Terms of Service

This Master Services and License Agreement including all Statements of Work (“SOW’s), Order Forms, Appendices 1 and 2 and all documents linked to herein and therein (collectively, this "Agreement") is a legal agreement between you ("you" or “Customer”) and Rimsys Inc., a Delaware corporation, with offices located at 100 S. Commons, Suite 102, Pittsburgh, PA 15212 (“Rimsys”, and together with Customer, the “Parties”, and each individually, a “Party”)., that governs your use of Rimsys’ proprietary Software (as defined in Appendix 1)  and Services (as defined below). This Agreement is effective between you and Rimsys as of the Effective Date noted on the Order Form. If no such Order Form exists, the Effective Date is the date you click the “accept” button or the date you access the Software or Services under this Agreement (the “Effective Date”). Your execution of an Order Form or SOW constitutes a binding non-cancelable commitment to license the Software and/or Services set forth in the Order Form under the terms and conditions of this Agreement. All Order Forms are incorporated into this Agreement by reference.

IMPORTANT - PLEASE READ CAREFULLY BEFORE YOU DOWNLOAD OR USE THE SOFTWARE OR ACCEPT SERVICES

By clicking on the “accept” button at the end of this document or by accessing, executing or otherwise using the Software or Services, you acknowledge that you have read this Agreement, understand it and agree to be bound by its terms and conditions. If you are not willing to be bound by the terms of this Agreement, do not access or use the Software or Services.

If you are agreeing to these terms in your capacity as employee or agent of a company or organization, then any references to “you” in this Agreement shall refer to such entity and not to you in your personal capacity. You warrant that you are authorized to legally bind the company or organization on whose behalf you are accessing the Software or Services. If you are not so authorized, then neither you nor your company or organization may use the Software or Services in any manner whatsoever.

1 PURPOSE

This AGREEMENT sets forth the Parties’ objectives and working relationship between the Parties for the use and provision of the Rimsys cloud-based regulatory information management platform (the “Services”).

2 SERVICE SECURITY, PRIVACY & SYSTEM COMPLIANCE

• Rimsys shall maintain server security and privacy measures in compliance with ISO27001 SOC2, General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA)

• Rimsys shall maintain system compliance with 21CFR11 and steady-state of validation in accordance with applicable regulations.

• Rimsys shall maintain Server uptime of no less than 99.00%, excluding scheduled maintenance and unscheduled maintenance.

• The Parties shall comply with the Data Processing Addendum (“DPA”) set forth at www.rimsys.io/legal/dpa

3 ESCALATION PROCESS

Upon Rimsys not delivering expected results, Customer shall promptly notify Rimsys via email at support@rimsys.io or other communication channels as provided by Rimsys.  Rimsys shall open an internal investigation and promptly attempt to resolve any outstanding Customer issues.  “Promptly”, for the purposes of this section only, shall be defined as within five (5) business days of the internal investigation being completed by Rimsys.  Rimsys shall provide the Services in accordance with Service Levels and support terms as set forth in the applicable SOW.

4 WARRANTY AND DISCLAIMER

Rimsys shall perform the Services in a professional and workmanlike manner and shall ensure that its personnel have the required skill, experience and qualifications to perform the Services. However, Rimsys does not warrant that the Services will be uninterrupted or error free; nor does it make any warranty as to the results that may be obtained from the use of the Services. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION, THE SERVICES ARE PROVIDED “AS IS” AND COMPANY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

5 LIMITATIONS OF LIABILITY

NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, RIMSYS AND ITS OFFICERS, AFFILIATES, REPRESENTATIVES, CONTRACTORS AND EMPLOYEES SHALL NOT BE RESPONSIBLE OR LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT OR TERMS AND CONDITIONS RELATED THERETO UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY, INDEMNIFICATION, OR OTHER THEORY: (A) FOR ERROR OR INTERRUPTION OF USE OR FOR LOSS OR INACCURACY OR CORRUPTION OF DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS, SERVICES OR TECHNOLOGY OR LOSS OF BUSINESS; (B) FOR ANY INDIRECT, EXEMPLARY, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES; (C) FOR ANY MATTER BEYOND RIMSYS’ REASONABLE CONTROL; OR (D) FOR ANY AMOUNTS THAT, TOGETHER WITH AMOUNTS ASSOCIATED WITH ALL OTHER CLAIMS, EXCEED THE FEES PAID BY CUSTOMER TO RIMSYS FOR THE SERVICES UNDER THIS AGREEMENT IN THE 12 MONTHS PRIOR TO THE ACT THAT GAVE RISE TO THE LIABILITY, IN EACH CASE, WHETHER OR NOT RIMSYS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

6 CUSTOMER RESPONSIBILITIES

Customer’s failure to meet certain key responsibilities may result in Service or project delays.

