exv10w103






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.




RESTATED AGREEMENT




between



GEN-PROBE INCORPORATED



and



NOVARTIS VACCINES AND DIAGNOSTICS, INC.



Dated as of July 24, 2009



 









 





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.



1









 





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






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          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).



3









 





     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.



4









 





     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.



5









 





     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



6









 




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.



7









 





     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.





8









 








     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.



9









 





     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




10









 





     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




          
11









 









          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,



14









 




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



15









 




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.



17









 





          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





18









 







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



19









 







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.



20









 





               (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.



23









 





               (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




24









 







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




25









 





          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.



28









 






               (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



29









 







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



30









 




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



31









 







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



32









 







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



35









 







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



36









 







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.



37









 





          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



38









 







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.



39









 




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



40









 




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.




41









 








     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.



42









 





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



43









 







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)



44









 




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 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.



          6.2.1 The terms of a proposed agreement between the U.S. National Institutes of Health (“NIH”)
and Novartis (the “NIH-Novartis Agreement”) will require payments to NIH for the sale of Blood
Screening Assays not to exceed the following:




               (a) Five annual payments of [...***...], beginning in the first quarter of [...***...],
increasing in amount to [...***...] annually if and when [...***...]; and



               (b) A sales royalty of [...***...] percent [...***...] beginning upon the earlier of (i)
[...***...] or (ii) [...***...].



          6.2.2 [...***...].




               (a) [...***...]:



                    (i) [...***...];



                    (ii) [...***...];



                    (iii) [...***...]



***Confidential Treatment Requested




45









 





                    (iv) [...***...]



               (b) [...***...]



          6.2.3 Novartis and Gen-Probe will work together and will use their best efforts to minimize
the aggregate payments to NIH and Institut Pasteur. Novartis will invoice Gen-Probe for any amount
properly due to Novartis as Gen-Probe’s share of a payment made by Novartis under the NIH-Novartis
Agreement. If not paid within thirty (30) days of the date the invoice is delivered to Gen-Probe,
Novartis may immediately deduct from payments due Gen-Probe under this Agreement the amount due
Novartis. [...***...] At least annually, the parties will retrospectively “true-up” their
obligations under the agreements with [...***...] to be consistent with the parties’ agreement to
share such obligations two-thirds by Novartis and one-third by Gen-Probe, subject to all provisions
of this Agreement, including all limitations of the immediately preceding sentence.




     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




46









 




               (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.




47









 





     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,



48









 







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.




49









 





               (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




50









 




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




51









 





               (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.



52









 





               (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



53









 




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




54









 




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.







55









 








     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.



56









 





     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



57









 






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



59









 







(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



62









 




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;



63









 






(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.



64









 





     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
 

Carl W. Hull
	 	By
	 	/s/ Peter Maag
 

Peter Maag
	 	 
	 

	 	President & CEO
	 	 	 	President, Diagnostics	 	 
	 

	 	July 24, 2009
	 	 	 	July 24, 2009	 	 






65









 





Schedule 1.51




Transcription-Based Amplification Versions



     “GEN-PROBE Version” shall mean transcription-based nucleic acid amplification using reverse
transcriptase, RNA polymerase and [...***...] wherein



     (a) the reverse transcriptase and RNase H activities are provided by a [...***...]



     (b) said protein has a minimal reverse transcriptase activity of [...***...] (where the unit
definition and assay conditions are equivalent to those set forth below); and



     (c) the amplification reaction is performed at [...***...]



     “TEKNIKA Version” shall mean transcription-based nucleic acid amplification using reverse
transcriptase, RNA polymerase and [...***...] wherein



     (a) [...***...]



     (b) [...***...] and



     (c) the amplification reaction is performed at [...***...]


ENZYME ASSAYS



[...***...]



[...***...]






***Confidential Treatment Requested






1









 







[...***...]



[...***...]



[...***...]



Equivalent unit definitions and assay conditions may be substituted as long as they produce results
that may be quantitatively converted by established valid procedures (e.g., multiplication by a
conversion factor or by reference to a standard curve) to the assay conditions and unit definitions
set forth above.



For example, [...***...]



Data supporting equivalence of any substitutions must be made available for inspection as set forth
in this Agreement.



