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AMENDED AND RESTATED DEVELOPMENT AND LICENSE AGREEMENT
THIS AGREEMENT is entered into and made effective as of the 13th day of
July, 1999, by and between ROCHE DIAGNOSTICS CORPORATION, an Indiana corporation
having a principal place of business at 0000 Xxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxx
00000 ("Roche Diagnostics"); and SPECTRX, INC., a Delaware corporation having a
principal place of business at 0000X Xxxxx Xxxxx, Xxxxxxxx, Xxxxxxx 00000
("SpectRx").
WITNESSETH:
WHEREAS, SpectRx and Boehringer Mannheim Corporation, n/k/a Roche
Diagnostics Corporation, entered into a Development and License Agreement dated
December 2, 1994 (the "1994 Development Agreement") for the purpose of
developing a non-invasive diabetes screening instrument as originally envisioned
by such parties;
WHEREAS, the parties wish to amend and restate the 1994 Development
Agreement in respect of the non-invasive diabetes screening instrument developed
to date (the "Device"), which amended and restated agreement will supersede the
1994 Development Agreement;
WHEREAS, certain know-how relating to a method and apparatus using
noninvasive instrumentation to measure molecular changes in human lenses for the
purpose of detecting diabetes is owned by Georgia Tech Research Corporation
("GTRC") and licensed exclusively to SpectRx pursuant to a License Agreement
dated as of May 7, 1991, between GTRC and Laser Atlanta Optics, Inc., which was
assigned to SpectRx on January 16, 1993, and amended on October 19, 1993 (the
"GTRC License");
WHEREAS, SpectRx has applied its know-how ("Know-How") to develop a
device to detect diabetes in humans and has built prototype devices and has
conducted clinical trials of such devices;
WHEREAS, Roche Diagnostics is in the medical diagnostics business and
has experience and expertise in the marketing of medical diagnostics products,
and desires to assist SpectRx in completion of the funding of the development of
the Device to the extent indicated herein and obtain worldwide exclusive
marketing rights to same;
NOW THEREFORE, in consideration of the premises and mutual agreements
expressed herein, the parties agree as follows:
1.0 DEFINITIONS
1.1 "Affiliate" shall mean, with respect to either party, any corporation,
partnership or other business entity that now or in the future
controls, is controlled by, or is under common control with, such
party. "Control" shall mean the direct or indirect ownership of fifty
percent (50%) or more of the
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voting interest in, or a fifty percent (50%) or more interest in the
income of, such corporation or other business entity, or such other
relationship as, in fact, constitutes actual control. Not withstanding
the foregoing, Genentech, Inc., shall not be deemed an Affiliate of
Roche Diagnostics.
1.2 "Device" means any non-invasive instrument and improvements thereto
developed by, for or with SpectRx that uses the Know How that measures
changes in human lenses or other structures of the human eye for the
qualitative detection of diabetes for screening purposes or for any
other application related to diabetes.
1.3 "Field" shall mean applications involving the non-invasive
determination of information about diabetes from the eye, including
diabetes screening, determining the duration of diabetes in a patient
and for any other applications related to diabetes.
1.4 "Know-How" shall mean technical information known to SpectRx related to
making and using the Device and also any and all intellectual property
owned or controlled by SpectRx that, in the absence of the licenses
contained herein would be infringed by the making, selling or using of
the Device. Know-How includes, without limitation, trade secrets and
Confidential Information of SpectRx; the design of the Device; any
applicable copyrights in documentation; information, including without
limitation non-public information licensed to SpectRx under the GTRC
License; US Patent 5,582,168 and US Patent 5,203,328 (the "Screening
Patents"); the US Patent Application internally referred to at SpectRx
as SPRX017 (the "Duration Patent Application"); any continuations,
continuations-in-part, divisionals and reissues of such patents and
patent application; and any foreign counterparts of such patents and
patent application.
1.5 "Product Launch" shall mean the earlier of:
(i) the date upon which Roche Diagnostics has received
delivery of a total of two hundred and fifty (250)
Devices purchased pursuant to the Supply Agreement
and FDA Regulatory Clearance for US sales has been
issued (or an FDA panel has reviewed the Device
application and given a favorable indication of
approval and both parties agree that such FDA
Regulatory Clearance is imminent), or
(ii) the date that is 18 months from the Agreement date,
if Roche Diagnostics is not using best efforts to
diligently pursuing FDA Clearance by pursuing all
recommendations requested by the FDA for the
submission including but not limited to completing
all clinical studies and data analysis, and preparing
all requested information for submittal to the FDA.