6.1 PERSONNEL

Customer will make all necessary resources reasonably available to the Rimsys project team.

6.2 APPROVALS

Customer is responsible for reviewing and approving all appropriate documentation in a timely manner.  

6.3 CUSTOMER ENVIRONMENT DOCUMENTATION

Customer will provide Rimsys access to information and documentation reasonably required in connection with the Services in accordance with any SOW.

6.4 PAYMENT OF FEES

Customer will pay Rimsys the fees described in any SOW for the Services in accordance with the terms therein (the “Fees”). If Customer’s use of the Services exceeds or is beyond the defined scope or otherwise requires the payment of additional fees, Customer shall be billed for such usage and Customer agrees to pay the additional fees in the manner provided.  If Customer believes Rimsys has billed Customer incorrectly, Customer must contact Rimsys no later than sixty (60) days after the date on the first billing statement in which the error or problem appeared, in order to receive an adjustment or credit.  Inquiries should be directed to Rimsys’ customer support department.

Rimsys may choose to bill through an invoice, in which case, full payment for invoices issued in any given month must be received by Rimsys within thirty (30) days of the date of the invoice. Unpaid amounts are subject to a finance charge of 1.5% per month on any outstanding balance, or the maximum permitted by law, whichever is lower, plus all expenses of collection and may result in immediate termination of Services. Customer shall be responsible for all taxes associated with Services other than United States taxes based on Rimsys’ net income.

7 STANDARD SERVICE EXCLUSIONS

The following activities are not included in the scope of the Services to be performed by Rimsys:

• Resolving interoperability issues with other vendors

• Any re-installation or modification of previously installed software or equipment, unless caused by the actions or omissions of Rimsys

• Any operating system patches and anti-virus software installation

• Any modification to existing customized applications or 3rd party vendor solutions

• Working with other 3^rd party vendors on issues not mentioned in scope

• Troubleshooting network issues, such as bandwidth, static, call quality, packet loss, jitter, delay, etc.

• Management of third-party customer vendors or support teams

• Any additional service or product that is not set forth in herein or in any SOW.

8 TERM AND TERMINATION

Subject to earlier termination as provided below, this AGREEMENT will become effective on the Effective Date and remain in effect  for an initial term set forth in an Order Form (the “Initial Service Term”), and shall automatically renew for additional periods of the same duration as the Initial Service Term (each, a “Renewal Term,” and collectively, the “Term”) unless written notification by either Party to terminate the AGREEMENT is provided within ninety (90) days of expiration of the then current Term.

In addition to any other remedies it may have, either Party may terminate this AGREEMENT or any SOW upon thirty (30) days’ written notice  if the other Party materially breaches any of the terms or conditions of this AGREEMENT, provided that the non-breaching Party first gives the breaching Party written notice of such breach, and the breaching Party has not cured such breach within that thirty (30) day period. Customer will pay in full for the Services up to and including the last day on which the Services are provided.  

This AGREEMENT and the Services hereunder will terminate, effective upon delivery of written notice by either Party to the other Party upon the following: (a) the institution of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of debts of the other Party; (b) the making of an assignment for the benefit of creditors by the other Party; or (c) the dissolution of the other Party.

In the event of any expiration or termination of this AGREEMENT for any reason, Rimsys will make all Customer Data available to Customer for electronic retrieval for a period of thirty (30) days following written notice of termination, and thereafter Rimsys may, but is not obligated to, delete stored Customer Data.  All sections of this AGREEMENT which by their nature will survive termination, including, without limitation, accrued rights to payment, confidentiality obligations, indemnification rights and obligations, warranty disclaimers, and limitations of liability, shall survive the expiration or earlier termination of the AGREEMENT.

