AGREEMENT.
IN THE
EVENT THE INFORMATION IN THE MRD, ON THE ONE HAND, AND THIS AGREEMENT, THE
COLLABORATION AGREEMENT OR THE QUALITY AGREEMENT, ON THE OTHER HAND, CONFLICT,
THE TERMS OF THE COLLABORATION AGREEMENT, THIS AGREEMENT OR THE QUALITY
AGREEMENT, AS APPLICABLE, WILL CONTROL.
4.4
MANUFACTURING.
SUBJECT TO THE TERMS AND
CONDITIONS OF THIS AGREEMENT, LILLY WILL USE ITS COMMERCIALLY REASONABLE EFFORTS
TO MANUFACTURE DEVICES FOR AMYLIN FROM LILLY'S FACILITIES, OR THE FACILITIES OF
ANY AGENT OF LILLY APPROVED BY AMYLIN (SUCH APPROVAL MAY NOT BE UNREASONABLY
WITHHELD OR DELAYED), AT THE TIMES AND IN THE QUANTITIES SET FORTH BY AMYLIN IN
A PURCHASE ORDER AND SUBJECT, HOWEVER, TO THE QUANTITY RESTRICTIONS SET FORTH IN
THIS AGREEMENT.
LILLY SHALL ESTABLISH DEDICATED CAPACITY FOR THE MANUFACTURE OF
DEVICES IN ACCORDANCE WITH THE DEVICE DEVELOPMENT PLAN OR AS OTHERWISE DIRECTED
BY THE COMMITTEE.
LILLY WILL USE ITS COMMERCIALLY REASONABLE EFFORTS TO ENSURE
THAT EACH SHIPMENT OF DEVICES:
(I) WILL HAVE BEEN MANUFACTURED IN ACCORDANCE
WITH THE SPECIFICATIONS, CGMP AND CQSR IN EFFECT AT THE TIME OF MANUFACTURE,
(II) WILL NOT BE ADULTERATED OR MISBRANDED WITHIN THE MEANING OF THE FD&C ACT BY
LILLY OR ANY OF ITS AGENTS, (III) WILL NOT HAVE BEEN MANUFACTURED OR SOLD IN
VIOLATION OF ANY APPLICABLE LAWS
11
IN ANY MATERIAL RESPECT, AND (IV) WILL HAVE BEEN MANUFACTURED IN ACCORDANCE WITH
APPLICABLE MARKETING APPROVALS.
4.5
MODIFICATIONS.
THE PARTIES ANTICIPATE THAT
THE SPECIFICATIONS WILL BE MODIFIED FROM TIME TO TIME TO REFLECT IMPROVEMENTS OR
MODIFICATIONS TO THE DEVICE.
ANY PROPOSED MODIFICATION TO THE SPECIFICATIONS
SHALL BE APPROVED BY THE COMMITTEE (SUBJECT TO SECTION 5.2 OF THE COLLABORATION
AGREEMENT) PRIOR TO IMPLEMENTATION OR FILING WITH ANY REGULATORY AUTHORITY.
AT
THE TIME OF ANY APPROVED CHANGE IN SPECIFICATIONS, THE PARTIES SHALL IDENTIFY
ALL COSTS AND RISKS, INCLUDING DEVICE DEVELOPMENT COSTS, RESULTING FROM THE
CHANGES, AND A TIMELINE FOR IMPLEMENTING THE CHANGES.
(A)
AMYLIN ACKNOWLEDGES THAT THE DEVICE WILL BE DEVELOPED BASED, IN
PART, UPON LILLY'S EXISTING INJECTION PEN PLATFORM AND UTILIZE MANUFACTURING
PROCEDURES BASED IN PART UPON THOSE THAT LILLY UTILIZES FOR PEN DEVICES FOR
DELIVERY OF OTHER DRUGS.
ACCORDINGLY, LILLY MAY FROM TIME TO TIME REQUEST
CHANGES TO THE SPECIFICATIONS OR SEEK TO MODIFY ITS MANUFACTURING PROCESS FOR
THE DEVICES IN ORDER TO FACILITATE PRODUCTION OF PEN DEVICES FOR DELIVERY OF
OTHER DRUGS.
AMYLIN SHALL AGREE TO ANY REQUESTED CHANGES PROVIDED SUCH
MODIFICATIONS DO NOT MATERIALLY IMPAIR THE FUNCTIONALITY OF THE DEVICE, INCREASE
ACTUAL MANUFACTURING COSTS PAYABLE BY AMYLIN OR OTHERWISE HAVE A MATERIAL
NEGATIVE IMPACT ON THE DEVICE OR AMYLIN.
LILLY WILL PROVIDE AMYLIN WITH
REASONABLE ADVANCE NOTICE OF ANY PROPOSED MATERIAL MODIFICATION AND WILL CONSULT
WITH, AND CONSIDER IN GOOD FAITH THE REASONABLE COMMENTS OF AMYLIN REGARDING
SUCH PROPOSED MATERIAL MODIFICATION.
EXCEPT FOR A CHANGE REQUIRED BY SUBSECTION
(C) BELOW, LILLY WILL BE SOLELY RESPONSIBLE FOR THE COSTS OF ANY SUCH CHANGES
REQUESTED BY IT TO THE EXTENT THAT SUCH CHANGES DO NOT RESULT IN OFF SETTING
BENEFIT TO THE DEVICE INCLUDING COSTS, QUALITY, PERFORMANCE, OR