Authorized End-User License Agreement for Vocabularies and Mapping Tables in the Common Data Model

IMPORTANT- PLEASE READ CAREFULLY:

Authorized End-User License Agreement (“EULA”) for Vocabularies and Mapping Tables in the Common Data Model
IMPORTANT- PLEASE READ CAREFULLY: This Authorized End-User License Agreement ("EULA") is a legal agreement between you (either as an individual person or as an authorized representative of an academic, business or governmental entity) and the Reagan-Udall Foundation for the Food and Drug Administration (“RUF”) relating to the Innovation in Medical Evidence Development and Surveillance (“IMEDS”) program, formerly the Observational Medical Outcomes Partnership (“OMOP”). This EULA governs Authorized Users’ (as defined below) access to the OMOP Common Data Model (“CDM”) and relational mapping tables (collectively the “Licensed Materials”). The EULA grants Authorized Users a limited license as set forth below to use the Licensed Materials solely within the United States and its territories and describes an Authorized User’s obligations with respect to the Licensed Materials.

If you have any questions about this EULA, or desire to contact RUF for any reason, go to comments@reaganudall.org.

In consideration of the mutual promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

I. Content of Licensed Materials; Grant of License.
The Licensed Materials that are the subject of this EULA consist of electronic information published or otherwise made available by RUF through licenses granted to RUF by Amazon Web Services, American Medical Association (“AMA”), CambridgeSoft Corporation, First DataBank, Inc., International Health Terminology Standards Development Organisation, National Library of Medicine, Northup Grumman, Oracle, Quintiles (“Outcome Sciences”), SAS Institute Inc., Truven Health Analytics, The Mathworks Inc., Wolters Kluwer Health, Inc. (“WKH”), the National Library of Medicine, Department of Health and Human Services (“NLM”) and Northrop Grumman Corporation (“Third Party Licensors”). This information is hereafter referred to in this EULA as the “Licensed Materials”.

The copyright and all rights, title and interest in and to the Licensed Materials and any trademarks or service marks relating thereto remain with RUF and/or its suppliers or applicable third parties. Authorized Users shall not have right, title or interest in the Licensed Materials except as expressly set forth in this EULA. Authorized Users may not resell, transfer for value or otherwise, the Licensed Materials. RUF hereby grants to Authorized Users a non-transferable, non-exclusive, non-sublicensable, limited right to use the Licensed Materials for the sole purpose of performing research related to drug outcome studies solely within the United States and its territories in accordance with this EULA.

II. Authorized Use of Licensed Materials by Authorized User.
“Authorized User” means (1) any person to whom, pursuant to this EULA, RUF has granted a right to access and use the Licensed Materials, or (2) any academic, business, or governmental entity (and its employees) to which, pursuant to this EULA and through the acceptance of this EULA by an authorized representative, RUF has granted such right. All Authorized Users are bound by the terms of this EULA. Authorized Uses. Authorized Users may use the Licensed Materials solely in accordance with this EULA. All use of the Licensed Materials as is consistent with the Fair Use Provisions of United States and international law is permitted. Nothing in this EULA is intended to limit in any way whatsoever Authorized Users’ rights under the Fair Use Provisions of United States or international law to use the Licensed Materials. The Licensed Materials may be used, copied or modified by an Authorized User solely for purposes of performing research related to drug outcome studies and solely within the United States and its territories.

III. Access by and Authentication of Authorized Users.
Login Name, and E-Mail Address. Each person who accepts this EULA, either on his or her individual behalf, or as an authorized representative of an academic, business, or governmental entity, shall be identified and authenticated by the use of a unique login name and email address provided to RUF during the registration process. Each such person’s identity will be shared with certain Third Party licensors, including the American Medical Association (“AMA”), Wolters Kluwer Health, Inc.(“WKH”), the National Library of Medicine, Department of Health and Human Services (“NLM”) and Northrop Grumman Corporation.

