EXHIBIT 10.35
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL
SUPPLY AGREEMENT
between
Boehringer Mannheim GmbH
Sandhofer Xxxxxxx 000
00000 Xxxxxxxx
Xxxxxxx
(hereinafter referred to as "BM")
and
Gen-Probe Incorporated
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx
XX 00000-0000 XXX
(hereinafter referred to as "GEN-PROBE")
PREAMBLE
GEN-PROBE desires to purchase from BM and BM desires to sell to GEN-PROBE
certain raw materials for Transcription Mediated Amplification ("TMA")
related diagnostic units.
In order to provide for the supply of the Products to GEN-PROBE, both
parties agree on the following:
SECTION 1 DEFINITIONS
1.1 "Products" shall mean those raw materials included in Categories A and B
unless otherwise agreed by the parties in writing:
CATEGORY A
1.) recombinant Xxxxxxx murine leukemia virus reverse
transcriptase; and
2.) recombinant bacteriophage T7 RNA Polymerase.
CATEGORY B
1.) deoxyribonucleotides (dGTP, dTTP, dATP, dCTP);
2.) ribonucleotides (ATP, CTP, GTP, UTP);
3.) proteinase K; and
4.) zwittergent,
in accordance with functional specifications and acceptance criteria as
set forth in Attachment A hereto, for the Intended Use. Within thirty (30)
days of the date of this Agreement, BM shall provide to Gen-Probe: (1) a
description of each BM test method identified in Attachment A; and (2) the
specifications for each Product identified by BM catalog number in
Attachment A.
With regard to T7 RNA Polymerase, the parties expect that the initial
specification set forth in Attachment A will be modified by GEN-PROBE and
mutually agreed upon within 180 days of the date of this Agreement. BM
agrees not to unreasonably withhold consent to such modified specification
for the T7 RNA Polymerase.
Page 1
1.2 "Intended Use" shall mean the use of the Products by GEN-PROBE in
connection with developing and producing Transcription-Mediated
Amplification related diagnostic products wherein Products meeting the
specifications set forth in Attachment A are appropriate for use.
1.3 "Affiliates" of either party shall mean any corporation, partnership
organization which such party directly or indirectly controls, is
controlled by or is under common control with. For the purpose of this
Agreement, "Control" shall mean the holding of 50% or more of the voting
stock or other ownership interest of the corporation or business entity
involved.
1.4 "Transformed Clone" shall mean a recombinant Xxxxxxx murine leukemia virus
reverse transcriptase clone, which was originally provided by GEN-PROBE to
BM, to the extent the original clone was modified or genetically
transformed by BM, using BM's confidential know how, for the purpose of
optimizing fermentation processes and characteristics. (The "Transformed
Clone" includes the material internally labeled by [***].) GEN-PROBE
acknowledges that it consented to and approved BM's modification of the
original clone, using BM's confidential know how, for the purpose of
optimizing fermentation processes and characteristics for GEN-PROBE's
exclusive benefit.
SECTION 2 SUBJECT MATTER OF THE AGREEMENT
2.1 The subject matter of this Agreement is the terms and conditions for the
supply of the Products by BM to GEN-PROBE.
2.2 The Products shall be manufactured and/or distributed by BM or its
Affiliates and shall conform to the specifications and acceptance criteria
set forth in Attachment A. No changes shall be made to the specifications
and acceptance criteria without the prior written approval of both
parties, which shall not be unreasonably withheld.
2.3 During the term of this Agreement GEN-PROBE shall purchase from BM and BM
shall supply to GEN-PROBE the minimum percentage of the worldwide usage by
GEN-PROBE for the Intended Use, as shown in Attachment C.
2.4 Gen-Probe shall, upon request by BM, provide documentation, reasonably
satisfactory to BM, verifying compliance with Section 2.3.
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 2
2.5 BM shall not make any change to its processes or procedures which may
alter any Product's stability or performance. BM shall provide notice of
any proposed change in its processes or procedures in accordance with
certified ISO procedures for change control applicable to in vitro
diagnostic raw material. BM's notice shall include a full description of
the proposed change. GEN-PROBE shall be provided with sufficient samples
of any Product made by a process which will be subject to the proposed
change to enable GEN-PROBE to determine that such Product(s) will meet
specifications and will function in Gen-Probe's TMA products.
