Terms of Sale
Kit Sales Terms and Conditions
Last Updated: September 30, 2024
These Kit Sales Terms and Conditions constitute a binding legal agreement (the “Agreement”) between the Veracyte legal entity (“Veracyte” or “we”, “our”, or “us”) and the customer (“Buyer” or “you” or “your”) identified on an order to Veracyte or to Veracyte’s authorized distributor, as applicable. This Agreement governs the sale by Veracyte, or by Veracyte’s authorized distributor, to Buyer of the Veracyte test kits for use on the nCounter FLEX system (the “Kits”) set forth in Buyer’s order. By placing an order with Veracyte or Veracyte’s authorized distributor for Kits in any manner, Buyer is agreeing to be bound by, and is becoming a party to, this Agreement. If Buyer is an authorized distributor for Veracyte, it shall require its purchasers of Kits to be bound by this Agreement. Veracyte’s or its authorized distributor’s acceptance of Buyer’s order is expressly conditioned upon Buyer’s assent to this Agreement, and any additional or different terms, including those on Buyer’s order, are hereby rejected by Veracyte.
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Ordering.
If the Veracyte entity party to this Agreement is Veracyte, Inc., then Buyer shall place all Kit orders by emailing its order to [email protected].
If the Veracyte entity party to this Agreement is Veracyte SAS, then Buyer shall place all Kit orders by emailing its order to [email protected].
Only individuals authorized by Buyer (“Authorized Personnel”) to place binding orders on Buyer’s behalf shall submit orders to Veracyte. Buyer is legally and financially responsible for payment of all orders placed by its Authorized Personnel. Buyer will promptly inform Veracyte through the appropriate email address as indicated above of any changes in the shipping or contact information that it has previously provided to Veracyte.
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Lab Qualification.
If Buyer is located in the United States, Buyer represents that it is a qualified high-complexity laboratory under the Clinical Laboratory Improvement Amendments of 1988 (42 CFR 493) (“CLIA”). If Buyer is an end user laboratory (not a distributor of Kits) located outside of the United States, Buyer represents that it has all required permits and qualifications to perform testing with the Kits under applicable national and local laws and regulations. Buyer agrees that it will purchase or use the Kits only at such time as the foregoing representation remains true and accurate. If Buyer is Veracyte’s authorized distributor of Kits, it represents and warrants that it will only resell Kits to end user laboratories that have all required permits and qualifications to perform testing with the Kits under applicable national and local laws and regulations.
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Price; Taxes.
The purchase price to Buyer for the Kits (“Purchase Price”) shall be the price set forth on Buyer’s Sales Agreement or Sales Quote as provided by Veracyte, or as has been agreed to in writing between Veracyte’s authorized distributor and Buyer. Purchase Price increases shall not affect unfulfilled purchase orders accepted by Veracyte prior to the effective date of the price increase. Buyer agrees that any applicable sales, use, excise, withholding and other taxes are the responsibility of and payable by Buyer. If Buyer is located outside of the United States, VAT (value added tax) and GST (goods and services tax) are also the responsibility of and payable by Buyer. In the event Veracyte is required by law or regulation to pay any such tax or charge, such amount will be added to the purchase price or subsequently invoiced to Buyer.
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Delivery.
The Kits will be packed in standard shipping packages. Veracyte may make partial deliveries. Veracyte does not guarantee that all Kits in an order will be shipped from the same lot. Veracyte will ship via carrier selected by Veracyte. Title and risk of loss transfers at time and place of shipment and a reasonable shipping and handling fee will be included in the invoice and paid by Buyer.
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Cancellation and Rejection.
Buyer may not cancel any Kits order once Veracyte has shipped Buyer’s order. Any claims for missing Kits or Kits missing components must be reported in writing to Veracyte by Buyer within five (5) days of a scheduled delivery date. For any valid claim made for missing Kits or Kits missing components, Veracyte shall, in its discretion, (i) replace the Kits or (ii) provide a financial credit to Buyer apportioned to the amounts paid to Veracyte for the Kits or affected portion of the Kits, which will be applied to Buyer’s next order. The foregoing shall be Buyer’s sole and exclusive remedy for missing Kits or Kits missing components. Veracyte has no obligation to accept any order placed by Buyer and may reject any order for any reason in its sole discretion.
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Payment.
Buyer will be invoiced at the time of shipment of each Kit. Buyer shall make payment in full within thirty (30) days of the date of the invoice, unless otherwise agreed upon in writing by the parties. Sales shipped outside the U.S. may require prepayment or payment on an irrevocable letter of credit acceptable to Veracyte. Veracyte, at its sole discretion, may charge for late payments at the rate of one and one-half percent (1.5%) percent per month, or the maximum allowed by law, whichever is less. Buyer shall reimburse Veracyte for all costs incurred in collecting any late payments, including, without limitation, attorneys’ fees. Further shipment of Kits 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 Veracyte. Where Buyer is an end user laboratory purchasing from Veracyte’s authorized distributor, payment terms are as agreed to between such end user laboratory and the distributor.
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Prosigna Starter Kits.
The Prosigna Starter Kits shall be used for validation use only. Buyer agrees not to, nor authorize any third party to, use any tests from the Prosigna Starter Kits for IVD use, or submit test results from the Prosigna Starter Kits for reimbursement.
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Veracyte Kits.
Buyer is required to use Veracyte FFPE RNA Extraction Kit, or other extraction kits as specified by Veracyte, for processing samples to be used for the Prosigna Kit. Such kits must be purchased from Veracyte at the price set forth in the order.
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Restrictions on Use/Ownership; Reports.
The Kits are for diagnostic use only and may not be used for investigational use, including clinical trials or research studies, without the prior written approval of Veracyte. Buyer shall use the Kits in compliance with all applicable laws and regulations, including but not limited to all applicable state and Federal physician referral laws. Buyer agrees not to: (a) resell any Kit, or (b) transfer, or distribute any Kit, directly or indirectly, to any third party for any purpose or use, except as otherwise approved by Veracyte in writing. Buyer agrees not to use, and agrees not to allow anyone else to use, any Kit more than once. In addition, Buyer agrees not to, nor authorize any third party to, engage in any of the following activities: (i) separate, extract or isolate components of the Kits, as applicable, (ii) subject the Kits, or components thereof to any analysis not expressly authorized by a Kit’s documentation, or (iii) reverse engineer, disassemble, redistribute or repackage the Kits. Buyer agrees to notify Veracyte of any third party with which Buyer enters into an arrangement (whether through written contract or otherwise) to market, advertise or otherwise promote testing services with the Kits. Buyer further agrees that the contents of and methods of operation of the Kits, are proprietary to Veracyte and that the Kits, contain or embody trade secrets of Veracyte. Buyer understands and agrees that except as expressly set forth in this Agreement, no right or license to any patent or other intellectual property owned or licensable by Veracyte is conveyed or implied by this Agreement or any Kit. In particular, no right or license is conveyed or implied to use any Kit provided hereunder in combination with a product not provided, licensed or specifically recommended by Veracyte for such use. The remaining portion of this paragraph applies to Buyer solely if Buyer is located in the United States: notwithstanding the foregoing, Buyer, as a qualified high-complexity laboratory under CLIA, shall be permitted to use the Kits as permitted by CLIA, provided, however, that Buyer shall be solely responsible for all claims, losses, demands, damages and liabilities arising under or in connection with the design, development, marketing and sale of the Kits or a laboratory-developed test based upon, derived from, or resulting from any modifications made to, the Kits, including any deviations from Veracyte’s recommended use of such Kits.
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Warranty.
