1
EXHIBIT 10.12
[CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS
DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH
THE COMMISSION]
DEVELOPMENT AND SUPPLY AGREEMENT
F1-METER
Between:
LRE Relais + Elektronik GmbH
- Medial Technology -
Xxxxxxxxxxx(xxxx)x 00
00000 Xxxxxxx
Xxxxxxx
(hereinafter referred to as LRE)
and
BIOSITE
Diagnostics Incorporated
00000 Xxxxxxx Xxxxxx
Xxx Xxxxx, XX 00000 U.S.A.
(hereinafter referred to as BIOSITE)
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ARTICLE I
Purpose of this Agreement
Subject matter of this agreement is the development, subsequent serial
production and supply of a portable, fluorescence remission photometer which is
defined in the specifications attached to this agreement as Attachment A
(hereinafter referred to as Fl-Meter).
The development and subsequent serial production of the Fl-Meter will
be done by LRE exclusively for BIOSITE in accordance with the objectives and
performance requirements as set out in the specifications and in conformity with
the Project Plan attached to this agreement (Attachment B).
Specifications (Attachment A) and Project Plan (Attachment B) can be
changed and/or extended only by written approval of both parties.
ARTICLE II
Development
LRE shall develop for BIOSITE a Fl-Meter in accordance with the below
paragraphs 2.1 to 2.4. For this development, BIOSITE shall bear all internal and
external cost which arise at LRE, shall reimburse these costs to LRE pursuant to
paragraphs 2.1 to 2.4.
2.1 Feasibility Study.
The feasibility study has been started November 1993. With the
completion of the feasibility study LRE will deliver the draft specifications
including the draft industrial design, the
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Project Plan and a breadboard reader to evaluate fluorescence remission signals
by a PC.
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION]
2.2 Functional Fluorescence Reader.
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION]
2.3 Prototype Meter.
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION]
2.4 Preproduction Meter.
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION]
2.5 Termination of Development.
(a) By BIOSITE.
During the development phase BIOSITE may terminate the agreement
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
If BIOSITE terminates the agreement during the development phase under
paragraph 10.3, then BIOSITE shall have the exclusive right to use and disclose
all inventions, discoveries, improvements, information, data and other
technology, whether patentable or not, (i) conceived solely by employees or
others on behalf of LRE during the term of the feasibility study or the balance
of the development program directly or indirectly with the use of funding,
materials or information provided by BIOSITE, or (ii) conceived jointly by
employees or others on
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behalf of LRE and by employees or others on behalf of BIOSITE under the
feasibility study or the balance of the development program, together with all
patent and other intellectual property rights thereto (collectively, the "Joint
Technology").
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION]
(b) By LRE.
During the development phase LRE may terminate the agreement
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
If LRE terminates the agreement in the development phase, under
paragraph 10.3, BIOSITE shall have no rights or license to use or disclose the
Joint Technology. If LRE terminates the agreement during the development phase
under paragraph 2.5(b)(ii), then BIOSITE shall have the exclusive right to use
and disclose the Joint Technology.
(c) Costs of Development.
In case of termination by either party during the development phase,
LRE shall use Is best efforts to limit or cancel any outstanding commitments in
connection with the development. Subject to paragraphs 2.1 to 2.5(b), BIOSITE
shall bear all costs incurred by LRE for all development work performed through
the effective termination date, and for all outstanding obligations which were
incurred by LRE in good faith in advance and which cannot be canceled.
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2.6 Cooperation.
LRE and BIOSITE will designate project leaders who shall be the main
contact persons during the development phase.
LRE shall keep BIOSITE reasonably informed throughout each stage of the
development phase of the status of Ks research and development efforts, of its
actual expenses incurred in relation to the budgeted expenses.
BIOSITE shall have the right to visit LRE's facilities on reasonable
request to inspect the research, development and manufacturing conducted by LRE,
to make copies of all applicable records and to discuss the same with employees
of LRE.
