Exhibit 10.103
***Text Omitted and Filed Separately
with the Securities and Exchange Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4)
and 240.24b-2.
Execution Copy
RESTATED AGREEMENT
between
GEN-PROBE INCORPORATED
and
NOVARTIS VACCINES AND DIAGNOSTICS, INC.
Dated as of July 24, 2009

 

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RESTATED AGREEMENT
     THIS RESTATED AGREEMENT (the “Agreement”), dated as of July 24, 2009 (the
“Effective Date”), is entered into between GEN-PROBE INCORPORATED, a Delaware
corporation (“Gen-Probe”), having a place of business at 10210 Genetic Center
Drive, San Diego, California 92121, and NOVARTIS VACCINES AND DIAGNOSTICS, INC.,
a Delaware corporation (“Novartis”), having a place of business at 4560 Horton
Street, Emeryville, California 94608.
RECITALS
     WHEREAS, Gen-Probe owns or has rights in certain patent rights, other
intellectual property rights and technology regarding in vitro diagnostic assays
based on or utilizing transcription mediated amplification and regarding certain
instruments to conduct such assays.
     WHEREAS, Novartis owns or has rights in certain patent rights, other
intellectual property rights and technology regarding hepatitis C virus and type
1 human immunodeficiency virus and the detection thereof.
     WHEREAS, Gen-Probe has developed certain assays and instruments, which
utilize inter alia such Gen-Probe patent rights, other intellectual property
rights and technology which Novartis wishes to distribute and sell, for use in
the blood screening field, on the terms and subject to the conditions of this
Agreement.
     WHEREAS, Novartis was formerly Chiron Corporation, and Gen-Probe and Chiron
Corporation previously entered into that certain Agreement dated June 11, 1998,
relating to the development, manufacture, marketing and distribution of products
in the blood screening and clinical diagnostic fields, as amended, supplemented,
and modified by various written agreements between Gen-Probe and Chiron
Corporation or Novartis, as applicable (collectively, as so amended,
supplemented, and modified, the “1998 Agreement”). Novartis succeeded Chiron
Corporation as a party to the 1998 Agreement and, accordingly, all references in
the 1998 Agreement to “Chiron” shall be interpreted to refer to Novartis.
     WHEREAS, subsequent to the execution of the 1998 Agreement, Chiron
Corporation, succeeded by Novartis, assigned its rights and obligations under
the 1998 Agreement with respect to Clinical Diagnostic Assays, Clinical
Diagnostic Instruments, and the Clinical Diagnostic Field (as such terms are
defined in the 1998 Agreement) to Chiron Diagnostics Corporation, which was
subsequently acquired by Bayer Corporation. Chiron Corporation, succeeded by
Novartis, retained all rights and obligations under the 1998 Agreement with
respect to Blood Screening Assays, Blood Screening Instruments and the Blood
Screening Field (as such terms are defined in the 1998 Agreement).
     WHEREAS, in connection with recent discussions between the parties and in
accordance with that certain Amendment No. 11 to the 1998 Agreement dated as of
January 1, 2009, the parties now desire to restate and clarify their agreement
as of the Effective Date, solely with respect to the Blood Screening Field (as
defined in the 1998 Agreement), as provided herein.

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     NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants set forth below, the Parties hereby agree as set forth herein:
ARTICLE 1
DEFINITIONS
     For purposes of this Agreement, the terms defined in this ARTICLE 1 shall
have the respective meanings set forth below:
     1.1 “Affiliate” shall mean, with respect to any Person, any other Person
which directly or indirectly controls, is controlled by, or is under common
control with, such Person. A Person shall be regarded as in control of another
Person if it owns, or directly or indirectly controls, more than fifty percent
(50%) of the voting stock or other ownership interest of the other Person (or
such lesser percentage as is the maximum percentage permitted under applicable
law for foreign ownership where control is exercised by contract or otherwise),
or if it directly or indirectly possesses the power to direct or cause the
direction of the management and policies of the other Person by any means
whatsoever.
     1.2 “Ancillary Product” means an item that is necessary for the use of
Blood Screening Assays with Blood Screening Instruments and that is sold by
Gen-Probe to Novartis for resale by Novartis for use with a Blood Screening
Assay or a Blood Screening Instrument.
     1.3 “Applicable Purchase Price” shall mean, with respect to any Blood
Screening Assay on a per unit basis, the following price:
          1.3.1 With respect to each HCV Blood Screening Assay, an amount equal
to the sum of:
               (a) Fifty percent (50%) of Gen-Probe’s Manufacturing Cost of such
HCV Blood Screening Assay, plus
               (b) The percentage specified below for the calendar year in which
such HCV Blood Screening Assay is sold, multiplied by the Net Sales of such HCV
Blood Screening Assay for the applicable period pursuant to Section 6.1.1.

      Calendar Year   Applicable Percentage 2009   44% 2010   46% 2011   46%
2012   47%

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      Calendar Year   Applicable Percentage 2013   47% 2014   48% 2015 and all
subsequent years during the Blood Screening Term   50%

          1.3.2 With respect to each Non-HCV Blood Screening Assay, an amount
equal to the sum of:
               (a) Fifty percent (50%) of Gen-Probe’s Manufacturing Cost of such
Non-HCV Blood Screening Assay, plus
               (b) Fifty percent (50%) of Net Sales of such Non-HCV Blood
Screening Assay for the applicable period pursuant to Section 6.1.1.
          provided, however, that the percentage referred to in (b) above shall
be adjusted to reflect the value of patent rights contributed by either party
covering the marker which is the subject of any such Non-HCV Blood Screening
Assay approved by the parties for development following the Effective Date, with
the amount of the adjustment determined by the Supervisory Board pursuant to
ARTICLE 4, based on the value of such patent rights and the degree of
exclusivity which is provided for the Non-HCV Blood Screening Assay; and
          provided, further, that the Supervisory Board may modify the allowable
deductions from Net Sales for Non-HCV Blood Screening Assays approved by the
parties for development following the Effective Date.
          1.3.3 Notwithstanding any other provision of this Agreement, except as
agreed to otherwise in writing by the parties, the Applicable Purchase Price for
any Blood Screening Assay shall not be less than Gen-Probe’s Manufacturing Cost
for such Assay.
     1.4 “Blood Screening Assays” shall mean, collectively, all blood screening
assays developed or commercialized under this Agreement, including both HCV
Blood Screening Assays and Non-HCV Blood Screening Assays.
     1.5 “Blood Screening Field” shall mean the nucleic acid probe based testing
of human blood, plasma or other blood products intended for direct transfusion
or other administration to humans.
     1.6 “Blood Screening Instruments” shall mean the Tigris Instrument, the
ESAS Instrument, the ESAS2 Instrument, the reagent preparation incubator, and
the Panther Instrument for use in the Blood Screening Field, and any
modifications and any such other instrument(s) for use in the Blood Screening
Field as are developed by Gen-Probe after the Effective Date and offered to and
accepted by Novartis (all pursuant to Section 3.1 below).

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     1.7 “Blood Screening Term” shall mean the period commencing on the
Effective Date and expiring on June 30, 2025, subject to earlier termination
pursuant to and in accordance with the provisions of this Agreement.
     1.8 “CBER” shall mean the Center for Biologics Evaluation and Research.
     1.9 “Change in Control” shall mean, with respect to a party, (a) the
acquisition of such party by another entity by means of any transaction or
series of related transactions (including, without limitation, any
reorganization, merger or consolidation, but excluding any merger effected
exclusively for the purpose of changing the domicile of such party); (b) the
sale, transfer or other disposition of all or substantially all of the assets of
such party (including without limitation all of its assets relating to this
Agreement); or (c) the sale of all or substantially all of the capital stock of
such party; unless in each of clauses (a) through (c) above, such party’s
stockholders of record immediately prior to such acquisition or sale hold (by
virtue of the securities issued in consideration for such party’s acquisition or
sale or otherwise) greater than fifty percent (50%) of the total voting power of
the surviving or acquiring entity.
     1.10 “Clinical Diagnostic Field” shall mean the nucleic acid probe based
testing of samples taken from a human patient for the purpose of detecting,
identifying or quantifying, or testing for drug susceptibility of, hepatitis
virus, other viral organisms, or cancer (including markers of early disease
stages), for the purpose of research, diagnosis or medical care; provided,
however, that the Clinical Diagnostic Field shall exclude the Blood Screening
Field. For purposes of clarity and to avoid uncertainty, the Clinical Diagnostic
Field shall exclude testing for genetic predisposition to disease. For purposes
of clarity and to avoid uncertainty, the Clinical Diagnostic Field shall include
the use in connection with the testing described above of standards and controls
which are not taken from a human patient.
     1.11 “Commercially Reasonable Efforts” shall mean:
          1.11.1 With respect to a party’s efforts under this Agreement to
develop, manufacture (or have manufactured), supply, promote, market, or sell a
Product, that level of effort devoted by such party to develop, manufacture (or
have manufactured), supply, promote, market or sell products of similar market
size and market character, and in the absence of/without consideration of
revenue from any licensee (other than the other party) of such party’s
intellectual property rights (i.e., the Gen-Probe IP Rights or the Novartis IP
Rights, as applicable).
          1.11.2 In all other instances that level of effort which would be
devoted by an independent entity reasonably seeking to pursue its own business
efforts in light of all relevant circumstances.
     1.12 “Competitive Probe Assay” shall have the meaning given to such term in
Section 8.1.1(b)(ii).
     1.13 “Component Instruments” shall mean, as of the Effective Date, the ESAS
Instruments and the reagent preparation incubator.

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     1.14 “Confidential Information” shall mean, with respect to a party, all
information of any kind whatsoever (including without limitation, compilations,
data, formulae, models, patent disclosures, procedures, processes, projections,
protocols, results of experimentation and testing, specifications, strategies,
and techniques), and all tangible and intangible embodiments thereof of any kind
whatsoever (including without limitation, apparatus, compositions, documents,
drawings, machinery, patent applications, records, and reports), which is
(i) not generally known and (ii) disclosed by such party to the other party
pursuant to and in accordance with the terms of ARTICLE 7 of this Agreement.
     Notwithstanding the foregoing, Confidential Information of a party shall
not include information which the other party can establish by written
documentation (a) to have been publicly known prior to disclosure of such
information by the disclosing party to the other party, (b) to have become
publicly known, without fault on the part of the other party, subsequent to
disclosure of such information by the disclosing party to the other party,
(c) to have been received by the other party at any time from a source, other
than the disclosing party, rightfully having possession of and the right to
disclose such information, (d) to have been otherwise known by the other party
prior to disclosure of such information by the disclosing party to the other
party, or (e) to have been independently developed by employees or agents of the
other party without access to or use of such information disclosed by the
disclosing party to the other party.
     1.15 “Customer” shall mean the Third Party to whom Products are sold,
transferred or otherwise conveyed by Novartis or its Affiliates.
     1.16 “Development Costs” shall mean, with respect to any Product, the
fully-burdened cost to a party of conducting the research and development
(including clinical trials and regulatory submissions) of such Product,
including the cost of materials, direct labor and overhead, all as determined in
accordance with such party’s standard accounting practices for other products
researched and developed by such party pursuant to and in accordance with the
applicable Development Program (including the applicable budget).
     1.17 “Development Program” shall mean, with respect to each Blood Screening
Assay or Blood Screening Instrument developed pursuant to this Agreement, the
product development program as described in ARTICLE 3 below to develop such
Blood Screening Assay or Blood Screening Instrument.
     1.18 “ESAS Instrument” shall mean the Enhanced Semi-Automated System
developed by Gen-Probe, and related software and appropriate repair parts, for
DNA/RNA amplified assay processing incorporating a separate magnetic wash
station and a chemiluminescent detection system (Leader HC) required to perform
the following steps: (a) magnetic separation of the captured target RNA/DNA,
(b) washing and aspiration of the captured target RNA/DNA, and
(c) chemiluminescent detection steps needed to support Gen-Probe’s patented
Hybridization Protection Assay (HPA) and TMA Assay processes and associated
reagent product lines. For purposes of this Agreement, “ESAS Instrument” does
not include Tecan automated pipetting stations such as the Genesis or EVO
instrument.

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     1.19 “ESAS 2 Instrument” shall mean the instrument developed pursuant to
the Modified Blood Screening Instrument — eSAS 2 Addendum, dated January 1,
2002, under the 1998 Agreement. As of the Effective Date, the eSAS 2 Instrument
consists of the ESAS Instrument plus the front-end pipettor (FEP) and/or the
reagent addition station (RAS).
     1.20 “FDA” shall mean the United States Food and Drug Administration, or
the successor thereto.
     1.21 “First Commercial Sale” shall mean, with respect to any Product, the
first sale of such Product in the United States, for use by a Third Party, after
FDA license approval or clearance of such Product (and without considering
product transfers made pursuant to an Investigational New Drug application).
     1.22 “Forecast” shall mean the twelve-month rolling forecast of Novartis’s
estimated purchase requirements of Blood Screening Assays or the fifteen-month
rolling forecast of Novartis’s estimated purchase requirements of Blood
Screening Instruments, as applicable, over the period covered by the forecast,
as set forth in Sections 5.3.1 and 5.4.1 of the Agreement, respectively set
forth on a product-by-product basis.
     1.23 “Gen-Probe Copyrights” shall mean all rights under the copyright laws
of any jurisdiction in the world, together with all rights commonly referred to
as “moral rights,” in and to the Blood Screening Instruments in which Gen-Probe
has an ownership or other licensable interest during the Blood Screening Term;
all to the extent and only to the extent that Gen-Probe has the right to grant
licenses, immunities or other rights thereunder.
     1.24 “Gen-Probe IP Rights” shall mean, collectively, the Gen-Probe
Copyrights, Gen-Probe Know-How and Gen-Probe Patent Rights.
     1.25 “Gen-Probe Know-How” shall mean all information of any type whatsoever
(including without limitation, formulae, procedures, protocols, techniques, data
and results of experimentation and testing), which is Confidential Information
of Gen-Probe and which (i) relates to the Gen-Probe Patent Rights and which is
necessary to exploit the Gen-Probe Patent Rights for use in the Blood Screening
Field or (ii) is disclosed by Gen-Probe pursuant to ARTICLE 7, all to the extent
and only to the extent that Gen-Probe has the right to grant licenses,
immunities or other rights thereunder.
     1.26 “Gen-Probe Marks” shall mean those trademarks owned by or licensed to
Gen-Probe (other than pursuant to this Agreement) which are used to market any
Product in accordance with the provisions of this Agreement.
     1.27 “Gen-Probe Patent Rights” shall mean (a) all the patents and patent
applications which cover nucleic acid probe assays and instrument technologies,
to the extent necessary for use in the Blood Screening Assays or Blood Screening
Instruments, but only to the extent in each case (i) of the design of the
Products as of the Effective Date and (ii) that Gen-Probe has an ownership or
other licensable interest therein; (b) such other Gen-Probe patent rights which
claim markers or their uses as may become subject to this Agreement pursuant to
the terms hereof with respect to Blood Screening Assays developed hereunder,
(c) all other patents and patent applications which cover nucleic acid probe
assays and instrument technologies, to the

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extent necessary for use in the Blood Screening Assays or Blood Screening
Instruments but only to the extent in each case of the design of the Products as
of the Effective Date and any future modifications to any such designs and/or
any new Products approved for development by Gen-Probe after the Effective Date
(subject to Section 6.2); (d) such Gen-Probe patent rights with respect to any
future modifications to any Blood Screening Instrument as become subject to this
Agreement pursuant to Section 3.1, and such Gen-Probe patent rights with respect
to any future Blood Screening Instrument as are developed by Gen-Probe after the
Effective Date and offered to and accepted by Novartis (all pursuant to
Section 3.1); or (e) such other Gen-Probe patent rights which become subject to
this Agreement pursuant to ARTICLE 8; (f) all patents that have issued or in the
future issue from any of the foregoing, including without limitation utility,
model and design patents and certificates of invention; and (g) all divisional,
continuations, continuations-in-part, reissues, renewals, extensions or
additions to any of the foregoing patent applications and patents; but in each
case only to the extent that Gen-Probe has or hereafter acquires an ownership or
other licensable interest as of the date (1) Gen-Probe approves a Product for
development or (2) a modification to an existing Product is made, considered on
a product-by-product basis, and all to the extent and only to the extent that
Gen-Probe has the right to grant licenses, immunities or other rights
thereunder.
     1.28 “HCV Blood Screening Assays” shall mean those Blood Screening Assays
which include as a constituent element an assay for HCV, including, as of the
Effective Date, the original duplex Blood Screening Assay for HIV-1 and HCV, the
Ultrio Assay Product, and the Ultrio Plus Assay Product (subject to the terms of
the Future Blood Screening Assay — Ultrio 2 Addendum, dated October 1, 2008,
under the 1998 Agreement).
     1.29 “HCV” shall mean hepatitis C virus.
     1.30 “HIV-1” shall mean type 1 human immunodeficiency virus.
     1.31 [Intentionally left blank.]
     1.32 “Manufacturing Cost” shall mean, with respect to any Product, the
fully-burdened cost to a party (expressed on a per unit basis) of manufacturing
or having manufactured such Product, together with the packaging thereof,
including the cost of materials, direct labor, quality control, warranty parts
and labor (only as to Blood Screening Instruments manufactured by Gen-Probe),
and overhead (but excluding royalties paid or payable to Third Parties), all as
determined in accordance with such party’s standard accounting practices for
other products manufactured. For the avoidance of doubt, Manufacturing Cost
shall include the cost of dry ice for frozen or refrigerated products. An
estimate of Manufacturing Cost for each Product shall be established by the
manufacturing party and provided to the other party on an annual basis. Within
seventy-five (75) days of the close of each calendar year the manufacturing
party will provide the other party with a detailed report of the aggregate of
all actual Manufacturing Costs incurred for Products, on a product-by-product
basis. In the event the aggregate of all actual Manufacturing Costs for a
Product manufactured in the calendar year exceeds, or is less than, the estimate
set and used to determine the Applicable Purchase Price paid for such Products
sold during such calendar year, the parties will “true up” the aggregate
Applicable Purchase Price paid for such Products accordingly.

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     1.33 “Net Sales” shall mean with respect to any Product(s), except as
otherwise provided in this Section 1.33, on a per unit basis where applicable
and in the aggregate where applicable, the gross sales price of such Product(s)
invoiced by any of (i) Novartis, (ii) Novartis’s Affiliates, (iii) Gen-Probe, or
(iv) or any distributor for Novartis in Japan, Germany, Italy, France, or the
United Kingdom (all of which are individually referred to hereafter in this
Section 1.33 as “Seller”), following shipment to unaffiliated Third Parties
less, to the extent actually paid or accrued by such Seller: (a) discounts,
rebates or chargebacks actually allowed and taken, to the extent consistent with
industry practices and price reductions given for similar products by such
Seller; and/or (b) amounts repaid or credited by reason of rejection, spoilage,
expiration or return; and/or (c) to the extent separately stated on purchase
orders, invoices or other documents of sale, taxes levied on and/or other
governmental charges made as to production, or transportation or insurance
charges; and/or (d) charges for freight, handling and transportation; and/or (f)
sales, use and value-added taxes and other similar taxes incurred and separately
stated on invoices; and/or (g) customs duties, surcharges and other governmental
charges incurred in exporting or importing such Product. Transfer to any
unaffiliated Third Party of a Blood Screening Instrument qualifying for sale
treatment under generally accepted accounting principles (GAAP) will be deemed
to be a “sale” for purposes of this Agreement, including without limitation the
calculation of “Net Sales” under this Section 1.33 and the compensation due
Gen-Probe on account of sales under Section 6.1.2 (including Sections 6.1.2(b)
and 6.1.2(c)). With respect to sales of Blood Screening Assays, the “per unit”
basis of calculating Net Sales may be either a “per test” or “per donation”
basis, in the same manner as which Novartis derives revenues from the sale of
such assays.
          1.33.1 In the event that a Product is sold in combination with another
product other than as addressed in Section 6.1.2(d), (a “Combination Product”)
for a single price in a particular period, Net Sales from sales of a Combination
Product for that period, for purposes of this Agreement, shall be calculated by
multiplying the Net Sales of that Combination Product for that period by the
fraction A/(A+B), where A is the average per unit Net Sales of the Product sold
separately in the country of sale in that period and B is the average per unit
Net Sales of the other product(s) sold separately in the country of sale in that
period. This calculation shall be made for each Product comprising the
Combination Product and the results added. In the event that no such separate
sales are made in the applicable period, Net Sales of such Combination Product
shall be determined based on a reasonable apportionment of the gross amount
invoiced therefor based upon the relative contribution of the Product to the
price of the Combination Product. Such apportionment shall be negotiated in good
faith between the parties and resolved pursuant to ARTICLE 11 if they are unable
to agree.
          1.33.2 For purposes of calculating Net Sales, the Seller may, at its
option, determine the allowable deductions from gross sales based on accruals
estimated reasonably and consistently with such party’s standard accounting
practices, which shall be notified to the other party on an annual basis. If
such accruals are used, within seventy-five (75) days of the close of each
calendar year the Seller will provide the other party with a reasonably detailed
report of all actual deductible expenses incurred. In the event the aggregate of
all actual deductible expenses for sales in the calendar year exceeds, or is
less than, the estimate set and used to determine Net Sales during such calendar
year, the parties will “true up” Net Sales accordingly.

