Exhibit 10.81
SUPPLY AND PURCHASE AGREEMENT
This Supply and
Purchase Agreement (“Agreement”), effective as of the
15 th
day of February, 2005 (the
“Effective Date”), is by and between F. HOFFMANN-LA
ROCHE LTD., a Swiss limited liability company with a place of
business at Grenzacherstrasse 124, CH-4070 Basle, Switzerland and
ROCHE MOLECULAR SYSTEMS, INC., a Delaware corporation with a place
of business at 4300 Hacienda Drive, Pleasanton, CA 94588
(collectively, “ROCHE”), and GEN-PROBE INCORPORATED, a
Delaware corporation with a place of business at 10210 Genetic
Center Drive, San Diego, CA 92121 and its Affiliates (as such term
is defined below) (collectively, “GPRO”).
BACKGROUND
GPRO requests that
ROCHE supply all of GPRO’s requirements for HPV Products (as
such term is defined below) solely for use with or in HPV TMA Test
Kits (as such term is defined below), and ROCHE is willing to
supply those requirements all on the terms and subject to the
conditions specified in this Agreement.
NOW,
THEREFORE, the parties agree as follows:
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1.
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Definitions .
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When used in this Agreement, the
following terms shall have the meanings set forth below.
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1.1
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“Affiliates” means, with
respect to any Person, any other Person that, directly or
indirectly, controls, is controlled by or is under common control
with, that Person, provided however, that in each case any such
other Person shall be considered to be an Affiliate only during the
time period during which such control exists. For purposes of this
definition, “control” (including, with correlative
meaning, the terms “controlled by” and “under
common control with”), as used with respect to any Person,
shall mean the possession, directly or indirectly, of the power to
direct and/or cause the direction of the management and policies of
such Person, whether through the ownership of voting securities, by
contract or otherwise. With regard to ROCHE, the term Affiliate
shall not include Genentech, Inc., 1 DNA Way, South San Francisco,
California 94080-4990, U.S.A. (“Genentech”) or Chugai
Pharmaceutical Co., Ltd, 1-9 Kyobashi 2-chome, Chuo-ku, Tokyo,
104-8301, Japan (“Chugai”).
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1.2
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“Certificate of
Analysis” means the documentation that accompanies the HPV
Products and confirms that such products meet the
Specifications.
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1.3
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“Confidential
Information” means: (i) any information designated in
writing by either party as proprietary or confidential, or if
orally disclosed, identified at the time of disclosure as
proprietary or confidential and confirmed in writing to be
proprietary and confidential within thirty (30) days of
disclosure; (ii) ROCHE’s business and marketing plans
with respect to the HPV Patent Rights and any other
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intellectual property rights owned
by or licensed to ROCHE; and (iii) the terms and conditions of
this Agreement and the negotiations between the parties with
respect to this Agreement.
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1.4
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“Days” means calendar
days.
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1.5
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“HPV” means the human
papilloma virus.
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1.6
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“HPV Products” means the
HPV Reagent Products and the HPV RNA Transcript and HPV DNA
Products.
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1.7
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“HPV Reagent Products”
means certain oligonucleotide reagents manufactured by ROCHE under
this Agreement pursuant to the applicable Specifications (as such
term is defined below) for use by GPRO in developing the HPV TMA
Test Kits and for incorporation by GPRO into the HPV TMA Test Kits
(as such term is defined below) all for use only with TMA (as
defined below).
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1.8
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“HPV RNA Transcript and HPV
DNA Products” means certain HPV transcripts and/or HPV DNA
manufactured by or on behalf of ROCHE under this Agreement pursuant
to the applicable Specifications (as such term is defined below)
for use by GPRO solely for development, formulation and quality
control of the HPV TMA Test Kits (as such term is defined
below).
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1.9
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“HPV TMA Test Kits”
means the diagnostic test kits for HPV (inclusive of ASR reagent
products) developed and sold by GPRO for use only with TMA, which
are designed to run on any current or future instrument appropriate
for such purpose.
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1.10
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“Individual HPV Test
Quantity” means that quantity of HPV Reagent Product(s)
necessary to generate a diagnostic result for a single patient with
respect to one or more types of HPV, as described in the
Specifications. Individual HPV Test Quantities shall be reported in
appropriate mass units as calculated from the individually measured
[...***...] provided to ROCHE by GPRO.
