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EXHIBIT 10.6
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF
THIS AGREEMENT. THE REDACTED PROVISIONS ARE IDENTIFIED BY THREE ASTERISKS AND
ENCLOSED BY BRACKETS. THE CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
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DEVELOPMENT AND MANUFACTURING AGREEMENT
by and between
ANSYS DIAGNOSTICS, INC.
and
ROCHE DIAGNOSTIC SYSTEMS, INC.
Dated
September 1, 1996
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DEVELOPMENT AND MANUFACTURING AGREEMENT
This Agreement, effective as of September 1, 1996, by and between Roche
Diagnostic Systems, in ("RDS"), a corporation organized and existing under the
laws of the State of New Jersey with offices at 0000 Xxxxxxx 000, Xxxxxxxxxx,
Xxx Xxxxxx 00000, and ANSYS, Inc. ("ANSYS"), a corporation organized and
existing under the laws of the State of California with offices at 2 Goodyear,
Xxxxxx, Xxxxxxxxxx 00000.
WHEREAS, RDS and ANSYS entered into a Commercial Agreement for the exclusive
manufacture and supply of a "No-Step Kit" (TesTcup); and
WHEREAS, RDS desires to appoint ANSYS as exclusive manufacturer of a new device
tentatively to be called TestStick (the "Device") based upon the same
technology; and
WHEREAS, RDS has agreed to pay ANSYS a developmental fee for the Device
packaging; and
WHEREAS RDS has agreed to provide capital sufficient to purchase certain
equipment in support of the manufacture of the Device; and
WHEREAS, in consideration of the above, ANSYS has agreed to assign to RDS all
rights and exclusive ownership to the Device.
NOW THEREFORE, in consideration of the premises and of the mutual covenants of
the parties set forth herein, the parties agree as follows:
1.0 DEFINITIONS
1.1 "Affiliate" shall mean:
(a) a business entity which owns, directly or indirectly,
a controlling interest in RDS, by stock ownership or
otherwise; or,
(b) a business entity which is owned by RDS, either
directly or indirectly, by stock ownership or
otherwise; or,
(c) a business entity, the majority ownership of which is
directly or indirectly common to the majority
ownership of RDS.
Anything to contrary in this paragraph notwithstanding, Genentech,
Inc., a Delaware corporation, shall not be deemed an Affiliate of RDS.
1.2 "Confidential Information" shall a party's technology, data,
know-how, or information whether technical or non-technical,
financial statements and reports, pricing, trade secrets,
secret processes, formulas and customer data (including
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customer lists), and the like, that is disclosed to the other
Party and which at the time of disclosure is clearly marked as
"Confidential." Oral communication shall be considered
Confidential Information provided that such communication is
reduced to writing, marked as "Confidential" and provided by
the disclosing party to the other party within thirty (30)
days after such oral disclosure.
1.3 "Device" shall mean the device (tentatively to be called
TestStick) developed by RDS and ANSYS to test various fluids
for biological and chemical analysis including, without
limitation, certain drugs of abuse through the utilization of
RDS's Regent Technology. The product specifications' for the
Device are set forth on Exhibit A, which RDS may, subject to
ANSYS's reasonable approval, modify from time to time. A copy
of Exhibit A is attached hereto and made a part hereof.
1.4 "RDS Reagent Technology" shall mean the products, reagents,
patents, patent rights, technology, manufacturing methods and
processes, formulas, designs, technical data, product
development and research data, know how, secret processes,
trade secrets, intellectual property rights, quality control
and quality assurance protocols, and the like, owned or
controlled by RDS that can be used to test for biological and
chemical analyses including, without limitation, certain drugs
of abuse through the use of immunoassay and chromatography
technology.
1.5 "RDS" shall mean Roche Diagnostic Systems and its Affiliates.
2.0 OWNERSHIP AND PATENT RIGHTS
2.1 Ownership.
(a) RDS shall own the entire proprietary right, title and
interest in and to the RDS Reagent Technology and
ANSYS shall have no right, title or interest therein.
(b) RDS shall own the entire proprietary right, title and
interest in and to the Device, and ANSYS shall have
no right, title or interest therein, except as
provided in Article 6 of this Agreement.
2.2 Patent Application.
(a) ANSYS shall prepare and file the necessary patent
applications to protect any and all patentable
inventions relating to the Device (excluding
reagents). ANSYS shall assign to RDS, in such patent
applications, any and all of its proprietary rights
to such inventions.
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(b) ANSYS shall not file any such patent applications
without RDS's prior written approval, and ANSYS shall
make any changes reasonably requested by RDS to the
applications before the filing thereof.
2.3 Additional Patent Rights to the Device. In the event that
during the term of this Agreement, or any renewal thereof, an
invention is made based upon the Device that results in
additional patentable rights to such product, then the
following provisions shall apply.
(a) All such additional patent rights shall belong to RDS
regardless of whether it was developed by (i) RDS,
(ii) ANSYS, or (iii) jointly by RDS and ANSYS.
(b) In the event that the additional patent rights are
developed (1) jointly by ANSYS and RDS, or (ii)
solely by ANSYS, then ANSYS shall prepare and file
the necessary patent applications to protect such
additional patent rights. ANSYS shall assign to RDS,
in such patent applications, all of its rights to
such inventions.