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     1.34 “Non-HCV Blood Screening Assays” shall mean those Blood Screening
Assays which do not include as a constituent element an assay for HCV, including
as of the Effective Date the WNV Assay Product.
     1.35 “Novartis Copyrights” shall mean all rights under the copyright laws
of any jurisdiction in the world, together with all rights commonly referred to
as “moral rights,” in and to the Blood Screening Assays or Blood Screening
Instruments in which Novartis has an ownership or other licensable interest
during the Blood Screening Term; all to the extent and only to the extent that
Novartis has the right to grant licenses, immunities or other rights thereunder.
     1.36 “Novartis Know-How” shall mean all information of any type whatsoever
(including without limitation, formulae, procedures, protocols, techniques, data
and results of experimentation and testing), which is Confidential Information
of Novartis and which (i) relates to the Novartis Patent Rights and which is
necessary to exploit the Novartis Patent Rights for use in the Blood Screening
Field or (ii) is disclosed by Novartis pursuant to ARTICLE 7, all to the extent
and only to the extent that Novartis has the right to grant licenses, immunities
or other rights thereunder.
     1.37 “Novartis Marks” shall mean those trademarks owned by or licensed to
Novartis (other than pursuant to this Agreement) which are used to market any
Product in accordance with the provisions of this Agreement.
     1.38 “Novartis Patent Rights” shall mean (a) all United States and foreign
patent applications covering (i) the composition of matter of HCV or HIV-1, or,
in each case of the foregoing, any nucleotide sequence thereof or (ii) the use
thereof in the Blood Screening Field; (b) such other Novartis patent rights
which claim markers or their uses as may become subject to this Agreement
pursuant to the terms hereof with respect to Blood Screening Assays developed
hereunder and sold by Novartis or pursuant to ARTICLE 8; (c) all other patents
and patent applications which cover nucleic acid probe assays and instrument
technologies, to the extent necessary for use in the Blood Screening Assays or
Blood Screening Instruments but only to the extent in each case of the design of
the Products as of the Effective Date and any future modifications to any such
designs and/or any new Products approved for development by Novartis after the
Effective Date (subject to Section 6.2); (d) all patents that have issued or in
the future issue from any of the foregoing, including without limitation
utility, model and design patents and certificates of invention; and (e) all
divisional, continuations, continuations-in-part; reissues, renewals, extensions
or additions to any of the foregoing patent applications and patents; but in
each case only to the extent Novartis has an ownership or other licensable
interest as of the date (1) Novartis approves a Product for development or (2) a
modification to an existing Product is made, considered on a product-by product
basis, and all to the extent and only to the extent that Novartis has or
hereafter acquires the right to grant licenses, immunities or other rights
thereunder.
     1.39 “Novartis IP Rights” shall mean, collectively, the Novartis
Copyrights, Novartis Know-How and Novartis Patent Rights.

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     1.40 “Panther Instrument” shall mean an integrated, fully-automated low to
mid volume molecular diagnostic instrument system to be developed by Gen-Probe
in accordance with Attachment B to Amendment No. 11 and pursuant to a new
product development addendum to be negotiated in good faith and to conclusion by
the parties immediately following the Effective Date. The parties intend that
the Panther Instrument will be designed to be able to process the Blood
Screening Assays, with an anticipated throughput of [...***...] tests in
[...***...] hours; continuous access to samples and reagents; and an estimated
transfer price from the manufacturer of approximately $[...***...].
     1.41 “Person” shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority or any other form of entity not
specifically listed herein.
     1.42 “Product” shall mean a Blood Screening Assay or Blood Screening
Instrument.
     1.43 “Purchase Order” shall mean the binding purchase order of Blood
Screening Assays or Blood Screening Instruments delivered in accordance with the
provisions of Section 5.3.3 or Section 5.4.2 of the Agreement, respectively.
     1.44 “Registration Trial” means the clinical trial activity required by a
governmental regulatory authority to be completed as a prerequisite to the sale
of a Product within the regulatory authority’s jurisdiction. Clinical trial
activity intended solely to foster customer acceptance (i.e., a “market trial”),
rather than intended to generate approval by a regulatory authority, shall not
be considered a Registration Trial.
     1.45 “Roche Promoter-Primer Patent Claims” means claims contained in EP
505012 or in any F. Hoffman-La Roche, Ltd. and Roche Molecular Systems, Inc.
(collectively “Roche”) patent drawn to compositions or methods claimed therein
having a priority date on or before the Effective Date (as such term is defined
in the HCV Probe License Agreement and HIV Probe License Agreement by and among
Chiron, F. Hoffman-La Roche, Ltd. and Roche Molecular Systems, Inc. and dated
October 10, 2000) or in any Roche patent issued or application that claims
priority, at least in part, from USSN 716,975 filed March 3, 1985 or USSN
791,308 filed October 25, 1985 or USSN 818,127 filed January 10, 1986 or USSN
935,587 filed November 26, 1986, including without limitation US Patent
5,176,995 or foreign counterparts thereof, but excluding the Roche Optioned
Patents (as such term is defined in the HCV Probe License Agreement and HIV
Probe License Agreement by and among Chiron, F. Hoffman-La Roche, Ltd. and Roche
Molecular Systems, Inc. and dated October 10, 2000).
     1.46 “Spare Part” means any field replaceable part required to ensure that
a Blood Screening Instrument performs as intended.
     1.47 “Supervisory Board” shall mean the committees comprising
representatives of Gen-Probe and Novartis as described in Section 4.1 below.
     1.48 “Territory” shall mean the entire world.
***Confidential Treatment Requested

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     1.49 “Third Party” shall mean any Person other than Gen-Probe, Novartis and
their respective Affiliates.
     1.50 “Tigris Instrument” shall mean the integrated, automated instrument,
and related software and appropriate repair parts, for DNA/RNA amplified assay
processing incorporating all systems required to perform the following steps:
(a) lysis/annealing, (b) enzymatic amplification, (c) hybridization/selection,
and (d) detection/decontamination, which utilize processing steps that include
heating/cooling, reagent addition, mixing, chemiluminescent detection and
aspiration needed to support Gen-Probe’s patented Hybridization Protection Assay
(HPA) and TMA Assay processes and associated reagent product lines.
     1.51 “TMA Assay” shall mean an in vitro diagnostic assay based on or
utilizing transcription-based nucleic acid amplification, but excluding the
“Teknika Version” of transcription-based amplification (as that term is defined
in Schedule 1.51).
     1.52 “Transfer Price” shall mean, with respect to any Product, on a per
unit basis, the following price:
          1.52.1 For each Blood Screening Assay sold as of the Effective Date,
the transfer price previously approved by the Supervisory Board. For each Blood
Screening Assay approved for development following the Effective Date, the
transfer price shall be established by the new product development addendum for
such assay and is expected to range between [...***...] of the Applicable
Purchase Price. The Transfer Price for each Blood Screening Assay shall be
reviewed by the Supervisory Board on an annual basis and shall be reasonably
adjusted to reflect material changes in Manufacturing Costs.
          1.52.2 The Transfer Price for each Tigris Instrument shall be equal to
the amount actually invoiced to Gen-Probe by its manufacturer.
          1.52.3 The Transfer Price for each ESAS Instrument shall be an amount
equal to the lesser of (a) [...***...], reasonably adjusted for inflation from
June 11, 1998, and (b) [...***...] of the Manufacturing Cost of such Blood
Screening Instrument. Should CBER mandate modifications to any Blood Screening
Instrument which results in extraordinary increases in the cost of the Blood
Screening Instrument, the parties shall negotiate in good faith with respect to
adjusting the amounts set forth herein.
          1.52.4 The Transfer Price for each reagent preparation incubator shall
be an amount equal to [...***...] of the Manufacturing Cost of such Blood
Screening Instrument.
          1.52.5 The Transfer Price for any Blood Screening Instrument, other
than the Tigris Instrument, the ESAS Instrument, and the reagent preparation
incubator shall be negotiated between the parties concurrently with the
negotiation of any development program for such other Blood Screening Instrument
pursuant to Section 3.1.3 (Development Program) or as part of the offer
described in Section 3.2.4 (Other Blood Screening Instruments).
***Confidential Treatment Requested

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          1.52.6 The Transfer Price for Spare Parts and Ancillary Parts
delivered to Novartis by Gen-Probe shall be equal to (i) [...***...] of the
amount actually invoiced to Gen-Probe by a Third Party manufacturer or
(ii) Gen-Probe’s Manufacturing Cost, as applicable.
          1.52.7 Gen-Probe shall promptly notify Novartis upon Gen-Probe’s
receipt of notice of a proposed or actual increase in the price of any Spare
Part or Ancillary Product supplied by a Third Party and use reasonable
commercial efforts to extend to Novartis, if made available by the manufacturer,
the benefit of any opportunity to acquire additional quantities of impacted
Spare Parts or Ancillary Products prior to the noticed date of the increase. In
no event shall Gen-Probe ship to Novartis any Spare Part or Ancillary Product
for which there has been a price increase without first notifying Novartis of
the price increase.
     1.53 “Ultrio Assay Product” shall mean the assay developed pursuant to the
Future Blood Screening Assay — Ultrio Addendum, dated January 1, 2001, under the
1998 Agreement.
     1.54 “Ultrio Plus Assay Product” shall mean the assay under development
pursuant to the Future Blood Screening Assay — Ultrio 2 Addendum, dated
October 1, 2008, under the 1998 Agreement.
     1.55 “Valid Claim” shall mean (a) a claim of an issued patent that has not
been held unenforceable or invalid by an agency or a court of competent
jurisdiction in any final judgment as to which the owner or rights holder has no
further right of appeal and, in addition (b) a claim of a patent application
which is being prosecuted or pursued in good faith for the United States and
which meets the requirements for patentability under applicable law and that has
not been abandoned or finally rejected without the possibility of appeal or
refiling. Either party may contest whether a claim in a pending patent
application for the United States meets the requirements for patentability under
applicable law. Such contest shall be made pursuant to the procedures
established by ARTICLE 11 except that (i) in lieu of submitting the issue to a
single arbitrator, the issue shall be submitted to a panel of three patent
attorneys with experience in the subject matter for binding determination and
(ii) there shall be no appeal from the decision of the majority of such panel.
The burden of proof before the arbitrators shall be a preponderance of the
evidence.
     1.56 “WNV Assay Product” shall mean the assay developed pursuant to the
Future Blood Screening Assay — West Nile Virus Addendum, dated June 1, 2003,
under the 1998 Agreement.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
     2.1 By Each Party. Each party hereby represents and warrants to the other
party as of the date of the execution of this Agreement (except as specifically
otherwise indicated below) as follows:
***Confidential Treatment Requested

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          2.1.1 Corporate Existence and Power. Such party (a) is a corporation
duly organized, validly existing and in good standing under the laws of the
state in which it is incorporated; (b) has the corporate power and authority and
the legal right to own and operate its property and assets, to lease the
property and assets it operates under lease, and to carry on its business as it
is now being conducted; and (c) is in compliance with all requirements of
applicable law, except to the extent that any noncompliance would not have a
material adverse effect on the properties, business, financial or other
condition of such party and would not materially adversely affect such party’s
ability to perform its obligations under this Agreement.
          2.1.2 Authorization and Enforcement of Obligations. Such party (a) has
the corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder, and (b) has taken all
necessary corporate action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such party, and
constitutes a legal, valid, binding obligation, enforceable against such party
in accordance with its terms.
          2.1.3 Consents. All necessary consents, approvals and authorizations
of all governmental authorities and other Persons required to be obtained by
such party in connection with this Agreement have been obtained on or before the
Effective Date.
          2.1.4 No Conflict. The execution and delivery of this Agreement and
the performance of such party’s obligations hereunder (a) do not conflict with
or violate any requirement of applicable laws or regulations, and (b) do not
conflict with, or constitute a default under, any contractual obligation of such
party.
     2.2 DISCLAIMER OF WARRANTIES. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED
AS A REPRESENTATION MADE, OR WARRANTY GIVEN, BY EITHER PARTY THAT ANY PATENT
WILL ISSUE BASED UPON ANY PENDING PATENT APPLICATION WITHIN THE GEN-PROBE PATENT
RIGHTS OR NOVARTIS PATENT RIGHTS, THAT ANY PATENT WITHIN THE GEN-PROBE PATENT
RIGHTS OR NOVARTIS PATENT RIGHTS WHICH ISSUES WILL BE VALID, OR THAT THE USE OF
ANY LICENSE GRANTED HEREUNDER OR THAT THE USE OF ANY GEN-PROBE PATENT RIGHTS OR
NOVARTIS PATENT RIGHTS WILL NOT INFRINGE THE PATENT OR OTHER INTELLECTUAL
PROPERTY RIGHTS OF ANY OTHER PERSON. FURTHERMORE (EXCEPT AS OTHERWISE EXPRESSLY
SET FORTH IN SECTION 5.7 BELOW), NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE GEN-PROBE PATENT RIGHTS OR
NOVARTIS PATENT RIGHTS OR THE PRODUCTS, INCLUDING WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT.

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ARTICLE 3
BLOOD SCREENING PRODUCTS
     3.1 Blood Screening Assays; Blood Screening Instruments.
          3.1.1 Current Products. Prior to the Effective Date, the parties have
developed Products for use in the Blood Screening Field, including Blood
Screening Assays and Blood Screening Instruments. The Blood Screening Assays
developed prior to the Effective Date are: the duplex Blood Screening Assay for
HIV-1 and HCV; the Ultrio Assay Product, the Ultrio Plus Assay Product, and the
WNV Assay Product. The Blood Screening Instruments developed prior to the
Effective Date are: the ESAS Instrument, the ESAS2 Instrument, and the Tigris
Instrument.
          3.1.2 New Product Development.
               (a) From time to time during the Blood Screening Term, the
Supervisory Board may discuss the selection and establishment of development
programs for one or more new Products, including without limitation the
development of modifications to the then-existing Products (which modifications
shall in and of themselves be considered Products). The rights granted by each
party to the other with respect to any of the Products during the Blood
Screening Term shall extend to and include any and all modifications to such
Product as are developed during the Blood Screening Term to improve the sample
processing, amplification, detection, analysis, or reliability of such Product
which utilize the same base technologies and which do not change the fundamental
character of such Product, to the extent that Gen-Probe is not prohibited as of
the Effective Date from granting such rights. From time to time during the Blood
Screening Term, the Supervisory Board shall consider potential modifications to
the Products.
               (b) If both parties wish to develop a Product, the Supervisory
Board shall discuss in good faith and propose a mutually acceptable written
Development Program and a budget for such development (both of which shall be
updated at least annually) for such Product which shall set forth (i) the
specifications for such Product, and (ii) the parties’ respective obligations to
develop such Product and to conduct such clinical trials and apply for such
regulatory approvals as necessary or appropriate to make and sell the Products
in the Territory for use in the Blood Screening Field. If a Blood Screening
Assay or Blood Screening Instrument is selected for development by both parties
in accordance with this Section, then the parties shall develop such Blood
Screening Assay or Blood Screening Instrument as set forth in Section 3.1.3.
               (c) If one party wishes to develop the Product and the other
party does not, the party wishing to conduct such development shall have the
right to proceed at its sole expense, in accordance with a Development Program,
including a budget, to be updated annually, approved by the Supervisory Board
(which approval shall not be unreasonably withheld or delayed), provided that
such developing party may elect to cease such development at any time in its
discretion. The other party shall have no obligation to fund any of the
Development Costs of conducting the Development Program for such Product. In any
event,

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subject to all terms of this Agreement, Novartis shall have the exclusive right
and obligation to market and sell all Products for use in the Blood Screening
Field pursuant to Section 3.1.9.
          3.1.3 Development Programs.
               (a) Establishment. For each Product selected for development by
both parties in accordance with Section 3.1.2, the parties shall prepare and
agree upon a final written Development Program and budget for each Product,
which shall set forth (i) the specifications for such Product, (ii) a proposed
schedule for the Development Program, and (iii) the parties’ respective
obligations to develop such Product and to conduct such clinical trials and
apply for such regulatory approvals as necessary or appropriate to make and sell
in the Territory such Product for use in the Blood Screening Field. The
Development Program as agreed by the parties for each Product may not be
modified except by the action of the Supervisory Board.
               (b) Responsibilities. Each party shall develop each Product in
accordance with its respective responsibilities as set forth in and assigned by
the applicable Development Program documents. In accordance with Section 3.1.6,
the parties shall conduct such clinical trials and apply for and endeavor to
obtain such regulatory approvals as necessary or appropriate to make and sell
each Product in the Territory for use in the Blood Screening Field. Each party
shall consult with the other party on such matters and each party shall
reasonably consider the other party’s advice and recommendations on all matters
relating to such Development Program.
               (c) Conduct of Development. Each party shall conduct its
respective obligations under the Development Program for each Product in
compliance in all material respects with all requirements of applicable laws and
regulations and all applicable good laboratory, clinical and manufacturing
practices. Gen-Probe and Novartis each shall proceed diligently with their
respective obligations under each such Development Program and shall use their
respective Commercially Reasonable Efforts to achieve its objectives efficiently
and expeditiously. Gen-Probe and Novartis each shall allocate sufficient
personnel, equipment, facilities and other resources to each such Development
Program to carry out their respective obligations and to accomplish the
objectives thereof.
               (d) Subcontracts. Upon approval of the Supervisory Board which
shall not be unreasonably withheld by either party (and except as to such
subcontracts which exist as of the Effective Date), Gen-Probe and Novartis each
may subcontract portions of the Development Program for each Product to be
performed by it in the normal course of its business; provided, however, that
(i) unless the other party gives its prior written consent, such subcontracting
shall not involve the transfer (including but not limited to any sublicense) of
any intellectual property rights of the other party or Confidential Information
of the other party to Third Parties; (ii) if the other party consents to the
subcontractor’s access to Confidential Information of the other party, the
subcontracted party shall enter into a confidentiality agreement with the
subcontracting party incorporating the terms of ARTICLE 7 below; (iii) the
subcontracting party shall supervise such subcontract work; (iv) the
subcontracted party shall be in compliance in all material respects with all
requirements of applicable laws and regulations, together with all applicable
good laboratory, clinical and manufacturing practices; (v) prior to
subcontracting any portion of the Development Program to a Third Party, each
party will offer

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the other party the opportunity to perform such portion on terms which, taken as
a whole, are equal to or better than those which could be obtained from a Third
Party; and (vi) if required by the Supervisory Board, the subcontracted party
shall enter into an agreement with the subcontracting party to effectuate the
provisions of ARTICLE 8 below, and which shall include a provision for
assignment of inventions arising from the subcontracted work.
          3.1.4 Funding.
               (a) Subject to Section 3.1.4(b) below, unless the parties agree
in writing otherwise, Gen-Probe and Novartis each shall pay one-half (1/2) of
the aggregate Development Costs of conducting the Development Program for each
Product which they mutually agree to develop. Within thirty (30) days after the
end of each calendar quarter, each party shall report to the other all
Development Costs incurred by such party (if any) during such calendar quarter
in conducting the Development Program for each Product. Within thirty (30) days
after receiving such reports, the parties shall make such payments to each other
as are necessary to cause each party to have paid its appropriate share under
this Section of the aggregate budgeted Development Costs incurred with respect
to the Development Program for such Product during such calendar quarter.
               (b) In the case of a Product which is funded by one party
pursuant to Section 3.1.2(c), such party shall be solely responsible for all
Development Costs of such Product.
               (i) If the funding party is Gen-Probe, Novartis shall pay an
additional royalty to Gen-Probe equal to a percentage, established by the
Supervisory Board at the time of approval of the Development Program, of Net
Sales of such Product, until the aggregate royalty paid to Gen-Probe solely
under this sentence effectively reimburses Gen-Probe for disproportionate
budgeted Development Costs incurred by Gen-Probe with respect to the Development
Program for such Product.
               (ii) If the funding party is Novartis, Novartis shall be entitled
to offset against amounts owing to Gen-Probe solely with respect to such Product
an amount equal to a percentage, established by the Supervisory Board at the
time of approval of the Development Program, of Net Sales of such Product, until
the aggregate offset taken solely under this sentence effectively reimburses
Novartis for disproportionate budgeted Development Costs incurred by Novartis
with respect to the Development Program for such Product. Novartis shall report
the amount of any such offsets in each report pursuant to Section 6.4.
               (iii) The additional royalty or offset established by the
Supervisory Board shall be intended to enable the funding party to recover such
Development Costs for such Development Program within the longer of (i) three
(3) years or (ii) a period equal to the duration of such Development Program.
The additional royalty or offset shall be set based on the information available
to the Supervisory Board at the time of its initial approval of the Development
Program and shall not be adjusted thereafter except at the sole discretion of
the Supervisory Board.

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          3.1.5 Records and Reports for Development Programs.
               (a) Records. Gen-Probe and Novartis each shall maintain records,
in sufficient detail appropriate for regulatory or patent purposes, which shall
be complete and accurate and shall fully and properly reflect all work done and
results achieved in the performance of the Development Programs for Blood
Screening Assays and Blood Screening Instruments (including all data in the form
required under all applicable laws and regulations).
               (b) Inspection of Records. Gen-Probe and Novartis each shall have
the right, during normal business hours and upon reasonable notice, to inspect
the records of the other party relating to the Development Programs for any
Blood Screening Assay and Blood Screening Instrument, to the extent reasonably
required for the performance of the Development Program. The parties shall
develop reasonable procedures for requesting and delivering copies of such
records to each other as may be necessary for the performance of the Development
Programs for Blood Screening Assays and Blood Screening Instruments. Each party
shall maintain such records and the information of the other party contained
therein in confidence incorporating the terms of ARTICLE 7 below and shall not
use such records or information except to the extent otherwise permitted by this
Agreement.
               (c) Development Reports and Information. Gen-Probe and Novartis
each shall keep the other informed of the progress of such party under the
Development Programs for Blood Screening Assays and Blood Screening Instruments.
          3.1.6 Regulatory Matters.
               (a) Gen-Probe and Novartis will share equal responsibility for
clinical trials for all Products. Disagreements on clinical trial issues shall
be resolved by the Supervisory Board, and if necessary through the dispute
resolution procedures set forth in ARTICLE 11.
               (b) Gen-Probe and Novartis will share equal responsibility for
regulatory and licensure strategy and management of regulatory submissions for
all Products, subject to all terms of this paragraph. Gen-Probe shall be the
licensed party for all Products manufactured by Gen-Probe and shall maintain its
status as the primary point of contact with the FDA. Schedule 3.1.6 sets forth a
list of licensed manufacturers for each Product as of the Effective Date. Except
as set forth herein or in the Quality Agreement dated May 28, 2009, Novartis
shall remain the primary point of contact with all regulatory and licensing
authorities outside the United States for submission and registration of
Products. Each party shall use its best efforts to execute its regulatory and
licensure responsibilities with appropriate timing and urgency pursuant to the
approved Development Program. Disagreements on regulatory and licensing issues
shall be resolved by the Supervisory Board, and if necessary through the dispute
resolution procedures set forth in ARTICLE 11, excluding arbitration. For
regulatory and licensing disputes that cannot be otherwise resolved, Gen-Probe’s
CEO shall have the right to make the final decision.

