[License-review] request for review of the 3D Slicer License

[Christopher Sean Morrison]

From a uniqueness / proliferation standpoint, this license reads to me like an amalgamation of a BSD license with the Apache 2.0 license with a couple extra medical-domain clauses added.

One potential issue I see with respect to the OSD is Part B.4 where users must assert and agree that it’s designed for “research purposes only” and “has not been reviewed or approved by …” the [U.S.] FDA.  That skirts on an edge of upsetting clause #6, discrimination against a field of endeavor (i.e., clinical applications and FDA-approved software).  That said, Part B.4 doesn’t appear to have teeth beyond saying they are "not recommended or advised” but not actually prevented.

I’m not sure what the implications are, if any, for agreeing to a blatantly false condition.  That is, Part B.1.a has me accept my code is research only and not FDA approved but then the prevailing intent is to then incorporate the Software into a non-research context and/or obtain FDA approval where it’s still covered by this license but that agreement as expressly written cannot be upheld truthfully.

I’m not sure what to make of Part A.6 … that feels like a restriction on other software (i.e., OSD #9).  How is it not?

Cheers!
Sean
 



> Date: Thu, 27 May 2021 15:11:04 -0400
> From: Steve Pieper <pieper at isomics.com>
> To: license-review at lists.opensource.org
> Cc: Ron Kikinis MD <kikinis at bwh.harvard.edu>,
> 	"jchris.fillionr at kitware.com" <JChris.FillionR at kitware.com>, Andras
> 	Lasso <lasso at queensu.ca>
> Subject: [License-review] request for review of the 3D Slicer License
> 
> Hello -
> 
> I'm requesting a review of the 3D Slicer license for Legacy Approval as a
> Non-Reusable license.
> 
> This license was drafted in 2005 by lawyers working for Brigham and Women's
> Hospital (BWH), a teaching affiliate of Harvard Medical School, to be
> BSD-like but with a few extra provisions related to medical software.  It
> is specific to BWH so it's not directly reusable.
> 
> It was written in part because BWH was the prime contractor on an
> NIH-funded development consortium (na-mic.org) and wanted all code
> contributions to be compatible with ultimate use in real-world medical
> products (that is, commercial FDA-approved medical devices, which are
> almost universally closed source even if they build on open software).
> Compliance with the Slicer License was required for subcontractors, a group
> that included General Electric and several universities (MIT, UNC...) who
> all reviewed and accepted this license.
> 
> The license has been in continuous use since 2005 on software (slicer.org)
> that has been downloaded something like a million times and has been
> referenced in about 12,000 academic publications (
> https://www.slicer.org/wiki/Main_Page/SlicerCommunity).  Some of the code
> is also now being used in several medical products, with this license
> having been reviewed and accepted by the companies involved.
> 
> Here are some of the key points that BWH included to increase their comfort
> at distributing open source medical software.
> 
> * contributors affirm that they have de-identified any patient data they
> contribute
> 
> * contributors explicitly grant royalty free rights if they contribute code
> covered by a patent they control (i.e. to avoid submarine patents) and the
> right to sublicense code, data, and patents
> 
> * no GPL or other copyleft allowed because that would make the code
> basically impossible to use in real medical products
> 
> * it states that the code is "designed for research" and "CLINICAL
> APPLICATIONS ARE NEITHER RECOMMENDED NOR ADVISED" just to make it extra
> clear that any commercial clinical uses of the code are solely the
> responsibility of the user and not BWH or the other developers.
> 
> The full text is linked and copied below for your consideration.
> 
> Thanks,
> Steve
> 
> https://github.com/Slicer/Slicer/blob/master/License.txt
> 
> 
> For more information, please see:
> 
>                      http://www.slicer.org
> 
> The 3D Slicer license below is a BSD style license, with extensions
> to cover contributions and other issues specific to 3D Slicer.
> 
> 
> 3D Slicer Contribution and Software License Agreement ("Agreement")
> Version 1.0 (December 20, 2005)
> 
> This Agreement covers contributions to and downloads from the 3D
> Slicer project ("Slicer") maintained by The Brigham and Women's
> Hospital, Inc. ("Brigham"). Part A of this Agreement applies to
> contributions of software and/or data to Slicer (including making
> revisions of or additions to code and/or data already in Slicer). Part
> B of this Agreement applies to downloads of software and/or data from
> Slicer. Part C of this Agreement applies to all transactions with
> Slicer. If you distribute Software (as defined below) downloaded from
