Affymetrix General Terms and Conditions of Sale
These Terms and Conditions of Sale (“Terms and Conditions”) shall govern the sale and license to the original purchaser (“Buyer”) of probe arrays, assays, reagents, instruments, software, and other products and related services (“Products”) from Affymetrix, one of its subsidiaries or authorized sellers named on the invoice or acknowledgement (Affymetrix, Inc. or any of its subsidiaries named on the invoice is referred to here as “Affymetrix”). These Terms and Conditions shall replace and supersede any current or future purchase orders or similar forms that are not mutually signed by Affymetrix and Buyer. Purchase orders, once accepted by Affymetrix, are not subject to cancellation or modification by Buyer without Affymetrix’s written consent.
(a) For Deliveries Outside Europe: Prices exclude all insurance, freight, taxes, fees, duties and levies, which shall be payable by Buyer.
(b) For Deliveries Within Europe: Prices include all insurance, duties and levies, unless stated otherwise on the quotation or invoice. Freight and handling fees will be prepaid by Affymetrix and added to the invoice for reimbursement by Buyer.
Products will be packed in Affymetrix’s standard shipping packages. Affymetrix may make partial deliveries. Affymetrix will ship via carrier selected by Affymetrix. Delivery dates set forth on a purchase order accepted by Affymetrix are subject to change and are predicated on conditions existing at that time. Affymetrix does not guarantee any delivery dates and shall not be responsible for any loss or damage of any kind or nature whatsoever caused by any delay in delivery irrespective of the cause of such delay.
(a) For Deliveries Outside Europe: Tender will be FCA shipping point. Title (except for software, in which case title does not pass to Buyer) and risk of loss or damage will pass to Buyer upon delivery of the Products to the carrier.
(b) For Deliveries Within Europe: Products shall be Delivered Duty Paid Excluding VAT (DDP Ex VAT) to the Buyer’s site and the Buyer will be the importer for the Products and be responsible for paying VAT or similar taxes within the Buyer’s country. Title (except for software, in which case title does not pass to Buyer) and risk of loss or damage will pass to Buyer upon delivery of the Products to the carrier.
Any claims for damaged, missing or defective Product must be reported in writing to Affymetrix by Buyer within five (5) 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.
Buyer will be invoiced at the time of shipment of each Product. Buyer shall make payment in full within thirty (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 declined without advance notice if Buyer fails to make any payment when due, or if the financial condition of Buyer becomes unsatisfactory to Affymetrix. Affymetrix may elect to retain a security interest in all Products sold to Buyer to secure all of Buyer’s obligations to Affymetrix under these Terms and Conditions, and Buyer will execute any documents necessary to create and perfect this interest. Sales by Affymetrix shipped outside the U.S. may require payment on an irrevocable letter of credit reasonably acceptable to Affymetrix.
6. Limited Warranty
• For new Affymetrix instruments, Affymetrix warrants only to Buyer for the period that is the shortest of (i) thirteen (13) months from the date of shipping; (ii) one (1) year from the date of installation; or (iii) the shortest period specified in the Affymetrix sales quote for limited-life parts, that the operating software and instruments are free from defects in material and workmanship and conform to Affymetrix’s published specifications in all material respects.
• For refurbished Affymetrix instruments, Affymetrix warrants only to Buyer for a period that is the shortest of (i) one-hundred twenty (120) days from shipment; (ii) ninety (90) days from the date of installation; or (iii) the shortest period specified in the Affymetrix sales quote for limited-life parts, that the operating software and instruments are free from defects in material and workmanship and conform to Affymetrix’s published specifications in all material respects.
• For used Affymetrix instruments, Affymetrix warrants only to Buyer for the period that is the shortest of (i) thirty (30) days from date of shipment; (ii) twenty (20) days from the date of installation or (ii) the shortest period specified in the Affymetrix sales quote for limited-life parts, that the instruments and operating software are free from defects in material and workmanship and conform to Affymetrix's published specifications in all material respects.
• For all Affymetrix instruments, warranty service will be provided pursuant to Affymetrix's standard service terms and conditions enumerated therein. Affymetrix's sole and exclusive liability (and Buyer’s sole and exclusive remedy) under the foregoing warranty shall be the repair or replacement of instruments, as solely determined by Affymetrix. Nonconforming instruments will be serviced at Buyer’s facility or, at Affymetrix's option, Affymetrix's facility.
• For 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 or at Affymetrix’s discretion, as a credit for future purchases, provided that such defective probe arrays or reagents were used by Buyer prior to their expiration date, or if there is no expiration date, the Products were used within six (6) months of receipt. The defect must be reported within thirty (30) days of discovery with appropriate detail to Affymetrix's Technical Support team. If the cause of the failure was due to an Affymetrix instrument malfunction, a replacement will be granted only during the instrument warranty period or if the instrument is under an instrument service contract, pursuant to the terms and conditions then in effect.
