HELD
BY THEM; AND (IV) ANY THIRD PARTY PERFORMING SUCH TESTING SERVICES SHALL BE
REQUIRED TO EXECUTE A NON-DISCLOSURE AGREEMENT WITH XTENT CONTAINING TERMS NO
LESS PROTECTIVE THAN THE TERMS CONTAINED IN SECTION 10.1 HEREOF, THE FORM OF
WHICH HAS BEEN APPROVED BY BESA IN ADVANCE.
XTENT SHALL PROVIDE A COPY OF SUCH
AGREEMENT TO BESA PROMPTLY AFTER THE EXECUTION THEREOF.
UPON XTENT'S REQUEST
AFTER REASONABLE ADVANCE NOTICE TO BESA AND RECEIPT OF A COPY OF THE EXECUTED
NON-DISCLOSURE AGREEMENT REFERENCED IN SUBSECTION (IV) ABOVE, BESA SHALL PROVIDE
TO XTENT OR ITS DESIGNATED THIRD PARTY SUCH INFORMATION WITH RESPECT TO THE BESA
ITEMS AS REASONABLY REQUESTED BY XTENT TO ENABLE IT TO CONDUCT SUCH TESTING.
BESA WILL ALSO PROVIDE NECESSARY AUTHORIZATIONS, INFORMATION AND MATERIAL
INCLUDING BESA'S DRUG/POLYMER COMPOSITE FORMULATION, BIOLIMUS A9 AND BESA'S
POLYMER COATING TO SUCH THIRD PARTY TO ENABLE TESTING REQUIRED FOR REGULATORY
APPROVALS, FUTURE ANALYTICAL METHOD DEVELOPMENT, OR LOT RELEASE TESTING. IN THE
EVENT ANY TESTING REQUIRED BY
17
A REGULATORY AGENCY FOR APPROVAL OF XTENT'S STENTS REQUIRES THE USE OF SAMPLES
OF BESA'S STENTS OR STENT SYSTEMS, BESA WILL REASONABLY COOPERATE WITH XTENT TO
ACCOMPLISH THE REQUIRED TESTING, OR BESA MAY ELECT TO PERFORM SUCH TESTING
ITSELF OR THROUGH A THIRD PARTY, IN EITHER CASE ACCORDING TO THE PROTOCOLS AND
SCHEDULE REASONABLY REQUESTED BY XTENT AND AGREED TO BY BESA. XTENT SHALL
CONTROL THE TESTING OF ITS OWN STENTS AND THE PROTOCOLS SHALL BE MUTUALLY AGREED
UPON BY THE PARTIES.
BESA SHALL HAVE THE RIGHT TO CHARGE XTENT FOR ALL OF SUCH
INFORMATION, MATERIALS AND LABOR ASSOCIATED WITH SUCH TESTING PERFORMED BY BESA
OR ITS AFFILIATES BASED ON THE DIRECT COSTS OF BESA AND ITS AFFILIATES PLUS
[****]PERCENT ([****]%). NEITHER BESA NOR ITS AFFILIATES SHALL BE RESPONSIBLE
FOR ANY TEST METHODS OR PROCESSES UTILIZED BY XTENT IN PERFORMING THE TESTING
HEREUNDER, WHETHER DEVELOPED BY BESA, ITS AFFILIATES OR OTHERS.
(b)
BESA's Access to XTENT's Information.
In the
event any testing required by a regulatory agency for approval of BESA's Stents
requires the use of samples of XTENT's Stents or Stent Systems, XTENT will
reasonably cooperate with BESA to accomplish the required testing, or XTENT may
elect to perform such testing itself or through a third party, in either case
according to the protocols and schedule reasonably requested by BESA and agreed
to by XTENT. BESA shall control the testing of its own Stents and the protocols
shall be mutually agreed upon by the Parties.
XTENT shall have the right to
charge BESA for all of such information, materials and labor associated with
such testing performed by XTENT based on the Direct Costs of XTENT plus [****].
5.2
BESA'S RESPONSIBILITY.
AT BESA'S OWN EXPENSE, IT SHALL
PERFORM STABILITY TESTING ON BIOLIMUS A9, BESA'S POLYMER COATING, AND BESA'S
DRUG/POLYMER COMPOSITE FORMULATION AS USED WITHIN THE BESA ITEMS.
IN ADDITION,
BESA SHALL UNDERTAKE ANY OTHER NECESSARY TESTING WHICH IS REQUIRED TO DEVELOP A
DRUG MASTER FILE ("DMF"), A MASTER APPLICATION FILE ("MAF") OR EQUIVALENT
TECHNICAL DOSSIER SUFFICIENT TO