> Slicer, all of the paragraphs of Part B of this Agreement must be
> included with and apply to such Software.
> 
> Your contribution of software and/or data to Slicer (including prior
> to the date of the first publication of this Agreement, each a
> "Contribution") and/or downloading, copying, modifying, displaying,
> distributing or use of any software and/or data from Slicer
> (collectively, the "Software") constitutes acceptance of all of the
> terms and conditions of this Agreement. If you do not agree to such
> terms and conditions, you have no right to contribute your
> Contribution, or to download, copy, modify, display, distribute or use
> the Software.
> 
> PART A. CONTRIBUTION AGREEMENT - License to Brigham with Right to
> Sublicense ("Contribution Agreement").
> 
> 1. As used in this Contribution Agreement, "you" means the individual
>   contributing the Contribution to Slicer and the institution or
>   entity which employs or is otherwise affiliated with such
>   individual in connection with such Contribution.
> 
> 2. This Contribution Agreement applies to all Contributions made to
>   Slicer, including without limitation Contributions made prior to
>   the date of first publication of this Agreement. If at any time you
>   make a Contribution to Slicer, you represent that (i) you are
>   legally authorized and entitled to make such Contribution and to
>   grant all licenses granted in this Contribution Agreement with
>   respect to such Contribution; (ii) if your Contribution includes
>   any patient data, all such data is de-identified in accordance with
>   U.S. confidentiality and security laws and requirements, including
>   but not limited to the Health Insurance Portability and
>   Accountability Act (HIPAA) and its regulations, and your disclosure
>   of such data for the purposes contemplated by this Agreement is
>   properly authorized and in compliance with all applicable laws and
>   regulations; and (iii) you have preserved in the Contribution all
>   applicable attributions, copyright notices and licenses for any
>   third party software or data included in the Contribution.
> 
> 3. Except for the licenses granted in this Agreement, you reserve all
>   right, title and interest in your Contribution.
> 
> 4. You hereby grant to Brigham, with the right to sublicense, a
>   perpetual, worldwide, non-exclusive, no charge, royalty-free,
>   irrevocable license to use, reproduce, make derivative works of,
>   display and distribute the Contribution. If your Contribution is
>   protected by patent, you hereby grant to Brigham, with the right to
>   sublicense, a perpetual, worldwide, non-exclusive, no-charge,
>   royalty-free, irrevocable license under your interest in patent
>   rights covering the Contribution, to make, have made, use, sell and
>   otherwise transfer your Contribution, alone or in combination with
>   any other code.
> 
> 5. You acknowledge and agree that Brigham may incorporate your
>   Contribution into Slicer and may make Slicer available to members
>   of the public on an open source basis under terms substantially in
>   accordance with the Software License set forth in Part B of this
>   Agreement. You further acknowledge and agree that Brigham shall
>   have no liability arising in connection with claims resulting from
>   your breach of any of the terms of this Agreement.
> 
> 6. YOU WARRANT THAT TO THE BEST OF YOUR KNOWLEDGE YOUR CONTRIBUTION
>   DOES NOT CONTAIN ANY CODE THAT REQURES OR PRESCRIBES AN "OPEN
>   SOURCE LICENSE" FOR DERIVATIVE WORKS (by way of non-limiting
>   example, the GNU General Public License or other so-called
>   "reciprocal" license that requires any derived work to be licensed
>   under the GNU General Public License or other "open source
>   license").
> 
> PART B. DOWNLOADING AGREEMENT - License from Brigham with Right to
> Sublicense ("Software License").
> 
> 1. As used in this Software License, "you" means the individual
>   downloading and/or using, reproducing, modifying, displaying and/or
>   distributing the Software and the institution or entity which
>   employs or is otherwise affiliated with such individual in
>   connection therewith. The Brigham and Women's Hospital,
>   Inc. ("Brigham") hereby grants you, with right to sublicense, with
>   respect to Brigham's rights in the software, and data, if any,
>   which is the subject of this Software License (collectively, the
>   "Software"), a royalty-free, non-exclusive license to use,
>   reproduce, make derivative works of, display and distribute the
>   Software, provided that:
> 
> (a) you accept and adhere to all of the terms and conditions of this
> Software License;
> 
> (b) in connection with any copy of or sublicense of all or any portion
> of the Software, all of the terms and conditions in this Software
> License shall appear in and shall apply to such copy and such
> sublicense, including without limitation all source and executable