(c) ANSYS shall not file any such patent applications
without RDS's prior written approval, and ANSYS shall
make any changes reasonably requested by RDS to the
applications before the filing thereof.
(d) RDS shall (i) pay for all reasonable expenses
associated with the preparation and filing of any
patent application provided for in this Section 2.3
and Section 2.2. (ii) pay for the maintenance of any
patents issued, and (iii) reimburse ANSYS for any
reasonable expenses incurred by ANSYS in connection
with the preparation and filing of the application.
Such reimbursement shall be in addition to the fees
that RDS shall pay ANSYS under Section 3.1(c).
2.4 Other Patent Rights. If a patent application is filed or
issued in connection with activities performed under this
Agreement or any renewal thereof, that does not cover the
Device and thus is not covered by Section 2.3 resulting in
inventions arising from or relating to the development or
manufacture of the Device, then this Section shall apply.
(a) Patent rights to such invention resulting solely from
the efforts of RDS shall be owned solely by RDS and
any such invention shall; be promptly disclosed in
writing by RDS to ANSYS.
(b) Patent rights to an invention resulting solely from
the efforts of ANSYS shall be owned solely by ANSYS
and any such invention shall be promptly disclosed in
writing by ANSYS to RDS.
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(c) Patent rights to an invention resulting from the
collaborative efforts of both parties shall be
jointly owned by the parties.
3.0 DEVELOPMENT, MANUFACTURE AND SUPPLY OF DEVICES
3.1 Development.
(a) ANSYS shall work in collaboration with RDS to further
develop and optimize the Device for RDS which shall
include optimizing the design of the Device,
completing product development, initiating production
activities, and manufacturing and supplying RDS with
various prototypes of the Device for preclinical and
clinical studies and other applications.
(b) ANSYS shall use its best efforts to complete, to the
satisfaction of RDS, any activities that RDS
reasonably requests ANSYS perform under this Section.
ANSYS shall not on its own initiate any activities
hereunder without receiving prior written approval
from RDS.
(c) In consideration of the services that ANSYS will
provide under this section 3.1, RDS shall pay ANSYS a
monthly fee of $[***], for each month that ANSYS is
performing services hereunder, or a pro rata portion
thereof, but in no event shall RDS pay ANSYS more
than $[***] to further develop and optimize the
Device for RDS. Notwithstanding that ANSYS will
receive a maximum of $[***] for performing services
under this Section, ANSYS shall continue to work on
and complete the development and optimization of the
Device until it meets the product specifications
listed on Exhibit A, even if it takes more than four
(4) months to accomplish.
(d) In the event that RDS makes changes to the product
specifications listed on Exhibit A, after the date of
this Agreement, but before the first commercial
manufacturing of the product pursuant to Section 3.6,
the fees and time schedule stated herein shall be
renegotiated in good faith by the parties.
(e) ANSYS shall not start manufacturing the Device for
RDS pursuant to section 3.6 until all the services
requested herein by RDS have been completed by ANSYS
to the satisfaction of RDS.
(f) ANSYS shall provide RDS with quarterly reports which
shall include estimates on completion time and
budgets, along with such other information as may be
reasonably requested by RDS.
[***] Confidential treatment has been requested for redacted portion. The
confidential redacted portion has been omitted and filed separately
with the Securities and Exchange Commission.
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3.2 Governmental Approvals.
(a) RDS shall secure and maintain governmental approvals
to market and sell the Device. RDS shall, in its sole
discretion, determine in which countries it will
pursue, and discontinue the pursuit of, such
governmental approval.
(b) ANSYS shall assist RDS, as requested by RDS, in
securing and maintaining such governmental approvals
for the Device. ANSYS's assistance may include
conducting studies and providing to RDS data or other
information required or requested by the governmental
authorities and assisting in the completion and
filing of applications and other forms necessary for
such governmental approvals.
(c) RDS is responsible for such governmental approvals
and shall reimburse ANSYS for any reasonable expenses
incurred by ANSYS in connection with such activities.
3.3 Manufacturing Equipment.
(a) ANSYS shall be responsible for selecting and
purchasing the equipment and materials, including
product designs, necessary to manufacture the Device,
all as set forth in the capital budget, Exhibit B
attached hereto and incorporated herein by this
reference. Other than as set forth on Exhibit B,
ANSYS shall not purchase any equipment or materials
without RDS's prior written approval. ANSYS shall
invoice RDS for expenditures under this Section
3.3(a). The invoices shall be sufficiently detailed
to describe the equipment or materials purchased and
the cost incurred therefor. In the event that RDS
modifies the product specifications set forth in
Exhibit A as provided herein, then ANSYS shall
provide RDS with a revised capital budget for
approval, which revised budget shall replace and
supersede Exhibit B for all purposes.
