Automated Bag Ventilation Machine License and Terms
AutoVent Foundation (“Company”) has developed and acquired certain rights to an automated bag ventilation machine (the “ABVM”). For purposes of helping the public good, Company wants to make the drawings and specifications for the ABVM (the “Documents”) and certain software that operates the ABVM (the “Software”) available to all under and subject to the terms of this ABVM System License and Terms (these “Terms”).
By clicking “Accept” you accept and agree to be bound by these Terms. Your use of any of the Documents or Software will be acceptance of these Terms. If you come into possession of the Documents or Software without having accepted these Terms through Company’s website, then you have no right or license to use the Documents or Software other than in strict compliance with these Terms.
For purpose of these Terms, “you” means both the individual person who accepts these Terms or uses the Documents or Software, and the entity using or on whose behalf is used the Documents or Software.
Format. These Terms consist of four Parts.
Part 1 includes certain disclaimers of liability and indemnifications protecting Company and its licensors.
Part 2 provides licenses to use the Documents and produce the ABVM. This Part is based on, but is different from, the Creative Commons Attribution-ShareAlike 4.0 International Public License.
Part 3 provides a license to use the Software under the [3-Clause BSD License].[1]
Part 4 includes certain general provisions.
Part 1: Disclaimers, Limitation of Liability and Indemnification
Company is making the Documents and Software available free of charge and for the public good, and Company is not normally in the business of designing, manufacturing, or selling medical products, such as the ABVM. As such, Company would not distribute or make available the Documents or Software other than pursuant to the protections provided in this Part 1. If any court of competent jurisdiction seeks to invalidate or modify these provisions, they shall be interpreted in a manner that, to the extent possible, most closely approximates an absolute disclaimer, waiver of all liability, and full protection of Company.
Disclaimer. COMPANY EXPRESSLY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, IN CONNECTION WITH THESE TERMS, THE ABVM, THE DOCUMENTS, AND THE SOFTWARE, INCLUDING ANY WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, COMPANY: (A) SHALL HAVE NO LIABILITY WHATSOEVER TO YOU OR ANY OTHER PERSON FOR OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OFFER FOR SALE, SALE, OR IMPORT OF THE ABVM OR ANY FUTURE IMPROVEMENT OR MODIFICATION THEREOF (EACH, A “ABVM PRODUCT”) OR OTHER PRODUCT OR OTHERWISE IN CONNECTION WITH THE USE OF THE DOCUMENTS OR SOFTWARE; AND (B) MAKES NO REPRESENTATION OR WARRANTY THAT ANY ABVM PRODUCTS HAS BEEN APPROVED (BY THE FDA OR OTHERWISE) OR IS FIT FOR USE FOR HUMANS AS A MEDICAL DEVICE.
Limitation of Liability. COMPANY WILL NOT BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, OR PUNITIVE DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR USE OF THE DOCUMENTS OR SOFTWARE HEREUNDER OR ANY ABVM PRODUCT, WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE AND WHETHER SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Indemnification. You shall indemnify, defend, and hold harmless Company, its licensors, and each of their its affiliates, officers, directors, employees, agents, and representatives against all losses, liabilities, claims, damages, actions, fines, penalties, expenses or costs (including court costs and reasonable attorneys’ fees) arising out of or in connection with any third-party claim, suit, action, or proceeding relating to use by you or anyone on your behalf of any Document or Software or the manufacture, use, marketing, offer for sale, sale, or importation of any ABVM Product, including any products liability claims or claims related to personal injury or death associated with any ABVM Product. YOU ACKNOWLEDGE THAT THIS INDEMNIFICATION MAY PROVIDE INDEMNIFIED PERSONS WITH INDEMNIFICATION FOR CLAIMS RESULTING FROM SUCH INDEMNIFIED PERSON’S OWN NEGLIGENCE AND AGREE THAT THIS INDEMNIFICATION SHALL STILL REMAIN EFFECTIVE TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW NOTWITHSTANDING THAT FACT.
Part 2: Use of Documents
Adapted Materialmeans material subject to Copyright and Similar Rights that is derived from or based upon the Documents and in which the Documents are translated, altered, arranged, transformed, or otherwise modified in a manner requiring permission under the Copyright and Similar Rights held by Company.
Adapter's Licensemeans the license you apply to your Copyright and Similar Rights in your contributions to Adapted Material in accordance with the terms and conditions of these Terms.
