BESA ITEMS MAY HAVE CAUSED OR
CONTRIBUTED TO THE DEATH OR SERIOUS INJURY.
ACCORDINGLY, A PARTY REPORTING SUCH
INFORMATION TO SUCH A REGULATORY AGENCY SHALL INFORM THE OTHER PARTY OF ANY SUCH
INFORMATION PROMPTLY AFTER BECOMING AWARE OF IT SO THAT THE OTHER PARTY CAN
COMPLY WITH ITS OWN REPORTING REQUIREMENTS.
5.8
INFORMATION.
(A)
BESA SHALL PROMPTLY PROVIDE TO XTENT OR DIRECTLY
TO THE REGULATORY AGENCY FOR CROSS-REFERENCE BY XTENT, ALL WRITTEN AND OTHER
INFORMATION IN BESA'S CONTROL (EXCLUDING CONFIDENTIAL INFORMATION OF THIRD
PARTIES) THAT IS NECESSARY FOR XTENT TO APPLY FOR, OBTAIN AND THEREAFTER
MAINTAIN APPROVALS (AS DEFINED IN SECTION 5.5) FOR THE COATED STENTS IN EUROPE,
JAPAN AND THE UNITED STATES, INCLUDING, WITHOUT LIMITATION, INFORMATION RELATING
TO THE FACILITIES AT WHICH THE BESA ITEMS ARE MANUFACTURED, PROCESSED OR
PACKAGED, AND INFORMATION ABOUT PROCESS, METHODOLOGY OR COMPONENTS USED IN THE
MANUFACTURE, PROCESSING, OR PACKAGING OF BESA ITEMS. IF AT BESA'S ELECTION, THE
INFORMATION IS PROVIDED DIRECTLY FROM BESA OR ITS AFFILIATES TO THE RESPECTIVE
REGULATORY AGENCIES, THEN SUCH INFORMATION SHALL BE PROVIDED IN THE FORMAT
REQUIRED OR REQUESTED BY EACH AGENCY, WHICH MAY INCLUDE ONE OR MULTIPLE OF THE
FOLLOWING FORMATS:
20
(I)
A DMF (BIOLIMUS A9 INFORMATION/PRE-CLINICAL AND
CLINICAL PHARM-TOX TESTING).
THE DMF WILL BE REFERRED TO AN EDMF IN CTD
FORMAT.
THE OPEN PART OF THE EDMF WILL BE PROVIDED DIRECTLY TO XTENT FOR USE IN
REGULATORY APPLICATIONS.
(II)
AN IND (BIOLIMUS A9 INFORMATION/PRE-CLINICAL AND
CLINICAL PHARM-TOX TESTING).
THIS DMF WILL BE REFERRED TO AS AN EDMF IN CTD
FORMAT.
(III)
A DMF OR MAF (BIOLIMUS A9 AND PLA FORMULATION
SPECIFIC TO XTENT).
(B)
FOR ITEMS (I) THROUGH (III) ABOVE, BESA WILL ALSO
PROVIDE DIRECTLY TO XTENT A "RIGHT TO REFERENCE" LETTER FOR INCLUSION IN THE
XTENT REGULATORY APPLICATIONS.
(C)
THE TIMELINE FOR SUBMITTAL BY BESA OR ITS
AFFILIATES OF REQUIRED FILES IN CONNECTION WITH XTENT'S REGULATORY APPLICATIONS
MUST BE AGREED UPON NO LESS THAN SIXTY (60) DAYS IN ADVANCE OF XTENT'S DESIRED
SUBMISSION DATE.
IF DEFICIENCIES IN THE FILINGS ARE IDENTIFIED BY THE RELEVANT
REGULATORY AGENCY, BESA OR ITS AFFILIATES WILL (I) PROVIDE AN ACTION PLAN TO
XTENT WITHIN THIRTY (30) DAYS OF RECEIVING WRITTEN NOTICE OF THE DEFICIENCY
OUTLINING HOW AND WHEN IT WILL RESPOND; AND (II) RESPOND TO THE REGULATORY
AGENCY AS SOON AS REASONABLY PRACTICABLE, BUT IN ANY EVENT PRIOR TO ANY
APPLICABLE DEADLINE SET BY THE RELEVANT AGENCY OR PRESCRIBED BY RULE OR STATUTE
UNLESS BESA NOTIFIES XTENT THAT IT CANNOT REASONABLY COMPLY WITH SUCH DEADLINE.
(D)
WITHOUT LIMITING THE PROVISIONS OF THIS
SECTION 5.8, BESA AND XTENT AGREE TO MEET AT LEAST ONCE PER QUARTER AT WHICH
TIME BESA SHALL INFORM XTENT WHEN ANY INFORMATION PROVIDED HEREUNDER IS NO
LONGER CURRENT OR NO LONGER REFLECTIVE OF CURRENT PRACTICES RELATED TO
PROCESSING, MANUFACTURING, PACKAGING AND PERFORMING THE BESA ITEMS, AND SHALL
PROVIDE UPDATED INFORMATION TO XTENT.
(E)
FOR AVOIDANCE OF DOUBT, TO THE EXTENT SUCH THE
INFORMATION PROVIDED TO XTENT UNDER THIS SECTION 5.8 IS CONFIDENTIAL INFORMATION
OF BESA, ITS AFFILIATES