Stick with your position. You have the right instincts on this one. If the
company is objecting to this indemnification if could very well be due to the
fact they are concerned there is real potential for exposure. You have no
control over the use to which the company will pur the results of the project.
They could very well interpret the data in ways you feel are incorrect or
inappropriate. They could use the data in ways you do not intend. In any event,
the bottom line is that if you don't have control over a situation, then those
that do bear responsibility should be the indemnifying party.

Steve

"Jessica K. Moraski" 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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--
Stephen Erickson, Director
Research Compliance and Intellectual Property Management
Boston College, McGuinn Hall 221
Chestnut Hill, MA 02467
Telephone: 617-552-3345
Fax to my computer:  413-895-8328

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 Instructions on how to use the RESADM-L Mailing List, including
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