• For Affymetrix Methods for Automated Target Preparation for GeneTitan®, subject to the conditions and limitations of liability stated herein, Affymetrix warrants, for one (1) year from the date of installation (“Warranty Period”) of the GeneTitan®, for the Buyer’s benefit that the Affymetrix methods for automated target preparation for the GeneTitan® family of instruments (the “Method”) shall operate substantially in accordance with the accompanying documentation provided that; (i) the Method is installed by a qualified Affymetrix representative, (ii) the automated target preparation instrument is installed by a qualified engineer and maintained under a valid service contract or warranty with the third party vendor, (iii) the Method is operated in accordance with the supplied technical instruction from Affymetrix ,(iv) that the associated storage media on which the Affymetrix Terms and Conditions of Sale Method resides is free from defects in material and workmanship. The foregoing warranty shall not apply to (i) Methods that are modified; (ii) Methods that are not the then-current version; (iii) problems caused by Buyer’s negligence or error, a hardware malfunction or other causes beyond the control of Affymetrix; or (iv) Methods installed in an operating environment or in a hardware environment not strictly complying with the Affymetrix specifications required for the Method set forth in the documentation. The warranty stated herein for the Methods do not cover damage to the automated target preparation instrument nor associated consumables and reagents not supplied by Affymetrix.
• Technical Assistance: Affymetrix may, but is not obligated to, furnish technical assistance and information with respect to the Products. Any suggestions by Affymetrix regarding use, selection, application or suitability of the Products shall not be construed as a warranty.
• Third Party Goods: Affymetrix does not provide any warranty with respect to any third party’s instruments, reagents, consumables or software. Third party goods are goods labeled or branded with a third party’s name.
Except as provided above, any warranty provided herein does not apply to any third party products, including third party instruments, reagents and software, or to any defect caused by Buyer’s 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. Affymetrix is not responsible for any costs or expenses incurred by the Buyer due to downtime. Affymetrix may at any time stop providing and supporting the Products (“End of Life”) and will use commercially reasonable efforts to communicate such End of Life events in advance. This warranty applies only to Buyer, and not third parties. Furthermore, this Warranty stated herein shall not apply to product performance failures that are caused by users of the Products who were not trained on and qualified to use the Products and assays by an Affymetrix field service engineer, Affymetrix application specialist, or an authorized Affymetrix seller. 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.
8. Limited License
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 Affymetrix’s Core Product IP to use the Product(s) provided to Buyer by Affymetrix, but only in accordance with the Product labels, inserts, manuals and written instructions provided by Affymetrix. “Core Product IP” is the intellectual property owned or controlled by Affymetrix as of the shipment date of a Product that covers one or more features of the Product that are applicable in all applications of the Product that are in accordance with the Product labels, inserts, manuals and written instructions provided by Affymetrix. The license granted herein to Buyer to the Core Product IP expressly excludes any use that: (i) is not in accordance with the Product labels, inserts, manuals and written instructions provided by Affymetrix, (ii) requires a license to intellectual property that covers one or more features of a Product that are only applicable within particular fields of use or specific applications, (iii) involves reverse engineering, disassembly, or unauthorized analysis of the Product and/or its methods of use, or (iv) involves the re-use of a consumable Product. 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 controlled by Affymetrix is granted by these Terms and Conditions upon purchase of any Product, whether by implication, estoppel or otherwise. In particular, no right or license is conveyed or implied to use any Product provided hereunder in combination with a product or service not provided, licensed or specifically recommended by Affymetrix for such use. Furthermore, Buyer understands and agrees that Buyer is solely responsible for determining whether Buyer possesses all intellectual property rights that may be necessary for Buyer’s specific use of the Product, including any rights from third parties.
9. Product Uses
Products of Affymetrix which are or may be drugs, food additives or diagnostic reagents, as described in the federal food, drug and cosmetic act, are for investigational use only in laboratory research animals or testing in vitro, and are not for drug, new drug, veterinary drug, food, food additive or human use. Unless otherwise indicated, Products are distributed and sold for chemical purposes only, not for drug use or for application to or ingestion by humans or for commercial horticulture use, for pesticide use, for application to or ingestion by animals or for veterinary drug use. All Products shall be used by qualified professionals only. The burden for safe use and handling of Products is entirely the responsibility of Buyer and anyone who purchases goods from Buyer and uses them. Absence of hazardous warnings does not imply non-toxicity.
10. Products Marketed for Research Use Only
(a) Products labeled 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, and are not for use in diagnostic or therapeutic procedures. 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. With respect to Products labeled for research use only, Affymetrix is not liable for any use by Buyer that is not in accordance with the research use only label.
(b) Products labeled for research use only may not be on the Toxic Substances Control Act (“TSCA”) inventory. Buyer assumes responsibility to ensure that the Products are approved under TSCA, if applicable. Consistent with Buyer’s agreement to comply with all TSCA and Research and Development substance exemption (the “R&D exemption”) requirements applicable to the purchase, Buyer agrees and warrants that Buyer will comply with all the requirements necessary to maintain the R&D exemption, including using the R&D substance under the supervision of a technically qualified individual, maintaining all necessary labeling, and providing all necessary notifications. Buyer also agrees and warrants that Buyer will use or sell (if so authorized) goods containing Products exclusively for R&D purposes or specified exempt commercial purposes. Buyer specifically agrees and warrants that Buyer will not sell or distribute Products or goods containing Products to consumers.
