PROVIDED, HOWEVER, THAT
IF AN APPROVAL OF A STENT UTILIZING BESA'S DRUG/POLYMER COMPOSITE FORMULATION,
BIOLIMUS A9 AND/OR BESA'S POLYMER COATING IS GRANTED BY THE MHLW, FDA, OR A
NOTIFIED BODY FOR CE MARK WITHIN TWELVE (12) MONTHS FROM THE EFFECTIVE DATE OF
THIS RESTATED AGREEMENT, THE FOREGOING RIGHT SHALL TERMINATE AND
SECTION 2.3(B) SHALL REMAIN IN FORCE; OR (III) IF NO SUCH APPROVAL IS OBTAINED
WITHIN TWELVE (12) MONTHS FROM THE EFFECTIVE DATE OF THIS RESTATED AGREEMENT,
THEN THIS RESTATED AGREEMENT WILL CONTINUE PURSUANT TO THE LICENSES UNDER
SECTIONS 2.1(A) AND (B), BUT SECTION 2.3(B) SHALL TERMINATE.
5.4
PAYMENT FOR TESTING, TRIALS AND SUBMISSIONS.
XTENT SHALL
BE SOLELY RESPONSIBLE FOR ALL COSTS AND EXPENSES IN CONNECTION WITH THE CONDUCT
OF ALL NECESSARY STUDIES, TESTING AND TRIALS IN CONNECTION WITH THE COATED
STENTS AND THE PREPARATION AND FILING OF SUBMISSIONS TO THE NECESSARY REGULATORY
BODIES. XTENT WILL HAVE THE SOLE RIGHT TO APPLY FOR REGULATORY APPROVALS FOR
XTENT'S STENTS AND XTENT STENT SYSTEMS IN ALL JURISDICTIONS.
19
5.5
REGULATORY AGENCIES AND INTERACTIONS.
THE PARTIES
UNDERSTAND AND AGREE THAT XTENT, ITSELF OR THROUGH ITS AGENTS, SHALL HAVE THE
SOLE RIGHT TO CORRESPOND WITH AND SUBMIT REGULATORY APPLICATIONS AND OTHER
FILINGS TO THE FDA, MHLW OR OTHER REGULATORY AGENCIES TO OBTAIN APPROVALS TO
IMPORT, EXPORT, SELL OR OTHERWISE COMMERCIALIZE THE COATED STENTS ALONE OR WITH
OTHER PRODUCTS OR SERVICES (COLLECTIVELY, "APPROVALS") AS XTENT DEEMS USEFUL OR
NECESSARY.
ACCORDINGLY, EXCEPT AS OTHERWISE REQUIRED BY LAW, BESA SHALL NOT
CORRESPOND DIRECTLY WITH THE FDA, MHLW OR ANY OTHER REGULATORY AGENCY RELATING
TO THE PROCESS OF OBTAINING APPROVALS OR ANY OBTAINED APPROVAL FOR THE COATED
STENTS, WITHOUT XTENT'S PRIOR PERMISSION, EXCEPT TO THE EXTENT IT IS SUBMITTING
THE DMF OR MAF TO THE APPLICABLE REGULATORY AUTHORITY.
5.6
IF BESA DESIRES TO MAKE ANY SIGNIFICANT CHANGE IN ITS
MATERIALS, SUPPLIERS, MANUFACTURING METHODS, LOCATIONS OR EQUIPMENT,
SPECIFICATIONS, ACCEPTANCE TESTS OR CRITERIA, QUALITY SYSTEMS OR OTHER RELATED
AREAS AFFECTING BESA ITEMS, BESA SHALL PROVIDE XTENT WITH INFORMATION REGARDING
SUCH SIGNIFICANT CHANGE IN ADVANCE THEREOF AND AN OPPORTUNITY FOR XTENT TO
DISCUSS THE PROPOSED CHANGES WITH BESA. BESA SHALL ONLY MAKE SIGNIFICANT
CHANGE(S) AFTER (I) REGULATORY APPROVAL FOR SUCH CHANGE(S) HAS BEEN OBTAINED AS
IT RELATES TO XTENT'S STENTS OR (II) BESA CONFIRMS AFTER CONSULTATION WITH XTENT
THAT APPROVAL OF THE CHANGE(S) IS NOT REQUIRED.
FOR THE PURPOSES OF THIS
SECTION, "SIGNIFICANT CHANGE" MEANS ANY CHANGE OF WHICH XTENT NEEDS TO BE
INFORMED DUE TO APPLICABLE LEGAL OR GOVERNMENTAL REQUIREMENTS, ANY CHANGE
CLEARLY NOTICEABLE ON THE PACKAGING OF BESA ITEMS, OR ANY CHANGE THAT WOULD HAVE
A POTENTIAL EFFECT ON XTENT'S OPERATING PROCEDURES OR REGULATORY FILINGS.
5.7
REPORTING.
PURSUANT TO THE FDA'S, THE MHLW'S, OR ANY
OTHER APPLICABLE REGULATORY AGENCY'S REGULATIONS AND POLICIES, XTENT MAY BE
REQUIRED TO REPORT TO SUCH REGULATORY AGENCY INFORMATION THAT REASONABLY
SUGGESTS THAT THE COATED STENTS MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATH OR
SERIOUS INJURY, AND BESA MAY BE REQUIRED TO REPORT TO SUCH REGULATORY AGENCY
INFORMATION THAT REASONABLY SUGGESTS THAT THE