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1.11
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“Manufacturing Cost”
shall mean the fully-burdened cost to ROCHE (expressed on a per
unit basis) of manufacturing or having manufactured the HPV
Products, together with the packaging thereof, including the cost
of materials, direct labor, quality control, and overhead
(including royalties paid to Third Parties), all as determined in
accordance with ROCHE’s standard accounting practices for
other products manufactured. For the avoidance of doubt,
Manufacturing Cost shall not include any cost component
attributable to excess or idle manufacturing capacity.
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1.12
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“Person” shall mean an
individual or any legally recognized entity, including any
corporation, partnership, limited partnership, limited liability
company, association or trust.
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1.13
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“ROCHE HPV Patents”
means certain patent rights owned by or licensed to ROCHE, covering
the HPV Products, as further specified in Exhibit A of
this Agreement, including all divisionals, continuations,
continuations-in-part applications, substitutes, reissues,
renewals, re-examinations and extensions of any of the said patent
rights, and all patents worldwide issuing on any of the patent
applications included within the said patent rights. Additional
patent rights developed by ROCHE and, to the extent permitted under
the applicable license or acquisition agreement of ROCHE with a
third Person, additional patent rights licensed or acquired by
ROCHE, directed solely to oligonucleotide probes and methods for
their use for the detection of HPV shall also be included within
the ROCHE HPV Patents. ROCHE HPV Patents licensed by ROCHE shall be
subject to the terms, conditions, limitations and restrictions
contained in the applicable license agreement of ROCHE with the
third Person.
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1.14
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“Specifications” means
the specifications set forth in Exhibit B of this
Agreement, pursuant to which ROCHE shall manufacture the HPV
Products under this Agreement, which specifications may be modified
from time to time upon request of GPRO, subject to the written
consent of ROCHE, such consent not to be unreasonably withheld,
conditioned or delayed. ROCHE acknowledges that it is aware that
GPRO is likely to request modification of the Specifications from
time-to-time in connection with GPRO’s development of the HPV
TMA Test Kits and prior to any First Commercial Sale
thereof.
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1.15
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“TMA” means
“Transcription-Mediated Amplification”, a
transcription-based process for amplifying a DNA or RNA target
source. TMA comprises a substantially continuous and isothermal
process of generating multiple RNA copies of the target sequence or
its complement. It is expressly understood that the heating of
target RNA to relax the molecule prior to the transcription-based
process can comprise a step in “TMA.” Further, it is
expressly understood that a transcription-based process, as
described herein, that begins with a single stranded DNA or RNA
target sequence or a double stranded DNA target sequence includes
no more than two cycles of heat denaturation and primer extension,
employs only one primer in the first primer extension step, and
produces a double stranded promoter sequence is included within the
meaning of “TMA.” Finally, it is expressly understood
and agreed that the TMA process is not polymerase chain reaction
(“PCR”) amplification, namely the amplification of a
nucleic acid sequence and the complement of that sequence by more
than two cycles of denaturation of a double stranded nucleic acid,
annealing and extension of two primers, wherein the sequence and
its complement are repeatedly separated, each separated strand
serves as a template for primer extension and the resulting double
stranded nucleic acid is used in further cycles of denaturation,
annealing and extension of primers.
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1.16
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“Transfer Fee” shall
have the meaning provided in Section 3.2, 3.3 or 3.4, as
applicable.
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3
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2.
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Supply and Purchase of HPV
Products .
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2.1
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Obligation to Purchase
. GPRO shall purchase
from ROCHE, upon GPRO’s request as provided in this
Agreement, all of its requirements of HPV Reagent Products for use
in HPV TMA Test Kits and all of its requirements of HPV RNA
Transcript and HPV DNA Products for use in connection with HPV TMA
Test Kits. GPRO’s obligation under this Section 2.1
shall terminate upon any termination of this Agreement pursuant to
Section 9.
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2.2
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Obligation to Supply
. ROCHE shall supply all
of GPRO’s requirements of HPV Reagent Products for use in HPV
TMA Test Kits and all of GPRO’s requirements of HPV RNA
Transcript and HPV DNA Products for use in connection with HPV TMA
Test Kits, as requested by GPRO under Section 2.1. ROCHE will
manufacture, or have manufactured, the HPV Products in accordance
with the Specifications and appropriate Quality Systems Regulations
and then current Good Manufacturing Practices (cGMP) controls. Any
material deviations from the prescribed ROCHE manufacturing process
shall be communicated to GPRO prior to ROCHE’s release of the
HPV Products. Manufacturing records for the HPV Products will be
kept at the facility where such HPV Products were manufactured and
will be available for necessary regulatory inspections as provided
in Section 6.2.1.