9 PROPRIETARY DATA RIGHTS

Customer represents and warrants that it has the necessary rights, power and authority to transmit Customer Data (as defined below) to Rimsys under this AGREEMENT and any SOW and that Customer has and shall continue to fulfill all obligations as required to permit Rimsys to carry out the terms hereof, including but not limited to compliance with all applicable laws, regulations and other constraints applicable to Customer Data. As between Customer and Rimsys, Customer owns all right, title and interest in and to (i) any data provided by Customer to Rimsys, including, but not limited to, Customer data included in any written or printed summaries or reports generated in connection with the Services (the “Customer Data”), (ii) all intellectual property, including patents, copyrights, trademarks, trade secrets and other proprietary information (“IP”) of Customer that may be made available to Rimsys in the course of providing Services under this AGREEMENT, and (iii) all confidential or proprietary information of Customer, including, but not limited to, Customer Data, Customer reports, and other Customer files, documentation and related materials, in each case under this clause (iii), obtained by Rimsys in connection with this AGREEMENT. Rimsys shall own and retain all right, title and interest in and to (a) the Services and software, and all improvements, enhancements or modifications thereto, (b) any software, applications, inventions or other technology developed in connection with support, and (c) all intellectual property rights related to any of the foregoing.

Customer grants to Rimsys a limited, non-exclusive license to use the Customer Data to perform the Services. This AGREEMENT does not transfer or convey to Rimsys or any third party any right, title or interest in or to the Customer Data or any associated IP rights, but only a limited right of use as granted in and revocable in accordance with this AGREEMENT, and subject to the confidentiality obligations and requirements of this AGREEMENT and the previously executed Mutual Non-Disclosure Agreement for as long as Rimsys has possession of such Customer Data.

10 CONFIDENTIALITY

Each Party that receives information (as applicable, the “Receiving Party”) understands that the other Party disclosing the information (as applicable, the “Disclosing Party”) has disclosed or may disclose business, technical or financial information relating to the Disclosing Party’s business (hereinafter referred to as “Proprietary Information” of the Disclosing Party). Proprietary Information of Rimsys includes, but is not limited to, non-public information regarding the features, functionality, and performance of the Service. Proprietary Information of Customer includes, but is not limited to, non-public data provided by Customer to Rimsys to enable the provision of the Services and Customer Data. The Receiving Party agrees: (i) to take reasonable precautions to protect such Proprietary Information, and (ii) not to use (except in the performance of the Services or as otherwise permitted herein) or divulge to any third person any such Proprietary Information. The Disclosing Party agrees that the foregoing shall not apply with respect to any information after five (5) years following the disclosure thereof or any information that the Receiving Party can document (a) is or becomes generally available to the public, or (b) was in its possession or known by it prior to receipt from the Disclosing Party, or (c) was rightfully disclosed to it without restriction by a third party, or (d) was independently developed without use of any Proprietary Information of the Disclosing Party or (e) is required to be disclosed by applicable law.

Notwithstanding anything to the contrary, Rimsys shall have the right to collect and analyze data and other information relating to the provision, use and performance of various aspects of the Services and related systems and technologies (including, without limitation, information concerning Customer Data and data derived therefrom), and Rimsys will be free (during and after the Term hereof) to (i) use such information and data to improve and enhance the Services and for other development, diagnostic and corrective purposes in connection with the Services and other Rimsys offerings, and (ii) disclose such data solely in aggregate or other de-identified forms in connection with its business. No rights or licenses are granted except as expressly set forth herein.

11 MISCELLANEOUS

If any provision of this AGREEMENT is found to be unenforceable or invalid, that provision will be limited or eliminated to the minimum extent necessary so that this AGREEMENT will otherwise remain in full force and effect and enforceable. This AGREEMENT is not assignable, transferable or sublicensable by Customer except with Rimsys’ prior written consent.  Rimsys may transfer and assign this AGREEMENT or any of its rights and obligations under this AGREEMENT without consent. This AGREEMENT shall be binding upon, inure to the benefit of, and be enforceable by the Parties hereto and their permitted successors and assigns. This AGREEMENT is the complete and exclusive statement of the mutual understanding of the Parties and supersedes and cancels all previous written and oral agreements, communications and other understandings relating to the subject matter of this AGREEMENT, and all waivers and modifications must be in a writing signed by both Parties.  No agency, partnership, joint venture, or employment is created as a result of this AGREEMENT and neither Party has any authority of any kind to bind the other Party in any respect whatsoever. In any action or proceeding to enforce rights under this AGREEMENT, the prevailing Party will be entitled to recover actual and reasonable costs (including reasonable attorneys’ fees). All notices under this AGREEMENT will be in writing and will be deemed to have been duly given when received, if personally delivered; when receipt is electronically confirmed, if transmitted by facsimile or e-mail; the day after it is sent, if sent for next day delivery by recognized overnight delivery service; and upon receipt, if sent by certified or registered mail, return receipt requested.  This AGREEMENT shall be governed by the laws of the Commonwealth of Pennsylvania without regard to its conflict of laws provisions.