SECTION 3 TERMS OF DELIVERY
3.1 The Products shall be delivered F.O.B destination, priority shipment.
3.2 Each delivery shall be accompanied by a release certificate by the quality
control laboratory of BM, confirming that the shipment conforms to the
specifications and acceptance criteria set forth in Attachment A and
setting forth the results of BM's quality control tests pursuant to the
test methods described in Attachment A.
SECTION 4 PURCHASE PRICE
4.1 (a) Fixed Prices to be paid by GEN-PROBE for the Products are specified in
Attachment B through the year 2004 and are contingent upon current
specifications and acceptance criteria as described in Attachment A.
(b) If acceptance criteria or specifications for the Products are changed
at GEN-PROBE's request, the prices are subject to change to the extent
necessary to compensate BM for such changes. The prices are also
subject to change pursuant to Section 9.2 of this Agreement,
concerning regulatory requirements.
Page 3
(c) If, at any time after the first anniversary date of this Agreement,
the U.S. Dollar - Deutsch Xxxx exchange rate (or the U.S. Dollar -
Euro exchange rate, if applicable), is more than 15% higher or lower
than the date existing on the date of this Agreement, then either
party may request that revised prices be negotiated to reflect such
change. The parties shall negotiate revised prices in good faith and
each party shall be entitled to take into account the economic impact
of the proposed change on its own interests. If despite good faith
negotiations, new prices cannot be agreed upon within ninety (90) days
following a request by either party, the party requesting the price
revision may terminate this Agreement upon ninety (90) days written
notice.
4.2 BM may, after the seventh (7th) anniversary of this agreement and subject
to the restrictions in the next two (2) sentences, adjust the purchase
prices in Attachment B to incorporate actual changes in the raw materials
and labor costs associated with the manufacture of the Products. [***]. BM
shall provide GEN-PROBE not less than one hundred and twenty (120) days
prior written notice of any proposed increase in the purchase price of the
Products. GEN-PROBE and BM agree to negotiate any such price changes in
good faith and with the intent of seeking a mutually beneficial
resolution. The increase in the price of any Product shall not exceed
[***] of the prior year's purchase price for that Product.
4.3 Upon written request by a party, the other party shall provide
documentation supporting any proposed price adjustment requested under the
terms of this Agreement to a mutually agreeable certified public
accountant who shall review the aforementioned documentation for
supporting the price adjustment. The certified public accountant shall
sign a secrecy agreement with the party providing the information and
shall act regarding the provided information in accordance with such
secrecy agreement. The certified public accountant shall only make a
statement whether the provided documentation supports the proposed price
adjustment or not.
4.4 The Product purchase price in any year shall be estimated by applying
GEN-PROBE's purchase order pursuant to Section 7.1 for that year to the
appropriate pricing tier schedule in Attachment B.
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 4
If the amount of any Product actually purchased by GEN-PROBE in any year
is more or less than that estimated and as a result a different pricing
tier schedule applies to the amount actually purchased, then not later
than sixty (60) days after the first anniversary and each anniversary
thereafter, the parties shall reconcile the effect on the purchase price
for that Product in the preceding year caused by any shortfall or overage
in the total quantity of the Product actually purchased, and any payment
due as a result of such reconciliation shall be made by the appropriate
party within 30 days.
SECTION 5 PAYMENT
GEN-PROBE shall pay each BM invoice for Product(s) within thirty (30) days
of the date of invoice. BM will invoice GEN-PROBE no earlier than the date
BM ships the Products described in the invoice to GEN-PROBE. Invoicing and
payment shall be made in US dollars.
SECTION 6 FORECASTING PROCESS
6.1 GEN-PROBE has set forth its initial estimates of its anticipated purchase
projection from BM in Attachment C. BM understands that these estimates
are not binding, except for 1998, and do not establish any minimum amount
of purchases by GEN-PROBE.