Veracyte warrants that the Kits or components of the Kits will conform in all material respects to Veracyte’s published specifications in the product data sheets supplied by Veracyte to Buyer until ninety (90) days from the date of shipment from Veracyte. In the event that Veracyte reasonably determines after investigation that any Kits purchased by Buyer are defective, independent of user error, Veracyte will, at its sole option, either (i) replace the defective Kits or the defective components of the Kits at no incremental cost to Buyer in the most advantageous manager Veracyte deems practical or (ii) provide a financial credit to Buyer apportioned to reflect Buyer’s actual monetary loss for the Kits or defective components of the Kits, which will be applied to Buyer’s next order; provided in each case that such defective Kits or components of the Kits were used by Buyer prior to their expiration date or shelf life date pre-printed on the Kits, and the defect was promptly reported with appropriate detail to Veracyte’s technical support. Replaced Kits or components of the Kits come with a ninety (90)-day warranty from the date of shipment. The foregoing warranties do not apply to the extent a defect or non-conformance is due to (i) abuse, misuse, neglect, negligence, accident, improper storage, or use contrary to the documentation or specifications, (ii) improper handling or maintenance, (iii) unauthorized alterations, (iv) a Force Majeure event (as defined below), or (v) use with a third party’s good not provided by Veracyte (unless the Kits’ documentation or specifications expressly state such third party’s good is for use with the Kits). This warranty applies only to Buyer, and not third parties. The foregoing shall be Buyer’s sole and exclusive remedy for non-conforming or defective Kits. TO THE EXTENT PERMITTED BY APPLICABLE LAW, VERACYTE AND ITS SUPPLIERS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE KITS OR COMPONENTS OF THE KITS, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, NON-INFRINGEMENT, TITLE, OR FITNESS FOR A PARTICULAR PURPOSE.
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Limitation of Liability.
NEITHER VERACYTE NOR ITS SUPPLIERS WILL 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 LIABILITY OR OTHERWISE, EVEN IF VERACYTE OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. EXCEPT TO THE EXTENT CAUSED BY VERACYTE’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR AS REQUIRED BY APPLICABLE LAW, VERACYTE’S AND ITS SUPPLIERS’ LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO VERACYTE FOR KITS OR COMPONENTS OF THE KITS WHICH GIVE RISE TO THE CLAIM UNDER THIS AGREEMENT IN THE PRIOR TWELVE (12) MONTHS. BUYER AND ITS END USERS ARE RESPONSIBLE FOR, AND VERACYTE AND ITS SUPPLIERS WILL BEAR NO LIABILITY FOR, ANY TREATMENT AND CARE THAT IS RECOMMENDED OR PROVIDED BASED ON THE DATA GENERATED FROM THE KITS OR THE RESULTS OF SUCH TREATMENT OR CARE. THE LIMITED REMEDIES AND LIABILITY LIMITS IN THIS AGREEMENT WILL APPLY EVEN IF THEY CAUSE A PROVISION OF THIS AGREEMENT TO FAIL OF ITS ESSENTIAL PURPOSE.
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Export Controls.
Where applicable, Buyer acknowledges that the Kits 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, including maintaining the necessary records in connection with such compliance, (b) cooperate fully with Veracyte 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 Kit or related technical documents or materials from any Kit 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 Veracyte and the applicable U.S. Government agency.
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Data Protection.
Except in connection with Veracyte providing support services (e.g., technical trouble shooting) in connection with the Kits (the “Support Services”), Buyer must ensure that any Personal Data (as that term is defined the Data Protection Laws), is not submitted, communicated, accessed by or otherwise disclosed to Veracyte, its employees and agents. Buyer represents and warrants that any and all Personal Data that is made available to or shared with Veracyte has been collected and processed for lawful and legitimate purposes and that such Personal Data may be made lawfully available to and shared with Veracyte for processing for the purposes of the Support Services by Veracyte in accordance with the applicable data protection laws, including but not limited to Regulation (EU) 2016/679 and the UK General Data Protection Regulation (together, the “Data Protection Laws”). To the extent the Support Services provided by Veracyte involve the transfer of Personal Data from the European Economic Area, the United Kingdom, or other country with equivalent Data Protection Laws, to Veracyte, the parties agree to the Standard Contractual Clauses (PDF) available here and incorporated herein by reference. Buyer shall be the Data Exporter whereby Veracyte will be regarded as the Data Importer.
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Reporting of Discounts.
Buyer shall comply with applicable provisions of 42 U.S.C. §1320a-7b(b)(3)(A) (the “anti-kickback statute” discount exemption) and 42 C.F.R. 1001.952(h) (the discount safe harbor) by properly disclosing and appropriately reflecting all discounts, rebates and other reductions in price provided in connection with this Agreement to representatives of Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)). Specifically, to the extent applicable and required by law, including, but not limited to, 42 U.S.C. 1320a-7b(b) and 42 C.F.R. 1001.952(h): (a) if Buyer reports its costs to a Federal health care program, Buyer will accurately reflect all discounts or other price reductions received hereunder; and (b) whether or not Buyer reports its costs to a Federal health care program, Buyer will retain this Agreement and other documentation provided by Veracyte pertaining to the discounts provided hereunder, and provide such documentation to authorized representatives of the U.S. Department of Health and Human Services or a state health care program on request. Buyer shall further comply with the applicable Medicare Clinical Laboratory Fee Schedule price reporting provisions of 42 U.S.C. § 1395m-1 and 42 C.F.R. § 414.502 et seq.
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Confidential Information.
All non-public, confidential or proprietary information of Veracyte, including but not limited to specifications, samples, designs, plans, drawings, documents, data, business operations, customer lists, pricing, discounts or rebates, disclosed by Veracyte to Buyer, whether disclosed orally or disclosed or accessed in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential” in connection with this Agreement, is confidential, and may be used by Buyer solely for the purpose of performing under this Agreement and may not be disclosed or copied unless authorized in advance by Veracyte in writing. Upon Veracyte’s request, Buyer shall promptly return all documents and other materials received from Veracyte. Veracyte shall be entitled to injunctive relief for any violation of this Section. This Section does not apply to information that is: (a) in the public domain; (b) known to Buyer at the time of disclosure; or (c) rightfully obtained by Buyer on a non-confidential basis from a third party.
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Unforeseen Events.
Veracyte 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 Veracyte (a “Force Majeure”). In the event of any such Force Majeure event, Veracyte shall have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
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Governing Law and Venue.
If the Veracyte entity party to this Agreement is Veracyte, Inc., then this Agreement is governed by the laws of New York, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in San Francisco, California, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
If the Veracyte entity party to this Agreement is Veracyte SAS, then this Agreement is governed by the laws of France, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in Marseille, France, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
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Miscellaneous.
Veracyte may include Buyer on Veracyte’s standard customer lists (including on its website) and Veracyte may use the tradenames, trademarks, and logos of Buyer for such publicity, subject to Buyer’s general written requirements for such usage. Any notice or communication required or permitted hereunder shall be in writing and shall be deemed effective on receipt. Both parties will perform their obligations under this Agreement in compliance with all applicable laws and regulations. Veracyte may assign this Agreement or delegate all or part of its activities to its affiliate, and may assign this Agreement to a third party in the context of a merger or acquisition. Buyer will not assign this Agreement, directly or indirectly, by operation of law or otherwise, without the prior written consent of Veracyte. The U.N. Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. This Agreement constitutes the entire agreement between Buyer and Veracyte with respect to the subject matter hereof and is the final, complete, and exclusive statement of the terms of the parties’ 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 of a provision of this Agreement shall not affect any other provision of this Agreement. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. This Agreement may be terminated by either party upon at least thirty (30) days written notice to the other party.
System Rental Terms and Conditions
Last Updated: December 12, 2023
These System Rental Terms and Conditions constitute a binding legal agreement (the “Agreement”) between the Veracyte legal entity (“Veracyte” or “we”, “our”, or “us”) and the customer (“Customer” or “you” or “your”) identified on an order to Veracyte. This Agreement governs the rental by Veracyte to Customer of the nCounter FLEX system (the “System”) set forth in Customer’s order. Veracyte’s acceptance of Customer’s order is expressly conditioned upon Customer’s assent to this Agreement, and any additional or different terms, including those on Customer’s order, are hereby rejected by Veracyte.
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Exchange or Upgrade of System.