At least once every six (6) months during the development phase, LRE
and BIOSITE shall meet, alternating between Munchen and San Diego, to discuss
the status of the development phase and the plans therefor. Such meeting shall
include the project leaders and such others as the parties determine reasonably
necessary or appropriate.
ARTICLE III
Tooling
3.1 Type of Tooling
The majority of tools will be molds for plastic housing parts.
3.2 Prototype Meter Tooling.
The total cost of the additional tooling necessary to efficiently
produce the estimated quantity of Prototype Meters
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is estimated to be [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION].
The tooling has to be ordered two-three (2-3) months prior to the build
of Prototype Meters. LRE will inform BIOSITE appropriately about delivery times,
conditions and actual costs. The tooling will be ordered by LRE after the
receipt of a written approval from BIOSITE to order the tooling. Payment of
tooling cost by BIOSITE are due
- [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION]
3.3 Preproduction Meter Tooling.
The total cost of tooling for the Preproduction Meters is estimated to
be [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
The tooling has to be ordered [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] prior to the build of Preproduction Meters. LRE
will inform BIOSITE appropriately about delivery times, conditions and actual
costs.
The tooling will be ordered by LRE after the receipt of a written
approval from BIOSITE to order the tooling. Payment of tooling cost by BIOSITE
are due
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION]
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- [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] production of the FI-
Meters by LRE.
3.4 Minimize Cost.
Both parties will properly cooperate to minimize risk and cost of
tooling.
ARTICLE IV
Development Results/Industrial Proprietary Rights
4.1 Tooling.
BIOSITE shall be the sole owner of all tooling including molds. Upon
expiration or termination of this agreement, LRE shall transfer to BIOSITE all
applicable tooling, including molds. LRE shall provide such technical assistance
to BIOSITE
4.2 Development Rights.
(a) LRE shall be the sole owner of all inventions, discoveries,
improvements, information, data and other technology, whether patentable or not,
(i) owned by LRE prior to beginning the feasibility study, (ii) licensed to LRE
prior to or during the term of this agreement, or (iii) conceived solely by
employees or others on behalf of LRE during the term of the feasibility study or
the balance of the development program without the use directly or indirectly of
funding, materials or information provided by BIOSITE, together with all patent
and other intellectual property rights thereto (collectively, the
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"LRE-Technology"). BIOSITE shall have the right to use, and subject to the
provisions of Article 9 Confidentiality to disclose, the LRE Technology
disclosed by LRE under this agreement solely for the purpose of performing its
obligations under this agreement.
(b) LRE and BIOSITE jointly shall own all Joint Technology. LRE shall
have the right to use, and subject to the provisions of Article 9
Confidentiality, to disclose, the Joint Technology (i) during the term of this
agreement and for a period of [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] after the expiration or termination of this
agreement, only for purposes to which BiOSITE gives its prior express written
consent, which shall not be unreasonably withheld, and (ii) thereafter, for any
purpose whatsoever without the prior written consent of BIOSITE; provided,
however, if this agreement is terminated (A) by BIOSITE under paragraph 10.3 or
(B) by LRE under paragraph 2.5(b)(ii). BIOSITE shall have the exclusive right to
use, and subject to the provisions of Article 9 Confidentiality, to disclose,
the Joint Technology for any purpose subject to the provisions of paragraph
4.3.(a). BIOSITE's right to use and disclose the Joint Technology after
termination or expiration of this agreement for whatever purpose shall survive
the termination or expiration of this agreement, except if LRE has terminated
the agreement pursuant to paragraph 10.3 or BIOSITE has terminated the agreement
during the development phase pursuant to paragraph 2.5(a).
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(c) BIOSITE shall be the sole owner of all inventions, discoveries,
improvements, information, data and other technology, whether patentable or nor,
(i) owned by BIOSITE prior to beginning the feasibility study, (ii) licensed to
BIOSITE prior to or during the term of this agreement, or (iii) conceived solely
by employees or others on behalf of BIOSITE during the term of the feasibility
study or the balance of the development program, together with all patent and
other intellectual property rights thereto (collectively, the "BIOSITE
Technology"). LRE shall have the right to use, and subject to the provisions of
Article 9 Confidentiality to disclose, the BIOSITE Technology disclosed by
BIOSITE under this agreement solely for the purpose of performing its
obligations under this agreement.