(b) RDS shall pay for all equipment and materials,
including product designs, that it approves the
purchase thereof under Section 3.3(a). Upon such
payment, RDS shall own the entire right, title and
interest to such equipment and materials, and ANSYS
shall have no right, title or interest therein,
except to use such equipment and materials to
manufacture and
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supply the Device to RDS pursuant to the terms of
this Agreement. Notwithstanding the foregoing, ANSYS
shall pay for capital expenditures in the excess of
one hundred fifteen percent (115 %) of the aggregate
amount set forth in Exhibit B, as Exhibit B may be
revised from time to time in accordance herewith.
Such equipment and materials shall be delivered by
ANSYS to RDS upon the expiration or termination of
this Agreement.
(c) During the term of this Agreement, RDS shall have the
right, upon reasonable notice to ANSYS, to audit the
books and records of ANSYS related to the equipment
and materials acquired pursuant to this Section 3,
and to identify and physically "tag" all such
equipment and materials at ANSYS's premises. RDS
shall bear its own cost or expense associated with
any such audit or identifying.
ANSYS shall be solely responsible for obtaining and
maintaining casualty insurance covering the full
replacement cost of the equipment and materials
purchased by RDS under the terms hereof.
3.4 Reagents. RDS shall supply ANSYS with the reagents necessary
to manufacture the Device.
3.5 Price. Pricing for the Device shall be as set forth in Exhibit
C, attached hereto. In the event RDS changes the Product
Specifications as set forth in Exhibit A, then the parties
agree to negotiate in good faith to modify Exhibit C if the
parties are unable to agree to a modification of Exhibit C
within 120 days from the change to Exhibit A, the parties
shall submit the matter to binding arbitration.
3.6 Exclusivity. During the term hereof, RDS appoints ANSYS as the
exclusive manufacturer of the Device and ANSYS shall
manufacture the Device at its facilities in Irvine,
California, or such other facility as may be mutually agreed
upon by both parties, and shall supply such products to RDS on
an exclusive basis, even as to ANSYS, worldwide; provided
however, that in the event ANSYS receives a license under
Article 6, ANSYS may manufacture and supply the Device in
those markets or market segments covered by such license.
Notwithstanding the foregoing, if, through no fault of RDS,
ANSYS becomes unable to manufacture the Device in accordance
with the terms of this Agreement, RDS may use another vendor
to manufacture the Device, provided, that RDS shall notify
ANSYS in writing of the basis for RDS determination that ANSYS
is unable to manufacture the Device, and ANSYS shall have
thirty (30) days after the date of such notice to cure the
condition. If ANSYS is unable to cure the condition within
such 30-day period, then RDS may use another vendor to
manufacture the Device.
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3.7 Packaging. ANSYS shall label the Device with language to be
supplied by RDS and shall package the product with a package
insert, the language of which shall also be supplied by RDS.
RDS shall have the right, in its sole discretion, to make
changes to the label, package insert and other labeling for
the Device, subsequent to the reasonable approval of ANSYS,
which changes shall be submitted by RDS to the applicable
governmental authorities, if required. ANSYS's name may, at
RDS's sole discretion, appear on the label, package insert and
other labeling for the Device.
3.8 Launch Date. The target launch date for the Device is twelve
(12) months after the execution date of this Agreement, but in
no event shall the launch date be delayed without mutual
consent of both parties with documented cause.
3.9 Quality Control and Assurance.
(a) ANSYS shall manufacture the Device in accordance with
the then current product specifications as set forth
on Exhibit A, as may be modified from time to time in
accordance with Section 1.3 above, as well as with
the then current quality control specifications,
which, at RDS's discretion, it may modify from time
to time, subject to the reasonable approval of ANSYS.
A copy of the quality control specifications will be
provided by RDS within a reasonable period after
execution of this Agreement and shall be attached
hereto as Exhibit D.
(b) ANSYS shall manufacture the Device in compliance with
all federal, state and local laws and regulations.
(c) ANSYS shall perform quality control and quality
assurance testing and verification to ensure that the
Device complies with the requirements set forth in
Section 3.9(a) and (b).
(d) Each time ANSYS ships the Device to RDS, ANSYS shall
provide RDS with a Certificate of Analysis at the
time of shipment, certifying that the products have
been evaluated by ANSYS's Quality Control and Quality
Assurance departments and that the product complies
with the requirements set forth in Sections 3.9(a)
and (b). Within a reasonable period after execution
of this Agreement RDS shall provide ANSYS with a
sample Certificate of Analysis which ANSYS shall use
pursuant to this Section.
4.O ORDERS, DELIVERY, INVOICING AND PAYMENT
4.1 Forecasts. Within a reasonable time from the date of this
Agreement, but in no event later than sixty (60) days prior to
the scheduled date of the product launch
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by RDS of the Device, RDS shall supply ANSYS with its current
estimates for the Device for each of the four (4)
three-calendar-month periods following the product launch
date. Each such estimate for four (4) three-calendar-month
periods hereinafter is called a "Rolling Forecast." RDS shall
thereafter provide ANSYS with Rolling Forecasts on a quarterly
basis. No minimum units for any three-calendar-month period of
any Rolling Forecast are required to be forecasted by RDS;
provided however, that the quantity of the Device for the
initial three-calendar-month period of any Rolling Forecast
may, without the consent of ANSYS, vary upward or downward
from RDS's prior estimate from such three-calendar-month
period by an amount not to exceed twenty percent (20%). RDS
and ANSYS shall be bound by RDS's estimates, if any, for the
first three-calendar-month period of each such Rolling
Forecast. ANSYS's obligations to manufacture the Device for
RDS under this Agreement shall be subject to its maximum
production capacity.
