator intends to be accompanied at a telephone conference or a
meeting by an attorney, the negotiator for the other party shall be given
at least three (3) days notice of such intention and may also be
accompanied by an attorney. All negotiations pursuant to this Section are
confidential and shall be treated as compromise and settlement
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negotiations for the purposes of the Federal Rule of Evidence and any
state rules of evidence.
17. MISCELLANEOUS
a) Nothing herein contained shall be construed to place the parties in the
relationship of partners or joint venturers or principal and agent or
create any entity or association, and neither party shall have the power
to obligate or bind the other in any manner whatsoever.
b) Neither party shall use the name of the other or any adaptation thereof
in any advertising, promotion, sales literature or packaging in a manner
which would constitute an expressed or implied endorsement for any
commercial product without prior express written consent.
c) Nothing herein contained, whether express or implied, shall be construed
to grant to GNSC any license or rights in any other of BD's Intellectual
Property.
d) Neither GNSC nor BD shall be responsible for and the terms of this
Agreement shall be inapplicable to any default or delays which are due to
cause beyond GNSC'S or BD's control, including but without limitation
acts of God or of the public enemy, acts or any order of a government,
fires, floods, or other natural disasters, embargoes, accidents,
explosions, strikes, or other labor disturbances (regardless of the
reasonableness of the demands of labor), shortages of fuel, power or raw
materials, inability to obtain or delays of transportation facilities,
incidents of war, or other events causing the inability of GNSC or BD,
acting in good faith with due diligence, to perform its obligations under
this Agreement.
e) This Agreement constitutes the entire agreement between the parties
hereto with respect to the subject matter hereof, and no modification of
this Agreement shall be effective unless it is in writing and is signed
by a duly authorized representative of each party. There are no
understandings, representations or warranties except as herein expressly
set forth.
f) The failure or delay of a party hereto to enforce any of its rights under
this Agreement shall not be deemed to be a continuing waiver or a
modification by such party of any of its rights under this Agreement, and
a party may, within the time provided by the applicable law, commence
appropriate legal proceedings to enforce any or all of its rights under
this Agreement. Any failure to enforce or delay in enforcement shall not
constitute a defense.
g) Neither party shall originate any publicity, news release or public
announcement, written or oral, whether to the public, press or otherwise,
relating to this Agreement, to any amendment hereto or performance
hereunder, without approval of the other party which approval shall not
be unreasonably withheld, save only such announcement as in the advice of
counsel to the party making such announcement is required by law to be
made. In the event GNSC is required by law to disclose this Agreement,
GNSC shall notify BD in writing within thirty (30) days before making
such disclosure and GNSC
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shall make every reasonable effort to only disclose a redacted version of
the Agreement that is approved in writing by BD.
h) BD and GNSC agree to negotiate in good faith to enter into a supply and
manufacturing arrangement in which BD would provide to GNSC any general
purpose reagents and analyte specific reagents for the BDProbeTec(TM) ET,
and in which BD would provide primers, probes and other reagents for
assay development, as designed and specified by GNSC.
i) If GNSC moves forward with a development project for development of a
test kit which is a Licensed Product, for which FDA clearance or approval
is required, GNSC agrees to extend to BD the option of working with GNSC
on that development project. BD must indicate its acceptance of this
option in writing to GNSC.
j) GNSC and BD agree to abide by any and all rules, regulations or laws
relating to its activities under this Agreement, including, for example,
the Clinical Laboratory Improvement Amendments of 1988 and the laws
administered by FDA with regard to the sale of medical devices.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed in duplicate originals as of the date first hereinabove written.
Becton, Xxxxxxxxx and Company Genaissance Pharmaceuticals, Inc.
By: /s/ L. E. Warfell By: /s/ K. Nandabalan
-------------------------------- ------------------------------
Name: Xxxxx X. Xxxxxx Name: Xxxxxxxx Xxxxxxxxxx
------------------------------- -----------------------------
Title: VP, Business Development Title: VP, Business Development
------------------------------ ----------------------------
Date: 12/18/02 Date: 12/20/02
------------------------------- -----------------------------
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APPENDIX A: LICENSED PATENTS
1. US Patent No. 5,270,184, entitled "Nucleic Acid Target Generation"
2. US Patent No. 5,422,252, entitled "Simultaneous Amplification of Multiple
Targets"
3. US Patent No. 5,455,166, entitled "Strand Displacement Amplification"
4. US Patent No. 5,536,649, entitled "Decontamination of Nucleic Acid
Amplification Reactions"
5. US Patent No. 5,547,861, entitled "Detection of nucleic acid
amplification"
6. US Patent No. 5,648,211, entitled "Strand Displacement Amplifcation Using
Thermophilic Enzymes"
7. US Patent No. 5,624,825, entitled "Simultaneous Amplification of Multiple
Targets"
8. US Patent No. 5,691,145, entitled "Detection of nucleic acids using
G-quartets"
9. US Patent No. 5,712,124, entitled "Strand Displacement Amplification"
10. US Patent No. 5,736,365 entitled "Multiplex nucleic acid amplification"
11. US Patent No. 5,744,311 entitled "Strand displacement amplification using
thermophilic enzymes"
12. US Patent No. 5,840,487, entitled "Internal controls for isothermal
nucleic acid amplification reactions"
13. US Patent No. 5,863,736, entitled "Method, apparatus and computer program
products for determining quantities of nucleic acid sequences in samples"
14. US Patent No. 5,888,739, entitled "Detection of nucleic acids using
G-quartets and I-tetraplexes"
15. US Patent No. 5,916,779, entitled "Strand displacement amplification of
RNA targets"
16. US Patent No. 5,919,630, entitled "Detection of nucleic acids by
fluorescence quenching"
17. US Patent No. 5,928,869, entitled "Detection of nucleic acids by
fluorescence quenching"
18. US Patent No. 5,935,791, entitled "Detection of nucleic acids by
fluorescence quenching"
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19. US Patent No. 5,958,700, entitled "Detection of nucleic acids by
fluorescence quenching"
20. US Patent No. 6,043,880, entitled "Automated optical reader for nucleic
acid assays"
21. US Patent No. 6,054,279, entitled "Detection of nucleic acids by
fluorescence quenching"
22. US Patent No. 6,066,458, entitled "Methods, apparatus and computer
program products for determining quantities of nucleic acid sequences in
samples using standard curves and amplification ratio estimates"
23. US Patent No. 6,132,684, entitled "Sample tube holder"
24. US Patent No. 6,216,049, entitled "Computerized method and apparatus for
analyzing nucleic acid assay readings"
25. US Patent No. 6,258,546, entitled "Detection of nucleic acid
amplification"
26. US Patent No. 6,261,784, entitled "Detection of nucleic acids by strand
displacement"
27. US Patent No. 6,316,200, entitled "Probes and methods for detection of
nucleic acids"
28. US Patent No. 6,379,888, entitled "Universal probes and methods for
detection of nucleic acids"
29. US Patent Application Serial Number [**]
30. US Patent Application Serial Number [**]
31. US Patent Application Serial Number [**]
32. US Patent Application Serial Number [**]
33. US Patent Application Serial Number [**]
34. US Patent Application Serial Number [**]
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APPENDIX B
PROPOSED BDX TRAINING PROGRAM FOR GNSC PERSONNEL AND PRODUCT INFORMATION
A. Routine training for new BDProbeTec(TM)ET system users through Technical
ServiceS
** CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION**
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APPPENDIX C: PRODUCTS
[To Be Added]
