ONE EMPLOYEE OF CYBERHEART TO ACT AS CYBERHEART'S LIAISON WITH RESPECT
TO THE DEVELOPMENT SERVICES ("CYBERHEART LIAISON").
THE CYBERHEART LIAISON
SHALL BE SUFFICIENTLY SENIOR AND EXPERIENCED TO UNDERTAKE AND PARTICIPATE IN THE
DEVELOPMENT SERVICES.
ACCURAY SHALL USE REASONABLE COMMERCIAL EFFORTS TO ENSURE
THAT EACH PROJECT MANAGER SHALL BE STAFFED UNDER EACH STATEMENT OF WORK TO WORK
CLOSELY WITH THE CYBERHEART LIAISON DURING THE PERIOD THAT DEVELOPMENT SERVICES
ARE PERFORMED.
ANY AND ALL COMMUNICATION FROM AND TO CYBERHEART WITH RESPECT TO
DEVELOPMENT SERVICES UNDER EACH STATEMENT OF WORK SHALL BE CHANNELED THROUGH THE
RELEVANT CYBERHEART LIAISON.
4.3
REPORTS AND ACCESS.
UNLESS OTHERWISE INDICATED ON THE APPLICABLE
STATEMENT OF WORK OR AGREED BY CYBERHEART, APPROXIMATELY ONCE EACH WEEK, THE
PROJECT MANAGER SHALL ARRANGE A MEETING WITH THE CYBERHEART LIAISON, EITHER IN
PERSON OR BY TELEPHONE, FOR A FORMAL PROGRESS PRESENTATION, DESCRIBING IN DETAIL
THE STATUS OF THE DEVELOPMENT SERVICES, INCLUDING WITHOUT LIMITATION RESULTS
ACHIEVED, PROJECTIONS FOR TIME OF COMPLETION, ISSUES AND DIFFICULTIES THAT HAVE
ARISEN OR ARE ANTICIPATED, STEPS NECESSARY TO RETURN TO THE SCHEDULE IN CASE OF
ANY DELAY, AND DISCUSSION OF POSSIBLE RESOLUTION OF ANY PROBLEMS THAT HAVE
ARISEN.
ADDITIONALLY, ACCURAY SHALL PROVIDE CYBERHEART WITH WRITTEN REPORTS
REGARDING THE PROGRESS OF THE DEVELOPMENT SERVICES AS REASONABLY REQUESTED BY
CYBERHEART.
WITHOUT LIMITING THE FOREGOING, ACCURAY SHALL NOTIFY CYBERHEART AS
SOON AS POSSIBLE OF ANY ISSUES THAT ARISE THAT MAY RESULT IN DELAY OR INABILITY
TO MEET GOALS. ADDITIONALLY, ACCURAY AGREES THAT IT SHALL MAKE ITS TECHNICAL
PERSONNEL AND CONSULTANTS REASONABLY AVAILABLE TO THE EMPLOYEES AND CONSULTANTS
OF CYBERHEART TO DISCUSS THE DEVELOPMENT SERVICES WORK, AND THE RESULTS OF SUCH
WORK, IN DETAIL AND TO PROVIDE REASONABLE INFORMATION AND FEEDBACK WITH RESPECT
TO OTHER DEVELOPMENT ACTIVITIES FOR CYBERHEART PRODUCTS, AS REASONABLY REQUESTED
BY CYBERHEART FROM TIME TO TIME.
5.
CLINICAL TRIALS AND REGULATORY MATTERS.
5.1
ACCURAY PRE-CLINICAL STUDIES AND CLINICAL TRIALS.
AS BETWEEN THE
PARTIES, ACCURAY SHALL BE SOLELY RESPONSIBLE, AT ITS EXPENSE, FOR ANY AND ALL
PRE-CLINICAL STUDIES AND CLINICAL TRIALS, AND HAVE THE EXCLUSIVE RIGHT TO
COMMUNICATE WITH REGULATORY AGENCIES AND SEEK
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AND OBTAIN REGULATORY APPROVALS, WITH RESPECT TO CYBERKNIFE SYSTEMS IN THE
ACCURAY FIELD IN ANY AND ALL JURISDICTIONS.
ACCURAY AGREES THAT IT SHALL KEEP
CYBERHEART REASONABLY INFORMED REGARDING ITS PRE-CLINICAL STUDIES AND CLINICAL
TRIALS OF SUCH CYBERKNIFE SYSTEMS, AND COOPERATE REASONABLY WITH CYBERHEART IN
ORDER TO COORDINATE ITS STUDIES AND TRIALS REASONABLY WITH THAT OF CYBERHEART.
ACCURAY ALSO SHALL DESIGN AND CONDUCT PRE-CLINICAL STUDIES AND CLINICAL TRIALS
FOR CYBERKNIFE SYSTEMS REASONABLY CONSIDERING FEEDBACK AND INFORMATION PROVIDED
BY CYBERHEART.
5.2
CYBERHEART PRE-CLINICAL STUDIES AND CLINICAL TRIALS.
5.2.1
CYBERHEART SHALL ESTABLISH A COMMITTEE, CONSISTING EITHER OF THREE
(3) OR OF FIVE (5) ADVISORS, WHICH SHALL REVIEW CYBERHEART'S CLINICAL TRIAL
PROTOCOLS AND CYBERHEART'S PRE-CLINICAL TEST RESULTS RELATING TO CYBERHEART
PRODUCTS, PRIOR TO CYBERHEART COMMENCING CLINICAL TRIALS FOR CYBERHEART PRODUCTS
(THE "CLINICAL ADVISORY COMMITTEE").
THE ROLE OF THE CLINICAL ADVISORY
COMMITTEE SHALL BE TO CONFIRM TO CYBERHEART THAT IT IS NOT UNREASONABLE FOR
CYBERHEART TO MOVE FORWARD WITH CLINICAL TRIALS