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          3.1.7 Initiation of “Companion Diagnostic” Program. The parties will
work together, on a non-exclusive basis, to research and develop molecular
diagnostic assays that could be used to help identify patients who are likely to
particularly benefit from medicines that Novartis or any of its Affiliates is
developing or marketing. To develop these potential “companion diagnostic”
tests, Novartis may contribute biomarkers discovered through its research
efforts, and Gen-Probe will provide its molecular diagnostics technologies and
assay development expertise. Novartis will also provide at least [...***...] in
aggregate research funding to Gen-Probe in 2009 and 2010 in support of initial
research and development. The parties will establish development agreements on a
case-by-case basis, with the parties expecting to share revenues associated with
any companion diagnostic tests that are successfully commercialized.
          3.1.8 Manufacturing.
               (a) Subject to Section 3.1.8(b) below, Gen-Probe shall have the
exclusive right and the obligation to manufacture (or to have manufactured) and
supply Novartis with its requirements of the Blood Screening Assays and Blood
Screening Instruments in the Territory for use in the Blood Screening Field in
accordance with ARTICLE 5 below.
               (b) Step-In Manufacturing Rights.
               (i) Assays. If Gen-Probe (i) fails at any time during the Blood
Screening Term to maintain the applicable FDA (CBER) license for the facility
used to manufacture a Blood Screening Assay (unless Gen-Probe is approved by
CBER to manufacture from an alternative location or the Supervisory Board agrees
within fifteen (15) days of such event that Gen-Probe shall retain the
manufacturing responsibility hereunder); or (ii) fails to supply Novartis within
forty-five (45) days after the requested delivery date with Novartis’s monthly
requirements for a Blood Screening Assay ordered in accordance with Section 5.3
below, for any three (3) months in any nine-month period (unless the Supervisory
Board agrees within fifteen (15) days of such event that Gen-Probe shall retain
the manufacturing responsibility hereunder), then Novartis shall have the right
to, and if Novartis elects to manufacture or have manufactured, the obligation
to use Commercially Reasonable Efforts to, manufacture (or to have manufactured)
its requirements of such Blood Screening Assay, to be conducted by the Blood
Screening Instruments in the Territory for use in the Blood Screening Field;
provided, however, such right of Novartis shall be on an assay-by-assay basis
for a failure to supply. In such event, Novartis shall consider in good faith,
as its preferred alternative upon Gen-Probe’s request, to take over control of
and responsibility for the facility used by Gen-Probe to manufacture the Blood
Screening Assays, and Gen-Probe promptly shall provide such reasonable technical
assistance, at Gen-Probe’s sole cost, as necessary to enable Novartis to
exercise its rights to manufacture (or have manufactured) such Blood Screening
Assay.
               (ii) Instruments. If Gen-Probe fails to supply Novartis within
forty-five (45) days after the requested delivery date with Novartis’s monthly
requirements for a Blood Screening Instrument ordered in accordance with
Section 5.4 below, for any three (3) months in any nine-month period (unless the
Supervisory Board agrees within fifteen (15) days of such event that Gen-Probe
shall retain the manufacturing
***Confidential Treatment Requested

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responsibility hereunder), then Novartis shall have the right to, and if
Novartis elects to manufacture or have manufactured, the obligation to use
Commercially Reasonable Efforts to, manufacture (or to have manufactured) its
requirements of such Blood Screening Instrument in the Territory for use in the
Blood Screening Field. In such event, Gen-Probe promptly shall provide such
reasonable technical assistance, at Gen-Probe’s sole cost, as necessary to
enable Novartis to exercise its rights to manufacture (or have manufactured)
such Blood Screening Instrument for use in the Blood Screening Field and
Gen-Probe shall provide to Novartis, directly or indirectly, to the greatest
possible extent, all remedies available to Gen-Probe against any Blood Screening
Instrument manufacturer which has failed to supply Gen-Probe in accordance with
the applicable manufacturing contract.
               (c) If Gen-Probe desires to subcontract with any Third Party
(except as to such subcontracts which exist as of the Effective Date) to
manufacture any of the Blood Screening Instruments, Gen-Probe shall grant to
Novartis the first right of negotiation for the right to manufacture such Blood
Screening Instrument, provided that Novartis is able to do so on commercially
reasonable and competitive terms and conditions, before Gen-Probe may offer such
opportunity to any Third Party. Any such subcontracts for the manufacture of any
of the Blood Screening Instruments (in whole), or any of the major functional
components or disposables thereof, shall be subject to the approval of the
Supervisory Board which shall not be unreasonably withheld by either party.
               (d) If either party exercises any right granted hereunder to have
any Blood Screening Assay or Blood Screening Instrument manufactured, then
(i) such party shall first require that the subcontracted party shall enter into
a confidentiality agreement with such party incorporating the terms of ARTICLE 7
below; (ii) such party shall supervise such subcontract work; (iii) the
subcontracted party shall comply in all material respects with all requirements
of applicable laws and regulations, together with all applicable good
laboratory, clinical and manufacturing practices; and (iv) the subcontracted
party shall enter into an agreement with such party to the extent necessary to
effectuate the provisions of ARTICLE 8 below.
          3.1.9 Commercialization.
               (a) Except as otherwise set forth in Sections 3.1.9(b) and
Section 3.2 below, during the Blood Screening Term, Gen-Probe hereby grants to
Novartis the exclusive distribution right in the Territory, at Novartis’s sole
cost, directly or through distributors, to promote, market and sell the Blood
Screening Assays to be conducted by the Blood Screening Instruments for use in
the Blood Screening Field (recognizing the lack of clear distinction between
blood screening and clinical diagnostic markets in certain countries). Except as
otherwise set forth in Sections 3.1.9(b) and Section 3.2 below, during the Blood
Screening Term, Gen-Probe hereby grants to Novartis the exclusive distribution
right in the Territory, at Novartis’s sole cost, directly or through
distributors, to promote, market and sell the Blood Screening Instruments to
conduct Blood Screening Assays for use in the Blood Screening Field. Novartis
shall, use its Commercially Reasonable Efforts to promote, market, sell and meet
the reasonably foreseeable market demands for the Blood Screening Assays and
Blood Screening Instruments in the Territory for use in the Blood Screening
Field. No nucleic acid probe based

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assays other than the Blood Screening Assays shall be conducted on the Blood
Screening Instruments purchased by Novartis.
               (b) Subject to regulatory requirements, the Products shall be
marketed under such trademarks as may be determined by the Supervisory Board to
give adequate recognition to the respective contributions and interests of the
parties. It is the intention of the parties that both parties’ contributions and
interests will be recognized.
               (c) Novartis shall have the right, and the obligation, at its
sole expense, to maintain and service all Blood Screening Instruments placed in
the Territory for use in the Blood Screening Field. Novartis shall be a party to
all service contracts for all such Blood Screening Instruments. Novartis shall
have the right to charge a fee to the users of such Blood Screening Instruments
for such service. Novartis may exclude from Net Sales all revenues received by
Novartis in consideration for providing instrument maintenance and repair
service for Blood Screening Instruments, including TECAN Genesis automatic
pipetting stations or any successor pipetting instrument (e.g., TECAN EVO)
(whether deemed part of a Blood Screening Instrument or not), regardless of the
form of the instrument transfer (sale, lease, or rental), location (U.S./Canada
or foreign), party providing instrument (Novartis or Third Party), or party
providing service (Novartis or Third Party service provider). Novartis shall
charge no more for such services than commercially reasonable values for the
diagnostic and/or blood screening markets consistent with standard industry
practice in those markets.
               (d) New Market Entry. The parties agree to create a process for
the approval of business cases concerning the proposed registration of Products
in new geographic markets. Where such business cases are approved pursuant to
this process, Registration Trial costs shall be split equally between the
parties. If Gen-Probe declines to approve a business case for a Product,
Novartis may proceed to enter the new market by paying all of the essential
costs for a Registration Trial for such Product. The essential costs for a
Registration Trial shall include (i) the actual costs of the Registration Trial
and (ii) to the extent included in a budget pre-approved by the other party,
consent not to be unreasonably withheld, all financial obligations incurred by a
party to Third Parties or to the other party for services that are essential to
the Registration Trial (by way of example, mandatory product modifications such
as local country translations of software or documents or fees charged for
regulatory submissions). Novartis shall be entitled to recover one-half of the
essential costs incurred by Novartis for such a Registration Trial by deducting
such amounts from the Applicable Purchase Price paid to Gen-Probe for sales of
the applicable Product made in such country in the first two years following its
registration and approval for sale, provided that the resulting Applicable
Purchase Price to be paid to Gen-Probe shall not be less than the sum of
(i) twenty-five percent (25%) of Net Sales of such Product in such country in
the applicable period and (ii) fifty percent (50%) of Gen-Probe’s Manufacturing
Costs for such Product sold in such country in the applicable period. For each
payment period as to which Novartis makes such deduction Novartis shall report
the amount and basis of the deduction in its report pursuant to Section 6.4.
               (e) For each Product to be commercially introduced after the
Effective Date, the parties shall agree upon the timing and amounts of
appropriate initial purchases of such Product by Novartis, in order to establish
initial inventory in accordance with the terms of this Agreement and reasonable
commercial practices.

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               (f) For each Product that the parties agree should not be offered
for sale beyond a specified date due to commercial obsolescence (“end-of-life”),
the parties shall agree upon an appropriate end-of-life plan for such Product.
The parties generally intend that they will share equally all end-of-life costs
incurred in accordance with the agreed plan. Each party shall use its best
efforts to minimize end-of-life costs, including scrap costs.
          3.1.10 Licenses.
               (a) During the Blood Screening Term, Novartis hereby grants to
Gen-Probe a nonexclusive license in the Territory under the Novartis IP Rights
(i) to conduct Gen-Probe’s obligations under each Development Program to develop
the Blood Screening Assays, and (ii) to manufacture or have manufactured the
Blood Screening Assays. Gen-Probe shall not have the right to grant sublicenses
under such license, without the prior express written consent of Novartis.
               (b) During the Blood Screening Term, Gen-Probe hereby grants to
Novartis a nonexclusive license in the Territory under the Gen-Probe IP Rights
to conduct Novartis’s obligations, if any, under each Development Program to
develop the Blood Screening Assays and the Blood Screening Instruments. Novartis
shall not have the right to grant sublicenses under such license, without the
prior express written consent of Gen-Probe.
               (c) If Novartis exercises its option to acquire the right to
manufacture (or have manufactured) any Blood Screening Assays or Blood Screening
Instruments under Section 3.1.8 above, during the balance of the Blood Screening
Term, Gen-Probe shall grant to Novartis a nonexclusive license in the Territory
under the Gen-Probe IP Rights to exercise its rights under Section 3.1.8 above
to manufacture (or have manufactured) such Blood Screening Assays and Blood
Screening Instruments for use in the Blood Screening Field. Novartis shall not
have the right to grant sublicenses under such license, without the prior
express written consent of Gen-Probe.
               (d) Gen-Probe’s Rights in Japan in the Clinical Diagnostic Field.
Notwithstanding anything in the Ultrio Addendum, the WNV Addendum or this
Agreement to the contrary, Gen-Probe shall have the right to manufacture and
sell the hepatitis B discriminatory probe assay portion of the Ultrio Assay
Product (the “HBV Discriminatory Assay”) and the WNV Assay Product for use in
the Clinical Diagnostic Field within the territory of Japan. Gen-Probe may
acquire the right to manufacture and sell the WNV Assay Product for use in the
Clinical Diagnostic Field in the remainder of the world by payment to Novartis
of [...***...]. Gen-Probe may acquire the right to manufacture and sell the HBV
Discriminatory Assay for use in the Clinical Diagnostic Field in the remainder
of the world by payment to Novartis of a commensurate amount.
               (e) Immunity Under Roche Promoter-Primer Patent Claims. Novartis
agrees that Gen-Probe shall be entitled to the benefit of the immunity from suit
previously granted to Chiron Corporation, and subject to the limitations as
granted to Chiron Corporation, by F. Hoffman-La Roche and Roche Molecular
Systems, Inc. under the Roche Promoter-Primer Patent Claims, which immunity was
previously granted to Chiron Corporation (and a party to be designated by Chiron
Corporation) by F. Hoffman-La Roche and Roche Molecular Systems, Inc.
***Confidential Treatment Requested

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     3.2 Noncompetition.
          3.2.1 Subject to the provisions of Section 1.3, during the Blood
Screening Term, Novartis shall have the right, in its sole discretion, to grant
licenses to Third Parties under the Novartis Patent Rights, with the following
limitations. With respect to the patent rights for each virus, and in the United
States and Japan only, once Novartis has granted one license in each such
country with respect to such virus for use in the Blood Screening Field, upon
the grant of a second license to such patent rights for such virus in such
country for use in the Blood Screening Field, Novartis shall pay to Gen-Probe
[...***...] of all consideration received by Novartis in return for the grant of
such license for such virus, including upfront fees, royalties and non-cash
consideration. Any further licenses of such patent rights for such virus in such
country for use in the Blood Screening Field may be granted only with the prior
written consent of Gen-Probe which shall not be unreasonably withheld so long as
Novartis adequately compensates Gen-Probe. A license by Novartis for an HIV-1 or
HCV assay for the sole purpose of confirming or supplementing the results of a
Blood Screening Assay shall not be considered as a license subject to the terms
and restrictions of this Section, so long as such confirmatory or supplemental
assay is mandated by applicable regulatory authorities or demanded by the
market.
          3.2.2 During the Blood Screening Term, neither party shall grant to
any Third Party any license or other rights to develop or commercialize any
nucleic acid probe-based assay for any virus or marker for which there is no
Blood Screening Assay then being developed or commercialized under this
Agreement for use in the Blood Screening Field (including an assay for the sole
purpose of confirming or supplementing the results of a Blood Screening Assay),
unless such party has first presented to the Supervisory Board the opportunity
to develop and commercialize a TMA Assay for such virus or marker under this
Agreement for use in the Blood Screening Field. Such opportunity may involve
nonexclusive or exclusive rights to the virus or marker, as negotiated by the
parties through the Supervisory Board. Such negotiation shall include a
determination of the Applicable Purchase Price pursuant to Section 1.3.2, which
shall take into account the extent to which the opportunity is exclusive or
nonexclusive. If the arrangement accepted by the Supervisory Board is
nonexclusive, the party holding the intellectual property for the virus or
marker shall be free to license rights to such virus or marker to Third Parties
for use in the Blood Screening Field; and if not, licensing shall be subject to
such restrictions as are then agreed upon.
          3.2.3 During the Blood Screening Term, Gen-Probe shall not grant to
any Third Party a license under the Gen-Probe IP Rights to develop or
commercialize (i) a TMA assay for use in the Blood Screening Field or (ii) an
assay utilizing Gen-Probe’s “Hybridization Protection Assay” (“HPA”) for use in
the Blood Screening Field.
          3.2.4 Other Blood Screening Instruments. If Gen-Probe develops any new
instrument for use in the Blood Screening Field, it shall offer to grant to
Novartis, during the Blood Screening Term and on reasonable terms to be
negotiated, rights to such instrument comparable to the rights granted under
this Agreement as to the Blood Screening Instruments existing on the Effective
Date, to the extent that Gen-Probe reasonably concludes that it is not
prohibited as of the Effective Date from granting such rights.
***Confidential Treatment Requested

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          3.2.5 New Technology; Alternative Technology. During the Blood
Screening Term, neither party shall develop, manufacture or sell (whether alone,
with or by its Affiliate, or in collaboration with any Third Party) any nucleic
acid probe based assay or other Product specifically intended for use in the
Blood Screening Field (recognizing the lack of clear distinction between blood
screening and clinical diagnostic markets in some countries), other than
pursuant to this Agreement and except as provided in Sections 3.2.1, 3.2.2, or
3.2.6, and except as follows:
               (a) New Technology. If a party or its Affiliate becomes aware of
any new or improved nucleic acid probe based assay method or products
incorporating such method, and/or instrumentation therefor, (collectively the
“New Technology”) which may reasonably be expected to offer technological
advantages over the TMA Assays provided for by this Agreement, and such party or
its Affiliate desires to develop or commercialize assay products for use in the
Blood Screening Field using such New Technology, then such party shall inform
the other party in writing and the parties shall discuss such New Technology and
shall use good faith efforts to reach agreement for the joint development and/or
commercialization of assay products in the Blood Screening Field incorporating
the New Technology, which agreement may include an adjustment of the Applicable
Purchase Price for such products.
               (b) If the parties cannot reach agreement for the joint
development and/or commercialization of any assay product incorporating New
Technology following good faith negotiations in accordance with Section
(a) above, and Novartis or its Affiliate is the person desiring to develop or
commercialize assay products incorporating the New Technology, Novartis or its
Affiliate may proceed with product development or commercialization only if
Novartis grants Gen-Probe a license of the Novartis IP Rights, on reasonable
commercial terms similar to those granted Third Parties, permitting Gen-Probe
and its Affiliates to make, have made, use, sell, and import under Gen-Probe’s
brands and trademarks the Blood Screening Assays and Blood Screening Instruments
for use in the Blood Screening Field (but solely with respect to that portion of
the Blood Screening Field that is likely to be adversely impacted — for example,
with respect to platelets or plasma or red blood cells only (such portion, the
“Impacted Field”)) that are likely to be adversely impacted by the introduction
of such products (collectively, but only for use in the Impacted Field, the
“Impacted Products”). The license to Gen-Probe for an Impacted Product shall be
effective, on a country-by-country basis and Impacted Product-by-Impacted
Product basis, on the date that is six (6) months prior to the anticipated first
commercial sale by Novartis of an assay product incorporating the New
Technology, provided that the license shall also permit Gen-Probe and its
Affiliates to undertake activities prior to such date that are necessary to
enable Gen-Probe to sell the Impacted Product as of such date. Upon the
effective date of Gen-Probe’s right to sell under the license, Novartis’s rights
under this Agreement with respect to the Impacted Products shall be modified to
be co-exclusive with the right of Gen-Probe and its Affiliates to promote,
market and sell the Impacted Products for use in the Blood Screening Field.
Gen-Probe and its Affiliates shall not have any right to develop or
commercialize Blood Screening Assays incorporating New Technology and/or Blood
Screening Instruments incorporating New Technology for use in the Blood
Screening Field during the Blood Screening Term except in collaboration with
Novartis.