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2.3
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Scope of GPRO’s Rights for HPV
Products .
GPRO shall utilize HPV Reagent Products purchased under this
Agreement solely for development of and incorporation into HPV TMA
Test Kits, and for no other purpose. GPRO shall utilize HPV RNA
Transcript and HPV DNA Products purchased under this Agreement
solely for its own internal development, formulation and quality
control of HPV TMA Test Kits, and for no other purpose. GPRO shall
not have the right to resell the HPV Products on a standalone basis
or as incorporated into any other product, but only as incorporated
into HPV TMA Test Kits (including as one component of ASR reagent
products). GPRO shall have the unrestricted and unconditional right
to incorporate the HPV Reagent Products into the HPV TMA Test Kits
and GPRO shall have the unrestricted and unconditional right to use
and sell the HPV TMA Test Kits (including to its
distributors).
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2.4
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Restriction on Supply by
ROCHE . ROCHE
shall not sell or supply the HPV Products manufactured by it under
this Agreement to any third Person.
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2.5
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Failure a Material Breach
. Failure by a party to
comply with Sections 2.1, 2.2, 2.3 and 2.4 shall constitute a
material breach of this Agreement by such party.
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3.1
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Manufacturing Access Fee and
Additional Charge for Patented Products . In consideration of ROCHE’s
agreement to manufacture and supply the HPV Products to GPRO under
the ROCHE HPV Patents pursuant to this Agreement, GPRO shall pay to
ROCHE a non-refundable manufacturing access fee and
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additional charge for the HPV
Products of Thirty Million United States Dollars (US$30,000,000),
payable in two installments as follows: (i) Twenty Million
United States Dollars (US$20,000,000) within ninety (90) days after
the Effective Date; and (ii) Ten Million United States Dollars
(US$10,000,000) within the earlier of (A) [...***...]
([...***...])[...***...], or (B) [...***...]. As used in this
Agreement, a “First Commercial Sale” shall mean the
first commercial sale by GPRO of any HPV TMA Test Kit (not
including any use or transfer for Non-Commercial Use (as defined
below) or Clinical Trial Use (as defined below)).
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3.2
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Transfer Fees for HPV Reagent
Products .
As additional consideration for ROCHE’s agreement to
manufacture and supply the HPV Reagent Products to GPRO under this
Agreement, GPRO shall pay to ROCHE, for the supply of bulk
quantities of the HPV Reagent Products during the term of this
Agreement, transfer fees (the “Reagent Transfer Fee”)
as follows:
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3.2.1
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Each purchase order submitted by
GPRO will ordinarily include each of the HPV Reagent Products to be
incorporated into the HPV TMA Test Kits. As to each such order,
GPRO shall pay to ROCHE in respect of each Individual HPV Test
Quantity of HPV Reagent Products manufactured and sold by ROCHE to
GPRO as follows: (i) from the Effective Date until [...***...]
([...***...])[...***...] after GPRO achieves the First Commercial
Sale of a HPV TMA Test Kit, US$[...***...] per Individual HPV Test
Quantity; (ii) for [...***...] ([...***...]) to [...***...]
([...***...]) after GPRO achieves the First Commercial Sale of a
HPV TMA Test Kit, US$[...***...] per Individual HPV Test Quantity;
(iii) for [...***...] ([...***...]) to [...***...]
([...***...]) after GPRO achieves the First Commercial Sale of a
HPV TMA Test Kits, US$[...***...] per Individual HPV Test Quantity;
(iv) for [...***...] ([...***...]) to [...***...]
([...***...]) after GPRO achieves the First Commercial Sale of a
HPV TMA Test Kit, US$[...***...] per Individual HPV Test Quantity;
and (iv) for the remainder of the term of this Agreement, the
greater of (A) US$[...***...] per Individual HPV Test
Quantity, or (B) the Manufacturing Cost thereof (or
ROCHE’s actual incurred cost if manufactured for ROCHE by a
third Person), plus a margin of [...***...] percent ([...***...]%),
provided however, that for individual orders of GPRO made during
such remainder of the term of the Agreement for a lot size of at
least [...***...] ([...***...]) Individual HPV Test Quantities per
order, such Transfer Fee shall not exceed US$[...***...] per
Individual HPV Test Quantity.
