I request access to the common database created and maintained by the members of the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Consortium (the “PRO-ACT Database”), a collection of institutions that have agreed to contribute data relating to ALS to the PRO-ACT Database for the purpose of scientific investigation, teaching, or the planning of clinical research studies.
I acknowledge that each of the following institutions has either contributed data or support to the PRO-ACT Database and/or are members of the PRO-ACT Consortium: Amylyx Pharmaceuticals, Inc., Cytokinetics, Inc., Knopp Biosciences, Neuraltus Pharmaceuticals, Inc., Neurological Clinical Research Institute at Massachusetts General Hospital, Northeast ALS Consortium, Novartis, Orion Corporation, Prize4Life Israel, Regeneron Pharmaceuticals, Inc., Sanofi, Teva Pharmaceutical Industries, Ltd., The ALS Association, and The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (MGH) (each a “Consortium Member” and collectively, the “Consortium Members” OR “PRO-ACT CONSORTIUM”) and that the Neurological Clinical Research Institute at Massachusetts General Hospital will bear primary responsibility for overseeing access to and the usage of the PRO-ACT Database.
I also acknowledge that in the future additional organizations may contribute data or support to the PRO-ACT Database and that from and after such contribution, each of these organizations will be considered a Consortium Member for all purposes hereunder and that from and after such contribution the term “Consortium Members” will be read to include any organization that has contributed data or support to the PRO-ACT Database.
I, on behalf of myself (if I am requesting access to the PRO-ACT Database in my individual capacity) or on behalf of my organization (if I am a representative of the organization that receives access to PRO-ACT Database) do hereby agree to the following terms and conditions:
- I will not attempt to establish the identity of, or make contact with, any individual whose data are included in the dataset.
- I will not disclose any of the data comprising the PRO-ACT Database unless such disclosure is made in accordance with these Terms and Conditions.
- I will not sell any of the data or any portion of the data comprising the PRO-ACT Database.
- I will not share access to the PRO-ACT Database with anyone.
- I represent and warrant that the information I provide to the Neurological Clinical Research Institute regarding identification of persons who will use the data contained in the PRO-ACT Database and the purpose-of-use for this data is accurate and complete.
- I will use appropriate safeguards to prevent use or disclosure of the data comprising the PRO-ACT Database and I will report to the Neurological Clinical Research Institute any use or disclosure of the data comprising the PRO-ACT Database not provided for herein of which I become aware immediately upon becoming aware of such use or disclosure.
- I will comply with any relevant rules and regulations imposed by my institution and, if applicable, its institutional review board in requesting and using these data.
- I hereby agree that I or my organization (as applicable) shall not engage in any transaction or series of transactions over any twelve (12) month period involving the sale, provision of access to, or similar commercial transaction involving data from the PRO-ACT Database, with any Country of Concern or with (as applicable) shall not engage in any transaction or series of transactions over any twelve (12) month period involving the sale, provision of access to, or similar commercial transaction involving any data from the PRO-ACT Database, with any Country of Concern or is not: (i) a foreign entity that is 50% or more owned, directly or indirectly, individually or in the aggregate, by one or more Countries of Concern or persons described in subsection (ii) hereof, or that is organized or chartered under the laws of, or has its principal place of business in, a Country of Concern; (ii) a foreign entity that is 50% or more owned, directly or indirectly, individually or in the aggregate, by one or more persons described in subsections (i), (iii), (iv) or (v) hereof; (iii) a foreign individual who is an employee or contractor of a Country of Concern or of an entity described in subsections (i), (ii) or (v) hereof; (iv) a foreign individual who is primarily a resident in the territorial jurisdiction of a Country of Concern; or (v) any person, wherever located, determined by the U.S. Attorney General to be a Covered Person (each, (i)-(v), a “Covered Person,” as that term is used in 28 CFR Part 202).
I or my organization (as applicable) shall promptly notify (mghproact@mgb.org) the Neurological Clinical Research Institute if I or my organization (as applicable) know(s) or suspect(s) that a “Country of Concern” or “Covered Person” has gained access to any data from the PRO-ACT Database.
