IT Solutions Terms and Conditions

Download the PDF version of these terms and conditions.

The following are Terms and Conditions (“Terms and Conditions”) associated with Roche IT Solutions, including Roche Middleware Solutions, cobas Infinity, VANTAGE, Virtuoso, and VENTANA Connect.

1. DEFINITIONS: Any capitalized term defined herein shall have the meaning ascribed to it in these Terms and Conditions. In addition to terms defined as used in these Terms and Conditions, the following definitions shall be used herein:

  1. “Software” means, the Software Product and Documentation provided to Customer
    1. “Software Product” means a specific software product identified in Appendix D, including drivers for instruments or accessories provided by Roche, as applicable.
    2. Documentation” means Roche’s then-current documentation for the Software made available to Customer by Roche in writing, including user manuals, training guides, instructions and other updates or alerts provided by Roche from time to time.
    3. Approved Third Party Software” means any third party software (including drivers for instruments or accessories provided by Roche) in a particular release version which Roche has expressly approved in writing or in any product information or other publication to be used in connection with or parallel to the Software.
  2. Software Services” means the maintenance and support services for the Software being provided by Roche. Software Services may include Updates or Upgrades.
    1. An “Update” is a change to Software which is necessary to enable the Software to continue to operate at existing functionality levels or to correct software defects.
    2. An “Upgrade” is an improvement to Software that adds new functionality to the Software or any Product. “Upgrade” does not include any new licensable features which Roche has determined, in Roche’s sole discretion; require payment of an additional license fee.
  3. Installation” means each licensed copy of Software installed at a Customer’s site.
  4. “Acceptance” means acknowledgement by Customer of completion of installation of the Software
  5. Roche Product Supply Agreement” means one or more separate agreement(s) entered into between Customer and Roche pursuant to which Customer has agreed to acquire reagents, supplies, consumables (collectively, the “Reagents/Supplies”), or purchase, lease or acquire equipment (the “Equipment,” and collectively with IT solutions other than Software, and Reagents/Supplies, the “Products”) and service from Roche for Customer’s use in performing in-vitro diagnostics testing. The Roche Product Supply Agreement may include an allowance, surcharge or discount for the Software or Software Services described in Appendix D or to pursuant to which the Products and Services are “bundled” into the transactions contemplated by the Roche Product Supply Agreement.

2. CERTIFICATION OF USE: By accepting these Terms and Conditions, Customer is certifying that (a) the party signing knows how the Software will be used, and (b) that the Software will not be used in a blood bank or transfusion setting as long as Customer continues to use the Software. For purposes of this certification, a blood bank or transfusion setting is any setting involving the collection, processing, compatibility testing, storage and/or distribution of blood and blood components, including the manufacturing and maintaining of these products and associated databases. If Customer’s use of the Software changes in a way that causes this certification to become inaccurate, Customer will notify Roche as soon as possible.

3. LICENSING CONDITIONS:

  1. License Grant. Subject to these Terms and Conditions and for the term of use specified in Appendix D, Roche grants Customer a perpetual, limited, personal, non-transferable, non-exclusive, non-assignable license to use the Software in object code only, and the Documentation for such Software, for Customer’s internal use in the United States of America.
  2. Installations. The number and type of Software Installations are set forth in Appendix D.
  3. Restrictions. Customer shall not, and shall not permit any third party to, translate, reverse engineer, decompile, recompile, update, reproduce or modify all or any part of the Software or merge the Software into any other software. Customer shall not allow any third party to have access to the Software without Roche’s prior written consent. Customer shall not sell, assign, transfer, publish, disclose, display or otherwise make available the Software or copies thereof to any third parties.
  4. Ownership of Materials. All patents, copyrights, trade secrets, trademarks and other proprietary rights in or related to the Software are and will remain the exclusive property of Roche, whether or not specifically recognized or perfected under the laws of the jurisdiction in which the Software is used or licensed. Customer will not take any action that jeopardizes Roche’s proprietary rights or acquire any right in the Software. Roche will own all rights in any copy, translation, modification, adaptation, derivation, compilation, updated works and partial copies of the Software including any improvement or development thereof. Customer shall assign and hereby assigns these rights to Roche and will obtain, at Roche’s request, the execution of any instrument that may be appropriate to perfect these rights in Roche’s name. Customer shall secure and protect the Software, Documentation and copies thereof in a manner consistent with the maintenance of Roche’s or applicable third party rights therein and to take appropriate action by instruction or agreement with its employees or consultants who are permitted access to the Software to satisfy its obligations hereunder.