Customer agrees not to discuss with competitors or potential competitors of Rimsys and to keep confidential any of the designs, inventions, ideas, and know-how related to the Products acquired by Customer during the relationship, all of which shall be the sole property of Rimsys. Customer agrees to exercise its best efforts in not allowing competitors and potential competitors to gain access to the sites where Rimsys equipment is being used during the course of the relationship. Customer represents that it is not presently working with any entity that manufactures or sells products competitive with those of Rimsys.

It is expressly understood, acknowledged and agreed that Customer shall, regardless of whether formally requested to do so by Rimsys, provide to Rimsys reasonable and constructive feedback, suggestions and comments regarding the Services, including but not limited to, ease of use, bug reports and test results (together, collectively, “Feedback”). Customer shall grant Rimsys the following worldwide, non-exclusive, perpetual, irrevocable, royalty-free, fully paid-up rights with respect to the Feedback:

• to use, copy, modify, sell, distribute, sub-license, and create derivative works of, the Feedback as part of any Rimsys product, technology, service, specification or other documentation (together, collectively, “Products”);

• to publicly perform or display, import, broadcast, transmit, distribute, license, offer to sell, and sell, rent, lease or lend copies of the Feedback (and derivative works thereof) as part of any Products; and

• to sublicense to third parties the foregoing rights, including the right to sublicense to further third parties.

In the event that Customer encounter any bugs, glitches, lack of functionality or other problems on the website, Customer shall provide written notice thereof to Rimsys within twenty-four (24) hours of such problem. Customer may contact Rimsys and submit its requests and issues to support@rimsys.io.

Customer agrees to reasonably cooperate with Rimsys to serve as a reference account upon request by Rimsys and to permit the use of Customer’s name, logo, trademark, or marks on Rimsys’ website, blog, articles, newsletters or the like for marketing and advertising purposes.

12 FORCE MAJEURE

Neither Party shall be liable to the other for any delay or failure to perform its obligations under this AGREEMENT (except for any obligations to make payments to the other Party under this AGREEMENT) if it arises from or is due to any cause or causes beyond the reasonable control of the Party affected, which impedes, delays or aggravates any obligation under this AGREEMENT including, but not limited to, acts of god, pandemics, terrorist attacks, acts of government, labor disturbances, shortage of or difficulty in obtaining raw materials or components, blockades, fire, or flood.  

Invoices shall be paid in-full in accordance with the terms of this SOW. ​​Annual License Fee pricing is determined by the Ordered number of Products being managed and countries being tracked (Registrations Module), as well as the number of GSPR documents that are being managed within the Rimsys platform (Essential Principles & Standards Management Module) (collectively, the “Platform User Level”) during the Initial Service Term (if applicable, pricing for the UDI and Writer Module is based on the Registrations Module). There shall be no penalty or additional fees owed during the then current Term should the Customer exceed the allowed Platform User Level.  Should this SOW be renewed for a Renewal Term, the Annual License Fee shall be adjusted automatically based on current pricing for the actual Platform User Level during the previous Term.  

The Parties may agree to renew for a Renewal Term at a higher Platform User Level, but this SOW cannot be renewed for a Renewal Term at a lower Platform User Level than the one calculated as per the aforementioned auto-adjustment method. A System audit would be performed immediately prior to any Renewal Term to determine the actual Platform User Level and the associated pricing for the Annual License Fee. At the beginning of any Renewal Term, Rimsys shall invoice the Customer in accordance with the terms of this SOW. System audit reports shall be made available to Customer upon request.

The Annual License Fee, which is a recurring fee, incorporates the following:

1. Unlimited users.

2. Updates and maintenance. For clarity, Upgrades are not included in the Annual License: