of this Agreement will survive any expiration or earlier termination
of this Agreement: Sections 2.6, 2.7, 2.8, 3.3, 4.1, 4.3, 5.2, 5.3, 5.4, 5.5,
5.6, 5.7, 5.10, 6.1, 6.4 6.5 and Articles 7, 8 and 9.
Article 5
Recordkeeping; Audits; Recalls
SECTION 5.1
MANUFACTURING QUALITY.
BAXTER
SHALL PERFORM THE OBLIGATIONS ASCRIBED TO BAXTER IN EXHIBIT E (INCLUDING
EXHIBITS E-1 AND E-2) (THE "QUALITY OBLIGATIONS"). IF CERUS DESIRES TO CHANGE
THE QUALITY OBLIGATIONS, SUCH CHANGES SHALL BE SUBJECT TO MUTUAL AGREEMENT BY
BOTH PARTIES AND MAY REQUIRE ADDITIONAL COMPENSATION TO BAXTER FOR MEETING SUCH
CHANGES. ALL MANUFACTURED PRODUCTS SHALL MEET THE PRODUCT SPECIFICATIONS AND
SHALL BE SUBJECTED TO QUALITY CONTROL INSPECTIONS BY BAXTER IN ACCORDANCE WITH
BAXTER'S QUALITY CONTROL STANDARDS AND SYSTEM.
SECTION 5.2
RECORD KEEPING.
BAXTER WILL
MAINTAIN THE DESIGN HISTORY FILE FOR THE PROCESS BY WHICH THE MANUFACTURED
PRODUCTS ARE PRODUCED AND THE COMPONENTS MASTER RECORD AND A COMPONENTS HISTORY
RECORD AS DESCRIBED IN THE QUALITY OBLIGATIONS. CERUS MAY HAVE ACCESS TO THE
MANUFACTURED PRODUCTS MASTER RECORD AND COMPONENTS HISTORY RECORD WHEN
15
necessary for purposes of audit.
Baxter shall continue to maintain the
Manufactured Products Master Record and Components History Record consistent
with Baxter's record retention policy and in accordance with regulatory
requirements.
SECTION 5.3
CUSTOMER COMPLAINTS.
IN THE
EVENT THAT ANY PARTY RECEIVES ANY COMPLAINT REGARDING THE PRODUCTS THAT MAY BE
CAUSED BY THE MANUFACTURED PRODUCTS PROVIDED UNDER THIS AGREEMENT, IT SHALL
NOTIFY THE OTHER PARTIES PROMPTLY.
BAXTER WILL ASSIST CERUS BY INVESTIGATING
THE PORTION OF THESE COMPLAINTS RELATING TO THE MANUFACTURED PRODUCTS AND
RESPONDING TO CERUS IN WRITING.
CERUS WILL MAKE AN EVALUATION OF EACH COMPLAINT
IT RECEIVES AND WILL CONDUCT ALL FOLLOW-UP AND COMMUNICATION WHICH IT DEEMS
APPROPRIATE. CERUS SHALL PROVIDE BAXTER WITH NOTICE OF ANY COMMUNICATIONS TO THE
REGULATING GROUPS THAT REFERS TO BAXTER AND COPIES OF ALL SUCH COMMUNICATION
(REDACTED TO PROTECT ANY CERUS PROPRIETARY INFORMATION).
SECTION 5.4
QUALITY AUDITS.
BAXTER SHALL
PERMIT CERUS TO REVIEW PERIODICALLY BAXTER'S PRODUCTION AND QUALITY CONTROL
PROCEDURES AND RECORDS AND TO VISIT BAXTER'S FACILITIES WITH REASONABLE
FREQUENCY AND AT REASONABLE TIMES, NOT TO EXCEED ONCE IN ANY TWELVE (12) MONTH
PERIOD PER FACILITY, (WITH A REPRESENTATIVE OF BAXTER PRESENT) IN ORDER TO
ASSURE SATISFACTION OF THE QUALITY OBLIGATIONS.
Section 5.5
Government Inspections.
Each
Party will promptly inform the other of any inspection by regulatory authority
in a country in the Territory that has authority or jurisdiction over the
Manufactured Products, whether relating to its development, manufacture,
marketing and commercialization, handling, storage, transportation, destruction,
or otherwise ("Regulating Groups"), related to the Manufactured Products, or the
facilities used to produce, test, or package the same.
A copy of all
observations and all warning letters concerning the production and distribution
of the Manufactured Products, and any related correspondence, will be promptly
provided by each Party to the other.
The Parties will assist each other in
responding to any warning letters, but the final responsibility to respond to
such matters will be that of the Party to whom such Regulating