4. TERM AND TERMINATION :

  1. Term. Customer’s contractual agreement with Roche relating to the Software (the “Term”) shall commence on the Effective Date of Appendix D and shall remain in effect until otherwise terminated in accordance with the provisions of these Terms and Conditions.
  2. Termination for Default. These Terms and Conditions shall remain in effect until the licenses for all Software Products licensed hereunder have terminated. Notwithstanding any other term or condition set forth herein, Roche may terminate: (i) if Customer is in default of, violates or fails to perform any term or condition of the applicable Roche Products Supply Agreement, Appendix D, or these Terms and Conditions and such failure continues for thirty (30) days after notice thereof by Roche; or (ii) as otherwise expressly permitted pursuant to these Terms and Conditions. Except as otherwise specifically expired pursuant to its terms, the rights and obligations under Section 11 (Limited Warranty; Limitation of Liability; Indemnity) of this Agreement shall survive the cancellation, termination, or expiration of Appendix D and/or these Terms and Conditions.
  3. Remedies on Default. In the event of default by Customer as set forth in these Terms and Conditions, in addition to any remedies set forth in these Terms and Conditions, Customer shall immediately (a) cease all use of the Software, and (b) immediately delivery to Roche all copies of all Software in Customer’s possession and certify in writing to Roche within ten (10) business days after termination that the foregoing actions haven been taken. Further, Roche shall have the right to pursue any other remedy provided by law. Customer agrees to pay all costs of collection, including without limitation, court costs, and reasonable attorneys’ fees.

5. BILLING AND PAYMENT TERMS: Roche will begin billing Customer for the Software Products and Services on the date of installation completion for the first Software Product installed. Service will be billed as per the payment method defined in Appendix D. Roche will provide Customer with payment terms of net thirty (30) days from the date of invoice. Payment by credit card is acceptable at point of sale only. Failure to pay invoices when due may result in non-shipment of all future orders of products that Customer purchases from Roche and/or Customer being notified by Roche that Customer is in default of these Terms and Conditions.

6. SOFTWARE EARLY TERMINATION FEE: Both parties agree and acknowledge that in the event of a default of these Terms and Conditions by Customer which results in the early termination of Customer’s obligations as set forth in these Terms and Conditions and/or Appendix D, the “Software Early Termination Fee” that Customer agrees to pay will be: (a) the sum of Customer’s remaining monthly payments for all rented and leased Software, less unearned interest; plus (b) the sum of Customer’s remaining payments for Software Service, whether or not included in the Software price; plus (c) the pro-rata remaining value of all Software and Software Services identified as “included” or “Included in Reagents”, provided at “No Additional Charge”, or identified as Discounts. Customer agrees that the provisions related to the Software Early Termination Fee are reasonable in light of the circumstances and are not disproportionate to the presumed injury or loss resulting from Customer’s default.

7. DELIVERABLES:

  1. Software. Roche shall provide Customer with the Software in object code only, pursuant to the Installation/Acceptance Section below, as well as Documentation for the Software in electronic form.
  2. Third Party Software. Any other third party software provided to Customer in connection with the Software is licensed subject to applicable third party terms and conditions. See Section 8.
  3. Network Connections and Infrastructure. Customer shall be responsible for the acquisition, installation, testing, monitoring and maintenance of adequate hardware, network connections and services, including but not limited to all network infrastructure related hardware and software such as switching and routing equipment, name resolution systems, centralized data backup and recovery systems, virus protection systems, firewall and intrusion detection systems, physical security, etc. This shall be known as the “IT Infrastructure”.
  4. Installation/Acceptance.
    1. The installation of each Software shall occur following the completion and approval by Customer and Roche of a detailed site survey in accordance with an installation timeline to be provided by Roche. Customer and Roche agree to use their best efforts to maintain the estimated schedule in the installation timeline, however, neither Customer nor Roche will be liable to the other for delays as a result of events beyond their control.
    2. Customer's acceptance of Software occurs upon the earlier of Customer’s (1) written confirmation of acceptance or (2) use of Software in a manner that exceeds the scope or duration of the tasks in the installation timeline (for example, use in the assistance of actually processing patient billable results).

8. SOFTWARE SUBLCIENSES:

a. The following Third Party Software Terms and Conditions ONLY apply to cobas Infinity and Roche Middleware Solutions

InterSystems Cache Database . Customer acknowledges that the Software will be delivered with, and works in conjunction with, InterSystems Caché database software, and Customer agrees to the INTERSYSTEMS END USER LICENSE AND SERVICES AGREEMENT (“EULA”) contained , below.