***Confidential Treatment Requested




2









 





Schedule 3.1.6




Licensed Manufacturers



	 	 	 	 	 	 	 
	 	 	Legal	 	Location of	 	 
	Product	 	Manufacturer	 	Manufacture	 	Current Document
	PROCLEIX®

OptivaTM Reagent 

Addition Station (RAS)

	 	Chiron Corporation
	 	Stratec Biomedical

Systems

Germany
	 	CFG, FDA 510(k)
Clearance, EIR
(Chiron), ISO 13485
(Chiron), ISO
9001:2000 (Chiron),
Declaration of
Conformity
	 
	 	 	 	 	 	 
	PROCLEIX®

OptivaTM Front End 

Pipetter (FEP)

	 	Gen Probe Incorp

Incorporated
	 	Stratec Biomedical

Systems

Germany
	 	Certificate of
Exportability, EIR
(Gen-Probe), ISO
13485 (Gen- Probe),
ISO 9001:2000
(Chiron),Declaration
of Conformity
	 
	 	 	 	 	 	 
	PROCLEIX®

TIGRIS®

System

	 	Gen-Probe Incorporated
	 	KMC Systems
Incorporated U.S.A.
	 	Certificate of
Exportability, ER
(Gen-Probe), ISO
13485 (Gen- Probe),
ISO 9001:2000
(Chiron),
Declaration of
Conformity
	 
	 	 	 	 	 	 
	PROCLEIX®

Reagent Preparation 

Incubator

	 	Gen-Probe

Incorporated
	 	Barnstead/ Lab- Line
U.S.A.
	 	Certificate of
Exportability, EIR
(Gen-Probe), ISO
13485 (Gen- Probe),
ISO 9001:2000
(Chiron),
Declaration of
Conformity
	 
	 	 	 	 	 	 
	PROCLEIX® System

	 	Gen-Probe

Incorporated
	 	 	 	 
	 
	 	 	 	 	 	 
	Target Capture
System

	 	Gen Probe Incorporated	 	 	 	CFG, FDA
510(k) Clearance,
EIR (Gen-Probe),
ISO 13485 (Gen-
Probe), ISO
9001:2000 (Chiron),
Declaration of
Conformity
	 
	 	 	 	 	 	 
	HC+ Luminometer

	 	Gen-Probe

Incorporated
	 	MGM Instruments
Incorporated
U.S.A.	 	 
	 
	 	 	 	 	 	 
	TECAN GENESIS RSP 150/8

	 	Gen-Probe Incorporated
	 	TECAN AG Switzerland	 	 
	 
	 	 	 	 	 	 
	Panther

	 	Expected to be
Gen-Probe Incorporated
	 	Stratec
Biomedical Systems

Germany
	 	TBD






1









 





Schedule 5.3.1(a)




Labeling Requirements



	 	 	 	 	 
	Part Number	 	Description	 	Label Options
	301034

	 	PROFICIENCY PANELS
	 	IVD
	301030

	 	5000T KIT DOMESTIC
	 	IVD
	301031

	 	1000T KIT DOMESTIC
	 	IVD
	301027

	 	TMA FLUIDS DOMESTIC
	 	IVD
	301026

	 	DISCRIMINATORY KIT DOMESTIC
	 	IVD
	301036

	 	CALIBRATORS DOMESTIC
	 	IVD
	301038

	 	AUTO DETECT DOMESTIC
	 	IVD
	301035

	 	CONTROL SET DOMESTIC
	 	IVD
	301030E

	 	5000T KIT EXPORT
	 	IVD
	301031E

	 	1000T KIT EXPORT
	 	IVD
	301026E

	 	DISCRIMINATORY KIT EXPORT
	 	IVD
	301036E

	 	CALIBRATORS EXPORT
	 	IVD
	301035E

	 	CONTROL SET EXPORT
	 	IVD
	TU0018

	 	TTU (1000 Tests) SAS	 	 
	TU0022

	 	TTU (1000 Tests) eSAS	 	 
	104578

	 	TTC (1000 Tests)	 	 
	102085

	 	Sealing Cards	 	 






1









 





Schedule 5.3.3




Sample Purchase Order


[...***...]





***Confidential Treatment Requested






1









 







[...***...]






***Confidential Treatment Requested






2









 







[...***...]





***Confidential Treatment Requested






3









 







[...***...]





***Confidential Treatment Requested







4









 








Schedule 6.1.2(e)




Reimbursement of Development Costs for FEP and RAS Components of eSAS2 Instrument



     (a) [Definitions.



