The U.S. Food and Drug Administration (“FDA”) offers some of its services through PrecisionFDA [located at https://precision.fda.gov] as part of the FDA’s work in building a strong community contributing to a standards-based approach for ensuring the accuracy of genetic tests incorporating next generation sequencing (NGS) technologies. Use of the services made available via PrecisionFDA is restricted to usage specifically related to the FDA’s PrecisionFDA program as determined by the FDA. The services are offered subject to your acceptance of the terms and conditions contained herein as well as any relevant sections of the FDA Website Policies.
These Terms of Service, which include the definitions for acceptable use of PrecisionFDA services, are an agreement between the User and the FDA and govern all access to, and use of, the services we provide through the website at https://precision.fda.gov (the "Site"). A “User” is a PrecisionFDA User or other entity to whom the User has granted permission to access the Services. “User Data” means the data, software and other information shared by a User to or through the services or derived from the data, software and other information shared.
The services provided at the Site are subject to these terms. Use of PrecisionFDA constitutes acceptance to this Agreement.
1.1. License. Subject to User’s compliance with this Agreement and applicable laws and regulations, FDA hereby grants User a nonexclusive, nontransferable, revocable, limited license during the term of this Agreement to access and use and to authorize Users to access and use the Services to transfer, store, process, analyze and display User Data in performing PrecisionFDA-related tasks. The “Services” means the PrecisionFDA website, application programming interface (API), software development kit (SDK), analysis software developed by FDA or third parties and provided as FDA publicly shared data, upload agent, command line tools and other software, data, documentation, systems and services licensed and provided by FDA for data management and analysis in the performance of PrecisionFDA-related tasks. User shall be solely liable for any use of the Services.
1.2. Restrictions. User shall use the Services solely in accordance with this Agreement and applicable laws and regulations. User shall not, and shall not cause or permit any other party to:
1.2.1. except with respect to software which is distributed under a free open-source license, copy, translate, modify, adapt, enhance, decompile, disassemble or reverse engineer the Services or otherwise determine or attempt to determine source code or protocols from the executable code of the Services or create any derivative works based upon the Services;
1.2.2. except with respect to software which is distributed under a free open-source license, reproduce or extract ideas, algorithms, procedures, workflows or hierarchies from the Services or otherwise use the Services for the purpose of creating a similar product or service;
1.2.3. provide unauthorized access to or use of the Services;
1.2.4. sell, rent, transfer or otherwise make available the Services to third parties in violation of this Agreement;
1.2.5. use the Services to reproduce, modify, distribute, perform, display, access or use User Data in violation of any applicable laws or agreements with the owners of User Data;
1.2.6. introduce any virus, malware, or spyware into the Services;
1.2.7. adversely impact the speed, security or integrity of the Services;
1.2.8. adversely impact the cost of delivering the Services;
1.2.9. circumvent or render ineffective measures implemented to protect and control the Services and User Data;
1.2.10. conduct any sort of penetration testing or exploit any vulnerabilities in the Services; or
1.2.11. use any Free and Open Source Software (“FOSS”) in a way that would cause the non-FOSS portions of the Services to be subject to any FOSS licensing terms or obligations. Free and Open Source Software means any software that is subject to terms that, as a condition of use, copying modification or redistribution, require such software or derivatives thereof to be disclosed and/or distributed in source code form, to be licensed for purposes of making derivative works, or to be redistributed free of charge, including without limitation software distributed under the GNU General Public License or GNU Lesser/Library GPL.
2. User Data.
2.1. Warranty. User represents, warrants and covenants that the acquisition and provision of User Data to PrecisionFDA for use in accordance with this Agreement (a) do not violate the rights of or breach any duty or obligation to any User or third party and (b) are done in compliance with applicable law, which includes providing all necessary notices to, and obtaining all necessary permissions and informed consents from, human subjects from whom samples were taken and the owners of nonhuman samples that User has obtained.