Veracyte reserves the right, upon fifteen (15) days’ prior written notice to Customer and during Customer’s regular business hours to, in Veracyte’s sole discretion, exchange, upgrade, swap-out, or substitute a System provided by Veracyte to Customer for Customer’s use under this Agreement.
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Installation.
Unless otherwise agreed between the parties, after receipt of import approval and/or any other required approvals and permits, the System will be shipped by Veracyte to Customer’s designated qualified laboratory where the System will be installed and qualified by Veracyte or its authorized designee. Customer will prepare the installation site for the System in accordance with the Dx Enablement Checklist to be provided by Veracyte and will reasonably cooperate with Veracyte to facilitate the pre-installation inspection, shipping, installation, and qualification of the System. Any costs associated with modifying the System installation site and any additional equipment and consumables required for the System shall be the responsibility of Customer.
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Training.
Following installation of the System, Veracyte will provide training on the System for up to four (4) technicians in a contiguous training session.
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Title to System.
Customer understands and agrees that at no time shall it own the System and that all right, title, and interest in and to the System shall remain in Veracyte.
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Limited Warranty.
Veracyte warrants that the System will conform in all material respects to Veracyte’s published specifications in the product data sheets supplied by Veracyte to Customer for the term of the order. Veracyte’s sole and exclusive liability under the foregoing warranty shall be to repair or replace the System at no cost, as solely determined by Veracyte. Nonconforming Systems will be serviced at Customer’s facility or, at Veracyte’s option, Veracyte’s facility or its authorized designee’s facility. If warranty service is performed at Veracyte’s facility, Veracyte will bear shipping costs. Except as provided above, this warranty does not apply to any defect caused by Third Party Software (as defined below) or to any Replacement Parts (as defined below). Veracyte warrants that Replacement Parts will conform to their specifications for a period of 90 days from the date the Replacement Parts are installed. Replacement Parts do not extend the warranty for the underlying System. “Replacement Parts” means Veracyte provided components, modifications, or enhancements to a System. In order to be eligible for repair, replacement or refund, as applicable, under these warranties, Customer must (i) promptly contact Veracyte’s technical support department to report the non-conformance, (ii) cooperate with Veracyte in confirming or diagnosing the non-conformance, and (iii) return the System, transportation charges prepaid to Veracyte following Veracyte’s instructions or, if agreed by Veracyte and Customer, grant Veracyte’s authorized repair personnel access to the System in order to confirm the non-conformance and make repairs. The foregoing warranties do not apply to the extent a defect or non-conformance is due to (i) misuse, neglect, negligence, accident, improper storage, or use contrary to the documentation or specifications, (ii) improper handling or maintenance, (iii) unauthorized alterations, (iv) a Force Majeure event, or (v) use with a third party’s goods not provided by Veracyte (unless the System’s documentation or specifications expressly state such third party’s goods are for use with the System). The foregoing warranties apply only to Customer, and not third parties, and shall be Customer’s sole and exclusive remedy for non-conforming or defective Systems.
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Limited Software License.
Subject to this Agreement and Veracyte’s agreements with its licensor, Veracyte hereby grants to Customer a limited, non-exclusive, non-transferable, non-sublicensable license to use any software or firmware provided as part of the System, if any, only in accordance with the manuals and written instructions provided by Veracyte and only as part of the System and not on a stand-alone basis. The System may be distributed with or contain or use certain open source or other third party software that may be covered by the terms of a different license (“Third Party Software”). Third Party Software is subject to and governed by (and licensee agrees to, and will indemnify Veracyte for noncompliance with) the respective licenses for such Third Party Software and this Agreement do not apply to the Third Party Software. The notices, license terms, and disclaimers applicable to Third Party Software are contained in the supplement to the product manual for the System.
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System Support and Maintenance.
During the Term, Veracyte will: (a) provide a phone number and email address for Customer to submit any System or software support requests; (b) respond to support requests within one business day by phone; (c) if needed, provide onsite support to Customer as necessary at no charge to ensure that the System is materially functioning in accordance with the functional specifications; and (d) provide one preventative maintenance visit per year which will be done at no additional charge.
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Damages to System; Return upon Expiration or Termination.
In addition to its other obligations under this Agreement, the Customer shall be responsible for, and shall indemnify Veracyte for all costs and expenses arising from, any damage caused to or suffered by any System arising after Veracyte (or its representative) has delivered such System to the carrier and any claims, damages, liabilities or losses (“Losses”) arising from Customer’s operation of the system, provided such Losses are not the result of a design defect in the System. The Customer shall maintain the System in good operating condition and repair and in proper working order. Customer agrees to not move the System and only allow trained operators to use it. Customer agrees to assume all risk of loss and damage and to purchase insurance for System naming Veracyte as loss payee. Upon request, Customer will provide Veracyte with a certificate of insurance as evidence of such insurance. Further Customer agrees to ensure that no liens or other encumbrances are placed on the System, that the name and branding are not removed, and that no servicing of the System is done outside that described in the documentation without instruction to do so from Veracyte. Upon any expiration or termination of this Agreement, the Customer shall cooperate with Veracyte regarding the return of the System to Veracyte in its original condition, normal wear and tear excepted.
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Restrictions on System Use.
Customer agrees not to reverse engineer or disassemble the System (including any software or firmware included with the System). Customer further agrees that the contents of and methods of operation of the System are proprietary to Veracyte or its licensor and that they contain or embody trade secrets of Veracyte or its licensor. Customer understands and agrees that except as expressly set forth in this Agreement, no right or license to any patent or other intellectual property owned or licensable by Veracyte is conveyed or implied by this Agreement. In particular, no right or license is conveyed or implied to use the System in combination with a product not provided, licensed or specifically recommended by Veracyte for such use.
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Termination.
Either party may terminate this Agreement immediately upon written notice to the other party if: (a) the other party commits a material breach of this Agreement, which is not cured within thirty (30) days of receipt of notice of the breach, or (b) immediately upon written notice if the other party becomes insolvent, is dissolved or liquidated, makes general assignment for the benefit of its creditors, files or has filed against it a petition for bankruptcy, or has a receiver appointed for a substantial part of its assets. In addition, this Agreement may be terminated by Veracyte for an Event of Default, or may be mutually terminated by the parties in the event of a purchase of the System by Customer, as described below. Upon expiration or termination of the agreement as set forth herein, unless the parties have entered into another agreement with respect to the System, Customer will cooperate with Veracyte in the removal of the System from Customer’s site and shipping back to Veracyte. The expiration or termination of this Agreement shall not relieve either party of the obligations set forth herein which by their nature are intended to survive, including Customer’s obligation of payment.
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Defaults and Remedies.
Any of the following events or conditions constitute an “Event of Default” by Customer under this Agreement: (a) the failure of Customer to make any payment when due under this Agreement; (b) the failure of Customer to comply with or perform any of the terms and conditions of this Agreement; (c) the failure of Customer to meet its minimum annual volume commitment of Kit purchases in a Commitment Year, (d) the making of assignment for the benefit of creditors by Customer; (e) the institution of bankruptcy, reorganization, liquidation, or receivership proceedings by or against Customer; and (f) insolvency of Customer or impairment of the credit of Customer. Upon the occurrence of any Event of Default, Veracyte in its sole discretion shall have the right to exercise any one or more of the following remedies: (a) to terminate this Agreement; (b) with or without notice, to demand or legal process to retake possession of the System and any Kits (and Customer authorizes and empowers Veracyte to enter upon the premises wherever the System and Kits may be found and (i) retain such System and Kits and all payments made under this Agreement and (ii) resell the Kits and retain any payments from resale to cover charges, taxes and assessments otherwise owing under this Agreement); and (c) pursue any other remedy available to Veracyte at law or in equity. Without limiting the generality of the foregoing, where applicable, Veracyte shall have all the rights and remedies of a secured party under the applicable laws, including but not limited to the applicable Uniform Commercial Code. Customer also agrees to pay all costs of collection, including without limitation, court costs, reasonable attorneys’ fees, and fees for repossession, repair, storage and sale of the System and Kits.
