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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