          (i) Revenues from the FEP Component and RAS Component. As used in this Schedule
6.1.2(e), “revenues from the PEP Component and RAS Component” for a fiscal quarter shall mean all
amounts received by a Party or a Party’s Affiliates for the sale, transfer, placement, lease or
other disposition of the FEP Component and RAS Component during such fiscal quarter; provided,
however, that:




     (A) Revenues for Collaboration Combination Products. If a PEP Component or RAS
Component is sold in combination with one or more non-FEP Component or non-RAS Component
instruments or instrument components (a “Collaboration Combination Product”) for a single price or
on a single invoice to the customer, the “revenues from the FEP Component and RAS Component” with
respect to such Collaboration Combination Product shall be calculated by multiplying the total
amount received by a Party or its Affiliates for such Collaboration Combination Product by the
fraction A/B, where A is the gross selling price of the FEP Component or RAS Component sold
separately and B is the gross single price or aggregate prices on a single invoice to the customer
for such Collaboration Combination Product. Such calculation of the Collaboration Combination
Product revenues shall be negotiated in good faith between the Parties and resolved pursuant to
ARTICLE 11 if they are unable to agree.



     (B) Revenues for Lease, Rental or Placement Programs. If the Ea Component or RAS
Component is not sold separately but rather is leased, placed or rented pursuant to a
reagent/rental program or comparable sale or lease program (including instrument
upgrade/maintenance programs) (each a “Program”) where the instrument revenue is included in such
Program revenue, then the “revenues from the FEP Component and RAS Component” with respect to such
Program shall: (i) be one hundred fifteen percent (115%) of the Fully Burdened Manufacturing Costs
(as defined below) until Novartis has been reimbursed for all FEP Component and RAS Component
Development Costs, and one hundred percent (100%) thereafter; based upon an imputed instrument
depreciation factor consistent with Novartis’s then- current accounting policy that provides for a
depreciation of at least three (3) years for each FEP Component and RAS Component.



     (C) Nothing herein shall amend the manner in which the Agreement determines the revenues for
Combination Products where the FEP Component or RAS Component is sold in combination with one or
more Third Party products.



          (ii) As used in this Schedule 6.1.2(e):




     (A) “FEP Component” shall mean the front end pipettor component developed pursuant to the
Modified Blood Screening Instrument — eSAS 2 Addendum, dated January 1, 2002, under the 1998
Agreement.



     (B) “Fully Burdened Manufacturing Costs” of the FEP Component and RAS Component shall mean
one hundred and twenty five percent (125%) of the reasonable Third



3









 




Party OEM invoice cost of the FkP Component or RAS Component (including freight, taxes,
etc.). The foregoing amount shall be used in lieu of the actual internal costs incurred or
allocated to the purchase for QA, purchasing, receiving and warehousing, etc.




     (C) the “Gen-Probe Blood Screening Split” used under Section (b) below with respect to sales
of the FEP Component or RAS Component in the Blood Screening Field shall be calculated, for a given
fiscal quarter, by taking the dollar weighted average of the Applicable Purchase Price earned by
Gen-Probe for all Blood Screening Assays sold as calculated under 1.2.1 and 1.2.2 of the Agreement
during such fiscal quarter.



     (D) the “Gen-Probe Clinical Diagnostic Split” used under Section (c) below with respect to
sales of the FEP Component or RAS Component in the Clinical Diagnostic Field shall be equal to the
Novartis Blood Screening Split.



     (E) the “Novartis Blood Screening Split” used under Section (b) below with respect to sales of
the FEP Component and RAS Component in the Blood Screening Field shall be the remainder of (I) one
hundred percent (100%) less (II) the Gen-Probe Blood Screening Split



     (F) the “Novartis Clinical Diagnostic Split” used under Section (c) below with respect to
sales of the FEP Component or RAS Component in the Clinical Diagnostic Field shall be equal to the
Gen-Probe Blood Screening Split.



     (G) “RAS Component” shall mean the reagent addition station component developed pursuant to
the Modified Blood Screening Instrument — eSAS 2 Addendum, dated January 1, 2002, under the 1998
Agreement.



     (b) Instrument Sales; Novartis Sales oft-EP Components and RAS Components.



          (i) Until Novartis has been reimbursed for all I-EP Component and RAS Component Development
Costs, within forty-five (45) days following the end of each fiscal quarter Novartis shall (A)
first, calculate (and provide written notice to Gen-Probe of such calculation) the revenues from
FEP Components and RAS Components sold and received by Novartis or its Affiliates during such
fiscal quarter; (B) second, calculate (and provide written notice to Gen-Probe of such calculation)
one hundred and fifty percent (150%) of the Fully Burdened Manufacturing Costs for the FEP
Components and RAS Components sold in such fiscal quarter by Novartis and its Affiliates; (C)
third, calculate (and provide written notice to Gen-Probe of such calculation) and retain the
lesser of (I) revenues from the FEP Components and RAS Components sold and received by Novartis and
its Affiliates in such fiscal quarter or (II) one hundred and fifty percent (150%) of the Fully
Burdened. Manufacturing Costs for the FEP Components and RAS Components sold in such fiscal quarter
by Novartis and its Affiliates; (D) fourth, apply and credit (and provide written notice to
Gen-Probe of such calculation) the difference between such retained amount and one hundred percent
(100%) of the Fully Burdened Manufacturing Costs for the FEP Components and RAS Components sold in
such fiscal quarter by Novartis and its Affiliates as reimbursement to Novartis of the PEP
Component and RAS Component Development Costs; (E) fifth, calculate (and provide written notice to
Gen-Probe of such calculation) and retain the Novartis Blood Screening Split, if any; and (F)
sixth, pay to Gen- Probe an amount equal to the Gen-Probe Blood Screening Split, if any.




4









 





          (ii) After Novartis has been reimbursed for all FEP Component and RAS Component Development Costs
under subparagraph (b)(i) above, within forty-five (45) days following the end of each fiscal
quarter Novartis shall thereafter (A) first, calculate (and provide written notice to Gen-Probe of
such calculation) revenues from the PEP Components and RAS Components sold and received by Novartis
and its Affiliates in such fiscal quarter; (B) second, calculate (and provide written notice to
Gen-Probe of such calculation) and retain one hundred and fifteen percent (115%) of the Fully
Burdened Manufacturing Costs for the FEP Components and RAS Components sold in such fiscal quarter
by Novartis and its Affiliates; (C) third, calculate (and provide written notice to Gen-Probe of
such calculation) and retain the Novartis Blood Screening Split, if any; and (D) fourth, pay to
Gen-Probe an amount equal to the Gen- Probe Blood Screening Split, if any.




          (iii) If the FEP Component or RAS Component is not sold separately by Novartis but rather is
leased, placed or rented by Novartis pursuant to a Program (as defined in subsection (a)(i)(B)
above), within forty-five (45) days following the end of each fiscal quarter Novartis shall
calculate (and (provide written notice to Gen-Probe of such calculation) and shall be entitled to
retain any and all revenues from the FEP Components and RAS Components sold, leased, placed or
rented pursuant to a Program and received by Novartis and its Affiliates in such fiscal quarter.




     (c) Instrument Sales; Gen-Probe Sales of FEP Components and RAS Components.



          (i) Within forty-five (45) days following the end of each fiscal quarter Gen-Probe sells PEP
Components and RAS Components, Gen-Probe shall (A) first, calculate (and provide written notice to
Novartis of such calculation) the revenues for the FEP Components and RAS Components received by
Gen-Probe and its Affiliates during such fiscal quarter from the sale, transfer, placement, lease
or other disposition of the FEP Components and RAS Components in the Clinical Diagnostic Field; (B)
second, calculate (and provide written notice to Novartis of such calculation) and retain one
hundred and fifteen percent (115%) of the Fully Burdened Manufacturing Costs for such FEP
Components and RAS Components; (C) third, calculate (and provide written notice to Novartis of such
calculation) and retain an amount equal to the Gen-Probe Clinical Diagnostic Split, if any; and (D)
fourth, pay to Novartis an amount equal to the Novartis Clinical Diagnostic Split, if any.




     (d) Service Revenues. Each Party is entitled to retain the aggregate commercially
reasonable revenues received by such Party and its Affiliates in consideration for required
maintenance and servicing of the FEP Components and RAS Components consistent with standard
industry practices; provided, however that the revenues retained may not exceed fifteen percent
(15%) of the Fully Burdened Manufacturing Costs of the FEP Components and RAS Components per year;
provided however that in the event that the revenues exceed fifteen percent (15%) of the Fully
Burdened Manufacturing Costs of the FEP Components and RAS Components in any given year, such
excess shall be shared by Gen-Probe and Novartis such that, for maintenance and service revenues of
FEP Components and RAS Components used in the Blood Screening Field, the parties shall receive such
amount equal to their respective Blood Screening Splits, and for maintenance and service revenues
of FEP Components and RAS Components used in the Clinical Diagnostic Field, the parties shall
receive such amount equal to their respective Clinical Diagnostic Splits.]




