TO THOSE PRODUCT QUALITY
COMPLAINTS ASSOCIATED WITH ADVERSE EVENTS, BY CONTACTING THE MLNM MEDICAL DRUG
INFORMATION CALL CENTER AT 1-866-VELCADE.
6.5
MLNM RESPONSIBILITY.
6.5.1
MLNM SHALL BE SOLELY RESPONSIBLE FOR (A) TAKING ALL ACTIONS AND
CONDUCTING ALL COMMUNICATION WITH ALL THIRD PARTIES IN RESPECT OF THE PRODUCT IN
THE UNITED STATES AND ITS TERRITORIES AND POSSESSIONS (OTHER THAN THE ACTIVITIES
TO BE PERFORMED BY OBI IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT OR THE
CO-PROMOTION PLAN), INCLUDING RESPONDING TO ALL PRODUCT QUALITY COMPLAINTS IN
RESPECT THEREOF, INCLUDING COMPLAINTS RELATED TO TAMPERING OR CONTAMINATION, AND
(B) INVESTIGATING, COMMUNICATING AND PROCESSING ALL PRODUCT QUALITY COMPLAINTS,
INFORMATION IT RECEIVES UNDER SECTION 6.3 AS IT RELATES TO SAFETY AND EFFICACY
CLAIMS, ADVERSE EVENTS, AND FIELD ALERTS IN RESPECT OF THE PRODUCT IN ACCORDANCE
WITH MLNM'S STANDARD PROCEDURES, THE PHARMACOVIGILANCE AGREEMENT ENTERED INTO BY
MLNM AND ORTHO BIOTECH, DATED MARCH 8, 2004, AS AMENDED FROM TIME TO TIME, AND
THE QUALITY AGREEMENT ENTERED INTO BY MLNM AND CILAG AG, AN AFFILIATE OF OBI,
DATED JANUARY 5, 2005, AS AMENDED FROM TIME TO TIME, AS APPLICABLE.
6.5.2
MLNM SHALL BE SOLELY RESPONSIBLE FOR THE PREPARATION, SUBMISSION
AND PROSECUTION OF ANY APPLICATION, REPORT, SUBMISSION AND RESPONSE TO ANY
GOVERNMENTAL AUTHORITIES IN CONNECTION WITH THE PRODUCT, INCLUDING REPORTING
ADVERSE EVENTS AND FIELD ALERTS; PROVIDED THAT WHEN FEASIBLE, MLNM SHALL CONSULT
WITH OBI WITH RESPECT TO ANY SUCH MATTER AND GIVE DUE CONSIDERATION TO ANY
COMMENTS PROVIDED BY OBI.
6.6
OBI COMMUNICATIONS.
UNLESS REQUIRED BY APPLICABLE LAW, OBI SHALL NOT
COMMUNICATE DIRECTLY WITH ANY GOVERNMENTAL AUTHORITIES REGARDING THE PRODUCT OR
OTHERWISE TAKE ANY ACTION CONCERNING ANY APPLICATION, REGISTRATION,
AUTHORIZATION OR APPROVAL UNDER WHICH THE PRODUCT IS SOLD.
OBI SHALL NOTIFY
MLNM PROMPTLY OF ANY COMMUNICATIONS WITH ANY GOVERNMENT AUTHORITIES CONCERNING
THE PRODUCT AND SHALL, TO THE EXTENT PERMITTED BY APPLICABLE LAW, ATTACH COPIES
OF ALL SUCH COMMUNICATIONS TO THE NOTICE SENT.
6.7
OBI COOPERATION.
OBI SHALL, AT MLNM'S EXPENSE, COOPERATE WITH ALL OF
MLNM'S REASONABLE REQUESTS AND USE ITS REASONABLE EFFORTS TO ASSIST MLNM IN
CONNECTION WITH (A) PREPARING ANY AND ALL SUCH REPORTS WITH GOVERNMENTAL
AUTHORITIES, (B) PREPARING AND
21
DISSEMINATING ALL SUCH COMMUNICATIONS WITH THIRD PARTIES, AND (C) INVESTIGATING
AND RESPONDING TO ANY PRODUCT QUALITY COMPLAINT OR ADVERSE EVENT RELATED TO THE
PRODUCT.
ARTICLE VII
AUDIT RIGHTS
7.1
AUDIT RIGHT PERIOD.
MLNM AND OBI EACH AGREE THAT IT SHALL, MAINTAIN
TRUE AND COMPLETE BOOKS AND RECORDS WITH RESPECT TO THE PERFORMANCE OF THEIR
OBLIGATIONS HEREUNDER, INCLUDING WITHOUT LIMITATION, REPORTS, TRAINING
ASSESSMENTS, FIELD COMMUNICATIONS AND DIRECTIONS, COMMUNICATIONS REGARDING
ADVERSE EVENTS AND COMMUNICATIONS TO OR FROM GOVERNMENTAL AUTHORITIES, OF ITEMS
UNDERLYING ALL PAYMENT CALCULATIONS, NET SALES AND INVOICES RELATED TO THIS
AGREEMENT OR THE CO-PROMOTION PLAN (THE "BOOKS AND RECORDS").
7.2
COMPLIANCE WITH LAWS. SUBJECT TO OBI'S RIGHT TO PRESERVE ITS
ATTORNEY-CLIENT PRIVILEGE,, MLNM AND/OR ITS AUTHORIZED AGENT MAY, AT ANYTIME
DURING THE CO-PROMOTION TERM, WITH PRIOR WRITTEN NOTICE TO OBI AND DURING NORMAL
BUSINESS HOURS, PERFORM AN AUDIT OF THE BOOKS AND RECORDS OF OBI FOR