Sensify NP Terms and Conditions
GRAIL, Inc. Standard Terms and Conditions of Sale for the SENSIFY™ NP Test (“T&Cs”)
ALL SALES MADE BY GRAIL, Inc. (“GRAIL”) TO THE PURCHASER (AS DEFINED BELOW) OF THE SENSIFY™ NP TEST ARE EXPRESSLY CONDITIONED ON PURCHASER’S AND DESIGNEE’S ACCEPTANCE OF THE FOLLOWING TERMS AND CONDITIONS. THESE TERMS AND CONDITIONS AND THE ATTACHED TRF CONSTITUTE THE ENTIRE AGREEMENT BETWEEN GRAIL AND PURCHASER AND DESIGNEE AND SUPERSEDE ALL PREVIOUS DISCUSSIONS AND UNDERSTANDINGS, WHETHER ORAL OR WRITTEN, BETWEEN THE PARTIES WITH RESPECT TO THE SUBJECT MATTER HEREOF. GRAIL WILL NOT BE BOUND BY ANY TERMS OF PURCHASER’S OR DESIGNEE’S PURCHASE ORDER OR OTHER DOCUMENTS THAT ARE ADDITIONAL OR INCONSISTENT WITH THE TERMS HEREIN AND ALL SUCH TERMS WILL BE EXCLUDED.
1.1 “Applicable Laws” means all laws, rules and regulations relevant to Purchaser and Designee’s performance under these T&Cs, including without limitation, the Personal Data (Privacy) Ordinance (Cap 486); the Medical Registration Ordinance (Cap 161); and the Code of Professional Conduct published by the Medical Council of Hong Kong.
1.2 “Authorized Use” means the collection by Purchaser of human samples using Test Materials in accordance with the Documentation and all applicable laws, rules and regulations, and the delivery of Test Results to physician or Patient for the purpose of a licensed physician providing diagnostic advice to the Patient regarding the Patient’s risk of having nasopharyngeal carcinoma. Purchaser is not authorized to transfer Test Materials to any third party and a Designee is not authorized to receive Test Materials.
1.3 “Designee” is an individual or entity authorized by a Purchaser to issue a TRF (Test Request Form, defined below).
1.4 “Documentation” means, with respect to a Test, GRAIL’s user manual, package insert, labelling, instructions for use, technical specifications and similar technical documentation, including the protocols, for such Test in effect on the date that such Test is performed, expiration dates for Test Materials, and any documentation of test results prepared or authorized by GRAIL.
1.5 “Informed Consent” means all consents required to ethically and legally collect, test, perform quality assurance on, and conduct research and product development using the Patient’s clinical data, results and samples, including without limitation the consents described in the Patient Brochure.
1.6 “Patient” means an individual whose sample is collected for the purpose of conducting the Test.
1.7 “Patient Brochure” means documentation supplied to Purchaser or Designee by GRAIL, entitled “Take Action Against Nasopharyngeal Cancer” that describes the nature and purpose of the Test and documents the Informed Consent that the Physician is required to obtain from the Patient as a condition to GRAIL performing the Test.
1.8 “Purchaser” means a purchaser of a Test from GRAIL.
1.9 “Submitting” with respect to a TRF means requesting a Test under a quote by delivering to GRAIL a TRF, whether the TRF is signed or unsigned, and includes submission of a TRF by the Purchaser or the Purchaser’s Designee. Submission of a TRF by the Designee indicates acknowledgment and acceptance of these T&Cs.
1.10 “Test” means the SENSIFY™ NP Test together with any associated packaging and sample collection materials (“Test Materials”), and reports of the results of testing (“Test Results”) supplied by or on behalf of GRAIL.
1.11 “TRF” means Test Requisition Form, which may be a form supplied by GRAIL or an electronic or paper form produced by Purchaser.
2. Terms and Conditions of Supply of Tests
2.1 Terms and Conditions. These T&Cs govern the sale to a Purchaser of Tests as set forth in a TRF from GRAIL. All TRF acceptances are conditioned upon a Purchaser’s and Designee’s unqualified acceptance of the T&Cs set forth herein. Any changes or additions to these terms must be approved in writing by GRAIL.
2.2 Order and Acceptance. All orders for Tests will be made by TRF submitted by a Purchaser or Designee via GRAIL’s test request portal (www.sensifytest.com) or by a printed TRF received by GRAIL’s appointed laboratory site at GRAIL Hong Kong Ltd., Units 1801, 09-16, 18/F, BEA Tower, Millennium City 5, 418 Kwun Tong Road, Kwun Tong, Kowloon, Hong Kong. All TRFs will reference these T&Cs. GRAIL will not accept TRFs that do not satisfy all criteria in GRAIL’s Documentation. GRAIL will have no liability to a Purchaser or Designee with respect to TRFs that are not so accepted. No Purchaser or Designee may order any Test hereunder without first obtaining the necessary authorization from a physician, and Purchaser and Designee each represents that it has obtained such an authorization prior to its submission of a TRF to GRAIL. In the event a TRF does not contain such an authorization, then upon GRAIL’s request, the applicable Purchaser and Designee each agrees to make available to GRAIL any and all documentation necessary to demonstrate that the physician authorization was obtained.
2.3 Delivery, Shipping, Risk of Loss. GRAIL will use reasonable efforts to deliver Test Materials and Test Results at the times specified in GRAIL’s Documentation. Purchaser is responsible for ensuring that the Purchaser’s correct name and address is provided to GRAIL. GRAIL’s obligations to provide the Test Results will be satisfied once such Test Results are sent (whether by mail, in electronic form or otherwise) to Purchaser at the name and address on file with GRAIL, and GRAIL will have no obligation for providing Test Results to the Patient and no liability with respect thereto to any Patient, Purchaser, Designee or third party. All Test Materials delivered hereunder will be suitably packed for shipment in GRAIL’s standard packaging, marked for shipment to Purchaser’s address specified in Purchaser’s TRF, and shipped via a carrier selected by GRAIL. All freight, insurance and other shipping expenses will be borne by GRAIL. If GRAIL fails to deliver an order to Purchaser within the period of time specified in the Documentation, GRAIL’s sole liability and Purchaser’s sole remedy will be to cancel the delayed order free of charge.
2.4 Acceptance of Test Materials. If Purchaser properly rejects a shipment of Test Materials, GRAIL’s sole liability and Purchaser’s sole remedy is limited to replacement of the applicable Test Materials.
3. Price and Payment
3.1 Price. Price for Tests will be GRAIL’s list price and pricing terms in effect at the time the TRF is issued or as may be otherwise agreed to on a quotation (“Sales Price”). GRAIL has the right to revise Sales Prices upon advance written notice to Purchaser. Sales Price increases will apply to all TRFs received after the effective date of the Sales Price revision. GRAIL will only invoice Purchasers for Tests for which GRAIL sends Test Results and not for any failed or canceled Tests.
3.2 Payment Terms. Payment terms will be net thirty (30) days after the date of GRAIL’s invoice. Purchaser will make payments to GRAIL regardless of whether the Purchaser receives payment from the Patient (or from another third party) for the applicable Test. Purchaser will make payments in Hong Kong Dollars by electronic payment, ACH, or wire transfer to an account designated by GRAIL. Any invoiced amount not paid when due will be subject to a charge equal to the lesser of one percent (1%) per month or the maximum rate permitted by law. If GRAIL undertakes collection or enforcement efforts, Purchaser will be liable for all costs thereof, including fees or disbursements of attorneys or other professionals.
3.3 Taxes. In addition to the Sales Price, Purchaser will be responsible for payment of all taxes (including without limitation, withholding, excise, sales, value-added, and use taxes) and customs duties paid or payable, however designated, levied, or based, but exclusive of taxes based on GRAIL’s net income. Grail will collect and remit any taxes, as required by applicable tax law.
4. Substitutions and Modifications. GRAIL will have the right to make substitutions and modifications in the specifications of Tests or protocols related to Tests sold by GRAIL provided that such substitutions or modifications will not materially affect overall Test performance.
5. Ownership, No License. GRAIL retains all proprietary rights in and to all designs, engineering details, software and other technology and information relating to the Tests, and all intellectual property rights in and to the Tests. Unless expressly set forth herein, the sale of Tests does not grant to, convey or confer upon Purchaser or Designee, a license, express or implied, under any patent right, copyright, or other intellectual property right of GRAIL.
6. Disclaimer. Purchaser and Designee each acknowledges that the Test (i) is not meant to be used as medical advice, diagnosis or treatment of any medical condition or health problem and (ii) is not meant to be a substitute for medical treatment. Purchaser and Designee each uses the Test at its own risk. THE TESTS ARE PROVIDED “AS IS” WITHOUT WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND GRAIL SPECIFICALLY DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE TEST, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
7. Purchaser Legal Compliance and Indemnification. Purchaser and Designee will comply with all Applicable Laws with respect to performing under these T&Cs; shipping, storing and using the Test Materials; storing and shipping Patients’ samples; communicating Test Results to Patients; maintaining the confidentiality of Patient data and Test Results; obtaining and maintaining all licenses required by law for ordering Tests; obtaining adequate Informed Consent; and obtaining and maintaining all licenses required by law for ordering Tests and delivering Test Results. Purchaser and Designee will defend, indemnify, and hold harmless GRAIL from and against any liability, damage, loss, or expense (including reasonable litigation fees and expenses of attorneys and other professionals) in connection with any third party claims, suits, or proceedings arising out of or relating to (i) Purchaser’s or Designee’s breach of any of these T&Cs, (ii) Purchaser’s or Designee’s use of the Tests in any manner or for any purpose other than an Authorized Use, as may be stated on the Test label, and as set forth in GRAIL’s written Documentation for the Test, or (iii) Purchaser’s or Designee’s violation of any applicable laws or regulations.
