We also need indemnification for Sponsor's use of the results for
PI-initiated studies.  Usually it is not a big issue, but about a year ago
we dealt with a sponsor that had huge problems with it (though they hadn't
in prior PI-initiated agreements we had with them).

There were big delays on 2 PI-initiated projects we had with them and we
conferred with our central legal dept who advised us to hang tight as we
should expect to be covered for this.  Since the projects were
PI-initiated, sponsor was not so concerned about the delays.  After lengthy
delays in which Sponsor was so amazingly unresponsive that we finally had
to prepare a project timeline and get one of the PI's involved, there was
some more detailed communication.

We had asked Sponsor why they did not want to indemnify for their use of
the results and could they think of a sitution where it would not be fair
to them.  They stated that perhaps we would publish the results and sponsor
would reference the publication, exposing sponsor to liability.  However,
if we publish, sponsor is not using the results, we are--Sponsor is just
referencing our use.  Nonetheless, we stated we could also make an
exception for NU's publication of results that Sponsor references.   After
much last minute discussions, Sponsor finally agreed to include the
language (without the exception).

Perhaps it would be helpful to determine sponsor's concerns so they coud be
addressed?

Aylin

At 09:35 AM 8/14/02 -0400, you wrote:
>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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**********************************************************
Aylin A. Regulski  M.S., J.D.
Research Administrator/ Clinical Trials and Industry
Office of Research and Sponsored Programs
Northwestern University
Abbott Hall, Room 506
710 N. Lake Shore Drive
Chicago, IL  60611-3078
Phone: 312-503-7905
Fax: 312-503-2234
Click here to visit our webpage:  http://nuinfo.nwu.edu/orsp/

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 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
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