Copyright and Similar Rightsmeans copyright and/or similar rights closely related to copyright including, without limitation, performance, broadcast, sound recording, and Sui Generis Database Rights, without regard to how the rights are labeled or categorized.
Effective Technological Measuresmeans those measures that, in the absence of proper authority, may not be circumvented under laws fulfilling obligations under Article 11 of the WIPO Copyright Treaty adopted on December 20, 1996, and/or similar international agreements.
License Elementsmeans Attribution and ShareAlike, with the meanings given those terms pursuant to the Creative Commons licenses.
Licensed IP means all intellectual property controlled by Company that is necessary or useful for the manufacture or use of the ABVM Products, but excludes all trademarks and trade names of Company; Company “controls” intellectual property only if and to the extent Company has sufficient rights in such intellectual property to grant the licenses set forth herein.
Sharemeans to provide material to the public by any means or process that requires permission under the Licensed IP, such as reproduction, public display, public performance, distribution, dissemination, communication, or importation, and to make material available to the public including in ways that members of the public may access the material from a place and at a time individually chosen by them.
Sui Generis Database Rightsmeans rights other than copyright resulting from Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases, as amended and/or succeeded, as well as other essentially equivalent rights anywhere in the world.
License grant.
Subject to the terms and conditions of these Terms, Company hereby grants you a revocable, non-exclusive, royalty-free, non-transferable, non-sublicensable license (or sublicense as applicable) to use the Licensed IP to:
reproduce and Share the Documents, in whole or in part;[2]
produce, reproduce, and Share Adapted Material; and[3]
manufacture, having manufactured, use, market, offer for sale, sell, and import ABVM Products.
Downstream recipients.
Offer from Company– Documents. Every recipient of the Documents automatically receives an offer from Company to exercise the Licensed IP under the terms and conditions of these Terms.
Additional offer from Company – Adapted Material. Every recipient of Adapted Material from you automatically receives an offer from Company to exercise the Licensed IP in the Adapted Material under the terms and conditions of these Terms.
No downstream restrictions. You may not offer or impose any additional or different terms or conditions on, or apply any Effective Technological Measures to, the Documents if doing so restricts exercise of the Licensed IP by any recipient of the Documents.
No endorsement. Nothing in these Terms constitutes or may be construed as permission to assert or imply that you are, or that your use of the Documents is, connected with, or sponsored, endorsed, or granted official status by, Company.
Other rights.
Moral rights, such as the right of integrity, are not licensed under these Terms, nor are publicity, privacy, and/or other similar personality rights.
Trademark rights are not licensed under these Terms.
Patent rights are not licensed under Sections 2a.1.A and 2a.1.B of this Part 2.
To the extent possible, Company waives any right to collect royalties from you for the exercise of the Licensed IP pursuant to these Terms, whether directly or through a collecting society under any voluntary or waivable statutory or compulsory licensing scheme. In all other cases Company expressly reserves any right to collect such royalties.
License Conditions.
Your exercise of the Licensed IP is expressly made subject to the following conditions.
Sale at Cost.[4] Company’s desire is that you provide any ABVM Products produced using the Documents and Software to healthcare providers at no cost. However, if you decide to charge any third party for the sale, transfer, or lease of any ABVM Product made using the Documents or Software, you may not charge such third party any amount in excess of your fully loaded costs of goods sold (including reasonable charges for overhead) for the applicable ABVM Product.
Attribution.
If you Share the Documents (including in modified form), you must:
retain the following if it is supplied by Company with the Documents:
identification of the creator(s) of the Documents and any others designated to receive attribution, in any reasonable manner requested by Company (including by pseudonym if designated);
a copyright notice;
a notice that refers to these Terms;
a notice that refers to the disclaimer of warranties, limitation of liabilities and indemnification protecting Company; and
a URI or hyperlink to the Documents to the extent reasonably practicable;
indicate if you modified the Documents and retain an indication of any previous modifications; and
indicate the Documents are licensed under these Terms, and include the text of, or the URI or hyperlink to, these Terms.
You may satisfy the conditions in Section 3a.1 in any reasonable manner based on the medium, means, and context in which you Share the Documents. For example, it may be reasonable to satisfy the conditions by providing a URI or hyperlink to a resource that includes the required information.