1.6 "Supply Agreement" shall mean that certain amended and restated supply
agreement for the purchase and sale of Devices of even date herewith
between SpectRx and Roche Diagnostics, as amended or supplemented by
agreement of the parties from time to time.
2.0 TERMINATION OF 1994 DEVELOPMENT AGREEMENT
The parties hereto agree that the 1994 Development Agreement is hereby
superseded in its entirety, and of no further force or effect,
including without
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limitation, any terms thereof that are stated to, or would otherwise,
survive a termination or expiration of such agreement, and that no
party has any remaining rights or obligations thereunder.
3.0 RIGHTS GRANTED BY SPECTRX AND ROYALTIES
3.1 In consideration of the payments set out in Section 4.1, below, and
Sections 4.1 and 4.2 of the Supply Agreement, and coming into effect
only after full payment thereof (the "License Effective Date") by Roche
Diagnostics to SpectRx, SpectRx hereby grants to Roche Diagnostics,
subject only to the terms and conditions set forth herein, a worldwide,
exclusive license in the Field to sell and market the Device (the
"Marketing License"). SpectRx may not, except as provided for in this
Agreement, sell, market or distribute, or give any third party rights
to sell, market or distribute any non invasive instrument developed by,
for or with SpectRx that competes with the Device in the Field.
3.2 The Marketing License shall remain exclusive (as provided for in
Section 3.1 hereof) for so long as Roche Diagnostics meets the minimum
volume requirements set forth on Exhibit B (or, in the event Roche
Diagnostics acquires the Manufacturing License (described below), the
Manufacturing License and the Marketing License shall remain exclusive
for so long as Roche Diagnostics meets the minimum royalty requirements
set forth on Exhibit B) and for so long as Roche Diagnostics does not
distribute an instrument that competes with the Device in the Field.
Should such minimum volumes not be met (or, in the event Roche
Diagnostics has acquired the Manufacturing License, should such minimum
royalties not be maintained), or should Roche Diagnostics distribute an
instrument that competes with the Device in the Field, the Marketing
License (and, in the event Roche Diagnostics has acquired the
Manufacturing License, the Marketing License and Manufacturing License)
shall become non-exclusive and shall be further limited to a license to
market and sell on a non-exclusive basis the Device into the managed
care, corporate account and government markets, and not permit Roche
Diagnostics to market or sell the Device into any and all other
markets, including, for example, the eyecare market. In such event,
Roche Diagnostics agrees to cooperate with SpectRx in enabling SpectRx
to obtain any government approvals or applications for approval
necessary for SpectRx to sell the Device in such countries where Roche
Diagnostics has sold or planned to sell the Device prior to the date
the Marketing License becomes non-exclusive.
3.3 While the Marketing License is in effect, and during the term of the
Supply Agreement, should Roche Diagnostics elect as it may do so under
certain conditions pursuant to the terms and conditions of the Supply
Agreement, to itself manufacture or otherwise provide for the
manufacture of the Device, a further license shall be deemed issued in
respect of the manufacture of the Device (the "Manufacturing License").
The Manufacturing License shall constitute the right to manufacture or
have manufactured the Device, in accordance with the specifications
therefor and such other modifications as the parties may have agreed
upon, on a worldwide and exclusive basis. The Manufacturing License
will issue, and be deemed in place and effective, upon the
determination by Roche Diagnostics to manufacture the Device, upon and
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after the termination of the Supply Agreement by notice by Roche
Diagnostics in accordance with its terms and the payment to SpectRx of
all sums payable thereunder. The term of the Manufacturing License,
unless sooner terminated pursuant to the terms and conditions hereof,
shall be coincident with the term of the Marketing License.
3.4 Neither the Marketing License nor the Manufacturing License, nor any
rights thereunder, may be assigned or sublicensed by Roche Diagnostics
to any person (other than an Affiliate of Roche Diagnostics) without
the express prior written consent of SpectRx, which may not be
unreasonably withheld.
