SUPPORT AN INVESTIGATIONAL NEW DRUG APPLICATION,
INVESTIGATIONAL DEVICE EXEMPTION, PREMARKET APPLICATION, OR EQUIVALENT
REGULATORY FILING IN THE UNITED STATES, JAPAN AND EUROPE AND TO ADDRESS ANY
DEFICIENCIES OR QUESTIONS IN SUCH FILINGS IDENTIFIED BY THE RELEVANT AGENCIES AS
REQUIRED FOR REGULATORY APPROVAL TO MARKET XTENT STENTS (COLLECTIVELY BESA'S
TESTING OBLIGATIONS"). ANY SUCH ASSISTANCE, IF RENDERED BY BESA OR ITS
AFFILIATES, SHALL BE CHARGED TO XTENT AT THE DIRECT COSTS OF BESA AND ITS
AFFILIATES PLUS [****] ([****]%). IN ADDITION, SUCH ASSISTANCE SHALL REQUIRE
ADVANCE DISCUSSIONS AND WRITTEN AGREEMENT BETWEEN BESA AND XTENT ON THE
PROTOCOLS AND TESTING TIMEFRAMES NEEDED BY XTENT.
(A)
BESA SHALL KEEP XTENT GENERALLY INFORMED OF THE
PROGRESS OF ANY REGULATORY ACTIONS RELATED TO THE BESA ITEMS AND SHALL PROVIDE
UPDATES AT LEAST ONCE PER CALENDAR QUARTER, AND MORE OFTEN IF NECESSARY.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [****],
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
18
(B)
IF ANY SUCH TESTING REQUIRED TO BE DONE BY BESA IS
DONE BY A THIRD PARTY ON BESA'S BEHALF OR UNDER LICENSE FROM BESA OR ONE OF ITS
AFFILIATES, THEN WITH RESPECT TO ANY TESTING OR CLINICAL DATA DEVELOPED OR
GATHERED IN SUCH TESTING AND RELEVANT TO OBTAINING APPROVALS OF XTENT'S STENT OR
THE XTENT STENT SYSTEM, BESA SHALL UTILIZE REASONABLE EFFORTS TO OBTAIN ACCESS
TO THE DATA WHICH MAY BE NECESSARY FOR XTENT PURSUANT TO SECTION 5.8.
TO THE
EXTENT SUCH INFORMATION IS SUBJECT TO CONFIDENTIALITY OBLIGATIONS TO A THIRD
PARTY AND TO THE EXTENT BESA OBTAINS PERMISSION FROM SUCH THIRD PARTY TO GIVE
ACCESS TO SUCH INFORMATION, BESA SHALL PROVIDE THE DATA ONLY TO THE APPLICABLE
REGULATORY BODIES WITHOUT DISCLOSURE TO XTENT OF SUCH THIRD PARTY CONFIDENTIAL
DATA.
(C)
IF BESA CONSIDERS THE RESULTS OF BESA'S TESTING
OBLIGATIONS CONFIDENTIAL, BESA SHALL HAVE THE RIGHT TO PROVIDE THE DATA DIRECTLY
TO THE APPLICABLE REGULATORY AUTHORITY WITHOUT DISCLOSURE TO XTENT.
(D)
NEITHER BESA NOR ANY OF ITS AFFILIATES SHALL HAVE
ANY OBLIGATION TO PROVIDE TO XTENT THE RESULTS OF ANY FUTURE WORK PERFORMED BY
ANY THIRD PARTY TESTING FACILITY AFTER THE EFFECTIVE DATE OF THIS RESTATED
AGREEMENT, EXCEPT TO THE EXTENT SUCH RESULTS ARE PART OF BESA'S TESTING
OBLIGATIONS (THE RESULTS OF WHICH MAY BE SUBMITTED DIRECTLY TO REGULATORY
AGENCIES).
5.3
IF A STENT USING BESA'S DRUG/POLYMER COMPOSITE
FORMULATION, BIOLIMUS A9 OR BESA'S POLYMER COATING HAS NOT BEEN APPROVED BY THE
MHLW, THE FDA OR A NOTIFIED BODY FOR CE MARK APPROVAL BY FEBRUARY 1, 2008 , OR
IF AT ANY TIME BESA ABANDONS DEVELOPMENT, TESTING OR COMMERCIALIZATION OF
BIOLIMUS A9 OR THE DRUG/POLYMER COMPOSITE FORMULATION, THEN, AT XTENT'S OPTION,
(I) XTENT MAY TERMINATE THIS RESTATED AGREEMENT WITH THIRTY (30) DAYS WRITTEN
NOTICE TO BESA; (II) AT XTENT'S OPTION, NOTWITHSTANDING SECTION 2.3(B), XTENT
SHALL HAVE THE RIGHT TO USE RAPAMYCIN OR OTHER ANALOGS THEREOF ON XTENT'S STENTS
FOR PURPOSES OF IN VITRO OR IN VIVO PRECLINICAL STUDIES;