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               (c) Alternative Technology Identified by Gen-Probe. If Gen-Probe
or its Affiliate become aware of an alternative technology or product that is
reasonably expected to substitute for or significantly reduce the need for
nucleic acid probe based assay methods in the Blood Screening Field (such as, by
way of example and not limitation, pathogen reduction or inactivation
technology) (collectively the “Alternative Technology”), and Gen-Probe or its
Affiliate desires to develop or commercialize products for use in the Blood
Screening Field using such Alternative Technology, then Gen-Probe shall inform
Novartis in writing and the parties shall discuss such Alternative Technology
and shall use good faith efforts to reach agreement on reasonable commercial
terms for the joint development and/or commercialization of products in the
Blood Screening Field incorporating such Alternative Technology pursuant to the
collaboration established by this Agreement. Gen-Probe or its Affiliate shall
not have any right to develop or commercialize products for use in the Blood
Screening Field incorporating Alternative Technology unless it has first offered
Novartis the opportunity to jointly participate in the development and
commercialization of such products on reasonable commercial terms.
               (d) Alternative Technology Identified by Novartis. If Novartis or
its Affiliate become aware of an Alternative Technology and Novartis or its
Affiliate desires to develop or commercialize products for use in the Blood
Screening Field using such Alternative Technology, then Novartis shall inform
Gen-Probe in writing. (For the avoidance of doubt, therapeutic and prophylactic
drugs and/or vaccines shall not be considered Alternative Technology for
purposes of this Agreement.) Novartis shall have the option, at its sole
discretion, of either: (i) offering Gen-Probe the opportunity to jointly
participate in the development and commercialization of such products on
reasonable commercial terms (Option 1); or (ii) commercializing the Alternative
Technology by itself, without first offering Gen-Probe the opportunity to
jointly participate in the development and commercialization of such products
(Option 2). Novartis shall notify Gen-Probe of its election in writing when
notifying Gen-Probe of the Alternative Technology. Any notice of Novartis’s
election of Option 2 shall be delivered not less than one hundred and twenty
(120) days prior to the first commercial sale by Novartis or its Affiliate of
the Alternative Technology product. If Novartis elects Option 1, the parties
shall discuss such Alternative Technology and shall use good faith efforts to
reach agreement on reasonable commercial terms for the joint development and/or
commercialization of products in the Blood Screening Field incorporating such
Alternative Technology pursuant to the collaboration established by this
Agreement.
               (e) If Novartis or its Affiliate elects Option 1 with respect to
the Alternative Technology, but the parties are unable to reach agreement on
commercially reasonable terms for the joint development and/or commercialization
of any product following good faith negotiations, Novartis or its Affiliate may
proceed with product development or commercialization only if Novartis grants
Gen-Probe a license of the Novartis IP Rights, on reasonable commercial terms
similar to those granted Third Parties, permitting Gen-Probe and its Affiliates
to make, have made, use, sell, and import under Gen-Probe’s brands and
trademarks the Impacted Products. The license to Gen-Probe for an Impacted
Product shall be effective on a country-by-country basis and Impacted
Product-by-Impacted Product basis as of the first date on which (i) Novartis or
its Affiliate has commenced sales in such country of the Alternative Technology
product and (ii) the number of blood donations screened with an Impacted Product
in such country for any calendar quarter have declined as a result of the
introduction of the Alternative Technology product by at least [...***...] (the
“Option 1 Threshold
***Confidential Treatment Requested

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Decline”) from the number of donations screened with such Impacted Product in
either (x) the quarter immediately proceeding Novartis’s written notice to
Gen-Probe of the Alternative Technology or (y) the corresponding quarter for the
prior calendar year. Upon the effective date of Gen-Probe’s right to sell under
the license, Novartis’s rights under the Agreement with respect to the Impacted
Product shall be modified to be co-exclusive with the right of Gen-Probe and its
Affiliates to promote, market and sell the Impacted Product for use in the Blood
Screening Field.
               (f) If Novartis or its Affiliate elects Option 2 with respect to
an Alternative Technology other than viral reduction or viral inactivation,
Novartis or its Affiliate may proceed with product development or
commercialization only if Novartis grants Gen-Probe a license of the Novartis IP
Rights, on reasonable commercial terms similar to those granted Third Parties,
permitting Gen-Probe and its Affiliates to make, have made, use, sell, and
import under Gen-Probe’s brands and trademarks the Impacted Products. The
license to Gen-Probe for an Impacted Product shall be effective on a
country-by-country basis and Impacted Product-by-Impacted Product basis as of
the first date on which (i) Novartis or its Affiliate has commenced sales in
such country of the Alternative Technology product and (ii) the number of blood
donations screened with an Impacted Product in such country for any calendar
quarter has declined as a result of the introduction of the Alternative
Technology product by at least [...***...] from the number of donations screened
with such Impacted Product in either (x) the quarter immediately proceeding
Novartis’s written notice to Gen-Probe of the Alternative Technology or (y) the
corresponding quarter for the prior calendar year (the “Option 2 [...***...]
Threshold”); provided that the license shall permit Gen-Probe and its Affiliates
to undertake activities prior to such date that are necessary to enable
Gen-Probe and its Affiliates to sell the Impacted Product as of such date. If
Novartis or its Affiliate elects Option 2 with respect to an Alternative
Technology for viral reduction or viral inactivation, the license to Gen-Probe
shall be effective on a country-by-country basis and Impacted
Product-by-Impacted Product basis as of the first date on which (iii) Novartis
or its Affiliate has commenced sales in such country of the Alternative
Technology product and (iv) the number of blood donations screened with an
Impacted Product in such country for any calendar quarter has declined as a
result of the introduction of the Alternative Technology product (the “Option 2
Viral Reduction Threshold”), and the Option 2 [...***...] Threshold shall not
apply. Upon the effective date of Gen- Probe’s right to sell under a license,
Novartis’s rights under this Agreement with respect to the Impacted Product
shall be modified to be co-exclusive with the right of Gen-Probe and its
Affiliates to promote, market and sell the Impacted Product for use in the Blood
Screening Field.
               (g) For purposes of this Section 3.2, “country-by-country” shall
mean, with respect to Germany, the United Kingdom, France, and Italy (the “Major
European Markets”), each country individually and/or the four countries
considered in the aggregate. By way of example, the Option 2 [...***...]
Threshold would be triggered as to France as a result of the requisite
percentage decline in the number of screened blood donations in France and would
also be triggered in France (and the other Major European Markets) as a result
of the requisite percentage decline in the number of screened blood donations in
the Major European Markets considered in the aggregate.
***Confidential Treatment Requested

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          3.2.6 Nothing contained in this Section 3.2 shall preclude Gen-Probe
from developing, manufacturing, using or selling nucleic acid probes to
ribosomal RNA pursuant to U.S. Patent No. 4,851,330, or U.S. Patent
No. 5,288,611 and divisional, continuations, continuations-in-part, reissues,
renewals, extensions or additions. Gen-Probe shall be entitled to use
Hybridization Protection Assays (HPA) in connection with any such nucleic acid
probes to ribosomal RNA. In the event that Gen-Probe commercializes any such
product for the Blood Screening Field, Gen-Probe shall grant Novartis a right of
first refusal to elect to become, on reasonable commercial terms to be
negotiated in good faith, the exclusive distributor for such product for the
Blood Screening Field in the United States and/or in Japan. Gen-Probe shall
reasonably consider extending such a right of first refusal as to other
countries for which it has a right to do so.
ARTICLE 4
SUPERVISORY BOARD
     4.1 Supervisory Board.
          4.1.1 Generally; Composition. The Development Programs for the
Products in the Blood Screening Field shall be overseen by the Supervisory
Board. The Supervisory Board shall be available to address escalated unresolved
conflicts between the parties under this Agreement and shall provide
executive-level strategy assessments regarding the subject matter of this
Agreement. The Supervisory Board shall be comprised of three (3) named
representatives of Gen-Probe and three (3) named representatives of Novartis.
Each party shall appoint its respective representatives to each Supervisory
Board from time to time, and may substitute one or more of its representatives,
in its sole discretion, effective upon notice to the other party of such change.
          4.1.2 Meetings. Each Supervisory Board shall meet not less than once
each calendar quarter during the term of this Agreement, on such dates and at
such times and places as agreed to by Gen-Probe and Novartis, alternating
between San Diego and Emeryville, or such other locations as the parties shall
agree. All meetings shall be set at times and places to be mutually agreed.
          4.1.3 Actions. Each party’s representatives shall collectively have
one vote as to all matters. Any approval, determination or other action agreed
to by both parties’ representatives shall be the approval, determination or
other action of the Supervisory Board. All board actions require a unanimous
vote. Any matters as to which the Supervisory Board cannot reach a unanimous
vote shall be presented to the parties’ respective presidents for consideration,
in accordance with ARTICLE 11.
          4.1.4 Reports. Within thirty (30) days following each Supervisory
Board meeting during the term of this Agreement, the Supervisory Board shall
prepare and provide to each party a reasonably detailed written summary report
which shall describe any approval, determination or other action by the
Supervisory Board.

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     4.2 Operating Committee.
          4.2.1 Purpose. The Novartis/Gen-Probe operating committee (“Operating
Committee”) has been established by the Supervisory Board to oversee Development
Programs and related operations to ensure effective execution and alignment such
that the collaboration can endeavor to act as one business. The Operating
Committee will recommend prioritization of activities and initiate, review and
report on projects designed to increase shareholder value within both parties.
          4.2.2 Activities. Expected Operating Committee activities will
include: (a) oversight of day-to-day operations and related decision making;
(b) increasing efficiencies and reducing unnecessary redundant activities
through techniques such as value stream mapping and other relevant processes;
(c) project review and reporting; (d) issue resolution; (e) selection of
appropriate business metrics; (f) oversight of preparation for Supervisory Board
topics; and (g) making recommendations to the Supervisory Board.
          4.2.3 Composition. The Operating Committee will be comprised of
functional representatives of both parties representing core activities, such
as: Marketing, Finance, Supply Chain, Quality, Regulatory, R&D, and Alliance
Management. Each party may appoint its respective representatives and may
substitute one or more of its representatives in its sole discretion, effective
upon notice to the other party.
          4.2.4 Operation. The Operating Committee will establish its own
charter and committee rules of operation, but will perform all activities at the
behest of and subject to the overall authority of the Supervisory Board.
ARTICLE 5
SUPPLY TERMS
     5.1 Manufacture and Sale. On the terms and subject to the conditions of
this ARTICLE 5, Gen-Probe shall manufacture, or have manufactured, sell and
deliver to Novartis, and Novartis shall purchase from Gen-Probe, such amounts of
the Products, as Novartis orders pursuant to Section 5.3 and Section 5.4 below.
Gen-Probe shall cause its subcontract manufacturers, if any, to comply with the
provisions of this ARTICLE 5. Gen-Probe acknowledges that Affiliates of Novartis
have the right to purchase Products pursuant to the terms of this Agreement.
Gen-Probe shall use Commercially Reasonable Efforts to meet the market demand
for the Products as to which it has undertaken an obligation to manufacture.
     5.2 Manufacturing Practices.
          5.2.1 Specifications. Gen-Probe shall manufacture all the Products
under this Agreement in accordance with all applicable laws and regulations and
in conformity with the product specifications.

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          5.2.2 Audit. Novartis shall have the right, at its sole expense, to
audit Gen-Probe for compliance with Section 5.2.1 upon reasonable notice during
normal business hours and not more than once in each calendar year (or such
additional times as may be necessary to ensure compliance with all material
requirements).
          5.2.3 Certificates of Analysis. Gen-Probe shall provide certificates
of analysis to Novartis for all the Blood Screening Assays manufactured and
supplied hereunder based upon a reference standard reasonably proposed by
Gen-Probe and acceptable to Novartis.
          5.2.4 Quality Control Information. Upon the reasonable request of
Novartis, Gen-Probe shall provide Novartis with such reasonable information,
including analytical and manufacturing documentation, requested by Novartis
regarding quality control, stability data and shipping validation for Products.
Novartis shall treat all such information disclosed pursuant to this Section as
confidential information of Gen-Probe subject to the provisions of ARTICLE 7
below.
     5.3 Blood Screening Assays: Forecasts and Orders; Purchase Obligation;
Purchase Orders; Inventory; Supply Obligation; Delivery and Acceptance.
          5.3.1 Blood Screening Assays Forecasts.
               (a) On or before the first (1st) day of each calendar month
during the term of this Agreement, Novartis shall provide to Gen-Probe a
Forecast, covering the period commencing the calendar month immediately
succeeding the month in which the Forecast is delivered (for example, on
January 1, Novartis will deliver a rolling twelve (12) month Forecast commencing
February 1), showing Novartis’s estimated purchase requirements over the period
covered by the Forecast. The Forecast shall include purchase requirements, at
the following level of detail:
               (i) for the first (1st), second (2nd), and third (3rd) calendar
months covered by the Forecast, the Forecast shall specify the Blood Screening
Assays by packaging configuration, including kit size and/or catalogue part
number, and associated quantities for purchase from Gen-Probe by Novartis in
such three-month period;
               (ii) for the fourth (4th), fifth (5th), and sixth (6th) calendar
months covered by the Forecast, the Forecast shall specify the Blood Screening
Assays and ancillary materials, by labeling requirement detailed according to
the provisions of Schedule 5.3.1(a), attached hereto, and associated quantities
that Novartis expects to order from Gen-Probe by Novartis in such period; and
               (iii) for the seventh (7th) through twelfth (12th) calendar
months covered by the Forecast, the Forecast shall specify the estimated
purchase requirements, by test, and associated quantities that Novartis expects
to order from Gen-Probe by Novartis in such period.

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               (iv) Subject to the additional provisions set forth in
subparagraph (v) below, in each Forecast delivered, Novartis may not (A) amend
the quantities of Blood Screening Assays from the quantities specified for the
first (1st), second (2nd) and third (3rd) calendar months in the immediately
preceding Forecast; (B) amend the quantities of Blood Screening Assays specified
in the Forecast for the fourth (4th), fifth (5th) and sixth (6th) calendar
months in the immediately preceding Forecast to an amount that is less than
ninety percent (90%) nor more than one hundred-ten percent (110%) of the amount
forecasted when the month being amended was the sixth (6th) calendar month;
(C) amend the quantities of Blood Screening Assays specified in the Forecast for
the seventh (7th) calendar month in the immediately preceding Forecast as it
transitions to the sixth (6th) calendar month in the delivered Forecast to an
amount that is less than eighty percent (80%) nor more than one hundred thirty
percent (130%) of the quantity of Blood Screening Assays specified in the
previous Forecast when the month in question was the seventh (7th) calendar
month; or (D) amend the quantities of Blood Screening Assays specified in the
Forecast for the eighth (8th) calendar month in the immediately preceding
Forecast as it transitions to the seventh (7th) calendar month in the delivered
Forecast to an amount that is less than eighty percent (80%) nor more than one
hundred forty percent (140%) of the quantity of Blood Screening Assays specified
in the previous Forecast when the month in question was the eighth (8th)
calendar month. For example, on January 1, Novartis will deliver a Forecast in
which February is the first (1st) calendar month and September is the eighth
(8th) calendar month of the Forecast. If Novartis estimates in such Forecast
that in August, the seventh (7th) calendar month, it will require 100,000 tests,
Novartis may not decrease its Forecast below 80,000 tests nor increase it above
130,000 tests as that month transitions to the sixth (6th) calendar month in the
next Forecast. Similarly, if Novartis estimates in a Forecast that in September,
the eighth (8th) calendar month, it will require 100,000 tests, then in the
subsequent Forecast Novartis may not decrease its Forecast below 80,000 tests
nor increase it above 140,000 tests when that month transitions to the seventh
(7th) calendar month. For purpose of the convenience of reference hereafter, the
Forecast delivered in which the applicable calendar month is the eighth (8th)
month is referred to as the “original Forecast”; and the quantity as forecast in
any subsequent Forecast, amended as permitted under this Section (i.e., the
Forecast delivered in which the applicable month transitions to the next lower
month, such as from the eighth (8th) month to the seventh (7th)), is referred to
as the “amended Forecast.”
               (v) Notwithstanding the provisions of subparagraph (iv) above,
the parties acknowledge that Gen-Probe incurs substantial expense ramping up
production and otherwise preparing to meet quantities forecasted by Novartis,
even in periods commencing the seventh (7th) calendar month and beyond in the
then-current Forecast. Therefore, the parties agree that Novartis may not reduce
the Forecast down under subparagraph (iv)(B) and (C), above, in the aggregate to
an amount that is less than eighty percent (80%) of the highest quantity of
Blood Screening Assays specified in any Forecast. (For example, on January 1,
Novartis will deliver a Forecast in which February 1 is the first (1st) month
and September is the eighth (8th) month of the Forecast. If Novartis estimates
in such Forecast that in September it will require 100,000 tests, then Novartis
may not amend the Forecast, at any time or in the aggregate, to an amount that
is less than 80,000 tests deliverable in September. In addition, if, in the
subsequent

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Forecast when the month in question transitions from the eighth (8th) to the
seventh (7th) month, Novartis increases the Forecast of the month in question
from 100,000 tests to 120,000 tests, then Novartis may not amend the Forecast to
an amount that is less than 96,000 tests deliverable in September (i.e., 80% of
120,000). Similarly, if in the next Forecast, when the month in question
transitions from the seventh (7th) to the sixth (6th) month, Novartis further
increases the Forecast to 150,000 tests, then Novartis may not amend the
Forecast to an amount that is less than 120,000 tests deliverable in September
(i.e., 80% of 150,000).
               (b) Commencing in the first full month following the Effective
Date, the parties shall meet monthly, on or before the twenty-third (23rd) day
of each calendar month, to review the previous month’s performance and the
current Forecast and production plan for the purpose of making production
planning and inventory management decisions necessary to meet Customer supply
needs in a cost-efficient manner. Such production planning meetings shall be
attended by qualified members of each party, and shall be sponsored by each
party’s senior supply chain executive.
               (c) In the event that any disagreement arises between the parties
pursuant to the obligations imposed in this Section 5.3.1, the parties shall
submit such dispute first to a discussion between responsible managers, and if
they cannot agree, then to the Supervisory Board for resolution as soon as is
reasonably achievable. In the event that the Supervisory Board is (i) unable to
resolve the issue at its next meeting, or (ii) is unable or unwilling to meet
within the thirty (30) day period after submittal of the issue to the
Supervisory Board, then the issue shall be referred by the parties for
resolution in accordance with the terms of ARTICLE 11 herein.
          5.3.2 Blood Screening Assays Purchase Obligation.
               (a) Novartis shall be required to purchase, in the respective
month, the quantity of Blood Screening Assays, by part number, specified in each
Forecast for the first (1st), second (2nd) and third (3rd) calendar months
covered by each Forecast. If any Forecast fails to conform with the provisions
of Section 5.3.1, considered in the aggregate, then for purposes of determining
Novartis’s purchase obligation under this Section 5.3.2(a) such non-conforming
Forecast shall be revised to comply with such provisions of Section 5.3.1.
               (b) Notwithstanding anything in this Agreement to the contrary,
the expiration or sooner termination of this Agreement, other than a termination
by Novartis for default of Gen-Probe in accordance with the provisions of
Section 10.2.1 and subject to the provisions of Section 12.2 governing force
majeure events, shall not operate to extinguish Novartis’s obligation to
purchase the quantity of Blood Screening Assays specified in accordance with
Section 5.3.1 through the eighth (8th) calendar month covered by the Forecast in
effect as of the effective date of expiration or sooner termination.
               (c) In the event that any disagreement arises between the parties
pursuant to the obligations imposed in this Section 5.3.2, the parties shall
submit such dispute first to a discussion between responsible managers, and if
they cannot agree, then to the Supervisory Board for resolution as soon as is
reasonably achievable. In the event that the

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Supervisory Board is (i) unable to resolve the issue at its next meeting, or
(ii) is unable or unwilling to meet within the thirty (30) day period after
submittal of the issue to the Supervisory Board, then the issue shall be
referred by the parties for resolution in accordance with the terms of ARTICLE
11 herein.
          5.3.3 Blood Screening Assays Purchase Orders.
               (a) Novartis or its Affiliates shall submit to Gen-Probe binding
Purchase Orders on or before the fifth (5th) day of each calendar month during
the term hereof covering the Blood Screening Assays forecasted by Novartis for
the third (3rd) calendar month covered by the then-current Forecast (for
example, on January 5, Novartis or its Affiliates will submit Purchase Orders
for Blood Screening Assays to be delivered in April). Each Purchase Order shall
be in writing and reasonably similar to the sample Purchase Order attached
hereto as Schedule 5.3.3. Each Purchase Order shall specify the quantity of
Blood Screening Assays ordered (by packaging configuration, including kit size
and/or catalogue part number), the place of delivery, the requested delivery
date, and such other information as Gen-Probe reasonably requests. Novartis or
its Affiliates may not request a delivery date for any Blood Screening Assays
that is less than eighty-five (85) days or more than ninety-five (95) days after
the date of the applicable Purchase Order (for example, a Purchase Order
submitted to Gen-Probe on January 5 may only specify a delivery date between the
first and the tenth of April).
               (b) Purchase Orders submitted to Gen-Probe by Novartis or its
Affiliates shall be binding on Gen-Probe as to that quantity of Blood Screening
Assays set forth in the then-current Forecast for such calendar month. If the
quantity of any Blood Screening Assays ordered by Novartis and its Affiliates in
aggregate for any calendar month exceeds the quantity of such Blood Screening
Assays set forth in the then-current Forecast for such month, then Gen-Probe
shall use Commercially Reasonable Efforts to deliver the amount of Blood
Screening Assays in excess of the forecasted amount. Gen-Probe shall provide
Novartis and its Affiliates with written notice of the anticipated delivery date
for such additional Blood Screening Assays.
               (c) In the event that the Purchase Orders received from Novartis
and its Affiliates herein fail to order in aggregate Blood Screening Assays of
the types and in the amounts specified in the then-current Forecast for the
applicable calendar month, Gen-Probe shall have the right to reject such
Purchase Order(s). Gen-Probe shall notify Novartis in writing within ten
(10) days of receipt of such Purchase Order(s). If not rejected by Gen-Probe
within ten (10) days of receipt, such Purchase Order(s) shall be deemed accepted
by Gen-Probe. In the event that Gen-Probe rejects a Purchase Order Novartis or
its Affiliate shall have five (5) days to correct the Purchase Order and
resubmit it to Gen-Probe.
               (d) In the event that any disagreement arises between the parties
pursuant to the obligations imposed in this Section 5.3.3, the parties shall
submit such dispute first to a discussion between responsible managers, and if
they cannot agree, then to the Supervisory Board for resolution as soon as is
reasonably achievable. In the event that the Supervisory Board is (i) unable to
resolve the issue at its next meeting, or (ii) is unable or unwilling to meet
within the thirty (30) day period after submittal of the issue to the
Supervisory

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Board, then the issue shall be referred by the parties for resolution in
accordance with the terms of ARTICLE 11 herein.
               (e) In the event of a conflict between the terms and conditions
of any Purchase Order and this Agreement, the terms and conditions of this
Agreement shall prevail.
          5.3.4 Blood Screening Assays Inventory.
               (a) The parties agree that the amount of inventory sufficient to
ensure uninterrupted testing by Customers in the event of a disruption of supply
of Blood Screening Assays from Gen-Probe is a minimum of (5) months’ forward
demand for such Blood Screening Assays, as determined by the most current
Forecast. Accordingly, Novartis shall purchase and maintain a minimum of a five
(5) months’ inventory of Blood Screening Assays based on the latest Forecast.
Compliance with this inventory requirement shall be determined by comparing the
five (5) months’ forward demand as determined by the most current Forecast
against the aggregate of the following: (i) inventory maintained at Novartis or
its Affiliate’s warehousing facilities; (ii) finished goods inventory on hand at
Gen-Probe or in-transit from Gen-Probe; and (iii) a reasonable estimate of
inventory held by Third Party or Affiliated distributors, all of (i) through
(iii) measured for each Blood Screening Assay on a global basis.
               (b) Notwithstanding the foregoing, Gen-Probe shall maintain
sufficient inventory of raw materials and work in progress as necessary to meet
the production requirements for Novartis’s commitments for the first through
eighth months of Novartis’s most current Forecast.
               (c) Each party shall give an independent certified public
accounting firm selected by the other party access to the applicable records
(and the applicable records of any Affiliate) for the purpose of permitting the
audit, at the auditing party’s expense and in accordance with Section 6.6 of
this Agreement, of compliance with this Section 5.3.4.
          5.3.5 Blood Screening Assays Supply Obligation.
               (a) Gen-Probe shall be required to supply in any given month the
quantity of Blood Screening Assays ordered by Novartis or its Affiliates
pursuant to Purchase Orders as to that quantity of Blood Screening Assays set
forth in the then-current Forecast for such month, as the forecasted demand may
be amended as permitted in Section 5.3.1(a)(iv) above. If Gen-Probe becomes
aware of any fact indicating that Gen-Probe may be unable to meet Novartis’s
forecasted demand as specified in the original Forecast as to any Blood
Screening Assay or indicating that Gen-Probe may be unable to meet Novartis’s
forecasted demand as specified in an amended Forecast permitted under Section
5.3.1(a)(iv), Gen-Probe shall promptly provide written notice of such fact to
Novartis’s senior supply chain executive. The parties’ senior supply chain
executives shall meet and attempt to agree upon a resolution, including
exploring ways to meet such increased demand. If the parties cannot agree on
such a resolution, then the issue will be referred to the Supervisory Board for
resolution no later than the later to occur of (i) thirty (30) days after such
referral, or (ii) the next regularly scheduled Supervisory Board meeting. If the
Supervisory Board fails to resolve the issue, the parties may invoke the
provisions of ARTICLE 11 herein. The failure of Gen-Probe to supply that
quantity