(d) LRE at its sole expense shall have the right to control the
preparation, filing, prosecution, maintenance and enforcement of all patent
applications and patents regarding the LRE Technology. BIOSITE at its sole
expense shall have the right to control the preparation, filing, prosecution,
maintenance and enforcement of all patent applications and patents regarding
BIOSITE Technology. Each party shall have the right to control the preparation,
filing, prosecution, maintenance and enforcement of all patent applications and
patents regarding Joint Technology, provided, however, if both parties wish to
control the patent rights with respect to any of the Joint Technology, then LRE
and BIOSITE shall meet and determine by mutual agreement which party shall have
the right
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to control the patent right with respect to such Joint Technology. The party
that controls the patent rights with respect to any Joint Technology shall bear
the costs therefor, including the accruing costs for the remuneration of
employees' inventions according to the Law on Employees' inventions (Gesetz uber
Arbeitnehmererfindungen), unless the parties otherwise agree in writing.
(e) If LRE directly or indirectly uses any Joint Technology for the
benefit of any third party or transfers any Joint Technology to any third party,
LRE shall pay to BIOSITE an amount equal to the cost paid to LRE by BIOSITE to
develop such technology.
4.3 Exclusivity.
(a) During the term of this agreement, BIOSITE shall be obligated to
purchase the Fl-Meter exclusively from LRE and not to commission any third party
to produce the Fl-Meters, except (i) if LRE is not capable to produce sufficient
quantity of Fl-Meters to satisfy BIOSITE's needs, or (ii) with respect to any
specific immunoassay application which BIOSITE requests, if LRE is prohibited
from producing Fl-Meters for BIOSITE for such immunoassay application. In
particular, BIOSITE shall not change the Fl-Meter on its own authority, and
shall not pass on to third parties any know-how relating to the individual
development phases and to the finished product Fl-Meter except to the extent
reasonably necessary to sell or use the Fl-Meter in the immunoassay field.
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(b) [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] Upon full payment of all development cost pursuant to Article 2
hereof, BIOSITE shall be entitled to purchase and sell the F1-Meter exclusively.
Notwithstanding the foregoing, the exclusivity rights and obligations under this
paragraph 4.3(b), [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] shall survive such expiration or termination for a period of
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] after
such expiration or termination, except (1) if this agreement is terminated by
LRE under paragraph 10.2(b) or 10.3, or (2) if this agreement is terminated by
BIOSITE under paragraph 2.5(a), other than for grounds specified under paragraph
10.3.
4.4 Technical Information.
BIOSITE will have access to all technical documentation such as
drawings, circuit diagrams, software listings, etc. produced under this
agreement exclusively for the Fl-Meter. The corresponding documents shall be
provided by LRE on the demand
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by BIOSITE after the receipt of payment for the actual development phase.
4.5 [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
ARTICLE V
Serial Production
5.1 For the term hereof, BIOSITE shall purchase all Fl-Meters it
requires exclusively from LRE, and LRE shall have the exclusive right and
obligation to produce all Fl-Meters required by BIOSITE, except (i) if LRE is
not capable to produce sufficient quantity of Fl-Meters to satisfy BIOSITE's
needs, or (ii) with respect to any specific immunoassay application which
BIOSITE requests, if LRE is prohibited from producing Fl-Meters for BIOSITE for
such immunoassay application.
5.2 Each Fl-Meter shall be manufactured in accordance with the
Specifications. The Specifications may be modified from time to time only by
written approval of both parties.
5.3 In order to appropriately prepare for the necessary production
volumes LRE needs firm orders for the [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] prior to the beginning of the first
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] of
production and an update each subsequent quarter (revolving forecast) for the
following [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION].
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The shipments will commence about [CONFIDENTIAL MATERIAL
REDACTED AND FILED SEPARATELY WITH THE COMMISSION] after receipt
of the corresponding orders.
