INFORMATION
REQUIRED BY THE OTHER PARTY AND REASONABLY REQUESTED BY IT (EITHER AS A ROUTINE
PRACTICE OR AS A SPECIFIC REQUEST) FOR PURPOSES OF COMPLIANCE WITH REGULATORY
REQUIREMENTS.
WITH RESPECT TO INFORMATION CONCERNING COMMERCIALIZATION,
SCHERING AGREES TO KEEP SONUS REGULARLY INFORMED ON ALL SUCH ACTIVITIES IN
ACCORDANCE WITH THE REQUIREMENTS OF ARTICLE VI OF THIS AGREEMENT.
SECTION 8.02
ADVERSE DRUG EVENT REPORTING.
(A)
FOLLOWING EXECUTION OF THIS AGREEMENT, THE
PARTIES WILL DEVELOP AND ADOPT A PHARMACOVIGILANCE AGREEMENT SPECIFYING THE
ROLES AND RESPONSIBILITIES OF BOTH PARTIES FOR ADVERSE EVENT REPORTING TO ASSURE
COMPLIANCE WITH REGULATORY REQUIREMENTS IN THE TERRITORY.
EACH PARTY SHALL
ADVISE THE OTHER PARTY, UNDER THE TERMS OF THE PHARMACOVIGILANCE AGREEMENT, IF
IT BECOMES AWARE OF ANY POTENTIALLY SERIOUS OR UNEXPECTED ADVERSE EVENT
(INCLUDING ADVERSE DRUG EXPERIENCES, AS DEFINED IN 21 C.F.R. § 314.80 OR OTHER
APPLICABLE REGULATIONS) INVOLVING THE PRODUCT.
AFTER THE PRODUCT LAUNCH,
SCHERING SHALL HAVE THE SOLE RESPONSIBILITY FOR PHARMACOVIGILANCE FOR MARKETED
PRODUCT, INCLUDING BUT NOT LIMITED TO: (I) MONITORING SUCH ADVERSE EVENTS; AND
(II) MAKING ANY REPORTS TO THE GOVERNMENTAL AUTHORITIES IN THE TERRITORY IN
ACCORDANCE WITH SCHERING'S STANDARD OPERATING PROCEDURES RELATING TO ADVERSE
EVENT REPORTING.
In the event either Party requires information regarding adverse events in
connection with the preparation or filing of reports required to be filed by it
in order to comply with Applicable Laws, including obligations to report adverse
events to the Governmental Authorities, each Party agrees to provide such
information to the other on a timely basis.
SECTION 8.03
RECORDS OF REVENUES AND EXPENSES.
(A)
EACH PARTY WILL MAINTAIN COMPLETE AND
ACCURATE RECORDS WHICH ARE RELEVANT TO REVENUES, COSTS, EXPENSES AND PAYMENTS ON
A COUNTRY-BY-COUNTRY BASIS IN THE TERRITORY UNDER THIS AGREEMENT AND SUCH
RECORDS SHALL BE OPEN DURING REASONABLE BUSINESS HOURS FOR A PERIOD OF TWO
(2) YEARS FROM CREATION OF INDIVIDUAL RECORDS FOR EXAMINATION AT THE OTHER
PARTY'S EXPENSE AND NOT MORE OFTEN THAN ONCE EACH YEAR BY A FIRM OF CERTIFIED
PUBLIC ACCOUNTANTS SELECTED BY THE OTHER PARTY, FOR THE SOLE PURPOSE OF
VERIFYING FOR THE INSPECTING PARTY THE CORRECTNESS OF CALCULATIONS AND
CLASSIFICATIONS OF SUCH REVENUES, COSTS, EXPENSES OR PAYMENTS MADE UNDER THIS
AGREEMENT.
EACH PARTY SHALL BEAR ITS OWN COSTS RELATED TO SUCH AUDIT; PROVIDED
THAT, FOR ANY UNDERPAYMENTS GREATER THAN FIVE (5) PERCENT BY
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THE OTHER PARTY, THE OTHER PARTY SHALL PAY TO THE INSPECTING PARTY THE AMOUNT OF
UNDERPAYMENT, INTEREST AS PROVIDED IN SECTION 8.03(B) BELOW AND THE INSPECTING
PARTY'S OUT-OF-POCKET EXPENSES.
FOR ANY UNDERPAYMENTS OF LESS THAN FIVE
(5) PERCENT BY THE OTHER PARTY FOUND UNDER THIS SECTION, THE OTHER PARTY SHALL
PAY TO THE INSPECTING PARTY THE AMOUNT OF UNDERPAYMENT ONLY.
ANY OVERPAYMENTS
BY THE OTHER PARTY WILL BE REFUNDED BY THE INSPECTING PARTY.
ANY RECORDS OR
ACCOUNTING INFORMATION RECEIVED FROM THE OTHER PARTY SHALL BE CONFIDENTIAL
INFORMATION FOR THE PURPOSES OF SECTION 10.01 RESULTS OF ANY SUCH AUDIT SHALL BE
PROVIDED TO BOTH PARTIES SUBJECT TO THE CONFIDENTIALITY OBLIGATIONS OF
SECTION 10.01.
(B)
DUE DATE; INTEREST.
ANY PAYMENTS