Terms of Use

1. Relationship to the Data License

These Terms of Use ("Terms") govern use of the CTD Commons website and repository (ctdcommons.org, the "Repository"), operated by 1Day Sooner, Inc. ("CTD Commons," "we," or "us"). They apply in addition to, and do not modify, the CTD Commons Data License (CDLA-Permissive-2.0), which separately governs your rights to use, modify, share, and commercialize the data itself, including for AI/ML training. Nothing in these Terms restricts any right granted to you under the Data License. 

2. What the Data Is and Where It Comes From

Data made available through the Repository (Common Technical Documents and related FDA regulatory correspondence, collectively the “Data”) is obtained either (a) directly from the original sponsor, its successors, or authorized representatives (“Donated Data”), or (b) through acquisition of non-exclusive rights via U.S. bankruptcy court order under 11 U.S.C. § 363 (“Acquired Data”). For Acquired Data, CTD Commons' own rights are limited to the non-exclusive rights transferred by the applicable bankruptcy order, and CTD Commons licenses to Users only the rights it has been granted.

Data made available through the Repository is not obtained from the FDA and is not subject to, and does not reflect any determination under, the Freedom of Information Act (“FOIA”) or FDA disclosure regulations. CTD Commons makes no representation regarding whether equivalent material has been or could be released by FDA through FOIA.

3. Redaction, Confidentiality, and Takedown Requests

CTD Commons undertakes a good-faith review process to remove personal identifiers and known trade secrets or confidential commercial information from Data prior to publication. This process is not infallible. If any person or entity believes that published Data contains (a) personal information, or (b) their trade secret or confidential commercial information, that was improperly included, they may submit a takedown request to legal@1daysooner.org. To be considered, a request must identify the requester, identify the specific Data and its location with enough detail for CTD Commons to locate it, and state the basis for the request.

Upon receiving a request that is not facially without merit, CTD Commons will:

• Acknowledge receipt within five (5) business days;

• Personal information. Where the request concerns personal information or other personally identifying material, promptly and temporarily restrict public access to the disputed Data pending review;

• Trade secret or confidential commercial information. Where the request concerns trade secrets or confidential commercial information, review the request on its merits and may, in its discretion, temporarily restrict public access to the disputed Data pending that review;

• Make a good-faith determination and either permanently redact or remove the disputed material where warranted, or restore any temporarily restricted Data where the request is not substantiated. If CTD Commons has not made a determination within thirty (30) days, any temporarily restricted Data may be restored pending completion of review.

CTD Commons may decline requests that are facially without merit, incomplete, or abusive. Because Data made available under the Data License may already have been downloaded or incorporated into other works, restricting or removing Data from the Repository does not retrieve or affect copies already distributed.

4. No Legal, Regulatory, or Medical Advice

The Repository and its contents are provided for informational and research purposes only. Nothing in the Data, and nothing provided by CTD Commons, constitutes legal, regulatory, or medical advice. Users are solely responsible for independently verifying any Data before relying on it for regulatory, clinical, investment, or other decisions.

5. Site Availability and Conduct

CTD Commons will make reasonable efforts to keep the Repository available but does not guarantee uninterrupted access and may modify, suspend, or discontinue the Repository, or remove specific Data (including in response to a takedown determination under Section 3), at its discretion. Bulk and automated downloading of Data for legitimate research, commercial, or AI/ML purposes is permitted and encouraged; however, Users may not access the Repository through automated means in a manner that materially disrupts, or imposes an unreasonable burden on, its infrastructure, and may not misrepresent their affiliation with CTD Commons or 1Day Sooner, Inc. 

6. Trademarks and Site Content

"CTD Commons," the CTD Commons name, and any associated logos are protected marks of the CTD Commons project. These Terms do not grant any license to use them, and they may not be used without prior written permission. Text and other content on the Repository website that is not itself Data (for example, descriptive or explanatory material CTD Commons has written) remains the property of CTD Commons unless otherwise noted. 

