AMENDED BY THE MEMORANDUM FROM [***] TO [***] SETTING FORTH THE
PARTIES' AGREED UPON REGULATORY STRATEGY, ATTACHED HERETO AS SCHEDULE 2.5.2.
PURSUANT AND SUBJECT TO SECTION F.6 OF THE SHORT FORM AGREEMENT, AS AMENDED BY
SCHEDULE 2.5.2, GEN-PROBE AGREES TO USE ITS BEST EFFORTS TO (I) REGULARLY REVIEW
BLOOD SCREENING REGULATORY/LICENSURE STRATEGY AND MANAGEMENT OF REGULATORY
SUBMISSIONS WITH CHIRON, (II) PROVIDE DRAFT COPIES OF ALL WRITTEN REGULATORY
SUBMISSIONS TO CHIRON AT LEAST FIVE WORKING DAYS PRIOR TO THE PROPOSED DATE OF
THEIR SUBMISSION, (III) MAKE AVAILABLE THE APPROPRIATE PERSONNEL FOR A
DISCUSSION OF ANY ADVICE OR RECOMMENDATIONS OF CHIRON ON ANY REGULATORY
SUBMISSIONS AND (IV) REASONABLY CONSIDER SUCH ADVICE OR RECOMMENDATIONS, BUT
GEN-PROBE IS NOT REQUIRED TO ACCEPT SUCH ADVICE AND RECOMMENDATIONS; IN EACH
CASE AS REASONABLY ATTAINABLE BY GEN-PROBE.
ALL DISAGREEMENTS ON
REGULATORY/LICENSURE ISSUES SHALL BE ADDRESSED BY THE SUPERVISORY BOARD AND, IF
NECESSARY, BY IMPLEMENTATION OF THE ESCALATION PROCEDURE DESCRIBED IN ARTICLE 13
OF THE AGREEMENT, EXCLUDING ARBITRATION.
FOR ISSUES THAT CANNOT BE RESOLVED
THROUGH SUCH PROCEDURES, GEN-PROBE'S CHIEF EXECUTIVE OFFICER SHALL HAVE THE
RIGHT TO MAKE A FINAL DECISION.
GEN-PROBE SHALL HAVE NO OBLIGATION UNDER THIS
ESAS 2 ADDENDUM TO APPLY FOR OR ENDEAVOR TO OBTAIN REGULATORY APPROVAL FOR ANY
ESAS 2 INSTRUMENT (OR ANY MODULE WITHIN THE ESAS 2 INSTRUMENT SYSTEM) THAT FAILS
TO MEETS THE CRITERIA SET FORTH IN THE APPLICABLE PRD AND SRS.
COSTS OF ALL
REGULATORY AND LICENSING ACTIVITIES (INCLUDING GEN-PROBE INTERNAL ESAS 2
DEVELOPMENT COSTS) WILL BE INCLUDED IN THE ESAS 2 DEVELOPMENT COSTS AND PAID FOR
BY CHIRON.
2.5.3
PROJECT LEADER DISAGREEMENTS.
IT IS RECOGNIZED
THAT THE PROJECT LEADERS MAY DISAGREE ON APPROACHES.
EVEN THOUGH ONE PARTY HAS
THE PRINCIPAL RESPONSIBILITY FOR DEVELOPMENT IN THE FUNCTIONAL AREA DESCRIBED IN
SECTION 2.5, DISAGREEMENTS THAT CANNOT BE RESOLVED BY PROJECT MANAGEMENT MAY BE
BROUGHT TO THE SUPERVISORY BOARD.
HOWEVER, WORK WILL PROCEED IN ACCORDANCE WITH
THE CHOICE OF THE PRINCIPALLY RESPONSIBLE PARTY, WHILE BEING DISCUSSED AT THE
SUPERVISORY BOARD.
IN THE EVENT THAT THE PARTIES DO NOT AGREE AT THE
SUPERVISORY BOARD LEVEL, THE PARTY WITH PRINCIPAL RESPONSIBILITY MAY CONTINUE TO
PROCEED PER THEIR BEST JUDGMENT.
IF A DISAGREEMENT ARISES IN A FUNCTIONAL AREA
FOR WHICH RESPONSIBILITY IS SHARED AND RESOLUTION CANNOT BE ACHIEVED AT THE
SUPERVISORY BOARD, EXCEPT AS TO REGULATORY/LICENSURE STRATEGY THAT SHALL BE
GOVERNED BY SECTION 2.5.2 ABOVE, WORK SHALL BE SUSPENDED IN SUCH FUNCTIONAL AREA
UNTIL A RESOLUTION IS REACHED THROUGH ARTICLE 13 OF THE AGREEMENT, INCLUDING
ARBITRATION.
3.
MODIFICATIONS.
3.1
ESAS 2 DEVELOPMENT PROGRAM DEFINITION.
3.1.1
[***] MODULES.
THE PARTIES HAVE PREPARED AND
AGREED UPON AN ESAS 2 DEVELOPMENT PROGRAM, AS DESCRIBED IN THE BINDER, FOR [***]
MODULES IN THE ESAS2 INSTRUMENT SYSTEM,
8
AND WILL NEED TO PREPARE AND AGREE UPON AN ESAS 2 DEVELOPMENT PROGRAM FOR THE
REMAINING [***] MODULES IN THE ESAS2 INSTRUMENT SYSTEM.
THE ESAS 2 DEVELOPMENT
PROGRAM, AS DESCRIBED IN THE BINDER WITH RESPECT TO [***] MODULES AND AS
PREPARED AND AGREED UPON WITH RESPECT TO THE REMAINING [***] MODULES, WILL
GOVERN