Prosigna® Sales Terms and Conditions
Last Updated: November 10, 2016
These Prosigna® Sales Terms and Conditions constitute a binding legal agreement (the “Agreement”) between NanoString Technologies, Inc. (“NanoString” or “we”, “our”, or “us”) and the customer (“Buyer” or “you” or “your”) identified on its order to NanoString or to NanoString’s authorized distributor, as applicable. This Agreement governs the sale by NanoString, or by NanoString’s authorized Distributor, to Buyer of the Prosigna Breast Cancer Prognostic Gene Signature Assays (the “Prosigna Kits”) and Roche FFPET RNA Isolation Kits (the “Roche Kits” and together with Prosigna Kits, the “Kits”) set forth in Buyer’s order. By placing an order with NanoString or NanoString’s authorized distributor for Prosigna Kits or Roche Kits in any other manner, Buyer is agreeing to be bound by, and is becoming a party to, this Agreement. If Buyer is an authorized distributor for NanoString, it shall require its purchasers of Prosigna Kits to be bound by this Agreement. NanoString’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 NanoString.
- Ordering. Buyer shall place all Prosigna Kit and Roche Kit orders by emailing its order to DXorders@nanostring.com or by faxing its order to 1-206-378-6288. Only individuals authorized by Buyer (“Authorized Personnel”) to place binding orders on Buyer’s behalf shall submit orders to NanoString. Buyer is legally and financially responsible for payment of all orders placed by its Authorized Personnel. Buyer will promptly inform NanoString via email to DXorders@nanostring.com of any changes in the shipping or contact information that it has previously provided to NanoString.
- 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 Prosigna Kits) located outside of the United States, Buyer represents that it has all required permits and qualifications to perform testing with the Prosigna Kits under applicable national and local laws and regulations. Buyer agrees that it will purchase or use the Prosigna Kits only at such time as the foregoing representation remains true and accurate. If Buyer is NanoString’s authorized distributor of Prosigna Kits, it represents and warrants that it will only resell Prosigna to end user laboratories that have all required permits and qualifications to perform testing with the Prosigna Kits under applicable national and local laws and regulations.
- Roche Kits. If Buyer is an end user laboratory located in the United States, Buyer is required to use Roche Kits for processing samples to be used for the Prosigna assay. If Buyer is an end user laboratory located outside of the United States, and provided that all required regulatory approvals, licenses, or registrations have been issued for the Roche Kits in the country in which they will be used, it is recommended, but not required, by NanoString that Buyer use Roche Kits for processing samples to be used for the Prosigna assay. The Roche Kits are available for purchase from NanoString at the price set forth on Buyer’s Prosigna Kits buyer information and pricing sheet.
- Price; Taxes. The purchase price to Buyer for the Prosigna Kits (“Purchase Price”) shall be the price set forth on Buyer’s Prosigna Kits buyer information and pricing sheet, or as has been agreed to between NanoString’s authorized distributor and Buyer, which Purchase Prices may be updated by NanoString in its sole discretion from time to time. Purchase Price increases shall not affect unfulfilled purchase orders accepted by NanoString 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 NanoString 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.
- Delivery. The Kits will be packed in NanoString’s standard shipping packages. NanoString may make partial deliveries. NanoString will ship via carrier selected by NanoString. Unless otherwise set forth in writing by NanoString or otherwise agreed by the parties, all shipments are made DAP (Incoterms 2010) to the address designated by Buyer at the time of ordering, provided that shipments to member countries of the European Union are made DDP (Incoterms 2010) excluding VAT. In all cases, title transfers at time of shipment and a reasonable shipping and handling fee will be added to the invoice and paid by Buyer.
- Cancellation and Rejection. Buyer may not cancel any Kits order once NanoString has shipped Buyer’s order. Any claims for Kits damaged upon receipt or missing must be reported in writing to NanoString by Buyer within five (5) days from the date of receipt of Kits (or in the case of a missing shipment, within five (5) days of a scheduled delivery date). For any valid claim made, NanoString shall, in its discretion, (i) replace the Kits or (ii) provide a financial credit to Buyer apportioned to reflect Buyer’s actual monetary loss for the 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 Kits damaged upon receipt or missing. NanoString has no obligation to accept any order placed by Buyer and may reject any order for any reason in its sole discretion.