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Limitation of Liability.
NEITHER VERACYTE NOR ITS SUPPLIERS WILL 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 LIABILITY OR OTHERWISE, EVEN IF VERACYTE OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. EXCEPT TO THE EXTENT CAUSED BY VERACYTE’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR AS REQUIRED BY APPLICABLE LAW, VERACYTE’S AND ITS SUPPLIERS’ LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY CUSTOMER TO VERACYTE FOR THE SYSTEM WHICH GIVE RISE TO THE CLAIM UNDER THIS AGREEMENT IN THE PRIOR TWELVE (12) MONTHS. CUSTOMER AND ITS END USERS ARE RESPONSIBLE FOR, AND VERACYTE AND ITS SUPPLIERS WILL BEAR NO LIABILITY FOR, ANY TREATMENT AND CARE THAT IS RECOMMENDED OR PROVIDED BASED ON THE DATA GENERATED FROM THE SYSTEM OR THE RESULTS OF SUCH TREATMENT OR CARE. THE LIMITED REMEDIES AND LIABILITY LIMITS IN THIS AGREEMENT WILL APPLY EVEN IF THEY CAUSE A PROVISION OF THIS AGREEMENT TO FAIL OF ITS ESSENTIAL PURPOSE.
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Export Controls.
Where applicable, Customer acknowledges that the System and related materials may be subject to export controls under the U.S. Export Administration Regulations and related U.S. laws. Customer will (a) comply strictly with all legal requirements established under these controls, including maintaining the necessary records in connection with such compliance, (b) cooperate fully with Veracyte 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 System or related technical documents or materials from any System 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 Veracyte and the applicable U.S. Government agency.
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Data Protection.
Except in connection with Veracyte providing support services (e.g., technical trouble shooting) in connection with the System (the “Support Services”), Customer must ensure that any Personal Data (as that term is defined the Data Protection Laws), is not submitted, communicated, accessed by or otherwise disclosed to Veracyte, its employees and agents. Customer represents and warrants that any and all Personal Data that is made available to or shared with Veracyte has been collected and processed for lawful and legitimate purposes and that such Personal Data may be made lawfully available to and shared with Veracyte for processing for the purposes of the Support Services by Veracyte in accordance with the applicable data protection laws, including but not limited to Regulation (EU) 2016/679 and the UK General Data Protection Regulation (together, the “Data Protection Laws”). To the extent the Support Services provided by Veracyte involve the transfer of Personal Data from the European Economic Area, the United Kingdom, or other country with equivalent Data Protection Laws, to Veracyte, the parties agree to the Standard Contractual Clauses (PDF) available here and incorporated herein by reference. Customer shall be the Data Exporter whereby Veracyte will be regarded as the Data Importer.
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Reporting of Discounts.
Customer shall comply with applicable provisions of 42 U.S.C. §1320a-7b(b)(3)(A) (the “anti-kickback statute” discount exemption) and 42 C.F.R. 1001.952(h) (the discount safe harbor) by properly disclosing and appropriately reflecting all discounts, rebates and other reductions in price provided in connection with this Agreement to representatives of Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)). Specifically, to the extent applicable and required by law, including, but not limited to, 42 U.S.C. 1320a-7b(b) and 42 C.F.R. 1001.952(h): (a) if Customer reports its costs to a Federal health care program, Customer will accurately reflect all discounts or other price reductions received hereunder; and (b) whether or not Customer reports its costs to a Federal health care program, Customer will retain this Agreement and other documentation provided by Veracyte pertaining to the discounts provided hereunder, and provide such documentation to authorized representatives of the U.S. Department of Health and Human Services or a state health care program on request. Customer shall further comply with the applicable Medicare Clinical Laboratory Fee Schedule price reporting provisions of 42 U.S.C. § 1395m-1 and 42 C.F.R. § 414.502 et seq.
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Confidential Information.
Customer will maintain the confidentiality of and not disclose to any third party without Veracyte’s prior consent: (a) any terms contained in this Agreement, (b) all non-public information disclosed by Veracyte to Customer, and (c) all non-public information about the operation, performance, price, or characteristics of the System or the Kits. All non-public, confidential or proprietary information of Veracyte, including but not limited to specifications, samples, designs, plans, drawings, documents, data, business operations, customer lists, pricing, discounts or rebates, disclosed by Veracyte to Customer, whether disclosed orally or disclosed or accessed in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential” in connection with this Agreement, is confidential, and may be used by Customer solely for the purpose of performing under this Agreement and may not be disclosed or copied unless authorized in advance by Veracyte in writing. Upon Veracyte’s request, Customer shall promptly return all documents and other materials received from Veracyte. Veracyte shall be entitled to injunctive relief for any violation of this Section. This Section does not apply to information that is: (a) in the public domain; (b) known to Customer at the time of disclosure; or (c) rightfully obtained by Customer on a non-confidential basis from a third party.
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Unforeseen Events.
Veracyte 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 Veracyte (a “Force Majeure”). In the event of any such Force Majeure event, Veracyte shall have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
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Governing Law and Venue.
If the Veracyte entity party to this Agreement is Veracyte, Inc., then this Agreement is governed by the laws of New York, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in San Francisco, California, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
If the Veracyte entity party to this Agreement is Veracyte SAS, then this Agreement is governed by the laws of France, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in Marseille, France, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
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Miscellaneous.
Veracyte may include Customer on Veracyte’s standard customer lists (including on its website) and Veracyte may use the tradenames, trademarks, and logos of Customer for such publicity, subject to Customer’s general written requirements for such usage. Any notice or communication required or permitted hereunder shall be in writing and shall be deemed effective on receipt. Both parties will perform their obligations under this Agreement in compliance with all applicable laws and regulations. Veracyte may assign this Agreement or delegate all or part of its activities to its affiliate, and may assign this Agreement to a third party in the context of a merger or acquisition. Customer will not assign this Agreement, directly or indirectly, by operation of law or otherwise, without the prior written consent of Veracyte. The U.N. Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. This Agreement constitutes the entire agreement between Customer and Veracyte with respect to the subject matter hereof and is the final, complete, and exclusive statement of the terms of the parties’ 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 of a provision of this Agreement shall not affect any other provision of this Agreement. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.
System Sales Terms and Conditions
Last Updated: December 12, 2023
These System Sales Terms and Conditions and any Sales Agreement or Sales Quote as provided by Veracyte regarding the System, constitute a binding legal agreement (the “Agreement”) between the Veracyte, legal entity (“Veracyte” or “we”, “our”, or “us”) and the customer (“Buyer” or “you” or “your”) identified on an order to Veracyte. This Agreement governs the sale by Veracyte, or by Veracyte’s authorized, to Buyer of the following types of products set forth in Buyer’s order, (the “System”).
- nCounter Dx-Enabled FLEX Analysis System
- Dx-Enablement Package
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Ordering.
If the Veracyte entity party to this Agreement is Veracyte, Inc., then Buyer shall place all System orders by emailing its order to [email protected]
If the Veracyte entity party to this Agreement is Veracyte, SAS., then Buyer shall place all System orders by emailing its order to [email protected].
Only individuals authorized by Buyer (“Authorized Personnel”) to place binding orders on Buyer’s behalf shall submit orders to Veracyte. Buyer is legally and financially responsible for payment of all orders placed by its Authorized Personnel. Buyer will promptly inform Veracyte through the appropriate email address as indicated above, of any changes in the shipping or contact information that it has previously provided to Veracyte.
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Price; Taxes.
The purchase price to Buyer for the System (“Purchase Price”) shall be the price set forth on Buyer’s Sales System Agreement or Sales Quote as provided by Veracyte, or as has been agreed to in writing between Veracyte and Buyer. Purchase Price increases shall not affect unfulfilled purchase orders accepted by Veracyte prior to the effective date of the price increase. Buyer agrees that any applicable sales, use, excise, withholding and other taxes are the responsibility of and payable by Buyer. If Buyer is located outside of the United States, VAT (value added tax) and GST (goods and services tax) are also the responsibility of and payable by Buyer. In the event Veracyte is required by law or regulation to pay any such tax or charge, such amount will be added to the purchase price or subsequently invoiced to Buyer.