5











 





Schedule 8.1.6(e)




Novartis Corporation Core Technologies



     Novartis Core Technology means (1) technology claimed in Valid Claims of the following patents
and (2) technology claimed in Valid Claims of patent applications pending before the United States
Patent & Trademark Office to the extent that such applications are substantially equivalent to the
claims in the patent applications listed below, both (1) and (2) together with any unlisted patents
and U.S. patent applications from which any of the listed patents claim priority and any and all
patents which have issued or in the future issue from the listed patents and applications and all
divisionals, continuations, continuations-in-part, reissues, renewals, re-examinations, extensions,
or additions thereof (all only to the extent that the claims thereof are to the same or
substantially the same subject matter claimed in the listed patents or patent applications).


HUMAN IMMUNODEFICIENCY VIRUS (HIV)




	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title of Invention	 	Patent/Pub. No.	 	 	Issue/Pub. Date	 	 	Priority Date	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





HEPATITIS C VIRUS (HCV)




	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title of Invention	 	Patent/Pub. No.	 	 	Issue/Pub. Date	 	 	Priority Date	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





[...***...]




	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title of Invention	 	Patent/Pub. No.	 	 	Issue/Pub. Date	 	 	Priority Date	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 






***Confidential Treatment Requested






1









 








	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title of Invention	 	Patent/Pub. No.	 	 	Issue/Pub. Date	 	 	Priority Date	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





[...***...]




	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title of Invention	 	Patent/Pub. No.	 	 	Issue/Pub. Date	 	 	Priority Date	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 






***Confidential Treatment Requested




2









 





Schedule 8.7




Gen-Probe Incorporated Core Technologies



     Gen-Probe Core Technologies means (1) technology claimed in Valid Claims of the following
patents and (2) technology claimed in Valid Claims of patent-applications pending before the United
States Patent & Trademark Office to the extent that such applications are substantially equivalent
to the claims in the patent applications listed below, both (1) and (2) together with any unlisted
patents and U.S. patent applications from which any of the listed patents claim priority and any
and all patents which have issued or in the future issue from the listed patents and applications
and all divisionals, continuations, continuations-in-part, reissues, renewals, re-examinations,
extensions, or additions thereof (all only to the extent that the claims thereof are to the same or
substantially the same subject matter claimed in the listed patents or patent applications).


A. [...***...]




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Title of Invention	 	Issue/Pub No	 	 	Issue/Pub Date	 	 	Priority Date	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 






***Confidential Treatment Requested




1









 








	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Title of Invention	 	Issue/Pub No	 	 	Issue/Pub Date	 	 	Priority Date	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





B. [...***...]




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





C. [...***...]




     [...***...]



	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 






***Confidential Treatment Requested






2









 







D. [...***...]




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





E. [...***...]




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 
	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 





F. [...***...]




     [...***...]



	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	[...***...]	 	 	[...***...]
	 	 	[...***...]	 	 	 	[...***...]	 	 	 	[...***...]	 






***Confidential Treatment Requested






3









 








Schedule 8.9




     Additional Clauses Relating to the Stanford Agreement and the Teknika Agreement




(Note: The text set forth below is quoted from the Stanford Agreement and the
Teknika Agreement, and all section references within the quoted text to paragraphs,
sections, and articles refer to the paragraphs, sections, and articles of the
applicable Stanford Agreement and the Teknika Agreement, and not to those of this
Agreement between Novartis and Gen-Probe.)


Stanford License




     The Stanford Agreement sets forth the following terms and conditions relating to required
provisions in any sublicense and to the continuation of sublicenses following termination of the
Stanford Agreement.



     4.3.2 Any such sublicense shall also expressly include the provisions of ARTICLEs 7, 8, and 9
for the benefit of STANFORD.



     4.3.3 Upon termination of this Agreement for any cause, any sublicense granted hereunder shall
continue with STANFORD provided the sublicensee agrees to thereafter assume the obligations of
GEN-PROBE insofar as they correspond to the scope of the sublicense.