IV. Specific Restrictions on Use of Licensed Materials.
Unauthorized Use. Except as specifically provided elsewhere in this EULA, Authorized Users shall not knowingly permit anyone other than Authorized Users to use the Licensed Materials. Modification of Licensed Materials. Authorized Users are prohibited from publishing, distributing via the Internet or other public computer-based information system, creating derivative works from (including translating), transferring, selling, leasing, licensing or otherwise making available to any unauthorized party the Licensed Materials, or a copy or portion of the Licensed Materials, without the express, prior written permission of RUF.

Copyright Notice. All copyrighted material is the property of its designated owners. CPT® codes, descriptions and other data are copyright 2012 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association (“AMA”). Authorized User shall not remove, obscure or modify any copyright or other notices included in the Licensed Materials.

License to use CPT® for any use not authorized herein must be obtained through the AMA, CPT Intellectual Property Services, 515 N. State Street, Chicago, IL 60610. Applications are available at the AMA Web Site, https://catalog.ama-assn.org/Catalog/cpt/cpt_home.jsp.
This material includes the entire content of RxNorm and SNOMED Clinical Terms® (“SNOMED CT®”). SNOMED CT® is used by permission of the International Health Terminology Standards Development Organisation (“IHTSDO”). All rights reserved. SNOMED CT® was originally created by The College of American Pathologists. “SNOMED” and “SNOMED CT” are registered trademarks of the IHTSDO.

NLM is the source of the UMLS Metathesaurus which is the source of the SNOMED CT® and RxNorm codes contained herein. Some material in the UMLS Metathesaurus is from copyrighted sources of the respective copyright holders. Users of the UMLS Metathesaurus are solely responsible for compliance with any copyright, patent or trademark restrictions and are referred to the copyright, patent or trademark notices appearing in the original sources. The provisions of the License Agreement for Use of the UMLS® Metathesaurus®, including its appendices, incorporated herein by reference, are available on the NLM Web site: (http://wwwcf.nlm.nih.gov/umlslicense/snomed/license.cfm).

MedDRA®, the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”). Authorized Users shall include the following acknowledgement statement in all articles referencing MedDRA: MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (“IFPMA”).

The National Drug Data File NDDF Plus™ and the Enhanced Therapeutic Classification System ETC are copyright 2009 First DataBank, Inc., a subsidiary of Hearst Corporation. The Multilex® Drug Data File - Europe MDDF is copyright 2009 First DataBank Europe Ltd., a subsidiary of The Hearst Corporation. The National Drug Data File (“NDDFTM”) Plus documentation and the database supplied with it may not be reproduced in any form or by any means, in whole or in part, without written consent from the publisher. Any unauthorized use of this copyright material will be subject to legal action. NDDF Plus is a trademark of First DataBank, Inc.

The Anatomical Therapeutic Chemical Classification ATC is copyright WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway. Use of all or parts of the material requires reference to the WHO Collaborating Centre for Drug Statistics Methodology.

The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright © 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (“UCUM”) Organization. All rights reserved. Licensed Materials includes all or a portion of the UCUM table, UCUM codes, and UCUM definitions or is derived from it, subject to a license from Regenstrief Institute, Inc. and The UCUM Organization. Your use of the UCUM table, UCUM codes, UCUM definitions also is subject to this license, a copy of which is available at http://unitsofmeasure.org. The current complete UCUM table, UCUM Specification are available for download at http://unitsofmeasure.org. The UCUM table and UCUM codes are copyright © 1995-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. Commercial Purposes. Authorized Users may not use the Licensed Materials for commercial purposes, including but not limited to the sale of the Licensed Materials or bulk reproduction or distribution of the Licensed Materials in any form.

Export Restrictions. If the Licensed Products are delivered to an Authorized User in the United States by RUF or its agents, or if the Authorized User is otherwise subject to United States jurisdiction, the Authorized User agrees to comply with all applicable international and national laws that apply to the Licensed Materials, including the U.S. Export Administration Regulations, as well as end-user, end-use and destination restrictions issued by U.S. and other governments that have jurisdiction over the Authorized User.

