OTHERS WITH PRIOR NOTICE OF ALL MEETINGS AND
TELECONFERENCES BETWEEN REPRESENTATIVES OF THE NOTIFYING PARTY AND REGULATORY
AUTHORITIES REGARDING ANY COLLABORATION PRODUCT FOR USE IN THE TERRITORY.
EXCEPT AS OTHERWISE PROVIDED HEREIN, THE PARTY RECEIVING SUCH NOTICE SHALL HAVE
THE RIGHT TO HAVE REPRESENTATIVES PARTICIPATE IN ALL SUCH MEETINGS AND
TELECONFERENCES.
EACH PARTY SHALL USE REASONABLE EFFORTS TO PROVIDE THE OTHER
PARTY WITH A REASONABLE OPPORTUNITY TO REVIEW AND COMMENT UPON SUBMISSIONS TO,
AND CORRESPONDENCE WITH, ANY REGULATORY AGENCY IN THE TERRITORY WITH RESPECT TO
COLLABORATION PRODUCTS PRIOR TO THE FILING OR DELIVERY OF SUCH SUBMISSIONS OR
CORRESPONDENCE.
WITHOUT LIMITING THE FOREGOING, EACH PARTY SHALL USE REASONABLE
EFFORTS TO CONFIRM IN WRITING TO THE OTHER PARTY ALL COMMUNICATIONS WITH A
REGULATORY AUTHORITY WITH RESPECT TO A REGULATORY APPROVAL (INCLUDING FILINGS
THEREFOR) AND TO PROVIDE TO THE OTHER PARTY COPIES OF ALL DOCUMENTS SENT TO OR
RECEIVED FROM SUCH REGULATORY AUTHORITY REGARDING SUCH REGULATORY APPROVALS.
5.2 DEVELOPMENT INFORMATION.
5.2.1
REPORTS AND INFORMATION EXCHANGE.
AS BETWEEN THE
PARTIES HERETO, (A) BIOMARIN/GENZYME LLC SHALL OWN ALL CLINICAL TRIAL DATA
ACCUMULATED FROM ALL CLINICAL TRIALS OF COLLABORATION PRODUCTS CONDUCTED AS PART
OF THE PROGRAM OR OTHERWISE FUNDED OR PARTIALLY FUNDED BY BIOMARIN/GENZYME LLC
AND (B) SUBJECT TO THE LICENSE GRANTED PURSUANT TO SECTION 3.1 ABOVE, BIOMARIN
OR GENZYME, AS THE CASE MAY BE, SHALL OWN ALL CLINICAL TRIAL DATA ACCUMULATED
FROM ALL CLINICAL TRIALS OF COLLABORATION PRODUCTS THAT ARE NOT CONDUCTED AS
PART OF THE PROGRAM.
EACH OF BIOMARIN AND GENZYME SHALL USE COMMERCIALLY
REASONABLE AND DILIGENT EFFORTS TO DISCLOSE TO BIOMARIN/GENZYME LLC AND TO THE
OTHER PARTY ALL MATERIAL INFORMATION RELATING TO ANY COLLABORATION PRODUCT
PROMPTLY AFTER IT IS LEARNED OR ITS MATERIALITY IS APPRECIATED.
THE PARTY
PERFORMING OR SUPERVISING CLINICAL TRIALS OF COLLABORATION PRODUCTS IN
ACCORDANCE WITH THE DEVELOPMENT PLAN SHALL, ON BEHALF AND IN THE NAME OF
BIOMARIN/GENZYME LLC, MAINTAIN THE DATABASE OF CLINICAL TRIAL DATA ACCUMULATED
FROM ALL CLINICAL TRIALS OF COLLABORATION PRODUCTS AND OF ADVERSE REACTION
INFORMATION FOR ALL SUCH COLLABORATION PRODUCTS.
EACH PARTY SHALL ALSO KEEP THE
PROGRAM MANAGEMENT TEAM INFORMED AS TO ITS PROGRESS IN THE DEVELOPMENT PLAN.
ALL PROTOCOLS FOR CLINICAL TRIALS TO BE CONDUCTED, AND ALL PRODUCT REGISTRATION
PLANS, FOR COLLABORATION PRODUCTS FOR APPLICATIONS WITHIN THE FIELD IN 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.
17
TERRITORY SHALL BE SUBMITTED TO THE PROGRAM MANAGEMENT TEAM FOR REVIEW AND
COMMENT BY THE PROGRAM MANAGEMENT TEAM PRIOR TO FILING OF SUCH PROTOCOLS OR
REGISTRATIONS WITH ANY REGULATORY AGENCY.
WITHIN SIXTY (60) DAYS FOLLOWING THE
END OF EACH CALENDAR QUARTER DURING THE DEVELOPMENT PROGRAM, EACH OF BIOMARIN
AND GENZYME SHALL PROVIDE THE OTHER PARTIES WITH A REASONABLY DETAILED WRITTEN
REPORT DESCRIBING THE PROGRESS TO DATE OF ALL ACTIVITIES FOR WHICH SUCH PARTY
WAS ALLOCATED RESPONSIBILITY DURING SUCH QUARTER UNDER THE DEVELOPMENT PLAN.
5.2.2
ADVERSE REACTION REPORTING.
EACH OF BIOMARIN AND
GENZYME SHALL NOTIFY THE OTHER