- 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. Sales shipped outside the U.S. may require prepayment or payment on an irrevocable letter of credit acceptable to NanoString. Late payments may incur a charge at the rate of one and one-half percent (1.5%) percent per month, or the maximum allowed by law, whichever is less. Further shipment of 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 NanoString. Where Buyer is an end user laboratory purchasing from NanoString’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 NanoString. 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. The Prosigna Starter Kits shall be used for validation use only. 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 NanoString 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 Prosigna Kits, as applicable, (ii) subject the Prosigna Kits, or components thereof to any analysis not expressly authorized by a Prosigna Kit’s documentation, or (iii) reverse engineer, disassemble, redistribute or repackage the Prosigna Kits. Buyer agrees to notify NanoString of (x) 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 Prosigna Kits or (y) Buyer’s use of the Prosigna Kits with tissue that has been received from outside of the country in which Buyer’s laboratory is located. Buyer further agrees that the contents of and methods of operation of the Prosigna Kits, are proprietary to NanoString and that the Prosigna Kits, contain or embody trade secrets of NanoString. 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 NanoString is conveyed or implied by this Agreement or any Prosigna Kit. In particular, no right or license is conveyed or implied to use any Prosigna Kit provided hereunder in combination with a product not provided, licensed or specifically recommended by NanoString for such use. Within fifteen (15) days of the end of each quarter, Buyer will make all commercially reasonable efforts to provide NanoString with its Prosigna test ordering data for such previous quarter by country and zip code of requesting physician (used to support NanoString’s incentive compensation plan). 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 Prosigna 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 Prosigna Kits or a laboratory-developed test based upon, derived from, or resulting from any modifications made to, the Prosigna Kits.
- Warranty. NanoString warrants that the Kits will conform in all material respects to NanoString’s published specifications in the product data sheets supplied by NanoString to Buyer until the later of (i) 3 months from the date of shipment from NanoString, and (ii) the expiration date or the end of the shelf life pre-printed on such Kits by NanoString. In the event that NanoString reasonably determines after investigation that any Kits purchased by Buyer are defective, independent of user error, NanoString will, at its option, either (i) replace the defective Kits on a 1:1, like-kind basis at no cost to Buyer, or (ii) provide a financial credit to Buyer apportioned to reflect Buyer’s actual monetary loss for the Kits, which will be applied to Buyer’s next order, provided in each case that such defective 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 NanoString’s technical support. Replaced Kits come with a 90-day warranty. 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 NanoString (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, NANOSTRING AND ITS SUPPLIERS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO 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 NANOSTRING 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 NANOSTRING OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. AS TO ANY LIABILITY NOT LEGALLY SUBJECT TO THE FOREGOING, EXCEPT TO THE EXTENT CAUSED BY NANOSTRING’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR AS REQUIRED BY APPLICABLE LAW, NANOSTRING’S AND ITS SUPPLIERS’ LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO NANOSTRING FOR KITS UNDER THIS AGREEMENT IN THE PRIOR TWELVE (12) MONTHS. BUYER AND ITS END USERS ARE RESPONSIBLE FOR, AND NANOSTRING AND ITS SUPPLIERS WILL BEAR NO LIABILITY FOR, ANY TREATMENT AND CARE THAT IS RECOMMENDED OR PROVIDED BASED ON THE DATA GENERATED FROM THE PROSIGNA 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.
- Export Controls. Buyer acknowledges that the Prosigna 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, (b) cooperate fully with NanoString 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 Prosigna Kit or related technical documents or materials from any Prosigna 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 NanoString and the applicable U.S. Government agency.
- Data Protection. 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 NanoString, its employees and agents. Should Buyer need to disclose any Personal Data to NanoString, or its employees and agents, it must first inform NanoString about its intent to disclose Personal Data and refrain from disclosing such data to NanoString, and its employees and agents prior to receiving NanoString prior approval. Upon NanoString’s approval, Buyer may disclose Personal Data to NanoString, its employees and agents, but it must ensure that individuals whose Personal Data is submitted to or is accessed by NanoString, its employees and agents have provided appropriate consent, as required by applicable law, including, if Buyer is located in the European Union, the EU Privacy Directive 95/46 with respect to the EU/European Economic Area and all European Commission and national laws and guidelines implementing this directive. 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 NanoString and inform NanoString 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 NanoString 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.
- Unforeseen Events. NanoString 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 NanoString (a “Force Majeure”). In the event of any such Force Majeure event, NanoString shall have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
- Miscellaneous. NanoString may include Buyer on NanoString’s standard service provider lists (including on its website) and NanoString may use the tradenames, trademarks, and logos of Buyer for such publicity, subject to Buyer’s general requirements for such usage. Both parties will perform their obligations under this Agreement in compliance with all applicable laws and regulations. This Agreement are governed by the laws of Washington, 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 Seattle, Washington 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 NanoString. 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 NanoString with respect to the subject matter hereof and is the final, complete, and exclusive statement of the terms of the agreement, superseding all prior written and oral agreements, understandings and undertakings with respect to the subject matter hereof. The waiver of any provision or any breach of a provision of this Agreement shall not affect any other provision of this Agreement.
Prosigna is indicated for use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II), or node-positive (Stage II) breast cancer to be treated with adjuvant endocrine therapy.