V. RUF Performance Obligations.
Availability of Licensed Materials. RUF shall make the Licensed Materials available to Authorized Users only and RUF reserves the right to deny access to the Licensed Materials at its sole discretion in accordance with the EULA. Withdrawal of Licensed Materials. RUF reserves the right to withdraw from the Licensed Materials any item or part of an item for which it no longer retains the right to publish, or which it has reasonable grounds to believe infringes copyright or is defamatory, obscene, unlawful or otherwise objectionable.

VI. Authorized User Performance Obligations.
Protection from Unauthorized Use. In the event of any unauthorized use of the Licensed Materials by an Authorized User, RUF may terminate such Authorized User’s access to the Licensed Materials. Maintaining Confidentiality of Access Passwords. Where access to the Licensed Materials is to be controlled by use of passwords, Authorized Users shall not divulge their passwords to any third party.

VII. Limitations on Liabilities and Warranties; Remedies.
Notwithstanding anything else in this EULA:
Neither party shall be liable for any indirect, special, incidental, punitive or consequential damages, including but not limited to loss of data, business interruption or loss of profits arising out of the use of or the inability to use the Licensed Materials. RUF makes no representation or warranty, and expressly disclaims any liability with respect to the content of any Licensed Materials, including but not limited to errors or omissions contained therein, libel, infringement of rights of publicity, privacy, trademark rights, moral rights or the disclosure of confidential information.

LICENSED MATERIALS ARE PROVIDED "AS IS WITH ALL FAULTS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, ARISING OUT OF OR RELATED TO THIS EULA INCLUDING BUT NOT LIMITED TO, ANY WARRANTIES REGARDING ACCURACY, QUALITY, CORRECTNESS, COMPLETENESS, COMPREHENSIVENESS, SUITABILITY, SYSTEM AVAILABILITY, COMPATIBILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NONINFRINGEMENT, OR OTHERWISE (IRRESPECTIVE OF ANY COURSE OF DEALING, CUSTOM OR USAGE OF TRADE). NO FEE SCHEDULES, BASIC UNIT, RELATIVE VALUES OR RELATED LISTINGS ARE INCLUDED IN THE LICENSED MATERIALS. THE RUF AND AMA DO NOT DIRECTLY OR INDIRECTLY PRACTICE MEDICINE OR DISPENSE MEDICAL SERVICES. THE RESPONSIBILITY FOR THE CONTENT OF THIS FILE/PRODUCT IS WITH RUF AND NO ENDORSEMENT BY THE RUF AND ITS THIRD PARTY LICENSORS IS INTENDED OR IMPLIED. THE RUF AND ITS THIRD PARTY LICENSORS DISCLAIM RESPONSIBILITY FOR ANY CONSEQUENCES OR LIABILITY ATTRIBUTABLE TO OR RELATED TO ANY USE, NON-USE, OR INTERPRETATION OF INFORMATION CONTAINED OR NOT CONTAINED IN THIS FILE/PRODUCT. IN ADDITION, AUTHORIZED USER ACKNOWLEDGES THAT THE DATA MAY BE SUBJECT TO LIMITATIONS, DELAYS, LATENCY ISSUES AND OTHER PROBLEMS INHERENT IN THE USE OF THE INTERNET AND ELECTRONIC COMMUNICATIONS, AND THAT THE FINH AND ITS THIRD PARTY LICENSORS ARE NOT RESPONSIBLE FOR ANY DELAYS, DELIVERY FAILURES, OR OTHER DAMAGE RESULTING FROM SUCH PROBLEMS. THIS EULA WILL TERMINATE IMMEDIATELY IF YOU VIOLATE ITS TERMS. THE THIRD PARTY LICENSORS ARE THIRD PARTY BENEFICIARIES TO THIS EULA.

Authorized User’s Exclusive Remedy. Notwithstanding any damages that Authorized Users might incur for any reason whatsoever (including without limitation all damages referenced above and all direct or general damages), the entire liability of RUF and its Third Party Licensors under any provision of this EULA and Authorized Users’ exclusive remedy for all the foregoing shall be limited to removal from RUF’s list of Authorized Users. The foregoing limitations, exclusions, and disclaimers shall apply to the maximum extent permitted by applicable law, even if any remedy fails its essential purpose.

