Terms and Conditions

Data Use Agreement for accessing the Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database - Terms and Conditions

The Requesting Institution (as defined and designated on page 3) requests access to the placebo data collected by the Critical Path Institute (C-Path) Multiple Sclerosis Outcome Assessments Consortium (MSOAC) for the purpose of scientific investigation, teaching, or the planning of clinical research studies and agrees to the following terms and conditions:

1. All data made available are intended to be de-identified before inclusion in the database.  Requestor will not attempt to establish the identity of, or make contact with, any of the subjects.
2. Requesting Institution will not disclose these data beyond the use(s) specifically outlined in this application.
3. Requesting Institution will require anyone with whom Requesting Institution shares these data (for the use specifically outlined in this application) to comply with the terms and conditions of this data use agreement.
4. Requesting Institution will accurately provide any information requested regarding persons who will use these data and the analyses that are planned using these data.
5. Requesting Institution will comply with any rules and regulations imposed by its institutional review board in requesting and using these data.
6. Requesting Institution will not sell any of the MSOAC placebo data.
7. Requesting Institution agrees that a brief non-confidential summary of their research plan may be provided on the C-Path website for other potential requesters to review.  A contact point for the Requesting Institution will also be included.  The purpose of this activity is to help eliminate duplication in research by providing a history of what research is already underway or completed.   

If Requesting Institution publishes abstracts using MSOAC Placebo data from Critical Path Institute, Requesting Institution agrees to the following:

8. Requesting Institution will cite the MSOAC as the source of the data.
9. Group authorship will not be cited in the authorship line of the abstract.

If Requesting Institution publishes manuscripts using MSOAC Placebo data from Critical Path Institute, Requesting Institution agrees to the following:

10. On the author line of the manuscript, after the named authors, Requesting Institution will include the phrase "for MSOAC*" with the asterisk referring to the following statement:

“*Data used in the preparation of this article were obtained from the Multiple Sclerosis Outcome Assessments Consortium (MSOAC).  As such, the investigators within MSOAC contributed to the design and implementation of the MSOAC Placebo database and/or provided placebo data, but did not participate in the analysis of the data or the writing of this report.”

11. Requesting Institution will submit all manuscripts to MSOAC prior to submitting them to a journal. This MSOAC review will not be a scientific review but is intended to ensure that the Requesting Institution has complied with these Terms and Conditions. The MSOAC will maintain confidentiality of the manuscript and will complete its review within two weeks of receipt.
12. Requesting Institution will ensure that Investigators who utilize MSOAC placebo data use appropriate administrative, physical, and technical safeguards to prevent the use or disclosure of the data other than as provided for by this Agreement.
13. Requesting Institution will report any use or disclosure of the data not provided for by this Agreement of which Requesting Institution becomes aware as soon as possible but no later than within 5 days of becoming aware of such use or disclosure.
14. MSOAC PLACEBO DATA ARE PROVIDED “AS IS.”  Neither C-Path nor any MSOAC member makes any representation or warranty, express, implied, statutory or otherwise, with respect to the MSOAC placebo database or the data contained therein.
15. Requesting Institution understands that neither C-Path, nor any MSOAC member, nor any of their respective directors, officers, employees, agents or affiliates, shall have any liability to Requesting Institution (or to anyone using the data on Requesting Institution’s behalf or at Requesting Institution’s direction) as a result of the use of the MSOAC placebo database or any of the data contained therein (whether as a result of direct, indirect, incidental, special, exemplary, punitive, consequential or other damages) however caused and on any theory of liability. This limitation will apply even if a MSOAC member has been advised of the possibility of such damage.
16.  By accessing the MSOAC placebo database, the Requesting Institution agrees to indemnify, defend and hold harmless C-Path, each MSOAC 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 Requesting Institution’s use of the MSOAC placebo database and/or Requesting Institution’s possession and use of any data Requesting Institution obtained from the MSOAC placebo database, whether by download or otherwise. Indemnification does not apply if the requester is a US Government employee, acting on behalf of the US Government. If any such claim or proceeding arises, Requesting Institution is entitled to prompt notice of the claim from the indemnified party.  Requesting Institution then shall have the right, at its own expense, to employ counsel to defend against the claim, and to compromise, settle or otherwise dispose of the claim, all at its own 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. Requesting Institution understands that if Requesting Institution does not initiate efforts to defend against or resist the claim within thirty (30) days after receiving notice from any indemnified party in the manner set forth below (including required copying of notice to counsel) , or the time, periods permitted by applicable law and court rules, whichever is later, the indemnified party may, at its option,  investigate, defend, compromise, settle or otherwise dispose of the claim and incur other costs in connection therewith, for the account and  at Requesting Institution’s expense,  in such manner as the indemnified party reasonably deems in its best interest and consistent with the purposes of this paragraph. Any notices, consents or other communications required or permitted under this Agreement must be in writing and shall be deemed to have been duly given as of the date it is (i)  delivered by hand; (ii) sent by registered or certified mail, postage prepaid, return receipt requested; or (iii) delivered by overnight courier, to the other party at the address as set forth below, or to such other address or addresses as may be designated in writing by notice given to the other party pursuant to this paragraph:

IMPORTANT NOTE: It is the intent of Critical Path Institute to add additional MSOAC placebo data if it becomes available. However, this process may continue for an extended timeframe as additional clinical trial data become available. Therefore, Requesting Institution understands that any data that Requesting Institution downloads might be preliminary and that results may change as new data are added.

Finally, in the event that Requesting Institution downloads data from the MSOAC placebo database for the purposes of analysis and future publication in the form of abstracts and/or publications, Requesting Institution will note the date of the data Requesting Institutiondownload, and Requesting Institution will check the database to determine if updated data have been provided prior to submission of any material for publication.

‘Requesting Institution’ means the individual accessing and using the database and any institution on whose behalf the individual is engaging in such access or use.  The individual represents that s/he has the authority to bind his or her institution to these Terms and Conditions.  Requesting Institution understands that failure to abide by these guidelines will result in termination of their access to the MSOAC placebo database as well as any other remedies that may be available to C-Path or MSOAC members pursuant to these Terms and Conditions or applicable law.

Requesting Institution: ______________________________

I signify, that as the representative of the Institution named above, have the authority to bind said Institution to these Terms and Conditions.

Authorized Signature:_______________________________                                        

Print Name: _______________________________________          

Title: _____________________________________________

Date: _____________________________________________