  1. The End User License & Service Agreement (“EULA”) is between the InterSystems entity identified on the attached order form (“ISC”) and the user identified on the attached order form (hereinafter “Licensee”) that has ordered license(s) to use ISC’s proprietary software (the “Licensed Software”) and/or services (“Services”) from ISC through Roche pursuant to the order form on page one. Licensee must read the following terms and conditions of this EULA carefully before using the Licensed Software. LICENSEE ACCEPTS AND AGREE TO BE BOUND BY TERMS OF THIS EULA BY USING THE SOFTWARE. If Licensee is accepting this EULA on behalf of another person or a company or other legal entity, Licensee represents and warrants that Licensee has full authority to bind that person, company, or legal entity. If Licensee is not willing to be bound by this EULA, the Licensed Software respectively the AP’ Software must be promptly returned to ISC or the AP.
  2. Subject to Licensees consent to ISC and Roche’s terms, ISC grants to Licensee a nontransferable and nonexclusive 30-year license to use the Licensed Software internally solely for Licensee’s internal business (the “License”) For the avoidance of doubt, the Licensed Software shall not include the open source or other third party software that may be shipped with, installed with, or used in conjunction with ISC’s proprietary software. No license shall be granted upon the physical delivery of any software to Licensee. The granting of each License is subject to the approval of ISC. A Trade In shall be deemed to be the cancellation of Licensees old License and the granting of a new License. Services ordered by Licensee shall be provided in accordance with the terms and conditions contained in ISC’s Price List (“Price List”) in effect on the date such Services are rendered, provided that ISC has received the appropriate fee therefore (“Service Fee”). If Licensee ordered a License or Services through an Application Partner (“AP”), Licensee may only use the Licensed Software and Services in conjunction with such AP’s software. To enter into a License, Licensee agrees to the terms herein by using the Licensed Software
  3. ISC hereby warrants to Licensee that (i) the Licensed Software will operate substantially in accordance with ISC’s documentation relating thereto for one (1) year following the Effective Date, and (ii) all Services shall be performed in a manner consistent with industry standards. The foregoing warranties are conditioned upon the use of the Licensed Software strictly in accordance with ISC’s documentation and instructions and upon the absence of any misuse, damage, alteration or modification thereto. ISC SHALL NOT BE DEEMED TO HAVE MADE ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, TO LICENSEE AS TO THE CONDITION, MERCHANTABILITY, TITLE, NON- INFRINGEMENT, DESIGN, OPERATION OR FITNESS FOR A PARTICULAR PURPOSE OF THE LICENSED SOFTWARE OR SERVICES. Licensee’s exclusive remedy for a breach of the above warranties shall be for ISC to use reasonable efforts to repair, replace or re-perform any non-conforming Licensed Software or Services, as applicable. In the event of a valid claim that any Licensed Software that has not been altered, modified, misused or damaged infringes upon the intellectual property rights of a third party when used in accordance with ISC’s documentation and instructions, ISC shall either (a) modify the Licensed Software, (b) procure a license for Licensee to use the Licensed Software or (c) terminate Licensee’s License, at ISC’s option. THE LIMITED WARRANTY HEREIN DOES NOT INCLUDE TECHNICAL ASSISTANCE AND SOFTWARE UPDATE SERVICES AND IS NOT A SUBSTITUTE FOR SUCH SERVICES, WHICH ARE AVAILABLE FOR A SEPARATE FEE.
  4. ISC’s liability to Licensee shall in no event exceed the License Fees or Services Fees received by ISC in respect of the specific Licensed Software or Services on account of which such liability arose. In no event shall ISC be liable to Licensee for any special, incidental, exemplary, indirect or consequential damages or lost profits.
  5. Either party may terminate this Agreement upon the other’s breach. Licensee shall be liable for all fees relating to Licensed Software or Services provided prior to termination, and Sections iv, v, vi, vii and ix of this Section 4(b) shall survive.
  6. The Licensed Software and related documentation are and shall remain the sole property of ISC. Licensee may make copies of the Licensed Software for backup and archival purposes only. Licensee agrees not to (i) decompile, disassemble, or reverse engineer the Licensed Software or (ii) disclose to others the Licensed Software or any data or information relating to the Licensed Software. In addition, Licensee agrees not to use or disclose any confidential information provided to Licensee by ISC or its affiliates relating to the Licensed Software, Services or this business relationship. Licensee agrees to allow ISC or its representatives to audit Licensee’s use of the Licensed Software upon five (5) days’ notice by ISC, including providing access to Licensee’s premises.
  7. This Agreement shall be governed by and construed in accordance with the laws of, and the parties agree to submit to exclusive jurisdiction in, Massachusetts, USA.
  8. Licensee agrees to comply with all applicable laws, including, but not limited to, U.S. export control or similar laws with respect to use of the Licensed Software and technical data. The English version of this Agreement shall control unless otherwise required by local law.
  9. These terms, together with the order form and the version of the Price List (including any applicable terms and conditions) in effect as of the Effective Date (or, in the case of Services, as of the date such Services are provided) constitute the entire agreement between Licensee and ISC relating to the subject matter hereof and supersede any prior understandings between us as well as any purchase orders or similar documents that may be submitted to ISC. ISC shall have the right to transfer or assign this Agreement without Licensee’s consent. This Agreement may only be modified or amended by a writing signed by both parties.

b. The following Third Party Software Terms and Conditions ONLY apply to Virtuoso

Customer agrees and acknowledges that:

  1. use of the Oracle Programs is restricted to the scope of the Software and to the business operations of Customer;
  2. the following are prohibited (a) the transfer of the Oracle Programs except for temporary transfer in the event of computer malfunction if the Software embeds the Oracle Programs in a physical device, (b) Customer assigning, giving, or transferring the Oracle Programs or an interest in them to another individual or entity (and if Customer grants a security interest in the Oracle Programs, the secured party has no right to use or transfer the Oracle Programs), (c) timesharing, service bureau, subscription service or rental use of the Oracle Programs and (d) title to the Oracle Programs passing to Customer or any other party;
  3. the reverse engineering (unless required by law for interoperability), disassembly or decompilation of the Oracle Programs and duplication of the Oracle Programs except for a sufficient number of copies of each Oracle Program for the Customer’s licensed use and one copy of each Oracle Program media are prohibited;
  4. to the extent permitted by applicable law, Oracle’s liability for any damages, whether direct, indirect, incidental, or consequential, arising from the use of the Oracle Programs is disclaimed;
  5. at the termination of the Agreement, Customer shall discontinue use and destroy or return to Roche Diagnostics Corporation all copies of the Oracle Programs and related documentation;
  6. publication of any results of benchmark tests run on the Oracle Programs is prohibited;
  7. Customer shall comply fully with all relevant export laws and regulations of the United States and other applicable export and import laws to assure that neither the Oracle Programs, nor any direct product thereof, are exported, directly or indirectly, in violation of applicable laws;
  8. Customer is on notice that the Oracle Programs are subject to a restricted license and can only be used in conjunction with the Software and that Customer is not permitted to modify the Oracle Programs;
  9. Oracle is not required to perform any obligations or incur any liability;
  10. Roche Diagnostics Corporation is permitted to audit Customer’s use of the Oracle Programs and report such use to Oracle or may assign such right to audit Customer’s use of the Oracle Programs to Oracle;
  11. Oracle is a third party beneficiary of the Agreement;
  12. the Uniform Computer Information Transactions Act does not apply to the Agreement;
  13. some Oracle Programs may include source code that Oracle may provide as part of its standard shipment of such programs, which source code shall be governed by the terms of the Agreement.

9. IT INFRASTRUCTURE:

  1. Requirements. Customer shall ensure that the IT Infrastructure is suitable to run the Software and meets the minimum hardware and Software specifications provided to Customer by Roche. Unless otherwise specified in Appendix D, Customer is responsible for acquiring all hardware required for use of the Software. Customer is also responsible for providing all network segmentation, virtual networks (VLANs) with access control lists (ACLs), for the system. Customer agrees further that it is Customer’s responsibility to limit the network communication to only essential traffic.
  2. Use of Approved Third Party Software. Customer shall ensure that no third party software other than Approved Third Party Software installed interferes with or negatively influences the Software. Roche does not guarantee that any third party software other than Approved Third Party Software does not negatively influence the Software or its performance, and vice versa. Roche denies any liability whatsoever if third party software is installed and such third party software is not an Approved Third Party Software.
  3. Remote Access Connectivity. Customer shall provide an internet enabled connection and shall host Roche remote diagnostics software provided by Roche for Roche to remotely access the necessary systems for the purpose of installation, troubleshooting, user training, Software updates and other appropriate uses related to Customer’s operation and Roche’s service of the Software. Roche shall not be obligated to provide Software Services contracted for hereunder if Customer fails to comply with this section. In the event Roche provides Software Service to Customer hereunder for which Roche would be considered a “Business Associate” (as that term is defined in the Health Insurance Portability and Accountability Act of 1996 and associated rules (together, “HIPAA”)), then the parties shall enter into and comply with the terms of a mutually acceptable Business Associate Agreement, as defined and in accordance with applicable laws.
  4. Security and Maintenance. Customer is responsible for the maintenance, security, disaster recovery and integrity of the IT Infrastructure and in particular the hardware, system software, malware protection, antivirus software and its ongoing management and network environment. Customer is responsible to ensure that the operating system is current with any security patches released by Microsoft and that any Approved Third Party Software is also patched. Customer is responsible to ensure all Software is backed up following Customer’s standard operating procedures for software and applications backup.
  5. Snapshot Expressly Prohibited. If Customer is operating Software in a virtual environment, CUSTOMER IS EXPRESSLY PROHIBITED from using Snapshot or any other similar backup method similar thereto for purposes of restoring previous test order, sample assignment or results processing. Roche expressly disclaims any and all liability for any claims, damages, judgments or losses arising from Customer’s use of Snapshot or any other similar backup method in violation of this express prohibition.

10. U.S. GOVERNMENT RESTRICTED RIGHTS: The Software licensed under these “Terms and Conditions” is “Commercial Computer Software” and “Commercial Computer Software Documentation” as those terms are defined in the applicable provisions of the Federal Acquisition Regulation (“FAR”) and supplements thereto, including the Department of Defense FAR Supplement (DFARS). The Software and related Documentation licensed hereunder is provided to end users for use, by and for the U.S. Government, with only those rights as are granted to all other end users pursuant to these Terms and Conditions. Use of the Software is permitted only by parties who are authorized by an appropriate U.S. Government official. This provision is in lieu of, and supersedes, any FAR, DFARS, or any other provision that relates to use of the commercial computer software licensed under these Terms and Conditions.

11. LIMITED WARRANTY; LIMITATIONS ON LIABILITY; INDEMNITY:

  1. Warranty. Roche warrants that the Software will function in conformance with its specifications and be free of material defects for a period of one (1) year from the date of Acceptance of the Software, provided the Software is used in accordance with these Terms and Conditions and operated on the IT Infrastructure directed by Roche.

