writing, with the understanding that failure to do so does not
constitute a designation of non-confidentiality, particularly when the
confidential nature is apparent from context and subject matter.
INVESTIGATOR and INSTITUTION further acknowledge that, except for the original
recruited subject records which belong to the recruited subjects involved in the
STUDY pursuant to APPLICABLE LAW, such CONFIDENTIAL INFORMATION is solely the
property of SPONSOR and that the continued success of SPONSOR depends in large
part on keeping this CONFIDENTIAL INFORMATION from becoming known by
competitors.
INSTITUTION and INVESTIGATOR agree:
(a)
not to use such CONFIDENTIAL INFORMATION except for the purpose of
conducting the STUDY; and
(b)
not to disclose or transfer CONFIDENTIAL INFORMATION to others, except to
those employees or agents who reasonably require same for the purpose hereof and
who are bound by like written obligations to protect SPONSOR'S CONFIDENTIAL
INFORMATION or information required by law or regulations to be disclosed to the
IRB/IEC, the recruited subjects, or the FDA without the express written
permission of SPONSOR, except:
(i)
that which the recipient can demonstrate by written records was previously
known to recipient;
(ii)
that which is now, or becomes in the future, publicly available other than
by breach of this AGREEMENT by the recipient; or
(iii)
that which is lawfully disclosed to the recipient on a non-confidential
basis by a third party who is not obligated to SPONSOR or any other party to
retain CONFIDENTIAL INFORMATION in confidence.
The furnishing of CONFIDENTIAL INFORMATION under this AGREEMENT shall not
constitute any grant, option or license to INSTITUTION or INVESTIGATOR under any
patent or other rights now or hereafter held by SPONSOR. Neither INSTITUTION nor
INVESTIGATOR shall acquire any rights of any land whatsoever with respect to the
PRODUCT as a result of this AGREEMENT or otherwise.
AH original recruited subject records are the sole and exclusive property of the
respective subjects, to be retained by INSTITUTION as required by Section 9 of
this AGREEMENT and all other APPLICABLE LAW. All data, information and results
generated by performance of this AGREEMENT shall be and are the exclusive
property of SPONSOR, and shall be delivered to SPONSOR and/or SPONSOR designee
in a timely fashion, and in no event later than ten (10) days after: any date
required by the PROTOCOL, receipt of SPONSOR'S or SPONSOR designee's written
request for the data, termination of the STUDY, and/or termination of this
AGREEMENT.
Upon request of SPONSOR or SPONSOR designee, at the completion or earlier
termination of the PROTOCOL, all CONFIDENTIAL INFORMATION and any copies thereof
shall be returned to SPONSOR, except that one record copy may be retained in
INSTITUTION's/INVESTIGATOR's legal files solely for purposes of determining
future compliance with the terms of this AGREEMENT.
-9-
In the event INSTITUTION or INVESTIGATOR is ordered to provide CONFIDENTIAL
INFORMATION by a lawful judicial or government order, INSTITUTION shall promptly
inform SPONSOR designee and SPONSOR and shall permit SPONSOR to oppose such
order of disclosure and shall assist in such defense to the extent