- I hereby represent and warrant that I or my organization (as applicable) are not a Covered Person. I shall immediately notify the Neurological Clinical Research Institute if I or my organization (as applicable) or any of your or your organization’s (as applicable) employees, agents, or other parties who receive access to the data from the PRO-ACT Database (i) is located in, organized or chartered under the laws of, has its principal place of business in, is ordinarily a resident in, or is 50% or more owned or controlled, directly or indirectly, by entities or persons located in, organized or chartered under the laws of, or having their principal place of business in, a “Country of Concern,” as such term is defined below, or (ii) is or otherwise becomes a Covered Person, including without limitation through designation as such by the U.S. Attorney General pursuant to the process set forth in 28 CFR Part 202. Upon receipt of such notification, the Neurological Clinical Research Institute may immediately terminate your or your organization’s (as applicable) access to the data from the PRO-ACT Database determines, in its sole discretion, that your or your organization’s (as applicable) continued access to and use of the data from the PRO-ACT Database would violate applicable law, including without limitation the U.S. Department of Justice Final Rule entitled “Preventing Access to U.S. Sensitive Personal Data and Government- Related Data by Countries of Concern or Covered Persons,” as codified at 28 CFR Part 202, and any sub-regulatory guidance issued thereunder (the “DOJ Final Rule”). Neurological Clinical Research Institute shall further have the right to modify the volume of data contained in the data from the PRO-ACT Database if the Neurological Clinical Research Institute determines, in its sole discretion, that provision of the data will violate the DOJ Final Rule or other applicable law.
For purposes of these Terms and Conditions, the terms “Country of Concern” or “Countries of Concern” shall mean the People’s Republic of China (including Hong Kong and Macau), Cuba, Iran, North Korea, Russia, and Venezuela, including in each case any political subdivision, agency, or instrumentality thereof, and any other country designated as a “Country of Concern” pursuant to the process set forth in 28 CFR Part 202.
If I publish an abstract using data from the PRO-ACT Database, I agree to the following:
- I will cite the PRO-ACT Database as the source of the data. Please see Citation/Attribution Guidelines.
- The PRO-ACT Consortium will not be cited in the authorship line of the abstract unless first agreed to in writing by a representative of the PRO-ACT Consortium.
If I publish a manuscript using data from the PRO-ACT Database, I agree to the following:
- On the author line of the manuscript, after the named authors, I will include the phrase "the Pooled Resource Open-Access ALS Clinical Trials Consortium*" with the asterisk referring to the following statement and list of names:
*Data used in the preparation of this article were obtained from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Database. As such, the following organizations and individuals within the PRO-ACT Consortium contributed to the design and implementation of the PRO-ACT Database and/or provided data, but did not participate in the analysis of the data or the writing of this report:
- Amylyx Pharmaceuticals, Inc.
- ALS Therapy Alliance
- Cytokinetics, Inc.
- Knopp Biosciences
- Neuraltus Pharmaceuticals, Inc.
- Neurological Clinical Research Institute at Massachusetts General Hospital
- Northeast ALS Consortium
- Novartis
- Orion Corporation
- Prize4Life Israel
- Regeneron Pharmaceuticals, Inc.
- Sanofi
- Teva Pharmaceutical Industries, Ltd.
- The ALS Association
- The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital
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I will include language similar to the following in the methods section of my manuscripts to accurately acknowledge data collection by the PRO-ACT Consortium. Depending upon the length and focus of the article, it may be appropriate to include more or less than the example below; however, inclusion of some variation of the language shown below is mandatory.
"Data used in the preparation of this article were obtained from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Database. The data available in the PRO-ACT Database have been volunteered by PRO-ACT Consortium members."
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I will submit all manuscripts to the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (mghproact@mgb.org) prior to submitting them to a journal. NCRI will review the author list and materials and methods to ensure compliance with articles 10 and 11 of these terms and conditions. NCRI will maintain confidentiality of the manuscript and will complete its review within 3 business days of receipt.
- NO CONSORTIUM MEMBER MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE WITH RESPECT TO THE PRO-ACT DATABASE OR THE DATA CONTAINED THEREIN.