For purposes of BM's long term manufacturing capacity planning, GEN-PROBE
shall provide to BM annually by the last day of September, a revised
projection of purchase volume for each of the succeeding three (3)
calendar years or for the remaining period of the contract, whichever
period is shorter. Each year BM and GEN-PROBE shall agree on the quantity
of the Products to be delivered in the next year for any Product as to
which GEN-PROBE ordered more than twice the projected amount for the
preceding year. The lead time to adjust BM's manufacturing capacity to
said quantity will be negotiated and agreed upon following agreement with
the new projection. All such estimates shall be considered to be
confidential and proprietary information of GEN-PROBE under this
Agreement.
SECTION 7 PURCHASE ORDERS, DELIVERY PROCESS AND SECURITY OF SUPPLY
7.1 GEN-PROBE shall submit to BM by the last day of September of each year a
purchase order of its requirements for the Products for the next
succeeding year. Each of GEN-PROBE's purchase orders for the Products
shall be in writing and shall constitute a binding obligation upon
GEN-PROBE to accept and pay for a minimum of [***] of the quantities
ordered. In conjunction with its annual purchase order, GEN-PROBE shall
provide to BM, in writing, a
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 5
quarterly delivery schedule which identifies quantities, destinations, and
approximate delivery dates.
Furthermore, both parties will agree annually in December of each calendar
year on adequate levels of safety stock and storage locations therefor to
ensure the agreed upon terms of delivery are achieved. The parties agree
that a significant portion of the safety stocks shall be maintained at
GEN-PROBE's facility at San Diego, California and the balance at BM's
facilities in the United States. As to any Products kept as safety stocks
at Gen-Probe's facilities, BM shall provide the information described in
Section 3.2 for such Products at the timof the delivery of those Products
into the safety stock. GEN-PROBE shall not be obligated to pay for the
safety stock Products except (1) upon use of such Products; (2) Pursuant
to Section 13.4; or (3) To the extent that GEN-PROBE requests that more
than a 90-day supply of Products be stored in San Diego as part of the
safety stock.
Additional provisions concerning the logistical arrangements for the
safety stock and creation of the initial safety stock shall be agreed by
the parties within 120 days of the date of this Agreement. It is the
parties' present intent that the safety stock shall include an amount of
each of the Products equal to GEN-PROBE's requirements for a six-month
period.
7.2 Proposed additions to the agreed upon annual purchase quantities
identified in the annual purchase order shall be submitted by GEN-PROBE in
writing to BM.
BM will use reasonable efforts to meet delivery times of ninety (90) days
from date of receipt of quantity changes. Delivery dates for quantities
outside of planned volumes will be negotiated at the time the written
change request is received.
7.3 As compensation for BM's R&D expenses, GEN-PROBE has committed to purchase
the Products and their stated amounts as set forth in Attachment C for the
year 1998.
7.4 Gen-Probe and BM have previously entered into a material transfer
agreement with respect to the transfer of reverse transcriptase clones
from GEN-PROBE to BM and certain research and development work by BM. The
provisions of any prior material transfer agreement between the parties
are hereby superseded with respect to use of the Transformed Clone and
ownership and use of any intellectual property of BM reflected or
incorporated in the Transformed Clone. All other provisions of the
material transfer agreements shall remain in effect.
Page 6
BM shall be solely and exclusively entitled to use and make Transformed
Clones. Notwithstanding the preceding sentence, GEN-PROBE may use the
Transformed Clone in accordance with the provisions set forth below in
this Section 7.4. GEN-PROBE shall not be entitled to use the Transformed
Clone in any manner or on any terms other than those set forth below in
this Section 7.4.
Immediately following the signing of this Agreement, and from time-to-time
thereafter if appropriate, BM shall deliver to GEN-PROBE examples of the
Transformed Clone, which sample shall be treated as and kept confidential
in accordance with paragraph 12 of this Agreement.
(A) USE OF THE TRANSFORMED CLONE BY GEN-PROBE DURING TERM OF AGREEMENT
SO LONG AS BM IS ABLE TO SUPPLY GEN-PROBE WITH REVERSE
TRANSCRIPTASE.