11. Products Marketed as Analyte Specific Reagents (ASR) or for In Vitro Diagnostic Use (IVD)
Products for clinical use are labelled as ASR or for IVD. Analytical and performance characteristics are not established for ASR Products. Products marketed by Affymetrix for IVD use have been cleared by the FDA, and/or CE marked in the European Union, 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, unless Affymetrix registers and meets registration requirements for IVD use in such country.
(a) The Affymetrix GeneChip® System 3000Dx v.2 (GCS 3000Dx) for IVD use requires calibration and maintenance twice a year by authorized Affymetrix personnel to ensure system performance. Failure to maintain the system as recommended may result in the failure of the system to perform in accordance with specifications published by Affymetrix.
(b) The CytoScan® Dx Assay is an application FDA cleared as an IVD with the GCS 3000Dx and related software. The assay can only be performed with the system and procedures detailed in the CytoScan Dx Assay Instructions for Use (IFU) and the CytoScan Dx Assay User Guide.
(c) The Gene Profiling Reagents are an IVD with no Affymetrix application. The reagents are used by Affymetrix partners or clinical laboratories to develop their own clinical application.
12. Use Restrictions
Buyer is not licensed to, and agrees not to:
(a) resell any Product, unless otherwise authorized by Affymetrix in writing
(b) transfer, or distribute any Product, directly or indirectly, to any third party for any purpose or use, except as otherwise approved by Affymetrix in writing;
(c) use or allow anyone to use any Product more than once, or dilute any Affymetrix-supplied reagent; or
(d) reverse engineer, disassemble, or conduct unauthorized analysis of any Product and/or its method of use.
13. Target Sequence Confidentiality for Custom Products
If Buyer discloses to Affymetrix a confidential set of nucleic acid or peptide target sequences (“Target Sequences”) for which Buyer desires Affymetrix to design and manufacture custom probe arrays or custom protein assay or custom nucleic acid assay pursuant to these Terms and Conditions, upon Buyer’s written request, 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 (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’s obligations under this Section shall terminate three (3) years following the date of disclosure.
14. Target Sequence Responsibility
Buyer shall be fully responsible for the Target Sequences, including the obtaining of all required consents, 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. Buyer agrees to fully cooperate with the Affymetrix Group and its counsel in its defense and preparation for any such action or proceeding.
(a) Indemnification by Buyer. Buyer shall defend, indemnify and hold harmless the Affymetrix Group against any claims, liabilities, damages, fines, penalties, causes of action, and losses of any and every kind, including without limitation, personal injury or death claims, and infringement of a third party’s intellectual property rights, resulting from, relating to, or arising out of (i) Buyer’s breach of any of these terms and conditions, (ii) Buyer’s use of the Product in any manner or for any purpose other than the use stated on the Product’s label, or (iii) any use of the Products not in accordance with the Product’s specifications or documentation.
(b) Third-Party Goods and Indemnification. Affymetrix has no indemnification obligations with respect to any goods originating from a third party and supplied to Buyer. Third-party goods are those that are labeled or branded with a third-party’s name. Buyer’s indemnification rights, if any, with respect to third party goods shall be pursuant to the original manufacturer’s or licensor’s indemnity. Upon written request Affymetrix will attempt to pass through such indemnity, if any, to Buyer.
16. Liability Limitation
EXCEPT TO THE EXTENT CAUSED BY AFFYMETRIX’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, OR REQUIRED BY APPLICABLE LAW, AFFYMETRIX SHALL HAVE NO 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 AFFYMETRIX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; AS TO ANY AFFYMETRIX LIABILITY NOT LEGALLY SUBJECT TO THE FOREGOING, AFFYMETRIX’S LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO AFFYMETRIX IN THE PRIOR TWELVE (12) MONTHS. BUYER UNDERSTANDS THAT THE RISKS OF LOSS HEREUNDER ARE REFLECTED 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 have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
19. Healthcare Law Compliance
Buyer acknowledges and agrees that Affymetrix may be required by applicable law and regulation (“Healthcare Laws”) to disclose the existence of this agreement, the terms of this agreement including financial terms, and the subject matter (e.g., the U.S. Sunshine Act, and state and foreign equivalents).
These Terms and Conditions constitute the entire agreement between Buyer 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 with respect to the subject matter hereof. The waiver of any provision or any breach thereof shall not affect any other provision of these Terms and Conditions.
21. Governing Law
(a) For Deliveries Outside Europe: 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.
(b) For Deliveries Within Europe: To the extent permitted by applicable law, these Terms and Conditions shall be governed by and construed according to the laws of England, without regard to conflict of law provisions.
(c) 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.