Sales Terms and Conditions
These Sales Terms and Conditions constitute a binding legal agreement (the “Agreement”) between Veracyte, Inc. (“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.
Buyer shall place all Kit orders by emailing its order to email@example.com. 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 via email to firstname.lastname@example.org of any changes in the shipping or contact information that it has previously provided to Veracyte.
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.
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.
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.
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.
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.
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. 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. 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.
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.
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.
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.
Buyer must ensure that any information relating to an identified or identifiable individual (“Personal Data”) is not submitted, communicated, accessed by or otherwise disclosed to Veracyte, its employees and agents. Should Buyer need to disclose any Personal Data to Veracyte, or its employees and agents, it must first inform Veracyte about its intent to disclose Personal Data and refrain from disclosing such data to Veracyte, and its employees and agents prior to receiving Veracyte prior written approval. Upon Veracyte’s approval, Buyer may disclose Personal Data to Veracyte, its employees and agents, but it must ensure that individuals whose Personal Data is submitted to or is accessed by Veracyte, its employees and agents have provided appropriate consent, as required by applicable law, and that such transfer is in accordance with all applicable laws and regulations governing the privacy and security of such Personal Data, including, if Buyer is located in the European Union, the European Union General Data Protection Regulation (Regulation (EU) 2016/679) and its implementing regulations and laws, as amended. Any consent provided by individuals for the Processing of Personal Data in the context of services must be freely given, specific and informed, and can be withdrawn at any time. When individuals withdraw their consent for the Processing of Personal Data in relation to services, Buyer must stop submitting these Personal Data to Veracyte and inform Veracyte without delay. “Processing of Personal Data” means any operation or set of operations which is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.
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.
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 13. This Section 13 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.
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.
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. This Agreement is governed by the laws of California, 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. 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. No modifications of or amendment to this Agreement shall be effective or binding on either party unless mutually agreed to in writing signed by both parties. 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.