COMMERCIALIZATION COSTS INCURRED ON OR AFTER JANUARY 1, 2008, (Y) ALL FULLY
ABSORBED COSTS INCURRED ON OR AFTER JANUARY 1, 2008 EXCEPT WITH RESPECT TO
QUANTITIES OF COLLABORATION PRODUCTS REQUIRED FOR THE ACTIVITIES DESCRIBED IN
CLAUSE (II) ABOVE AND (Z) ALL OTHER COSTS THAT ARE ALLOCATED BETWEEN THE PARTIES
UNDER THE MANUFACTURING, MARKETING AND SALES AGREEMENT OR THE FILL AGREEMENT OF
EVEN DATE HEREWITH BY AND BETWEEN BIOMARIN AND GENZYME (THE "FILL AGREEMENT").
THE PARTIES SHALL MAINTAIN SEPARATE RECORDS FOR PROGRAM COSTS INCURRED ON OR
PRIOR TO DECEMBER 31, 2007 AND FOR PROGRAM COSTS INCURRED ON OR AFTER THE
EFFECTIVE DATE.
1.36
"PROGRAM MANAGEMENT TEAM" SHALL MEAN THE JOINT TEAM
COMPOSED OF REPRESENTATIVES OF GENZYME AND BIOMARIN DESCRIBED IN SECTION 8.1.1
HEREOF.
1.37
"REGULATORY APPROVALS" SHALL MEAN ALL APPROVALS FROM
REGULATORY AUTHORITIES IN ANY COUNTRY IN THE TERRITORY REQUIRED LAWFULLY TO
MANUFACTURE AND MARKET COLLABORATION PRODUCTS IN ANY SUCH COUNTRY, INCLUDING
WITHOUT LIMITATION APPROVAL OF ANY BLA, ANY ESTABLISHMENT LICENSE APPLICATION
FILED WITH THE FDA TO OBTAIN APPROVAL OF THE FACILITIES AND EQUIPMENT TO BE USED
TO MANUFACTURE A COLLABORATION PRODUCT, AND ANY PRODUCT PRICING APPROVALS WHERE
APPLICABLE.
1.38
"REGULATORY SCHEME" SHALL MEAN THE UNITED STATES
PUBLIC HEALTH SERVICE ACT AND THE REGULATIONS, INTERPRETATIONS AND GUIDELINES
PROMULGATED THEREUNDER BY THE FDA OR THE REGULATORY SCHEME APPLICABLE TO THE
COLLABORATION PRODUCTS IN ANY COUNTRY OTHER THAN THE UNITED STATES, AS SUCH
STATUTES, REGULATIONS, INTERPRETATIONS AND GUIDELINES OR REGULATORY SCHEMES MAY
BE AMENDED FROM TIME TO TIME.
1.39
"RELATED AGREEMENTS" SHALL MEAN THE MANUFACTURING,
MARKETING AND SALES AGREEMENT, THE MEMBERS AGREEMENT, THE FILL/FINISH
MANUFACTURING AGREEMENT AND THE OPERATING AGREEMENT.
1.40
"SPECIFICATIONS" WITH RESPECT TO A PARTICULAR
COLLABORATION PRODUCT (OTHER THAN ALDURAZYME) SHALL MEAN THE WRITTEN
SPECIFICATIONS FOR SUCH COLLABORATION PRODUCT DETERMINED BY THE PROGRAM
MANAGEMENT TEAM AND APPROVED BY THE STEERING COMMITTEE; PROVIDED THAT SUCH
SPECIFICATIONS SHALL AT ALL TIMES COMPLY WITH THE RELEVANT REGULATORY SCHEME IN
THE COUNTRY OF SALE AND IN THE COUNTRY OF USE.
SUCH SPECIFICATIONS MAY BE
AMENDED FROM TIME TO TIME BY THE PROGRAM MANAGEMENT TEAM PROVIDED THAT SUCH
AMENDMENTS ARE APPROVED BY THE STEERING COMMITTEE OR THE WRITTEN AGREEMENT OF
THE PARTIES, AS THE CASE MAY BE.
COPIES OF THE THEN-CURRENT SPECIFICATIONS
SHALL BE MAINTAINED BY BOTH BIOMARIN AND GENZYME AND SHALL BECOME A PART OF THIS
AGREEMENT AS IF INCORPORATED HEREIN.
THE TERM "SPECIFICATIONS" WITH RESPECT TO
ALDURAZYME SHALL HAVE THE MEANING SET FORTH IN THE MANUFACTURING, MARKETING AND
SALES AGREEMENT.
1.41
"STEERING COMMITTEE" SHALL MEAN THE GOVERNING BODY
OF BIOMARIN/GENZYME LLC COMPOSED OF REPRESENTATIVES OF BIOMARIN AND GENZYME
APPOINTED AS DESCRIBED IN SECTION 8.2.1 HEREOF.
[**] = 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.
7
1.42
"TECHNOLOGY" SHALL MEAN INVENTIONS, TRADE SECRETS,
COPYRIGHTS, KNOW-HOW, DATA AND OTHER INTELLECTUAL PROPERTY OF ANY KIND
(INCLUDING WITHOUT LIMITATION ANY PROPRIETARY BIOLOGICAL OR OTHER MATERIALS,
COMPOUNDS OR REAGENTS, BUT NOT INCLUDING PATENT RIGHTS).
1.43
"TERM" SHALL MEAN THE