4.2 Orders. RDS will order products by providing ANSYS with
written Purchase Orders, which shall contain the purchase
order number, product numbers, names and quantities, unit and
total purchase price and shipping instructions. No additional
terms or conditions shall be permitted to be added by ANSYS to
any Purchase Order, whether by way of altering same or
providing a document that purports to contain additional
terms, and any such additional terms and conditions shall be
void and of no force or effect, notwithstanding that RDS may
accept and perform its obligations hereunder with respect to
any such allegedly modified Purchase Order without rejecting
specifically such additional terms and conditions.
4.3 Shipments. ANSYS shall ship and deliver the Device F.O.B.
ANSYS shipping point to such RDS locations as requested by
RDS. ANSYS shall, is requested by RDS, ship and deliver the
Device to customers of RDS, at the sole cost and expense of
RDS. RDS may select the freight carrier used by ANSYS to ship
the products and may monitor ANSYS's shipping/freight
practices as they pertain to this Agreement. ANSYS shall ship
the Device within thirty (30) days of receipt of a Purchase
Order from RDS.
4.4 Invoices and Payment. ANSYS shall submit to RDS, with each
shipment of the Device, an invoice covering such shipment.
Each such invoice shall identify the RDS Purchase Order
number, product numbers, names and quantities, unit price,
freight charges and total amount to be remitted by RDS. RDS
shall pay for all such invoices within thirty (30) days after
its receipt of such invoices.
4.5 Lot Numbering/Expiration Dates. ANSYS shall make arrangements
for and implement the imprinting of lot numbers and expiration
dates for each Device shipped. Such lot numbers and expiration
dates shall be affixed on the product and on the shipping
carton of each product as is required under good commercial
practice.
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5.0 COOPERATION
5.1 Technical Support. ANSYS shall provide reasonable technical
support and training relating to the Device to RDS as
requested by RDS.
5.2 Records and Accounting by ANSYS. ANSYS shall keep records of
the manufacture, testing and shipping of the products supplied
hereunder by ANSYS, and retain samples of such products that
are necessary to assist with, and support, good manufacturing
practices, product complaints, investigations and other
regulatory requirements. Such records and samples shall be
made available to RDS upon its request, and shall be retained
by ANSYS and be available to RDS for a period of three (3)
years following termination of this Agreement, or longer if
required by law.
5.3 Product Recal1s. ANSYS and RDS shall each maintain records as
may be necessary to permit a recall or a field correction of
any Device delivered to RDS or customers of RDS, effected by
voluntarily or under a threat of, or a directive by, any
governmental agency. Each party shall give immediate notice by
telephone (to be confirmed in writing) to the General Counsel
of the other party upon discovery that any Device should be
recalled or corrected, and each party upon receiving any such
notice or upon any such discovery, shall cease and desist from
further shipments of Device in its possession or control until
a decision has been made whether a recall or some other
corrective action is necessary. The decision to initiate a
recall or to take some other corrective action shall be made
by RDS after conferring with ANSYS. Each party shall cooperate
with the other in developing any necessary recall plan, and
the manner and extent of such plan shall be subject to prior
consultation, which consultation shall not delay such plan by
more than forty-eight (48) hours from the time of initial
notice. Any such recall or corrective action shall be made at
ANSYS's cost and expense if, and to the extent that, such
recall or corrective action results from, or arises out of,
any breach by ANSYS of its warranties or covenants hereunder.
All other product recalls or corrective action shall be made
at RDS's cost and expense.
5.4 Product Returns. RDS shall have the responsibility for
handling customer returns of the Device. ANSYS shall provide
RDS with such assistance as RDS may need to handle such
returns. Any such return shall be made at ANSYS's cost and
expense if, and to the extent that, such return results from,
or arise out of, any breach by ANSYS of its warranties or
covenants hereunder. All other product returns shall be made
at RDS's cost and expense.
5.5 Governmental Agencies. Each party may communicate with any
governmental agency, including but not limited to the United
States Food and Drug
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Administration, regarding the Device if in the opinion of that
party's counsel, such communication is necessary to comply
with the terms of this Agreement or the requirements of any
law, governmental order or regulation; provided however, that
unless in the reasonable opinion of its counsel there is a
legal prohibition against doing so, such party shall permit
the other party to accompany and take part in any
communications with the agency, and to receive copies of all
such communications from the agency.
5.6 Customer Questions and Complaints. (a) RDS shall have the
responsibility for responding to questions and complaints
regarding the Device. Questions or complaints received by
ANSYS shall be promptly referred to RDS. RDS shall provide
ANSYS with reports summarizing such complaints and customer
questions, as requested by ANSYS, but in no event shall RDS
have to provide such reports more frequently than on a
quarterly basis.
(b) Within a reasonable time from the date of this
Agreement, but in no event later than the sixty (60)
days prior to the scheduled date of the product
launch by RDS of the Device, ANSYS shall provide RDS
with all necessary information that will enable RDS
to respond properly and promptly to questions or
complaints relating to the Device. ANSYS shall use
its best efforts to keep such information current.