3.5 No royalty will be due or payable in respect of the Marketing License.
During the term of the Manufacturing License, Roche Diagnostics shall
pay to SpectRx, on a quarterly basis, on or before the sixtieth (60th)
day following the end of each calendar quarter, royalties equal to
[ * ] of the total consideration paid or payable to Roche Diagnostics
upon the sale of all Devices (or other value received therefor in
respect of the use of the Device), provided such sale is made on an
arms-length basis to a purchaser unaffiliated to Roche Diagnostics. In
addition, during the term of the Manufacturing License Roche
Diagnostics agrees to pay to GTRC any royalties attributable to the
manufacture and sale of the Device under the GTRC License. If a Device
is sold or given to a purchaser on a non-arms-length basis, including
without limitation a fee per test or other similar arrangement, or if
the Device is provided to a purchaser as an accommodation, the
royalties shall be equal to [ * ] of the fair salable value of such
Devices. If the parties hereto cannot agree as to the fair salable
value of any Devices so sold, the issue shall be settled by dispute
resolution pursuant to Section 10.6 hereof. A Device shall be
considered sold for purposes of this Agreement when it is billed out
to a third party, or when not billed out, when it is delivered,
otherwise conveyed or paid for, whichever occurs first. It is intended
that the foregoing royalty shall be paid in respect of and computed on
the basis of the sales price to parties who are not Affiliates of
Roche Diagnostics, and that inter-company transfers shall not be
considered as sales. Contemporaneously with each royalty payment,
Roche Diagnostics shall furnish to SpectRx a complete statement
certified to be accurate by Roche Diagnostics, showing the number,
country in which manufactured, country in which sold to or to which
shipped and description and sales price in respect of each Device sold
during the preceding calendar quarter. Such a statement shall be
furnished to SpectRx whether or not any Devices have been sold during
the calendar quarter to which such statement refers. The books and
records of Roche Diagnostics relating to such royalty payments shall
be open during business hours for reasonable inspection by a certified
public accountant appointed by SpectRx and reasonably acceptable to
Roche Diagnostics to determine the accuracy of such royalty statements
and payments, but for no other purpose. If such audit reveals that the
royalties reported by Roche Diagnostics are understated by ten percent
(10%) or greater, Roche Diagnostics shall pay for the full cost of the
audit; otherwise, SpectRx shall pay for the audit. In any event, any
underpayment of royalties revealed by such audit shall be promptly
corrected by Roche
(*) Confidential treatment requested pursuant to a request for
confidential treatment filed with the Securities and Exchange
Commission. Omitted portions have been filed separately with the
Commission.
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Diagnostics, and any overpayment shall be creditable against future
royalties. Roche Diagnostics shall keep, maintain and preserve, during
the term of the Manufacturing License and for at least two (2) years
following the termination or expiration of such license, complete and
accurate records of account in respect thereof, including, without
limitation, invoices, correspondence and other records. Roche
Diagnostics shall require its Affiliates and other sublicensees to
maintain similar records necessary for the accurate computation and
payment of the royalties payable hereunder.
3.6 Should the Marketing License be terminated pursuant to Section 9.4
hereof prior to the Product Launch and SpectRx undertakes to sell the
Device, then SpectRx shall pay, on a quarterly basis, on or before the
sixtieth (60th) day following the end of each calendar quarter,
royalties equal [ * ] per Device sold in such quarter, although in no
event shall the aggregate sum of all royalties payable to Roche
Diagnostics under this Section 3.6 exceed an amount equal to [ * ] plus
all amounts actually paid SpectRx pursuant to Section 4.3 hereof. The
procedures set forth in Section 3.5 governing the determination of
royalties; statements, records and notices in respect thereof; and
auditing and underpayment or overpayment thereof shall likewise govern
the royalties payable pursuant to this Section 3.6 and pursuant to
Section 3.7.
3.7 Should the Marketing License be terminated pursuant to Section 9.4
hereof within four years after Product Launch, and SpectRx undertakes
to sell the Device, then SpectRx shall pay, on a quarterly basis, on or
before the sixtieth (60th) day following the end of each calendar
quarter, royalties which for the first quarter year succeeding such
termination shall be [ * ] per Device sold in such quarter, with such
rate descending in equal quarterly increments so that such quarterly
royalties in respect of the fourth quarter of the year succeeding such
termination, and for each quarter year thereafter, is [ * ] per Device
sold in such quarter, although in no event shall the aggregate sum of
all royalties payable to Roche Diagnostics under this Section 3.7
exceed [ * ], subject to adjustment if in connection with and prior to
Product Launch Roche Diagnostics expends less than an aggregate of
[ * ] in startup marketing costs for the Device. In such case, each per
Device dollar royalty amount provided for in this Section 3.7 shall be
reduced by multiplying each of such amounts by a quotient, the
numerator being the actual such startup marketing costs incurred by
Roche Diagnostics, and the denominator being [ * ], and the aggregate
dollar limitation will be reduced to an amount equal to [ * ] less the
excess of [ * ] over the actual such startup marketing costs incurred
by Roche Diagnostics.