    THE ABOVE IS A LIMITED WARRANTY AND IS THE ONLY WARRANTY MADE BY ROCHE FOR THE SOFTWARE AND SOFTWARE SERVICES. ROCHE MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, AND EXPRESSLY EXCLUDES ALL WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. NO WARRANTY IS MADE THAT THE OPERATION OF SOFTWARE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT ALL ERRORS IN THE SOFTWARE WILL BE CORRECTED. NOTWITHSTANDING ANY OTHER PROVISIONS OF THESE TERMS AND CONDITIONS, BUT EXCLUDING ANY CLAIMS FOR INFRINGEMENT INDEMNIFICATION SPECIFICALLY PROVIDED FOR UNDER THESE TERMS AND CONDITIONS, IN NO EVENT WILL ROCHE OR ANY OF ROCHE’S AFFILIATES (OR THEIR RESPECTIVE OFFICERS, EMPLOYEES, CONSULTANTS, ATTORNEYS OR AGENTS) BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGE TO COMPUTER SOFTWARE OR HARDWARE (WHETHER OR NOT PROVIDED BY ROCHE), LOST PROFITS, LOST DATA OR INFORMATION, LOSS OF USE OF THE SOFTWARE, BUSINESS INTERRUPTION, LOSS OF BUSINESS REPUTATION OR GOODWILL, DOWNTIME COSTS, OR ANY OTHER COMMERCIAL DAMAGES OR LOSSES WHICH CUSTOMER MAY INCUR OR EXPERIENCE, DIRECTLY OR INDIRECTLY, ARISING OUT OF OR RELATING TO THE SOFTWARE OR THE SERVICES FURNISHED BY ROCHE, HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY, EVEN IF ROCHE OR ANY OF ITS AFFILIATES HAD BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. ROCHE’S TOTAL LIABILITY FOR ALL DAMAGES ARISING OUT OF OR RELATING TO THE USE OR NON-USE OF THE SOFTWARE BY CUSTOMER SHALL BE LIMITED, AT ROCHE’S OPTION, TO REPLACEMENT OF THE SOFTWARE OR A REFUND BY ROCHE OF ANY LICENSE FEES RECEIVED FROM CUSTOMER WITH RESPECT TO THE SOFTWARE.

  2. IP Indemnification. During the Term, if a third party makes a claim against Customer that Software, when used in accordance with the Documentation and these Terms and Conditions, directly infringes any U.S. patent, copyright, or trademark or misappropriates any trade secret (“IP Claim”); Roche will (1) defend Customer against the IP Claim at Roche’s cost and expense, and (2) pay all costs, damages and expenses (including reasonable legal fees) finally awarded against Customer by a court of competent jurisdiction or agreed to in a written settlement agreement signed by Roche arising out of such IP Claim. If the Software is held to infringe, or Roche believes it is likely that the Software infringes a third party’s intellectual property rights then as Customer’s exclusive remedy, Roche shall have the option, at its expense, to (a) replace or modify the Software to be non-infringing, or (b) obtain for Customer a license to continue using the Software. If it is not commercially reasonable to perform either of the options specified in the preceding sentence, then Roche may terminate the license for the infringing Software and refund to Customer the unamortized portion of the applicable license fee actually paid by Customer to Roche for the Software. Roche’s obligation to indemnify shall be contingent upon timely notification by Customer to Roche of any claims; control by Roche over the conduct and disposition of any claim; and cooperation by Customer in the defense of the claim.
  3. Third Party Hardware. Third Party hardware includes a standard manufacturer’s warranty from date of shipment.
  4. Third Party Patches. Customer is solely responsible for all effects and consequences of loading any third party patches onto the operating system or the system software within the IT Infrastructure. This excludes patches provided by Roche to fulfill its contractual obligations and patches approved by Roche for Approved Third Party Software.

e. The following Warranty Terms and Conditions ONLY apply to cobas Infinity and Roche Middleware Solutions

  1. No Warranty on Functionality. The Software offers sample optimization functionality in two specific ways: software-driven configuration management in which Customer provide operational guidelines (in the form of data) to be executed by the Software, including workflow instructions and autoverification parameters (“Data-Driven Functionality”), and customer-driven rules-based decision making in which Customer create and implement algorithms to direct the Software in the processing of test results (“Rules -Driven Functionality”). Customer agrees that any parameters used for workflow instructions, autoverification parameters or “rules” implemented by Customer using Data-Driven Functionality or Rules-Driven Functionality shall be the sole responsibility of Customer. Customer will not, at any time, rely upon Roche to make any determinations regarding the data inputted by Customer relating to Data-Driven Functionality or the content and direction of any of Customer’s “rule-writing” or result processing decisions relating to Rules-Driven Functionality. ACCORDINGLY, ROCHE MAKES NO REPRESENTATIONS AND WARRANTIES WITH RESPECT TO ANY WORKFLOW INSTRUCTIONS, AUTOVERIFICATION, ALGORITHMS OR RULES IMPLEMENTED VIA DATA-DRIVEN FUNCTIONALITY AND/OR RULES-DRIVEN FUNCTIONALITY AND FURTHER SPECIFICALLY DISCLAIMS ANY WARRANTIES NOT EXPRESSLY MADE HEREIN.

