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 EXHIBIT 10.10
EXECUTION COPY
SUPPLEMENTAL AGREEMENT
TO THE
AGREEMENT DATED JUNE 11, 1998
FOR
DEVELOPMENT, DISTRIBUTION AND LICENSING OF TMA
PRODUCTS
DATED AS OF APRIL 2, 2001
Execution Copy of Development,
Distribution and Licensing Agreement
SUPPLEMENTAL AGREEMENT
TO THE
AGREEMENT DATED JUNE 11, 1998
FOR
DEVELOPMENT, DISTRIBUTION AND LICENSING OF TMA PRODUCTS
THIS SUPPLEMENTAL AGREEMENT made as of April 2nd, 2001 (this "Agreement") by
and between GEN-PROBE INCORPORATED, a Delaware corporation having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
(hereinafter called "Gen-Probe") and BAYER CORPORATION, an Indiana
corporation, acting through its Business Group Diagnostics with its principal
place of business at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇.▇.▇. ▇▇▇▇▇ and
an address for purposes of this Agreement at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇
▇▇▇▇▇ (hereinafter called "Bayer").
WITNESSETH:
WHEREAS, Gen-Probe and Chiron Corporation entered into an Agreement dated June
11, 1998 (such agreement, as heretofore amended and supplemented by the
documents referenced in Section 14.01 of this Agreement, being referred to
herein as the "Basic Agreement") relating to the development, distribution and
licensing of certain nucleic acid probe assays and related instruments for use
in Blood Screening Field and in the Clinical Diagnostic Field; and
WHEREAS, Chiron Corporation, with the consent of Gen-Probe, has assigned all of
its rights and obligations with respect to the Clinical Diagnostic Field,
Clinical Diagnostic Assays and Clinical Diagnostic Instrument to Bayer; and
WHEREAS, the Parties now wish to agree upon details of performance under the
Basic Agreement that were not covered in the Basic Agreement, to clarify
matters which may not have been clearly stated in the Basic Agreement, and to
modify the Agreement as necessary to facilitate the successful distribution of
Products for the benefits of both Parties;
NOW, THEREFORE, the Parties hereto agree as follows:
ARTICLE I. DEFINITIONS
For the purpose of this Agreement, capitalized terms used herein without
definition shall have the meanings assigned thereto in the Basic Agreement. In
addition, the following terms shall have the respective meanings set forth
below.
1.01 "Assay" shall mean a Clinical Diagnostic Assay as defined in the Basic
Agreement and as to which Bayer holds exclusive or co-exclusive distribution
rights.
1.02 "Instrument" shall mean a Clinical Diagnostic Instrument as defined in the
Basic Agreement.
1.03 "Non-Commercial Use Price" means, as to any Clinical Diagnostic Assay, the
price established pursuant to Section 6.10 of the Basic Agreement for purchases
for the purposes specified in such Section.
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CONFIDENTIAL
1.04 "Products" means all Assays, Instruments, and related items to be
supplied by Gen-Probe to Bayer hereunder, including without limitation
spare parts for Instruments, as set forth in Exhibit A to this Agreement.
1.05 "Release" means a software update which corrects problems in prior
software versions.
1.06 "Specifications" means as to each Product the specifications of the
Product set forth in the product requirements document and any further or
additional specifications included in the Product label or package insert.
1.07 "Version" means a software edition comprising new or modified software
functions.
ARTICLE II. PRODUCTS, PRICES, SPECIFICATIONS AND QUALITY
ASSURANCE
2.01 Products and Prices. Attached hereto as Exhibit A-1 is a list of Products
that will be available for purchase by Bayer upon the release for sale of
the Initial Clinical Diagnostic Assay for the qualitative detection of HCV
(HCV QLT TMA Assay)(the "Initial Products"). Exhibit A-1 includes the
Transfer Price of each Product when purchased for resale and the
Non-Commercial Use Price. Prices are determined and subject to adjustment
as provided in the Basic Agreement and where based on Manufacturing Cost
are subject to audit as provided in the Basic Agreement. Prior to the
release for sale of any new Assay or Instrument ("Additional Products"),
the Parties shall agree upon and add to this Agreement additional Exhibits
▇-▇, ▇-▇, etc., providing the equivalent information with respect to such
Additional Products. Any changes to the transfer price of the Initial
Products or the Initial Clinical Diagnostic Assay for the qualitative
detection of HIV will be made pursuant to sections 1.58.4 and 1.58.5 of
the Basic Agreement. The Parties shall promptly execute an updated Exhibit
A to reflect the amount of the adjusted Transfer Price(s).
2.02 Specifications. The Specifications for the Initial Products are set forth
in the product requirements document. Gen-Probe may not make changes to
(i) the specifications of any Product if these changes affect the fit,
form, or function of any instrument or part thereof or the performance,
stability, reliability or safety of any Assay component or (ii) final
release specifications identified in Exhibit B without the prior written
approval of the changes by Bayer QA. Gen-Probe will provide requests for
change, with any required supporting information, to Bayer 90 days prior
to implementation. Bayer will not unreasonably withhold approval of
requested changes. Bayer will make a reasonable effort to respond to
requests for changes made with less than 90 days notice.
