BiotechAccess Agreement
10.50c
AFFYMETRIX
This
BiotechAccess Agreement (the "Agreement") is entered into by and between
Affymetrix, Inc., having its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("Affymetrix") and Gene Logic Inc. ("Gene
Logic"), having its principal place of business at ▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇, ▇▇▇, each a "Party," and together the "Parties" to
this
Agreement as of January 1,2007 (the "Effective Date").
Subject
to
the terms of this Agreement, Affymetrix is pleased to offer to Gene Logic
participation in our BiotechAccess™ Program ("Program"). This Program is
specifically designed to meet the needs of smaller biotechnology companies
desiring access to Affymetrix' array technology. The benefits you will receive
as a BiotechAccess subscriber are described below:
Definitions
"Affiliates"
means any corporation, company, partnership, joint venture and/or firm which
is
controlled by or controls a Party or is under common control with a Party,
but
only for so long as such Affiliate remains an Affiliate of a Party, and only
if
such Affiliate is bound by the terms of this Agreement. For purposes of this
Section, "control" shall mean, (i) beneficial ownership of at least fifty
percent (50%) of the voting securities of a corporation or other business
organization with voting securities (or such other percentage as required to
establish control in the relevant jurisdiction); or (ii) a fifty percent (50%)
or greater interest in the net assets or profits of a partnership or other
business organization without voting securities; (or such other percentage
as
required to establish control in the relevant jurisdiction).
"Database"
means a collection of data derived from Probe Arrays and licensed or otherwise
made available by Gene Logic or a third party to multiple unrelated parties
in
whole or in part for use in analysis or otherwise to derive additional
information.
"GeneChip
Products" means all Probe Arrays and the related kits and reagents currently
~available for sale as listed on Exhibits
1
and any
other kits, reagents or other consumable products now or hereafter generally
offered for sale by Affymetrix and any custom Probe Arrays available through
the
programs specified in the definition of Probe Array.
"Instruments"
means any instruments or other equipment sold by Affymetrix for use with
GeneChip Products.
"Internal
R&D" means using GeneChip Products and/or Probe Arrays, other than for
providing Services and more specifically for (a) internal research, testing,
validation, or training at Gene Logic, (b) product or service development,
including, but not limited to, generating data for inclusion in Databases made
available by Gene Logic or offered for license or sale, and (c) research
projects involving collaboration with one or more customers or other third
parties.
"Marks"
means the trademarks, service marks, logos and tradenames owned or controlled
by
each Party.
"Probe
Array" means a solid support having an array of polynucleotides with known
location and sequence fabricated by or for and sold by Affymetrix for use in
expression analysis and genotyping and shall include all probe arrays generally
offered by Affymetrix for commercial sale during the Term as well as arrays
available through Affymetrix' current CustomExpress®, NimbleExpress™ and
Made-to-Order programs, as well as resequencing arrays available through
Affymetrix' current CustomSeq® program, including those now available as
indicated on Exhibits
1.
Such
arrays must be purchased in whole wafer increments unless otherwise indicated
in
Exhibits
1.
All
other custom arrays/array designs will be mutually agreed to in writing between
the Parties in advance.
"Services"
means the use of GeneChip Products in generation of data that will be provided
to a third party for a service fee. Services shall include data developed by
Gene Logic and/or its Affiliates for a third party for such third party's use.
Services may include "Data Generation Services," in which samples are processed
to obtain data for a third party, and "Analysis Services," in which Gene Logic
may provide analysis services using its data or data obtained from a third
party
or from processing samples provided by Gene Logic or the third party. Services
shall not include activities classified hereunder as Internal
R&D.
"Software"
means any software installed on an Instrument or otherwise made available by
Affymetrix for use with GeneChip Products or other commercially available
Affymetrix products or servIces.
"Term"
has
the meaning defined in Section 10 of this Agreement.
"Effective
Date" shall have the meaning set forth in the first paragraph of the
Agreement
1.
License
to Buy and Use GeneChip Products and/or Probe Arrays at Reduced
Pricing:
As
a
participant in the Program and subject to the terms of this Agreement, Gene
Logic shall, during the Term, be entitled to purchase and use for Internal
R&D the GeneChip Products and Probe Arrays and related reagents ("Products")
listed in the price sheet(s) attached as Exhibit 1 hereto ("Price Lists(s)").
Any deviation from standard GeneChip Product or Probe Array design and
manufacturing processes will require a specific quotation for an individual
design and will be considered outside of the CustomExpress program. Additional
specifications are available in the Affymetrix GeneChip CustomExpress Array
Design Guides. All CustomExpress Arrays must be ordered and purchased in whole
lot increments, which may be changed upon reasonable notice from
Affymetrix.
2.
Reductions
to Price During the Term.
If
during
the Term Affymetrix reduces the price of its products or services from those
in
the Price List whether by amendment or bye-mail notice or by any other written
document and such price reduction is offered to Gene Logic, Gene Logic may
purchase quantities of products upon such terms provided by Affymetrix and
subject to any conditions specified by Affymetrix in connection
therewith.
3.
Software.