During the term of this Agreement and so long as BM is able to
supply GEN-PROBE with transformed reverse transcriptase, GEN-PROBE
agrees that it will not, without the prior express written consent
of BM, do any of the following:
(1) [***]
(2) [***]
(3) [***]
(4) [***]
(5) [***]
(6) [***]
During the term of this Agreement and so long as BM is able to
supply GEN-PROBE with transformed reverse transcriptase, GEN-PROBE
may only use the Transformed Clone for the following specific
purposes:
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 7
(1) [***]
(2) [***]
(3) [***]
(B) USE OF TRANSFORMED CLONE UPON FAILURE OF BM TO SUPPLY.
In the event that BM fails to supply Gen-Probe with reverse
transcriptase in accordance with this Agreement, BM may use a third
party supplier as necessary for securing the supply of reverse
transcriptase. The use of the aforementioned third party supplier by
BM is subject to prior written consent by GEN-PROBE, which consent
shall not unreasonably withheld. The third party shall sign a
material transfer agreement with BM and with GEN-PROBE regarding the
Transformed Clones which shall, among such other things as may be
provided by BM, protect and preserve GEN-PROBE's rights in the
Transformed Clone and GEN-PROBE's confidential materials and
information. The Third Party shall receive the Transformed Clones
and the know how with regard to the fermentation and the
purification and shall return the Transformed Clones and the know
how with regard to the fermentation and the purification to BM
promptly after BM has become able to supply GEN-PROBE with reverse
transcriptase. If a third party supplier is not found by BM within
three (3) months after the event of non-supply has occurred, then
GEN-PROBE may, at its option, assign a third party supplier (which
assignment is subject to prior written consent of BM, which consent
shall not unreasonably withheld), or after seeking such a third
party supplier may terminate this Agreement. The third party shall
sign a material transfer agreement with BM and with GEN-PROBE
regarding the Transformed Clones, shall receive the Transformed
Clones and the know how with regard to the fermentation and the
purification and shall return the Transformed Clones and the know
how with regard to the fermentation and the purification to BM
promptly after GEN-PROBE has had a reasonable opportunity to arrange
for an alternative source of supply, not to exceed three years.
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 8
(C) USE OF TRANSFORMED CLONE UPON TERMINATION OF AGREEMENT.
After expiration or termination of this Agreement for any reason
whatsoever, GEN-PROBE shall not use the Transformed Clone except
upon obtaining a non-exclusive royalty bearing license from BM to
use BM's know how incorporated in the transferred Transformed Clone
and in the field and territory as set forth in the this Agreement in
order to continue the manufacture of reverse transcriptase required
to manufacture TMA related diagnostic units by GEN-PROBE. (The
foregoing sentence is subject to GEN-PROBE'S rights as set forth in
subsection 7.4(B) above.)
BM hereby grants an option to GEN-PROBE for such a license. The
option shall be exercised by GEN-PROBE within sixty (60) days after
expiration or termination of this Agreement. GEN-PROBE shall not use
the know-how to be licensed by BM for purposes other than those
described in this section and described in the license agreement.
The royalty to be paid and the other terms and conditions of the
license agreement shall be negotiated between BM and GEN-PROBE in
good faith and shall not exceed commercially reasonable terms
reflecting the terms charged by others for comparable technology.
The annual royalties to be agreed upon, however, shall not exceed an
annual amount of [***] of the Average of the Total Sales of the
reverse transcriptase which average total sales shall be calculated
of the calendar year of the termination or expiration and the two
(2) preceding calendar years. If this Agreement is terminated within
three (3) years upon execution of this Agreement, the annual
royalties to be agreed upon shall not exceed an annual amount of
[***] of the total sales of the reverse transcriptase in the
calendar year preceding the termination. If this Agreement is
terminated during the first calendar year upon execution the annual
royalties to be agreed upon shall not exceed an annual amount of
[***] of the total sales of the reverse transcriptase in the
calendar year of termination.
The license to be granted hereunder shall not authorize GEN-PROBE to
conduct research to [***] in any GEN-PROBE development work.
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 9
SECTION 8 ACCEPTANCE
GEN-PROBE shall, within thirty (30) days upon receipt of any shipment,
inspect The Products to determine whether or not the delivery conforms to
the applicable specifications and acceptance criteria. GEN-PROBE shall
promptly give BM written notice of any failure or nonconformity. If
GEN-PROBE fails to notify BM of any nonconformity of any Product within
forty-five (45) days of receipt of the Product, GEN-PROBE shall be deemed
to have accepted that Product as properly shipped and suitable for the
Intended Use, except as to the stability specification for any Product, as
to which GEN-PROBE shall be deemed to have accepted the Product if it does
not give written notice within 30 days of discovery of the failure of the
Product to meet the stability specification.