7. Disclaimer as to the Repository Service

THE REPOSITORY AND ITS ASSOCIATED WEBSITE, TOOLS, AND SERVICES ARE PROVIDED “AS IS” AND “AS AVAILABLE,” WITHOUT WARRANTY OF ANY KIND. THIS IS IN ADDITION TO, AND DOES NOT REPLACE, THE SEPARATE DISCLAIMER OF WARRANTIES APPLICABLE TO THE DATA ITSELF UNDER THE DATA LICENSE. TO THE MAXIMUM EXTENT PERMITTED BY LAW, CTD COMMONS, 1DAY SOONER, RENAISSANCE PHILANTHROPY, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AND AGENTS SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES ARISING FROM OR RELATED TO USE OF THE REPOSITORY OR ITS WEBSITE.

8. Changes to These Terms

CTD Commons may update these Terms prospectively. Changes will not retroactively revoke rights already granted under the Data License for Data previously accessed. Continued use of the Repository after a change to these Terms constitutes acceptance of the updated Terms.

9. Contact

Questions about these Terms or requests for a different arrangement should be directed to ctd@1daysooner.org . Takedown requests under Section 3 should be sent to legal@1daysooner.org. 

Data License

The data made available through the CTD Commons repository (ctdcommons.org) is licensed under the Community Data License Agreement — Permissive, Version 2.0 ("CDLA-Permissive-2.0"), reproduced in full below. 1Day Sooner, Inc., operating CTD Commons, is the "Data Provider" referenced in the agreement below. This license is granted subject to Section 2 of the Terms of Use, which describes the source and scope of the rights CTD Commons holds. 

Community Data License Agreement – Permissive – Version 2.0

This is the Community Data License Agreement - Permissive, Version 2.0 (the "agreement"). Data Provider(s) and Data Recipient(s) agree as follows:

1. Provision of the Data

1.1. A Data Recipient may use, modify, and share the Data made available by Data Provider(s) under this agreement if that Data Recipient follows the terms of this agreement.

1.2. This agreement does not impose any restriction on a Data Recipient's use, modification, or sharing of any portions of the Data that are in the public domain or that may be used, modified, or shared under any other legal exception or limitation.

2. Conditions for Sharing Data

2.1. A Data Recipient may share Data, with or without modifications, so long as the Data Recipient makes available the text of this agreement with the shared Data.

3. No Restrictions on Results

3.1. This agreement does not impose any restriction or obligations with respect to the use, modification, or sharing of Results.

4. No Warranty; Limitation of Liability

4.1. All Data Recipients receive the Data subject to the following terms:

THE DATA IS PROVIDED ON AN "AS IS" BASIS, WITHOUT REPRESENTATIONS, WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OR CONDITIONS OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

NO DATA PROVIDER SHALL HAVE ANY LIABILITY FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE DATA OR RESULTS, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

5. Definitions

5.1. "Data" means the material received by a Data Recipient under this agreement.

5.2. "Data Provider" means any person who is the source of Data provided under this agreement and in reliance on a Data Recipient's agreement to its terms.

5.3. "Data Recipient" means any person who receives Data directly or indirectly from a Data Provider and agrees to the terms of this agreement.

5.4. "Results" means any outcome obtained by computational analysis of Data, including for example machine learning models and models' insights.

Privacy Policy

CTD Commons respects the privacy of visitors to ctdcommons.org. This policy explains the limited information we collect and how it is used.

• No account or personal information is required to browse the Repository or access the Data. You can search and download without registering or providing identifying information.

• Standard technical data. Like most websites, our hosting and analytics providers automatically collect standard technical information — such as IP address, browser type, device information, pages visited, and referring pages — for security, troubleshooting, and to understand how the site is used. The site is hosted on Google Sites, so your use is also subject to Google's Privacy Policy (policies.google.com/privacy).

• Cookies and analytics. We and our providers may use cookies and similar technologies to operate the site, remember preferences, and measure aggregate usage. You can control cookies through your browser settings.

• Search. The site search box is provided through our hosting platform; search queries are processed to return results and may be logged in aggregate to improve the site.

• No sale of personal information. We do not sell information about visitors and share it only as needed to operate the site (for example, with our hosting and analytics providers) or as required by law.

• Correspondence. If you contact us (for example, at ctd@1daysooner.org or legal@1daysooner.org), we retain your message and contact details to respond and to keep records of any requests.

• Changes. We may update this policy prospectively; the "last updated" date above reflects the most recent version.

• Contact. Questions about this policy: ctd@1daysooner.org.