TO ASSUME RESPONSIBILITY FOR MANUFACTURE
AND SUPPLY OF THE PRODUCT PURSUANT TO SECTION 7.05 OF THIS AGREEMENT, SONUS
SHALL SUPPLY ALL OF SCHERING'S REQUIREMENTS OF PRODUCT [*] TOGETHER, AFTER FIRST
PRODUCT LAUNCH, WITH [*] AS THE PARTIES SHALL AGREE IN THE MANUFACTURING AND
SUPPLY AGREEMENT TO BE NEGOTIATED PURSUANT TO SECTION 7.02 ABOVE.
NOTWITHSTANDING THE FOREGOING, IF SCHERING HAS NOT, WITHIN [*] OF PRODUCT LAUNCH
IN THE US, EXERCISED THE OPTION TO MANUFACTURE OR HAVE MANUFACTURED PROVIDED FOR
IN SECTION 7.05 BELOW, THEN, EXCEPT WHERE SCHERING'S FAILURE TO EXERCISE THE
OPTION IS DUE TO A RESTRICTION IN ANY THIRD PARTY CONTRACT ENTERED INTO BY SONUS
PRIOR TO THE EXECUTION DATE WHICH WOULD PREVENT SCHERING FROM ASSUMING
RESPONSIBILITY FOR MANUFACTURE OF ALL REQUIREMENTS OF THE PRODUCT IN THE
TERRITORY, SCHERING AND SONUS SHALL RE-NEGOTIATE THE MANUFACTURING AND SUPPLY
AGREEMENT PROVIDED FOR IN SECTION 7.02 TO ALLOW SONUS TO CHARGE [*] FOR THE
MANUFACTURING AND SUPPLY SERVICES PROVIDED BY SONUS THEREUNDER AND NOT OTHERWISE
REIMBURSED BY SCHERING.
SECTION 7.05
SCHERING OPTION.
NOTWITHSTANDING
ANYTHING TO THE CONTRARY HEREIN, SCHERING MAY, AT ANY TIME, BY DELIVERY OF
WRITTEN NOTICE TO SONUS, ELECT TO BECOME THE MANUFACTURING PARTY HEREUNDER IN
RESPECT OF THE PRODUCT AND TO MAKE OR HAVE MADE THE PRODUCT.
SUBJECT TO THE
TERMS OF ALL RELEVANT THIRD PARTY CONTRACTS RELATED TO MANUFACTURE OF THE
PRODUCT, SUCH ELECTION SHALL BECOME EFFECTIVE ON THE DATE SPECIFIED IN SUCH
NOTICE, WHEREUPON SONUS WILL BE DEEMED TO HAVE TRANSFERRED AND ASSIGNED TO
SCHERING (AND WILL PROMPTLY TRANSFER TO SCHERING) ALL INFORMATION REGARDING
SONUS KNOW-HOW AND ALL THIRD PARTY CONTRACTS RELATED TO THE MANUFACTURE OF THE
PRODUCT, SUBJECT TO THE TERMS OF ALL RELEVANT THIRD PARTY CONTRACTS.
IN THE
EVENT THAT SCHERING WISHES TO USE PROPERTY, PLANT AND EQUIPMENT OF SONUS
DEDICATED TO THE MANUFACTURE OF THE PRODUCT, SONUS SHALL SELL SUCH PROPERTY,
PLANT AND EQUIPMENT TO SCHERING AT FAIR MARKET VALUE.
ANYTHING HEREIN TO THE
CONTRARY NOTWITHSTANDING, NOTHING HEREIN SHALL BE DEEMED TO CONSTITUTE AN
ASSIGNMENT OF ANY THIRD PARTY CONTRACT THAT REQUIRES CONSENT TO ASSIGNMENT.
[*]
CONFIDENTIAL PORTIONS OMITTED AND FILED
SEPARATELY WITH THE COMMISSION
25
ARTICLE VIII
INFORMATION AND REPORTS
SECTION 8.01
INFORMATION AND REPORTS DURING
DEVELOPMENT AND COMMERCIALIZATION.
SCHERING AND SONUS WILL DISCLOSE AND MAKE
AVAILABLE (SUBJECT TO ANY CONFIDENTIALITY AGREEMENTS OR REQUIREMENTS OF LAW) TO
EACH OTHER WITHOUT CHARGE ALL PRECLINICAL, CLINICAL, REGULATORY, MARKETING,
PRICING, SALES AND OTHER INFORMATION INCLUDING COPIES OF ALL PRECLINICAL AND
CLINICAL REPORTS HELD BY SCHERING OR SONUS DIRECTLY CONCERNING THE PRODUCT
WITHIN THE FIELD AT ANY TIME DURING THE TERM OF THIS AGREEMENT.
EACH PARTY SHALL OWN AND MAINTAIN ITS OWN DATABASE OF CLINICAL TRIAL DATA
ACCUMULATED FROM ALL CLINICAL TRIALS OF THE PRODUCT FOR WHICH IT WAS
RESPONSIBLE, AND OF ADVERSE DRUG EVENT INFORMATION FOR THE PRODUCT.
AT THE
OPTION OF THE REQUESTING PARTY, SUCH DATA SHALL BE PROVIDED IN A COMPUTER
READABLE FORMAT BY THE PROVIDING PARTY TO THE EXTENT AVAILABLE.
WITHOUT
LIMITING THE FOREGOING, EACH PARTY SHALL SUPPLY TO THE OTHER THE