BIOSITE shall place its orders and forecasts, and shall purchase
Fl-Meters, as follows:
BIOSITE shall purchase a specified quantity of Fl-Meters specified in
each order and forecast as follows: BIOSITE shall purchase in the [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] all Fl-Meters firmly
ordered for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] according to BIOSITE's binding order. BIOSITE shall purchase in the
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] at
least [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION]
of the quantity ordered for the [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION]. The remaining [CONFIDENTIAL MATERIAL REDACTED
AND FILED SEPARATELY WITH THE COMMISSION] of the quantity firmly ordered for the
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] may be
accepted by BIOSITE alteratively in the [CONFIDENTIAL MATERIAL REDACTED AND
FILED SEPARATELY WITH THE COMMISSION] following the order and forecast. The
forecast for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] following the order and forecast shall not be binding on BIOSITE.
BIOSITE shall be obligated to reimburse LRE for the costs of materials purchased
for that quantity of Fl-Meters forecast for the [CONFIDENTIAL MATERIAL REDACTED
AND FILED SEPARATELY WITH THE COMMISSION] and not purchased in the
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[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION]
following the order and forecast, which costs were incurred by LRE in good faith
in advance and which cannot be canceled; provided, however, that BIOSITE shall
be entitled to credit such reimbursed costs ratably against the purchase price
of a like quantity of Fl-Meters purchased thereafter. BIOSITE shall have this
right to credit for a period of at least one (1) year after BIOSITE has
reimbursed LRE for such cost of materials. The forecast for the [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] following the order
and forecast shall not be binding on BIOSITE and shall be used for orientation.
Each firm purchase order shall provide delivery dates and delivery
information requirements.
5.4 If serial production is not possible for whatever reason--unless
BIOSITE terminated this agreement under paragraph 10.2 (c) or 10.3--or if
BIOSITE fails to order and purchase [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] F1-Meters during the first twelve (12) months of
production, BIOSITE shall reimburse LRE for that portion of the cost for the
specific tooling purchased by LRE for the Fl-Meter specific production equipment
that was not reimbursed through the pricing structure for the first twelve (12)
months of production.
5.5 Delivery by LRE shall be made at least quarterly. LRE shall deliver
a minimum quantity of [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION] F1-Meters in
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each delivery. LRE shall deliver a quantity in excess of the minimum quantity as
soon as it is able to do so. After BIOSITE has informed LRE of the needed
quantity and has placed the respective orders, LRE shall use its commercially
reasonable efforts to meet BIOSITE's requested delivery dates, although the
quantities to be delivered and the dates of delivery may vary in accordance with
LRE's capacity. BIOSITE's order shall be delivered in the quarter following the
order. Within a quarter LRE may deliver the whole quantity at once or may,
alteratively, make up to six (6) partial deliveries the quantities of which to
be determined by LRE, unless still provided otherwise by the contract parties.
5.6 If BIOSITE discontinues its orders for a period of [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION], (a) in the event
that the material necessary for BIOSITE's next order is already available at LRE
or will be promptly available somewhere else, delivery by LRE shall commence not
later than [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] after receipt of BIOSITE's next order, or (b) otherwise, delivery by
LRE shall commence not later than [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] after receipt of BIOSITE's next order.
5.7 If a shipment of Fl-Meter or any portion thereof is damaged or
defective, then BIOSITE shall have the right to reject such shipment or the
portion thereof that fails to conform. BIOSITE in good faith shall consult with
LRE, and if applicable the carrier, in making any determination that any
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shipment or portion is defective. BIOSITE shall give written notice to LRE of
its rejection hereunder, specifying the grounds for such rejection. BIOSITE
shall hold the defective shipment or portion for up to [CONFIDENTIAL MATERIAL
REDACTED AND FILED SEPARATELY WITH THE COMMISSION], for return to LRE or
disposition at LRE's option and at LRE's expense, if found to be not in
conformance with the Specifications. LRE shall use its commercially reasonable
efforts to cure such rejection or replace such spoiled, damaged or defective
shipment of Fl-Meter within ninety (90) days after receipt of notice of
rejection thereof. If no notice of rejection is given by BIOSITE within thirty
(30) days after receipt of any shipment of Fl-Meters, the shipment of the
Fl-Meters shall be deemed to have been accepted.
