TASKS AND (B) A
DETAILED DESCRIPTION AND BUDGET FOR THE ACTIVITIES PROPOSED FOR THE COVERED
PERIOD.
THE PROJECT MANAGEMENT TEAM SHALL BE PRIMARILY RESPONSIBLE FOR
PREPARING THE ANNUAL UPDATES TO THE DEVELOPMENT PLAN AND, IN CONNECTION WITH THE
PREPARATION OF SUCH UPDATES, SHALL CONSULT WITH GENZYME AND BIOMARIN REGARDING
THE IDENTIFICATION, TIMING AND EXECUTION OF AND BUDGET FOR THE MAJOR TASKS AND
DETAILED ACTIVITIES REQUIRED TO PERFORM THE UPDATED DEVELOPMENT PLAN.
EACH SUCH
UPDATED DEVELOPMENT PLAN APPROVED BY THE STEERING COMMITTEE SHALL BE SIGNED BY
AN AUTHORIZED REPRESENTATIVE OF EACH OF BIOMARIN AND GENZYME.
THE MEMBERS OF
THE PROGRAM MANAGEMENT TEAM SHALL ACTIVELY CONSULT WITH ONE ANOTHER THROUGHOUT
THE TERM OF THE DEVELOPMENT PLAN SO AS TO ADJUST THE SPECIFIC WORK PERFORMED
UNDER THE DEVELOPMENT PLAN TO CONFORM TO EVOLVING DEVELOPMENTS IN TECHNOLOGY AND
THE RESULTS OF THE DEVELOPMENT WORK PERFORMED.
ANY CHANGES IN THE SCOPE OR
DIRECTION OF THE WORK AND ANY CHANGES TO THE TOTAL AMOUNT BUDGETED IN ANY
CALENDAR YEAR FOR THE DEVELOPMENT PROGRAM MUST BE APPROVED BY THE STEERING
COMMITTEE, IN THE ABSENCE OF WHICH APPROVAL THE MOST RECENTLY APPROVED
DEVELOPMENT PLAN SHALL REMAIN IN EFFECT.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.
An unredacted version of this exhibit has been filed
separately with the Commission.
15
5.1.4
STUDIES REQUIRED BY REGULATORY AUTHORITIES.
(A)
EXISTING MARKETS.
IN THE EVENT THAT ANY
REGULATORY AUTHORITY IN ANY COUNTRY IN WHICH ALDURAZYME HAS RECEIVED ALL
NECESSARY REGULATORY APPROVALS AS OF THE EFFECTIVE DATE ("EXISTING MARKETS")
REQUIRES A POST-MARKETING STUDY RELATED TO ALDURAZYME (OTHER THAN ANY REGISTRY
PROGRAM EXISTING ON THE EFFECTIVE DATE OR POST-MARKETING STUDIES RELATED TO THE
MANUFACTURE OF ALDURAZYME, EACH OF WHICH SHALL BE GOVERNED BY THE TERMS AND
CONDITIONS OF THE MANUFACTURING, MARKETING AND SALES AGREEMENT) THAT IS NOT
CONTEMPLATED BY THE INITIAL DEVELOPMENT PLAN DESCRIBED ABOVE, THEN SUCH STUDY
SHALL AUTOMATICALLY BE ADDED TO THE DEVELOPMENT PROGRAM AND (I) THE PROGRAM
MANAGEMENT TEAM SHALL PROMPTLY PREPARE A PLAN FOR THE CONDUCT OF SUCH REQUIRED
POST-MARKETING STUDY (INCLUDING WITHOUT LIMITATION A TIMELINE AND REASONABLY
DETAILED BUDGET) AND SUBMIT THE PLAN TO THE STEERING COMMITTEE FOR REVIEW AND
APPROVAL AND (II) THE STEERING COMMITTEE SHALL PROMPTLY REVIEW SUCH PLAN AND,
UPON APPROVAL OF SUCH PLAN BY THE STEERING COMMITTEE, THE THEN-CURRENT
DEVELOPMENT PLAN SHALL AUTOMATICALLY BE UPDATED TO INCLUDE THE STUDY AND THE
BUDGET INCLUDED IN THE APPROVED PLAN; PROVIDED, HOWEVER, THAT IN THE EVENT THAT
ANY REGULATORY AUTHORITY REQUIRES A POST-MARKETING STUDY TO BE CONDUCTED THROUGH
OR AS PART OF THE REGISTRY PROGRAM, THEN, NOTWITHSTANDING ANYTHING TO THE
CONTRARY HEREIN, SUCH STUDY AND THE INCREMENTAL COSTS ASSOCIATED WITH CONDUCTING
SUCH STUDY (I.E., SUCH COSTS ABOVE THE GENERAL COST OF MAINTAINING THE REGISTRY
PROGRAM) SHALL BE ADDED TO THE DEVELOPMENT PLAN IN ACCORDANCE WITH THE PROCESS
SET FORTH IN THIS SECTION 5.1.4(A).
(B)
NEW MARKETS.
IN THE EVENT THAT CLINICAL
STUDIES ARE REQUIRED TO APPLY FOR REGULATORY APPROVAL FOR ALDURAZYME IN ANY
COUNTRY THAT IS NOT AN EXISTING