SAFETY, AS
REASONABLY AGREED BY THE PARTIES.
(B)
EITHER PARTY WILL NOTIFY THE OTHER AS SOON AS PRACTICAL OF ANY
CHANGES TO ANY SPECIFICATIONS OR PROCEDURES THAT ARE REQUIRED BY THE FDA, A
REGULATORY AUTHORITY OR APPLICABLE LAWS THAT COULD HAVE AN IMPACT ON LILLY'S
PERFORMANCE OF THIS AGREEMENT.
LILLY SHALL UTILIZE ITS COMMERCIALLY REASONABLE
EFFORTS TO IMPLEMENT SUCH CHANGES.
(C)
IN NO EVENT WILL LILLY BE REQUIRED TO MAKE A MODIFICATION THAT IS
PROHIBITED BY APPLICABLE LAWS OR REGULATORY AUTHORITIES.
IN NO EVENT WILL LILLY
BE PROHIBITED FROM MAKING A MODIFICATION THAT IS REQUIRED BY APPLICABLE LAWS OR
REGULATORY AUTHORITIES UNDER THIS SECTION; PROVIDED, HOWEVER, THAT LILLY SHALL
CONSULT WITH AMYLIN PRIOR TO MAKING ANY SUCH MODIFICATION; AND PROVIDED FURTHER
THAT LILLY SHALL USE ITS COMMERCIALLY REASONABLE EFFORTS TO IMPLEMENT ANY SUCH
MODIFICATION.
12
4.6
QUALITY CONTROL AND ASSURANCE; CGMP AUDIT.
(A)
QUALITY CONTROL AND ASSURANCE.
LILLY WILL USE ITS COMMERCIALLY
REASONABLE EFFORTS TO MANUFACTURE THE DEVICES IN COMPLIANCE WITH THE
SPECIFICATIONS.
LILLY WILL PERFORM QUALITY CONTROL TESTING AND QUALITY
OVERSIGHT ON THE DEVICES TO BE DELIVERED TO AMYLIN HEREUNDER IN ACCORDANCE WITH
THE MRD, QUALITY AGREEMENT, SPECIFICATIONS, CGMP AND CQSRS.
(B)
ACCESS TO LILLY FACILITIES BY AMYLIN REPRESENTATIVES.
UPON NO
LESS THAN FORTY-FIVE (45) DAYS' ADVANCE WRITTEN NOTICE TO LILLY AND, NO MORE
THAN TWO (2) TIMES EACH CALENDAR YEAR, EXCEPT IN THE CASE OF AMYLIN ATTENDANCE
AT INSPECTIONS BY REGULATORY AUTHORITIES OR QUALITY AUDITS (DEFINED BELOW) BY
AMYLIN THAT ARE REQUIRED BY APPLICABLE LAWS, LILLY WILL PERMIT AMYLIN'S
REPRESENTATIVES (SUCH REPRESENTATIVES TO BE REASONABLY ACCEPTABLE TO LILLY) TO
CONDUCT AN AUDIT OF LILLY'S FACILITIES DURING REGULAR BUSINESS HOURS FOR THE
PURPOSE OF MAKING QUALITY CONTROL INSPECTIONS TO ASSURE CGMP COMPLIANCE OF THE
FACILITIES USED IN THE MANUFACTURING OF THE DEVICES FOR AMYLIN (THE "QUALITY
AUDIT").
AMYLIN REPRESENTATIVES SHALL HAVE THE RIGHT TO REINSPECT SUCH
FACILITIES UPON REASONABLE ADVANCE WRITTEN NOTICE TO LILLY, AT A TIME TO BE
AGREED BY THE PARTIES IN THE EVENT OF SIGNIFICANT ADVERSE FINDINGS DURING AN
AMYLIN QUALITY AUDIT OR REGULATORY AUDIT, OR PRODUCT RECALLS REQUIRING
RESOLUTION BY THE PARTIES.
AMYLIN REPRESENTATIVES WILL BE ADVISED OF THE
CONFIDENTIALITY OBLIGATIONS UNDER THIS AGREEMENT, AND WILL FOLLOW SUCH SECURITY,
SAFETY AND FACILITY ACCESS PROCEDURES AS ARE REASONABLY DESIGNATED BY LILLY.
Lilly may require that at all times the Amylin representatives be accompanied by
a Lilly representative to assure protection of Lilly Information or confidential
information of a Third Person.
Lilly will respond in writing to any written
audit observations provided by Amylin within sixty (60) days in the form of a
mutually agreed upon action plan.
(C)
SAFETY PROCEDURES.
LILLY WILL HAVE RESPONSIBILITY FOR DEVELOPING,
ADOPTING AND ENFORCING SAFETY PROCEDURES FOR THE HANDLING AND PRODUCTION OF
DEVICES BY LILLY AND THE HANDLING AND DISPOSAL OF ALL WASTE RELATING THERETO.
LILLY'S RESPONSIBILITY FOR THE HANDLING OF ANY PARTICULAR DEVICE WILL TERMINATE
AS TO THAT PARTICULAR DEVICE UPON DELIVERY THEREOF TO AMYLIN'S COMMON CARRIER.
(D)
APPLICABLE LAWS.
LILLY AND AMYLIN WILL EACH COMPLY WITH ALL
APPLICABLE