As
a
participant in the Program and subject to the terms of this Agreement (including
the Terms and Conditions) and the licenses applicable to such products, Gene
Logic may purchase during the Term the following Affymetrix software products
at
prices discounted ten percent (10%) from Affymetrix' then current regional
list
prices:
a)
Perpetual licenses for Affymetrix GeneChip Operating Software (GCOS) and
GeneChip DNA Analysis Software (GDAS); and
b)
All
External Developers Program software.
These
discounts will not apply to Software packages that are sold in combination
with
computer hardware. Gene Logic may purchase Affymetrix' standard software
maintenance services pursuant to an Affymetrix Software Maintenance Agreement
available from Affymetrix.
4.
Training
As
a
participant in the Program and subject to the terms of this Agreement, Gene
Logic shall be entitled during the Term to receive one (1) day of training
per
year. Additional days training may be purchased at a rate of
$5,000.00/day.
5.
Access
Fees.
In
exchange for the licenses and rights granted to Gene Logic herein, Gene Logic
agrees to pay to Affymetrix the annual, non-refundable subscription payment
of
$50,000 ("BiotechAccess Fee"). The BiotechAccess Fee will be paid to Affymetrix
within thirty (30) days of the Effective Date and on each subsequent anniversary
of the Effective Date during the Term. Gene Logic acknowledges and agrees that
the foregoing BiotechAccess Fee is not creditable toward the purchase of any
products or services. All fees payable under this Agreement exclude sales,
use,
VAT, consumption and other similar taxes and Gene Logic shall be responsible
for
paying all such taxes. The BiotechAccess Fee in addition to the fees associated
with the purchase of GeneChip Products and Probe Arrays are the only
consideration furnished by Gene Logic for the rights and licenses granted
herein. Accordingly, Gene Logic shall not be obligated to pay any additional
annual access or subscription fee(s) or royalties to Affymetrix under this
Agreement during the Initial Term (without prejudice to any amounts owed under
previous agreements between the parties).
Notwithstanding
the foregoing, for any year in which Gene Logic is an Affymetrix Service
Provider under the terms and conditions of the Service Provider Agreement,
Affymetrix agrees to waive the BiotechAccess Fee otherwise applicable to that
year.
7.
Site
Restrictions.
Gene
Logic
acknowledges and agrees that all GeneChip Products and Probe Arrays purchased
pursuant to this Agreement may only be used at Gene Logic's sites listed in
Exhibit
2.
Additional sites may be added or new sites may be substituted for old sites
during the Term by Gene Logic pursuant to written notification to Affymetrix.
Affymetrix reserves the right to charge a "Site Fee" for additional
sites.
8.
Terms
and Conditions.
The
Products and services provided to Gene Logic under this Agreement shall be
subject to Terms and Conditions of Sale (including all Addenda) attached hereto
as Exhibit 3 ("Terms and Conditions"). If any of the terms of this Agreement
conflict with the Terms and Conditions, then the terms of this Agreement shall
govern. Unless otherwise defined herein, all capitalized terms used in this
Agreement shall have the meaning ascribed to them in the Terms and
Conditions.
9.
Trademark
Use.
a)
Each
Party recognizes that the other Party hereto has developed valuable Marks,
as
listed on Exhibit 4 hereto, and may in the future develop additional Marks.
Each
Party may desire to describe the other Party as a customer (in the case of
Service Provider) or a supplier (in the case of Affymetrix) in public marketing
materials and technical materials published by such Party for marketing purposes
and to use the other Party's Marks in such materials. Each Party may make such
a
general description of the Parties' relationship and use the other Party's
Marks
to assist with such description (i.e., to refer to or generally describe such
Party's products or services) without the prior approval of the other Party,
provided that the description is not inconsistent with information on the other
Party's website or current published materials and, provided further, that
the
use of the other Party's ▇▇▇▇ is limited to text and is not the logo or stylized
▇▇▇▇ itself. Each Party shall allow the other Party reasonable prior review
and
approval of any more detailed description of the other Party's products or
services, and any use of the other Party's logos or stylized Marks, in any
of
its proposed marketing materials, such approval not to be unreasonably withheld
or delayed. Service Provider will also include on its website a link to the
Affymetrix website along with a brief description of the relationship between
Affymetrix and Service Provider that has been approved in advance by Affymetrix,
such approval not to be unreasonably withheld or delayed.
(b)
Each
Party acknowledges the ownership and renown of all Marks used by the other
Party
prior to this Agreement that are listed on Exhibit
4.
Each
Party will maintain a quality standard, in connection with its products and
services promoted in a manner that uses the other Party's Marks or refers to
the
other Party's products and/or services, that is at least as high as the standard
such Party maintains for any of its other comparable products or services.
Subject in all cases to the terms of Section 9(a) and this Section 9(b), each
Party hereby authorizes the other Party to use its name and Marks for the
specific purpose of identifying and/or promoting the other Party's products
and
services and identifying the manner in which such Party is involved in the
other
Party's products or services, and for no other purpose. If, in each Party's
sole
discretion, the other Party's use of the first Party's Marks in marketing
materials does not meet the first Party's trademark usage policy, the first
Party may notify the other Party of the specific objection to the use of a
specific ▇▇▇▇ or Marks and, if the other Party is unable to correct its usage
to
the reasonable satisfaction of the party owning the Marks within sixty (60)
days
after receipt of such notice, such Party at its option, may terminate the right
of the other Party to use such specific ▇▇▇▇ or Marks.