- NO CONSORTIUM MEMBER, NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES SHALL HAVE ANY LIABILITY TO YOU OR YOUR ORGANIZATION AS A RESULT OF YOUR USE OF THE PRO-ACT DATABASE OR ANY OF THE DATA CONTAINED THEREIN (WHETHER AS A RESULT OF DIRECT, INDIRECT, INCIDENTIAL, SPECIAL, EXEMPLARY, PUNITIVE, CONSEQUENTIAL OR OTHER DAMAGES) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF A CONSORTIUM MEMBER HAS BEEN ADVISED OF THE POSSIBLITY OF SUCH DAMAGE.
- BY ACCESSING THE PRO-ACT DATABASE YOU AGREE TO INDEMNIFY, DEFEND AND HOLD HARMLESS EACH CONSORTIUM MEMBER AND EACH OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS AND AFFILIATES (EACH AN “INDEMNIFIED PARTY” AND COLLECTIVELY, THE “INDEMNIFIED PARTIES”), FROM AND AGAINST ANY AND ALL LIABILITIES, LOSSES, DAMAGES, COSTS AND EXPENSES (AND ALL LEGAL COSTS INCLUDING REASONABLE ATTORNEYS’ FEES, COURT COSTS, EXPENSES AND SETTLEMENTS RESULTING FROM ANY ACTION OR CLAIM) INCURRED BY, OR ASSERTED AGAINST ANY INDEMNIFIED PARTY ARISING FROM OR RELATING TO ANY CLAIM OR ACTION BROUGHT BY A THIRD PARTY THAT ARISES FROM OR RESULTS FROM YOUR USE OF THE PRO-ACT DATABASE AND/OR YOUR POSSESSION AND USE OF ANY DATA YOU OBTAINED FROM THE PRO-ACT DATABASE, WHETHER BY DOWNLOAD OR OTHERWISE. IF ANY SUCH CLAIM OR PROCEEDING ARISES, THE APPLICABLE INDEMNIFIED PARTY SHALL GIVE WRITTEN NOTICE OF THE CLAIM TO YOU PROMPTLY AFTER THE INDEMNIFIED PARTY RECEIVES NOTICE OF ITS EXISTENCE. YOU SHALL HAVE THE RIGHT, AT YOUR EXPENSE, TO EMPLOY COUNSEL TO DEFEND AGAINST THE CLAIM, AND TO COMPROMISE, SETTLE OR OTHERWISE DISPOSE OF THE CLAIM, ALL AT YOUR EXPENSE, PROVIDED THAT NO COMPROMISE OR SETTLEMENT OF ANY CLAIM ADMITTING LIABILITY OF OR IMPOSING DUTIES OR PERFORMANCE UPON ANY INDEMNIFIED PARTY MAY BE EFFECTED WITHOUT THE PRIOR WRITTEN CONSENT OF SUCH INDEMNIFIED PARTY. IF YOU DO NOT INITIATE EFFORTS TO DEFEND AGAINST OR RESIST THE CLAIM WITHIN THIRTY (30) DAYS AFTER RECEIVING NOTICE FROM ANY INDEMNIFIED PARTY, THE INDEMNIFIED PARTY SHALL BE FREE TO INVESTIGATE, DEFEND, COMPROMISE, SETTLE OR OTHERWISE DISPOSE OF THE CLAIM AND INCUR OTHER COSTS IN CONNECTION THEREWITH, FOR THE ACCOUNT AND AT THE EXPENSE OF YOU IN SUCH MANNER AS THE INDEMNIFIED PARTY DEEMS IN ITS BEST INTEREST.
- The Neurological Clinical Research Institute may change these Terms and Conditions at any time. We will provide reasonable notice, by posting a revised version of these Terms and Conditions on our website located at www.alsdata.org. By continuing to access and use data from the PRO-ACT Database, you agree to the new Terms and Conditions.
IMPORTANT NOTE: The
PRO-ACT Consortium will update and add additional data as it becomes available. I understand that any data that I downloaded in the past may not reflect the most current data in the database.
Finally, in the event that I download data from the
PRO-ACT Database for the purposes of analysis and future publication in the form of abstracts and/or publications, I will note the date of data download, and I will check the
PRO-ACT Database to determine if updated data have been provided prior to submission of any material for publication.
I understand that failure to abide by these terms and conditions may result in termination of my access to the
PRO-ACT Database and constitute breach of contract and that I will be required to destroy any data previously downloaded and if requested by The Neurological Clinical Research Institute to provide reasonably satisfactory evidence of the same.