SECTION 9 REGULATORY MATTERS
9.1 A Design History File (DHF), Device Master Record (DMR), and Device
History Record (DHR) shall be kept by BM at its premises for all Category
A Products and for all deoxyribonucleotides and ribonucleotides and shall
be available to the FDA directly or confidentially through a third party
for necessary regulatory inspections. If the aforementioned documents have
to be filed at the FDA the costs of this filing shall be paid by
GEN-PROBE. To the extent that BM reasonably incurs significant costs for
complying with the requirements of this Section as to deoxyribonucleotides
and ribonucleotides, the parties will negotiate in good faith to
compensate BM for such costs and to define a reasonable time period for
completion of such requirements.
9.2 If the applicable regulatory agencies request amendments of the
documentation or design of the Products including but not limited to DHF,
DMR and DHR, BM undertakes to use its reasonably best efforts to fulfill
these requirements. Any such amendments shall be mutually agreed upon
between GEN-PROBE and BM. The parties shall agree upon compensation to BM
in connection with fulfilling the requirements of the amendments before
any action is taken, unless such amendments are the result of BM's failure
to comply with manufacturing standards requiring utilization of such
manufacturing processes as are controlled and validated, with adequate
records of the processes used. To the extent that adequate compensation
for such proposed changes cannot be provided to BM by way of reasonable
adjustment to the purchase price of the Products, the parties will
negotiate in good faith for another form of payment to BM. If the parties
are not able to agree on such compensation, either party may terminate
this Agreement.
Page 10
SECTION 10 INTELLECTUAL PROPERTY RIGHTS
10.1 The ownership of any and all intellectual property rights of BM as
reflected in the Transformed Clone and BM's T7 RNA Polymerase shall remain
with BM. BM recognizes that the Transformed Clone is a derivative of an
original clone supplied to BM by GEN-PROBE and BM therefore agrees not to
transfer the Transformed Clone to any other person or entity (with the
exception of affiliates of BM or subcontractors appointed by BM and
authorized by GEN-PROBE, which affiliates and subcontractors shall have
the same secrecy obligations as the Parties with regard to the original
GEN-PROBE clone and the Transformed Clone).
10.2 In the Event that claim of patent infringement is made against BM or any
of its Affiliates, by any third party by reason of GEN-PROBE's sale or use
of the Products in combination with GEN-PROBE technology, to the extent
that the infringement is based upon the new combination product, GEN-PROBE
hereby agrees to indemnify, defend and save each of them, harmless of and
from and all liability, loss, cost, injury, damage, demand and expense
(including, without limitation, reasonable attorney's fees) of any kind
whatever arising out of, on account of, or in connection with such claim
of infringement. Excepted from such hold harmless obligation shall be
indirect or consequential damages whether or not based on negligence.
In the event that claim of patent infringement is made against GEN-PROBE
or any of its Affiliates, by any third party by reason of GEN-PROBE's sale
or use of the Products, BM hereby agrees to indemnify, defend and hold
GEN-PROBE, and its parents, subsidiaries, Affiliates, officers, directors,
agents and employees, and each of them, harmless of and from any and all
liability, loss, cost, injury, damage, demand and expense (including,
without limitation, reasonable attorney's fees) of any kind whatsoever
arising out of, on account of, or in connection with such claim of
infringement. Excepted from such hold harmless obligation shall be
indirect or consequential damages whether or not based on negligence.
10.3 BM and GEN-PROBE agree to give prompt written notice to the other of the
commencement of any action, suit or proceeding for which the foregoing
indemnification may be sought, and the other party, through counsel
reasonably satisfactory to BM or GEN-PROBE, shall assume the defense
thereof. It is agreed that the party claiming a right to indemnification
shall be entitled to participate in any such action, suit or proceeding
with counsel of its own choice, but at its own expense.
