PROVIDE
DOCUMENTATION THAT REASONABLY SUPPORTS ANY AMOUNT INVOICED HEREUNDER.
SCHERING
WILL PAY ANY AND ALL TAXES (OTHER THAN TAXES BASED UPON SONUS' INCOME), DUTIES,
ASSESSMENTS AND OTHER CHARGES AND EXPENSES IMPOSED BY ANY GOVERNMENT AUTHORITY
IN CONNECTION WITH THE DELIVERY AND SALE OF THE PRODUCT TO SCHERING.
3.3
COST SHARING.
ANY COST SHARING FOR SUPPLY OF PRODUCT PROVIDED FOR
UNDER ARTICLE V OF THE LICENSE AGREEMENT SHALL BE RECONCILED QUARTERLY AS
PROVIDED IN THE LICENSE AGREEMENT.
4.
REGULATORY
4.1
REGULATORY INSPECTIONS.
IF A FACILITY THAT MANUFACTURES THE
PRODUCT IS INSPECTED BY REPRESENTATIVES OF ANY SUPRA-NATIONAL, NATIONAL,
FEDERAL, STATE OR LOCAL REGULATORY AGENCY IN CONNECTION WITH MANUFACTURE OF THE
PRODUCT, SONUS SHALL NOTIFY SCHERING PROMPTLY (BY TELEPHONE AND IN WRITING) UPON
LEARNING OF SUCH INSPECTION, AND SHALL SUPPLY SCHERING WITH COPIES OF ANY
RELATED CORRESPONDENCE OR OTHER DOCUMENTATION, OR PORTIONS THEREOF, IN THE
POSSESSION OF SONUS RELATING TO THE PRODUCT.
SCHERING MAY SEND REPRESENTATIVES
TO SUCH FACILITIES AND PARTICIPATE FULLY
5
in any portion of such inspection, subject to agreement by the Third Party
manufacturer where such agreement by the Third Party manufacturer is required.
Promptly upon Sonus' receipt thereof, Sonus shall provide Schering with a copy
of any regulatory letter or comments from any federal, state or local regulatory
agency in connection with the manufacture of the Product, including any Form 483
(Inspectional Observations) or warning letter.
4.2
RECORDS.
SONUS SHALL KEEP COMPLETE, ACCURATE AND AUTHENTIC
ACCOUNTS, NOTES, DATA AND RECORDS OF THE WORK PERFORMED UNDER THIS AGREEMENT
(INCLUDING, WITHOUT LIMITATION, BATCH RECORDS FOR THE PRODUCT).
ALL SUCH
RECORDS RELATING TO THE MANUFACTURE OF THE PRODUCT SHALL BE MAINTAINED FOR SUCH
PERIOD OF TIME AS MAY BE REQUIRED BY APPLICABLE LAWS, RULES OR REGULATIONS AND,
IN ANY EVENT, FOR A PERIOD OF TIME NOT LESS THAN SEVEN (7) YEARS.
PRIOR TO THE
DESTRUCTION OF ANY RECORD, SONUS SHALL GIVE ADVANCE WRITTEN NOTICE TO SCHERING
OF SONUS' INTENTION TO DESTROY ANY SUCH RECORD; SCHERING SHALL THEN HAVE THE
RIGHT TO REQUEST, RECEIVE AND RETAIN SUCH RECORDS WITH NO FURTHER COMPENSATION
TO SONUS.
5.
CONFIDENTIALITY.
THE PARTIES EACH AGREE THAT THE OBLIGATIONS OF
CONFIDENTIALITY, NON-USE AND NON-DISCLOSURE SET FORTH IN THE LICENSE AGREEMENT
ARE INCORPORATED INTO THIS AGREEMENT FOR PURPOSES OF DETERMINING THE PARTIES'
RIGHTS AND OBLIGATIONS WITH RESPECT TO CONFIDENTIAL INFORMATION DISCLOSED BY
EACH PARTY UNDER THIS AGREEMENT.
6.
TERM AND TERMINATION
6.1
TERM.
THE TERM OF THIS AGREEMENT SHALL COMMENCE ON THE EFFECTIVE
DATE AND SHALL CONTINUE UNTIL THE EARLIER TO OCCUR OF (I) PRODUCT LAUNCH (AS
DEFINED IN THE LICENSE AGREEMENT); OR (II) THE EFFECTIVE DATE OF TERMINATION OF
THE MSA.
6.2
TERMINATION FOR CAUSE.
EITHER PARTY MAY TERMINATE THIS AGREEMENT
(I) IF THE OTHER PARTY IS IN MATERIAL BREACH OF THIS AGREEMENT AND SUCH BREACH
IS NOT CURED WITHIN NINETY (90) DAYS FOLLOWING RECEIPT BY THE BREACHING PARTY OF
WRITTEN NOTICE FROM THE OTHER PARTY SPECIFYING THE BREACH IN REASONABLE DETAIL
AND DEMANDING ITS CURE; PROVIDED, HOWEVER, THAT, IF SAID BREACH CANNOT BE CURED
DURING SUCH NINETY