PARTIES OF ANY ADVERSE REACTION INFORMATION
RELATING TO ANY COLLABORATION PRODUCT WITHIN TWENTY-FOUR (24) HOURS OF THE
RECEIPT OF SUCH INFORMATION AND AS NECESSARY FOR COMPLIANCE WITH REGULATORY
REQUIREMENTS.
"ADVERSE REACTION INFORMATION" INCLUDES WITHOUT LIMITATION
INFORMATION RELATING TO ANY EXPERIENCE THAT (A) SUGGESTS A SIGNIFICANT HAZARD,
CONTRAINDICATION, SIDE EFFECT OR PRECAUTION, (B) IS FATAL OR LIFE THREATENING,
(C) IS PERMANENTLY DISABLING, (D) REQUIRES OR PROLONGS INPATIENT
HOSPITALIZATION, (E) INVOLVES A CONGENITAL ANOMALY, CANCER OR OVERDOSE OR (F) IS
ONE NOT IDENTIFIED IN NATURE, SPECIFICITY, SEVERITY OR FREQUENCY IN THE CURRENT
INVESTIGATOR BROCHURE OR THE UNITED STATES LABELING FOR THE COLLABORATION
PRODUCT.
5.2.3
CLINICAL AND REGULATORY AUDITS.
EACH OF BIOMARIN AND
GENZYME SHALL PERMIT BIOMARIN/GENZYME LLC AND THE OTHER PARTY OR THE
REPRESENTATIVES OF BIOMARIN/GENZYME LLC OR THE OTHER PARTY TO HAVE ACCESS DURING
REGULAR BUSINESS HOURS AND UPON REASONABLE ADVANCE NOTICE, AT THE AUDITING
PARTY'S OWN EXPENSE AND NO MORE THAN ONCE IN EACH CALENDAR YEAR DURING THE TERM,
TO THE NON-AUDITING PARTY'S RECORDS AND FACILITIES RELATING TO THE DEVELOPMENT
PROGRAM FOR THE PURPOSE OF MONITORING COMPLIANCE WITH GOOD CLINICAL PRACTICE AND
OTHER APPLICABLE REQUIREMENTS OF THE REGULATORY SCHEME IN CONNECTION WITH SUCH
PARTY'S PERFORMANCE OF ITS OBLIGATIONS HEREUNDER.
5.3 REGULATORY APPROVAL FILINGS.
EXCEPT AS SET FORTH IN THE MANUFACTURING,
MARKETING AND SALES AGREEMENT, REGULATORY APPROVAL FILINGS IN THE TERRITORY FOR
THE COLLABORATION PRODUCTS AND FOR THE FACILITIES USED TO MANUFACTURE SUCH
COLLABORATION PRODUCTS SHALL BE FILED IN THE NAME OF BIOMARIN/GENZYME LLC OR, IF
REQUIRED WITH RESPECT TO FILINGS TO BE MADE WITH GOVERNMENTAL AUTHORITIES OR
DEEMED TO BE IN THE BEST INTEREST OF THE PARTIES BY THE STEERING COMMITTEE, IN
THE NAME OF SUCH OTHER ENTITY AS MAY BE AGREED UPON BY THE STEERING COMMITTEE
(SUCH AS FILINGS WITH EUROPEAN REGULATORY AUTHORITIES).
PRIOR TO SUBMISSION TO
THE FDA, THE PARTIES, THROUGH THE PROGRAM MANAGEMENT TEAM, SHALL CONSULT,
COOPERATE IN PREPARING AND MUTUALLY AGREE ON THE CONTENT AND SCOPE OF SUCH
REGULATORY APPROVAL FILINGS.
IN THE EVENT THAT REGULATORY APPROVALS ARE
REQUIRED TO BE FILED IN THE NAME OF AN ENTITY OTHER THAN BIOMARIN/GENZYME LLC,
THE STEERING COMMITTEE SHALL ENSURE THAT A DULY AUTHORIZED OFFICER OF SUCH
ENTITY AGREES IN WRITING THAT (A) SUCH ENTITY SHALL HOLD THE LICENSES ISSUED IN
RESPECT OF SUCH REGULATORY APPROVAL FILINGS, MAINTAIN CONTROL OVER THE
MANUFACTURING FACILITIES, EQUIPMENT AND PERSONNEL, AND ENGAGE IN
PHARMACOVIGILENCE TO THE EXTENT REQUIRED BY THE REGULATORY SCHEME, (B) SUCH
ENTITY SHALL MAINTAIN COMPLIANCE WITH APPLICABLE REGULATORY SCHEMES, (C) SUCH
ENTITY SHALL PROVIDE MANUFACTURING AND SUPPLY SERVICES TO BIOMARIN/GENZYME LLC
AT THE FULLY ABSORBED COST OF GOODS OF COLLABORATION PRODUCTS SO MANUFACTURED
AND SUPPLIED, (D) THE PARTIES SHALL HAVE AN IRREVOCABLE RIGHT OF ACCESS AND
REFERENCE TO SUCH REGULATORY APPROVAL FILINGS, LICENSES AND FACILITIES AND
(E) SUCH ENTITY AGREES TO COMPLY WITH THE PROVISIONS OF ARTICLE 12 OF THE
MANUFACTURING, MARKETING AND SALES AGREEMENT WITH RESPECT TO THE
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.
An unredacted version of this exhibit