5.8 BIOSITE shall have the right to designate one or more third
parties, including E. Merck, to purchase Fl-Meters under this agreement for sale
and use on such terms and conditions as agreed by BIOSITE and E. Merck or such
other third party. Each such third party shall have the right to purchase
Fl-Meters directly from LRE, and shall be obligated to make forecasts, place
orders and pay the transfer price therefor directly to LRE, on the terms and
conditions of this agreement. BIOSITE shall give written notice to LRE of any
third party so designated.
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ARTICLE VI
Supply Price and Volume
6.1 Prices are fixed for the [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] of production and depend on the total quantity
of Fl-Meters ordered during such period. The transfer prices are:
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
After the [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] of production, the transfer
prices will be reduced as follows:
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
- [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION]
The transfer price for the Fl-Meters for each order shall be calculated
based on the forecasted orders for Fl-Meters for such year. After the actual
quantity of Fl-Meters ordered in any year are calculated after the end of such
year, the transfer price for all Fl-Meters ordered during such year shall be
adjusted, and the parties shall promptly settle any amounts underpaid or
overpaid during such year in a manner mutually acceptable to both parties.
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6.2 Prices are free on board Munich airport or Frankfurt airport for
Fl-Meters in adequate bulk packing for overseas shipments. If BIOSITE desires
single packing which is fit for final sale, LRE will offer packing as specified
by BIOSITE at additional cost.
Prices do not include the German value added tax or any US taxes.
6.3 For each delivery accepted pursuant to paragraph 5.7, BIOSITE shall
make payment within 30 days from receipt of such delivery and the corresponding
invoice.
ARTICLE VII
Quality Control
LRE will perform regular in-process controls and a final test for each
Fl-Meter shipped in accordance with the specifications, keeping complete records
of the results of each test.The testing procedures and the permissible
variations and tolerances will be agreed upon between LRE and BIOSITE and laid
down in the final specifications.
The test reports of each Fl-Meter delivered can be provided to BIOSITE
if desired.
LRE shall not make any changes to the final specification without
BIOSITE's prior written approval.
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ARTICLE VIII
Warranty
The warranty period for each Fl-Meter produced under this agreement
will be twenty-four (24) months from the date of shipment. It will cover defects
in material, workmanship, design and performance as per specifications and
intended use of the Fl-Meter. Warranty does not cover any battery-related
defects.
LRE will repair or replace any defective Fl-Meter during the
warranty-period at its own expense. Upon request, BIOSITE shall return all
defective Fl-Meters to LRE at LRE's expense.
ARTICLE IX
Confidentiality
9.1 During the term of this agreement and for a period of [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] after, each party
will hold in strict confidence and not disclose to third parties, not use except
for the purposes of this agreement, and restrict access to those persons
(including consultants) carrying out activities under this agreement, any and
all information disclosed by the other party under this agreement and treated as
confidential by such party. Notwithstanding the foregoing, LRE and BIOSITE each
shall have the right to disclose Joint Technology to any third party with whom
it has or proposes to enter into a business relationship, provided that such
third party has executed a written agreement
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with it to maintain in confidence and not use such confidential information
except as otherwise authorized by this agreement.
Excepted from this only shall be the information which
(a) is in public domain at the time of disclosure,
(b) becomes otherwise part of public domain through no
fault of the receiving party,
(c) was in the possession of the receiving party at the time of
disclosure by the other party as shown by the receiving party's written records,
or thereafter becomes available from a third party who has the right to disclose
it. Companies which LRE or BIOSITE control or are under common control with LRE
or BIOSITE are not regarded as third parties. These companies and persons
(including consultants) carrying out activities under this agreement may be
given such information only if they have accepted the confidentiality terms of
this agreement as binding them.
9.2 For purposes of the Article 9, Joint Technology shall constitute
confidential information with respect to both parties.
