ANY TRADEMARK OR TRADENAME OR A PART THEREOF THAT USES THE
NAME "MOMENTA", "SANDOZ" OR A DERIVATIVE OF THE FOREGOING OR ANY OTHER TRADEMARK
OR PART OR DERIVATIVE THEREOF THAT IS THE NAME OR DERIVATIVE OF A NAME OF ANY
MOMENTA AFFILIATE OR SANDOZ AFFILIATE, WITHOUT THE PRIOR APPROVAL OF MOMENTA.
ONCE SANDOZ, ITS AFFILIATE OR SUBLICENSEE BEGINS SELLING A PARTICULAR PRODUCT IN
A PARTICULAR COUNTRY IN THE RELEVANT TERRITORY, SANDOZ SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO SELL SUCH PRODUCT IN SUCH COUNTRY IN SUCH TERRITORY,
ITSELF OR THROUGH ITS AFFILIATES OR SUBLICENSEES, UNLESS SANDOZ MAKES A
COMMERCIALLY REASONABLE DECISION TO CEASE SELLING SUCH PRODUCT IN SUCH COUNTRY.
6.2.
PRE FINAL LEGAL CLEARANCE LAUNCH.
NOTWITHSTANDING ANY OTHER
PROVISION IN THIS AGREEMENT, THE PARTIES AGREE THAT IF APPLICATION FINAL
APPROVAL FOR A PRODUCT HAS BEEN OBTAINED IN A COUNTRY IN THE RELEVANT TERRITORY
BUT FINAL ROW LEGAL CLEARANCE OR FINAL U.S. LEGAL CLEARANCE (AS APPLICABLE) HAS
NOT YET BEEN OBTAINED WITH RESPECT TO SUCH PRODUCT IN SUCH COUNTRY, SANDOZ MAY,
IN ITS SOLE DISCRETION, AFTER REASONABLE CONSULTATION WITH AND DUE CONSIDERATION
OF INPUT FROM MOMENTA, DECIDE WHETHER TO PROCEED WITH LAUNCH OF SUCH PRODUCT IN
SUCH COUNTRY, OR TO DEFER LAUNCH UNTIL FINAL ROW LEGAL CLEARANCE OR FINAL U.S.
LEGAL CLEARANCE, RESPECTIVELY, HAS BEEN OBTAINED WITH RESPECT TO SUCH PRODUCT IN
SUCH COUNTRY; SUBJECT TO THE PENULTIMATE SENTENCE OF SECTION 5.2.
UPON DECIDING
TO PROCEED WITH PRE FINAL LEGAL CLEARANCE LAUNCH WITH RESPECT TO SUCH PRODUCT IN
SUCH COUNTRY, SANDOZ SHALL PROMPTLY NOTIFY MOMENTA OF SUCH DECISION.
7.
REGULATORY MATTERS
7.1.
REVIEW AND OVERSIGHT.
ALL RESPONSIBILITIES UNDER THIS ARTICLE 7
SHALL BE SUBJECT TO THE REVIEW AND OVERSIGHT OF THE COMMITTEES AS SET FORTH IN
ARTICLE 5.
7.2.
APPLICATION FILING.
SANDOZ SHALL FILE APPLICATION(S) IN
ACCORDANCE WITH THE RELEVANT ANNUAL COLLABORATION PLANS FOR EACH PRODUCT IN THE
RELEVANT TERRITORY UNDER SANDOZ'S NAME.
IF THE U.S. TERRITORY APPLICATION FOR
THE COPAXONE-REFERENCED PRODUCT INCLUDES A PARAGRAPH IV CERTIFICATION, SANDOZ
SHALL ALSO PROVIDE TO THE APPLICABLE INNOVATOR NOTICE, AS REQUIRED BY 21 U.S.C.
§ 355(B)(3) OR 21 U.S.C. § 355(J)(2)(B), RESPECTIVELY.
7.3.
OWNERSHIP OF THE APPLICATIONS.
SANDOZ SHALL OWN ALL APPLICATIONS
FOR THE APPLICABLE PRODUCT IN THE RELEVANT TERRITORY, SUBJECT TO SECTION 2.1.2.
7.4.
APPLICATION RESPONSIBILITY.
THE JSC SHALL DETERMINE THE
RESPONSIBILITIES OF EACH PARTY WITH RESPECT TO THE PREPARATION OF THE
APPLICATIONS FOR THE PRODUCTS FOR THE RELEVANT TERRITORIES AND RELATED
ACTIVITIES.
MOMENTA SHALL BE RESPONSIBLE FOR COMPILING MODULES OF ANY
REGISTRATION DOSSIER WHICH ARE RELATED TO ITS ACTIVITIES HEREUNDER AND TO
PROVIDE ANSWERS THAT CAN BE GIVEN TO THE RELEVANT REGULATORY AUTHORITY THEREFOR.
7.5.
REGULATORY INTERACTION.
EXCEPT AS PROVIDED IN SECTION 7.6, THE
JSC SHALL DETERMINE THE RESPONSIBILITIES OF EACH PARTY WITH RESPECT TO
INTERACTIONS WITH THE FDA OR OTHER
39
REGULATORY AUTHORITY WITH RESPECT TO THE PRODUCTS IN THE RELEVANT TERRITORIES;
PROVIDED, HOWEVER, THAT ADVERSE EVENT REPORTING OBLIGATIONS WITH RESPECT TO THE
PRODUCTS SHALL BE THE PRIMARY RESPONSIBILITY OF SANDOZ, WITH MOMENTA'S
ASSISTANCE IF REASONABLY REQUESTED BY SANDOZ.
7.6.
REGULATORY