7. REPORTS, PAYMENTS, AND ACCOUNTING




     7.1 Quarterly Royalty Payment and Report. GEN-PROBE shall make written reports and royalty
payments to STANFORD within ninety (90) days after the end of each calendar quarter. This report
shall state the number, description, and aggregate Net Sales of Licensed Product(s) during such
completed calendar quarter, and resulting calculation pursuant to Paragraph 6.2 of earned royalty
payment due STANFORD for such completed calendar quarter. Concurrent with the making of each such
report, GEN-PROBE shall include payment due STANFORD of royalties for the calendar quarter covered
by such report.



     7.2 Accounting, GEN-PROBE agrees to keep records for a period of three (3) years showing the
manufacturing, sales, use, and other disposition of products sold or otherwise disposed of under
the license herein granted in sufficient detail to enable the royalties payable hereunder by
GEN-PROBE to be determined, and further agrees to permit its books and records to be examined to
the extent necessary to verify reports provided for in Paragraph 7.1 by an independent certified
public accountant, provided that such audits occur no more than one (1) time per calendar year and
provided further that accountant shall report to STANFORD only errors regarding calculation of
royalties. Such examination is to be made by STANFORD, at the expense of STANFORD, except in the
event that the results of the audit reveal a discrepancy in GEN-PROBE’S favor of ten percent (10%)
or more, then the audit fees shall be paid by GENPROBE.



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8. WARRANTY AND NEGATION OF WARRANTIES




     8.1 Nothing in this Agreement is or shall be construed as:



     (a) A warranty or representation by STANFORD as to the validity or scope of any Licensed
Patent(s);



     (b) A warranty or representation that anything made, used, sold, or otherwise disposed of
under any license granted in this Agreement is or will be free from of patents, copyrights, and
other rights of third parties;



     (c) An obligation to bring or prosecute actions or suits against third parties for
infringement, except to the extent and in the circumstances described in ARTICLE 12; or



     (d) Granting by implication, estoppel, or otherwise any licenses under patents of STANFORD or
other persons other than Licensed Patent(s), regardless of whether such patents are dominant or
subordinate to any Licensed Patent(s)



     8.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, STANFORD MAKES NO REPRESENTATIONS AND
EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE LICENSED
PRODUCT(S) WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES.


9. INDEMNITY




     9.1 GEN-PROBE agrees to indemnify, hold harmless, and defend STANFORD and its trustees,
officers, employees, students, and agents against any and all claims for death, illness, personal
injury, property damage, and improper business practices arising out of the manufacture, use, sale,
or other disposition of Invention, Licensed Patent(s), or Licensed Product(s) by GEN-PROBE, its
sublicenses or their customers.



     9.2 GEN-PROBE shall at all times comply, through insurance or self-insurance, with all
statutory workers’ compensation and employers’ liability requirements covering any and all
employees with respect to activities performed under this Agreement.



     9.3 GEN-PROBE shall maintain, beginning, on the first day GEN-PROBE or any GEN-PROBE
sublicensee ships a therapeutics product manufactured by the licensed process, commercial general
liability insurance, including products liability insurance, with minimum limits of liability of $5
million with reputable and financially secure insurance carrier(s) to cover the activities of
GEN-PROBE and its sublicensee(s). Any and all such policies of insurance described in the previous
sentence shall include as additional named insureds STANFORD, Stanford Health Services, their
trustees, directors, officers, employees, students and agents, and shall provide that such policies
may not, without 30 days prior written notice to STANFORD, be canceled or changed to materially
adversely affect any such additional named insured’s coverage. Such insurance shall be written to
cover liability of such additional named insureds



2









 




incurred beginning on the first day GEN-PROBE or any GEN-PROBE sublicensee ships a
therapeutics product.



Teknika Agreement




     The Teknika Agreement sets forth the following sets forth the following terms and conditions
relating to rights of Gen-Probe’s Licensees should a breach by Gen-Probe terminate its rights under
the Teknika Agreement:



     10.3 Upon termination of this Agreement, as permitted by Section 10.2, the non- breaching
party shall grant direct immunity from legal action to Licensees of the breaching party, under the
terms and conditions set forth in this Agreement, provided that:



     (a) the non-breaching party shall have received express written notice of the license granted
to such Licensee prior to the effective termination date of this Agreement;


(b) the Licensee expressly agreed in writing on or before the ninetieth (90th) day prior to the
effective termination date of this Agreement to be bound by the terms and conditions of this
Agreement.





3