2.2. User Responsibilities. User shall be solely responsible for (a) the use and operation of software that User or Users install or that are installed on User’s or Users’ behalf, (b) User’s or Users’ sharing of User Data with any third party and (c) the backup of User Data.
2.3. Protected Health Information. Users shall not store Protected Health Information (PHI) on PrecisionFDA.
2.4. Personally Identifiable Information. Users shall not store Personally Identifiable Information (PII) on PrecisionFDA unless all necessary permissions and informed consents have been obtained.
2.5. Confidential Commercial Information. Users shall not store Confidential Commercial Information on PrecisionFDA in a manner which renders the information accessible to all Users and the FDA.
2.6. Trade Secrets. PrecisionFDA Users shall not store Trade Secrets on PrecisionFDA.
3. Privacy and Security. FDA shall not access information contained solely in a private space. FDA shall maintain administrative, physical and technical safeguards for protection of the security, confidentiality and integrity of User Data that are consistent with industry standards for services similar to the Services. FDA may monitor User’s use of the API and Apps for quality assurance, management and improvement of the Services and verification of compliance with this Agreement.
4. Accessing and Using the Services. When creating any login account to access and use the Services, User shall provide complete, accurate and up-to-date information, including, for example, email addresses used to provide notices to User under this Agreement and shall update or correct such information as needed. User shall promptly notify FDA of any unauthorized access or use of the Services.
5. Intellectual Property. Except as expressly stated or as required by laws of the United States of America, this Agreement does not grant either party any rights, implied or otherwise, to the other’s intellectual property.
5.1. User IP. As between the parties, User has and shall retain all right, title and interest, including Intellectual Property Rights, in and to User Data (“User IP”). “Intellectual Property Rights” means all current and future worldwide rights under the laws of patents, copyrights, trade secrets, trademarks, moral rights and other intellectual property. User hereby grants FDA a nonexclusive, nontransferable, revocable, royalty-free, limited license during the term of this Agreement to access and use User IP solely for the purpose of delivering Services.
6.1. Applicable Law. User agrees to comply with all local and state laws and regulations and the laws of the United States of America, including without limitation those pertaining to personal data security and privacy and export and re-export restrictions and regulations of the Department of Commerce and any other United States or foreign agencies and authorities in connection with User’s use of the Services. In particular, but without limitation, User shall not export or re-export the Services in violation of any laws into any US embargoed country or to anyone on the US Treasury Department’s list of Specially Designated Nationals or the US Commerce Department’s Table of Deny Orders.
6.2. Other Agreements. User represents, warrants and promises that execution of this Agreement and the exercise and performance of any rights and obligations under this Agreement do not conflict with or breach an agreements with any third party.
7. Availability; Backups.
7.1. Availability; Backups. FDA makes no representations or warranties regarding the durability or availability of third party cloud services, such as Amazon Web Services, that FDA uses to provide the Services. FDA will have no obligation to back up User Data or any other software, data or information provided by User or Users.
8. Term and Termination.
8.1. Term. The term of this Agreement begins on the date of acceptance of these Terms of Service or date of the first use of Services, whichever is earlier. The term of this agreement ends upon Termination for Any Reason, Termination for Breach, or Termination of Services, whichever occurs first.
8.2. Termination for Any Reason. Either party may terminate this Agreement at any time provided at least 30 days’ prior written notice of termination is provided to the other party.
8.3. Termination for Breach. Either party may terminate this Agreement for material breach upon 15 days’ notice if the material breach remains uncured at the end of the notice period.
8.4. Termination of Services. Services are currently delivered under an FDA research grant which terminates on April 30th, 2016, at which time FDA may terminate Services without prior notice.
8.5. Effect. Upon termination of this Agreement, all applicable licenses and other rights granted to Customer will immediately terminate, and FDA will have no obligation to store or provide access to any User Data, which may be deleted without liability.