Page 11
SECTION 11 WARRANTY AND LIABILITY
11.1 BM hereby warrants that the Products will be produced in accordance with
the applicable regulations and statutory requirements, will fully conform
to the Product specifications listed in Attachment A hereto, and will be
free from defects in materials or workmanship. BM's manufacturing
processes shall meet the requirements of any manufacturing standards
applicable to materials included or used in the manufacture of in vitro
diagnostic products of like kind as GEN-PROBE's TMA products, but not less
than such manufacturing processes as are controlled and validated, with
adequate records of the processes used. If BM incurs additional costs in
order to meet standards imposed after the Signing Date of this Agreement,
the prices charged pursuant to Section 4 are subject to change to the
extent necessary to compensate BM for such changes. To the extent that
adequate compensation for such proposed changes cannot be provided to BM
by way of reasonable adjustment to the purchase price of the Products, the
parties will negotiate in good faith for another form of payment to BM. If
the parties are not able to agree on such compensation, either party may
terminate this Agreement.
Beyond the warranties expressly stated herein, BM shall assume no warranty
as to the fitness of the Products for the purpose intended by GEN-PROBE.
THE FOREGOING WARRANTY SHALL BE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WAY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO CASE SHALL BM
BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES.
The financial liability of BM in connection with its warranty obligations
under this Section 11.1 shall be limited to the reimbursement or crediting
of the price of the defective Products to GEN-PROBE or, where this may be
agreed between the Parties hereto, to the supply of the Products in
replacement for the defective Products. Nothing in this Section shall
limit GEN-PROBE's rights under Section 11.2.
11.2 BM will defend, indemnify and hold harmless GEN-PROBE from any and all
claims, liabilities or reasonable out-of-pocket expenses arising from or
related to any and all claims and will pay all cost of damages finally
awarded in any proceedings or any settlement made with BM's consent with
respect to any claims for damages alleged to have been sustained as a
result of BM's negligent acts or omissions. Excepted from such hold
harmless obligation shall be indirect or consequential damages whether or
not based on negligence.
Page 12
GEN-PROBE will defend, indemnify and hold harmless BM from any and all
claims, liabilities or reasonable out-of-pocket expenses arising from or
related to any and all claims and will pay all cost of damages finally
awarded in any proceedings or any settlement made with GEN-PROBE's consent
with respect to any claims for damages alleged to have been sustained as a
result of GEN-PROBE's negligent acts or omissions. Excepted from such hold
harmless obligation shall be indirect or consequential damages whether or
not based on negligence.
Any liability of BM or GEN-PROBE under this Section 11.2 shall be limited
to [***].
11.3 Each party agrees to promptly give written notice to the other party of
the commencement of any action, suit or proceeding for which
indemnification may be sought, and the indemnifying party, through counsel
reasonably satisfactory to the indemnified party shall assume the defense
thereof. It is agreed, however, that the indemnified party shall be
entitled to participate in any such action, suit or proceeding with
counsel of its own choice, but at its own expense.
SECTION 12 SECRECY OBLIGATION
Each party shall keep all information and know how communicated to it or
otherwise obtained from the other party at any time during the term of
this Agreement and in connection with this Agreement (including but not
limited to know-how, technology, pricing, usage rates, and business
projections) secret and confidential and shall not disclose the same or
any part thereof to any third party. Excepted herefrom is information:
a) which is in the public domain at the time of disclosure,
b) which is published or otherwise becomes part of the public domain
through no fault of the party receiving the information,
c) which was in the possession of the receiving party at the time of
disclosure, as shown by prior written records, or becomes available
from a third party who has the right to disclose it;
d) which is required to be communicated to authorities or customers for
the purpose of sale of the Products, or
e) which has been independently developed by the receiving party at or
before the date of disclosure.
***Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Page 13
SECTION 13 TERM AND TERMINATION
13.1 This Agreement becomes effective as of the date of signature of the last
party to sign and shall remain in force for an initial period of ten (10)
years from the execution of this Agreement. Thereafter the Agreement
automatically prolongs for two (2) year terms if not terminated by one of
the parties at the end of the initial period or prolongation period with
twelve (12) months prior written notice.