(c) ANSYS shall provide RDS with such other assistance as
RDS may need to investigate and respond to customer
questions or complaints.
5.7 Product Modifications. (a) ANSYS shall only make alterations,
modifications or improvements to the product specifications or
performance characteristics for the Device supplied by ANSYS
to RDS under this Agreement if (i) prior written approval is
given by RDS, and (ii) new pricing for the Device, if
necessary because such alteration, modification or improvement
changes the cost to manufacture the Devices, is agreed upon by
the parties utilizing the methodology set forth in Exhibit C.
6.0 LICENSE
6.1 RDS may offer in writing to license the Device to ANSYS in
those markets or market segments that RDS has determined it
will not sell the product.
6.2 (a) In the event that RDS offers in writing to license the
Device to ANSYS pursuant to Section 6. 1, ANSYS shall have
ninety (90) days from the receipt of such written offer to
inform RDS in writing that it desires to obtain such a license
from RDS. Thereafter, the parties agree to negotiate in good
faith a licensing agreement that shall include a licensing fee
not to exceed ten percent (10%) of gross sales, less returns
and allowances, of the product. Agreement by the parties
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on all the terms of the licensing agreement shall be a
precondition before any such license can become effective.
(b) In the event that ANSYS does not notify RDS
within the 90-day period set forth in Section 6.2(a) informing
RDS that it desires to obtain the license offered by RDS, then
RDS shall be free to offer such license to third parties
without any further obligation to ANSYS.
6.3 ANSYS expressly acknowledges and agrees that in the event that
it receives a license from RDS to the Device under this
Article 6 it shall have no right to sublicense, assign or
otherwise transfer its rights under such license, without
prior written approval of RDS, except to a successor in
interest to substantially all of the assets of ANSYS, whether
by purchase, merger, or operation of law.
6.4 The terms and conditions of this Article 6 shall survive
termination or expiration of this Agreement and shall extend
until all of RDS's patent rights in the Device expire,
including any renewals, extensions or modifications thereof.
7.O TERM, RENEWAL AND TERMINATION
7.1 Term. This Agreement, effective as of the execution date,
shall expire five (5) years from the date of the product
launch by RDS, unless terminated by one of the parties in
accordance with this Agreement. RDS and ANSYS agree to
memorialize in writing the date of the product launch and
initial expiration date of this Agreement within thirty (30)
days after the product launch.
7.2 Renewal. RDS shall have the option, in its sole discretion,
to, extend this Agreement for additional three-year terms upon
written notice to ANSYS no later than 180 days prior to the
expiration of this Agreement, subject to the same terms and
conditions of this Agreement. In the event that RDS renews
this Agreement, the parties agree to negotiate in good faith a
mutually acceptable price for the Devices in the manner set
forth in Exhibit C.
7.3 Termination. (a) Upon failure of either party to remedy its
breach of any of the obligations or provisions of this
Agreement within thirty (30) days following receipt of written
notice of said breach, the aggrieved party shall have the
right to terminate this Agreement immediately by written
notice; provided however, that if the breach is due to a
product failure or defect in the Device and the actions needed
to cure such problem requires more than 30 days, then the cure
period shall be extended for a reasonable period of time.
(b) Either party at its sole option may immediately
terminate this Agreement upon written notice, but
without prior advance notice, to the other party in
the event that (i) the other party is declared
insolvent or bankrupt by a
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court of competent Jurisdiction; (ii) a voluntary
petition of bankruptcy is filed in any court of
competent jurisdiction by such other party; or (iii)
this Agreement is assigned by such other party for
the benefit of creditors.
(c) Either party may terminate this Agreement upon thirty
(30) days written notice in the event that the Food
and Drug Administration takes any action, or raises
any objection, that permanently prevents RDS from
importing, exporting, purchasing or selling the
Devices to customers.
(d) Any termination or expiration of this Agreement shall
not affect any outstanding obligations or payments
due hereunder prior to such termination or
expiration, nor shall it prejudice any other remedies
that the parties may have under this Agreement.
8.0 REPRESENTATIONS AND WARRANTIES
8.1 Product Specifications. ANSYS represents and warrants that the
Devices shall comply with the then current product
specifications and then current quality control specifications
and with all federal, state and local laws and regulations.
8.2 Good Manufacturing Practices. ANSYS represents and warrants
that the Devices shall comply with and will be manufactured in
accordance with all applicable Good Manufacturing Practices
("GMPs").
8.3 Warranty of Purpose. ANSYS represents and warrants that the
Devices supplied under this Agreement are suitable and may be
used for the purpose set forth in the product specification.
8.4 Product Development. ANSYS represents and warrants that the
Devices will be manufactured by ANSYS, or by third parties for
ANSYS free and clear of any claims by such third parties.
ANSYS may contract with third parties for certain sub-assembly
of the Device but all final assembly and packaging shall be
performed by ANSYS directly.
8.5 Authority. Each party represents and warrants to the other
party that it has the full right and authority to enter into
this Agreement, and that it is not aware of any impediment
that would inhibit its ability to perform its obligations
hereunder.