9.3 The obligations of confidentiality and non-use contained in Article
9 shall not apply to the extent that the receiving party is required to disclose
information by applicable law, regulation or court order.
9.4 Neither party shall disclose any terms or conditions of this
agreement to any third party without the prior consent of the other party.
Notwithstanding the foregoing, the parties shall agree upon the substance of
information that can be used
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to describe the terms of this transaction without the other
party's prior consent.
ARTICLE X
Term
10.1 During the Development Phase.
This agreement may be terminated by either party during the development
phase only as provided in paragraph 2.5.
10.2 During Serial Production.
(a) This agreement can be terminated by either party by giving
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] prior
written notice, [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION].
(b) LRE can terminate the agreement earlier [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION].
(c) BIOSITE can terminate this agreement earlier ff LRE fails to supply
BIOSITE with its firmly ordered quantities of Fl-Meters for [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION]
10.3 At Any Time.
Either party has the right to terminate this agreement at
any time, without previous notice for cause, if
(a) the other party commits a material breach of any of the covenants
and terms herein contained and has not, [CONFIDENTIAL MATERIAL REDACTED AND
FILED SEPARATELY WITH THE COMMISSION] after having been required in writing to
do so, remedied such breach; provided, however, that there shall not
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exist a material breach within the meaning of this paragraph 10.3(a) ff the
parties mutually determine under paragraph 2.5(b)(ii) that the intended result
of the development cannot be achieved or, for reasons beyond the reasonable
control of LRE, can only be achieved at expenditure by LRE, significantly in
excess of the costs described in paragraphs 2.1 to 2.4, for which BIOSITE is
unwilling to reimburse LRE after notice thereof; or
(b) a petition is filed by or against the other party under any
bankruptcy or insolvency laws; provided that if the other party gives adequate
assurance of contesting any such petitions and such petitions are dismissed
within one hundred eighty (180) days of filing, such filing shall not constitute
a cause of termination.
10.4 Notice.
Notice of termination shall be effective upon receipt.
10.5 Effect.
Expiration or termination of this agreement shall not
relieve the parties of any obligation accruing prior to such expiration or
termination. The provisions of Articles 4.9 and 11 shall survive the expiration
or earlier termination of this agreement.
10.6 Force Majeure.
Neither party shall be held liable or responsible to the other party
nor be deemed to have defaulted under or breached this agreement for failure or
delay in fulfilling or performing any term of this agreement to the extent, and
for so long as,
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such failure or delay is caused by or results from causes beyond the reasonable
control of the affected party including fire, floods, embargoes, war, acts of
war (whether war be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, act of God or acts, omissions or
delays in acting by any governmental authority or the other party.
ARTICLE XI
Indemnification and Insurance
11.1 Regarding LRE's liability, the provisions of German law relating
to damages and product liability shall apply.
11.2 LRE shall maintain products liability insurance against claims
regarding the manufacture of the Fl-meters by LRE in such amounts as it
customarily maintains for its manufacture of similar products in Germany. LRE
shall maintain such insurance during the term of this agreement and thereafter
for so long as it maintains insurance for such covering such activities.
ARTICLE XII
Conciliation
BIOSITE and LRE shall exercise their commercially reasonable efforts to
settle between themselves in an amicable way any dispute, controversy or claim
which may arise out of or relating to this agreement within thirty (30) days
after one
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party receives notice from the other party of such dispute, controversy or
claim.
ARTICLE XIII
Final Provisions
13.1 This agreement and the transactions contemplated thereby are
governed exclusively by the substantive laws of the Federal Republic of Germany
exclusive of the German international law and any supranational or international
bodies of law. This shall not apply to the provisions regarding the confidential
information of BIOSITE, pursuant to Article 9 Confidentiality, which shall be
construed and interpreted in all respects in accordance with the laws of the
State of California.