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3.2.2
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Notwithstanding the fact that each
purchase order submitted by GPRO will ordinarily include each of
the HPV Reagent Products to be incorporated into the HPV TMA Test
Kits, GPRO shall have the right to separately order and purchase
from ROCHE one or more individual oligonucleotide reagents included
within the HPV Reagent Products. As to each such order, GPRO shall
pay to ROCHE a Transfer Fee per Individual HPV Test Quantity of
each individual oligonucleotide reagent.
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Such Transfer Fee shall be equal to
the Transfer Fee set forth in Section 3.2.1, above, multiplied
by [...***...], where “[...***...]” is the [...***...]
of [...***...] then [...***...] within the [...***...] and
[...***...] by [...***...] into the [...***...]. Nothing contained
in this Section 3.2.2 shall diminish GPRO’s obligation
under Section 2.1 to purchase from ROCHE all of GPRO’s
requirements of HPV Reagent Products for use in HPV TMA Test
Kits.
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3.3
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Transfer Fees for HPV RNA Transcript
and HPV DNA Products . As additional consideration for
ROCHE’s agreement to manufacture and/or supply the HPV RNA
Transcript and HPV DNA Products to GPRO under this Agreement, GPRO
shall pay to ROCHE, for the supply of bulk quantities of the HPV
RNA Transcript and HPV DNA Products during the term of this
Agreement, a transfer fee in respect of such HPV RNA Transcript and
HPV DNA Products sold by ROCHE to GPRO (the “Transcript
Transfer Fee”) equal to ROCHE’s Manufacturing Cost,
plus a margin of [...***...] percent ([...***...]%), or
ROCHE’s actual incurred cost if manufactured for ROCHE by a
third Person, plus a margin of [...***...] percent ([...***...]%),
provided however, that if HPV RNA Transcript and HPV DNA Products
are manufactured by ROCHE and sold to GPRO, the Transcript Transfer
Fee shall not exceed [...***...] percent ([...***...]%) of the
Transcript Transfer Fee that GPRO can reasonably demonstrate would
have been charged if ROCHE had alternatively had such HPV
Transcript Product manufactured by a third Person for ROCHE for
sale to GPRO.
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3.4
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HPV Reagent Products for
Non-Commercial Use . Notwithstanding Section 3.2 of
this Agreement, GPRO shall be entitled to purchase a limited
quantity of the HPV Reagent Products for “Non-Commercial
Use”. For the purpose of this Section 3.4,
“Non-Commercial Use” shall mean that the intended use
of such HPV Reagent Products, as demonstrated by GPRO to
ROCHE’s reasonable satisfaction, shall be solely for
GPRO’s internal research and development and not for transfer
or sale by GPRO to any third Person. GPRO currently estimates that
it will require approximately [...***...] Individual HPV Test
Quantities for Non-Commercial Use.
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3.5
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HPV Reagent Products for Clinical
Trials .
Notwithstanding Section 3.2 of this Agreement, GPRO shall be
entitled to purchase a limited quantity of the HPV Reagent Products
for use only in those clinical trials required to obtain applicable
governmental regulatory approvals (“Clinical Trial
Use”), provided that GPRO shall furnish such HPV Reagent
Products (and/or corresponding HPV TMA Test Kits) to the clinical
trial researchers or governmental agencies at no charge and shall
not sell such HPV Reagent Products (and/or corresponding HPV TMA
Test Kits) to any third Person and, provided further, that GPRO may
only purchase up to [...***...] Individual HPV Test Quantities of
the HPV Reagent Products for use for such purposes, and provided
finally, that if GPRO can demonstrate to ROCHE’s reasonable
satisfaction that additional HPV Test Quantities are reasonably
needed by GPRO for such purposes, GPRO may purchase an
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additional amount of HPV Test
Quantities up to a maximum of [...***...] additional Individual HPV
Test Quantities for use only for such purposes.