13.2 In the event that either party fails or becomes unable to substantially
perform any of the obligations or undertakings to be performed by it under
this Agreement then the other party shall provide the defaulting party
with written notification of such default. If such default or inability
is not cured within ninety (90) days to the mutual satisfaction of both
parties, then the non-defaulting party shall have the right to terminate
this Agreement upon 15 days upon written notice. Notwithstanding the
foregoing provisions, if BM's default is limited only to an inability to
deliver, within ten (10) working days after the scheduled delivery date on
the purchase order, any single Product, then GEN-PROBE shall be obligated
to first use one-half of the then-available safety stock of that Product
established pursuant to section 7.1 of this Agreement, and -- after using
one-half of the safety stock of that Product -- then GEN-PROBE shall only
have the right to partially terminate this Agreement as to the single
Product which BM has failed to deliver.
13.3 Both parties shall have the right to terminate this Agreement forthwith in
the event that the other party shall become bankrupt or insolvent, or make
any arrangement with its creditors and/or a winding-up order is made and/
or if its business shall be placed in the hands of a receiver, assignee or
trustee, whether by the voluntary act or otherwise.
All rights granted hereunder by BM to its intellectual property or
confidential information under any title whatsoever, except for the rights
set forth in Section 7.4 B and C, shall return to BM after termination or
expiration of this Agreement.
13.4 After any termination of the Agreement (except for a termination by
GEN-PROBE due to BM's failure to meet Product specifications or due to
BM's intentional and willful default), GEN-PROBE shall purchase from BM
the complete existing safety stock of the Products at the prices as agreed
upon between BM and GEN-PROBE for the last full year in which The Products
have been sold. BM shall provide the information described in Section 3.2
for the safety stock Products at the time of the delivery of those
Products. As to any Products which are kept as safety stocks at a
GEN-PROBE facility, GEN-PROBE shall accept or reject such Products
pursuant to Section 8 of this Agreement within 30 days of the initial
delivery of such Products to GEN-PROBE for use as safety stock.
Page 14
13.5 Upon the termination of this Agreement, BM shall destroy all Transformed
Clones. Upon the termination of this Agreement, Gen-Probe shall destroy
all Transformed Clones except to the extent it has continuing rights with
respect to the Transformed Clone under Section 7.4 of this Agreement.
13.6 The following provisions shall survive termination of this Agreement:
Sections 4, 5, 7.4, 10, 11, 12, 13.4, 14 and 15.
SECTION 14 ARBITRATION
Any controversy, claim or dispute existing out of or relating to this
Agreement, or the breach thereof, shall be resolved by binding
arbitration, with any proceedings or hearings to take place rendered by
arbitration may be entered in any Court having jurisdiction. If parties do
not agree upon location, the arbitrator shall determine the location. If
arbitration is necessary pursuant to this paragraph, the Parties shall
agree upon a single arbitrator. If the Parties are unable to agree on an
arbitrator, then they will obtain nominations of three potential
arbitrators from the International Chamber of Commerce of New York, USA
and each party will have the right to strike one candidate's name from the
list. The International Chamber of Commerce of New York, USA will then
designate the arbitrator. Any arbitration award shall also include, but
shall not be limited to, any and all court or arbitration costs, attorney
fees and any other costs or charges reasonably necessary to adjudicate the
controversy, in addition to any and all damages deemed fair by the
arbitrator. Nothing contained herein shall deprive any party of his or her
right to obtain injunctive or other equitable relief.
SECTION 15 GENERAL PROVISIONS
15.1 Entire Agreement
This Agreement constitutes the entire understanding between the parties
with respect to the subject matter hereof, and supersedes and replaces all
prior agreements, understandings, writings and discussions between the
parties relating to said subject matter, except as to any and all prior
material transfer or confidential disclosure agreements between the
parties, which are superseded only with respect to the Transformed Clone
in the manner expressly set forth in Sections 1.4, 7.4, and 10.1.
Page 15
15.2 Amendments; Waivers
This Agreement may be amended and any of its terms or conditions may be
waived only by a written instrument executed by both parties, or, in the
case of a waiver, by the party waiving compliance. The failure of either
party at any time to require performance of any provision hereof shall in
no manner affect its rights at a later time to enforce the same. No waiver
by either party of any condition or term in any instance shall be
construed as a further or continuing waiver of such condition or term or
of another condition or term.