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Delivery.
System will be packed in Veracyte’s standard shipping packages. Veracyte may make partial deliveries. Shipping and delivery dates provided by Veracyte are approximate and are based upon prompt receipt of all necessary payment and information. Any delivery date, “ship no later than” date, “required by” date, etc., specified on a purchase order by Buyer will be of no force and effect. Veracyte will not be liable for failure to ship System in connection with a Force Majeure event (as defined below), including inability to obtain labor or other materials or other product delays, in which case Veracyte may postpone delivery or shipment at its option without liability. Unless otherwise set forth in writing by Veracyte or otherwise agreed by the parties, all shipments are made EXW (Incoterms 2021) from Veracyte’s manufacturing facility, except for shipments to member countries of the European Union, which are made DDP (Incoterms 2021) excluding VAT. Veracyte will ship via carrier selected by Veracyte. In all cases, title to the System (except for software, in which case Veracyte shall retain title) and risk of loss shall pass to Buyer on delivery to the carrier. A reasonable fee will be added to the invoice and paid by Buyer to cover shipping and handling. Veracyte is not responsible for damage caused in transit. It is the responsibility of Buyer to file damage claims directly with the freight company. If errors or shortages are detected in any shipment, Buyer must notify Veracyte within three (3) business days of receipt.
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Cancellation.
Buyer may not cancel any order once Veracyte has shipped Buyer’s order. Buyer will be responsible for, and immediately pay, any fees incurred by Veracyte or payments owed by Buyer with respect to Buyer’s order in the case of a cancellation after the target acceptance date.
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Installation.
Unless otherwise agreed between the parties, after receipt of import approval and/or any other required approvals and permits, the System will be shipped by Veracyte to Buyer’s designated qualified laboratory where the System will be installed and qualified by Veracyte or its authorized designee. Buyer will prepare the installation site for the System in accordance with the Dx Enablement Checklist to be provided by Veracyte and will reasonably cooperate with Veracyte to facilitate the pre-installation inspection, shipping, installation, and qualification of the System. Any costs associated with modifying the System installation site and any additional equipment and consumables required for the System shall be the responsibility of Buyer.
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Training.
Subject to the provisions set forth on Buyer’s Sales System Agreement or Sales Quote as provided by Veracyte, or as has been agreed to in writing between Veracyte and Buyer, following installation of the System, Veracyte will provide training on the System for up to four (4) technicians in a contiguous training session.
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Limited Warranty.
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Veracyte warrants that the System will conform in all material respects to Veracyte’s published specifications in the product data sheets supplied by Veracyte to Buyer for a period of twelve (12) months after its shipment date from Veracyte unless the instrument includes Veracyte-provided installation, in which case the warranty period begins on the date of installation or thirty (30) days after the date it was delivered, whichever occurs first.. Veracyte’s sole and exclusive liability under the foregoing warranty shall be to repair or replace the System at no cost, as solely determined by Veracyte. Nonconforming Systems will be serviced at Buyer’s facility or, at Veracyte’s option, Veracyte’s facility or its authorized designee’s facility. If warranty service is performed at Veracyte’s facility, Veracyte will bear shipping costs. Except as provided above, this warranty does not apply to any defect caused by Third Party Software (as defined below) or to any Replacement Parts (as defined below).Veracyte warrants that Replacement Parts will conform to their specifications for a period of ninety (90) days from the date the Replacement Parts are installed. Replacement Parts do not extend the warranty for the underlying System. “Replacement Parts” means Veracyte provided components, modifications, or enhancements to a System.
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In order to be eligible for repair, replacement or refund, as applicable, under these warranties, Buyer must (i) promptly contact Veracyte’s technical support department to report the non-conformance, (ii) cooperate with Veracyte in confirming or diagnosing the non-conformance, and (iii) return the System, transportation charges prepaid to Veracyte following Veracyte’s instructions or, if agreed by Veracyte and Buyer, grant Veracyte’s authorized repair personnel access to the System in order to confirm the non-conformance and make repairs.
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The foregoing warranties do not apply to the extent a defect or non-conformance is due to (i) misuse, neglect, negligence, accident, improper storage, or use contrary to the documentation or specifications, (ii) improper handling or maintenance, (iii) unauthorized alterations, (iv) a Force Majeure event, or (v) use with a third party’s goods not provided by Veracyte (unless the System’s documentation or specifications expressly state such third party’s goods are for use with the System). The foregoing warranties apply only to Buyer, and not third parties, and shall be Buyer’s sole and exclusive remedy.
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The foregoing warranties shall be Buyer’s sole and exclusive remedy for non-conforming or defective System. TO THE EXTENT PERMITTED BY APPLICABLE LAW, VERACYTE AND ITS LICENSORS AND SUPPLIERS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO SYSTEM, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, NON-INFRINGEMENT, TITLE, OR FITNESS FOR A PARTICULAR PURPOSE.
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Limited Software License.
Subject to this Agreement and Veracyte’s agreements with its licensor, Veracyte hereby grants to Buyer a limited, non-exclusive, non-transferable, non-sublicensable license to use any software or firmware provided as part of the System, if any, only in accordance with the manuals and written instructions provided by Veracyte and only as part of the System and not on a stand-alone basis. The System may be distributed with or contain or use certain open source or other third party software that may be covered by the terms of a different license (“Third Party Software”). Third Party Software is subject to and governed by (and licensee agrees to, and will indemnify Veracyte for noncompliance with) the respective licenses for such Third Party Software and this Agreement do not apply to the Third Party Software. The notices, license terms, and disclaimers applicable to Third Party Software are contained in the supplement to the product manual for the System.
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Restrictions on System Use.
Buyer shall use the System in compliance with all applicable laws and regulations. Buyer agrees not to: (a) resell any System, or (b) transfer, or distribute any System directly or indirectly, to any third party for any purpose or use, except as otherwise approved by Veracyte in writing. Buyer agrees not to, nor authorize any third party to, engage in any of the following activities: (i) separate, extract or isolate components of the System, as applicable, (ii) subject the System, or components thereof to any analysis not expressly authorized by a System’s documentation, or (iii) reverse engineer, disassemble, redistribute or repackage the System. Buyer agrees to notify Veracyte of any third party with which Buyer enters into an arrangement (whether through written contract or otherwise) to market, advertise or otherwise promote services with the System. Buyer further agrees that the contents of and methods of operation of the System are proprietary to Veracyte or its licensor and that the System contain or embody trade secrets of Veracyte or its licensor. Buyer understands and agrees that except as expressly set forth in this Agreement, no right or license to any patent or other intellectual property owned or licensable by Veracyte is conveyed or implied by this Agreement. In particular, no right or license is conveyed or implied to use the System in combination with a product not provided, licensed or specifically recommended by Veracyte for such use. Buyer shall be solely responsible for all claims, losses, demands, damages, and liabilities arising under or in connection with the design, development, marketing, and sale of a product developed by Buyer which (i) is based on or derived from the System, or (ii) results from any modification made by Buyer to any of Veracyte ’s System, except to the extent such claims, losses, demands, damages, and liabilities are directly resulting from gross negligence or willful misconduct of Veracyte or a design defect in a System.
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Limitation of Liability.