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2.03 Dating. All Products sold to Bayer shall have a remaining shelf life of at
least nine (9) months. Parties may mutually agree to accept material with
less than nine (9) months dating.
2.04 Quality Assurance. Gen-Probe shall manufacture (or have manufactured by
its subcontractors) all Products in accordance with the applicable
Specifications and all applicable regulatory requirements. To confirm
compliance with the Specifications and Quality Assurance Policy, Gen-Probe
will provide Certificates of Compliances and Certificates of Analysis, as
applicable. The forms and information to be provided will be mutually
agreed by the Parties for each Product. Gen-Probe will hold retention
samples as requested by Bayer for each production lot manufactured under
this Agreement. Bayer shall purchase any Products requested as retention
samples in excess of two (2) units per production lot at the
Non-Commercial Use Price. Gen-Probe will retain any material required by
the FDA at Gen-Probe's expense. Bayer's incoming inspection and test
procedures, where needed, will be proposed by Bayer and be subject to the
agreement of Gen-Probe, such agreement not to be unreasonably withheld or
delayed.
2.05 Packaging. The Specifications for packaging of each Initial Product are
set forth in the product requirements document. Gen-Probe will be
responsible for all loss of, or damage to, any Products resulting from
failure to comply with the packaging specifications.
2.06 Labels and Package Inserts. A list of labels and package inserts with
current revision for the Initial Products are attached hereto as Exhibit
B-1. Prior to the release for sale of any Additional Products, the Parties
shall agree upon and add to this Agreement additional Exhibits ▇-▇, ▇-▇,
etc., providing the equivalent information with respect to such Additional
Products. Material copy and specifications will be mutually agreed upon
between the Parties. Artworks labels and package inserts will be prepared
by Bayer and jointly approved by both Bayer and Gen-Probe. The approved
electronic art will then be forward to Gen-Probe who will be responsible
for printing and inventory. No change shall be made to any label or
package insert without the consent of both Parties, which shall not be
unreasonably withheld or delayed. Any changes to the labels or inserts
will be made only by mutual agreement and, if initiated by Bayer, will be
at Bayer's expense, including reimbursement to Gen-Probe for any unused
Bayer Labeling in Gen-Probe inventory.
2.07 Documentation. Gen-Probe will provide information required by Bayer to
generate and maintain customer and service documentation. Gen-Probe
proprietary information will not be disclosed to customers except upon
mutual agreement of the Parties. Exhibit C identifies information
authorized to be disclosed as of the date thereof and describes to whom
and in what form such disclosure may be made. For manuals, material copy
and specifications will be
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mutually agreed upon between the Parties. Artwork for manuals will be
prepared by Bayer and jointly approved by both Bayer and Gen-Probe. The
approved electronic art will then be forwarded to Gen-Probe who will be
responsible for having manuals printed and placed into inventory. Any
changes to the manuals will be made only by mutual agreement and, if
initiated by Bayer, will be at Bayer's expense. Additionally, Gen-Probe
will provide information to Bayer required to generate Material Safety
Data Sheets (MSDS). The information to be disclosed to customers will be
agreed upon between the Parties. Bayer will generate the MSDS and an
electronic copy of each MSDS will be provided to Gen-Probe for review.
ARTICLE III. OPERATIONAL MATTERS, FORECASTING, ORDERING AND SHIPPING
3.01 Aggregation of IVD, IUO and ASR Versions. Each Clinical Diagnostic Assay
may be available in IVD, IUO and ASR versions. For purposes of Product
forecasting, under Section 6.3.1 of the Agreement, forecasts for months
six (6) through twelve (12) of any forecast may aggregate the forecast
amounts for all three versions of any Clinical Diagnostic Assay, while
forecasts for months one through five shall specify the amounts of each
such assay to be labeled for IVD, IUO and ASR respectively. With the
exception of the Initial Clinical Diagnostic Assay for the qualitative
detection of HCV, Bayer's Purchase Obligation for each product will be
pursuant to Sections 6.3.2 and 6.3.3 of the original Agreement. For the
Initial Clinical Diagnostic Assay for the qualitative detection of HCV
Bayer will issue a binding purchase order on a quarterly basis and no
later that 60 days prior to the start of each quarter. Bayer may also
issue additional firm purchase orders for products and Gen-Probe agrees to
make commercially reasonable efforts to fill such orders but will not be
in breach of this Agreement due to failure to fill such orders despite
such efforts. For all Assays, each order should be for a minimum of 50,000
tests once the product has been on the market for 12-18 months, unless
otherwise agreed between the Parties. Bayer may change the quantity of the
forecast on a monthly basis, but cannot change the quantity of a firm
order pursuant to the Basic Agreement.