8.6 Damages. In the event of a breach of any representation or
warranty, express or implied, in addition to other rights RDS
may have, it may withhold payment and/or cause such breach to
be corrected and charge ANSYS. Notwithstanding the following,
ANSYS's financial liability for damages hereunder is limited
to the price paid to ANSYS by RDS for the Devices. Except as
specifically provided herein, ANSYS makes no other
representations or warranties express or implied.
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8.7 Equitable Release. The parties agree that in the event of a
breach of any provisions of this Agreement, the aggrieved
party shall have, in addition to all other rights and remedies
available to it hereunder and under the law, the right to
specifically enforce this Agreement and/or enjoin the breach
by the breaching party.
9.0 INDEMNITY
9.1 (a) RDS agrees to defend, indemnify and hold ANSYS, its
officers, directors, employees and agents harmless
against any and all losses, damages, costs, claims,
demands, judgments and liability resulting from, or
relating to RDS's performance under this Agreement,
or RDS's instructions or product specifications to
ANSYS under the terms hereof, except to the extent
that any such losses, damages, costs, demands,
claims, judgments and liability are due to the
negligence or wrongful act(s) of ANSYS, its employees
or agents.
(b) If by reason of manufacturing or selling the Devices
to RDS under this Agreement ANSYS is sued or
threatened with suit for alleged patent infringement
covering (i) the Device, or (ii) the process for
producing the Device, RDS shall, at its own expense,
defend such suit and indemnify ANSYS against all
losses and expenses incurred in connection with such
suit or threatened suit including judgments decrees,
court costs and attorney fees, except to the extent
that the claim relates to, or results from ANSYS's
noncompliance with the terms of this Agreement.
9.2 ANSYS agrees to defend, indemnify and hold RDS, its officers,
directors, employees and agents harmless against any and all
losses, damages, costs, demands, claims, judgments and
liability resulting from, or relating to ANSYS's performance
under this Agreement, except to the extent that any such
losses, damages, costs, demands, costs, claims, judgments and
liability are due to (i) the negligence or wrongful act(s) of
RDS, its employees or agents, or (ii) patent infringement
suits or threatened suits that, pursuant to Section 9.1 RDS
has agreed to defend and provide indemnification to ANSYS.
10.0 CONFIDENTIALITY
10.1 During the term and in furtherance of this Agreement, each
party may disclose certain of its Confidential Information to
the other party.
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10.2 During the Term of this Agreement, and for a period of five
(5) years from the termination thereof, RDS and ANSYS each
agree (i) to use the Confidential Information only in
connection with the terms of this Agreement, (ii) to treat the
Confidential Information as it would its own proprietary
information, and (iii) to take all reasonable precautions to
prevent the disclosure of the Confidential information to any
third party, other than an Affiliate without the prior written
consent of the other party.
10.3 A party shall be relieved of any and all of the obligations
under Section 10.2 regarding Confidential Information which
(i) was known to the party receiving the Confidential
Information (the "Receiving Party") prior to receipt
hereunder, (ii) at the time of disclosure by the disclosing
party to the Receiving Party, was generally available to the
public, or which after disclosure hereunder becomes generally
available to the public through no fault attributable to the,
Receiving Party; or (iii) is hereafter made available to the
Receiving Party for use or disclosure by the Receiving Party
from any third party having a right to do so.
11.0 MISCELLANEOUS
11.1 Independent Contractors. The parties shall be deemed to be
independent contractors, and this Agreement shall not be
construed to create between ANSYS and RDS any other
relationship such as, by way of example only, that of
employer-employee, principal-agent, joint-venturers, partners
or any similar relationship, the existence of which is
expressly denied by the parties hereto.
11.2 Inspection. RDS may inspect ANSYS reports and records relating
to its performance under this Agreement during normal business
hours and with reasonable advance notice.
11.3 Access. ANSYS shall provide RDS access to any of its
facilities, during normal business hours and with reasonable
advance notice, in which the Devices are manufactured, stored,
handled, shipped or used in order to permit RDS verification
of ANSYS's compliance with this Agreement and applicable laws.
11.4 Insurance. ANSYS and RDS shall each maintain liability and
other insurance coverage satisfactory to the other party,
during the term of this Agreement and for five (5) years
thereafter, which insurance shall name the other Party as an
additional insured. Such insurance shall include comprehensive
general, liability contractual liability, and product
liability and have limits no less than $2,000,000 per
occurrence. Each party shall provide to the other a
Certificate of Insurance evidencing such coverage and shall
provide proper written notice of any change or modification
thereto.
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11.5 Taxes. ANSYS shall be liable for any and all local, state and
federal taxes and license fees, arising out of the sale of the
Devices to RDS pursuant to this Agreement. RDS shall be liable
for any and all taxes and fees arising from the sale of the
Device to any third party.
11.6 New Products. (a) During the term of this Agreement, RDS shall
have the right of first refusal to market exclusively any and
all new products developed by ANSYS using RDS reagent
technology.