8. Restrictions. Purchaser may not, and for the avoidance of doubt, Purchaser is not granted any right or license to, (a) resell, distribute or transfer any Tests, directly or indirectly, to any third party for any purpose or use other than an Authorized Use, except as otherwise approved by GRAIL in writing (provided in all cases that the entity to which the Test is resold, distributed or transferred agrees in writing to be bound by GRAIL’s then-current T&Cs, a copy of which may be found at grail.com/sensify-np-terms-and-conditions); (b) use any Test Materials or Test Results for any use that is not an Authorized Use or not in accordance with such Test’s Documentation; (c) re-use previously used Test Materials; (d) modify, disassemble, reverse-engineer, or decompile, or otherwise analyze any Test Materials, except as otherwise approved by GRAIL in writing; (e) separate, extract, or isolate components of any Test Materials or carry out any other analysis of any Test Materials or samples collected using Test Materials that is not expressly authorized by GRAIL in writing; (f) adapt, modify, copy, reproduce, distribute, or prepare derivative works based on, any Test or Documentation without the express prior written consent of GRAIL (each of (a)-(f), an “Excluded Use”), nor authorize or purport to authorize any third party in relation to an Excluded Use. Purchaser acknowledges that failure to comply with any restriction of use set forth herein will (i) constitute a breach of these T&Cs, (ii) invalidate any warranty provided herein, and (iii) constitute a violation or infringement of GRAIL’s and/or a third party’s intellectual property rights.
9. Limitation of Liability. GRAIL’s liability and Purchaser’s remedies arising out of or related to sale of the Tests will not exceed the Sales Price paid by Purchaser for the Tests giving rise to such liability. IN NO EVENT WILL GRAIL BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS, LOST PROFITS OR BUSINESS OPPORTUNITIES OR ANY OTHER INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR RELIANCE DAMAGES, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE. THESE LIMITATIONS WILL APPLY REGARDLESS OF WHETHER GRAIL HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. No oral or written information or advice given by GRAIL or its employees will create a warranty, and Purchaser may not rely on any such information or advice.
10. Export Controls. Purchaser agrees that it will not directly or indirectly export Tests from Hong Kong without the prior written consent of GRAIL or in violation of any Hong Kong export laws or regulations.
11. Assignment. These T&Cs and Purchaser’s rights hereunder may not be transferred or assigned by Purchaser expressly, by operation of law, or otherwise, without the prior written consent of GRAIL. Any transfer or assignment in violation of this section is null and void.
12. Healthcare Law Compliance. Purchaser acknowledges and agrees that GRAIL may be required by applicable law, rules and regulations (“Healthcare Laws”) to disclose the existence of these T&Cs, the terms of these T&Cs including financial terms and the subject matter.
13. Miscellaneous. No representations or statements, other than those expressly set forth herein, were relied upon by the parties in entering into these terms. No modification or waiver of, addition to, or deletion from, the terms of these T&Cs (“Alternative Terms”), whether by purchase order, a non-GRAIL supplied TRF, or any other form supplied by Purchaser or a Designee, will be effective unless such Alternative Terms are reduced to writing and signed by duly authorized representatives of the parties hereto. The Tests are provided for Purchaser’s use only and may not be resold, exported or otherwise transferred to or used by anyone other than Purchaser. These terms will be governed by and interpreted in accordance with the laws of Hong Kong without reference to conflicts of law principles. Any dispute arising out of these terms will be brought in, and the parties consent to exclusive jurisdiction of the Hong Kong courts. Failure or delay by either party in exercising any right hereunder will not operate as, or be deemed a waiver of such right or of any other right hereunder, except for violations which, after discussion and mutual agreement by the parties, are waived in writing. Except for payment obligations, neither party will be liable for damages for any delay arising out of causes beyond their reasonable control, including without limitation acts of God, labor disputes, riots, wars and component shortages. If any provision of these terms is held to be invalid or unenforceable, the remainder of these terms will continue in full force and effect and will be interpreted to reflect the original intent of the parties.