3.8 Should the Marketing License be terminated pursuant to Section 9.4
hereof, SpectRx agrees to not enter into any marketing alliance or
distribution agreement as to the Device with any companies (or
Affiliates thereof) in the glucose monitoring business. Further, should
the Marketing License be terminated pursuant to Section 9.4 hereof
subsequent to Product Launch, SpectRx agrees to use commercially
reasonable efforts to perform, on behalf of Roche Diagnostics, for a
period of six (6) months any distribution agreements to which Roche
Diagnostics is a party in respect of the Device in existence at the
time of such termination.
(*) Confidential treatment requested pursuant to a request for
confidential treatment filed with the Securities and Exchange
Commission. Omitted portions have been filed separately with the
Commission.
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3.9 Coincident with the execution and delivery of this Agreement, SpectRx
will transfer by assignment to Roche Diagnostics royalty free,
world-wide exclusive license, irrevocable, with right of sublicense, to
U.S. Patent Application for the Method and Apparatus for Determining
Duration of Medical Condition (Reference No.SPRX017).
4.0 DEVELOPMENT PAYMENTS
4.1 As consideration for the Marketing License and the option to obtain the
Manufacturing License, and for the world-wide exclusive license to the
patent application as provided in Section 3.9 hereof Roche Diagnostics
will simultaneously with and upon the same day as the execution and
delivery of this Agreement pay to SpectRx, by wire transfer of
immediately available funds to a bank account designated by SpectRx,
[ * ]. (This payment is separate from certain simultaneous payments to
be made to SpectRx pursuant to the Supply Agreement.)
4.2 The Specifications for the Device are set forth on Exhibit C attached
hereto. SpectRx agrees to use commercially reasonable efforts, at its
own cost with milestone payments from Roche to complete development of
the Device according to the Specifications. The Specifications may be
modified upon mutual agreement of the parties, with any additional
development costs related to modifications proposed by Roche
Diagnostics to be paid by Roche Diagnostics with the exception of
changes reasonably required for safety reasons.
4.3 As additional consideration for the licenses referred to in Section
4.1, Roche Diagnostics agrees to pay SpectRx, within thirty (30) days
of receipt of an invoice therefor the following milestones payments
upon the completion of such indicated milestones:
Initiate Validation Clinicals [ * ] $ [ * ]
Agency Testing Approval [ * ] $ [ * ]
Initiate Reliability/Lifetime Test (3 Devices[ * ] $ [ * ]
Deliver 4 devices to Roche for clinical testing) [ * ] $ [ * ]
Pilot Production Complete
(30 Devices Shipped to Roche Diagnostics) [ * ] $ [ * ]
The dates indicated for each milestone are estimated target completion
dates. For each full thirty (30)-day period as to which the completion
is delayed beyond any target completion date, the corresponding
milestone payment will be reduced by [ * ], unless Roche Diagnostics
agrees to extend such deadline, although in no event will any milestone
payment be reduced more than [ * ]in the aggregate. The deadlines
provided for herein above will be deemed extended to accommodate delays
caused by Roche Diagnostics, including without limitation delays due to
changes in the design, the development process, the manufacturing
process, packaging, or additional testing requested by Roche
Diagnostics.
(*) Confidential treatment requested pursuant to a request for
confidential treatment filed with the Securities and Exchange
Commission. Omitted portions have been filed separately with the
Commission.
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4.4 Roche Diagnostics shall give technical, clinical and marketing input to
the SpectRx project team during completion of the development tasks
outlined in Section 4.3. Roche Diagnostics will pay the cost of
obtaining clearance from the Food and Drug Administration and its
foreign counterparts necessary for Roche Diagnostics to sell the
Device.
