Hmmmmmm......
We want to be indemnified for everything -- but never thought of "use of
study results" as something to be named separately!.  Who advised that
language?   Suggest you check with your attorney for broad language (using
terms of art appropriate to your jurisdiction) that covers
everything,  including but not specifically stating "use of study
results".  Obviously their attorney is trying to limit the indemnification
they give -- so just restate it!

Of course, since the matter has been raised they will probably want to say
"everything except use of study results."  Good Luck!!

Chuck

At 09:08 AM 8/14/2002 -0400, you wrote:
>Good Morning All,
>
>We are currently negotiating a clinical trial agreement  and seem to have
>hit an impasse. It is our standard requirement that companies indemnify our
>organization for "Use of Study Results".  Specifically the company shall
>defend, indemnify and hold harmless our Institution, Principal Investigator
>etc. from any and all liabilities, claims etc. resulting from The Company's
>use of the study results.  (we do include the standard provisions that the
>study is in accordance to protocol, there is no negligence on our part,
>etc.)
>
>The Company has asked us what our concern is, and we gave the example we
>study 200 women who take this drug.  There are no adverse effects.  The
>drug goes to market, or the Company uses the results in a publication
>stating our results.   Then when the population takes the drug something
>awful happens and those who have taken the drug, not only sue the company
>but those involved in the clinical trial.
>
>In the instance of the agreement we are negotiating the Company has
>indicated they no longer will indemnify for "use of results".  (We have
>past agreements where they do.)   They tell me other universities and
>medical centers have agreed to forgo "use of results".  They feel that the
>phrase is too broad and if we can write language that will cover just the
>above example they would consider it.
>
>My questions:
>
>1)   Do others feel "use of results" is as important as we have in the
>past. Have there been agreements in clinical trials in which use of results
>are not required?  (In our case it can be a deal breaker)
>2)  Are there other examples of potential problems which I am overlooking
>if we do not obtain such indemnification?
>
>Thanks in advance.
>
>****************************
>Jessica Moraski, CRA
>Grant Administrator
>Health Research, Inc.
>One University Place
>Rensselaer, NY  12144
>(518) 431-1265
>(518) 431-1234 (FAX)
>xxxxxx@health.state.ny.us
>
>
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Herbert B. Chermside, CRA
Director, Sponsored Programs Administration
Virginia Commonwealth University
PO BOX 980568
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