10.
Term
and Termination; Entire Agreement.
This
Agreement will be effective as of the Effective Date and will be in force for
three (3 J years ("Initial Term"). This Agreement may be renewed for additional
one 0) year periods through mutual written consent ("Renewal Term"). Initial
Term and any Renewal Term(s) shall be referred collectively as "Term". The
pricing extended to Gene Logic may be updated by Affymetrix from time-to-time
during the Initial Term of the Agreement and subsequent Renewal Terms, if
any.
This
Agreement may be executed in any number of counterparts, each of which shall
be
deemed an original but all of which together shall constitute one and the same
instrument. Accordingly, the pricing set forth in this Agreement will only
apply
to firm Gene Logic orders accepted by Affymetrix during the Term. The provisions
of the Terms and Conditions shall survive the termination of this Agreement
in
accordance with their terms.
This
Agreement, together with its exhibits (including the Terms and Conditions),
constitutes the entire agreement between Gene Logic and Affymetrix with respect
to the subject matter hereof and is the final, complete, and exclusive statement
of the terms of the Agreement, superseding all prior written and oral
agreements, understandings and undertakings, as well as the terms of any current
future purchase orders or similar forms.
11.
Assignment.
Gene
Logic
may assign this Agreement without Affymetrix' consent to an Affiliate and to
a
successor to substantially all (or a substantial part that constitutes a
majority) of the business of Gene Logic that relates to providing Services
and/or undertaking Internal R&D, whether in merger, sale of stock, sale of
assets or other similar transaction (and in connection with such an assignment
may also transfer to such successor any portion of the inventory of Gene Chip
Products or Probe Arrays then held by or on order from or in shipment to Gene
Logic. Otherwise, this Agreement shall not be assignable by Gene Logic without
the prior written consent of Affymetrix, such consent not to be unreasonably
withheld or delayed.
If
these
terms are agreeable to you, please have an authorized representative of Gene
Logic sign below and either fax, mail or send us an electronic copy for our
counter-signature. A fully executed copy will then be sent back to you for
your
records
AGREED
AND ACKNOWLEDGED:
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Affymetrix,
Inc.
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By:
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/s/
▇▇▇▇▇ ▇▇▇▇▇▇▇, Ph.D.
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By:
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/s/
▇▇▇▇▇ ▇▇▇▇▇▇▇
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Name:
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▇▇▇▇▇
▇▇▇▇▇▇▇, Ph.D.
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Name:
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▇▇▇▇▇
▇▇▇▇▇▇▇
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Title:
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Sr.
Vice President
Marketing
& Sales
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Title:
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Sr.
Vice President & General Manager
Genomics
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Date:
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1/9/07
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Date:
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1/4/07
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Exhibit
3
Affymetrix
Terms and Conditions of Sale
1.
General.
These
Terms and Conditions of Sale ("Terms and Conditions") shall govern the sale
and
license to the purchaser ("Buyer") of probe arrays, reagents, instruments,
software, and other products and related services ("Products") by the Affymetrix
entity named on the invoice or acknowledgement ("Affymetrix") provided to Buyer
in connection therewith. These Terms and Conditions shall replace and supersede
any current or future purchase orders or similar forms other than those as
provided in paragraph 1.3 of the Service Provider Agreement or that are mutually
signed by Affymetrix and Buyer.
2.
Price.
Except
for deliveries within Europe, prices exclude all insurance, freight, taxes,
fees, duties and levies, which shall be payable by Buyer.
3.
Delivery.
Products
will be packed in Affymetrix' standard shipping packages. Affymetrix may make
partial deliveries. Affymetrix will ship via carrier selected by
Affymetrix.
3.1
For
Deliveries Outside Europe: Tender will be F.O.B./FCA shipping point. Title
(except for software in which case Affymetrix shall retain title) and risk
of
loss or damage will pass to Buyer upon delivery of the Products to the
carrier.
3.2
For
Deliveries Within Europe: Products shall be Delivered Duty Paid to the Buyer's
site and the Buyer will be the importer for the Products and be responsible
for
paying the import VAT or similar taxies) within the Buyer's country. Title
(except for software in which case Affymetrix shall retain title) and risk
of
loss will pass to Buyer upon delivery of the Products to the carrier. Insurance
costs will be borne by Affymetrix to the Buyer's site.
3.3
Custom
Arrays.