3.02 Items Not Subject to Forecast Requirements. The spare parts, consumables
and other products identified in Exhibit D shall not be subject to the
forecast and ordering provisions of the agreement, but will be shipped by
Gen-Probe within the lead time specified for each such item in Exhibit D.
These routine lead times will not apply to emergency spare part orders for
instrumentation, which Gen-Probe will use best efforts to ship the same
day or no later than 24 hours from receipt of the spare part by Gen-Probe.
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3.03 Warehousing and Shipping. Gen-Probe will hold available warehousing space
for Products which have been purchased by Bayer sufficient to meet the
requirements set forth in Exhibit E. The Exhibit E may be amended from
time to time by mutual agreement. Gen-Probe will manage Product inventory
and order fulfillment for shipments to Bayer's customers using the Bayer
CENSYS system. Bayer will install and maintain, at Gen-Probe, a computer
terminal for this purpose and will train Gen-Probe personnel in the use of
this system. Bayer shall issue shipping orders for reagents, software and
consumables by the required shipment date through CENSYS. Gen-Probe shall
pack and ship the product as defined in Gen-Probe Document ▇▇-▇▇-▇▇-▇▇▇
("Bayer Shipment Procedure"), provided such shipments are in accordance
with all post COCOM regulations. Gen-Probe will make reasonable best
efforts to fill orders by required delivery date. Gen-Probe will give
special notice to emergency service part orders for same-day shipment, or
no later than 24 hours from receipt, if the requested spare parts are in
stock. Gen-Probe will use Bayer's Carrier account for freight charges. The
costs payable by Bayer for Gen-Probe's performance of warehousing and
order fulfillment services shall be as set forth in Exhibit E. In
addition, Bayer will be responsible for all shipping and insurance costs
of outbound freight.
3.04 Deviation Release. Gen-Probe will not release any product that deviates
from (i) the manufacturing procedures if such deviations would reasonably
be expected to affect the fit, form, or function of any Instrument or part
thereof or the performance, stability, reliability or safety of any Assay
component or (ii) final release specifications identified in Exhibit B
without the prior written approval by Bayer QA. Bayer will not
unreasonably withhold approval of requested deviations. Gen-Probe will
provide written notice of such deviation in a timely manner. The written
notice will include a description of the deviation, the expected impact of
the deviation, and a plan for corrective and preventative action. Bayer
will respond to such notices in a timely manner.
ARTICLE IV. MANUFACTURING CHANGES
4.01 Gen-Probe may not make changes to manufacturing procedures or to any
Product (Assay component, Instrument, or software) if these changes would
reasonably be expected to alter the form, fit, or function of any
Instrument or part thereof or the performance, product stability,
reliability or safety of any Assay component, without the prior written
approval of the changes by Bayer QA. Gen-Probe will provide requests for
such changes, with any required supporting information, to Bayer 90 days
prior to implementation. Bayer will not unreasonably withhold approval of
requested changes. Bayer will make a reasonable effort to respond to
requests for changes made with less than 90 days notice.
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ARTICLE V. SERVICE AND WARRANTY OBLIGATIONS
5.01 Reagents, Consumables and Software. Bayer shall provide its customers
with prompt and proper installation, service and maintenance for Products
at its own expense and responsibility. Bayer will provide first-level
technical support from its branches and second-level technical support
from Bayer's designated facility at its own cost and expense to provide
the aforementioned services, if it is able to do so. Communication to
customers will be by Bayer. Upon review of first and second level support
documentation, Gen-Probe will provide third-level technical support from
its facilities for the Products at its own cost and expense, as reasonably
required for purposes of this Agreement. Such third-level technical
support will include, without limitation, communications to answer
customer inquiries through Bayer regarding information, interpretation of
results, problems and complaints that cannot be answered or resolved by
Bayer. Gen-Probe will respond to technical inquiries within 24 hours of
receipt. All customer communications will be coordinated through Bayer.
Upon determination that any Products, other than Instruments, are
defective within the applicable dating of such Products, Gen-Probe shall
provide replacement products at no charge. For purposes of providing
service hereunder, Bayer and Gen-Probe agree to maintain appropriate
service facilities, including reasonable number of qualified persons
acquainted with the installation and maintenance of Products.
5.02 Instruments. Bayer shall provide its customers with prompt and proper
installation, service and maintenance for Instruments at its own expense
and responsibility. Gen-Probe shall pass through all Instrument warranties
that it receives from the Instrument manufacturer. Bayer shall have the
right to directly negotiate warranty agreements with the suppliers of
instruments or parts.
5.03 Spare Parts. Spare parts will have the original manufacturers warranty.
Gen-Probe will ship all spare parts to Bayer by the required ship date.
Reasonable best efforts will be made to fill emergency spare part orders.
Bayer will purchase spare parts from Gen-Probe. In the event that
Gen-Probe cannot supply spares within the required lead-time, or cannot
supply spare parts to fill emergency orders, Bayer will have the right to
purchase directly from the suppliers.