4.5 SpectRx shall at its own expense, with Roche Diagnostics' assistance,
continue to pay maintenance fees and prosecute applications in respect
of the Screening Patents in the following countries: Belgium,
Switzerland, Germany, Spain, Great Britain, Italy, Australia, Canada ,
France, Netherlands, Mexico, and Japan, as reasonably practical as
determined by SpectRx, and maintain any such patents when issued. Roche
Diagnostics shall, at the expense of Roche Diagnostics, with SpectRx's
assistance, prosecute the Duration Patent Application in the name of
SpectRx as owner and in respect of such Application and the patent to
be issued thereunder, file applications for the same patent in the name
of SpectRx as owner in all major markets of the world for the Device
and shall diligently prosecute, at the expense of Roche Diagnostics,
such patent applications and maintain any such patents when issued.
Roche Diagnostics may, at its own expense, file, prosecute and maintain
additional applications for patents anywhere in the world with respect
to applications in the Field, which applications and patents issued
thereunder shall be in the name of and owned by SpectRx, which patent
applications and patents shall become part of the "Know-How."
5.0 CONFIDENTIALITY
5.1 It is contemplated that the parties may wish to transmit to each other
confidential information. Each party agrees to receive such
confidential information, if it is in writing or other tangible form
and clearly marked by the transmitting party prior to transmittal as
being confidential and agrees not to disclose such confidential
information to any third party for a period of five (5) years following
any termination of this Agreement unless the information (a) was known
to the receiving party prior to the time of disclosure, (b) is obtained
from a third party having an apparent right to disclose the
information, (c) was or becomes available to the public through no
fault of the receiving party or (d) was independently developed by
employees of the receiving party who have not had access to the
confidential information. Each party agrees not to use the confidential
information of the other for any purpose other than those set forth in
this Agreement. In the event a party considers certain information
which has been marked confidential to be excluded from the above
obligations of confidence and non-use and intends to make disclosure of
such information to a third party, thirty days written notice of such
intent and the reasons therefor shall be given to the other party. It
is also understood that confidential information may be transmitted
orally between the parties if it is identified at the time of
transmittal as being confidential and within thirty days thereafter
confirmed in writing or other tangible form by the disclosing party and
marked as being confidential. . Each party is entitled to rely on the
non-confidential, non-trade secret status of all information otherwise
transmitted. The covenants in this Section 5.1 also cover Confidential
Information transmitted at any time prior to
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the date of this Agreement, including without limitation Confidential
Information transmitted pursuant to, and prior to, the 1994 Development
Agreement.
5.2 It is understood that disclosure of any information by one party to the
other under this Agreement shall in no way be considered as a grant of
any right or license to the receiving party to use such information
except for the purposes set forth in this Agreement. The provisions of
this Section 5.0 shall survive any termination of this Agreement for
any reason.
6.0 JOINT OBLIGATIONS
6.1 Roche Diagnostics and SpectRx each agree to cooperate with the other in
the completion of the development of the Device, including the specific
tasks outlined in Section 4.3 hereof.
6.2 The parties agree to make reasonable efforts to keep each other
informed promptly of:
(a) all improvements relevant to the Device, if any;
(b) all technical information relating to the Know-How as
such data and information are acquired or developed
by either party, if any;
(c) all data or information concerning the clinical
evaluations or studies made by or for
either party relating to the Device for diabetes; and
(d) all publications coming to the attention of either
party relating to the Device, if any for diabetes.
7.0 RELATIONSHIP OF THE PARTIES
This Agreement is not intended to create nor shall it be deemed to
constitute, a partnership, agency, employer-employee, or joint venture
relationship between the parties. The respective activities by the
parties hereunder shall be provided as independent contractors. Neither
party shall incur any debts or make any commitments for the other,
except to the extent, if at all, specifically provided herein.
8.0 GOVERNMENT REGULATIONS AND GUIDELINES
Each party shall use its best efforts to assure that all further work
conducted hereunder shall be in accordance with the laws, rules and
guidelines applicable to the parties carrying out such work, in
particular, so far as applicable, the present and future guidelines for
Good Laboratory Practices and Good Manufacturing Practices set forth,
as amended from time to time, in the Code of Federal Regulations of the
United States of America and the corresponding local law of such other
countries as may be applicable to such work.
