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).
- DEFINITIONS: HeartGenetics Intellectual Property means HeartGenetics owned or controlled intellectual property rights that pertain to this Product (and use thereof) only with regard to specific field(s) or specific application(s). Any HeartGenetics patent, utility model, domain name, moral right, trade secret, know-how, confidential Information, formulation, trade mark, sign and service mark, rights in designs, trade or business names or signs, copyrights, database rights and topography rights (whether or not any of these is registered and including applications for registration of any such thing and all rights to apply for the same) and all rights or forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world. Documentation means HeartGenetics’s User Guide for this Product, including without limitation any other documentation that accompany this Product or that are referenced by the Product or in the packaging for the Product in effect on the date of shipment from HeartGenetics. Documentation includes this document. Consumable(s) means HeartGenetics’ genetic testing kits reagents and consumable items that are intended by HeartGenetics for use with, and are to be consumed through the use of, IPlexHardware. IPlexHardware means MassARRAY® System by Agena Bioscience™ accessories or peripherals. Hardware means any computer, accessories or peripherals that stores, executes or communicates with the HeartGenetics’ branded software. Software means HeartGenetics’ branded software (e.g., hardware operating software, reporting software system, data analysis software, proprietary databases). All Software is licensed and not sold and may be subject to additional terms that will be defined by contract with each customer. Proprietary database(s) is a HeartGenetics’ database(s) that is privately owned and password protected. Product means the product that this document accompanies (e.g., Hardware, Consumables, or Software). Purchaser is the person or entity that rightfully and legally acquires this Product from HeartGenetics or a HeartGenetics authorized dealer. Specifications means HeartGenetics’ written specifications for this Product in effect on the date that the Product ships from HeartGenetics.
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.
- LIMITED LIABILITY: IN NO EVENT SHALL HEARTGENETICS OR ITS SUPPLIERS BE LIABLE TO CUSTOMER OR ANY THIRD PARTY FOR LOST PROFITS, DATA OR BUSINESS, THE COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR SERVICES, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH USE OF THE HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION PROVIDED TO CUSTOMER BY HEARTGENETICS, HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE), TO THE EXTENT PERMITTED BY LAW.
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.
- LIMITATIONS ON HEARTGENETICS PROVIDED WARRANTIES: EXCEPT FOR THE EXPRESS LIMITED WARRANTY SET FORTH HEREIN, HEARTGENETICS MAKES NO OTHER WARRANTIES, ORAL OR WRITTEN, EXPRESS, IMPLIED, OR BY STATUTE, WITH RESPECT TO THIS PRODUCT, OR ANY HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION REGARDING ANY OF THE FOREGOING, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF PATENT RIGHTS OR VIOLATION OF INTELLECTUAL PROPERTY RIGHTS OF ANY KIND, OR ARISING FROM COURSE OF DEALING, PERFORMANCE, USAGE OR TRADE. FOR THE AVOIDANCE OF DOUBT, HEARTGENETICS DOES NOT WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE, OF THIS PRODUCT OR ANY HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE, TO THE EXTENT PERMITTED BY LAW.
- PRODUCT WARRANTY: All warranties are personal to the Purchaser and may not be assigned or transferred to a third-party, including an affiliate of Purchaser, unless otherwise agreed upon in writing by HeartGenetics. All warranties are facility specific and do not transfer if the Product is used at another facility of Purchaser, unless HeartGenetics approves.
- 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.
- CONFLICTS: In the event of a conflict between the terms and conditions of this Document and any terms and conditions provided by Purchaser, or work order, purchase order, billing statement, or invoice related to the purchase, license, or transfer of any HeartGenetics’ products, technology or services, the language of this Document shall govern and control, and the conflicting terms, provisions, and conditions of any such other documents shall be deemed null, void, and unenforceable.
- Infringement Indemnification by HeartGenetics: Subject to these terms and conditions, including without limitation, the Exclusions to HeartGenetics’ Indemnification Obligations (Section below), the Conditions to Indemnification Obligations (Section below), HeartGenetics shall (i) defend and hold harmless Purchaser against any third-party claim or action alleging that this Product, in accordance with this document, and in accordance with this Product’s Design and Device Description Specifications infringes the valid and enforceable intellectual property rights of a third party. If this Product or any part thereof, becomes, or in HeartGenetics’ opinion may become, the subject of an infringement claim, HeartGenetics shall have the right, at its option, to (A) procure for Purchaser the right to continue using this Product, (B) modify or replace this Product with a substantially equivalent non-infringing substitute, or (C) require the return of this Product and terminate the rights, license, and any other permissions provided to Purchaser with respect this Product and refund to Purchaser the depreciated value of the returned Product at the time of such return; provided that, no refund will be given for used-up or expired Consumables. This Section states the entire liability of HeartGenetics for any infringement of third party intellectual property rights.
- Exclusions to HeartGenetics’ Indemnification Obligations: HeartGenetics has no obligation to defend, indemnify or hold harmless Purchaser for any HeartGenetics Infringement Claim to the extent such infringement arises from: (i) the use of this Product in any manner not in accordance with its Specifications, its Documentation, the rights expressly granted to Purchaser hereunder, or any breach by Purchaser of these terms and conditions; (ii) the use of this Product to perform any assay or other process not supplied or developed by HeartGenetics, or (iii) HeartGenetics’ compliance with specifications or instructions for this Product furnished by, or on behalf of, Purchaser (each of (i) – (iii), is referred to as an “Excluded Claim”).
- Indemnification by Purchaser: Purchaser shall defend, indemnify and hold harmless HeartGenetics, its affiliates and development partners that contributed to the development of this Product, and their respective officers, directors, representatives and employees against any claims, liabilities, damages, fines, penalties, causes of action, and losses of any and every kind, including without limitation, personal injury or death claims, and infringement of a third party’s intellectual property rights, resulting from, relating to, or arising out of (i) Purchaser’s breach of any of these terms and conditions; (ii) personal injury or harm from the use, sale or other disposition of any product or service or information provided to a third party by Purchaser and/or its contractual partners, customers, or collaborators; (iii) any use of this Product not in accordance with this Product’s Specifications or Documentation; (iv) a claim that a Purchaser product, assay, test analysis, method, or procedure infringes any patent, trade secret or other intellectual property rights of any third party, unless such claim is solely based on Purchaser’s non-assay-specific use of HeartGenetics’ products according to the authorized and intended use for such product and in compliance with user operating manuals and package inserts provided with such products; (v) any Excluded Claim.
- Conditions to Indemnification Obligations: The parties’ indemnification obligations are constrained upon the party seeking indemnification (i) promptly notifying the other party in writing of such claim or action; (ii) giving the other party exclusive control and authority over the defense and settlement of such claim or action; (iii) not admitting infringement of any intellectual property right without prior written consent of the other party; (iv) not entering into any compromise of any such claim or action without the other party’s prior written consent; and (v) providing reasonable assistance to the other party in the defense of the claim or action; provided that, the party reimburses the indemnified party for its reasonable out-of-pocket expenses incurred in providing such assistance.
- Third-Party Goods and Indemnification: HeartGenetics has no indemnification obligations with respect to any goods originating from a third party and supplied to Purchaser. Third-party goods are those that are labeled or branded with a third-party’s name. Purchaser’s indemnification rights, if any, with respect to third party goods shall be pursuant to the original manufacturer’s or licensor’s indemnity. Upon written request HeartGenetics will attempt to pass through such indemnity, if any, to Purchaser.