Upon
Affymetrix confirming receipt of complete Buyer Target Sequences and related
information for each new Custom Probe Array design, Affymetrix will use
reasonable efforts to design, layout, produce masks, and manufacture the initial
lot of Custom Probe Arrays for each such custom design as follows: (i) within
12
weeks if Buyer orders only one Custom Probe Array design; (ii) within fourteen
(14) weeks for up to four (4) custom designs; and (iii) for more than four
(4)
custom designs, according to the schedule quoted to Buyer and/or its Affiliates
at the time they order such Custom Probe Array designs. Where Buyer and/or
its
Affiliates have ordered more than one custom design, Affymetrix reserves the
right to provide the initial lots of Custom Probe Arrays for each such design
at
separate times, at Affymetrix' sole discretion, subject to the maximum time
periods described in the previous sentence; in such case, the order that the
initial lots of each such design will be provided relative to such other designs
will be determined by a priority list submitted by Buyer at the time it orders
the designs or, if no such list is submitted, in Affymetrix’ discretion. In no
event shall Affymetrix be obligated to supply more than twelve (12) custom
designs per year. Delivery times for all additional lots of Custom Probe Arrays
ordered pursuant to this letter will be quoted at the time Affymetrix receives
a
firm order for such products and shall not exceed four (4) weeks from the date
of such order. Buyer acknowledges that implementation of any deviations for
a
particular custom design may increase the time period between order placement
and delivery of Custom Probe Arrays based on any such design. All such time
extensions for a particular custom design will be discussed with Buyer prior
to
start of such design. All Custom Probe Arrays must be ordered and purchased
in
whole-lot increments.
3.4
Excluding
Custom Probe Arrays.
Affymetrix will use commercially reasonable efforts to ship the Products within
twenty-one (21) business days of receipt of a valid, accurate purchase order(s).
Affymetrix or its representative will ship via carrier selected by Affymetrix
or
its representative to Buyer at ▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇,
▇▇▇▇▇, ▇▇▇ or such other address as may be specified by Buyer. If shipment
is
delayed at Buyer's request, Buyer will reimburse Affymetrix for all reasonable
costs of storage.
4.
Rejection.
Any
claims for visibly damaged, missing or apparently defective Product must be
reported in writing to Affymetrix by Buyer within five (5) business days from
the date of receipt of Product. For any valid claim made, Affymetrix shall
repair or replace the Product. The foregoing shall be Buyer's sole and exclusive
remedy for damaged or missing Products, and, except for express warranty rights,
for defective Products.
5.
Payment.
Buyer
will be invoiced at the time of shipment of each Product. Except as otherwise
agreed in writing by Affymetrix, Buyer shall make payment in full within 30
days
of the date of the invoice. Late payments may incur a charge at the rate of
one
and one-half percent (1.5%) percent per month, or the maximum allowed by law,
whichever is less. Further shipment of Products may be deferred until payment
is
received if Buyer fails to make any undisputed payment when due and thereafter
fails to cure such nonpayment within ten (10) business days after receipt of
notice thereof. If Buyer's account is more than thirty (30) days past due and
is
referred to an attorney or collection agency for collection, Buyer shall pay
Affymetrix' reasonable expenses incurred in such collection efforts including,
without limitation, court costs and reasonable legal fees and expenses. Sales
by
Affymetrix shipped outside the U.S. may require payment on an irrevocable letter
of credit reasonably acceptable to Affymetrix.
6.
Limited
Warranty.
Affymetrix warrants to and only to Buyer for thirteen (13) months from the
date
of shipping or one (1) year from the date of installation (or for the period
specified in the Affymetrix sales quote for limited-life parts), whichever
occurs first, that the software and instruments are free from defects in
material and workmanship and conform to Affymetrix' published specifications
in
all material respects. Service will be provided pursuant to Affymetrix' standard
service terms and conditions. Affymetrix' sole and exclusive liability (and
Buyer's sole and exclusive remedy) under the foregoing warranty shall be to
repair or replace software and instruments or provide Buyer a refund, as solely
determined by Affymetrix. Nonconforming instruments will be serviced at Buyer's
facility or, at Affymetrix' option, Affymetrix' facility. If service is
performed at Affymetrix' facility, Affymetrix will bear shipping
costs.
Probe
Arrays or reagents reasonably determined by Affymetrix to be defective,
independent of user error, shall be replaced by Affymetrix on a 1: 1, like-kind
basis at no cost to Buyer provided that such defective probe arrays or reagents
were used by Buyer prior to their expiration date, and the defect was promptly
reported with appropriate detail to Affymetrix' technical support. Affymetrix
agrees to meet with Buyer on a quarterly basis to review the defect
determination to ensure that the Probe Arrays or reagents are properly
categorized as being "defective". Except as provided above, this warranty does
not apply to consumables, or to any defect caused by failure to provide a
suitable storage, use, or operating environment, use of non-recommended
reagents, spills, or the use of the Products for a purpose or in a manner other
than that for which they were designed, modifications or repairs done by Buyer,
or any other abuse, misuse, or neglect of the Products. This warranty applies
only to Buyer, and not third parties. The foregoing is not intended to limit
any
warranty extended to Buyer by a third party original equipment manufacturer
of a
Product or component thereof, provided that any remedy received by Buyer under
any such warranty shall relieve Affymetrix of its obligations with respect
to
the subject of such remedy. TO THE EXTENT PERMITTED BY APPLICABLE LAW,
AFFYMETRIX AND ITS SUPPLIERS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES,
EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCTS AND SERVICES, INCLUDING BUT NOT
LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY,
NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
7.
Pre-release
Products (Not Applicable to Products Marketed for IVD Use).