5.04 Out of Warranty Parts. Bayer may repair or refurbish spare parts of
Products that are out of warranty. In such cases, Gen-Probe assumes no
risk and shall not be subject to any liability. However, Gen-Probe shall
render product design prints information, where available, to allow Bayer
to accomplish the foregoing.
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5.05 Service Documentation. Gen-Probe shall furnish Bayer with a draft of
documentation in English, necessary or useful for installation, operation,
service and repair of Products. This shall include all software including,
but not limited to, Gen-Probe's applications software, diagnostic and test
programs required for performance and specification compliance. Bayer
shall make derivative works from such documentation and reproduce and
distribute the documentation. Material copy and specifications will be
controlled by Bayer. Bayer will notify Gen-Probe of modification to
materials, which are subject to regulatory review.
ARTICLE VI. COMPLAINTS AND RECALLS
6.01 Complaints. Each party will promptly provide to the other, relevant
information from all significant consumer complaints received by such
party that are relevant to the performance, reliability or safety of the
Products or any substantially identical product that Gen-Probe sells.
Gen-Probe and Bayer will cooperate in investigating such complaints in
accordance with FDA regulations and applicable international standards.
Further, each party will notify the other in writing, within 48 hours, of
any other matter affecting the Products or any substantially identical
product Gen-Probe sells that may reasonably: (a) be construed as a safety
or performance problem, (b) cause any FDA or similar governmental action,
or (c) adversely affect Bayer's marketing of the Products. Gen-Probe will
acknowledge complaints within 24 hours (provided that such period includes
one working day) from receipt of Bayer's advice of a complaint. Complaints
received from Bayer by Gen-Probe's standard operating procedure document,
SOP #23-01 (customer complaint procedure). Bayer will communicate
complaints to Gen-Probe through the call handling scheme summarized in
Exhibit F.
6.02 Product Recalls. Bayer will, prior to implementation, notify Gen-Probe's
regulatory affairs department of any intended market correction or removal
action, as defined in 21 CFR 806 or 21 CFR 7 or similar market corrective
action affecting the Products, to enable Gen-Probe to consider any
appropriate market corrective actions for the Product(s). Gen-Probe and
Bayer will mutually agree on the appropriate course of action associated
with any such market corrections or removal actions of Product from the
Market. Gen-Probe shall, prior to implementation, notify Bayer of any
recall or similar action of product similar or related to those
manufactured for Bayer. In the event such market recall is caused solely
by the failure of the product to meet specifications or product claims,
Gen-Probe will provide replacement Product(s), at its expense, for those
Product(s) being recalled. Further, Gen-Probe will, at its expense,
reasonably cooperate with Bayer concerning all market recalls and Medical
Device Reporting ("MDR") requirements of Bayer.
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6.03 Product Performance Data. Bayer and Gen-Probe shall furnish each other,
from time to time, with their customary service and reliability data,
statistics and analyses relating to failure rates, failure mechanisms and
repair time of Products, based on each party's respective experience.
ARTICLE VII. SOFTWARE
7.01 Systems Covered. Gen-Probe shall cooperate with Bayer to enable Bayer to
understand the following four software systems in detail, their functions,
and their operation:
(a) Instrument Control and Instrument Diagnostic Software
(b) User Interface Software
(c) Data Management Software
(d) Laboratory Information System Interface Software
Any modification in the software shall be made by Gen-Probe.
7.02 New Releases. Gen-Probe shall provide regular releases of software to
Bayer at an interval to be determined by both Gen-Probe and Bayer, when a
sufficient number of "bugs" or problems exist to warrant the Release. Bayer
shall provide to Gen-Probe documentation on all identified anomalies and an
indication of the degree of urgency to fix the problem. Gen-Probe is to
communicate, on a monthly basis, the status of identified "bugs" and the
projected correction time and/or if "work-arounds" or patches are
available. Each Release shall include a list of all corrected anomalies in
the software.
7.03 New Versions. From time to time, Bayer may request new Versions of software
(any of the four defined in Paragraph 7.01, above). New Versions are to be
jointly defined by Gen-Probe and Bayer in a mutually agreeable time frame.
Each Version must be accompanied by an updated software specification. The
price for new versions of software will be negotiated and agreed upon by
both Parties.
7.04 Ongoing Support. Gen-Probe agrees that during the term hereof and for six
(6) months after the sale to Bayer of the last Products, it shall either
equip Bayer to, or shall itself respond immediately to, the detection by
Bayer of "fatal software flaws", which are herein agreed to mean major
"bugs" or problems in the software which result in the generation of
incorrect results. This clause shall survive the termination or expiration
of this Agreement.
7.05 Software Media. Gen-Probe will provide software, which can be pre-loaded
onto new CPUs or loaded by Bayer onto existing CPUs located at customer
sites.
7.06 Documentation. Gen-Probe will provide the following software documentation:
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User's guide
Installation protocols
Validation protocols and reports
7.07 Bayer Rights. Bayer will have exclusive rights to those specific elements
of the software modules created or modified for its specific use and that
were funded directly by Bayer.