VIII. Indemnities.
Authorized User shall indemnify, defend and hold harmless and advance defense costs (if requested by the indemnified parties) to RUF and WKH, their affiliates and their respective officers, directors, employees, contractors and agents, to the fullest extent provided by law for any losses, claims, damages, awards, judgments, costs, penalties or injuries incurred by any third party, including reasonable attorneys’ fees, which arise from, out of or relate to (i) any alleged breach of such indemnifying party’s representations and warranties, covenants or conditions made under this EULA, (ii) any act or omission by the Authorized User in connection with the Licensed Materials; or (iii) the Authorized User’s re-export, deemed export to a non-US Person or export of the Licensed Materials outside of the United States. The indemnifying party shall have the sole right to defend such claims at its own expense. The other party shall provide, at the indemnifying party’s expense, such assistance in investigating and defending such claims as the indemnifying party may reasonably request. If Authorized User is a government entity, or an employee of a governmental entity, that is subject to statutory limitations that apply to this paragraph, the government entity shall provide the indemnifications to the full extent permitted by the statutory limitations prior to the Authorized User gaining access to the Licensed Products.

This indemnity shall survive the termination of this EULA.

IX. Governing Law.
This EULA shall be construed and interpreted in accordance with the laws of State of Maryland, without regard to conflict of law principles that would dictate the application of another jurisdiction’s laws. In the event of a dispute in connection with the Agreement, the exclusive venue shall be laid in the state courts sitting in Montgomery County, Maryland and for the United States District Court for the District of Maryland, Southern Division.

X. Entire Agreement.
This EULA constitutes the entire agreement of the parties and supersedes all prior communications, understandings and agreements relating to the subject matter hereof, whether oral or written.

XI. Amendment.
RUF reserves the right to amend, modify or terminate this EULA at any time for any reason, in its sole discretion. If the EULA is amended, those persons and academic, business or governmental entities who have previously accepted the EULA will be asked to review the amended EULA and to indicate and confirm acceptance of the amended EULA by clicking the “Accept” and/or “Confirmed” buttons. Bypassing or otherwise disabling the “Accept” and/or “Confirmed” button and still using the Licensed Materials will be deemed acceptance of the terms and conditions in the amended EULA. If any amendment alters a material term of the EULA that is unacceptable to a person or entity that has previously accepted the EULA the sole and exclusive remedy is termination of the EULA and removal of that person and/or entity from RUF’s list of Authorized Users.

XII. Severability.
If any provision or provisions of this EULA shall be held to be invalid, illegal, unenforceable or in conflict with the law of any jurisdiction, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

XIII. Waiver of Contractual Right.
Waiver of any provision herein shall not be deemed a waiver of any other provision herein, nor shall waiver of any breach of this EULA be construed as a continuing waiver of other breaches of the same or other provisions of this EULA.

XIV. US Government Rights.
Applicable FARS/DFARS restrictions apply to government use.
The Licensed Materials includes CPT®, which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Medical Association, 515 North State Street, Chicago, Illinois, 60654. U.S. government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227- 7015(b)(2) (November 1995) and/or subject to the restrictions of DFARS 227.7202-1(a) (June 1995) and DFARS 227.7202-3(a) (June 1995), as applicable, for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (June 1987) and/or subject to the restricted rights provisions of FAR 52.227-14 (June 1987) and FAR 52.227-19 (June 1987), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.

XV. Termination in Event of Default.
This Agreement will automatically terminate in the event of a default by Authorized User.

XVI. Expiration.
An Authorized User’s rights to use the codes in the relational mapping tables under this Agreement will automatically terminate when RUF’s rights to the codes terminate. An Authorized User may apply directly to a Third Party Licensor for a license to enable the Authorized User to continue to use any code in the Licensed Materials.

END OF LICENSE AGREEMENT