This document and its contents are proprietary to HeartGenetics, Genetics and Biotechnology SA (hereinafter referred to as “HeartGenetics”), and are intended solely for the contractual use of its customer in connection with the use of the product(s) described herein and for no other purpose. The information in this document shall not be used or distributed for any other purpose without the prior written consent of HeartGenetics. HeartGenetics does not convey any license under its patent, trademark, copyright, or common-law rights nor similar rights of any third parties by this document or purchase of this product alone.
Please read these safety instructions carefully and make sure that you understand them fully before you start using the product(s) described herein. Failure to completely read and explicitly follow all the instructions contained herein may result in damage of the product(s), injury to persons, including to users or others, and damage to other property.
HEARTGENETICS, GENETICS & BIOTECHNOLOGY SA WILL NOT BE LIABLE WHETHER IN CONTRACT, TORT, WARRANTY, OR UNDER ANY STATUTE, OR ANY OTHER BASIS OF SPECIAL, INCIDENTAL, INDIRECT PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH IN ARISING FROM THIS DOCUMENT, OR IMPROPER USE OF THE PRODUCT(S) DESCRIBED HEREIN (INCLUDING PARTS THEREOF OR SOFTWARE) OR ANY USE OF SUCH PRODUCT(S) OUTSIDE THE SCOPE OF THE EXPRESS WRITTEN LICENSES OR PERMISSIONS GRANTED BY HEARTGENETICS, GENETICS & BIOTECHNOLOGY SA, TO THE EXTENT ALLOWED BY LAW.
The information in this User Guide is subject to change without notice due to software upgrades and new scientific developments.
© 2015 HeartGenetics, Genetics and Biotechnology SA.
All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means (electronic, mechanical, photocopying or recording) or stored in a retrieval system, for any reason other than a licensee’s internal use without the prior written permission of HeartGenetics.
HeartGenetics®, HeartDecode®|2016, DNArterial®|2016, TromboGene Kit™|2016, LipoGene Kit™|2016, Warfarin PGX Kit™|2016, Clopidogrel PGX Kit™|2016, and Simvastatin PGX Kit™|2016 are registered trademarks owned by HeartGenetics, Genetics and Biotechnology. All other trademarks or service marks set forth herein are the property of their respective owners.
READ BEFORE USING HEARTGENETICS’ PRODUCTS
HeartGenetics’ products, and its uses and dispositions, are subject to a number of terms and conditions that are detailed here and in the commercial contract established with each client. If Purchaser does not agree to these terms and conditions then Purchaser is not authorized by HeartGenetics to use HeartGenetics’ products and Purchaser must not use such Product(s).
REGULATORY: HeartDecode® and HeartGenetics’s Genetic Testing Kits, including TrombogeneTM|2016, DNArterial®|2016, Clopidogrel PGX kitTM|2016, Warfarin PGX kitTM|2016 and Simvastatin PGX kitTM|2016, are licensed as in vitro medical devices to be used for In Vitro Diagnostic Testing Services, for research and development, for profit research, development and commercial services, all by mass spectrometry (MassARRAY® System by Agena Bioscience™). HeartGenetics is the proprietary of HeartDecode® in vitro medical device, including the installed software and databases. HeartGenetics is the proprietary of Genetic Testing Kit Trombogene KitTM |2016″, Medical Device for In Vitro Diagnostic, including the primer sequences and Control DNA template sequences.
This Product has been approved, cleared, or licensed by the Portuguese Regulatory Authority INFARMED (Portuguese National Authority of Medicines and Health Products). This Product is labeled as CE-IVD ” Trombogene KitTM|2016″.
UNAUTHORIZED USES: The licensed rights are for the benefit of Customer only. Purchaser agrees: (a) to use each Consumable for the specified number of genetic tests and (b) to use only HeartGenetics consumables/reagents with MassARRAY® System by Agena Bioscience™. The limitations in (a)-(b) do not apply if the Documentation or Specifications for this Product state otherwise. Purchaser agrees not to, nor authorize any third party to, engage in any of the following activities: (i) disassemble, reverse-engineer, reverse-compile, or reverse-assemble the Product, (ii) transfer or resale products and their components, purchased from HeartGenetics, to any third-party, (iii) re-manufacture HeartGenetics´Consumables, (iv) separate, extract, or isolate components of this Product or subject this Product or components thereof to any analysis not expressly authorized in this Product’s Documentation, (v) gain access to or attempt to determine the methods of operation of this Product, or (vi) transfer to a third-party, or grant a sublicense, to any Software or any third-party software. Purchaser also agrees that the contents of and methods of operation of this Product are proprietary to HeartGenetics and this Product contains or embodies trade secrets and possibly patents of HeartGenetics. The conditions and restrictions found in these terms and conditions are bargained for conditions of sale and therefore control the sale of and use of this Product by Purchaser.
HEARTGENETICS’ TOTAL AND CUMULATIVE LIABILITY TO PURCHASER OR ANY THIRD PARTY ARISING OUT OF OR IN CONNECTION WITH THESE TERMS AND CONDITIONS, INCLUDING WITHOUT LIMITATION, THIS PRODUCT (INCLUDING USE THEREOF) AND HEARTGENETICS’ PERFORMANCE HEREUNDER, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, SHALL IN NO EVENT EXCEED THE AMOUNT PAID TO HEARTGENETICS FOR THIS PRODUCT, FROM CUSTOMER PURSUANT TO PURCHASE ORDER AND INVOICE OR WRITTEN CONTRACT WITH CUSTOMER.