ARTICLE VIII. REGULATORY APPROVALS
8.01 Initial Approvals. Gen-Probe, at its expense, shall make its Commercially
Reasonable Efforts to obtain all licenses or approvals required for the
marketing, sales or use of Instruments, and the Initial Products, each as
previously agreed upon in the Basic Agreement.
8.02 Changes in Regulatory Requirements. Whenever, because of changes in
regulatory agencies or regulations outside of the United States, any
additional or different requirements are imposed regarding the marketing,
sales, use or manufacture of Products or in the Products, themselves,
Bayer, at its expense, shall make its reasonable best effort to comply
with the said requirements regarding the marketing, sales or use of
Products, and Gen-Probe at its expense shall use its reasonable best
efforts to comply with said requirements regarding the manufacture of the
Products or with respect to the Products, themselves. Gen-Probe and Bayer
will mutually work to comply with the European in-vitro diagnostics (IVD)
directive. Gen-Probe will provide to Bayer appropriate information
required for submissions to notified bodies in order to meet IVD directive
requirements.
8.03 UL and CE Approval. Gen-Probe will make necessary changes to obtain and
will obtain Instrument approvals, as required in the product requirements
document in a timely manner. Gen-Probe will be responsible for any
retesting necessary caused by changes in product through its life cycle
that impact the approval status. Bayer has the rights to review Gen-Probe
records and have certificate of compliance on record. Bayer will be
responsible for the cost to obtain approvals for changes to
instrumentation requested by Bayer.
8.04 Gen-Probe shall export the Products after authorization is obtained from
appropriate governmental authorities, if such authorization is necessary.
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ARTICLE IX. INSPECTION AND REGULATORY REQUIREMENTS
9.01 Product Inspections. Bayer, at its option, shall have the right to source
inspect any and all Products at Gen-Probe's facility(s) prior to shipment
by Gen-Probe to insure conformity to mutually agreed upon acceptance
criteria, written specifications, test requirements, or other mutually
agreed upon acceptance criteria. In addition, Gen-Probe will provide Bayer
with detailed product test and release data for the first five (5)
distinct kit lots eligible for sale and distribution. Delivery of each lot
will be held until Bayer has conveyed release approval to Gen-Probe. After
receipt by Bayer of the agreed upon product certificate of analysis, if
Bayer has not rejected a lot within two weeks of notification, the lot
will be released to Bayer's quarantined inventory.
9.02 QC and Testing. Gen-Probe will be responsible for administering and
monitoring the stability testing program for all product/package
configuration manufactured for Bayer. Results of the stability may be
reviewed by Bayer during regularly scheduled audits. Summary results of
stability studies will be provided to Bayer upon release of each product
and when any changes in stability claims are made.
9.03 QSR and ISO Compliance. Gen-Probe shall be in compliance with United
States' Quality System Regulations (QSRs) and International Standards
Organization (ISO) requirements. Gen-Probe and Bayer shall co-operate in
meeting requirements of the guidelines published by the United States Food
and Drug Administration (FDA), ISO and other U.S. and non-U.S.
governmental regulatory agencies. Gen-Probe and Bayer shall use their best
efforts to answer specific questions relating to quality assurance, as
soon as possible, upon either company's receipt of such questions.
9.04 Facilities Visits. Bayer shall have the right during normal business hours
to visit Gen-Probe facilities (or subcontractor's facilities) to conduct
quality audits, evaluations and review the performance of Gen-Probe's
obligations under this Agreement. Bayer shall also have the right to meet
with Gen-Probe's personnel and review development, production, process,
and quality records relevant to the subject matter in this Agreement,
subject to the confidentiality provisions of the Basic Agreement.
Bayer shall provide reasonable notice to Gen-Probe prior to each such
visit. Bayer will not copy records without Gen-Probe agreement.
Gen-Probe's agreement regarding copying will not be unreasonably withheld.
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ARTICLE X. TRAINING
10.01 Gen-Probe will provide initial training to Bayer personnel on the
operation, installation, maintenance and repair of Products. Gen-Probe
will also provide updated training when modifications are made to
Products. If such modifications are request by Bayer, then Bayer shall pay
for the updated training. The training will be sufficient in scope and
detail to permit Bayer to effectively operate, install, maintain, and
repair Products and to teach the same to others. Each party shall bear its
own costs incurred by the training.