NEITHER VERACYTE NOR ITS LICENSORS OR ITS SUPPLIERS WILL 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 LIABILITY OR OTHERWISE, EVEN IF VERACYTE OR ITS LICENSORS OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. EXCEPT TO THE EXTENT CAUSED BY VERACYTE’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR AS REQUIRED BY APPLICABLE LAW, VERACYTE’S AND ITS LICENSORS OR ITS SUPPLIERS’ LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO VERACYTE FOR THE SYSTEM WHICH GIVE RISE TO THE CLAIM UNDER THIS AGREEMENT IN THE PRIOR TWELVE (12) MONTHS. BUYER AND ITS END USERS ARE RESPONSIBLE FOR, AND VERACYTE AND ITS LICENSORS OR ITS SUPPLIERS WILL BEAR NO LIABILITY FOR, ANY TREATMENT AND CARE THAT IS RECOMMENDED OR PROVIDED BASED ON THE DATA GENERATED FROM THE SYSTEM OR THE RESULTS OF SUCH TREATMENT OR CARE. THE LIMITED REMEDIES AND LIABILITY LIMITS IN THIS AGREEMENT WILL APPLY EVEN IF THEY CAUSE A PROVISION OF THIS AGREEMENT TO FAIL OF ITS ESSENTIAL PURPOSE.
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Export Controls.
Where applicable, Buyer acknowledges that the System 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, including maintaining the necessary records in connection with such compliance, (b) cooperate fully with Veracyte 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 System or related technical documents or materials from any System 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 Veracyte and the applicable U.S. Government agency.
Data Protection
Except in connection with Veracyte providing support services (e.g., technical trouble shooting) in connection with the Sytem (the “Support Services”), Buyer must ensure that any Personal Data (as that term is defined the Data Protection Laws), is not submitted, communicated, accessed by or otherwise disclosed to Veracyte, its employees and agents. Buyer represents and warrants that any and all Personal Data that is made available to or shared with Veracyte has been collected and processed for lawful and legitimate purposes and that such Personal Data may be made lawfully available to and shared with Veracyte for processing for the purposes of the Support Services by Veracyte in accordance with the applicable data protection laws, including but not limited to Regulation (EU) 2016/679 and the UK General Data Protection Regulation (together, the “Data Protection Laws”). To the extent the Support Services provided by Veracyte involve the transfer of Personal Data from the European Economic Area, the United Kingdom, or other country with equivalent Data Protection Laws, to Veracyte, the parties agree to the Standard Contractual Clauses (PDF) available here and incorporated herein by reference. Buyer shall be the Data Exporter whereby Veracyte will be regarded as the Data Importer.
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Reporting of Discounts.
Buyer shall comply with applicable provisions of 42 U.S.C. §1320a-7b(b)(3)(A) (the “anti-kickback law” discount exemption) and 42 C.F.R. 1001.952(h) (the discount safe harbor) by properly disclosing and appropriately reflecting all discounts, rebates and other reductions in price provided in connection with this Agreement to representatives of Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)). Specifically, to the extent applicable and required by law, including, but not limited to, 42 U.S.C. 1320a-7b(b) and 42 C.F.R. 1001.952(h): (a) if Buyer reports its costs to a Federal health care program, Buyer will accurately reflect all discounts or other price reductions received hereunder; and (b) whether or not Buyer reports its costs to a Federal health care program, Buyer will retain this Agreement and other documentation provided by Veracyte pertaining to the discounts provided hereunder, and provide such documentation to authorized representatives of the U.S. Department of Health and Human Services or a state health care program on request. Buyer shall further comply with the applicable Medicare Clinical Laboratory Fee Schedule price reporting provisions of 42 U.S.C. § 1395m-1 and 42 C.F.R. § 414.502 et seq.
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Confidential Information.
All non-public, confidential or proprietary information of Veracyte, including but not limited to specifications, samples, designs, plans, drawings, documents, data, business operations, customer lists, pricing, discounts or rebates, disclosed by Veracyte to Buyer, whether disclosed orally or disclosed or accessed in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential” in connection with this Agreement, is confidential, and may be used by Buyer solely for the purpose of performing under this Agreement and may not be disclosed or copied unless authorized in advance by Veracyte in writing. Upon Veracyte’s request, Buyer shall promptly return all documents and other materials received from Veracyte. Veracyte shall be entitled to injunctive relief for any violation of this Section. This Section does not apply to information that is: (a) in the public domain; (b) known to Buyer at the time of disclosure; or (c) rightfully obtained by Buyer on a non-confidential basis from a third party.
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Unforeseen Events.
Veracyte 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 Veracyte (a “Force Majeure”). In the event of any such Force Majeure event, Veracyte shall have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
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Governing Law and Venue.
If the Veracyte entity party to this Agreement is Veracyte, Inc., then this Agreement is governed by the laws of New York, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in San Francisco, California, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
If the Veracyte entity party to this Agreement is Veracyte SAS, then this Agreement is governed by the laws of France, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in Marseille, France, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
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Miscellaneous.
Veracyte may include Buyer on Veracyte’s standard customer lists (including on its website) and Veracyte may use the tradenames, trademarks, and logos of Buyer for such publicity, subject to Buyer’s general written requirements for such usage. Any notice or communication required or permitted hereunder shall be in writing and shall be deemed effective on receipt. Both parties will perform their obligations under this Agreement in compliance with all applicable laws and regulations. Veracyte may assign this Agreement or delegate all or part of its activities to its affiliate and may assign this Agreement to a third party in the context of a merger or acquisition. Buyer will not assign this Agreement, directly or indirectly, by operation of law or otherwise, without the prior written consent of Veracyte. The U.N. Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. This Agreement constitutes the entire agreement between Buyer and Veracyte with respect to the subject matter hereof and is the final, complete, and exclusive statement of the terms of the parties’ 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 of a provision of this Agreement shall not affect any other provision of this Agreement. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.
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System Service Terms and Conditions
Last Updated: September 30, 2024
These System Service Terms and Conditions and any Service Sales Agreement or Sales Quote as provided by Veracyte constitute a binding legal agreement (the “Agreement) between the Veracyte legal entity (“Veracyte” or “we”, “our”, or “us”) and the customer (“Customer” or “you” or “your”) identified on an order to Veracyte regarding all orders for purchases from Veracyte of services and parts (“System Services”) and/or other services relating to the Covered Equipment (as defined below), including Maintenance Service (as defined below) and training, unless other terms are specifically agreed to by the parties in a written agreement signed by both parties. Veracyte’s provision of the services hereunder is expressly conditioned upon Customer’s acceptance of the terms and conditions contained in this Agreement. By placing an order for System Services hereunder, Customer accepts and agrees to be bound by the terms and conditions in this Agreement. If a purchase order or other form containing terms and conditions is used by Customer, Veracyte objects to any such terms and conditions. Any additional or different terms or conditions (pre-printed or otherwise) proposed by Customer will not become part of the Agreement.
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Covered Equipment.
“Covered Equipment” under this Agreement shall include the nCounter® Dx-Enabled FLEX Analysis System. User-serviceable parts not covered under this Agreement include, without limitation, o-rings and grease for the Prep Station, and electrode assemblies. In no event shall Veracyte be obligated hereunder to service instruments, attachments, components, accessories, features, or devices other than Covered Equipment.
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Consent Requirements.
The purchase price to Buyer for the System (“Purchase Price”) shall be the price set forth on Buyer’s Sales System Agreement or Sales Quote as provided by Veracyte, or as has been agreed to in writing between Veracyte and Buyer. Purchase Price increases shall not affect unfulfilled purchase orders accepted by Veracyte prior to the effective date of the price increase. Buyer agrees that any applicable sales, use, excise, withholding and other taxes are the responsibility of and payable by Buyer. If Buyer is located outside of the United States, VAT (value added tax) and GST (goods and services tax) are also the responsibility of and payable by Buyer. In the event Veracyte is required by law or regulation to pay any such tax or charge, such amount will be added to the purchase price or subsequently invoiced to Buyer.
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Customer must receive Veracyte’s written consent before any instrument, accessory, component, feature, or device is attached to or used in conjunction with the Covered Equipment during the term of this Agreement. Veracyte may withdraw this consent at any time if it determines, using its sole discretion, that such attachment or use in conjunction with the Covered Equipment adversely affects Veracyte’s ability to perform maintenance service hereunder. Upon receipt of Customer’s request for such written consent, Veracyte shall, at its election take one of the following actions: 1) provide written consent for the use or attachment of said instrument, accessory, component, feature, or device, and, if appropriate, make an additional charge therefor, 2) approve the inclusion of said instrument, accessory, component, feature, or device in the Covered Equipment from the date of such consent and, if appropriate, make an additional charge therefor; or 3) decline to provide consent for the use or attachment of said instrument, accessory, component, feature, or device.