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3.6
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Transfer Fee and Order Size for
Non-Commercial Use and Clinical Trial Use . The Transfer Fee and order size
for GPRO’s purchase of HPV Reagent Products for
Non-Commercial Use and Clinical Trial Use shall be in accordance
with Exhibit C to this Agreement. With respect to any
Individual HPV Test Quantities ordered by GPRO pursuant to this
Section 3.6 that are not used by GPRO for Non-Commercial Use
or Clinical Trial Use as provided in Sections 3.4 and 3.5 and
are instead reclassified by GPRO for commercial use and
incorporation by GPRO into HPV TMA Test Kits, upon the earlier of
such reclassification or incorporation into HPV TMA Test Kits, GPRO
shall immediately notify ROCHE. GPRO shall concurrently pay ROCHE
the difference between the applicable Transfer Fees in effect
pursuant to Section 3.2 as of the date of original delivery
thereof for such Individual HPV Test Quantities and the applicable
price previously paid by GPRO for such Individual HPV Test
Quantities as provided in Exhibit C .
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3.7
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Third Party Royalties
. Any royalties or other
fees owed by ROCHE to any third Person for the practice of the
ROCHE HPV Patents shall be borne exclusively by ROCHE. Any
royalties or other fees owed to any third Person for or in
connection with the HPV TMA Test Kits or the practice of TMA shall
be borne exclusively by GPRO.
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3.8
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Replacement of Scrapped HPV Reagent
Products. During the term of this Agreement,
if GPRO demonstrates to ROCHE’s reasonable satisfaction that
any HPV Reagent Products, ordered by GPRO for incorporation into
HPV TMA Test Kits and paid for pursuant to Section 3.2, have
been fully and finally scrapped by GPRO due to GPRO internal
accidental damage or loss, then ROCHE shall supply replacement HPV
Reagent Products and GPRO shall pay ROCHE [...***...] percent
([...***...]%) of the Transfer Fee then in effect but in no event
less than the greater of (a) US$[...***...] per Individual HPV
Test Quantity, or (b) the Manufacturing Cost thereof plus a
margin of [...***...] percent ([...***...]%). For the avoidance of
doubt, this Section 3.8 shall not apply to HPV Reagent
Products ordered by GPRO for Non-Commercial Use or Clinical Trial
Use.
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4.
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Forecasts and Orders
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4.1
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Forecast . Each calendar quarter, on or about
the first day of each quarter, GPRO will provide to ROCHE a rolling
forecast of its requirements for HPV Products for the next
([...***...])[...***...], based on GPRO’s good faith
estimates of anticipated sales of HPV TMA Test Kits. Such forecast
shall include good faith estimates of anticipated delivery dates.
Failure to provide such information may result in product shortages
or delays. GPRO’s forecasts shall not be binding.
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4.2
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Purchase Orders
. GPRO shall purchase
HPV Products hereunder by issuing a written purchase order
identifying the HPV Products to be purchased, the
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quantity, total order purchase price
based on the then applicable Transfer Fees, delivery instructions,
delivery dates and any other special information. The delivery date
specified in each purchase order shall be at least sixty
(60) days after the date of the purchase order when ordering
[...***...] to [...***...] lots of HPV Reagent Products, ninety
(90) days after the date of the purchase order when ordering
[...***...] to [...***...] lots of HPV Reagent Products and one
hundred twenty (120) days after the date of the purchase order
when ordering [...***...] to [...***...] lots of HPV Reagent
Products, provided however, that GPRO recognizes that delivery
dates for initial shipments of HPV Products may be longer than the
periods set forth in this Section 4.2 and the parties agree to
confer and reasonably agree upon reasonable lead times for the
delivery of initial shipments of the HPV Products with the goal and
intention of achieving lead times as close to one hundred twenty
(120) days as possible with commercially reasonable efforts.
Except as otherwise provided in Exhibit C, a “lot”
of HPV Reagent Product shall be the equivalent of one million
Individual HPV Test Quantities and the minimum order for a purchase
order shall be one (1) lot and the maximum order for a
purchase order shall be [...***...] lots. Each purchase order shall
specifically reference this Agreement. Within seven (7) days
of the delivery of each purchase order, as partial pre-payment for
the applicable HPV Products, GPRO shall deposit with ROCHE
US$[...***...] per Individual HPV Test Quantity for the HPV Reagent
Products that were the subject of the purchase order and the
Transfer Fee pursuant to Section 3.3 for the HPV RNA
Transcript and HPV DNA Products that were the subject of the
purchase order.
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4.3
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Acceptance of Purchase
Orders .
