ADVERSELY AFFECT THE DEVELOPMENT, MARKETING, DISTRIBUTION OR COMMERCIALIZATION
OF SUCH LICENSED PRODUCT OR ANY OTHER LICENSED PRODUCT WITHIN OR OUTSIDE THE
TERRITORY FOR OTHER INDICATIONS; CUBIST SHALL PROMPTLY CONVENE A MEETING OF THE
JCT TO DISCUSS SAME.
PRIOR TO THE MEETING, CUBIST WILL PROVIDE TO CHIRON ALL
RELEVANT DOCUMENTS, MATERIALS AND INFORMATION SUGGESTING THE LIKELIHOOD OF
EVENTS DESCRIBED IN CLAUSES (I) AND (II) ABOVE, AS WELL AS CUBIST'S
RECOMMENDATIONS TO CHIRON ON THE COURSE OF ACTION (E.G., NOT SEEKING APPROVAL OF
A PARTICULAR LICENSED PRODUCT OR NOT SEEKING APPROVAL OF A PARTICULAR
INDICATION, ETC.).
AT THE JCT, THE PARTIES WILL DISCUSS AND ATTEMPT TO REACH
CONSENSUS ON THE COURSE OF ACTION.
FOLLOWING SUCH DISCUSSION, IN THE ABSENCE OF
CONSENSUS, CUBIST SHALL HAVE THE RIGHT TO REQUIRE CHIRON TO MODIFY OR
DISCONTINUE THOSE REGULATORY ACTIVITIES THAT CUBIST REASONABLY AND IN GOOD FAITH
BELIEVES, BASED ON THE TOTALITY OF THE DATA, FACTS AND KNOWLEDGE PRESENTED TO
CHIRON AND THE DATA, FACTS AND KNOWLEDGE PRESENTED BY CHIRON IN RESPONSE, ARE
SUBSTANTIALLY LIKELY TO RESULT IN THE EVENTS DESCRIBED IN CLAUSE (I) OR CLAUSE
(II) ABOVE IN THIS SECTION 5.1(E).
5.2.
OWNERSHIP OF REGULATORY APPROVALS.
EXCEPT TO THE EXTENT OTHERWISE
PROVIDED ELSEWHERE IN THIS AGREEMENT, CHIRON SHALL FILE IN ITS OWN NAME AND OWN
ALL DRUG APPROVAL APPLICATIONS AND REGULATORY APPROVALS FOR LICENSED PRODUCTS IN
THE TERRITORY, AND SHALL BE
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
32
solely responsible for all communications with regulatory authorities in such
countries. All such filings shall be made in such manner as may be required
under the laws of the applicable jurisdiction to allow for the expeditious
transfer of such Drug Approval Applications and Regulatory Approvals for
Licensed Products to Cubist if such transfer is required pursuant to Article 13
hereof upon termination (but not expiration) of this Agreement.
Promptly
following execution of this Agreement, Cubist shall transfer and assign to
Chiron any and all such Drug Approval Applications or Regulatory Approvals held
by Cubist as of the date hereof.
5.3.
CHIRON ACCESS TO CUBIST AND OTHER LICENSEE DATA.
(A)
INFORMATION SHARING.
SUBJECT TO THE PROVISIONS OF SECTION 5.3(D) BELOW,
DURING THE TERM, CUBIST WILL PROVIDE TO CHIRON ANY CUBIST DATA AND OTHER
LICENSEE DATA NECESSARY OR USEFUL FOR MAKING REGULATORY FILINGS FOR, OR
MARKETING OF, LICENSED PRODUCTS IN THE TERRITORY AS SUCH CUBIST DATA AND OTHER
LICENSEE DATA ARE OR BECOME AVAILABLE. THE PARTIES SHALL DISCUSS, VIA THEIR
PARTICIPATION IN THE JCT, THE FORM IN WHICH CUBIST SHALL PROVIDE CHIRON CUBIST
DATA AND OTHER LICENSEE DATA PURSUANT TO THIS SECTION 5.3(A).
SUBJECT TO THE
PROVISIONS OF SECTION 5.3(C) BELOW, ANY SUCH OTHER LICENSEE DATA SO PROVIDED
SHALL BE STRICTLY FOR INFORMATION PURPOSES ONLY AND CHIRON SHALL HAVE NO RIGHT
TO USE THE OTHER LICENSEE DATA FOR ANY PURPOSE WHATSOEVER, INCLUDING WITHOUT
LIMITATION, TO ACCESS, REFERENCE, INTERPRET, DISCLOSE, TABULATE, ANALYZE OR
OTHERWISE USE ANY SUCH OTHER LICENSEE DATA FOR THE PURPOSE OF SUPPORTING ANY
DRUG APPROVAL APPLICATION ANYWHERE IN