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Customer is not to make or participate in any modification, adjustment, movement, or repair of the Covered Equipment without the prior consent of an authorized Veracyte representative. Veracyte may withdraw this consent at any time if it determines, using its sole discretion, that such modification, adjustment, movement, or repair adversely affects Veracyte’s ability to perform maintenance service hereunder.
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Maintenance Service.
Veracyte will provide Customer with Maintenance Service during the term of the Agreement. “Maintenance Service” shall include: (a) Remedial Maintenance of malfunctioning Covered Equipment that does not perform within legal manufacturer’s published specifications. “Remedial Maintenance” means providing service assistance via telephone, at a Veracyte service center, or by an on-site visit by a Veracyte technical representative, at Veracyte’s sole discretion, to resolve Covered Equipment malfunctions. Such maintenance shall be furnished on an on-call basis within four (4) Regular Business Days after an authorized Veracyte representative receives notice of malfunctioning from Customer; (b) a maximum of one (1) “Preventative Maintenance” per year, which includes use of procedures during which Veracyte service engineers will inspect the defective parts and correct if applicable; update software if applicable; and clean, lubricate, adjust, and exercise the Covered Equipment in all of its operational modes to ensure continuing optimum performance. This subparagraph (b) does not apply to instruments without an existing Veracyte service agreement; (c) installation of such engineering changes or software bug fixes in Covered Equipment as Veracyte, in its sole discretion, shall deem appropriate or which are required by regulatory authorities; and (d) except as provided herein, replacement of parts deemed appropriate, in Veracyte’s sole discretion, for preventive or remedial maintenance furnished under this Agreement.
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Covered Location.
Except as otherwise provided herein, on-site Maintenance Service shall be furnished under this Agreement only at the site where the Covered Equipment was originally installed by Veracyte (“Covered Location”). The place of service for all mail-in maintenance service will be designated by Veracyte at the time of mail-in maintenance service.
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Removal of Covered Equipment.
Veracyte may temporarily remove from a Covered Location any Covered Equipment or part thereof for repair if Veracyte, in its sole discretion, deems such removal appropriate to provide Maintenance Service. Veracyte, in its sole discretion,may provide Customer with temporary use of equipment to replace any Covered Equipment removed from a Covered Location on an “as available” basis.
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Provision of Services.
Services are provided during normal working hours (Monday through Friday 8:00 AM to 5:00 PM, excluding holidays). Telephone support hours are 8:00 AM to 5:00 PM Pacific Standard Time, excluding U.S. holidays. Planned maintenance (“Planned Maintenance”) will be performed in accordance with Veracyte’s Planned Maintenance procedures and checklist for the Covered Equipment being serviced. Veracyte may require recertification of Covered Equipment on a time and materials basis as a condition to performing services if the Covered Equipment has not been under warranty or a service plan immediately prior to the time of service.
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Replacement Parts.
The decision to repair or replace any parts of the Covered Equipment will be made by Veracyte on the basis of which approach will provide Customer with the best service. Parts and components replaced or otherwise utilized in the repair of the Covered Equipment may be either new or refurbished at the discretion of Veracyte. Veracyte warrants that Replacement Parts will conform to their specifications for a period of ninety (90) days from the date the Replacement Parts are installed. Replacement Parts do not extend the warranty for the underlying instrument.
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Scheduling.
Veracyte will use reasonable efforts under the circumstances to provide services as quickly as possible. The service will be scheduled at a time mutually agreed upon by Veracyte and Customer.
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Veracyte Warranty; Disclaimer.
Veracyte warrants that it will provide its services at least in accordance with generally accepted standards prevailing in the instrument repair industry at the time and place performed. Warranty claims must be made within ninety (90) days after services are performed. VERACYTE MAKES NO OTHER WARRANTIES OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY WITH RESPECT TO ITS SERVICES, WHICH WARRANTIES ARE EXPRESSLY DISCLAIMED. VERACYTE’S SOLE LIABILITY AND RESPONSIBILITY UNDER THIS AGREEMENT FOR BREACH OF WARRANTY IS RE-PERFORMANCE OF THE SERVICES WITHIN A REASONABLE TIME OR RETURN OF THE FEE PAID FOR THE DEFECTIVE SERVICES AT VERACYTE’S OPTION. THESE ARE CUSTOMER’S SOLE AND EXCLUSIVE REMEDIES FOR ANY BREACH OF WARRANTY.
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Plan Coverage.
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System Services do not cover replacement of parts, costs, repairs, or adjustments for defects resulting from or necessitated by acts of nature, damage not caused by Veracyte, accident, neglect, carelessness, misuse, including without limitation: operation with incompatible solvents or samples in the system; operation outside of the environmental or use specifications or not in conformance with the instructions for the Covered Equipment system, software, or accessories; improper or inadequate maintenance by the user; installation of software or interfacing, or use in combination with software or products not supplied or authorized by Veracyte; or modification, repair, service transfer to another location of the Covered Equipment made by Customer, Customer’s employees, agent, or an unauthorized contractor, or intrusive activity, including without limitation computer viruses, hackers, or other unauthorized interactions with Covered Equipment or software that detrimentally affects normal operations. System Services also do not cover repair or replacement of parts that are radioactive or contaminated with biological, toxic, or other dangerous materials or substances.
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System Services do not cover costs, repairs, or adjustments made necessary by connection of the Covered Equipment to electrical services or other utilities not in accordance with the installation requirements for the Covered Equipment or by any interruption or surge in voltage (see Instruction Manual for specifications).
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Prices; Taxes.
The purchase price to Buyer for the Maintenance Service or a System Services(“Purchase Price”) shall be the price set forth on Buyer’s Service Agreement or Sales Quote as provided by Veracyte, or as has been agreed to in writing between Veracyte and Buyer. Purchase Price increases shall not affect unfulfilled purchase orders accepted by Veracyte prior to the effective date of the price increase. Buyer agrees that any applicable sales, use, excise, withholding and other taxes are the responsibility of and payable by Buyer. If Buyer is located outside of the United States, VAT (value added tax) and GST (goods and services tax) are also the responsibility of and payable by Buyer. In the event Veracyte is required by law or regulation to pay any such tax or charge, such amount will be added to the purchase price or subsequently invoiced to Buyer.
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Term and Termination of Service Plans.
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Veracyte may accept or reject at its discretion a purchase order for Maintenance Service or System Services. Unless otherwise expressly stated by Veracyte in writing or under the terms of the purchased System Services, the initial term of a Service Plan and this Agreement is one year, commencing on the date designated by Veracyte in its quotation or in the Service Sales Agreement or otherwise specified to Customer. An Agreement may be terminated by either party upon at least thirty (30) days written notice to the other party. Termination will be effective thirty (30) days after the receipt of such notice, or at a later date if one is so specified in the notice (“Termination Date”). Termination cannot be made effective prior to thirty (30) days after notice is received, provided, however, that Veracyte may terminate an Agreement immediately in the event that the Covered Equipment is transferred to another location. Veracyte will cease service under this Agreement and underlying System Services on the Termination Date unless Customer specifies a separate, earlier date in writing (“Cessation Date”). In that event, Veracyte will cease providing service under this Agreement and the underlying System Services on such Cessation Date.
