(II)
PACKAGING AND (III) PACKAGE INSERT FOR REVIEW AND COMMENT. VERTEX SHALL PROMPTLY
PROVIDE TO JANSSEN COPIES OF ANY DOCUMENTS OR CORRESPONDENCE PERTAINING TO
LABELING RECEIVED BY VERTEX OR ITS RELATED PARTIES FROM THE FDA. JANSSEN SHALL
PROMPTLY PROVIDE TO VERTEX COPIES OF ANY DOCUMENTS OR CORRESPONDENCE PERTAINING
TO LABELING RECEIVED BY JANSSEN OR ITS RELATED PARTIES FROM EMEA OR REGULATORY
AUTHORITIES IN THE MAJOR MARKET COUNTRIES, AND IN ADDITION, ANY SUCH DOCUMENTS
OR CORRESPONDENCE, IRRESPECTIVE OF THE COUNTRY TO WHICH THE DOCUMENTS OR
CORRESPONDENCE RELATE, WHICH ADDRESS MATERIAL ISSUES CONCERNING THE LABEL. UPON
VERTEX'S REASONABLE REQUEST, JANSSEN SHALL PROVIDE VERTEX WITH ANY ENGLISH
TRANSLATIONS OF THE DOCUMENTS AND CORRESPONDENCE DESCRIBED IN THE PRECEDING
SENTENCE THAT ARE PRODUCED FOR JANSSEN'S OWN USE. NEITHER PARTY SHALL HAVE THE
RIGHT TO APPROVE THE PROPOSED LABELING FOR THE PRODUCT IN ANY COUNTRY IN THE
OTHER PARTY'S TERRITORY. HOWEVER, EACH PARTY SHALL HAVE THE RIGHT TO OBJECT TO
THE LABELING TO BE INITIALLY SUBMITTED (OR RESUBMITTED FOLLOWING RECEIPT OF
COMMENTS FROM, OR NEGOTIATIONS WITH, REGULATORY AUTHORITIES) FOR THE PRODUCT IN
ANY COUNTRY IN THE OTHER PARTY'S TERRITORY OR TO ANY PROPOSED VARIATIONS OR
MODIFICATIONS TO ANY LABELING THAT HAS RECEIVED REGULATORY APPROVAL, BUT IN EACH
CASE SOLELY ON THE GROUNDS THAT SUCH LABELING COULD IN SUCH PARTY'S'S REASONABLE
JUDGMENT HAVE A MATERIAL ADVERSE EFFECT; AND PROVIDED, FURTHER, THAT SUCH PARTY
SHALL NOT BE ENTITLED TO OBJECT TO ANY VARIATIONS OR MODIFICATIONS TO ANY
LABELING REQUIRED BY LAW OR BY ANY REGULATORY AUTHORITY. ANY OBJECTION OR
RESPONSE TO THE OTHER PARTY'S LABEL OR PROPOSED LABEL SHALL BE MADE PROMPTLY SO
AS TO NOT DELAY THE SUBMISSION OR APPROVAL OF THE LABEL. ANY SUCH OBJECTION
SHALL BE SUBMITTED IN WRITING TO THE JSC, WITH A FULL EXPLANATION OF THE
CONCERNS UNDERLYING THE OBJECTION, AND THE MATTER SHALL BE ADDRESSED BY THE JSC
AT A MEETING CALLED
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this exhibit has been filed separately with the
Commission.
19
FOR THAT PURPOSE AS SOON AS REASONABLY PRACTICABLE. FAILING AGREEMENT BY THE
JSC, THE OBJECTION SHALL BE REFERRED FOR RESOLUTION UNDER SECTION 14.2 HEREOF.
3.7.4
RIGHT TO CROSS-REFERENCE. EACH PARTY SHALL HAVE THE RIGHT TO
CROSS-REFERENCE AND MAKE ANY OTHER USE OF THE OTHER PARTY'S NDAS/MAAS AND
INDS/CTAS FOR THE PRODUCT THAT IT WOULD HAVE IF IT WERE THE OWNER [***]
INCLUDING WITHOUT LIMITATION ACCESS TO ALL DATA CONTROLLED BY THE OTHER PARTY
AND CONTAINED OR REFERENCED IN SUCH NDAS/MAAS AND INDS/CTAS, IN EACH CASE AS MAY
BE REASONABLY NECESSARY TO ENABLE SUCH PARTY TO DEVELOP, MANUFACTURE OR
COMMERCIALIZE PRODUCTS AS PERMITTED UNDER THIS AGREEMENT. IN ADDITION, EACH
PARTY SHALL HAVE THE RIGHT TO CROSS-REFERENCE THE OTHER PARTY'S DRUG MASTER FILE
("DMF") IN CONNECTION WITH THE PERFORMANCE OF ITS OBLIGATIONS UNDER THIS
AGREEMENT.
3.7.5
[***]. SUBJECT TO APPLICABLE LAW, JANSSEN SHALL PROVIDE VERTEX AT
ITS REQUEST WITH ALL MATERIAL INFORMATION RELATING TO JANSSEN'S [***] IN THE EU
AND MATERIAL INFORMATION THAT SERVES AS THE BASIS FOR [***]