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of Blood Screening Assays in a Novartis Purchase Order in excess of Novartis’s
forecasted demand as specified in the then-current Forecast or amended Forecast,
as permitted under Section 5.3.1(a)(iv) for such month, shall not trigger the
Novartis manufacturing rights set forth in Section 3.1.8(b) of the Agreement.
               (b) As of the Effective Date, and except as otherwise stated
below or as may be otherwise agreed by the parties subject to Sections 3.1.9(e)
and (f) of this Agreement, Gen-Probe shall ensure that the expiration date for
Blood Screening Assays and Ancillary Products supplied to Novartis shall be no
earlier than (i) eleven (11) months after the date of shipment to Novartis or
its Affiliate if designated for export; and (ii) eight (8) months after the date
of shipment to Novartis or its Affiliate if designated for sale by Novartis in
the United States. Recognizing that expiration dating is directly related to
order volume, manufacturing lot size, and Manufacturing Costs, the parties shall
work together in an effort to increase the minimum expiration dating for Blood
Screening Assays delivered to Novartis to twelve (12) months. The Syscheck,
Flashcheck, and System Fluid Preservative Ancillary Products shall not be
subject to the minimum expiration dating requirement set forth above, but the
expiration date for such Ancillary Products shall be no earlier than five
(5) months after the date of shipment to Novartis. Novartis shall not be
required to hold any minimum amount of inventory of such Ancillary Products and
the parties shall work together in an effort to increase the minimum expiration
dating for such Ancillary Products to six (6) months when delivered to Novartis.
          5.3.6 Blood Screening Assays Delivery and Acceptance.
               (a) All Blood Screening Assays purchased by Novartis or its
Affiliates under this Agreement shall be shipped f.o.b. place of manufacture to
such location as designated by Novartis or its Affiliates in the applicable
Purchase Order. Novartis or its Affiliates shall have the right to select the
carrier.
               (b) Novartis or its Affiliates shall be responsible for all
freight, insurance charges, taxes, import and export duties, inspection fees and
other charges applicable to the sale and transport of Blood Screening Assays
purchased by Novartis or its Affiliates to such location designated by Novartis
or its Affiliates in the applicable Purchase Order. Gen-Probe shall, to the
extent possible, charge such expenses to Novartis’s carrier accounts or pre-pay
such charges. When Gen-Probe pre-pays such charges, it shall invoice such
charges to Novartis in reasonable detail, specifying the Blood Screening Assays
to which such charges apply. Novartis shall pay all such invoices within thirty
(30) days of date of invoice.
     5.4 Blood Screening Instruments: Forecasts; Purchase Orders and Purchase
Obligation; Supply Obligation; Shipping and Delivery; Engineering Change
Notification.
          5.4.1 Blood Screening Instrument Forecasts. With respect to Forecasts
of Blood Screening Instruments: (i) Novartis shall submit Forecasts for Tigris
Instruments to Gen-Probe in accordance with the provisions set forth in this
Section 5.4.1 and (ii) Novartis shall not be required to submit Forecasts for
Component Instruments and for Spare Parts, but Novartis shall place orders for
Component Instruments and for Spare Parts in accordance with Section 5.4.2(b)
and Section 5.4.2(c) below, respectively.

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               (a) On or before the first (1st) day of the first month of each
calendar quarter (i.e., January, April, July and October) during the term of
this Agreement, Novartis shall provide to Gen-Probe a fifteen (15) month rolling
Forecast for delivery of Tigris Instruments, covering the period commencing on
the first calendar month of the quarter. For example, on or before January 1,
2009, Novartis will deliver a Forecast showing Novartis’s estimated purchase
requirements for the period covering January 1, 2009 through April 1, 2010. This
Forecast may be provided more frequently, upon mutual written agreement by the
parties. The first twelve (12) months of each rolling Forecast submitted to
Gen-Probe by Novartis shall be fixed and binding upon the parties.
               (b) The parties shall meet monthly, on or before the twenty-third
day of each calendar month, to review the most recent Forecast submitted by
Novartis, the status of prior Blood Screening Instrument forecasts and
allocations, and production planning for future deliveries of Tigris
Instruments. The purpose of these meetings will be to make decisions concerning
ordering Blood Screening Instruments, production planning, and inventory
allocation, as necessary to meet Novartis’s and Gen-Probe’s supply chain needs
in a cost efficient manner. Such meetings shall be attended by qualified members
of each party and shall be sponsored by the parties’ senior supply chain
executives. The meeting agenda shall include a review of Novartis’s Forecasts
for Tigris Instrument deliveries, the Blood Screening Instrument production
schedule, and the allocation, as between Novartis and Gen-Probe, of Tigris
Instruments to be delivered during each month of the remaining Forecast period
following the meeting. Once the allocation described in the foregoing sentence
is agreed upon, neither party may change its allocation of Tigris Instruments
for the period covered by the plan without the express written consent of both
parties. This agreed plan is henceforth referred to as the “Tigris Instrument
Allocation Plan.”
               (c) Both parties acknowledge that Gen-Probe incurs substantial
expense involved in purchasing the parts required to manufacture Tigris
Instruments for use by Gen-Probe in the Clinical Diagnostic Field and for use by
Novartis in the Blood Screening Field in that these parts must be purchased nine
(9) months in advance of the delivery of a Tigris Instrument. At the monthly
meetings mentioned in the paragraph above, Novartis and Gen-Probe will review
the inventory of Blood Screening Instrument parts required for Tigris Instrument
production. Novartis and Gen-Probe participants in such meeting will jointly
confirm the amount of Tigris Instrument parts to be purchased to cover
forecasted deliveries of manufactured Blood Screening Instruments as scheduled
in the Tigris Instrument Allocation Plan, recognizing the nine (9) month lead
time between ordering parts and the delivery of manufactured Blood Screening
Instruments. The parties acknowledge that purchases of Spare Parts and other
Ancillary Products may be reasonably increased to facilitate economical order
quantities.

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          5.4.2 Blood Screening Instruments Purchase Orders and Purchase
Obligation.
               (a) Tigris Instruments. Novartis or its Affiliates shall place
binding purchase orders for Tigris Instruments (“Tigris Instrument Purchase
Orders”) as set forth in this Section 5.4.2(a).
               (i) Novartis or its Affiliates shall submit Tigris Instrument
Purchase Orders in writing by registered mail, facsimile or email, addressed to
the attention of the Gen-Probe Customer Service Department. Each Tigris
Instrument Purchase Order shall specify the quantity of Tigris Instruments
ordered, the place of delivery for completed Tigris Instruments, and such other
information as Gen-Probe reasonably requests in writing. Gen-Probe shall confirm
acceptance or rejection of each Novartis Tigris Instrument Purchase Order within
five (5) business days of receipt of such Tigris Instrument Purchase Order. In
the event of a conflict between the terms and conditions of any Tigris
Instrument Purchase Order and this Agreement, the terms and conditions of this
Agreement shall prevail. Each Tigris Instrument Purchase Order for manufactured
Tigris Instruments shall include Novartis or its Affiliate’s shipping
instructions, which may require shipment by Gen-Probe or its designee to
multiple locations.
               (ii) Novartis or its Affiliates shall submit, on or before the
first day of the current calendar quarter, binding Tigris Instrument Purchase
Orders for Tigris Instruments to cover the fixed twelve (12) month period
commencing on the first day of the current calendar quarter, for delivery to
Novartis or its Affiliates pursuant to the most recent Tigris Instrument
Allocation Plan. For example, on or before January 1, 2009, Novartis or its
Affiliates shall submit to Gen-Probe Tigris Instrument Purchase Orders for all
Tigris Instruments represented in the current Tigris Instrument Allocation Plan
for the period covering January 1, 2009 through December 31, 2009. If such
Tigris Instrument Purchase Orders do not match the then-current Tigris
Instrument Allocation Plan, Gen-Probe’s acceptance of deviations to such Tigris
Instrument Allocation Plan will be at Gen-Probe’s discretion.
               (iii) Each Novartis Tigris Instrument Purchase Order for
completed Tigris Instruments shall be submitted no less than (12) twelve months
prior to the month in which delivery was requested in the most recent Tigris
Instrument Allocation Plan. Each Tigris Instrument Purchase Order shall be for
no less then the number of Tigris Instruments specified for the applicable month
in the most recent Tigris Instrument Allocation Plan.
               (b) Component Instruments. Novartis or its Affiliates shall place
binding Purchase Orders for Component Instruments (“Component Instrument
Purchase Orders”) with Gen-Probe as set forth in this Section 5.4.2(b).
               (i) Novartis or its Affiliates shall submit such Component
Instrument Purchase Orders in writing by registered mail, facsimile or email,
addressed to the attention of the Gen-Probe Customer Service Department. Each
Component Instrument Purchase Order shall specify the quantity of each Component
Instrument

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ordered, the place of delivery, and such other information as Gen-Probe
reasonably requests. As of the Effective Date, Gen-Probe has provided Novartis
with the minimum lead times required for deliveries of Component Instruments,
which may be adjusted upon reasonable notice to the extent any manufacturer of
Component Instruments changes its lead time requirements. If the Component
Instrument Purchase Order specifies a delivery date that complies with the
minimum required lead time, Gen-Probe shall confirm acceptance or rejection of
each Novartis Component Instrument Purchase Order within five (5) business days
of receipt of such Component Instrument Purchase Order. If the Component
Instrument Purchase Order specifies a delivery date that complies with the
minimum required lead time and if Gen-Probe fails to respond to Novartis or its
Affiliates within said five (5) business days, the Component Instrument Purchase
Order shall be deemed accepted by Gen-Probe as issued by Novartis or its
Affiliates with respect to the quantity, shipping schedule, and shipping
instructions. Likewise, if Novartis or its Affiliates fail to respond to
Gen-Probe’s written response within five (5) business days of Novartis or its
Affiliate’s receipt of such written response, then the modifications to the
Component Instrument Purchase Order set forth in such Gen-Probe written response
shall be deemed accepted by Novartis. In the event of a conflict between the
terms and conditions of any Component Instrument Purchase Order and this
Agreement, the terms and conditions of this Agreement shall prevail.
               (ii) Component Instrument Purchase Orders for each Blood
Screening Instrument must be placed with a requested delivery date far enough in
advance to allow the manufacturer the time required to manufacture and release
the Blood Screening Instrument. Component Instrument Purchase Orders for Blood
Screening Instruments that do not meet the lead time requirements must be
submitted to Gen-Probe for review and approval; Gen-Probe shall have no
obligation with respect to any such Component Instrument Purchase Order until
Gen-Probe has affirmatively approved quantities and delivery dates. Once the
quantities and delivery dates are agreed upon, Gen-Probe will forward the short
lead time Component Instrument Purchase Order to the manufacturer or supplier.
               (c) Spare Parts. Novartis or its Affiliates shall order Spare
Parts for Tigris Instruments directly from the supplier/manufacturer, (e.g., KMC
Systems, Inc) and Novartis shall order Spare Parts for the front-end pipettor
and the reagent addition station components of the ESAS2 Instrument directly
from STRATEC Biomedical Systems AG. Novartis shall place binding Purchase Orders
for Spare Parts for Component Instruments (“Spare Parts Purchase Orders”) as set
forth in this Section 5.4.2(c).
               (i) Novartis or its Affiliates shall submit Spare Parts Purchase
Orders in writing by registered mail, telefax or email, addressed to the
attention of the Gen-Probe Customer Service Department. Each Spare Parts
Purchase Order shall specify (A) the quantity of each Spare Part ordered,
(B) the requested shipping schedule for such Spare Parts, (C) shipment
instructions for such Spare Parts, which may require shipment by Gen-Probe or
its designee to multiple locations, and (D) such other information as Gen-Probe
reasonably requests. With the exception of such quantity, shipping schedule,
shipping instructions, and information requested by Gen-Probe, and unless
otherwise mutually agreed in writing by the parties, all other terms and
conditions of any Spare

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Parts Purchase Order shall be null and void. In the event of a conflict between
the terms and conditions of any Spare Parts Purchase Order and this Agreement,
the terms and conditions of this Agreement shall prevail.
               (ii) Gen-Probe will provide to Novartis or its Affiliates a
written response to each Spare Parts Purchase Order within five (5) business
days of Gen-Probe’s receipt of such Spare Parts Purchase Order, indicating
either that the terms of the Spare Parts Purchase Order are acceptable as
stated, or setting forth necessary adjustments. As of the Effective Date,
Gen-Probe has provided Novartis with the minimum lead times required for
deliveries of Spare Parts for Component Instruments, which may be adjusted upon
reasonable notice to the extent any manufacturer of Spare Parts for Component
Instruments changes its lead time requirements. If the Spare Parts Purchase
Order specifies a delivery date that complies with the minimum required lead
time and if Gen-Probe fails to respond to Novartis or its Affiliates within said
five (5) business days, the Spare Parts Purchase Order shall be deemed accepted
by Gen-Probe as issued by Novartis or its Affiliates with respect to the
quantity, shipping schedule, and shipping instructions. Likewise, if Novartis or
its Affiliates fail to respond to Gen-Probe’s written response within five
(5) business days of Novartis or its Affiliate’s receipt of such written
response, then the modifications to the Spare Parts Purchase Order set forth in
such Gen-Probe written response shall be deemed accepted by Novartis.
               (iii) Spare Parts Purchase Orders that do not meet the lead time
requirements must be submitted to Gen-Probe for review and approval. Gen-Probe
shall have no obligation with respect to any such Spare Parts Purchase Order
until Gen-Probe has affirmatively approved quantities and delivery dates. Once
the quantities and delivery dates are agreed upon, Gen-Probe will forward the
short lead time Spare Parts Purchase Order to the manufacturer or supplier.
               (iv) Novartis shall pay Gen-Probe the amount of each accepted
Spare Parts Purchase Order for Spare Parts within thirty (30) days following
delivery and receipt of the invoice for such Spare Parts.
               (d) Emergency Purchase Orders. Either party may submit a purchase
order for expedited shipment for a part or parts of a Blood Screening Instrument
in response to an “instrument down” situation in which the party submitting the
purchase order does not have a required part(s) in inventory in a stock
location(s) from which the part(s) could be obtained within the time required to
meet the customer requirements for repair of the applicable Blood Screening
Instrument (such purchase order, an “Emergency Purchase Order”). If the other
party has the required part(s) in inventory, it will make every commercially
reasonable effort to supply the needed part(s) as soon as possible.

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          5.4.3 Blood Screening Instruments Supply Obligation
               (a) Tigris Instruments.
               (i) Gen-Probe shall use its best efforts to obtain from the
supplier/manufacturer and supply to Novartis or its Affiliates in any given
month, the quantity of Tigris Instruments ordered by Novartis or its Affiliates
pursuant to a Tigris Instrument Purchase Order in accordance with the quantity
of Tigris Instruments set forth in the then-current Tigris Instrument Allocation
Plan for such month. If Gen-Probe becomes aware of any fact indicating that
Gen-Probe may be unable to meet Novartis or its Affiliate’s demand as specified
in an agreed upon Tigris Instrument Allocation Plan, Gen-Probe will immediately
notify Novartis. The parties shall communicate and attempt to agree upon a
resolution, including exploring ways to meet such demand.
               (ii) Gen-Probe will make every commercially reasonable effort to
deliver the latest version of each Tigris Instrument at the time of
manufacturing.
               (iii) Gen-Probe will use Commercially Reasonable Efforts to
supply Tigris Instruments that Novartis or its Affiliates may request that are
in addition to those agreed upon in the Tigris Instrument Allocation Plan.
Novartis or its Affiliates shall provide Gen-Probe with as much notice as
possible if and when Novartis or its Affiliates requests additional Tigris
Instruments. Gen-Probe shall provide Novartis or its Affiliates with notice of
the anticipated delivery date for such additional Tigris Instruments.
               (iv) If for any three (3) months in any twelve-month period
Gen-Probe fails to supply Novartis with Novartis or its Affiliates’ aggregate
monthly requirements of a Blood Screening Instrument, ordered by Novartis or its
Affiliates in accordance with this Agreement, within forty-five (45) days after
the requested delivery date, then Novartis or its Affiliates shall have the
right to place orders directly with the Blood Screening Instrument manufacturer,
unless Gen-Probe’s failure to supply was caused by the manufacturer.
               (b) Component Instruments. Gen-Probe shall use its best efforts
to obtain from the manufacturer and supply to Novartis or its Affiliates in any
given month the quantity of Component Instruments ordered by Novartis or its
Affiliates pursuant to a Component Instrument Purchase Order. If Gen-Probe
becomes aware of any fact indicating that Gen-Probe may be unable to meet
Novartis or its Affiliates’ demand as specified in a Component Instrument
Purchase Order, Gen-Probe will immediately notify Novartis. The parties shall
communicate and attempt to agree upon a resolution, including exploring ways to
meet such demand.
               (c) Spare Parts
               (i) For those Spare Parts properly and timely identified on Spare
Parts Purchase Orders submitted to Gen-Probe by Novartis or its Affiliates,
Gen-Probe shall use its best efforts to obtain from the supplier/manufacturer
and supply to Novartis or its Affiliates in any given month the quantity of
Spare Parts ordered by Novartis or its Affiliates. Gen-Probe will routinely
monitor overdue Spare Parts

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Purchase Orders and work with their suppliers to assign new delivery dates. If
Gen-Probe becomes aware of any fact indicating that Gen-Probe may be unable to
meet the terms of a Novartis Spare Parts Purchase Order for any Spare Part,
Gen-Probe will immediately notify Novartis Purchasing. The parties shall
communicate and attempt to agree upon a resolution, including exploring ways to
meet such demand.
               (ii) If Novartis or its Affiliates requires Spare Parts to be
delivered earlier than the lead times specified in this Agreement for such Spare
Parts, Gen-Probe shall use its Commercially Reasonable Efforts to supply in
accordance with Novartis or its Affiliates’ requested delivery dates, and shall
provide Novartis or its Affiliates with notice of the anticipated delivery date
for such Spare Parts. Novartis or its Affiliates shall provide Gen-Probe with as
much advance notice as possible if and when Novartis or its Affiliates so
requests early delivery of Spare Parts. The parties hereby acknowledge and agree
that in any event, Gen-Probe shall not be in breach of its obligations hereunder
for not satisfying delivery requests that do not meet the lead times specified
in this Agreement.
               (iii) If Gen-Probe terminates its agreement with any of the
manufacturers of Spare Parts required to maintain Gen-Probe supplied Blood
Screening Instruments, Gen-Probe shall promptly notify Novartis and use
Commercially Reasonable Efforts to provide Spare Parts to Novartis from an
alternative manufacturer. If Gen-Probe fails to secure a supply of Spare Parts
from an alternative manufacturer within ninety (90) days of the termination of
the prior Spare Parts agreement, Novartis may manufacture or have manufactured
the necessary Spare Parts. In such event, Gen-Probe promptly shall provide such
reasonable technical assistance, at Gen-Probe’s sole cost, as necessary to
enable Novartis to manufacture (or have manufactured) such Spare Parts.
               (d) Five Year Support and Parts Availability. Gen-Probe will
provide applicable support and Spare Parts availability for at least five
(5) years after a given Blood Screening Instrument falls out of production.
Gen-Probe will provide written notification if Gen-Probe expects any Blood
Screening Instrument to fall out of production with sufficient lead time to
consider and potentially place orders for last-time purchases of such Blood
Screening Instrument. With respect to Spare Parts obsolescence, Gen-Probe will:
(i) notify Novartis in writing of any planned Spare Part obsolescence, and any
plan to initiate a design change will be communicated in advance in writing to
Novartis; (ii) purchase material for last-time Spare Part purchases that include
quantities designated for all released Novartis Blood Screening Instruments; and
(iii) bear the cost of such last-time purchases, including any field instrument
upgrades that are required due to Spare Part obsolescence, as well as storage
costs to hold such materials.
          5.4.4 Blood Screening Instruments Shipping and Delivery
               (a) Tigris Instruments. Gen-Probe shall release Tigris
Instruments to Novartis or its Affiliates according to Tigris Instrument
Purchase Order delivery dates. Gen-Probe shall supply a Certificate of
Compliance, a Declaration of Conformity, and a Configuration List when a Tigris
Instrument is released by Gen-Probe Quality Control.