    IN ADDITION TO ANY OTHER LIMITATIONS ON LIABILITY AND WARRANTY DISCLAIMERS CONTAINED IN THESE TERMS AND CONDITIONS, UNDER NO CIRCUMSTANCES SHALL ROCHE BE LIABLE FOR ANY LOST PROFITS, LOSS OF INCOME, LOSS OF DATA OR INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES ASSOCIATED WITH THE USE OF THE DATA-DRIVEN FUNCTIONALITY OR RULES-DRIVEN FUNCTIONALITY. CUSTOMER IS SOLELY RESPONSIBLE FOR THE CONTENT, STRUCTURE, CONSISTENCY AND CORRECTNESS OF ALL RULES APPLIED, E.G., MULTIPLE-STAGE DIAGNOSTIC DECISION TREES OR VALIDATION RULES.

  2. Customer Indemnity of Roche. Customer agrees to defend, indemnify and hold Roche harmless from any demands, claims, actions, losses, damages, expenses or liabilities (including reasonable attorneys’ fees and court costs) arising out of, relating to, or in connections with the processing or use of patient test results using Data-Driven Functionality or Rules-Driven Functionality as implemented by Customer. Customer agrees and acknowledges that the representations, warranties and agreements set forth in Sections 10(c) and (d) will survive the termination of the underlying Appendix D and/or Terms and Conditions and shall remain in effect for as long as continues to use the Software.

12. MAINTENANCE AND SUPPORT SERVICES: Customer is required to maintain Service plan coverage for the Software (“Software Services”) for the duration of the Term. The scope of Software Service provided by Roche pursuant to any service plan shall be as follows:

  1. Scope of Software Services. Roche will provide the following Services to Customer during the Term of Software Service coverage for the Software:
    1. Corrections of material defects in the Software so that the Software will operate in accordance with the Documentation. All Software Services will be performed via telephone, modem connection and/or web tunneling or in the case of updates, via the best delivery method as determined by Roche.
    2. Periodic updates of Software that may incorporate corrections of any material defects or fixes of any minor bugs. Customer is responsible for installation of all updates and upgrades to the Software provided by Roche within thirty (30) days of receipt.
      1. Generally. Subject to any limitations provided in this Section 6, all Software Updates and Upgrades will be provided to Customer at no additional charge. However, it shall be Customer’s responsibility during the Term to ensure that all Updates and Upgrades made available by Roche are installed in a timely fashion such that all Software remains within two (2) versions of the then-current version being sold by Roche to new customers (the “Current Release”). To the extent that Customer fails to maintain within two versions of the Current Release, Roche is no longer required to provide a warranty or any support to Customer’s Software (regardless of the existence of any Service component of these Terms and Conditions) unless Customer upgrades all Software to a version within two versions of the Current Release and further, Roche may charge Customer for such upgrades.
      2. Planned Obsolescence. Next Generation Replacement Software. During the Term, Roche may, in its sole discretion, cease supporting any version of the Software because it is opting to make that version of Software obsolete. If, during the Term, the version of Software used by Customer is subject to such a planned obsolescence, Roche will provide Customer with a more current Software version or alternative Software product, at Roche’s option, at no additional charge to Customer. The replacement software provided by Roche will have functionality at least equivalent to the version subject to the planned obsolescence.
    3. Telephone support 24 hours per day, seven days per week, to assist Customer in using and troubleshooting the Software.
    4. Remote system support for diagnostics, training, troubleshooting and the provision of Software updates.
    5. Assistance with configuration changes required as part of new Roche instrument or assay purchases.
    6. Roche will work with Customer to plan and deliver its standard training for the Software licensed under Appendix D and these Terms and Conditions. Additional telephone support is available 24 hours per day, 365 days per year, by calling Roche Diagnostics at 1-800-440-3638.
  2. Additional Services. Additional training, maintenance and services may be provided to Customer by Roche at Roche’s standard rates pursuant to mutually agreeable terms.
  3. Services Not Included. Software Services do not include:
    1. Following completion of the Software installation and acceptance by Customer, work performed by Roche to accommodate changes or modifications to Customer’s hardware, software or network that affect their operation or interaction with Software or affect the Software’s. This includes but is not limited to adjustments to the Software configuration required because of (A) Customer’s LIS migration or upgrades, (B) maintenance and support of Customer’s IT Infrastructure, including uninterruptible power supplies, power conditioners and other items external to the Software, and/or (C) configuration changes to any third party systems connected to the Software.
    2. The repair, correction, or replacement of the Software when such repair, correction or replacement is due, directly or indirectly, to: (A) Customer’s failure to adhere to the standards of, or to follow operation or maintenance instructions as set forth in, the Documentation; (B) the use of media, supplies, or consumable supplies which are not compatible with the Software; (C) the unauthorized repair, maintenance, modification or alteration of the Software unless specifically approved in writing by Roche in advance; (D) hardware or software not supplied or authorized by Roche; (E) negligent acts or omissions of Customer; (F) power failure, surges or electrical damage, lightning, fire or water damage, accident or disruptive events reasonably within Customer’s control; (G) changes in Customer’s operation standards that would require Roche to modify its standard configurations or procedures, or (H) other causes external to the Software and not attributable to Roche, including but not limited to any acts of nature or any Third Party Device.
    3. Major new releases of a Software containing substantial new enhancements, features or functionality, that are not distributed generally by Roche as a periodic update pursuant to (a)(ii) of this Section.
    4. Maintenance and support of Customer hardware or software other than Software licensed hereunder and other services not set forth in this Section.

