has been filed
separately with the Commission.
18
OWNERSHIP AND/OR DISPOSITION OF SUCH REGULATORY APPROVALS IN THE EVENT THIS
AGREEMENT IS TERMINATED AND TO PROVIDE THE LEVEL OF COOPERATION DESCRIBED IN
SECTION 14.1 HEREOF IN CONNECTION THEREWITH.
5.4
Clinical Data.
In all agreements with Third
Parties or Affiliates involving the development of preclinical or clinical data
for a Collaboration Product, Genzyme and BioMarin shall require that such Third
Parties and Affiliates provide BioMarin/Genzyme LLC and the other Party access
to all such data, to the extent such data is required to be obtained from such
Third Parties by the Japanese Ministry of Health and Welfare, the U.S. FDA, the
Commission of Proprietary Medicines of the European Community, the European
Medicines Evaluation Agency or other regulatory agency, in each case with
respect to Regulatory Approvals.
5.5
FACILITIES VISIT.
REPRESENTATIVES OF BIOMARIN
AND GENZYME MAY VISIT ALL MANUFACTURING SITES AND THE SITES OF ANY CLINICAL
TRIALS OR OTHER EXPERIMENTS BEING CONDUCTED BY THE OTHER PARTY OR
BIOMARIN/GENZYME LLC IN CONNECTION WITH THE DEVELOPMENT PROGRAM.
IF REQUESTED
BY THE OTHER PARTY, BIOMARIN AND GENZYME SHALL CAUSE APPROPRIATE INDIVIDUALS
WORKING ON THE DEVELOPMENT PROGRAM TO BE AVAILABLE FOR MEETINGS AT THE LOCATION
OF THE FACILITIES WHERE SUCH INDIVIDUALS ARE EMPLOYED AT TIMES REASONABLY
CONVENIENT TO THE PARTY RESPONDING TO SUCH REQUEST.
ARTICLE VI
[RESERVED]
ARTICLE VII
MANUFACTURE AND SUPPLY; SALES AND MARKETING
Subject to the terms and conditions of this Agreement, Collaboration Products
shall be manufactured and supplied for preclinical and clinical testing and for
commercial sale upon the following terms and conditions.
For purposes of this
Article 7, the term "Collaboration Products" shall be deemed to exclude
Aldurazyme except as explicitly provided below.
7.1 GENERAL.
FOR ANY COLLABORATION PRODUCT THAT MAY BE COMMERCIALIZED, THE
PARTIES SHALL NEGOTIATE IN GOOD FAITH TO INCLUDE THE ADDITIONAL COLLABORATION
PRODUCT TO THE MANUFACTURING MARKETING AND SALES AGREEMENT TO ALLOW FOR BIOMARIN
TO MANUFACTURE SUCH COLLABORATION PRODUCT AND FOR GENZYME TO COMMERCIALIZE SUCH
COLLABORATION PRODUCT (THE "COMMERCIALIZING PARTY") ON FINANCIAL TERMS AND SUCH
OTHER TERMS AND CONDITIONS APPROPRIATE FOR SUCH COLLABORATION PRODUCT AS MAY BE
MUTUALLY AGREED UPON BY THE PARTIES.
7.2 MANUFACTURE AND SUPPLY OF COLLABORATION PRODUCTS.
BIOMARIN/GENZYME LLC
SHALL MANUFACTURE (OR, SUBJECT TO SECTION 7.2.1, HAVE MANUFACTURED) AND SUPPLY
COLLABORATION PRODUCTS FOR
[**] = 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.
19
PRECLINICAL AND CLINICAL ACTIVITIES UPON THE FOLLOWING TERMS AND CONDITIONS (AND
SUCH OTHER TERMS AND CONDITIONS ESTABLISHED BY THE STEERING COMMITTEE CONSISTENT
WITH THE PROVISIONS OF THIS AGREEMENT):
7.2.1
GENERAL. ALL DECISIONS RELATING TO THE MANUFACTURE OF
COLLABORATION PRODUCTS SHALL BE SUBJECT TO THE APPROVAL OF, OR MODIFICATION BY,
THE STEERING COMMITTEE.
7.2.2
FACILITIES.
NOTWITHSTANDING ANY PROVISION OF THIS
AGREEMENT TO THE CONTRARY, THE PARTIES ACKNOWLEDGE AND AGREE THAT
BIOMARIN/GENZYME LLC SHALL NOT BEAR ANY COSTS RELATING TO THE CONSTRUCTION OF
MANUFACTURING FACILITIES FOR A COLLABORATION PRODUCT (OTHER THAN THROUGH NORMAL
DEPRECIATION AND