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Novartis or its Affiliates shall be responsible for all outbound freight,
insurance charges, taxes, import and export duties, and other charges applicable
to the sale and transport of Tigris Instruments purchased by Novartis or its
Affiliates to such location designated by Novartis or its Affiliates in the
applicable Tigris Instrument Purchase Order. Novartis or its Affiliates will
make arrangements for the shipment of released Tigris Instruments to customers
of Novartis or its Affiliates or Novartis-approved third parties for storage.
Shipping terms shall be FCA the supplier/manufacturer’s facility or other
storage facility utilized by Gen-Probe, as governed by Incoterms 2000. Proof of
delivery shall be upon receipt by Novartis or its Affiliates of a faxed copy of
a packing slip from Gen-Probe or its designee indicating the Tigris Instrument
is available for shipment. Novartis or its Affiliates agree to accept ownership
of the Tigris Instrument upon receipt of such a packing slip.
          (b) Component Instruments. With respect to Component Instruments,
Gen-Probe shall supply a Certificate of Compliance for those Component
Instruments released by Gen-Probe Quality Control. Novartis or its Affiliates
shall be responsible for all outbound freight, insurance charges, taxes, import
and export duties, and other charges applicable to the sale and transport of
such Component Instruments purchased by Novartis or its Affiliates to such
location designated by Novartis or its Affiliates in the applicable Component
Purchase Order. Shipment and receipt of such Component Instruments shall be FCA
Gen-Probe, 10210 Genetic Center Drive, San Diego, California 92101, as governed
by Incoterms 2000.
          (c) Spare Parts. Shipping terms for software, manuals and Component
Instrument Spare Parts shall be FCA Gen-Probe, 10210 Genetic Center Drive, San
Diego, California 92101, as governed by Incoterms 2000.
     5.4.5 Blood Screening Instruments Engineering Change Notification
          (a) Tigris Instruments. Unless otherwise agreed by the parties in
writing, Gen-Probe shall be the owner of the design of the Tigris Instruments
and, as such, only Gen-Probe has the right to effect any change to the design of
a Tigris Instrument. Gen-Probe shall notify Novartis in writing of any change to
a Tigris Instrument within five (5) business days after such change has been
approved by Gen-Probe. Gen-Probe shall bear the cost of any and all parts
required to implement Tigris Instrument modifications that are 1) mandated by
the FDA or any comparable foreign regulatory body or 2) mandated by Gen-Probe to
assure or increase Tigris Instrument safety or reliability, or ensure proper
Tigris Instrument performance according to the Tigris Instrument specifications.
This shall include replacing or upgrading any Spare Parts in Novartis’s
inventory that can no longer be used as a result of a change, at no additional
cost to Novartis. Novartis shall bear the cost of parts required to implement
all other changes not mandated by the FDA or Gen-Probe. When changes to Tigris
Instruments in the field or in inventory will be performed at the expense of
Novartis, Novartis retains the right to determine if and when a change to the
Tigris Instruments in the field will be implemented, dependent upon availability
of the parts and other internal business conditions necessary to implement the
change.
          (b) Component Instruments. Unless otherwise agreed by the parties in
writing, with respect to Component Instruments, Gen-Probe shall be the owner of
the design of such Component Instruments and, as such, only Gen-Probe has the
right to effect any change to

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the design of such Component Instrument. Gen-Probe shall notify Novartis in
writing of any change to such Component Instrument within five (5) business days
after such change has been approved by Gen-Probe.
               (c) Spare Parts. Unless otherwise agreed by the parties in
writing, Gen-Probe shall be the owner of the design of the Spare Parts and, as
such, only Gen-Probe has the right to effect any change to the design of a Spare
Part. Gen-Probe shall notify Novartis in writing of any change to a Spare Part
within five (5) business days after such change has been approved by Gen-Probe.
     5.5 Packaging. All Products supplied under this Agreement shall be packaged
in such manner as Novartis reasonably determines and Gen-Probe does not
reasonably object.
     5.6 Rejection and Cure
          5.6.1 Blood Screening Assays. If a shipment of Blood Screening Assays
or any portion thereof is spoiled, damaged or defective, or fails to have the
appropriate remaining life, then Novartis or its Affiliates shall have the right
to reject such shipment or the portion thereof that fails to so conform, as the
case may be. Novartis or its Affiliates shall give written notice to Gen-Probe
of its rejection hereunder, within thirty (30) days after Novartis or its
Affiliates’ receipt of such shipment, specifying the grounds for such rejection
and requesting a return material authorization. All or any part of any shipment
may be held for Gen-Probe’s disposition, at Gen-Probe’s expense if found to be
not in conformance with the applicable specifications. Gen-Probe shall use its
Commercially Reasonable Efforts to cure such rejection or replace such rejected
shipment (or portion of shipment) after receipt of notice of rejection thereof.
          5.6.2 Blood Screening Instruments. If any Blood Screening Instrument
is damaged, defective or fails to conform to the specifications therefor, then
Novartis or its Affiliates shall have the right to reject such damaged,
defective or nonconforming Blood Screening Instrument. Novartis or its
Affiliates shall give written notice to both Gen-Probe and any manufacturer
designated by Gen-Probe of its rejection hereunder, within ten (10) days after
installation of such Instrument, specifying the grounds for such rejection and
requesting a return material authorization. The Blood Screening Instrument shall
be held for Gen-Probe’s disposition, at Gen-Probe’s expense, if found to be
damaged, defective or nonconforming. Gen-Probe shall use its Commercially
Reasonable Efforts to replace such rejected Blood Screening Instrument after
receipt of notice of rejection thereof.
          5.6.3 LIMITATION OF LIABILITY. EXCEPT AS OTHERWISE SPECIFICALLY SET
FORTH IN THIS AGREEMENT, GEN-PROBE’S SOLE LIABILITY TO NOVARTIS, AND NOVARTIS’S
SOLE REMEDY, WITH RESPECT TO THE SPECIFIC MATTERS ADDRESSED UNDER SECTION 5.6
ABOVE SHALL BE THE REJECTION AND REPLACEMENT OF NON-CONFORMING PRODUCTS. NOTHING
IN THIS SECTION SHALL LIMIT ANY RIGHTS OR REMEDIES UNDER ARTICLE 9 OR ANY RIGHT
OF NOVARTIS TO ASSUME RESPONSIBILITY FOR THE MANUFACTURE OF THE PRODUCTS UNDER
ARTICLE 3.

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     5.7 Warranty. Gen-Probe warrants that all the Products delivered to
Novartis pursuant to this Agreement shall conform with the applicable
specifications, shall be free from defects in material and workmanship, and
shall be manufactured in compliance with applicable laws and regulations. Any
and all warranties by subcontract manufacturers of the Blood Screening
Instruments shall inure to the benefit of Novartis, to the extent permitted by
such subcontract manufacturer.
          5.7.1 LIMITATION OF LIABILITY. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
IN THIS AGREEMENT, GEN-PROBE MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH
RESPECT TO THE PRODUCTS. GEN-PROBE DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND
IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.
          5.7.2 Complaint Resolution. The parties agree that prompt
investigation is required of any complaint concerning product quality, in order
to minimize product scrap and provide optimal customer service. The parties
shall use best efforts to respond promptly to any complaint that potentially
implicates product quality, in accordance with the May 28, 2009 Quality
Agreement and the parties’ “Complaint Handling Plan.”
     5.8 Independent Purchaser Status. Novartis and its Affiliates shall be
independent purchasers and resellers of the Products. Novartis and its
Affiliates shall be free to use and resell the Products on such terms as each
may, in its sole discretion, determine, including price, returns, credits and
discounts.
     5.9 Non-Commercial Products. Gen-Probe agrees to provide to Novartis or its
Affiliates reasonable quantities of Blood Screening Assays manufactured by
Gen-Probe for uses other than sale to customers, including without limitation
research studies, marketing studies, internal research and development, and
troubleshooting (all for Novartis or its Affiliate’s use only in direct
furtherance of the express purposes of this Agreement and without any implied
license for any purpose other than such express purposes), to the extent such
Products are specifically ordered by Novartis or its Affiliates for such
purposes (“Non-commercial Products”). The entire compensation to Gen-Probe for
Non-commercial Products shall be not greater than one hundred twenty percent
(120%) of Gen-Probe’s Manufacturing Cost. The quantities of Non-commercial
Products ordered by Novartis or its Affiliates shall be subject to review by the
Supervisory Board.
     5.10 Internal Commercial Use. For all Products which are used commercially
by Novartis or its Affiliates, Novartis shall pay to Gen-Probe the compensation
which would be due Gen-Probe had such Products been the subject of an arm’s
length commercial sale by Novartis.

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ARTICLE 6
PAYMENTS AND REPORTS
     6.1 Compensation
          6.1.1 Compensation to Gen-Probe for Blood Screening Assays. In
consideration for the rights granted, and the obligations accepted, by
Gen-Probe, Novartis or its Affiliates, as applicable, shall pay to Gen-Probe the
following amounts:
               (a) Transfer Price. Within thirty (30) days after receipt of
invoice, Novartis shall pay to Gen-Probe the Transfer Price for each Blood
Screening Assay purchased by Novartis or its Affiliates.
               (b) Applicable Purchase Price. Novartis shall pay to Gen-Probe
the Applicable Purchase Price for each Blood Screening Assay sold by a Seller to
a Third Party in a calendar month, less the Transfer Price actually paid to
Gen-Probe for such Blood Screening Assay, within thirty (30) days after the end
of each calendar month and concurrently with the written report required by
Section 6.4.
          6.1.2 Compensation to Gen-Probe for Blood Screening Instruments. In
consideration for the rights granted, and the obligations accepted, by
Gen-Probe, Novartis or its Affiliates, as applicable, shall pay to Gen-Probe the
following amounts:
               (a) Transfer Price. Within thirty (30) days of invoice, Novartis
shall pay to Gen-Probe the Transfer Price for each Blood Screening Instrument
purchased by Novartis or its Affiliates.
               (b) Instrument Sales in the United States and Canada. Within
thirty (30) days after the end of each calendar month, Novartis shall pay to
Gen-Probe an amount equal to fifty percent (50%) of the difference of (A) Net
Sales of each Blood Screening Instrument sold by Novartis or its Affiliates to
independent customers in the United States and Canada during such calendar
month, and (B) the Transfer Price actually paid to Gen-Probe for each Blood
Screening Instrument included with the calculation of Net Sales for such
calendar month.
               (i) If Novartis or its Affiliates places an instrument with a
customer in the United States or Canada and receives revenue for Blood Screening
Instruments and Blood Screening Assays on a combined basis (such arrangement, a
“Reagent Rental”), such revenue shall be allocated to the Blood Screening Assays
and in determining Net Sales for the Blood Screening Assays Novartis shall not
be entitled to deduct any amount allocated to an imputed charge for instruments.
Nothing contained in this subsection shall limit Novartis’ right to deduct, in
accordance with Section 3.1.9(c), instrument service revenue received pursuant
to a Reagent Rental arrangement.
               (ii) This Section expressly excludes from Net Sales all revenues
received in connection with the sale of TECANs, whether deemed part of a Blood
Screening Instrument or not, so long as the transfer qualifies as a sale under
generally accepted accounting principles (GAAP). For the avoidance of doubt,
such

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exclusion from Net Sales shall be taken by Novartis only for TECANs purchased
from Gen-Probe. Further, Novartis agrees to transfer such TECANs at no more than
commercially reasonable values for the diagnostic and/or blood screening markets
consistent with standard industry practice in those markets.
               (c) Instrument Sales Outside the United States and Canada. Except
as otherwise agreed by the parties in writing, Novartis shall retain the
aggregate revenues received by it or its Affiliates from sales of Blood
Screening Instruments outside the United States and Canada.
               (d) Reagent Rentals Outside the United States and Canada. If
Novartis or its Affiliates leases or intends to lease a Blood Screening
Instrument to an independent customer outside the U.S. and Canada in combination
with the sale of Blood Screening Assays, and Novartis is to receive revenues for
the Blood Screening Instruments, Blood Screening Assays and maintenance and
repair service on a combined, unallocated basis, Novartis shall be entitled to
deduct from the gross revenue received, prior to determining Net Sales for the
Blood Screening Assays, an amount equal to one hundred percent (100%) of the
actual, out-of-pocket cost of the instrument, reasonably allocated for the
applicable period, assuming a five year life for the instrument, together with a
reasonable allocation of the actual, out-of-pocket costs of service. Once
Novartis has deducted an amount equal to its total, actual, out-of-pocket cost
for the instrument, no further deductions shall be allowed. If Novartis or its
Affiliates leases or intends to lease a Blood Screening Instrument to an
independent customer outside the U.S. and Canada in combination with the sale of
Blood Screening Assays, and Novartis is to receive revenues for the Blood
Screening Instruments, Blood Screening Assays and maintenance and repair service
on an allocated basis, Novartis shall be entitled to deduct from the gross
revenue received, prior to determining Net Sales for the Blood Screening Assays,
only those portions allocated in the customer agreement for the Blood Screening
Instruments and the maintenance and repair services, each at no more than
commercially reasonable value consistent with standard industry practice in the
diagnostic and/or blood screening markets.
               (e) Reimbursement of Development Costs for FEP and RAS Components
of eSAS 2 Instrument. As set forth in Schedule 6.1.2(e), Novartis shall be
entitled to reimbursement of development costs for the FEP component and the RAS
component of the eSAS2 Instrument solely from revenues from sales of such
components.
          6.1.3 Compensation to Gen-Probe for Ancillary Products. In
consideration for the rights granted, and the obligations accepted, by
Gen-Probe, Novartis or its Affiliates, as applicable, shall pay to Gen-Probe the
following amounts:
               (a) Transfer Price; Shipping. Within thirty (30) days after
receipt of invoice, Novartis shall pay to Gen-Probe the Transfer Price for each
Ancillary Product purchased by Novartis or its Affiliates.
               (b) Additional Compensation. Ancillary Products shall generally
be sold by Novartis at a price that is approximately equal to Novartis’ cost. If
in any month Novartis’ aggregate revenues from the sale of Ancillary Products
exceeds one hundred twenty percent (120%) of the aggregate Transfer Price paid
for such Products, then within thirty (30)

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days after the end of such calendar month, Novartis shall pay to Gen-Probe an
amount equal to fifty percent (50%) of the excess amount. Where Ancillary
Products are sold by Novartis on a combined, unallocated basis with other
Products, Novartis shall not be entitled to deduct from revenue any amount in
excess of the Transfer Price for such Ancillary Products in determining Net
Sales of such other Products.
     6.2 Gen-Probe’s Agreement To Contribute To HIV Patent Payments. Pursuant to
Section 8.6 and subject to this Section 6.2, the parties agree to share the
payment obligation of Novartis and Gen-Probe for the license of HIV-1
intellectual property rights [...***...]
***Confidential Treatment Requested

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[...***...]
     6.3 Invoicing. Upon shipment of the Products to Novartis, Gen-Probe shall
submit invoices therefor indicating the applicable Transfer Price to Novartis.
     6.4 Reports. Within thirty (30) days after the end of each calendar month
during the Blood Screening Term, as applicable in connection with Novartis’s
payment obligations hereunder, Novartis shall furnish to Gen-Probe a written
report showing in reasonably specific detail (a) the gross sales, on a
Product-by-Product and country-by-country basis, of all Products sold by
Novartis and its Affiliates to independent customers in the Territory during
such period as to which Novartis is obligated to make payments hereunder based
on Product sales and the calculation of Net Sales on a worldwide basis from such
gross sales; (b) the allowable deductions taken pursuant to Section 1.33,
Section 3.1.4(b)(ii), or Section 3.1.9(d) (each subject to the provisions of
Section 1.33.2 concerning the use of accruals based upon estimates); (c) all
amounts owing to Gen-Probe hereunder payable in United States dollars, if any,
which shall have accrued hereunder based upon such sales of Products; (d) the
withholding taxes, if any, required by law to be deducted in respect of such
sales; (e) the date of the First Commercial Sale of each Product in each country
in the Territory during such period; and (f) the exchange rates used in
determining the amount of United States dollars. Novartis shall keep complete
and accurate records in sufficient detail to properly reflect all gross sales
and Net Sales and to enable all amounts payable hereunder to be determined.
***Confidential Treatment Requested

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               (a) Reagent Rental Reports. Novartis shall provide to Gen-Probe,
no later than thirty (30) days following the end of a calendar year, an annual
report that (i) identifies with specificity the number of Blood Screening Assays
sold concurrently or in connection with the placement of Blood Screening
Instruments, and (ii) contains an accounting in reasonable detail of the
permitted deductions taken pursuant to Section 6.1.2(d) in the prior calendar
year with regard to such reagent rentals. Gen-Probe shall have the right to
audit the books and records of Novartis to determine the accuracy and
sufficiency of any such report in accordance with this Agreement not more than
once every other year.
     6.5 Exchange Rates. With respect to sales of Products invoiced in United
States dollars, all such amounts calculated under this Agreement shall be
expressed in United States dollars. With respect to sales of Products invoiced
in a currency other than United States dollars, all such amounts calculated
under this Agreement shall be expressed in the domestic currency of the party
making the sale together with the United States dollar equivalent of such
amounts calculated using Novartis’s standard accounting methods for calculating
worldwide sales of its other products.
     6.6 Audits.
          6.6.1 Upon the written request of either party (the “Requesting
Party”) and not more than once in each calendar year, the other party (the
“Responding Party”) shall permit an independent certified public accounting firm
of nationally recognized standing, selected by the Requesting Party and
reasonably acceptable to the Responding Party, at the Requesting Party’s
expense, to have access during normal business hours to such of the records of
the Responding Party as may be reasonably necessary to verify the accuracy of
the payment reports and invoices hereunder for any year ending not more than
thirty-six (36) months prior to the date of such request. The accounting firm
shall disclose to the Requesting Party only whether the payment reports and
invoices are correct or not and the specific details concerning any
discrepancies. No other information shall be shared.
          6.6.2 If such accounting firm concludes that undercharged or
overcharged amounts are owing from one party to the other for such period, the
appropriate party shall pay such amounts within thirty (30) days of the date the
Requesting Party delivers to the Responding Party such accounting firm’s written
report so concluding. The fees charged by such accounting firm shall be paid by
the Requesting Party; provided, however, if the audit discloses either (a) that
the amounts payable by the Responding Party for the audited period are more than
one hundred five percent (105%) of the amounts actually paid for such period, or
(b) that the amounts charged by the Responding Party for the audited period are
more than one hundred five percent (105%) of the amounts actually incurred for
such period, then the Responding Party shall pay the reasonable fees and
expenses charged by such accounting firm.
          6.6.3 The Requesting Party shall treat all financial information
subject to review under this Section 6.6 as confidential, and shall cause its
accounting firm to retain all such financial information in confidence with a
confidentiality agreement reasonably acceptable to the Responding Party.

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     6.7 Payment Method. All payments by Novartis to Gen-Probe under this
Agreement shall be paid in United States dollars, and all such payments shall be
originated from a United States bank located in the United States and made by
bank wire transfer in immediately available funds to such account as Gen-Probe
shall designate before such payment is due.
     6.8 Exchange Control. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country in the Territory
where the Product is sold, payment shall be made through such lawful means or
methods as the parties reasonably shall determine.
     6.9 Sales and Use Taxes. Any federal, state, county or municipal sales or
use tax, excise or similar charge, or other tax assessment (other than that
assessed against income), assessed or charged on the sale of the Products sold
by Gen-Probe to Novartis pursuant to this Agreement shall be paid by Novartis.
     6.10 Withholding Taxes. Novartis shall be entitled to deduct the amount of
any withholding taxes, value-added taxes or other taxes, levies or charges
(other than United States taxes) with respect to amounts payable by Novartis,
its Affiliates or, in the case of Products for the Blood Screening Field, by
distributors in Japan, Germany, Italy, France, or the United Kingdom, or any
taxes required to be withheld by Novartis, its Affiliates, or such distributors,
to the extent Novartis, its Affiliates, or such distributors pay to the
appropriate governmental authority on behalf of Gen-Probe such taxes, levies or
charges. Novartis shall use reasonable efforts to minimize any such taxes,
levies or charges required to be withheld on behalf of Gen-Probe by Novartis,
its Affiliates, or such distributors. Novartis promptly shall deliver to
Gem-Probe proof of payment of all such taxes, levies and other charges, together
with copies of all communications from or with such governmental authority with
respect thereto.
     6.11 Late Payments. Unless otherwise provided in this Agreement, a party
shall pay interest to the other party on the aggregate amount of any amounts
payable by such party that are not paid on or before the date such amounts are
due under this Agreement at a rate per annum equal to the lesser of the prime
rate of interest as reported by Bank of America NT&SA in San Francisco,
California, from time to time, plus two percent (2%), or the highest rate
permitted by applicable law, calculated on the number of days such payment is
delinquent.
ARTICLE 7
CONFIDENTIALITY
     7.1 Confidential Information. For the period commencing on the date this
Agreement is first signed by both parties and ending seven (7) years following
the expiration or earlier termination hereof, a party (the “Receiving Party”)
shall maintain in confidence the Confidential Information of the other party,
and shall not disclose, use, or grant the use of the Confidential Information of
the other party (the “Disclosing Party”) except on a need-to-know basis to its
(and its Affiliates’) directors, officers and employees, and to its consultants
and to other Third Parties, and then only to the extent that such disclosure or
use is reasonably necessary in connection with such party’s activities as
expressly authorized by this Agreement. To the extent that disclosure to any
Person is authorized by this Agreement, prior to disclosure,

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the Receiving Party shall obtain written agreement of such Person to hold in
confidence and not disclose, use or grant the use of the Confidential
Information of the other party except as expressly permitted under this
Agreement. The parties agree that the term of the non-disclosure and non-use
obligations of a Third Party will end seven (7) years after the end of the
contractual arrangement with such Third Party. Each Receiving Party shall notify
the Disclosing Party promptly upon discovery of any unauthorized use or
disclosure of the Disclosing Party’s Confidential Information. Upon the
expiration or earlier termination of this Agreement, each party shall return to
the other party all tangible items regarding the Confidential Information of the
other party and all copies thereof; provided, however, that each Receiving Party
shall have the right to retain one (1) copy for its legal files for the sole
purpose of determining its obligations hereunder.
     7.2 Terms of this Agreement. The terms of this Agreement shall be
considered Confidential Information subject to the obligations of
confidentiality, non-disclosure and non-use in this ARTICLE 7. Notwithstanding
the foregoing, either party may disclose the terms of this Agreement in order to
comply with applicable laws, rules and regulations (including those of the
United States Securities and Exchange Commission), provided, however, that
reasonably in advance of such disclosure the disclosing party shall provide
written notice to the other party so that such other party may review the
proposed disclosure and provide comments to the disclosing party, including by
requesting confidential treatment of certain terms (such as the financial terms)
of this Agreement, and the disclosing party shall take into account the other
party’s comments and, to the extent consistent with applicable laws, rules and
regulations, seek confidential treatment of such terms.
     7.3 Permitted Disclosures. The confidentiality obligations under this
ARTICLE 7 shall not apply to the extent that a party is required to disclose
information by applicable law, regulation or order of a governmental agency or a
court of competent jurisdiction, provided that such party shall provide written
notice thereof to the other party and sufficient opportunity to object to any
such disclosure or to request confidential treatment thereof.
ARTICLE 8
INVENTIONS AND INTELLECTUAL PROPERTY RIGHTS
     8.1 Ownership of Inventions.
          8.1.1 Except as otherwise set forth in Sections 8.1.2 through 8.1.7
below, the entire right and title in all discoveries, inventions or other
technology, data or information (whether patentable or not), together with all
patent and other intellectual property rights therein, made or conceived during
and as a result of a Development Program or the performance of other obligations
under this Agreement, (e.g., manufacturing) (collectively, the “Inventions”)
(a) by employees of Gen-Probe or others acting solely on behalf of Gen-Probe
(the “Gen-Probe Inventions”) shall be owned solely by Gen-Probe, (b) by
employees of Novartis or others acting solely on behalf of Novartis (the
“Novartis Inventions”) shall be owned solely by Novartis, and (c) jointly by
employees of Gen-Probe or others acting on behalf of Gen-Probe and employees of
Novartis or others acting on behalf of Novartis (the “Joint Inventions”) shall
be owned jointly by Gen-Probe and Novartis.