The following are Terms and Conditions associated with Roche Middleware Consulting Services.

  1. Middleware Consulting Services. The Middleware Consulting Services for Autoverification, Moving Averages and/or Laboratory Intelligence that Customer are purchasing will be defined as "Middleware Consulting Services".
  2. Services to be performed. See Middleware Consulting Services Exhibits(s). Roche offers separate Middleware Consulting Services for Autoverification, Moving Averages and for laboratory Intelligence. The Middleware Consulting Services Exhibits(s) details the Middleware Consulting Services to be performed under this Schedule and the additional obligations of Roche and Customer as it relates to the those specific Middleware Consulting Services.
  3. Discount Information. The information set forth on the Middleware Consulting Services Exhibit(s) details any Discounts associated with the Middleware Consulting Services acquired under this Schedule. All Discounts hereunder shall constitute a "Discounts" (as that term is defined in 42 CFR part 1001.952(h)). The values for the items listed as “Included in Reagents” and/or “No Additional Charge” are provided for use in preparing Customer’s Medicare cost reports. In the event of a default by You, Roche may require Customer to pay for the pro-rata remaining value of any Discounts.
  4. Requirements. To receive the Middleware Consulting Services, certain Middleware requirements must be met as described below. If Customer’s current Middleware does not meet these version and/or feature requirements, Customer agree to execute an agreement to acquire these versions and features as necessary for Roche to provide the Middleware Consulting Services.
    1. Middleware Consulting Services for Autoverification require Roche Middleware version 8.13 or newer with the Specimen Management and the Rules Package.
    2. Middleware Consulting Services for Moving Averages require Middleware version 8.13 or newer with the Specimen Management and the Moving Averages license.
    3. Middleware Consulting Services for Laboratory Intelligence require Roche Middleware version 8.14 or newer, Laboratory Intelligence license, Specimen Management, report server and Laboratory Intelligence connection licenses.
  5. Term. Roche will complete the Middleware Consulting Services in a time period mutually agreed to by the parties using commercially reasonable standards. Roche shall provide Customer with written notice (“Service Completion Notice”) when the Middleware Consulting Services are completed. The Service Completion Notice may take the form of an email to an email address previously provided by Customer for regular communication regarding the Middleware Consulting Services.
  6. Use and Ownership of Rules, Protocols and Dashboards.
    1. Autoverification - Roche hereby grants Customer a perpetual, non-exclusive, non-transferable right to use any Roche Middleware decision-making algorithms or “rules” created by Roche in the provision of the Middleware Consulting Services. This right is granted solely for Customer’s own use in Customer’s processing of laboratory patient results. The rights provided under this Section are granted to Customer and Customer’s sites specifically included on this Schedule only, and shall not be considered granted to any of Customer’s subsidiary, holding or other affiliated companies unless expressly agreed to by Roche. Customer may continue to use any rules created for Customer during the Term of Middleware Consulting Services and for so long as Customer continue to use the Roche Middleware Solutions software product pursuant to the Schedule
    2. Moving Averages - Roche hereby grants Customer a perpetual, non-exclusive, non-transferable right to use any Roche Middleware Moving Averages protocols or “graphs” created by Roche in the provision of the Middleware Consulting Services. This right is granted solely for Customer’s own use in Customer’s processing of laboratory patient results. The rights provided under this Section are granted to Customer and Customer’s sites specifically included on this Schedule only, and shall not be considered granted to any of Customer’s subsidiary, holding or other affiliated companies unless expressly agreed to by Roche. Customer may continue to use any protocols created for Customer during the Term of Middleware Consulting Services and for so long as Customer continue to use the Roche Middleware Solutions software product pursuant to the Schedule.
    3. Laboratory Intelligence - Roche hereby grants Customer a perpetual, non-exclusive, non-transferable right to use any Roche Middleware Laboratory Intelligence dashboards created by Roche in the provision of the Middleware Consulting Services. This right is granted solely for Customer’s own use in Customer’s interpretation of laboratory metrics based on patient samples. The rights provided under this Section are granted to Customer and Customer’s sites specifically included on this Schedule only, and shall not be considered granted to any of Customer’s subsidiary, holding or other affiliated companies unless expressly agreed to by Roche. Customer may continue to use any dashboards created for Customer during the Term of Middleware Consulting Services and for so long as Customer continue to use the Roche Middleware Solutions software product pursuant to the Schedule.
  7. Responsibilities.
    1. Responsibility for Value List Data, Validation Plans, Validation of Rules and Laboratory Standard Operating Procedures : Customer expressly agrees and acknowledges that although Roche is providing Customer with the Middleware Consulting Services (including assistance in establishing or customizing certain algorithms or “rules” to direct the Middleware software in the processing of patient test results within Customer’s laboratory), Customer remains solely and exclusively responsible for (a) determining the data values and parameters associated with all rules implemented within Customer’s institution (even to the extent these data values and parameters are used by Roche in rule-creation on Customer’s behalf), (b) creating a plan to validate any rules Customer implement, (c) fully validating any rules in accordance with Customer’s validation plan to ensure compliance with all standards promulgated by any applicable regulatory agencies or other governing bodies, and (d) creating, implementing, training on and maintaining compliance with standard operating procedures which govern the use of these rules within Customer’s laboratory.