If any
Product is a beta, technology access, early access, or other pre-commercial
release version ("Pre-release Product"), then this Section applies. To the
extent that any provision in this Section is in conflict with any other term
or
condition in these Terms and Conditions, this Section shall supersede such
other
term(s) and condition(s) with respect to the Pre-release Product, but only
to
the extent necessary to resolve the conflict. Buyer acknowledges that the
Pre-release Product is a pre-release version, does not represent final product
from Affymetrix, and may contain defects, bugs, errors and other problems that
could cause system or other failures, sample loss and data loss. CONSEQUENTLY,
THE PRE-RELEASE PRODUCT IS PROVIDED TO YOU "AS IS", AND AFFYMETRIX DISCLAIMS
ALL
WARRANTIES (INCLUDING THE LIMITED WARRANTY SET FORTH ABOVE) AND ALL LIABILITY
OBLIGATIONS TO BUYER OF ANY KIND. Buyer acknowledges that Affymetrix has not
promised or guaranteed to Buyer that Pre-release Product will be announced
or
made available to anyone in the future, that Affymetrix has no express or
implied obligation to Buyer to announce or introduce the Pre-release Product
and
that Affymetrix may elect not to introduce a product similar to or compatible
with the Pre-release Product. Accordingly, Buyer acknowledges that any research
or development that Buyer performs using the Pre-release Product or any product
associated with the Pre-release Product is done entirely at Buyer's own Risk.
If
Buyer has been provided the Pre-release Product pursuant to a separate written
agreement with Affymetrix, this Section shall not apply and Buyer's use of
the
Pre-release Product is governed by such agreement, unless expressly provided
otherwise therein.
8.
Limited
License.
8.1
Subject to these Terms and Conditions, and to the terms and conditions of any
license provided by Affymetrix that is specific to a particular Product (which
shall govern with respect to such Product in the event of conflict with these
Terms and Conditions), Affymetrix hereby grants to Buyer a non-exclusive,
non-transferable, non-sublicensable license to use the Product(s) provided
to
Buyer by Affymetrix only in accordance with the manuals and written instructions
provided by Affymetrix. Buyer may make one (1) copy of software Products for
backup purposes only. Buyer agrees not to disassemble, decompile or otherwise
reverse engineer, or adapt or modify, any software Product.
8.2
Notwithstanding any other provision hereof, nothing herein is intended as a
contractual obligation precluding Buyer from using non-Affymetrix products,
such
as target labeling and processing reagents, with the Products supplied to Buyer
pursuant to the Agreement; provided however, that Affymetrix makes no
representations or warranties regarding any suitability of non-Affymetrix
products for use with such Products, or vice versa, and Affymetrix hereby
disclaims such representations and warranties. Buyer uses such non-Affymetrix
products entirely at Buyer's own risk and Affymetrix shall have no liability
to
Buyer or any third party in respect of such use. Affymetrix shall not provide
any support to Buyer in respect of such use of non-Affymetrix
products.Furthermore, notwithstanding any other provision hereof, nothing herein
is intended as a contractual obligation precluding Buyer from using Products,
including Affymetrix-offered reagents, with other products from third parties.
Buyer agrees to indemnify the Affymetrix Group (as defined below) for any claims
made by or on the part of a third party arising from Buyer's use of
non-Affymetrix products in connection with Products. However, this paragraph
shall not be construed as conveying, by implication, estoppel or otherwise,
or
expanding to the scope of, any right or license to Buyer under any patent right
of Affymetrix.
8.3
Buyer
understands and agrees that except as expressly set forth in these Terms and
Conditions (or in the Affymetrix-provided license specific to a particular
Product), no right or license to any patent or other intellectual property
owned
or licensable by Affymetrix is conveyed or implied by these Terms and Conditions
or any Product. In particular, no right or license is conveyed or implied to
use
any Product provided hereunder in combination with a product not provided,
licensed or specifically recommended by Affymetrix for such use.
9.
Products
Marketed for Research Use Only.
Products
marketed by Affymetrix for research use only do not have the approval or
clearance of the U.S. Food and Drug Administration ("FDA") or other regulatory
approval, clearance or registration for in vitro diagnostic ("IVD") use. No
license is conveyed or implied for Buyer to use, and Buyer agrees not to use,
such Products in any manner requiring FDA or other regulatory approval,
clearance or registration relating to IVD use.
10.
Products
Marketed for In Vitro Diagnostic Use.
Products
marketed by Affymetrix for IVD use have been cleared by the FDA, CE marked
in
the European Union and registered in Canada, for IVD use. No license is conveyed
or implied for Buyer to use, and Buyer agrees not to use, such Products in
any
manner requiring other regulatory approval, clearance or registration relating
to IVD use.
11.
Use
Restrictions.
Buyer is
not licensed to, and agrees not to: (a) resell any Affymetrix-supplied probe
array or reagent, (b) transfer, or distribute any Affymetrix-supplied probe
array or reagent, directly or indirectly, to any third party for any purpose
or
use, except as otherwise approved by Affymetrix in writing; or (c) use or allow
anyone to use any Affymetrix-supplied probe array or reagent more than once,
or
dilute any Affymetrix-supplied reagent.
12.
Product
Improvements.