(b) In the event that ANSYS manufactures or develops such
a product, ANSYS shall so immediately notify RDS in
writing and shall provide RDS with sufficient
information, data and samples for RDS to evaluate the
product and determine its interest, if any, in the
product. RDS shall have thirty (30) days from the
receipt of such information, data and samples to
evaluate the product and if interested, shall notify
ANSYS in writing within ten (10) business days of the
conclusion of this evaluation period.
(c) In the event that RDS expresses such an interest, the
Parties shall negotiate in good faith to enter into
an exclusive marketing agreement upon terms and
conditions that are commercially reasonable. In the
event that the parties fail to reach a negotiated
agreement within forty (40) days from RDS's
completion of the evaluation, ANSYS may then offer
such product to other potential companies, provided
that such offer shall not be more favorable to such
company than previously offered to RDS.
11.7 Choice of Law. This Agreement shall be construed under, and
the rights of the parties hereto shall be governed by the laws
of the suite of California.
11.8 Disputes. In the event of any dispute between ANSYS and RDS in
connection with this Agreement, the unsuccessful party shall
pay to the prevailing party all costs and expenses, including
reasonable attorney fees, incurred in enforcing this Agreement
or redressing a breach of this Agreement, whether by
agreement, arbitration, or any action or proceeding and in any
appeal in connection therewith by such prevailing party, and
any such costs, expenses and reasonable attorney fees shall be
included as a part of any such judgment entered in favor of
such prevailing party.
11.9 Other Products. Nothing in the Agreement shall be construed to
prevent or limit either party from selling any of its other
products in any market.
11.10 No Waiver. Either party's failure to require the other party
to comply with any provision of this Agreement shall not be
deemed a waiver of such provision or any other provision of
this Agreement.
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11.11 Severability. In the event that one or more of the provisions
of this Agreement shall, for any reason, be held to be
invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect
any of the other provisions of this Agreement, but this
Agreement shall be construed as if such invalid, illegal or
unenforceable provision or provisions had never been herein
contained.
11.12 Assignment. This Agreement shall not be assignable nor its
rights hereunder transferred in any way by either party
hereto other than to an Affiliate, except to a successor in
interest to substantially all of the assets of either party,
whether by purchase, merger, or operation of law, or except
with the written consent of the other party, which consent
shall not be unreasonably withheld.
11.13 Binding Effect. This Agreement shall bind and inure to the
benefit of the parties hereto and their respective successors
and permitted assigns.
11.14 Force Majeure. Neither party shall be liable for the failure
to perform its obligations under this Agreement if such
failure is occasioned by a contingency beyond such party's
reasonable control, including, but not limited to, strikes
or other labor disturbances, unavailability of supplies or
raw materials, boycotts, lockouts, riots, wars, fires,
floods or storms. A party claiming a right to excused
performance under this Section shall immediately notify the
other party in writing of the extent of its inability to
perform, which notice shall specify the occurrence beyond
its reasonable control that prevents such performance.
11.15 Notices. Any notice, or other written communication required
or permitted hereunder shall be sufficient if made or given
to the other party by personal in hand delivery, by
telecopier communication or by sending the same by first
class mail, postage prepaid, to the mailing address or
telecopier numbers set forth below:
If to RDS: Roche Diagnostic Systems, Inc.
0000 Xxxxxxx 000
Xxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: Sr. Director, Diagnostic
Research Development and
Manufacturing Support
Telecopier No.: (000) 000-0000
with a copy to: Jordan X. Xxxxxx, Esq.
Roche Diagnostics, Systems, Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
Telecopier No.: (000) 000-0000
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If to ANSYS ANSYS, Inc.
2 Goodyear
Xxxxxx, Xxxxxxxxxx 00000-0000
Attention: President/C.E.O.
Telecopier No.: (000) 000-0000
with a copy to: Smith, Silbar, Xxxxxx & Xxxxxxxxx
00000 Xxx Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxx, XX 00000
Telecopier No.: (000)000-0000
Attention: Xxxx Xxxxxx
or to such other addresses or telecopier numbers provided to
the other party in accordance with the terms of this Section.
Notices or written communications made or given by personal
in-hand delivery or by telecopier shall be deemed to have
been sufficiently made or given when confirmed as received,
or if mailed, three (3) days after being deposited in the
United States Mail, postage prepaid or upon receipt,
whichever is sooner.
11.16 Entire Agreement. This Agreement constitutes the full,
complete, final and integrated agreement between the parties
hereto relating to the subject matter hereof and supersedes
all previous written or oral negotiations, commitments,
agreements, transactions or understandings with respect to
the subject matter hereof. Except for Exhibit A (Product
Specifications) and Exhibit D (Quality Control
Specifications) which RDS may modify, under the terms hereof,
from time to time, any modification, amendment or supplement
to this Agreement must be in writing and signed by authorized
representatives of both parties.
11.17 Headings. The titles and headings herein are for convenience
only and shall not be used to interpret or construe the terms
and conditions of this Agreement.
11.18 Singular Terms. Except as otherwise expressly provided herein
or unless the context otherwise requires, all references to
the singular shall include the plural as well.
11.19 Execution in Counterparts. This Agreement may be executed in
two (2) counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and
the same instrument.