9.0 TERM AND TERMINATION
9.1 This Agreement shall remain in effect until terminated in accordance
with sections 9.2 or 9.3,
9.2 This Agreement may be terminated at any time by Roche Diagnostics upon
written notice thereof to SpectRx provided, however, that in the event
of termination pursuant to this section, Roche Diagnostics shall have
no further rights to the Device or the Know-How, the Marketing License
shall terminate and the Manufacturing License (if then granted) shall
terminate, and all sums paid or payable shall remain the property of
SpectRx and shall not be refundable, and to the extent accrued but
unpaid any such sums owed to SpectRx shall thereupon
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be immediately due and payable. Roche Diagnostics further agrees that,
if it terminates this agreement under this Section 9.2, for a two year
period, following the effective date of termination, it will not market
an instrument that competes with the Device in the Field. Either party
may terminate this Agreement (and the Manufacturing License if then in
effect) (i) by written notice in the event the other party materially
breaches this Agreement and does not cure such breach within thirty
(30) days of written demand for cure, or (ii) by written notice upon
the liquidation or bankruptcy of, or an assignment for the benefit of
creditors of, or a declaration of insolvency by, the other party.
9.3 If, at any time Roche Diagnostics ceases, or fails to commence, active
marketing efforts in respect of the Device, SpectRx may provide Roche
Diagnostics with written notice of its intent to terminate the
Marketing License and this Agreement. Such termination shall become
effective thirty (30) days after Roche Diagnostics' receipt of such
notice; provided, however, that if Roche Diagnostics gives SpectRx
written notice that it disagrees with SpectRx's conclusion that Roche
Diagnostics is not engaged in active marketing efforts in respect of
the Device, then the Marketing License and this Agreement shall
continue in effect until the parties have resolved their dispute
pursuant to Section 10.6 hereof.
9.4 Upon termination of this Agreement pursuant to this Article 9, the
Marketing License and the Manufacturing License (if granted) shall
terminate and all rights in and to the Device and Know-How shall be
solely and exclusively held by SpectRx. Roche Diagnostics will
thereupon use its reasonable best efforts to cause to be transferred to
SpectRx any governmental approvals obtained or applications submitted
by Roche Diagnostics and necessary for SpectRx to market the Device.
10. MISCELLANEOUS PROVISIONS
10.1 This Agreement constitutes and contains the entire Agreement of the
parties and supersedes any and all prior negotiations, correspondence,
understandings and agreements between the parties respecting the
subject matter hereof. This Agreement may be amended or modified or one
or more of the provisions thereof waived only by written instrument
signed on behalf of the parties.
10.2 Any notice required to be given hereunder shall be sent by first class
registered or certified mail addressed to the party to whom it is to be
given as follows:
To Roche Diagnostics: Roche Diagnostics Corporation
Attn.: President
0000 Xxxxx Xxxx
Xxxxxxxxxxxx, Xxxxxxx 00000
with copy to Legal Department at
same address
To SpectRx: SpectRx, Inc.
Attn.: President
0000X Xxxxx Xxxxx
Xxxxxxxx, Xxxxxxx 00000
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All notices shall be deemed given when sent by registered or certified
mail, postage prepaid, to the addresses listed above. The date of
postmark shall be the date of such notice.
10.3 SpectRx warrants and represents that, as of the date of this Agreement,
it has the right to grant to Roche Diagnostics the rights granted
herein and that there are no outstanding agreements, assignments or
encumbrances inconsistent with this Agreement. SpectRx further
represents and warrants to Roche Diagnostics that it has given Roche
Diagnostics access to substantially all technical and clinical data
thus far generated with respect to the Device and that all such data is
accurate and complete in all material respects to the best of SpectRx's
knowledge. Roche Diagnostics warrants and represents that it has no
outstanding agreements that are inconsistent with this Agreement.
10.4 This Agreement shall be construed according to the laws of the State of
Georgia. Venue for any litigation under this Agreement shall be state
court, Gwinnett County, Georgia.
10.5 During the term of this Agreement or any extension thereof none of the
parties hereto will make any publications relating to the details of
the business arrangement between them contemplated hereunder, including
business plans, without the approval of the other; provided, however,
that such approval shall not be unreasonably withheld. Notwithstanding
the foregoing or anything else provided in this Agreement, neither this
Section 10.5, nor the provisions of Section 10.9, shall restrict (nor
provide a penalty payment as to) publicity or disclosure of this
Agreement or information concerning this Agreement which a party hereto
reasonably determines is required to fulfill its disclosure obligations
to its shareholders under applicable securities laws or as otherwise
customarily provided by such party to its shareholders; provided,
however, that prior to making any such disclosures the party seeking to
make such disclosures shall use reasonable efforts to obtain approval
of the other party of the contents of such disclosures.