THE LIMITATIONS SET FORTH IN THIS SECTION SHALL APPLY REGARDLESS OF FORESEEABILITY AND EVEN IF HEARTGENETICS OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSSES, COSTS, OR DAMAGES. THE FOREGOING SHALL APPLY REGARDLESS OF ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
- Warranty for Consumables: HeartGenetics warrants that Consumables will be free from defects in materials and workmanship and will conform to HeartGenetics’s specifications in effect as of the date of delivery, and perform accordingly from the date of delivery up to the expiration date specified on the product packaging (the “Warranty Period”), provided that such consumables have been stored, handled, and used according to HeartGenetics’ specifications, and otherwise remain unchanged and in the original condition supplied by HeartGenetics.
- Warranty for Hardware: HeartGenetics warrants that the Hardware (where the HeartDecode® software system and databases are hosted), other than Upgraded Components, owned by HeartGenetics, will be free from defects in materials and workmanship and will conform to HeartGenetics specifications in effect as of the date of delivery, and perform accordingly under the contract agreement; and only so long as the Hardware remains unchanged and in the original condition supplied by HeartGenetics. “Upgraded Components” means HeartGenetics provided components, modifications, or enhancements to Hardware, will conform to their Specifications under the contract agreement.
- Limited Warranty for Software. HeartGenetics warrants that the Software will perform substantially in accordance with the accompanying documentation under the contract agreement. HeartGenetics makes no other representations, warranties, guarantees, or claims, of any kind or nature, as to the accuracy of, reliability, utility, performance, effectiveness, or otherwise, of the Software provided herein or the results obtained therefrom, nor does HeartGenetics assume any responsibility for the results, quality of results, or lack of results. THE SOFTWARE IS PROVIDED “AS IS” AND WITHOUT WARRANTY OF ANY KIND, WRITTEN OR ORAL, EXPRESS OR IMPLIED, DIRECT, INDIRECT, BY ESTOPPEL, OR OTHERWISE, AND SPECIFICALLY EXCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF ANY THIRD PARTY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS, AND ANY OTHER WARRANTIES PROVIDED FOR BY THE UNIFORM COMMERCIAL CODE, USAGE IN THE INDUSTRY, OR COURSE OF DEALING BETWEEN THE PARTIES.
- Warranty Exclusions: The foregoing warranty does not include, and Purchaser is responsible for: (i) periodic maintenance or calibration recommended for certain products and equipment necessary to its normal function; and (ii) maintaining a procedure to back-up any and all data generated by the HeartDecode® Software System. Further, the foregoing warranty shall not apply to an HeartGenetics’ product that (i) has been subjected to improper or inadequate maintenance, abuse, misuse, neglect, negligence, accident, improper storage, unauthorized alterations, or use contrary to the Documentation or Specifications; (ii) improper handling, installation, maintenance, or repair (other than if performed by HeartGenetics’ personnel); (iii) has been used with third party hardware, software, interfacing, or other products or components provided by parties not approved in writing by HeartGenetics; (iv) has failed or been damaged due to environmental conditions at the site of installation including exposure to Bio- Safety Level 3 or 4 (as defined by the United States Occupational Health and Safety Administration) agents; exposure to radioactivity; or the use of or invasion by malicious software programs such as viruses; or (v) has failed or been damaged due to causes beyond its reasonable control, including, but not limited to, acts of civil or military authority, riots, wars, terrorism, fires, floods, earthquakes, lightning, storms, and other Force Majeure events.
- Procedure for Warranty Coverage: In order to be eligible for repair or replacement under this warranty Purchaser must (i) promptly contact HeartGenetics’ support department to report the non-conformance, (ii) cooperate with HeartGenetics in confirming or diagnosing the non-conformance, and (iii) return this Product, transportation charges prepaid to HeartGenetics following HeartGenetics’ instructions provided at the time, or if no specific instructions are provided at the time, in accordance with HeartGenetics’ then current written return procedures (which may be amended from time to time) or, if agreed by HeartGenetics and Purchaser, grant HeartGenetics’ authorized repair personnel access to this Product, to its facility and information deemed necessary to facilitate a repair, in order to confirm the non-conformance and make repairs.
Prior to any service visit, Purchaser must notify HeartGenetics in writing of any decontamination of the facility or any product that has been exposed to toxic or dangerous substances. No products or components may be returned to HeartGenetics under any circumstances without HeartGenetics’ prior authorization. During service performed at Customer’s facility, Customer must have a Customer representative on-site at all times.
- Sole Remedy under Warranty: If during the Warranty Period HeartGenetics is provided with prompt written notice by Purchaser of any product failure along with a detailed written description of the failure, then upon HeartGenetics’ inspection and testing as may be necessary to confirm the failure and upon its determination that none of the warranty exclusions above are applicable, HeartGenetics shall at its sole discretion and option, as Purchaser’s sole remedy and HeartGenetics’ sole obligation under the foregoing warranty: (1) replace the products in whole or components thereof; or (2) repair (and recalibrate as necessitated by repair) the products. Replacement and repaired products and components may include functionally equivalent, reconditioned, refurbished, or new parts.
For consumables, provided that HeartGenetics has confirmed the failure and determined that none of the warranty exclusions above are applicable, HeartGenetics reserves the right at its sole discretion to either replace the consumables or to provide Purchaser with credit for the purchase price paid only, prorated for the unusable portion of the consumables, to be used to offset future purchases. Repaired or replaced Consumables come with a 30-day warranty. No refunds will be made.
- Third-Party Goods and Warranty: HeartGenetics has no warranty obligations with respect to any goods originating from a third party and supplied to Purchaser hereunder. Third-party goods are those that are labeled or branded with a third-party’s name. The original manufacturer provides the warranty, if any, for third-party goods. Upon written request HeartGenetics will attempt to pass through any such warranty to Purchaser.