ARTICLE XI. MISCELLANEOUS
11.01 Entire Agreement. This Agreement, together with the Basic Agreement
(including the handwritten addition of the words "Initial Blood Screening
Assays, Initial Clinical Diagnostics Assays" to the end of the second line
of Section 9.6, a copy of the relevant page showing such addition and
signed by the representatives of each party having been transmitted by
facsimile from ▇. ▇▇▇▇▇▇▇▇ of Gen-Probe to ▇. ▇▇▇▇▇▇▇▇ of Chiron on June
30, 1998, the letter dated June 11, 1998 from ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ of
Gen-Probe to ▇▇▇▇ ▇▇▇▇▇ of Chiron, the Addendum to the Agreement dated
June 26, 1998, the letter dated June 30, 1998 from ▇▇▇▇ ▇▇▇▇▇ of Chiron to
▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ of Gen-Probe, and the Consent as to fulfillment of
Conditions Precedent dated June 30, 1998, constitutes the entire agreement
between the Parties with respect to the subject matter hereof and
supercedes all prior express or implied agreements or understandings,
either written or oral. Except as expressly amended by this Agreement,
the Basic Agreement remains in full force and effect, subject to the
assignment to Bayer of the rights of Chiron Corporation under the Clinical
Diagnostic portions of the Agreements. In the event of conflict between
the terms of the Basic Agreement and this Agreement, the terms of this
Agreement shall prevail.
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IN WITNESS WHEREOF, the parties have caused their respective duly authorized
representative to sign this Agreement in counterparts on the day first above
written.
BAYER CORPORATION, Business GEN-PROBE INCORPORATED
Group Diagnostics
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇▇
------------------------------ ------------------------------
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇ ▇▇▇▇▇▇▇▇
---------------------------- ----------------------------
Title: Vice President Title: CEO and President
Nucleic Acid Diagnostics
--------------------------- ---------------------------
Date: April 2, 2001 Date: April 19, 2001
---------------------------- ----------------------------
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LIST OF EXHIBITS
EXHIBIT A-1 Initial Products Price and Part Number List
EXHIBIT B-1 Revision of Specs and Labels for Initial Products
EXHIBIT C Information for Disclosure to Customers
Attachment 1 HCV TMA Amplification
Attachment 2 Rationale for Acceptable Temperature Range in the Detection
Step of the DKA HIV/HCA Assay
EXHIBIT D Order Lead Times for Spare Parts and Consumables
EXHIBIT E Warehousing Space Description and Cost of Space and Services
EXHIBIT F Gen-Probe/Bayer Call Handling Scheme
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EXHIBIT A-1
REAGENTS
[***]
***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.
EXHIBIT A-1
INSTRUMENTS & ANCILLARIES
[2 Pages of Instruments and Ancillaries Deleted Pursuant to Confidential
Treatment Request]
EXHIBIT A-1
PARTS
[4 Pages of Parts Deleted Pursuant to Confidential Treatment Request]
EXHIBIT A-1
CONFIGURATION
[3 Pages of Configurations Deleted Pursuant to Confidential Treatment Request]
Exhibit B
[3 Pages of Product Information Deleted
Pursuant to Confidential Treatment Request]
EXHIBIT C
[7 Pages of Technical Information Deleted Pursuant to Confidential Treatment
Request]
EXHIBIT D
PARTS
______________________________________________________________________________________
LEADER HC PLUS
SPARE PARTS Part Description Lead Time
______________________________________________________________________________________
104796 1 Bar Code Scanner Assembly 4-6 weeks
104797 1 Scanner Interface Cable 4-6 weeks
104798 1 Serial Switch Assembly 4-6 weeks
104799 1 Injector Assembly, Leader 4-6 weeks
104800 1 Injector, Sub Assembly 4-6 weeks
104801 1 Variable Injector Pump Assembly 4-6 weeks
104802 1 Lead Nut Assembly 4-6 weeks
104803 1 Bellow Assembly 4-6 weeks
104804 1 Stepper Motor Assembly 4-6 weeks
104805 1 Stepper Motor Sub Assembly 4-6 weeks
104806 1 Injector Controller Assembly 4-6 weeks
104807 1 Injector Controller PCB Assembly 4-6 weeks
104861 1 EPROM Set, Leader HC+ 4-6 weeks