10.6 Dispute Resolution. Any dispute arising out of or relating to this
Agreement shall be resolved as provided in, and pursuant to the terms
and conditions of Sections 11.6(a) and 11.6(b) of the Supply Agreement,
which provisions are incorporated herein by this reference.
10.7 All payments made pursuant to this Agreement shall be net of
withholding and other taxes (except for taxes that are due on the net
income of a party) that may be due on such payments.
10.8 This Agreement shall not be assignable by either party without the
prior written consent of the other, such consent will not be
unreasonably withheld; provided, however, that Roche Diagnostics may
assign this Agreement to any Affiliate.
10.9 Prior to Product Launch the parties shall meet and negotiate in good
faith a communications policy to be effective conincent with Product
Launch. Prior to Product Launch, nNo news release, advertisement,
marketing announcement, public announcement, denial or confirmation of
same, of any kind regarding any part of the subject matter of this
agreement or device shall be made by SpectRx without prior written
approval of Roche Diagnostics. Such material shall be presented to
Roche Diagnostics two weeks prior to deadlines for review and
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written approval. Failure to comply with the foregoing requirement
will result in a [ * ] payment by SpectRx to Roche Diagnostics per
documented occurrence.
10.10 The acceptable performance of the device per Section 8.3.1 of the
System Specification Document ("SSD") is based on meeting the stated
performance on the defined test population. In no event would SpectRx
be required to invest in R & D or engineering to meet
acceptable/approvable performance other than as defined in the SSD.
WITNESS WHEREOF, the parties hereto, intending to be legally bound,
have duly executed this Agreement as of the date first above written.
SPECTRX, INC.
By:
-------------------------------------
Title:
----------------------------------
ROCHE DIAGNOSTICS CORPORATION
By:
-------------------------------------
Title:
----------------------------------
(*) Confidential treatment requested pursuant to a request for
confidential treatment filed with the Securities and Exchange
Commission. Omitted portions have been filed separately with the
Commission.
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Exhibit A
GTRC License
[on File as Exhibit 10.11(A) to Form 10K]
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Exhibit B
Volume Requirements Per Section 3.4
(1) Volume requirements will be deemed not met for the two (2)-year period
commencing on the day immediately succeeding the date of Product Launch
if an annual average of less than [ * ] Devices are purchased by Roche
Diagnostics within the two (2) years comprising such period (or should
the Manufacturing License issue, royalties thereunder are paid (or
accrued) in respect of an annual average of less than [ * ] Devices
during such two (2) year period).
(2) Volume requirements will be deemed not met if for any year commencing
on the second (2nd) anniversary, or any subsequent anniversary, of the
date immediately succeeding the date of Product Launch, less than [ * ]
Devices are purchased by Roche Diagnostics during such year (or should
the Manufacturing License issue, royalties thereunder are paid (or
accrued) in respect of less than [ * ] Devices during any such year.
(3) Provided the Marketing License (and Manufacturing License if then in
effect) are maintained as exclusive licenses during the five (5)-year
period commencing on the day immediately succeeding the date of Product
Launch, such licenses shall remain exclusive indefinitely thereafter
(unless terminated in accordance with Section 9 or Roche distributes an
instrument that competes with the Device in the Field as otherwise
provided in Section 3.2 if during such five (5)-year period more than
[ * ] Devices are purchased by Roche Diagnostics (or while the
Manufacturing License is in effect, a royalty is paid (or accrued) in
respect thereof during such period).
(4) For year 2000, Roche Diagnostics [ * ] resulting from reduced purchase
volumes in accordance to the following formula:
[ * ] less the number of units actually purchased by Roche in the year
2000, that difference then multiplied by [ * ]
Any payment shall be requested in writing and will be paid upon
review of the supporting details. Payment will be made within 30 days
of the end of the year in question.
(*) Confidential treatment requested pursuant to a request for
confidential treatment filed with the Securities and Exchange
Commission. Omitted portions have been filed separately with the
Commission.
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Exhibit C
Specifications for Device
[*]
(*) CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. OMITTED
PORTIONS HAVE BEEN FILED SEPARATELY WITH THE COMMISSION.