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IN WITNESS WHEREOF, the duly authorized representatives of the parties have
executed this Agreement as of the dates set forth below:
ANSYS, Inc. ROCHE DIAGNOSTIC SYSTEMS, INC.
By: /s/ Xxxxxxx X. Xxxxxxxxxx By: /s/ Xxxxx Xxxxxx
----------------------------- -----------------------------
Name: Xxxxxxx X. Xxxxxxxxxx Name: Xxxxx Xxxxxx
Title: President/CEO Title: President
Date: September 5, 1996 Date: September 5, 1996
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF
THIS AGREEMENT. THE REDACTED PROVISIONS ARE IDENTIFIED BY THREE ASTERISKS AND
ENCLOSED BY BRACKETS. THE CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT A
PRODUCT SPECIFICATIONS
I. REAGENT STRIPS (Strips)
A. FORMAT: Size of strips:
4.83 mm wide [***]
49.76 mm long [***]
Reagents shall be positioned as follows:
Latex Stripe: [***]
Result Line: [***]
Test Valid Line: [***]
B. MATERIALS: Mylar-backed nitrocellulose with laminate
Nitrocellulose: [***]
Mylar backing: [***]
Latex laminate: [***]
Mylar adhesive to hold latex: [***]
II. TESTSTICK ("Device")
A. The Device assembly shall consist of one Strip retained inside
a plastic Housing assembly with a Wick protruding from one end
and an adsorbent pad at the other end. A sliding Cover shall
protect the Wick from contact with objects prior to use and
after use and shall prevent drips from the Wick.
B. The Device Wick must require not more than a five second
immersion into urine in order to operate properly. The target
range of immersion time shall be 3 - 5 seconds.
C. Results of the assay should be interpretable within 3 minutes
after dipping the wick into the urine sample and in no case
longer than 5 minutes.
D. Device and reagents must work with samples ranging in
temperature from 18 to 37 C.
[***] Confidential treatment has been requested for redacted portion. The
confidential redacted portion has been omitted and filed separately with
the Securities and Exchange Commission.
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E. Sample must not drip or leak from the Device or Wick after
Wick is immersed and removed from the urine sample.
F. Reagents contained within the Device shall not enter the
sample when the Wick is immersed into the sample, and shall
not cause interference or destabilizing effect on the sample.
G. Plastic Housing of the Device shall be designed such that it
may snap into a holder clip with multiple Devices for
simultaneous dipping into samples.
H. Device must have a retractable Sleeve which covers the Wick
bef6re and after the Wick has been dipped into a sample.
I. Device must have an area designated ID/DATE with room to enter
a sample identification name or number and date. Area must be
able to be written upon with marker pen.
J. Device must have a "plus sign" result window and a round "Test
Valid" window.
K. Result window is to be covered until the Test Valid window is
developed, at which time whatever is covering the result
window can be moved or removed to allow interpretation of the
test result.
L. Storage must be at room temperature.
III. PACKAGING
A. Each Device shall be individually packaged in a foil-lined
pouch with desiccant.
B. Lot number and expiration date shall be printed on each
individual pouch and on the Kit label.
C. Each Device and its pouch shall be color-coded to reflect
assay type, Device shall have one color printed on one side of
the Housing.
D. A Kit shall consist of 50 Devices packaged in a box with one
box label and one multi-language package insert. Box label
shall be color coded to reflect assay type, consistent with
color of Device and its pouch.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF
THIS AGREEMENT. THE REDACTED PROVISIONS ARE IDENTIFIED BY THREE ASTERISKS AND
ENCLOSED BY BRACKETS. THE CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT B
CAPITAL BUDGET
Prototype Development $ [***]
Research and Process Lot Devices $ [***]
Production Equipment (includes tax) $ [***]
Final assembly lines $ [***]
Production molds $ [***]
Reel-to-Reel Strip Processing Equip. $ [***]
Laminating Equipment $ [***]
Contingency $ [***]
Total Capital Budget $ [***]
[***] Confidential treatment has been requested for redacted portion. The
confidential redacted portion has been omitted and filed separately with
the Securities and Exchange Commission.
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EXHIBIT C
PRICING
TestStick Devices shall be priced as follows:
Prototype Devices up to quantity of 100: no charge (included under Prototype
Development.)
Research Lot Devices manufactured with prototype molds: $[***]
Process Lot Devices manufactured with production molds: $[***]
NOTE: Above Devices will be billed under the Capital Budget (Research, and
Process Lot Devices).
Production Devices manufactured prior to setup of automated lines:
Annual production rate below 2 million Devices: $ [***]
Annual production rate at or above 2 million Devices: $ [***]
Production Devices manufactured with automated lines @ 4 million annual rate:
$ [***]
Production Devices manufactured with automated lines @ 8 million annual rate:
$ [***]
Production Devices manufactured with automated lines @ 12 million annual rate:
$ [***]
Notes:
Full automation is estimated to be available within 6 months after product
launch.
Prices are subject to annual CPI adjustment.
Prices are subject to adjustment due to change in cost of high-impact
polystyrene.
[***] Confidential treatment has been requested for redacted portions. The
confidential redacted portion has been omitted and filed separately
with the Securities and Exchange Commission.
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