12.1
For
purposes of this Section, "Assay Improvement Invention" shall mean any invention
conceived or reduced to practice by Buyer or its Affiliates during the Term
using Affymetrix Probe Arrays that relates to manual or automated assay
techniques that may be used in connection with Probe Arrays or similar products,
but only insofar as such techniques are used for and after nucleic acid
extraction and up to and including annealing and washing hybridization mixtures
with a Probe Array, but not to techniques used thereafter.
12.2
For
purposes of this Section, "Product Improvement Invention" shall mean any
invention conceived or reduced to practice by Buyer or its Affiliates during
or
after the Term using Affymetrix Probe Arrays supplied to Buyer or its Affiliates
during the Term that relates to (a) design, manufacturing, layout or packaging
of nucleic acid probes or probe arrays; or (b) software techniques relating
to
the extraction or storage of data generated using Probe Arrays after samples
have been annealed to the Probe Arrays (e.g., techniques used in generation
of
*.cel and *.dat files), but not including any techniques used thereafter (e.g.,
software techniques for analysis or other processing of data beyond what is
required for generation of *.cel and *.dat files). Product Improvement
Inventions also shall not (1) include data generated using Probe Arrays or
discoveries derived therefrom (except as expressly set forth in (a) and (b)
above} or (2) any Assay Improvement Invention, as defined herein. Neither
Product Improvement Inventions nor Assay Improvement Inventions shall include
(3) Target Sequences identified by Buyer as hereinafter described or (4) any
discoveries or inventions made using data obtained from use of the Affymetrix
Probe Arrays, including but not limited to, discoveries or inventions relating
to identification of markers used in biological, toxicological and clinical
applications, correlations between nucleic acid sequences and functions, targets
for drug discovery and development and processes for determining and
understanding toxicity. For clarification, such markers include without
limitation, those derived from analysis of gene expression and genotyping data
generated from Probe Arrays.
12.3
As
used herein an invention conceived or reduced to practice "using Affymetrix
Probe Arrays" means an invention that was actually made using such
arrays.
12.4
For
purposes of this Agreement, "Affymetrix Probe Array(s)" shall mean Probe Arrays
for which Target Sequences have been selected by Affymetrix ("Affymetrix Target
Sequences"), or jointly by Affymetrix and Buyer ("Buyer Target Sequences")
for
use on Probe Arrays to be supplied by Affymetrix as set forth
below.
12.5
Except to the extent prohibited by applicable law, Buyer hereby grants to
Affymetrix and its Affiliates a nonexclusive, worldwide, fully paid-up,
royalty-free, irrevocable, perpetual license to all Product Improvement
Inventions, with a right for Affymetrix and its Affiliates to sublicense but
only to Affymetrix' and its Affiliates' partners and customers for use with
Affymetrix Probe Arrays. Buyer need not disclose any Product Improvement
Inventions to Affymetrix except as may be reasonably required to comply with
the
foregoing license.
12.6
If
Buyer elects, at its sole discretion, to commercialize a product or process
that
embodies an Assay Improvement Invention for use by multiple unrelated parties,
then to the extent that Buyer makes such product or process available to other
parties, Buyer agrees to negotiate in good faith with Affymetrix (and, if
necessary with Affymetrix customers and partners) to make each such product
or
process available to Affymetrix and all Affymetrix customers and partners for
use with Affymetrix Probe Arrays on commercially reasonable terms comparable
to
those granted to other parties, provided that such terms may differ based on
the
type of party (e.g., non-profit vs. for-profit), the size of the party, the
number of individual users or volume of use of the product or process, the
size
of the party's R&D budget, the type of use intended or other factors fairly
applied, and, provided further, that this obligation to license on comparable
terms shall not apply to licenses granted or products sold for limited uses,
including evaluation, validation and testing or small sales for one-time or
otherwise very limited use. For clarity, if Buyer elects to commercialize such
product or process by making it available to others subject to restrictions
or
other terms that would preclude others from using such product or process in
business activities that would directly compete with Buyer's business
activities, then Buyer would not be obligated to make such product or process
available to Affymetrix or Affymetrix customers or partners on terms that did
not include the same restrictions or other terms precluding use of such products
or processes that would directly compete with Buyer's business
activities.
12.7
Notwithstanding the above, Buyer need not make available such Assay Improvement
Invention to Affymetrix and all required Affymetrix customers and partners
on
comparable terms if a third party has already been granted in good faith by
Buyer a conflicting assignment or license (or an option to obtain such an
assignment or license) at or prior to the time the embodied Assay Improvement
Invention is made. Buyer need not disclose Assay Improvement Inventions to
Affymetrix until such time as Buyer has elected to commercialize such product
or
process and makes it available to multiple other parties.
13.
Indemnity
for Intellectual Property Infringement Claims.
13.1
Affymetrix will indemnify Buyer and its Affiliates against liability and will
settle or defend any suit or proceeding brought against Buyer and its Affiliates
to the extent based on a claim that Buyer or its Affiliates in using the
Products delivered hereunder directly infringe an issued patent in the United
States of America, the European Patent System (EPO), Japan or the Republic
of
Korea.