ROCHE may accept or reject purchase orders within seven
(7) working days of ROCHE’s receipt of written purchase
orders. Provided that a purchase order does not request lot
quantities of HPV Products greater than [...***...]% of previously
forecasted quantities, ROCHE shall accept all purchase orders that
are issued in conformance with the provisions of this Agreement.
ROCHE shall use commercially reasonable efforts to accommodate lot
quantities of HPV Products greater than [...***...]% of previously
forecasted quantities. Upon acceptance of a purchase order, such
purchase order and acceptance shall constitute a binding contract
between GPRO and ROCHE (subject to the terms and conditions of this
Agreement).
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4.4
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Deferral and Cancellation
. Prior to the scheduled
delivery date specified on a purchase order, GPRO may defer
delivery of HPV Products specified in such purchase order for a
period not to exceed [...***...] ([...***...]) days, provided
however, that in all cases upon the expiration of such [...***...]
([...***...]) days, ROCHE may deliver the HPV Products and invoice
for the applicable amount due. Deferrals related to that purchase
order must be by written notice, and shall be subject to a charge
of [...***...]% of the unpaid purchase price for the deferred HPV
Products for each thirty (30) days deferred based on the
Transfer Fee in effect on the date of the purchase
order.
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4.5
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Acceptance or Rejection
. GPRO shall inspect all
HPV Products within [...***...] ([...***...]) Days of receipt
thereof, and may reject any HPV Product that does not conform to
the Specifications, provided that it has not been used, abused or
damaged by GPRO or GPRO’s agents. Any HPV Product not
properly and timely rejected by GPRO shall be deemed accepted. To
reject an HPV Product, GPRO shall notify ROCHE in writing within
sixty (60) Days of receipt of the HPV Product of its rejection
and shall promptly return the rejected HPV Product to ROCHE. All
returned HPV Products shall be accompanied by suitable
documentation, as specified by ROCHE in response to GPRO’s
notification of rejection. GPRO shall also provide all reasonable
assistance to ROCHE to facilitate ROCHE’s investigation and
confirmation of the non-conformance basis for rejection. After
confirmation of the non-conformance basis for rejection, ROCHE
shall replace the rejected HPV Product with conforming HPV Product
as promptly as reasonably possible and within the periods set forth
in Section 4.2. Notwithstanding the foregoing, if GPRO first
discovers any non-conforming condition in HPV Products as
manufactured by or for ROCHE after the aforementioned 60-day period
and such condition would not have been detected in an initial
inspection using commercially reasonable inspection methods (a
“Latent Defect”) and GPRO immediately notifies ROCHE of
such non-conforming condition, then such HPV Product shall be
deemed to be non-conforming under this Agreement and GPRO shall
have all remedies originally available to it under this
Section 4.5 with respect to such non-conforming HPV
Products.
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4.6
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Inconsistencies
. Notwithstanding the
content of GPRO’s purchase order. ROCHE’s invoice, or
any other document submitted by one party to the other, this
Agreement shall take precedence over such purchase order or other
document, and this Agreement shall govern and control over any
conflicting or inconsistent terms of such purchase order(s),
invoices(s) or other documents, and all terms which are
inconsistent with those provided in this Agreement shall be null
and void.
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4.7
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Product Modifications
. Each party will notify
the other party promptly (and, in any case, no later than thirty
(30) Days) after it receives information that the processes,
Specifications or materials used to manufacture the HPV Products
will be changed. Without pre-approval by GPRO, which shall not be
unreasonably withheld, conditioned or delayed, ROCHE shall not make
any change in the manufacturing process for the HPV Products that
would cause the HPV Products not to meet the Specifications. The
parties shall discuss any such changes and agree on their
acceptability and any potential financial impact the changes may
have on the Transfer Fee. Any such agreement shall be in the form
of a signed amendment to this Agreement.
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5.1
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Delivery . ROCHE will use commercially
reasonable efforts to effect delivery on or before the date
indicated in GPRO’s purchase order, provided that date is
in
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conformance with the terms and
conditions of this Agreement. ROCHE shall not be liable for any
delay or failure in performance or delivery where such delay or
failure arises or results from any cause beyond ROCHE’s
reasonable control, including, but not limited to, strike, boycott,
or other labor disputes, failures or delays by common carriers,
embargo, governmental regulation, or delay in obtaining materials,
earthquakes, storms, power outages or acts of God. In the event of
any such delay or failure in performance due to a cause beyond
ROCHE’s reasonable control, ROCHE shall have such additional
time within which to perform its obligations hereunder as may
reasonably be necessary in ROCHE’s reasonable
judgment.