If requested by Company, you must remove any of the information required by Section 3a.1.A to the extent reasonably practicable.
ShareAlike.
In addition to the conditions in Section 3a, if you Share Adapted Material you produce, the following conditions also apply.
The Adapter’s License You apply must be a Creative Commons license with the same License Elements, version 4 or later, or a BY-SA Compatible License.
You must include the text of, or the URI or hyperlink to, the Adapter's License you apply. You may satisfy this condition in any reasonable manner based on the medium, means, and context in which You Share Adapted Material.
You may not offer or impose any additional or different terms or conditions on, or apply any Effective Technological Measures to, Adapted Material that restrict exercise of the rights granted under the Adapter's License you apply.
Part 3: Use of Software
Your use of the Software is subject to the terms and conditions in this Part 3.
Copyright 2020 AutoVent Foundation
Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.
Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.
Neither the name of the copyright holder nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission.
THIS SOFTWARE IS PROVIDED BY COMPANY AND CONTRIBUTORS "AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL COMPANY OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING OUT OF OR IN CONNECTION WITH THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
To the extent the Software contains any software code of a third-party other than Company that is made available under its own open source license, such third-party software is made available subject to the terms of its relevant open source license and not these Terms.
Part 4: General
Term. These Terms will remain in place until terminated by Company upon written notice to you. If you fail to comply with these Terms, then your rights and licenses under these Terms terminate automatically. For the avoidance of doubt, this Section does not affect any right Company may have to seek remedies for your violations of these Terms. Part 1 and Part 4 survive termination of these Terms.
Assignment. You may not assign or transfer any of your rights or obligations under these Terms. Any purported assignment or transfer in violation of the foregoing will be void and of no force and effect.
Amendments; No Third-Party Beneficiaries. These Terms solely benefit the parties and their respective permitted successors and assigns and nothing (other than the indemnification provisions above) in these Terms, express or implied, confers on any other person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of these Terms.
Severability. If any portion of these Terms is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any other term or provision of these Terms or invalidate or render unenforceable such term or provision in any other jurisdiction.
Governing Law. These Terms and all matters arising out of or in connection with these Terms, are governed by, and construed in accordance with, the laws of the State of Vermont, without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Vermont.
Waiver. Except as otherwise set forth in these Terms, no failure to exercise, or delay in exercising, any rights, remedy, power, or privilege arising from these Terms will operate or be construed as a waiver thereof, nor will any single or partial exercise of any right, remedy, power, or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power, or privilege.
Entire Agreement. These Terms constitute the sole and entire agreement of Company and you with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, regarding such subject matter. For the avoidance of doubt, Company may also offer Documents and Software under separate terms or conditions or stop distributing the Documents and Software at any time; however, doing so will not terminate these Terms.
[1] Beta: Please advise as to desired Open Source License to use. The BSD is fairly permissive license and will allow others to make general use of the software.
[2] Beta: This license allows users to further disseminate the Plans. We kept this as it is consistent with the goal of getting the ABVM plans in the most people’s hands, but please advise if you want to limit this. Also, please advise if Beta wants to have any part of the plans remain subject to confidentiality.
[3] Beta: This allows the users to make modifications to the ABVM plans. Confirm this is acceptable.
[4] Beta: Please review and confirm that this limitation is desired by Beta.
To deploy an automatic bag ventilation machine (ABVM) to help as many patients and caregivers as possible during the COVID-19 pandemic.
The Vision
Increase access to emergency ventilation by open source sharing of our ABVM design and production documentation and through partnerships to facilitate rapid production and distribution worldwide.
To deploy an automatic bag ventilation machine (ABVM) to help as many patients and caregivers as possible during the COVID-19 pandemic.
The Vision
Increase access to emergency ventilation by open source sharing of our ABVM design and production documentation and through partnerships to facilitate rapid production and distribution worldwide.
Developed by the non-profit AutoVENT Foundation, comprised of a team of aerospace controls, mechanical and reliability engineers from BETA Technologies Inc. Clinical oversight provided by several UVMMC Clinicians.
Current Status:
Engineering units have completed thermal and stress runs with reliability tests ongoing. Production of first 50 units is planned for mid-April with scale up plans underway. We are in the process of working with the FDA to receive Emergency Use Authorization for the Automated Bag Valve Machine in the near future. Further, we expect to publish open source design & BOM in mid-May.