104955 1 Injector Harness 4-6 weeks
104994 1 Power Harness 4-6 weeks
104986 1 LHC+ Front Panel, Painted 4-6 weeks
104987 1 LHC+ Front Panel (painted)/all components 6-8 weeks
______________________________________________________________________________________
______________________________________________________________________________________
LEADER HC
SPARE PARTS Part Description Lead Time
______________________________________________________________________________________
103436 1 Bellows Assay 5-6 weeks
104517 1 37" Power Transformer Harness 5-6 weeks
104654 1 LHC Dual Injector Assembly 5-6 weeks
104655 1 LHC Injector Pump Assembly 5-6 weeks
104656 1 LHC Solenoid 5-6 weeks
104666 1 LHC Front Panel, Painted 5-6 weeks
104774 1 LHC Front Panel (painted)/all components 6-8 weeks
______________________________________________________________________________________
______________________________________________________________________________________
LEADER HC PLUS
SPARE PARTS Part Description Lead Time
______________________________________________________________________________________
104673 1 TCS Vacuum Bottle, 4 Liter 4-6 weeks
104703 1 TCS In-Line Filter for HighFlow Vacuum 5-6 weeks
Trap (Rev. B)
104729 1 TCS Closure, ▇▇▇▇▇▇ 5-6 weeks
104731 1 TCS 10' LTH tube, 1/2", ▇▇▇▇▇▇ 5-6 weeks
104732 1 TCS Quick Disconnect Body, ▇▇▇▇▇▇ 5-6 weeks
104733 1 TCS Quick Disconnect Insert, ▇▇▇▇▇▇ 5-6 weeks
104735 1 TCS Quick Disconnect Insert, ▇▇▇▇▇▇ 5-6 weeks
104737 1 TCS 1.6" LTH tube, 1/2", ▇▇▇▇▇▇ 5-6 weeks
104738 1 TCS 4.5" LTH tube, 1/2", ▇▇▇▇▇▇ 5-6 weeks
______________________________________________________________________________________
Execution Copy of Development
CONFIDENTIAL Distribution and Licensing Agreement
EXHIBIT D
PARTS
LEADER HC &
LEADER HC PLUS
SPARE PARTS PART DESCRIPTION LEAD TIME
103425 1 LHC Line Cord 5-6 weeks
103428 1 Paper Spool 5-6 weeks
103431 1 Display Assay 5-6 weeks
103432 1 Pushbutton Assay 5-6 weeks
103441 1 Bottle Caps (Clear) 5-6 weeks
103871 1 Sensor Assay, Tube Present 6-8 weeks
103880 1 LHC Shutter Motor 5-6 weeks
103900 1 LHC Printer Head 5-6 weeks
103907 1 LHC Shutter LED 5-6 weeks
103927 1 LHC Power Transformer Assay 5-6 weeks
103948 1 Main Board 6-8 weeks
103953 1 Fuse, 0.500 A, MDL 250V. 5-6 weeks
103954 1 LHC Cassette 5-6 weeks
103955 1 LHC Sensor Assay. I.L. & Cassette Limit 5-6 weeks
103956 1 Sensor, Lid Closed 6-8 weeks
104035 1 Solenoid Valve, 200-300uL 5-6 weeks
104195 1 Inlet Tubing Set 14" 5-6 weeks
104223 1 Keyboard PCB Assay MEMBRANE 4-6 weeks
104312 1 Cassette Limit Sensor Assay 4-6 weeks
104446 1 Front Shroud (For Tub) 4-6 weeks
104449 1 Inner Lid 4-6 weeks
104451 1 LHC Cassette Housing (Teflon) 6-8 weeks
104452 1 LHC Lid Gasket, Lower Lid Seal 6-8 weeks
104453 1 LHC Gasket, PMT Block Assay. 6-8 weeks
104454 1 Shutter Cover 6-8 weeks
104455 1 LHC Bracket, Lid Release 6-8 weeks
104457 1 LHC Guide Plate, Cassette 6-8 weeks
104458 1 LHC Lid Latch Plate (left) 6-8 weeks
104459 1 LHC Lid Latch Plate (right) 6-8 weeks
104460 1 LHC Cassette Guide Plate, rear 6-8 weeks
104462 1 LHC Lid Lock Wedge 6-8 weeks
104463 1 LHC Lid Latch Handle 6-8 weeks
104464 1 LHC Lid Latch Body 6-8 weeks
EXHIBIT D
PARTS
LEADER HC &
LEADER HC PLUS
SPARE PARTS PART DESCRIPTION LEAD TIME
104465 1 LHC Lid Handle Spacer 6-8 weeks
104466 1 LHC Cassette Drive Assay 6-8 weeks
104467 1 LHC Motor Assay. Cassette Drive 6-8 weeks
104468 1 LHC Lid Spring Assay. 6-8 weeks
104472 1 LHC Lid Release Solenoid 6-8 weeks
104473 1 LHC Spacer, Lower Lid Latch 6-8 weeks
104474 1 LHC Washer, Lid Lock/Release 6-8 weeks
104475 1 LHC Spring, Lid Release Solenoid 6-8 weeks
104477 1 LHC Lid Hinge Spacer 6-8 weeks
104478 1 LHC Lid Handle Washer 6-8 weeks
104479 1 LHC Extractor Tool, Cassette 6-8 weeks
104482 1 LHC Decal, Inner Lid 6-8 weeks
104484 1 LHC Side Panel (Cut for Inlet Tubing) 6-8 weeks
104500 1 LHC Shutter Rack Assay. 6-8 weeks
104509 1 LHC Tear Bar, Printer 6-8 weeks
104510 1 LHC Display Window 6-8 weeks
104511 1 LHC Rubber Feet 6-8 weeks
104515 1 LHC Printer Cable Assay. 6-8 weeks
104519 1 LHC Platen for Seiko Printer 6-8 weeks
104520 1 Smart Watch Socket DS1216C 6-8 weeks
104521 1 32KX8 SRAM Chip MS62256 6-8 weeks