13.2
Affymetrix will also indemnify Buyer and its Affiliates against liability and
will settle or defend any suit or proceeding brought against Buyer and its
Affiliates to the extent based on a claim that Buyer or its Affiliates in using
the Products delivered hereunder indirectly (i.e. through contributory
infringement or inducement) infringe an issued patent in the United States
of
America, EPO, Japan or the Republic of Korea if (i) a hybridization method
using
probe arrays, or probe arrays themselves, or equivalent hybridization devices
are specifically identified as an element of the claims of such patent in a
device claim, or use of these is specifically identified as an element of the
claims of such patent in a method claim, and (ii) the patentability of such
device or method claims was materially related to the recitation of the
hybridization method or the probe arrays or equivalent hybridization device,
or
their use.
13.3
Affymetrix shall have no liability under this Section to the extent that the
alleged infringement arises out of any addition or modification to the Products
or their use by Buyer and its Affiliates in any material respect not specified
or approved by Affymetrix, or Buyer's and its Affiliates' combination of the
Products with other devices not specified or approved by Affymetrix, and Buyer
shall indemnify Affymetrix and its Affiliates against liability and will settle
or defend any suit or proceeding brought against Affymetrix and its Affiliates
to the extent based on the foregoing. The indemnifying Party shall pay all
damages and costs finally awarded against the indemnified Party for such
infringement including reasonable attorney's fees.
13.4
For
this Section to apply, the indemnified Party must promptly inform the
indemnifying Party (so as not to prejudice the indemnifying Party in its
preparation of a defense) of its receipt of notice of any claim or suit being
made or brought, and give the indemnifying Party the full authority,
information, and assistance necessary to settle or defend such suit or
proceeding, provided that the indemnifying Party shall not have any authority
to
agree to any settlement that imposes any liability or obligation on the
indemnified Party without the consent of the indemnified Party, which consent
will not be unreasonably withheld so long as the indemnifying Party will satisfy
or pay without recourse any liability imposed on the indemnified Party and
the
indemnified Party is not required to take any action or refrain from taking
any
other action other than discontinuing use of any product or process found to
be
infringing. Neither Party shall be bound in any manner by any settlement made
without its prior written consent.
13.5
In
the event that the Products are held to infringe and their use is enjoined
as a
result of infringement for which it has indemnified Buyer and its Affiliates,
as
part of its indemnification, Affymetrix may obtain for Buyer and its Affiliates
the right to continue using such Products, modify them or the processes for
using them to become non-infringing in such manner that does not materially
impair their usefulness to Buyer, or grant Buyer and its Affiliates a credit
for
the cost of unused Products, and accept the return of unused
Products.
13.6
In no
event shall an indemnifying Party's aggregate, cumulative liability arising
out
of or relating to its indemnity obligations described in this Section exceed
an
amount equal to the amounts paid by Buyer to Affymetrix under this Agreement
(the "Cap"). The Cap is in the aggregate with all expenses incurred by the
indemnifying Party arising out of or relating to its indemnity obligations
(including, without limitation, damages, settlement amounts, costs, and legal
fees) being aggregated to determine satisfaction of the limit. The existence
of
one or more claims or suits will not enlarge the Cap. THE PROVISIONS OF THIS
SECTION STATE THE ENTIRE LIABILITY AND OBLIGATION OF EACH PARTY AS AN
INDEMNIFYING PARTY, AND THE EXCLUSIVE REMEDY OF EACH PARTY AS AN INDEMNIFIED
PARTY, WITH RESPECT TO ANY ALLEGED OR ACTUAL INFRINGEMENT OF INTELLECTUAL
PROPERTY RIGHTS, AND ARE IN LIEU OF ALL WARRANTIES OF NONINFRINGEMENT, EXPRESS
OR IMPLIED.
14.
Target
Sequence Confidentiality for Custom Products.
If Buyer
discloses to Affymetrix a confidential set of nucleic acid target sequences
("Target Sequences") for which Buyer desires Affymetrix to design and
manufacture custom Probe Arrays or custom nucleic acid probe panels pursuant
to
these Terms and Conditions, Affymetrix agrees to use reasonable efforts not
to
disclose or use such confidential information disclosed to it by Buyer for
any
purpose other than designing and manufacturing such Products, supplying them
to
Buyer and/or other parties designated by Buyer, otherwise performing its
obligations to Buyer (and any obligations Affymetrix may have to such other
parties), and for other purposes authorized by Buyer. The provisions of this
Section shall not apply to any information which Affymetrix can demonstrate
by
competent proof (a) is known or used by Affymetrix prior to Buyer's disclosure
to Affymetrix; (b) is disclosed to Affymetrix by a third party under no
obligation of confidentiality to Buyer; (c) is or becomes published or generally
known to the public through no fault of Affymetrix; or (d) is independently
developed without reference to such confidential information disclosed to
Affymetrix by Buyer. Notwithstanding the foregoing, Affymetrix shall be
permitted to disclose such information in order to comply with applicable laws,
a court order, or governmental regulations, provided that Affymetrix has
provided Buyer with prior notice of such disclosure, to the extent reasonably
practicable. Affymetrix' obligations under this Section shall terminate five
(5)
years following the date of disclosure.
15.
Target
Sequence Responsibility.