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               (a) Novartis Inventions shall be included within the Novartis IP
Rights, Gen-Probe Inventions shall be included within the Gen-Probe IP Rights,
and Joint Inventions shall be within both the Novartis IP Rights and Gen-Probe
IP Rights, so that they are available for use within the scope of this
Agreement.
               (b) Each party shall have the right, subject to the provisions of
this Agreement, to freely exploit, transfer, license or encumber its rights in
both its own inventions hereunder (except that each party expressly agrees that
this sentence does not create in any way an implied license to the intellectual
property of the other party and that there are no such implied licenses in this
Agreement) and in any Joint Invention hereunder (or the patent and other
intellectual property rights therein) without the consent of, or compensation or
accounting to, the other party, except as to a Joint Invention to the extent
that:
               (i) Such use or application of a Joint Invention would require a
license from the other party (under a Valid Claim other than those claiming the
Joint Invention), each party expressly agreeing that in this Agreement there are
no implied licenses to the intellectual property of the other party; and
               (ii) except that, absent mutual written agreement or as provided
for otherwise herein, no use of any such Joint Invention shall be made during
any term of this Agreement in connection with a Competitive Probe Assay (which
shall mean for all purposes of this Agreement as to both parties, a nucleic acid
probe-based assay which is used for the same clinical indication as any Blood
Screening Assay developed under this Agreement); and
               (iii) Such use or application of a Joint Invention resulting from
application of Section 8.1.6(d) or 8.1.6(e) is made in connection with any
product which competes directly with a nucleic acid probe-based assay product of
the other party which has been sold as of the Effective Date of this Agreement.
               (c) Notwithstanding any other provision of this Agreement, the
parties agree that a Derivative Invention (as defined in Section 8.1.4 below) as
to which any substantial use would infringe a claim of [...***...]), shall be
owned jointly by the parties and considered a Joint Invention. Gen-Probe waives
any and all rights in any such Derivative Invention to the extent (and only to
the extent) that such Derivative Invention is used in connection with
immunoassays or protein binding assays and such use would infringe the
[...***...]. Gen-Probe agrees that Novartis shall have exclusive rights with
respect to such uses. Novartis waives any and all rights in any such Derivative
Invention to the extent (and only to the extent) that such Derivative Invention
is used in connection with nucleic acid hybridization assays and such use would
infringe the [...***...]. Novartis agrees that Gen-Probe shall have exclusive
rights with respect to such uses.
               (d) Notwithstanding any other provision of this Agreement, the
parties agree that a Derivative Invention (as defined in Section 8.1.4 below) as
to which any substantial use would infringe a Valid Claim of [...***...]), shall
be owned jointly by the parties and considered a
***Confidential Treatment Requested

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Joint Invention. Gen-Probe waives any and all rights in any such Derivative
Invention to the extent (and only to the extent) that such Derivative Invention
made by Novartis is used in connection with immunoassays or protein binding
assays, provided however that nothing contained herein shall constitute a
license to Novartis of any rights under the [...***...]. Novartis waives any and
all rights in any such Derivative Invention to the extent (and only to the
extent) that such Derivative Invention is used in connection with nucleic acid
hybridization assays. Novartis agrees that Gen-Probe shall have exclusive rights
with respect to such uses.
               (e) Notwithstanding any other provision of this Agreement, the
parties agree that a Derivative Invention (as defined in Section 8.1.4 below)
made by Novartis as to which any substantial use would infringe a Valid Claim
which issues from [...***...]), shall be owned jointly by the parties and
considered a Joint Invention. Gen-Probe waives any and all rights in any such
Derivative Invention to the extent (and only to the extent) that any such
Derivative Invention made by Novartis is used in connection with immunoassays or
protein binding assays, provided however that nothing contained herein shall
constitute a license to Novartis of any rights under [...***...]. Novartis
waives any and all rights in any such Derivative Invention to the extent (and
only to the extent) that such Derivative Invention is used in connection with
nucleic acid hybridization assays. Novartis agrees that Gen-Probe shall have
exclusive rights with respect to such uses. This subsection 8.1.1(e) shall apply
only to claims of the [...***...] when such claims have issued.
               (f) Any party granting a license of a Joint Invention shall
require as a term of the license that the licensee agree to the restrictions set
forth in Sections 8.1.1(b), 8.1.1(c), 8.1.1(d) and 8.1.1(e) and to include such
restrictions in any further licenses or sublicenses.
          8.1.2 Neither Novartis nor Gen-Probe shall have any rights in or to
the patent rights or other intellectual property rights of the other party for
any use or application other than those expressly and specifically granted by
this Agreement.
          8.1.3 The parties acknowledge and agree that, notwithstanding that
only limited rights have been granted hereunder, certain new technology may be
discovered, invented or created solely by Novartis through Novartis’s use of the
Gen-Probe IP Rights within the uses and in the manner contemplated by this
Agreement. The Parties also acknowledge and agree that, notwithstanding that
only limited rights have been granted hereunder, certain new technology may be
discovered, invented or created solely by Gen-Probe through Gen-Probe’s use of
the Novartis IP Rights within the uses and in the manner contemplated by this
Agreement. The rights and obligations of the Parties with respect to all such
new technology shall be governed by this ARTICLE 8.
          8.1.4 As used herein, a “Derivative Invention” shall mean any
Invention made after the date of this Agreement and claimed in a Valid Claim of
the Inventing Party which:
               (a) is discovered, invented or created by a party (the “Inventing
Party”) during any term of this Agreement; and
***Confidential Treatment Requested

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               (b) was made through or with, and would not have been made but
for, the Inventing Party’s use of Confidential Information of the other party
(the “Disclosing Party”), if such information was confidential when the
invention was made.
          8.1.5 Neither party shall use any Derivative Invention in connection
with a Competitive Probe Assay during any term of this Agreement.
          8.1.6 A Disclosing Party shall have the exclusive option to acquire,
on Commercially Reasonable Terms, all right, title and interest in any
Derivative Invention which represents an improvement to, and as to which any
substantial use would infringe a Valid Claim for, that Core Technology of the
Disclosing Party (as defined in Schedule 8.1.6(e) and Schedule 8.7, as
applicable) which was the subject of the Confidential Information through or
with which the Derivative Invention was made and without which it would not have
been made. The option hereby granted the Disclosing Party shall expire six
(6) months after the Derivative Invention is first disclosed to the Disclosing
Party by the Inventing Party unless the Disclosing Party has elected within such
period to exercise such option. With respect to any such Derivative Invention,
following the Disclosing Party’s election to acquire ownership:
               (a) The Disclosing Party may use such Derivative Invention for
all uses and purposes other than those prohibited by Section 8.1.5 and other
than those which would require a license from the Inventing Party under a Valid
Claim (other than a Valid Claim for the Derivative Invention). The Disclosing
Party shall have the right to license the Derivative Invention without the
consent of the Inventing Party, but any such license shall contain the same use
restrictions set forth in the first sentence of this subparagraph (a); and
               (b) the Inventing Party may use such Derivative Invention for
(i) any of the purposes expressly permitted by the terms of this Agreement with
respect to the Confidential Information of the Disclosing Party and (ii) any use
or application which does not require a license of a Valid Claim of the
Disclosing Party, but only to the extent that such use is not made in connection
with any product which competes directly with a nucleic acid probe-based assay
product of the Disclosing Party which has been sold as of the Effective Date of
this Agreement. The Inventing Party shall not have the right to sublicense its
rights hereunder except with the consent of the Disclosing Party, which consent
shall not be unreasonably withheld. In any event, any such sublicense approved
by the Disclosing Party shall contain the same use restrictions set forth in
clauses (i) and (ii) of this subparagraph (b).
               (c) The “Commercially Reasonable Terms” referred to above shall
give full recognition, in favor of the Disclosing Party, to both the value of
the Confidential Information of such Disclosing Party with which the Derivative
Invention was made (and without which the Derivative Invention would not have
been made) and the value of the rights granted to the Inventing Party as to such
Derivative Invention. The “Commercially Reasonable Terms” referred to above
shall also give full recognition, in favor of the Inventing Party, to the value
of the inventive application of such Confidential Information.

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               (d) Notwithstanding any other provision of this Section 8.1.6,
the parties agree that if substantial uses of a Derivative Invention would
infringe a Valid Claim for Core Technology of both parties (as defined in
Schedule 8.1.6(e) and Schedule 8.7, as applicable), then such Derivative
Invention shall be considered as a Joint Invention under Section 8.1.1,
provided, however, that this subsection (d) shall not apply to:
               (i) A Derivative Invention as to which any substantial use would
infringe any Valid Claim to the same or substantially the same subject matter
claimed in the patents and patent applications identified on Schedule 8.7 as
items A1 through A11, A16, B1 through B3, B5 through B6, C1 through C6, or D1;
or
               (ii) A Derivative Invention as to which any substantial use would
infringe any Valid Claim which issues from the patent applications identified on
Schedule 8.7 as items A13 or A15, effective immediately upon issuance or
approval of such claim as to Derivative Inventions made after that date. (Any
license of a Derivative Invention shall include such limitation.)
               (e) The parties agree, solely for purposes of the use restriction
of Sections 8.1.6(a) and (b)(ii) and Sections 8.1.7(a)(i) and 8.1.7(b)(ii), that
the term “Valid Claim” shall not include unissued claims set forth in pending
patent applications pertaining to the Core Technology of the Disclosing Party
identified on Schedule 8.1.6(e) and Schedule 8.7, respectively; provided,
however, that the term “Valid Claim” shall include a claim of such a patent
application immediately upon issuance or approval of the claim and that any
license of a Derivative Invention shall include such limitation. This subsection
(e) shall not apply to exempt from the use restrictions referenced above a
Derivative Invention as to which any substantial use would infringe any Valid
Claim to the same or substantially the same subject matter claimed in the patent
applications identified on Schedule 8.7 as items A9 through A11, B6, C5 or C6.
          8.1.7 An Inventing Party shall own all right, title and interest in
any Derivative Invention which is not subject to Section 8.1.6 or which the
Disclosing Party does not elect to acquire within the six-month period permitted
by Section 8.1.6. With respect to any such Derivative Invention,
               (a) The Inventing Party may use such Derivative Invention for all
uses and purposes other than those prohibited by Section 8.1.5, but only to the
extent that (i) such use does not require a license under a Valid Claim of the
Disclosing Party of further rights to Confidential Information of the Disclosing
Party which was previously disclosed hereunder or (ii) such use is not made in
connection with any product which competes directly with a nucleic acid
probe-based assay product of the Disclosing Party which is sold as of the
Effective Date of this Agreement. The Inventing Party shall have the right to
license the Derivative Invention without the consent of the Disclosing Party,
but any such license shall contain the same use restrictions set forth in the
first sentence of this subparagraph (a); and
               (b) The Disclosing Party may use such Derivative Invention
(i) for any of the purposes expressly permitted by the terms of this Agreement
and (ii) pursuant to the terms of a license granted under Section 8.1.7(c), for
all uses and applications other than those prohibited under Section 8.1.5, which
would not require a license from the Inventing Party under a Valid Claim (other
than a Valid Claim for the Derivative Invention). Upon exercise of the

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option for a license, the Disclosing Party shall not have the right to
sublicense its rights thereunder except with the consent of the Inventing Party,
which consent shall not be unreasonably withheld. In any event, any such
sublicense approved by the Inventing Party shall contain the same use
restrictions set forth in clauses (i) and (ii) of this subparagraph (b).
               (c) Upon request, the Inventing Party shall grant a nonexclusive
license to the Disclosing Party on Commercially Reasonable Terms to be
negotiated to enable the Disclosing Party to use such Derivative Invention for
the purposes described in Section 8.1.7(b)(ii). The “Commercially Reasonable
Terms” referred to above shall give full recognition, in favor of the Disclosing
Party, to the value of the Confidential Information of such Disclosing Party
with which the Derivative Invention was made (and without which the Derivative
Invention would not have been made). The “Commercially Reasonable Terms”
referred to above shall also give full recognition, in favor of the Inventing
Party, to the value of the inventive application of such Confidential
Information.
          8.1.8 Without limiting the generality of Section 8.1.7, each Inventing
Party under Section 8.1.7 agrees not to assert its rights in a Derivative
Invention in such a manner as would block or diminish the Disclosing Party’s
rights to practice independently of the Derivative Invention itself, the
technology of the Disclosing Party directly related to the Confidential
Information with which the Derivative Invention was made and without which the
Derivative Invention would not have been made.
          8.1.9 Gen-Probe and Novartis shall promptly report to each other any
and all Derivative Inventions as each may discover, invent or create during the
Blood Screening Term.
          8.1.10 Gen-Probe and Novartis shall execute and deliver to each other
such assignments, instruments or other documents as each may reasonably consider
necessary to assure compliance with the provisions of this Section 8.1. Novartis
shall have the exclusive right to prosecute and defend any and all patents and
patent applications concerning any Derivative Invention owned by Novartis and,
as between Gen-Probe and Novartis, Novartis shall be solely responsible for the
expense of such patents and patent applications. Gen-Probe shall have the
exclusive right to prosecute and defend any and all proceedings concerning any
Derivative Invention owned by Gen-Probe and, as between Gen-Probe and Novartis,
Gen-Probe shall be solely responsible for the expense of such proceedings. As to
any Derivative Invention assigned to the Disclosing Party upon exercise of the
option described in Section 8.1.6, the Disclosing Party shall take all such
actions as may be reasonably and specifically requested by the Inventing Party
in connection with the prosecution of a patent application to protect the
Inventing Party’s rights in the Derivative Invention under Section 8.1.6(b),
provided that the Inventing Party shall be fully responsible for all incremental
costs and expenses incurred in connection with any such actions. If the
Inventing Party requests any such action, the parties shall thereafter
reasonably cooperate in the prosecution of such patent application.
          8.1.11 In the event the Parties cannot agree as to the classification
of any technology for any purpose under this ARTICLE 8 (including the mediation
described in Section 11.1), the Parties shall consider in good faith the
possibility of submitting such disputes for accelerated decision by an expert
arbitration under such guidelines and expedited schedule as may be mutually
agreed (provided that no party shall be under an obligation to so agree). In the

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absence of such mutual agreement, such disagreement or dispute as to
classification shall be resolved by arbitration as provided in this Agreement,
except that the arbitrator may, at the request of either party, appoint one or
more experts, individually or jointly, to advise and report on such
classification, and the arbitrator shall place such reliance on such advice or
report as he or she deems appropriate.
          8.1.12 Nothing in this Agreement shall be interpreted as giving a
party the right to analyze, dissect, or disassemble any instrument, reagent,
component, object, software or other property of the other party provided under
the terms of this Agreement, and which is not properly available from other
sources which have the right to transfer such property and authorize such
activity, in order to circumvent the need for a license of the technology
reflected therein.
     8.2 Patent Rights. Except as provided in Section 8.1.10, each party shall
be responsible for and shall control, at its sole expense, the preparation,
filing, prosecution, maintenance and enforcement of all patent rights owned by
or licensed to it (except for those patent rights licensed to it from the other
party) which are the subject of this Agreement. The parties shall jointly have
the right to prepare, file, prosecute, maintain, and enforce patent rights
covering Joint Inventions as described in Section 8.1.1 and the expenses thereof
shall be reasonably shared by parties as they may agree prior to the initiation
of any such proceedings. Each party shall cooperate with the other party,
execute all lawful papers and instruments and make all rightful oaths and
declarations, as reasonably requested by the other party and at the other
party’s expense, as may be necessary in connection with the preparation,
prosecution, maintenance and enforcement of all patent rights which are the
subject of this Agreement. Each party shall place appropriate patent markings on
all products which would infringe the patent rights of the other party licensed
under this Agreement, to the extent such patent marking is required by
applicable law, regulation or order to enable the other party to enforce such
patent rights, all as requested in writing by the other party.
     8.3 Copyrights.
          8.3.1 Gen-Probe Copyrights and Novartis Copyrights. Each party hereby
acknowledges that the other party has claimed, or may claim, copyright
protection with respect to certain parts of the Products and related materials.
Each party further acknowledges the validity of the other party’s right to claim
copyright protection with respect to such items. Each party shall take no action
or make no omission which is in any way inconsistent with the other party’s
claim of copyright protection with respect to such items.
          8.3.2 Copyright Protection. In order to protect against infringement
of the other party’s copyrights, each party shall mark all of the other party’s
copyrighted materials, as requested by the other party in writing, used by such
party in conducting its activities contemplated by this Agreement with
appropriate copyright markings. Each party shall cooperate with the other party,
take such actions and execute such documents, as reasonably requested by the
other party and at the other party’s expense, to assist the other party in the
protection of the other party’s copyrights. Any dispute as to which party owns a
copyright will be resolved pursuant to ARTICLE 11.

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     8.4 Trademarks.
          8.4.1 Gen-Probe Marks and Novartis Marks. Gen-Probe shall own the
Gen-Probe Marks and shall pay all expenses of the registration thereof. Novartis
shall own the Novartis Marks and shall pay all expenses of the registration
thereof. Except as otherwise expressly set forth in this Agreement, each party
shall not use, without the prior express written consent of the other party, any
of the other party’s marks (i.e., the Gen-Probe Marks or the Novartis Marks, as
applicable), or any word, title, expression, trademark, design or marking that
is confusingly similar thereto. Subject to Section 5.5, each party shall not
alter, remove, cover or modify any of the other party’s marks (i.e., the
Gen-Probe Marks or the Novartis Marks, as applicable) from the Products, their
packaging or labeling without the other party’s prior express written consent.
Gen-Probe shall control, at its sole cost, the registration, prosecution,
maintenance and enforcement of the Gen-Probe Marks. Novartis shall control, at
its sole cost, the registration, prosecution, maintenance and enforcement of the
Novartis Marks.
     8.5 Other Technology Rights. Except as otherwise expressly provided in this
Agreement, under no circumstances shall a party, as a result of this Agreement,
obtain any ownership interest or other right in any discovery, invention or
other technology, data or information (or any patent, copyright, trademark, or
other intellectual property rights therein) of the other party, including items
transferred by the other party to such party at any time pursuant to this
Agreement. Except as expressly provided in this Agreement, neither party shall
be under any obligation to grant to the other party any rights in any patent,
copyright, trademark, or other intellectual property.
     8.6 Third Party Technology. The Supervisory Board will discuss Third Party
patent rights which may be necessary for (i) Blood Screening Assays or
(ii) modifications to Blood Screening Assays or Blood Screening Instruments. The
Supervisory Board will consider the costs of acquiring rights in such Third
Party patent rights in connection with such Products, allocate the costs between
the parties, and agree upon methods for implementing such cost allocations.
Pursuant to the foregoing and subject to the conditions of Section 6.2, the
parties agree to share the payment obligation of Novartis and Gen-Probe for the
license of HIV-1 intellectual property rights owned by the National Institutes
of Health and Institut Pasteur as follows: Novartis will pay two-thirds of the
obligation and Gen-Probe shall pay one-third of the obligation. Gen-Probe shall
make all payments due hereunder to Novartis.
     8.7 Stanford Agreement. The patent rights designated as “Selective
Amplification”, U.S. Patent No. 5,437,990 (Item A.2 on Schedule 8.7) Application
No. 080,479 with a filing date of July 31, 1987 are sublicensed to Novartis by
Gen-Probe under the terms of a co-exclusive license agreement (the “Stanford
Agreement”) effective April 27, 1997 between Gen-Probe and The Board of Trustees
of the Leland Stanford Junior University, Palo Alto, California (“Stanford”).
Under the terms of the Stanford Agreement, certain provisions as set forth in
Schedule 8.9 attached hereto are incorporated into this Agreement by reference.