104648 1 LHC Rear Panel, Painted 6-8 weeks
104649 1 LHC RS 232 Cable, Internal 6-8 weeks
104650 1 LHC RS 232 Cable, External 6-8 weeks
104651 1 LHC Fuse, 0.250 A Type 6-8 weeks
104652 1 LHC Fuse Kit, 0.250 A Type 6-8 weeks
104653 1 LHC Power Entry Module 6-8 weeks
104657 1 LHC 32" Outlet Tubing SS Tip Blue/Red 6-8 weeks
104659 1 LHC Injector Nozzle Block 6-8 weeks
104660 1 LHC Main Board 6-8 weeks
104661 1 LHC Base, Painted 6-8 weeks
104662 1 LHC Lid Assembly 6-8 weeks
104663 1 LHC PMT Module 10-12 weeks
104664 1 LHC Block Assembly 6-8 weeks
104667 1 LHC Printer Assembly 6-8 weeks
104697 1 Lid Kit, Leader HC 6-8 weeks
104773 1 LHC Shutter Block Cover 4-6 weeks
104860 1 Null Modern Cable 4-6 weeks
104871 1 Lid Latch Assay 4-6 weeks
104872 1 Lid Latch Screw Assay 4-6 weeks
104915 1 Rear Cassette Guide Plate 4-6 weeks
104916 1 Tab LED PCB Assay 4-6 weeks
104917 1 Tab Sensor PCB Assay 4-6 weeks
103441-B 1 LHC Bottle Caps (amber) 4-6 weeks
Execution Copy of Development,
CONFIDENTIAL Distribution and Licensing Agreement
EXHIBIT D
PARTS
TARGET CAPTURE
SYSTEM SPARE
PARTS PART DESCRIPTION LEAD TIME
104600 1 TCS Magnet Strip 6-8 weeks
104601 1 TCS Guide Block 6-8 weeks
104602 1 TCS Aspiration Manifold 6-8 weeks
104603 1 TCS Guide Rail Label 6-8 weeks
104604 1 TCS Guide Rod Springs 6-8 weeks
104606 1 TCS Aspirator Tubing Connector (1/8) 6-8 weeks
104609 1 TCS Ten Tip Cassette Rack 6-8 weeks
104612 1 TCS Dispense Manifold 6-8 weeks
104614 1 TCS Dispenser Vinyl Tubing 6-8 weeks
104616 1 TCS Dispenser Tubing Adaptor 6-8 weeks
104617 1 TCS Dispenser Tubing Guide 6-8 weeks
104618 1 TCS Dispenser Reagent Bottle 6-8 weeks
104619 1 TCS Dispenser Pump 10-12 weeks
104622 1 TCS Dispenser Priming Trough 10-12 weeks
104685 1 TCS Aspirator Tubing Connector (1/8 to 3/8) 4-6 weeks
104775 2 TCS, e-Clip Aspiration Manifold 8-10 weeks
104776 2 TCS, Internal Spring Aspiration Manifold 8-10 weeks
104778 2 TCS, Nozzle Cleaning Tool 8-10 weeks
Execution Copy of Development,
CONFIDENTIAL Distribution and Licensing Agreement
EXHIBIT E
Summary of warehousing/shipping costs incurred by Gen-Probe to be
reimbursed by Bayer
Warehousing storage costs:
Gen-Probe will utilize room temperature warehouse space and refrigerated/frozen
(2-8C or -20C) warehouse space to store Bayer inventory. The space will
initially be existing warehouse space at Genetic Center Drive. As the business
grows, Gen-Probe may acquire additional space which will be similar to GCD
warehouse space. Any new refrigerated/frozen warehouse space will be validated
by Gen-Probe personnel prior to the storage of products for Bayer.
Storage costs will be as follows:
Ambient storage [***]
Refrigerated/Frozen storage [***]
Storage costs will be billed monthly based upon end of month storage assessment
by GP personnel
WAREHOUSING PERSONNEL COSTS:
Based upon 2001 forecasts, 1 warehouse person will be required to support the
Bayer warehousing effort. Current Cost = [***]
In future years, the cost per person will increase by 5% per year. The number
of personnel required will be estimated based upon the forecast for each future
year. The resource requirements will be reviewed and evaluated on a quarterly
basis.
SHIPPING SUPPLY COSTS:
Shipping containers and shipping supplies are charged as follows:
(Shipping supplies include dry ice, cold packs, tape, labels, bubble wrap, etc.)
Description Box number box cost + supplies = total per box
▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇▇ $25.62 + $13.00 = $38.62
Box 1 IUO/IVD BX0088 $32.73 + $13.00 = $45.73
▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇▇ $30.11 + $ 2.00 = $32.11
Box 2 IUO/IVD BX0082 $37.94 + $ 2.00 = $39.94
▇▇▇ ▇ ▇▇▇/▇▇▇/▇▇▇ ▇▇▇▇▇▇ $44.31 + $ 1.00 = $45.31
▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇ $ 4.30 + $ 1.00 = $ 5.30
▇▇▇ ▇ ▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇ $32.73 + $13.00 = $45.73
Note: The above costs will be billed monthly to Bayer based upon actual usage
of boxes and storage space.
Execution Copy of Development,
CONFIDENTIAL Distribution and Licensing Agreement
*** 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.
[***] Exhibit F
*** 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.
