SAME MANNER AND TO THE SAME EXTENT AS SUCH PARTY HAS PROVIDED
SUCH GENERAL AND ADMINISTRATIVE SERVICES TO BIOMARIN/GENZYME LLC PRIOR TO THE
EFFECTIVE DATE) AT NO COST TO BIOMARIN/GENZYME LLC.
TO THE EXTENT THAT THERE
ARE ANY THIRD PARTY COSTS (SUCH AS LEGAL OR ACCOUNTING COSTS OR INSURANCE
PREMIUMS), ALL SUCH COSTS SHALL BE PAID FOR [**].
ARTICLE V
THE DEVELOPMENT PROGRAM
5.1 CONDUCT OF THE DEVELOPMENT PROGRAM.
5.1.1
GENERAL.
THE PARTIES AGREE TO USE COMMERCIALLY
REASONABLE AND DILIGENT EFFORTS TO EXECUTE AND SUBSTANTIALLY PERFORM AND TO
COOPERATE WITH EACH OTHER IN CARRYING OUT THE DEVELOPMENT PLAN FOR EACH
COLLABORATION PRODUCT.
NEITHER BIOMARIN NOR GENZYME SHALL BE REQUIRED TO
UNDERTAKE ACTIVITIES IN FURTHERANCE OF THE DEVELOPMENT PLAN IN THE ABSENCE OF
FUNDING FROM BIOMARIN/GENZYME LLC PURSUANT TO THE PROVISIONS OF THIS AGREEMENT.
AS USED IN THIS AGREEMENT,
[**] = 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.
14
THE PHRASE "COMMERCIALLY REASONABLE AND DILIGENT EFFORTS" WILL MEAN THAT LEVEL
OF EFFORT WHICH, CONSISTENT WITH THE EXERCISE OF PRUDENT SCIENTIFIC AND BUSINESS
JUDGMENT, IS APPLIED BY THE PARTY IN QUESTION TO ITS OTHER THERAPEUTIC PRODUCTS
AT A SIMILAR STAGE OF DEVELOPMENT AND WITH SIMILAR COMMERCIAL POTENTIAL.
5.1.2
DEVELOPMENT PLAN.
THE DEVELOPMENT PROGRAM SHALL BE
CONDUCTED BY THE PARTIES FOR BIOMARIN/GENZYME LLC IN ACCORDANCE WITH THE
THEN-CURRENT DEVELOPMENT PLAN WHICH SHALL DESCRIBE THE PROPOSED OVERALL PROGRAM
OF DEVELOPMENT FOR EACH COLLABORATION PRODUCT, INCLUDING PRECLINICAL STUDIES,
TOXICOLOGY, FORMULATION, MANUFACTURING, CLINICAL TRIALS AND REGULATORY PLANS AND
OTHER KEY ELEMENTS.
PURSUANT TO THE DEVELOPMENT PLAN, DEVELOPMENT WORK MAY BE
SUBCONTRACTED TO GENZYME AND BIOMARIN OR THEIR RESPECTIVE AFFILIATES, AT FULLY
ABSORBED COSTS DETERMINED BY GAAP.
THE RESPECTIVE CHARGES TO BIOMARIN/GENZYME
LLC FOR DEVELOPMENT COSTS INCURRED BY A PARTY SHALL BE INVOICED FOLLOWING
COMPLETION OF THE WORK, AND SHALL BE PAYABLE BY BIOMARIN/GENZYME LLC WITHIN A
COMMERCIALLY REASONABLE TIME THEREAFTER (BUT IN NO EVENT LATER THAN FORTY-FIVE
(45) DAYS OF THE DATE OF INVOICE THEREFOR).
THE DEVELOPMENT PLAN SHALL INCLUDE
(I) A SUMMARY OF ESTIMATED DEVELOPMENT COSTS EXPECTED TO BE INCURRED BY EACH
PARTY HEREUNDER IN PERFORMING ACTIVITIES OF THE DEVELOPMENT PROGRAM ASSIGNED TO
SUCH PARTY PURSUANT TO SECTION 5.1.4 BELOW AND (II) A SUMMARY BUDGET FOR ALL
DEVELOPMENT PROJECTS PROPOSED FOR THE APPLICABLE PERIOD AND FOR EACH
COLLABORATION PRODUCT.
5.1.3
INITIAL AND UPDATED DEVELOPMENT PLAN.
THE PARTIES
HAVE AGREED TO AN INITIAL THREE (3) YEAR DEVELOPMENT PLAN AND BUDGET FOR THE
PERIOD BEGINNING ON THE EFFECTIVE DATE AND ENDING ON DECEMBER 31, 2010, WHICH IS
ATTACHED HERETO AS APPENDIX A.
THE ROLLING THREE (3) YEAR DEVELOPMENT PLAN
SHALL BE UPDATED ANNUALLY BY THE PROGRAM MANAGEMENT TEAM AND SUBMITTED TO THE
STEERING COMMITTEE FOR REVIEW AND APPROVAL NOT LATER THAN SIXTY (60) DAYS PRIOR
TO JANUARY 1 OF EACH YEAR DURING THE DEVELOPMENT PROGRAM.
EACH SUCH UPDATED
DEVELOPMENT PLAN SHALL INCLUDE (A) AN OVERALL DEVELOPMENT PLAN FOR EACH
COLLABORATION PRODUCT WHICH SETS FORTH ALL MAJOR DEVELOPMENT