13.2 Any dispute arising out of or in relation to this agreement
including disputes regarding its validity shall be resolved by binding
arbitration conducted under the International Chamber of Commerce Arbitration
Rules. The procedural rules shall follow the German rules of Civil Procedure,
unless the rules of the International Chamber of Commerce provide for different
rules. Any such arbitrations shall be conducted in English language with such
rules, and shall be held in Munchen, Germany. One judge shall be named by the
party bringing the action, one judge shall be named by the party defending such
action and the presiding judge shall be named by the two judges appointed. At
least one of the judges shall have command of the German language. The
arbitrators shall have the authority to grant specific performance, and to
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allocate between the parties the costs of arbitration in such equitable manner
as they determine. Judgment upon the award so rendered may be entered in any
court having jurisdiction or application may be made to such court for judicial
acceptance of any award and an order of enforcement, as the case may be.
13.3 This agreement and its Attachments embody the entire and standing
agreement among the parties and supersede all previous written or oral
agreements with respect to the development and sale of the Fl-Meter.
13.4 Modifications of and amendments to this agreement as well as the
suspension of its provisions shall become effective only when approved by both
parties in writing.
13.5 Subject to the choice of law provisions of paragraph 13.1, LRE and
BIOSITE shall comply in all material respects with all applicable laws and
regulations in the performance of their respective obligations under this
agreement.
13.6 Any consent, notice or report required or permitted to be given or
made under this agreement by one of the parties to the other shall be in
writing, delivered personally or by facsimile (and promptly confirmed by
personal delivery, air mail, internationally-recognized delivery service or
courier), air mail, internationally-recognized delivery service or courier,
postage prepaid (where applicable), addressed to such other party at its address
indicated below, or to such other address as the addresses shall have last
furnished in writing to the addressor and (except as otherwise provided in this
agreement) shall be effective upon receipt by the addresses.
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If to BIOSITE: BIOSITE Diagnostics Incorporated
00000 Xxxxxxx Xxxxxx
Xxx Xxxxx, Xxxxxxxxxx 00000, X.X.X.
Attention: Xxx X. Xxxxxxxxxxxx
President
with a copy to: Pillsbury Madison & Sutro
000 Xxxxxxxxxx Xxxxxx, 15th Floor
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, X.X.X.
Attention: Xxxxxx X. Xxxxxx, Xx.
If to LRE: LRE Relais + Elektronik GmbH
Xxxxxxxxxxx(xxxx)x 00
00000 Xxxxxxx
Xxxxxxx Xxxxxxxx of Germany
Attention: Xxxxxxxx Xxxxxxxx
President
13.7 BIOSITE and LRE each acknowledge that the development and
commercialization rights and information disclosure requirements of this
agreement are subject to certain laws and regulations of the Federal Republic of
Germany and the United States of America relating to the export of products and
technical information. without limiting the application of paragraph 13.1,
BIOSITE and LRE each shall comply with all applicable laws and regulations.
13.8 It is expressly agreed that BIOSITE and LRE shall be independent
contractors and that the relationship between the two parties shall not
constitute a partnership, joint venture or agency. Neither BIOSITE nor LRE shall
have the authority to make any statements, representation or commitments of any
kind, or to take any action, which shall be binding on the other, without the
prior consent of the party to do so.
13.9 The English language version of this agreement shall govern and
control any translations of this agreement into any other language.
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13.10 In the event of one or more provisions of this agreement becoming
void, the remaining provisions contained herein shall remain in full force and
effect. The parties agree to have provisions having become void shall be deemed
as severable and be replaced by valid provisions which maintain the intentions
of the invalid provisions as far as possible.
Munchen/Nordlingen, San Diego,
September 23, 1994 September 23, 1994
LRE Relais + Elektronik GmbH BIOSITE Diagnostics
Incorporated
/s/ Xxxxxxxx Xxxxxxxx /s/ Xxx X. Xxxxxxxxxxxx
---------------------------- -------------------------
Xxxxxxxx Xxxxxxxx Xxx X. Xxxxxxxxxxxx
President President
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EXHIBIT A
[34 PAGES OF ENGINEERING SPECIFICATIONS AND OTHER CONFIDENTIAL MATERIALS
REDACTED AND FILED SEPARATELY WITH THE COMMISSION]