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     8.8 Teknika Agreement. Gen-Probe is a party to a non-assertion agreement
effective February 7, 1997 (the “Teknika Agreement”) with Organon Teknika B.V.,
having a place of business at Boseind 15, 5281 RM Boxtel, The Netherlands
(“Teknika”), which agreement grants certain rights and imposes certain
conditions with respect to the transcription-based amplification patent rights
set forth in Schedule 8.7. Novartis agrees, at the request of Teknika, to permit
and to cooperate fully with an annual review of its manufacturing records (and
such other records as may be required) by an impartial, technically qualified
third party to verify compliance with the provisions of Section 3.3 of the
Teknika Agreement. Selection of such third party shall be subject to the
approval of Novartis, such approval to be not unreasonably withheld. The results
of such a review as provided to Teknika will consist solely of a finding of
compliance or non-compliance. The cost of such review shall be born by Teknika
and shall not be unreasonably burdensome for Novartis.
     8.9 Continuation of Rights. In the event the Stanford Agreement or Teknika
Agreement is terminated for any reason, the rights under such agreements which
are granted by Gen-Probe to Novartis under this Agreement, as applicable, may be
continued with Stanford and/or Teknika, as applicable, provided that certain
conditions precedent, as set forth in Schedule 8.9, shall have been fulfilled.
ARTICLE 9
INDEMNIFICATION AND INSURANCE
     9.1 Indemnity.
          9.1.1 By Gen-Probe. Gen-Probe shall indemnify and hold Novartis
harmless from and against all losses, liabilities, damages and expenses
(including reasonable attorneys’ fees and costs) resulting from any claims,
demands, actions or other proceedings by any Third Party arising from (a) the
breach of any representation, warranty or covenant by Gen-Probe under this
Agreement, (b) the failure of Gen-Probe or its subcontractor to manufacture the
Products in conformity with the specifications therefor, (c) the negligence or
willful misconduct of Gen-Probe in performing its obligations under this
Agreement; or (d) the manufacture, sale, or use of any instrument or assay sold
by or on behalf of Gen-Probe, its Third Party licensees, or any of their
Affiliates, or distributors (other than by Gen-Probe to Novartis under the terms
of this Agreement); in each case except to the extent arising from the
negligence or willful misconduct of Novartis.
          9.1.2 By Novartis. Novartis shall indemnify and hold Gen-Probe
harmless from and against all losses, liabilities, damages and expenses
(including reasonable attorneys’ fees and costs) resulting from any claims,
demands, actions or other proceedings by any Third Party arising from (a) the
breach of any representation, warranty or covenant by Novartis under this
Agreement, (b) the failure of Novartis or its subcontractor to manufacture the
Products in conformity with the specifications therefor, in the event Novartis
has assumed responsibility for the manufacture of such Products, (c) the
negligence or willful misconduct of Novartis in performing its obligations under
this Agreement; or (d) except to the extent Section 9.1.1 applies, the
manufacture, sale, or use of any instrument or assay sold by or on behalf of
Novartis, or its

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Affiliates, or distributors; except in each case to the extent arising from the
negligence or willful misconduct of Gen-Probe.
     9.2 Procedure. A party (the “Indemnitee”) that intends to claim
indemnification under this ARTICLE 9 shall promptly notify the other party (the
“Indemnitor”) of any claim, demand, action or other proceeding for which the
Indemnitee intends to claim such indemnification. The Indemnitor shall have the
right to participate in, and, to the extent the Indemnitor so desires, jointly
with any other indemnitor similarly noticed, to assume the defense thereof with
counsel selected by the Indemnitor; provided, however, that the Indemnitee shall
have the right to retain its own counsel, with the reasonable fees and expenses
to be paid by the Indemnitee, if the Indemnitee reasonably determines that
representation of the Indemnitee by counsel retained by the Indemnitor would be
inappropriate due to actual or potential differing interests between the
Indemnitee and any other party represented by such counsel in such proceedings.
The indemnity obligations under this ARTICLE 9 shall not apply to amounts paid
in settlement of any claim, demand, action or other proceeding if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be unreasonably withheld or delayed. The failure to deliver notice to
the Indemnitor within a reasonable time after the commencement of any such
action or other proceeding, if prejudicial to its ability to defend such action
or other proceeding, shall relieve such Indemnitor of any liability to the
Indemnitee under this ARTICLE 9, but the omission so to deliver notice to the
Indemnitor will not relieve it of any liability that it may have to any
Indemnitee otherwise than under this ARTICLE 9. The Indemnitor may not settle,
or otherwise consent to an adverse judgment in, any such action or other
proceeding that diminishes the rights or interests of the Indemnitee without the
express written consent of the Indemnitee. The Indemnitee, its employees and
agents, shall cooperate fully with the Indemnitor and its legal representatives
in the investigation of any claim, demand, action or other proceeding covered by
this indemnification.
     9.3 Insurance. Each party shall maintain liability insurance (including
product liability insurance) with respect to conduct of its obligations under
this Agreement in such amounts as it customarily maintains with respect to the
conduct of its similar activities. Each party shall maintain such insurance for
so long as each continues to conduct such obligations, and thereafter for so
long as it maintains insurance for itself covering its similar activities.
ARTICLE 10
TERM AND TERMINATION
     10.1 Expiration. Unless terminated earlier pursuant to Section 10.2 below,
this Agreement shall expire on the expiration of the Blood Screening Term.
     10.2 Termination.
          10.2.1 Breach. Each party may terminate this Agreement upon or after
the material breach of any material provision of this Agreement, if the
breaching party has not cured such breach within ninety (90) days after notice
thereof from the non-breaching party.

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               (a) Any dispute with respect to the right of a party to terminate
all or a portion of this Agreement pursuant to this Section 10.2.1 shall be
subject to resolution pursuant to ARTICLE 11. During the pendency of any
arbitration proceeding, at the request of the non-breaching party, the
arbitrator may take such interim steps and make such preliminary orders as the
arbitrator deems necessary to preserve the rights of the non-breaching party
pending a final arbitration award, including ordering the grant, on a temporary
basis, of such licenses or rights as may be necessary to enable the
non-breaching party to preserve its economic interest in the Products for the
Blood Screening Field. At the conclusion of any such arbitration if the
arbitrator determines that the respondent materially breached this Agreement and
that money damages will not adequately compensate the claimant and that no other
remedy is adequate in the circumstances considered as a whole, then the
arbitrator may order the breaching party to grant to the non-breaching party
such rights (including a nonexclusive, worldwide license, bearing a reasonable
commercial royalty, under intellectual property rights of the breaching party
which are the subject of this Agreement) as may be reasonably necessary to
enable the claimant to complete development already in progress of, make, use,
offer for sale, sell and/or import Products for use in the Blood Screening Field
for the lesser of (a) five years or (b) the then-remaining period of this
Agreement.
          10.2.2 Voluntary Bankruptcy. Each party may terminate this Agreement
if the other party shall (a) seek the liquidation, dissolution, or winding up of
itself (other than dissolution or winding up for the purposes of reconstruction
or amalgamation) or the composition or readjustment of all or substantially all
of its debts, (b) apply for or consent to the appointment of, or the taking of
possession by, a receiver, custodian, trustee or liquidator of itself or of all
or substantially all of its assets, (c) make a general assignment for the
benefit of its creditors, (d) commence a voluntary case under the Bankruptcy
Code, (e) file a petition seeking to take advantage of any other law relating to
bankruptcy, insolvency, reorganization, winding-up or composition or
readjustment of debts, or (f) adopt any resolution of its Board of Directors or
stockholders for the purpose of effecting any of the foregoing.
          10.2.3 Involuntary Bankruptcy. Each party may terminate this Agreement
if a proceeding or case shall be commenced without the application or consent of
the other party and such proceeding or case shall continue undismissed, or an
order, judgment or decree approving or ordering any of the following shall be
entered and continue unstayed in effect, for a period of ninety (90) days from
and after the date service of process is effected upon the other party, seeking
(a) its liquidation, reorganization, dissolution or winding up, or the
composition or readjustment of all or substantially all of its debts, (b) the
appointment of a trustee, receiver, custodian, liquidator or the like of itself
or of all or substantially all of its assets, or (c) similar relief under any
law relating to bankruptcy, insolvency, reorganization, winding up or
composition or readjustment of debts.
     10.3 Effect of Expiration and Termination. Except as provided in
Section 10.2.1(a), upon expiration or termination of this Agreement, all rights
and licenses granted hereunder shall terminate. Expiration or termination of
this Agreement shall not relieve the parties of any obligation accruing prior to
such expiration or termination. The provisions of Section 2.2 (disclaimer of
warranties),Section 5.7 (product warranties), Section 6.6 (audit of payments),
Article 7 (confidentiality), Section 8.1 (ownership of inventions), the third
sentence of Section 8.2 (duty to cooperate with patent filings), Section 8.5
(other technology rights), Article 9

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(insurance and indemnification), Section 10.3 (effect of expiration and
termination), Article 11 (arbitration), and Article 12 (miscellaneous) shall
survive the expiration or termination of this Agreement.
ARTICLE 11
ARBITRATION
     11.1 Executive Mediation. Prior to submitting any dispute arising out of or
related to this Agreement to arbitration pursuant to Section 11.2, the matter
shall be submitted to the Chief Executive Officers of the parties for
resolution. If such officers are unable to resolve the matter directly, they
may, by mutual agreement, utilize such dispute resolution methods, including
mediation, as are mutually agreed. If no resolution is reached within fifteen
(15) days following submission of such dispute to such officers, unless
otherwise mutually agreed, the dispute shall be submitted to arbitration
pursuant to Section 11.2.
     11.2 Arbitration Procedure. Any controversy or claim relating to, arising
out of, or in any way connected to any provision of this Agreement shall be
finally resolved by final and binding arbitration in accordance with this
Section by a single arbitrator who is a former state or federal judge, to be
conducted in California. Unless the parties agree otherwise, the arbitration
shall be conducted by JAMS, or by any similar arbitration provider who can
provide a former judge to conduct such arbitration if JAMS is no longer in
existence. JAMS may order a change of venue upon a showing of good cause by
respondent. Subject to the JAMS Appeal Procedure described in Section 11.3
below, the decision of the arbitrator shall be final, nonappealable and binding
upon the parties, and it may be entered in any court of competent jurisdiction.
The arbitrator shall be bound by all rules relating to the admissibility of
evidence, including without limitation, all relevant privileges and the attorney
work product doctrine. Discovery shall be permitted in accordance with the rules
and procedures of the forum state unless otherwise agreed to by the parties or
ordered by the arbitrator on the basis of strict necessity adequately
demonstrated by the party requesting an extension of time. The arbitrator shall
have the power to grant equitable relief where applicable under the law. The
arbitrator shall issue a written opinion setting forth his or her decision and
the reasons therefor within thirty (30) days after the arbitration proceeding is
concluded. The obligation of the parties to submit any dispute arising under or
related to this Agreement to arbitration as provided in this ARTICLE 11 shall
survive the expiration or earlier termination of this Agreement. Notwithstanding
the foregoing, but subject to Section 10.2.1(a), either party may seek and
obtain an injunction or other appropriate relief from a court to preserve or
protect intellectual property rights or to preserve the status quo with respect
to any matter pending conclusion of the arbitration proceeding, but no such
application to a court shall in any way be permitted to stay or otherwise impede
the process of the arbitration proceeding.
     11.3 Review. The decision of the arbitrator shall be subject to review only
in accordance with the JAMS “Optional Appeal Procedure” in effect upon execution
of this Agreement or any other comparable arbitration appeal procedure. The
parties agree to submit any request for review in accordance with said
procedure. The JAMS Appeal Panel appointed under said procedure will apply the
same standard of review as the first-level appellate court in the jurisdiction
where the arbitration was conducted would apply under similar circumstances.

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The decision and award of the JAMS Appeal Panel (and the decision and award of
the original arbitrator if there is no appeal pursuant to this Section 11.3)
will be final for all purposes and binding upon the parties, and it may be
entered in any court of competent jurisdiction.
ARTICLE 12
MISCELLANEOUS
     12.1 Notices. 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, addressed to such other party at its address indicated below, or to
such other address as the addressee shall have last furnished in writing to the
addressor, and shall be effective upon receipt by the addressee.

         
     If to Gen-Probe:
  Gen-Probe Incorporated
 
      10210 Genetic Center Drive
 
      San Diego, California 92121
 
      Attention: President and
 
      Chief Executive Officer
 
       
     If to Novartis:
  Novartis Vaccines and Diagnostics, Inc.
 
      4560 Horton Street
 
      Emeryville, California 94608
 
      Attention: President, Diagnostics

     12.2 Force Majeure. In the event that a party is prevented or delayed from
fulfilling or performing any of its obligations under this Agreement (other than
an obligation to pay money) due to the occurrence of causes beyond the
reasonable control of such party, including but not limited to fires, floods,
embargoes, wars, acts of war (whether war is declared or not), insurrections,
riots, civil commotions, strikes, lockouts or other labor disturbances, acts of
God or acts, omissions or delays in acting by any governmental authority or the
other party, then such party’s performance shall be excused, and the time for
performance shall be extended, for the period of inability or delay due to such
occurrence; provided, however, that such party shall have used its Commercially
Reasonable Efforts to avoid such inability or delay, and such party shall have
given prompt written notice to the other party of such occurrence. Nothing
contained in this section shall limit Novartis’s right to manufacture or have
manufactured any Product pursuant to the terms of this Agreement, provided
always that in the event of a force majeure, Novartis and Gen-Probe shall apply
all legally-available safety stocks to meet Novartis’s need before such right to
manufacture or have manufactured shall accrue and further provided that Novartis
shall not exercise such right in the event of a force majeure unless the
Supervisory Board has met and discussed all available options and reasonably not
been able to agree that re-establishment of production at a Gen-Probe facility
is the most efficient alternative for maintaining continuity of production.

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     12.3 Assignment.
          12.3.1 This Agreement may not be directly or indirectly assigned or
otherwise transferred, nor, except as expressly provided hereunder, may any
rights or obligations hereunder be assigned or transferred by either party
(whether voluntarily, by operation of law or otherwise) without the consent of
the other party which shall not be unreasonably withheld; provided, however,
that, except as otherwise provided in Section 12.3.2 below, either party may,
without such consent, assign or transfer this Agreement and its rights and
obligations hereunder in connection with the transfer or sale of all or
substantially all of its assets (including without limitation all of its assets
relating to this Agreement), or in the event of its merger, consolidation, other
Change in Control or similar transaction. Any permitted assignee or transferee
shall assume all obligations of its assignor or transferor under this Agreement.
On any such assignment, the assignor shall be relieved of all obligations
assigned hereunder, except those accrued prior to the date of assignment and
except as provided in Section 12.3.2 below. Any purported assignment or transfer
in violation of this Section 12.3 shall be void.
          12.3.2 Assignment by a party of its rights and obligations under this
Agreement shall not relieve that party of its obligations under ARTICLE 7,
ARTICLE 8, or ARTICLE 11. Assignment by a party of its rights and obligations
under this Agreement shall not relieve it of its obligations under Section 3.2.1
or any then-existing restrictions on licensing of intellectual property
pertaining to specific viruses or markers as to which such party became
obligated, prior to such assignment, pursuant to the last sentence of
Section 3.2.2 and if following such assignment such transferring party makes,
uses or sells any nucleic acid probe-based assay for use in the Blood Screening
Field for the detection or quantitation of any virus or marker subject to
Section 3.2.1 or such licensing restrictions of Section 3.2.2, such use shall be
considered as a “license” for purposes of Section 3.2.1 or such licensing
restrictions of Section 3.2.2; however a license to the assignee pursuant to
Section 12.3.1 shall not be considered a license for purposes of Section 3.2.1
or such licensing restrictions of Section 3.2.2.
          12.3.3 Gen-Probe hereby acknowledges that it has given its consent to
Novartis’s assignment of its rights under this Agreement with respect to the
Products for the Blood Screening Field to any transferee, other than the parties
identified in this Section, provided that such transferee is reasonably capable
of performing all of Novartis’s obligations in connection therewith and provided
that such transferee receives a license from Novartis of the Novartis IP Rights
as reasonably necessary to perform all obligations of Novartis in connection
therewith. Novartis shall have no right to directly or indirectly assign or
otherwise transfer its rights and obligations with respect to the Products
(whether voluntarily, by operation of law or otherwise) to any of the following
(or their respective Affiliates): Abbott Laboratories, Inc.; Roche Diagnostic
Systems, Inc.; or Becton, Dickinson and Company. The rights granted in this
Section 12.3.3 are personal to Novartis and shall not be assignable.
     12.4 Severability. Each party hereby acknowledges that it does not intend
to violate any public policy, statutory or common laws, rules, regulations,
treaty or decision of any government agency or executive body thereof of any
country or community or association of countries. Should one or more provisions
of this Agreement be or become invalid, the parties shall substitute, by mutual
consent, valid provisions for such invalid provisions, which valid provisions in
their economic effect are sufficiently similar to the invalid provisions that it
can be

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reasonably assumed that the parties would have entered into this Agreement with
such provisions. In case such provisions cannot be agreed upon, the invalidity
of one or several provisions of this Agreement shall not affect the validity of
this Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
parties would not have entered into this Agreement without the invalid
provisions.
     12.5 Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard to the
conflicts of law principles thereof.
     12.6 Entire Agreement. Except as set forth herein, this Agreement contains
the entire understanding of the parties with respect to the subject matter
hereof as of the Effective Date. Nothing contained in this Section shall affect
other agreements between the parties which are not directly related to the
subject matter of this agreement.
          12.6.1 Except as set forth herein, as of the Effective Date, Gen-Probe
and Novartis agree to prospectively terminate and hereby terminate (i) the 1998
Agreement, and (ii) all amendments, supplemental agreements, side letter
agreements, settlement agreements and addenda relating thereto (together with
the 1998 Agreement, the “Prior Agreements”), and further prospectively terminate
and hereby discharge any and all executory obligations thereunder, regardless of
whether the Prior Agreements provide that any such obligations shall survive
termination. Gen-Probe and Novartis further agree that any and all action(s),
cause(s) of action, suits, debts, liability, claims, demands, damages, losses,
costs or expenses, of any nature whatsoever, known or unknown, fixed or
contingent (“Claims”) accruing after the Effective Date, arising out of, based
upon, or relating to this Agreement, and not expressly released by the Prior
Agreements, shall be brought solely under the terms and conditions of this
Agreement.
          12.6.2 Notwithstanding Section 12.6.1, the following agreements are
not terminated and survive the execution of this Agreement and shall not be
merged and integrated with this Agreement, provided that all references in the
following agreements to the 1998 Agreement (or any other Prior Agreement) shall,
mutatis mutandis, be deemed to be references to this Agreement:
(a) The Confidentiality and Joint Interest Agreement dated October 30, 2001;
(b) The Addendum for the Development of Special Software for the Tecan EVO
Instrument, effective January 1, 2008;
(c) The Future Blood Screening Assay — Ultrio 2 Addendum, dated October 1, 2008;
(d) The Confidentiality and Joint Interest Agreement dated February 4, 2009;
(e) The Quality Agreement for Alliance Partnership, dated May 28, 2009;

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(f) The Regulatory Affairs Roles and Responsibilities Agreement, dated May 2008;
and
(g) The specific provisions of Amendment No. 11 to the 1998 Agreement which
directly concern the Panther Instrument, which provisions shall survive until
such time as the new product development addendum for the Panther Instrument is
signed by the Parties.
          12.6.3 Gen-Probe and Novartis hereby agree that any and all Claims
accruing prior to the Effective Date and arising out of, based upon, or relating
to the Prior Agreements (whether discovered prior to or after the Effective Date
of this Agreement), shall survive the execution of this Agreement and shall be
brought under the terms and conditions of the Prior Agreements.
          12.6.4 Notwithstanding Section 12.6.1, the execution of this Agreement
shall in no way affect any rights and obligations under the Prior Agreements
with respect to the Clinical Diagnostic Assays, Clinical Diagnostic Instruments,
and the Clinical Diagnostic Field (as such terms are defined in the 1998
Agreement), which rights and obligations shall be wholly unaffected by this
Agreement, as between Gen-Probe and Bayer Corporation (as the successor to such
rights and obligations).
     12.7 Amendment. This Agreement may be amended, or any term hereof modified,
only by a written instrument duly executed by both parties.
     12.8 Expenses and Attorney’s Fees. The prevailing party in any dispute
between the parties which is the subject of arbitration or litigation shall be
entitled to recover the expenses reasonably incurred in connection with such
arbitration or litigation, including reasonable attorney’s fees. The amount of
such expenses and fees due the prevailing party shall be subject to the
arbitration provisions of ARTICLE 11.
     12.9 Independent Contractors. It is expressly agreed that Gen-Probe and
Novartis shall be independent contractors and that the relationship between the
two parties shall not constitute a partnership, joint venture or agency. Neither
Gen-Probe nor Novartis shall have the authority to make any statements,
representations 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.
     12.10 Waiver. The waiver by either party of any right hereunder or the
failure to perform or of a breach by the other party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
     12.11 Drafting Party. The provisions of this Agreement, and the documents
and instruments referred to in the Agreement, have been prepared, examined,
negotiated and revised by each party and their respective lawyers, and no
implication will be drawn and no provision will be construed against any party
by virtue of the purported identity of the drafter of this Agreement, or any
portion of this Agreement.

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     12.12 Third Parties. None of the provisions of this Agreement shall be for
the benefit of or enforceable by any Third Party.
     12.13 Affiliates. The rights and obligations of Novartis under this
Agreement shall apply to Novartis’s Affiliates, and the rights and obligations
of Gen-Probe under this Agreement shall apply to Gen-Probe’s Affiliates,
provided that Novartis and Gen-Probe shall be fully responsible for the
performance by their respective Affiliates of their respective obligations under
this Agreement.
     12.14 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
     IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first set forth above.

              GEN-PROBE INCORPORATED   NOVARTIS VACCINES AND DIAGNOSTICS, INC.
 
           
By
  /s/ Carl W. Hull   By   /s/ Peter Maag
 
           
 
       Carl W. Hull            Peter Maag
 
       President & CEO            President, Diagnostics
 
       July 24, 2009            July 24, 2009

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Schedule 1.51
Transcription-Based Amplification Versions
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

2

--------------------------------------------------------------------------------

 

Schedule 3.1.6
Licensed Manufacturers
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

Schedule 5.3.1(a)
Labeling Requirements
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

Schedule 5.3.3
Sample Purchase Order
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

2

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

3

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

2

--------------------------------------------------------------------------------

 

Schedule 6.1.2(e)
Reimbursement of Development Costs for FEP and RAS Components of eSAS2
Instrument
[...***...]
***Confidential Treatment Requested

3

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

4

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

5

--------------------------------------------------------------------------------

 

Schedule 8.1.6(e)
Novartis Corporation Core Technologies
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

2

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

3

--------------------------------------------------------------------------------

 

Schedule 8.7
Gen-Probe Incorporated Core Technologies
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

2

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

3

--------------------------------------------------------------------------------

 

Schedule 8.9
Additional Clauses Relating to the Stanford Agreement and the Teknika Agreement
[...***...]
***Confidential Treatment Requested

1

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

2

--------------------------------------------------------------------------------

 

[...***...]
***Confidential Treatment Requested

3