inspecting agency.
7.6 ACCESS TO FACILITIES.
EACH PARTY SHALL HAVE THE RIGHT TO AUDIT ANNUALLY
THOSE PORTIONS OF THE MANUFACTURING, FINISH PROCESSING OR STORAGE FACILITIES OF
THE MANUFACTURING PARTY WHERE COLLABORATION PRODUCTS ARE BEING MANUFACTURED,
FINISHED OR STORED, OR ANY SUBCONTRACTOR WHO IS MANUFACTURING, FINISHING OR
STORING COLLABORATION PRODUCTS FOR THE MANUFACTURING PARTY, AT ANY TIME DURING
REGULAR BUSINESS HOURS AND UPON REASONABLE ADVANCE NOTICE TO ASCERTAIN
COMPLIANCE WITH THE GOOD MANUFACTURING PRACTICES OF THE FDA OR OTHER APPLICABLE
REGULATORY AUTHORITY, AS THE SAME MAY BE AMENDED FROM TIME TO TIME.
SUBJECT TO
THE TERMS AND CONDITIONS OF SECTION 10.1 BELOW, CONFIDENTIAL INFORMATION
DISCLOSED TO OR OTHERWISE GATHERED BY THE PARTY CONDUCTING SUCH INSPECTION
DURING ANY SUCH INSPECTION SHALL BE MAINTAINED AS CONFIDENTIAL.
7.7 RESPONSIBILITIES OF THE OTHER PARTIES.
NO PARTY OTHER THAN THE
COMMERCIALIZATION PARTY SHALL ACTIVELY SOLICIT FOR ITS OWN ACCOUNT SALES OF
COLLABORATION PRODUCTS IN THE TERRITORY.
ANY SOLICITATIONS OR REQUESTS TO
PURCHASE COLLABORATION PRODUCTS RECEIVED BY A PARTY OTHER THAN THE
COMMERCIALIZATION PARTY FROM ANY CUSTOMER OR PROSPECTIVE SHALL BE IMMEDIATELY
REFERRED TO THE COMMERCIALIZATION PARTY.
ARTICLE VIII
MANAGEMENT
8.1 PROGRAM MANAGEMENT TEAM.
8.1.1
GENERAL.
THE PARTIES HAVE ESTABLISHED A PROGRAM
MANAGEMENT TEAM TO OVERSEE AND CONTROL DEVELOPMENT OF COLLABORATION PRODUCTS.
THE PROGRAM MANAGEMENT TEAM IS AND SHALL CONTINUE TO BE COMPOSED OF FOUR
(4) REPRESENTATIVES APPOINTED BY BIOMARIN AND FOUR (4) REPRESENTATIVES APPOINTED
BY GENZYME.
SUCH REPRESENTATIVES WILL INCLUDE INDIVIDUALS WITH EXPERTISE AND
RESPONSIBILITIES IN SUCH AREAS AS PRECLINICAL DEVELOPMENT, CLINICAL DEVELOPMENT,
MANUFACTURING, AND REGULATORY AFFAIRS.
THE PROGRAM MANAGEMENT TEAM SHALL MEET
AS NEEDED BUT NOT LESS THAN MONTHLY.
THE PROGRAM MANAGEMENT TEAM SHALL APPOINT
ONE OF ITS MEMBERS TO ACT AS SECRETARY.
SUCH MEETINGS SHALL BE AT TIMES AND
PLACES OR IN SUCH FORM (E.G., TELEPHONE OR VIDEO CONFERENCE) AS THE MEMBERS OF
THE PROGRAM MANAGEMENT TEAM SHALL AGREE.
A PARTY MAY CHANGE ONE OR MORE OF ITS
REPRESENTATIVES TO THE PROGRAM MANAGEMENT TEAM AT ANY TIME.
MEMBERS OF THE
PROGRAM MANAGEMENT TEAM MAY BE REPRESENTED AT ANY MEETING BY ANOTHER MEMBER OF
THE PROGRAM MANAGEMENT TEAM OR BY A DEPUTY.
ANY APPROVAL, DETERMINATION OR
OTHER ACTION AGREED TO BY A MAJORITY OF THE MEMBERS OF THE PROGRAM MANAGEMENT
TEAM APPOINTED BY EACH OF BIOMARIN AND GENZYME OR THEIR DEPUTIES PRESENT AT THE
RELEVANT TEAM MEETING SHALL BE THE APPROVAL, DETERMINATION OR OTHER ACTION OF
THE PROGRAM MANAGEMENT TEAM, PROVIDED AT LEAST TWO (2) REPRESENTATIVES OF EACH
OF BIOMARIN AND GENZYME ARE PRESENT AT SUCH MEETING.
REPRESENTATIVES OF EITHER
BIOMARIN AND GENZYME WHO ARE NOT MEMBERS OF THE PROGRAM MANAGEMENT TEAM MAY
ATTEND MEETINGS OF THE
[**] = 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.
21
PROGRAM MANAGEMENT TEAM AS AGREED TO BY THE REPRESENTATIVE MEMBERS OF THE OTHER
PARTY.
THE PROGRAM MANAGEMENT TEAM MAY DESIGNATE PROJECT LEADERS TO THE EXTENT
IT DEEMS IT NECESSARY OR ADVISABLE.
THE PARTIES SPECIFICALLY AGREE THAT THE
PRODUCT