Clinical Investigation Agreement
Category: Uncategorized
CLINICAL INVESTIGATION AGREEMENT
THIS CLINICAL INVESTIGATION AGREEMENT (this “Agreement”) made and effective as
of this 13th day of February, 2007 (the “Effective Date”), is by and between
HeartWare Limited, Suite 4 Level 46, 2 Park Street, Sydney NSW 2000 ABN 34 111
970 257 (“Sponsor”); and St. Vincent’s Hospital Sydney Limited (“Hospital”)
having its address at 390 Victoria Street, Darlinghurst, NSW 2010, Australia ABN
77 054 038 872, on behalf of itself and Paul Janz, (“Investigator”), Hospital’s
employee.
WHEREAS, Sponsor desires Hospital and Investigator to conduct, and Hospital and
Investigator desire to conduct for Sponsor, a Clinical Study of Sponsor’s
implantable left ventricular assist System “LVAD” (the “Device”), according to
the protocol number HW002 (the “Protocol”), which is attached hereto as Exhibit
A (which, upon the reasonable request of any party hereto, may be amended from
time to time as set forth in section 10.5 of this Agreement);
WHEREAS, the Clinical Study detailed in the protocol is of mutual interest and
benefit to Sponsor, Hospital and Investigator.
NOW, THEREFORE, in consideration of the mutual promises and covenants contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties hereto mutually
covenant and agree as follows:
1. SCOPE OF WORK; TERM
1.1 Clinical Study
Hospital and Investigator agree to use best efforts and professional expertise
to perform the Clinical Study according to the Protocol as set forth in Exhibit
A.
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