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5.2
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Delivery Terms
. Delivery of HPV
Products shall be made by Roche to GPRO at GPRO’s designated
facility or facilities as is specified in GPRO’s purchase
order. ROCHE shall invoice GPRO for all transportation
charges.
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5.3
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Packaging . All HPV Products delivered
pursuant to this Agreement shall be suitably packed in
ROCHE’s standard transportation cartons, marked for delivery
to the relevant delivery address, and delivered to GPRO as provided
herein. ROCHE shall comply with any special packaging requirements
set forth in the Specifications. ROCHE shall select the
carrier.
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5.4
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Custody, Control, Title, Risk of
Loss and Location of Sale . Control, custody, title and risk
of loss with respect to all HPV Products shall pass from ROCHE to
GPRO upon delivery of the HPV Products to GPRO at its designated
facility. Accordingly, the sale of HPV Products by ROCHE to GPRO
shall occur for all purposes of this Agreement upon delivery to
GPRO’s designated facility. The parties further acknowledge,
intend and agree that upon ROCHE’s sale of the HPV Products
for use in or with the HPV TMA Test Kits that the doctrine of
patent exhaustion will apply with respect to such use and as to all
claims of the ROCHE HPV Patents. GPRO acknowledges and agrees that
following the sale of the HPV Products hereunder GPRO will not
transport such HPV Products (including as incorporated into HPV TMA
Test Kits) from the jurisdiction in which they were delivered and
purchased to any other jurisdiction in which the doctrine of patent
exhaustion would not apply to the importation, offer for sale, sale
or use thereof based on the original sale and delivery in the first
jurisdiction. (By way of example and not of limitation, under
current law GPRO acknowledges and agrees that HPV Reagent Products
sold to it in the United States will not be transported to, or sold
by GPRO in HPV TMA Test Kits in, Europe and GPRO will purchase and
take delivery in Europe of all HPV Products to be used in or with
HPV TMA Test Kits to be sold in Europe.)
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5.5
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Disclaimer of Patent Exhaustion or
Implied Licenses as to Other ROCHE Patents . In connection with the delivery
and sale of HPV Products pursuant to this Agreement, ROCHE hereby
disclaims any applicability of the doctrine of patent exhaustion
with respect to, or any grant of implied license rights under, any
patent rights of ROCHE or its Affiliates other than the ROCHE HPV
Patents, and GPRO
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acknowledges and agrees that it
obtains no benefit of the doctrine of patent exhaustion or implied
license rights under any other patent rights of ROCHE or its
Affiliates.
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5.6
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Certificate of Analysis
. ROCHE shall provide a
Certificate of Analysis with each delivery of HPV
Products.
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6.
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Invoicing and Payment; Inspections
and Audits, Etc.
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6.1
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Invoicing and Payment
. ROCHE will invoice
GPRO for the Transfer Fees after ROCHE has delivered the HPV
Products. The Transfer Fee to be charged shall be the Transfer Fee
in effect pursuant to Section 3.2 on the date the subject HPV
Products were delivered to GPRO, less the deposit made by GPRO
pursuant to Section 4.2. GPRO shall pay all applicable amounts
due in respect of each purchase order within thirty (30) days
after receipt of ROCHE’s invoice therefor. Payment terms are
net thirty (30) Days from receipt of ROCHE’s invoice to GPRO.
GPRO shall be liable for the invoiced price of all HPV Products
substantially conforming to a GPRO purchase order, unless GPRO
properly rejected the HPV Products in a timely manner. If payment
is not received by the due date, a service charge may be added at
the rate of [...***...]% per [...***...] ([...***...]% per
[...***...]) or the maximum legal rate, whichever is less, to
unpaid invoices from the due date thereof, and GPRO agrees to pay
such charge. If GPRO consistently fails to make payments when due,
ROCHE reserves the right to require alternative payment terms,
including, without limitation, sight draft, letter of credit, or
payment in advance. Upon making such demand, ROCHE may suspend
production and/or deliveries. If, within the period stated in such
demand, but in no event longer than thirty (30) Days, GPRO
fails to give adequate assurance of due performance, ROCHE may make
deliveries under reservation of a security interest and demand
payment against tender of documents of title. GPRO hereby
represents to ROCHE that GPRO is now solvent and agrees that each
acceptance of delivery of HPV Product sold hereunder shall
constitute reaffirmation of this representation at such
time.
