REVIEWED AND APPROVED
IN ADVANCE BY SCHERING.
(B)
COOPERATION.
THE PARTIES SHALL CONSULT AND
COOPERATE (INCLUDING, IN THE CASE OF SONUS, PROVIDING SUCH COMMERCIALLY
REASONABLE ASSISTANCE AS SCHERING SHALL REASONABLY REQUEST) IN THE PREPARATION
OF EACH APPROVAL APPLICATION AND IN OBTAINING AND MAINTAINING APPROVAL
APPLICATIONS IN THE TERRITORY, PROVIDED HOWEVER, THAT, EXCEPT WITH REGARD TO THE
PIVOTAL TRIAL, PRIOR TO AND FOLLOWING APPROVAL OF AN APPROVAL APPLICATION,
SCHERING SHALL BE SOLELY RESPONSIBLE FOR INTERACTIONS WITH GOVERNMENTAL
AUTHORITIES THROUGHOUT THE TERRITORY.
SUBJECT TO THE FOREGOING, SCHERING SHALL
PROVIDE SONUS AND SONUS SHALL PROVIDE SCHERING (UNTIL TRANSFER OF APPROVAL
APPLICATIONS FOR PERMISSION TO CONDUCT CLINICAL DEVELOPMENT AND THEREAFTER
SOLELY IN RESPECT OF THE PIVOTAL TRIAL) WITH REASONABLE ADVANCE NOTICE OF ANY
SCHEDULED MEETING WITH THE FDA RELATING TO ANY APPROVAL APPLICATION, AND SONUS
OR SCHERING, AS APPLICABLE, SHALL HAVE THE RIGHT TO PARTICIPATE IN ANY SUCH
MEETING.
IN THE EVENT THAT ANY GOVERNMENTAL AGENCY THREATENS TO OR INITIATES AN
ACTION TO REMOVE THE PRODUCT FROM THE MARKET IN ANY COUNTRY OF THE TERRITORY,
SCHERING SHALL NOTIFY SONUS OF SUCH COMMUNICATION WITHIN THREE BUSINESS DAYS OF
RECEIPT BY SCHERING.
AS BETWEEN THE PARTIES, SCHERING SHALL BE THE LEGAL AND
BENEFICIAL OWNER OF ALL APPROVAL APPLICATIONS AND APPROVALS IN THE TERRITORY.
SECTION 5.09
COSTS OF DEVELOPMENT
(A)
CORE DEVELOPMENT COSTS AND
CMC/MANUFACTURING COSTS.
ALL CORE DEVELOPMENT COSTS AND CMC/MANUFACTURING COSTS
SHALL BE SHARED EQUALLY BY THE PARTIES, INCLUDING DEVELOPMENT COSTS INCURRED BY
SONUS AS OF THE EXECUTION DATE IN THE PERFORMANCE OF THE PIVOTAL TRIAL, PROVIDED
HOWEVER, THAT SUCH DEVELOPMENT COSTS INCURRED BY SONUS IN THE PERFORMANCE OF THE
PIVOTAL TRIAL WILL BE SHARED SOLELY TO THE EXTENT THAT SUCH COSTS ARE INCLUDED
IN THE CORE DEVELOPMENT PLAN AND BUDGET.
EACH PARTY SHALL CALCULATE AND
MAINTAIN RECORDS OF CORE DEVELOPMENT COSTS AND CMC/MANUFACTURING COSTS INCURRED
BY IT IN ACCORDANCE WITH PROCEDURES TO BE AGREED UPON BY THE PARTIES.
ACCOUNTING BY SCHERING FOR CORE DEVELOPMENT COSTS AND CMC/MANUFACTURING COSTS
SHALL BE IN ACCORDANCE WITH IFRSS CONSISTENTLY APPLIED.
ACCOUNTING BY SONUS
SHALL BE IN ACCORDANCE WITH US GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
CONSISTENTLY APPLIED.
EACH PARTY SHALL REPORT QUARTERLY TO THE OTHER ON CORE
DEVELOPMENT COSTS AND CMC/MANUFACTURING COSTS, WITH SUCH REPORTS TO BE SUBMITTED
WITHIN THIRTY (30) DAYS OF THE END OF EACH CALENDAR QUARTER.
AT THE END OF EACH
CALENDAR YEAR, THE PARTIES SHALL ASSESS THE CORE DEVELOPMENT COSTS AND
CMC/MANUFACTURING COSTS INCURRED
21
AND DOCUMENTED BY EACH PARTY.
IN THE EVENT THAT EITHER PARTY DISAGREES WITH THE
ASSESSMENT, THEN THE CHIEF FINANCIAL OFFICER OF SONUS AND THE HEAD OF CORPORATE
ACCOUNTING OF SCHERING SHALL MEET AND ATTEMPT TO RESOLVE THE DISAGREEMENT.
IF
THE CHIEF FINANCIAL OFFICER AND HEAD OF CORPORATE ACCOUNTING ARE UNABLE TO
RESOLVE THE DISAGREEMENT, IT SHALL THEN BE RESOLVED IN THE SAME MANNER AS AN
AUDIT DISAGREEMENT PURSUANT TO SECTION 8.03(D).
EACH PARTY SHALL ALSO HAVE THE
RIGHT TO AUDIT THE CORE DEVELOPMENT COSTS AND THE CMC/MANUFACTURING COSTS AND
ANY NON-CORE DEVELOPMENT COSTS REPORTED BY THE OTHER PARTY PURSUANT TO