15.3 Successors and Assigns
This Agreement shall be binding upon and inure to the benefit of and be
enforceable by the parties hereto and their respective successors and
permitted assigns. BM shall be entitled to assign this Agreement if
necessary after the merger with Xxxxxxxx-Xx Xxxxx to its succeeding legal
entity with the exception that no GEN-PROBE-designated proprietary
information shall be disclosed to competing operating business units
affiliated with BM, including Xxxxxxx-Xx Xxxxx.
15.4 Governing Law
This Agreement will be in all events and for all purposes governed by, and
construed in accordance with the law of the State of Indiana.
15.5 Severability
The parties agree that if any part, term or provision of this Agreement
shall be found illegal or in conflict with any valid controlling law, the
validity of the remaining provisions shall not be affected thereby.
In the event the legality of any provision of this Agreement is brought
into question because of a decision by a Court of competent jurisdiction
of any country in which this Agreement applies, GEN-PROBE and BM will
negotiate in good faith in order to revise or delete the provision in
question so as to comply with the decision of said Court.
In the event that the terms and conditions of this Agreement are
materially altered as a result of the preceding sub-paragraphs, the
Parties shall re-negotiate the terms and conditions of this Agreement in
order to resolve any inequities.
Page 16
15.6 Headings and titles in this Agreement are for convenience purposes only
and shall not in any way influence the construction, performance and
enforcement of any of its provisions.
15.7 Written Notices required to be given under this Agreement shall be
considered duly given upon receipt by the addressee if mailed by first
class registered mail with return receipt requested, postage prepaid and
addressed as follows:
If to BM:
Boehringer Mannheim GmbH
Legal Counsel, Biochemical Division
Xxxxxxxxx Xxxxxxx 000
00000 Xxxxxxxx
Xxxxxxx
If to GEN-PROBE:
Gen-Probe Incorporated
Attention: General Counsel
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, Xxxxxxxxxx, X.X.X. 00000-0000
15.8 Force Majeure
In the event that either party is prevented from performing or is unable
to perform any of its obligations due to any act of God, war, labor
difficulties, riot, fire, flood, hurricane, wind storm, failure of public
utilities, acts of default by common carriers, governmental laws, act or
regulations (including withdrawal or suspension of governmental sale of
Product), shortages of materials or any other occurrence beyond the
control of the party affected thereby, if such party shall have used its
best effort to avoid such occurrence, such party shall give notice to the
other promptly in writing, and thereupon the affected party's performance
shall be excused and the time for performance shall be extended for the
period of the delay or inability to perform due to such occurrence;
provided always that upon BM's inability to supply any Product, GEN-PROBE
shall have the right, after using one-half of the safety stock of any
affected Product(s), to obtain such Product(s) from an alternative source
and to exercise its rights under section 7.4 if necessary.
Page 17
15.9 The following attachments to this Agreement are hereby incorporated into
this Agreement by this reference and shall be considered integral parts of
this Agreement.
Attachment A: Specifications and Product
Acceptance Criteria
Attachment B: BM Product Pricing Schedule
Attachment C: Annual Product Projections
IN WITNESS WHEREOF, the parties have signed this Agreement, which shall be
effective on a date that it is signed by the last party to sign (the "Signing
Date").
Mannheim, Germany San Diego, California U.S.A.
March 5, 1998 March 2, 1998
Boehringer Mannheim GmbH Gen-Probe Incorporated
By: /s/ XXXX XXXX By: /s/ XXXXX X. XXXXXXXX
--------------------------- -----------------------------------
Xxxx Xxxx Xxxxx X. Xxxxxxxx
Senior Vice President President and
Chief Executive Officer
By: /s/ JAN VAN DER VALK
--------------------------
Jan van der Valk
Senior Director Legal Counsel
Page 18
ATTACHMENT A: SPECIFICATIONS AND ACCEPTANCE CRITERIA
[44 Pages of Specifications and Product Information Deleted Pursuant to
Confidential Treatment Request]
Attachment B, Category A
[***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Attachment B, Category B
[***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Attachment C
[***]
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