> forms and on any user documentation, prefaced with the following
> words: "All or portions of this licensed product (such portions are
> the "Software") have been obtained under license from The Brigham and
> Women's Hospital, Inc. and are subject to the following terms and
> conditions:"
> 
> (c) you preserve and maintain all applicable attributions, copyright
> notices and licenses included in or applicable to the Software;
> 
> (d) modified versions of the Software must be clearly identified and
> marked as such, and must not be misrepresented as being the original
> Software; and
> 
> (e) you consider making, but are under no obligation to make, the
> source code of any of your modifications to the Software freely
> available to others on an open source basis.
> 
> 2. The license granted in this Software License includes without
>   limitation the right to (i) incorporate the Software into
>   proprietary programs (subject to any restrictions applicable to
>   such programs), (ii) add your own copyright statement to your
>   modifications of the Software, and (iii) provide additional or
>   different license terms and conditions in your sublicenses of
>   modifications of the Software; provided that in each case your use,
>   reproduction or distribution of such modifications otherwise
>   complies with the conditions stated in this Software License.
> 
> 3. This Software License does not grant any rights with respect to
>   third party software, except those rights that Brigham has been
>   authorized by a third party to grant to you, and accordingly you
>   are solely responsible for (i) obtaining any permissions from third
>   parties that you need to use, reproduce, make derivative works of,
>   display and distribute the Software, and (ii) informing your
>   sublicensees, including without limitation your end-users, of their
>   obligations to secure any such required permissions.
> 
> 4. The Software has been designed for research purposes only and has
>   not been reviewed or approved by the Food and Drug Administration
>   or by any other agency. YOU ACKNOWLEDGE AND AGREE THAT CLINICAL
>   APPLICATIONS ARE NEITHER RECOMMENDED NOR ADVISED. Any
>   commercialization of the Software is at the sole risk of the party
>   or parties engaged in such commercialization. You further agree to
>   use, reproduce, make derivative works of, display and distribute
>   the Software in compliance with all applicable governmental laws,
>   regulations and orders, including without limitation those relating
>   to export and import control.
> 
> 5. The Software is provided "AS IS" and neither Brigham nor any
>   contributor to the software (each a "Contributor") shall have any
>   obligation to provide maintenance, support, updates, enhancements
>   or modifications thereto. BRIGHAM AND ALL CONTRIBUTORS SPECIFICALLY
>   DISCLAIM ALL EXPRESS AND IMPLIED WARRANTIES OF ANY KIND INCLUDING,
>   BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR
>   A PARTICULAR PURPOSE AND NON-INFRINGEMENT. IN NO EVENT SHALL
>   BRIGHAM OR ANY CONTRIBUTOR BE LIABLE TO ANY PARTY FOR DIRECT,
>   INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES
>   HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY ARISING IN ANY WAY
>   RELATED TO THE SOFTWARE, EVEN IF BRIGHAM OR ANY CONTRIBUTOR HAS
>   BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. TO THE MAXIMUM
>   EXTENT NOT PROHIBITED BY LAW OR REGULATION, YOU FURTHER ASSUME ALL
>   LIABILITY FOR YOUR USE, REPRODUCTION, MAKING OF DERIVATIVE WORKS,
>   DISPLAY, LICENSE OR DISTRIBUTION OF THE SOFTWARE AND AGREE TO
>   INDEMNIFY AND HOLD HARMLESS BRIGHAM AND ALL CONTRIBUTORS FROM AND
>   AGAINST ANY AND ALL CLAIMS, SUITS, ACTIONS, DEMANDS AND JUDGMENTS
>   ARISING THEREFROM.
> 
> 6. None of the names, logos or trademarks of Brigham or any of
>   Brigham's affiliates or any of the Contributors, or any funding
>   agency, may be used to endorse or promote products produced in
>   whole or in part by operation of the Software or derived from or
>   based on the Software without specific prior written permission
>   from the applicable party.
> 
> 7. Any use, reproduction or distribution of the Software which is not
>   in accordance with this Software License shall automatically revoke
>   all rights granted to you under this Software License and render
>   Paragraphs 1 and 2 of this Software License null and void.
> 
> 8. This Software License does not grant any rights in or to any
>   intellectual property owned by Brigham or any Contributor except
>   those rights expressly granted hereunder.
> 
> PART C. MISCELLANEOUS
> 
> This Agreement shall be governed by and construed in accordance with
> the laws of The Commonwealth of Massachusetts without regard to
> principles of conflicts of law. This Agreement shall supercede and
> replace any license terms that you may have agreed to previously with
> respect to Slicer.