    2. Responsibility for Moving Averages Protocols and Laboratory Standard Operating Procedures: Customer expressly agrees and acknowledges that although Roche is providing Customer with the Services (including assistance in establishing or customizing certain protocols or “graphs” to direct the Middleware software in the processing of patient test results within Customer’s laboratory), Customer remain solely and exclusively responsible for (a) determining the data values and parameters associated with all protocols implemented within Customer’s institution (even to the extent these data values and parameters are used by Roche in protocol creation on Customer’s behalf), (b) creating a plan to determine the n value, (c) creating, implementing, training on and maintaining compliance with standard operating procedures which govern the use of these protocols within Customer’s laboratory.
    3. Responsibility for Laboratory Intelligence Dashboards and Laboratory Standard Operating Procedures: Customer expressly agrees and acknowledges that although Roche is providing Customer with the Services (including assistance in creating and customizing Laboratory Intelligence dashboards to direct the Middleware software in the interpretation of laboratory statistics within Customer’s laboratory), Customer remain solely and exclusively responsible for (a) determining the data values and parameters required for populating each dashboard within Customer’s institution (even to the extent these data values and parameters are used by Roche in dashboard-creation on Customer’s behalf), (b) determining what data to exclude from any dashboard, (c) evaluating accuracy of all dashboards based on data Customer’s laboratory provided (d) creating, implementing, training on and maintaining compliance with standard operating procedures which govern the use of these dashboards within Customer’s laboratory
  8. No Warranties Provided; LIMITATION OF LIABILITIES.
    1. No Middleware Consulting Services Warranties. The Middleware Consulting Services are not being provided with any specific warranties by Roche, except that Roche will use commercially reasonable efforts to ensure that the Middleware Consulting Services are provided in a professional manner.
    2. No Rules-Writing Warranties. Customer agree that any parameters used for algorithm-based decision-making or “rules” implemented at Customer’s institution were derived from data values or other information provided by You, and that Customer remain solely responsible for the provision of this data and for the validation of any rules implemented by You. Roche makes no representations or warranties with respect to any algorithms or rules implemented by You, even if developed via the Middleware Consulting Services.
    3. No Protocol-Writing Warranties. Customer agree that any parameters used for protocols or “graphs” implemented at Customer’s institution were derived from data values or other information provided by You, and that Customer remain solely responsible for the provision of this data and for the validation of any protocols implemented by You. Roche makes no representations or warranties with respect to any protocols implemented by You, even if developed via the Middleware Consulting Services.
    4. No Dashboard Content Warranties. Customer agree that any parameters used for populating a dashboard used at Customer’s institution were derived from data values or other information provided by You, and that Customer remain solely responsible for the provision of this data and for the use of all dashboards implemented by You. Roche makes no representations or warranties with respect to any dashboard content created by You, even if developed via the Middleware Consulting Services.
    5. LIMITATION ON LIABILITIES. ROCHE SHALL HAVE NO LIABILITIES UNDER THIS SCHEDULE IN CONNECTION WITH THE MIDDLEWARE CONSULTING SERVICES OUTLINED HEREIN FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO ANY DAMAGES, COSTS, FEES OR EXPENSES RELATING TO OR ARISING FROM THE IMPLEMENTATION BY CUSTOMER OF ANY RULES OR THE USE OF RULES-BASED DECISION PROCESSING BY CUSTOMER’S LABORATORY.
  9. Customer’s Obligation to Indemnify Roche. Customer agree to defend, indemnify and hold Roche harmless under the Schedule from any demands, claims, actions, losses, damages, expenses or liabilities (including reasonable attorneys’ fees and court costs) arising out of, relating to, or in connection with the processing or use of patient test results using rules-based decision processing or rules as implemented by You, the protocols or use of patient data in Quality Control (QC) as implemented by You, or the use of any Laboratory Intelligence dashboards as implemented by You, even to the extent implemented with the assistance of Roche via provision of the Middleware Consulting Services.
  10. Roche's Obligation to Indemnify You. Customer and Roche agree and acknowledge that the indemnity obligation set forth in this Section applies to the Middleware Consulting Services described in this Schedule only and is not intended to in any way to modify or negate any indemnity provided to one party by the other party in any other agreement between Customer and Roche. Roche agrees to defend, indemnify and hold Customer harmless under the Schedule for any demands, claims, actions, losses, damages, expenses or liabilities (including reasonable attorneys’ fees and court costs) arising out of, relating to, or in connection with Roche’s gross negligence or willful misconduct in the provision of the Middleware Consulting Services, provided that the parties understand that implementation of an algorithm or “rule”, a protocol or “graph, or dashboards, using data values provided by Customer shall not constitute negligence or willful misconduct so long as the algorithm or “rule”, protocol or “graph, or dashboards was properly implemented by Roche and the demand, claim, loss, damage, expense or liability relates to the data values or information implemented as provided by You, and not the service of implementing those data values or information.