Buyer
shall be fully responsible for the Target Sequences, and Buyer agrees to
indemnify Affymetrix and its employees, officers, directors, representatives,
contractors, suppliers and any affiliate of the foregoing (the "Affymetrix
Group") and hold each of them harmless from and against any losses, liabilities,
demands, damages, costs and expenses, including without limitation reasonable
legal fees and expenses, arising from or relating to the Target Sequences or
their use as permitted herein, except to the extent that such losses,
liabilities, demands, damages, costs and expenses result from the gross
negligence or willful misconduct of Affymetrix. Buyer agrees to fully cooperate
with the Affymetrix Group and its counsel in its defense and preparation for
any
such action or proceeding.
16.
Liability
Limitation.
EXCEPT
AS PROVIDED IN THE INDEMNITY FOR INTELLECTUAL PROPERTY HERElN OR TO THE BY
EITHER PARTY’S GROSS NEGLIGENCE OR WILFUL MISCONDUCT, OR REQUIRED BY APPLICABLE
LAW, NEITHER PARTY NOR ITS REPRESENTATIVES SHALL HAVE ANY LIABILITY FOR ANY
LOSS
OF USE OR PROFITS, PROCUREMENT OF SUBSTITUTE GOODS OR ANY INDIRECT,
CONSEQUENTIAL, INCIDENTAL, OR SPECIAL DAMAGES OF ANY KIND, HOWEVER CAUSED AND
REGARDLESS OF FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE),
STRICT PRODUCT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY HAS BEEN ADVISED
OF
THE POSSIBILITY OF SUCH DAMAGES; AS TO ANY LIABILITY OF EITHER PARTY TO THE
OTHER NOT LEGALLY SUBJECT TO THE FOREGOING, THE LIABILITY OF EITHER PARTY SHALL
NOT EXCEED THE CAP AS TO THE INDEMNITY FOR INTELLECTUAL PROPERTY INFRINGEMENT
AS
PROVIDED IN SECTION 13 HEREOF AND AS TO ANYTHING ELSE AN AMOUNT EQUAL TO THE
AMOUNT PAID BY BUYER TO AFFYMETRIX IN THE PRIOR TWELVE (12) MONTHS. EACH PARTY
UNDERSTANDS THAT THE RISKS OF LOSS HEREUNDER ARE REJECTED IN THE PRICE OF THE
PRODUCTS AND THAT THESE TERMS WOULD HAVE BEEN DIFFERENT IF THERE HAD BEEN A
DIFFERENT ALLOCATION OF RISK.
17.
Export
Controls.
Buyer
acknowledges that the Products and related materials may be subject to export
controls under the U.S. Export Administration Regulations and related U.S.
laws.
Buyer will (a) comply strictly with all legal requirements established under
these controls, (b) cooperate fully with Affymetrix in any official or
unofficial audit or inspection that relates to these controls and (c) not
export, re-export, divert, transfer or disclose, directly or indirectly, any
Product or related technical documents or materials or any direct product
thereof to any country (or to any national or resident thereof which the U.S.
Government determines from time to time is a country (or end-user) to which
such
export, re-export, diversion, transfer or disclosure is restricted, without
obtaining the prior written authorization of Affymetrix and the applicable
U.S.
Government agency.
18.
Unforeseen
Events.
Affymetrix shall not be liable for delay or failure in performance of any
obligations hereunder if performance is rendered impracticable by the occurrence
of any condition beyond the reasonable control of Affymetrix. In the event
of
any such delay or failure in performance, Affymetrix shall promptly notify
Buyer
of such delay or non-performance and the cause thereof and then shall have
such
additional time within which to perform its obligations hereunder as may
reasonably be necessary under the circumstances, provided Affymetrix shall
use
commercially reasonable efforts to limit the delay or overcome the cause of
the
nonperformance and Affymetrix shall have the right, to the extent necessary
in
Affymetrix' sole reasonable judgment, to apportion fairly among its various
customers in such manner as Affymetrix may consider equitable the Products
then
available for delivery. If such delay or non-performance will continue for
more
than one month, Affymetrix shall provide monthly updates as to the status of
resolving the delay or non-performance.
19.
Miscellaneous.
These
Terms and Conditions and the applicable agreement in which they are incorporated
as an exhibit or by reference constitute the entire agreement between Buyer
and
Affymetrix with respect to the subject matter hereof and are the final,
complete, and exclusive statement of the terms of the agreement, superseding
all
prior written and oral agreements, understandings and undertakings with respect
to the subject matter hereof. For avoidance of doubt, the following agreements
between the Parties shall continue in full force and effect: the HTA Agreement,
the Limited Research and Development License Agreement dated November 2, 2004
and all current Instrument and Software service agreements. The waiver of any
provision or any breach thereof shall not affect any other provision of these
Terms and Conditions. To the extent permitted by applicable law, these Terms
and
Conditions shall be governed by and construed according to the laws of
California, without regard to conflict of law provisions. The U.N. Convention
on
Contracts for the International Sale of Goods shall not apply to these Terms
and
Conditions. In the event that any provision of this Agreement or portion thereof
is found to be illegal or unenforceable, the Agreement shall be construed
without the unenforceable provision or portion thereof.