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6.2
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Inspections and Audits
.
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6.2.1
GPRO Audits . ROCHE shall permit and assure GPRO access
during reasonable business hours and upon thirty (30) days
written notice to conduct an audit (i) of those areas of all
facilities where the HPV Products are manufactured, tested, filled,
released, packaged, labeled, stored and/or handled, as applicable,
and (ii) all quality control records, test records and
manufacturing records for the HPV Products, each in order for GPRO
to perform a quality assurance audit of such facilities and
activities, (iii) ROCHE’s qualification policies and
procedures for third Person manufacturers and suppliers, and
(iv) in the event the Transfer Fee for HPV Products is
determined based upon ROCHE’s Manufacturing Cost thereof; the
cost basis for such Manufacturing Cost, provided, however, that
GPRO shall not cause such an audit to occur more than once in any
given
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[...***...] ([...***...])[...***...] period,
except as may be required by cGMP or any other applicable law or
regulation, and, provided, further, that all such audits shall be
conducted in such a manner as to not unreasonably interfere with
the conduct of regular business activities at the audited facility.
ROCHE shall permit GPRO or a third Person designated by GPRO to
copy, under reasonable confidentiality obligations, such documents
as GPRO can reasonably establish are required to be copied for
regulatory purposes.
6.2.2
GPRO Books and Records . GPRO shall maintain regular and
complete records for a period of [...***...] ([...***...]) years
after the expiration of the calendar quarter to which they pertain,
sufficient to enable verification of GPRO’s compliance with
the terms and conditions of this Agreement and the accuracy of all
statements and payments made by GPRO. Such records shall be
maintained at GPRO’s regular place of business and, on thirty
(30) days notice, shall be available for inspection and audit
by ROCHE’s outside accountants, acting in confidence, during
normal business hours, for [...***...] ([...***...]) years
immediately following the end of the calendar quarter to which they
pertain; provided, however, that ROCHE shall not cause such an
inspection and audit to occur more than once in any given
[...***...] ([...***...])[...***...] period or with respect to any
records after the expiration of [...***...] ([...***...]) years
after the end of the calendar quarter to which such records pertain
and, provided, further, that all such inspections and audits shall
be conducted in such a manner as to not unreasonably interfere with
the conduct of the GPRO’s regular business activities. Should
any such audit reveal a payment short fall by GPRO, the amount of
the short fall shall be paid promptly by GPRO after the discovery
thereof, together with interest thereon calculated at the lower of
(i) the prime rate of the Bank of America plus [...***...]
percent ([...***...]%), or (ii) the maximum rate provided
under applicable law, until paid. If the payment shortfall revealed
in any audit is greater than [...***...] percent ([...***...]%),
GPRO shall also pay all costs and expenses of the audit, including
all charges of ROCHE’s outside accountants.
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6.3
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Taxes and Duties
. The purchase price of
all HPV Products is exclusive of any taxes, fees, duties, licenses
or levies now or hereinafter imposed upon the production, storage,
sale, transportation or use of the HPV Products, and such taxes and
items shall be paid by GPRO (other than a tax measured by
ROCHE’s net income). In lieu of payment, GPRO shall provide
an exemption certificate acceptable to the taxing
authorities.
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7.
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Label Statement; Patent Marking;
Trademarks .
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7.1
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Label Statement
. GPRO shall include on
and with each HPV TMA Test Kit a statement to the effect that the
product is sold and intended for use only in Human In Vitro
Diagnostics and that all other implied licenses are expressly
disclaimed. The location of such label disclaimer shall be on the
outside of the packaging for each HPV TMA Test Kit and on any
product insert included with the product or
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otherwise published by GPRO, or such
other reasonably prominent location(s) as shall be specified by
ROCHE from time to time.
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7.2
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Patent Marking
. ROCHE will mark all
HPV Products as appropriate under statutory patent provisions with
respect to the ROCHE HPV Patents. GPRO will also mark all HPV TMA
Test Kits as appropriate under statutory patent provisions with
respect to the ROCHE HPV Patents on both the outside packaging and
any product insert included with the product or otherwise published
by GPRO as reasonably directed by ROCHE from time to time. With
respect to containers of HPV Products included in
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