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In the event of termination of a System Services under Section 12(a), if the termination is by Customer, Veracyte shall calculate at its sole discretion the total price of service actually performed and expenses actually and reasonably incurred in servicing the Covered Equipment under the underlying System Services from its effective date until the Termination Date. Customer’s total payment obligation to Veracyte under this Agreement shall equal (1) the amount so calculated or (2) the prorated price of the underlying System Services from its effective date until the Termination Date, whichever is greater, plus fifteen percent (15%) of the total fee paid for the underlying System Services, not to exceed the total amount paid. Any payments made by Customer to Veracyte in excess of this amount shall be credited to Customer’s account within thirty (30) days after the Termination Date toward future purchases of Veracyte instruments, consumables, or System Services. Any unpaid portion of this amount shall be immediately due upon Customer’s receipt of an invoice from Veracyte. If the termination is by Veracyte, other than for cause, Veracyte will credit Customer with or refund to Customer, at Veracyte’s option, the prorated price of the underlying System Services from its effective date until the Termination Date. If an Agreement is terminated early in connection with the trade in of used Veracyte Covered Equipment for new Veracyte Covered Equipment, the credit may be applied toward purchase of System Services for the new Covered Equipment. Contact your Veracyte service representative for details. No cash refunds will be made on account of the early termination of any System Services or other agreement for services.
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Limitation of Liability.
NEITHER VERACYTE NOR ITS LICENSORS OR ITS SUPPLIERS WILL 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 LIABILITY OR OTHERWISE, EVEN IF VERACYTE OR ITS LICENSORS OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. EXCEPT TO THE EXTENT CAUSED BY VERACYTE’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR AS REQUIRED BY APPLICABLE LAW, VERACYTE’S AND ITS LICENSORS OR ITS SUPPLIERS’ LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO VERACYTE FOR THE SYSTEM SERVICES WHICH GIVE RISE TO THE CLAIM UNDER THIS AGREEMENT IN THE PRIOR TWELVE (12) MONTHS. BUYER AND ITS END USERS ARE RESPONSIBLE FOR, AND VERACYTE AND ITS LICENSORS OR ITS SUPPLIERS WILL BEAR NO LIABILITY FOR, ANY TREATMENT AND CARE THAT IS RECOMMENDED OR PROVIDED BASED ON THE DATA GENERATED FROM THE SYSTEM OR THE RESULTS OF SUCH TREATMENT OR CARE. THE LIMITED REMEDIES AND LIABILITY LIMITS IN THIS AGREEMENT WILL APPLY EVEN IF THEY CAUSE A PROVISION OF THIS AGREEMENT TO FAIL OF ITS ESSENTIAL PURPOSE.
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Non-Covered Equipment.
Use of any non-Veracyte parts or reagents that are reasonably determined by Veracyte to have caused instrument failure or malfunction will require remedial repairs of the affected parts to be completed outside of the System Services at Veracyte’s then prevailing rates for billable service.
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Compliance with Laws.
Veracyte makes no representation whatsoever that services provided by Veracyte satisfy or will satisfy any requirements of any governmental body or other organization, including, but not limited to, any requirement of the United States Food and Drug Administration or the International Organization for Standardization. Customer agrees that it is Customer’s responsibility to ensure that such services are adequate to meet its regulation/certification requirements and that all requirements of any governmental body or other organization, including, but not limited to any requirement of the United States Food and Drug Administration or the International Organization for Standardization are the responsibility of Customer.
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Customer Warranty.
Veracyte may require a completed Certificate of Decontamination, or transfer of Covered Equipment to a suitable safe and secure location reasonably determined by Veracyte, as a condition to providing Maintenance Services for Covered Equipment. Customer warrants that any Covered Equipment or component to be serviced will be fully decontaminated of radioactive, biological, toxic or other dangerous materials or substances prior to servicing so that the service technician will not be exposed to any such materials.
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Relocation.
System Services do not include Customer training or services related to the relocation of Covered Equipment unless otherwise specifically stated in writing by Veracyte in any particular case.
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Data Protection.
Except in connection with Veracyte providing the System Services and/or Maintenance Service, Buyer must ensure that any Personal Data (as that term is defined the Data Protection Laws), is not submitted, communicated, accessed by or otherwise disclosed to Veracyte, its employees and agents. Buyer represents and warrants that any and all Personal Data that is made available to or shared with Veracyte has been collected and processed for lawful and legitimate purposes and that such Personal Data may be made lawfully available to and shared with Veracyte for processing for the purposes of the System Services and/or Maintenance Service by Veracyte in accordance with the applicable data protection laws, including but not limited to Regulation (EU) 2016/679 and the UK General Data Protection Regulation (together, the “Data Protection Laws”). To the extent the System Services and/or Maintenance Service provided by Veracyte involve the transfer of Personal Data from the European Economic Area, the United Kingdom, or other country with equivalent Data Protection Laws, to Veracyte, the parties agree to the Standard Contractual Clauses (PDF) available here and incorporated herein by reference. Buyer shall be the Data Exporter whereby Veracyte will be regarded as the Data Importer.
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Reporting of Discounts.
Buyer shall comply with applicable provisions of 42 U.S.C. §1320a-7b(b)(3)(A) (the “anti-kickback law” discount exemption) and 42 C.F.R. 1001.952(h) (the discount safe harbor) by properly disclosing and appropriately reflecting all discounts, rebates and other reductions in price provided in connection with this Agreement to representatives of Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)). Specifically, to the extent applicable and required by law, including, but not limited to, 42 U.S.C. 1320a-7b(b) and 42 C.F.R. 1001.952(h): (a) if Buyer reports its costs to a Federal health care program, Buyer will accurately reflect all discounts or other price reductions received hereunder; and (b) whether or not Buyer reports its costs to a Federal health care program, Buyer will retain this Agreement and other documentation provided by Veracyte pertaining to the discounts provided hereunder, and provide such documentation to authorized representatives of the U.S. Department of Health and Human Services or a state health care program on request. Buyer shall further comply with the applicable Medicare Clinical Laboratory Fee Schedule price reporting provisions of 42 U.S.C. § 1395m-1 and 42 C.F.R. § 414.502 et seq.
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Confidential Information.
All non-public, confidential or proprietary information of Veracyte, including but not limited to specifications, samples, designs, plans, drawings, documents, data, business operations, customer lists, pricing, discounts or rebates, disclosed by Veracyte to Buyer, whether disclosed orally or disclosed or accessed in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential” in connection with this Agreement, is confidential, and may be used by Buyer solely for the purpose of performing under this Agreement and may not be disclosed or copied unless authorized in advance by Veracyte in writing. Upon Veracyte’s request, Buyer shall promptly return all documents and other materials received from Veracyte. Veracyte shall be entitled to injunctive relief for any violation of this Section. This Section does not apply to information that is: (a) in the public domain; (b) known to Buyer at the time of disclosure; or (c) rightfully obtained by Buyer on a non-confidential basis from a third party.
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Unforeseen Events.
Veracyte 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 Veracyte (a “Force Majeure”). In the event of any such Force Majeure event, Veracyte shall have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
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Governing Law and Venue.
If the Veracyte entity party to this Agreement is Veracyte, Inc., then this Agreement is governed by the laws of New York, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in San Francisco, California, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
If the Veracyte entity party to this Agreement is Veracyte SAS, then this Agreement is governed by the laws of France, without reference to conflict of law principles. All disputes arising out of or related to it will be subject to the exclusive jurisdiction of the courts located in Marseille, France, and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts.
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Miscellaneous.
Veracyte may include Buyer on Veracyte’s standard customer lists (including on its website) and Veracyte may use the tradenames, trademarks, and logos of Buyer for such publicity, subject to Buyer’s general written requirements for such usage. Any notice or communication required or permitted hereunder shall be in writing and shall be deemed effective on receipt. Both parties will perform their obligations under this Agreement in compliance with all applicable laws and regulations. Veracyte may assign this Agreement or delegate all or part of its activities to its affiliate and may assign this Agreement to a third party in the context of a merger or acquisition. Buyer will not assign this Agreement, directly or indirectly, by operation of law or otherwise, without the prior written consent of Veracyte. The U.N. Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. This Agreement constitutes the entire agreement between Buyer and Veracyte with respect to the subject matter hereof and is the final, complete, and exclusive statement of the terms of the parties’ 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 of a provision of this Agreement shall not affect any other provision of this Agreement. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.