ANY OTHER SIMILAR OR DISSIMILAR CAUSE, IN EACH CASE
TO THE EXTENT BEYOND ITS REASONABLE CONTROL ("FORCE MAJEURE") , SUCH PARTY WILL
PROVIDE WRITTEN NOTICE OF SUCH EVENT TO THE OTHER PARTY.
SAID NOTICE WILL BE
PROVIDED WITHIN FIVE (5) BUSINESS DAYS OF THE OCCURRENCE OF SUCH EVENT AND WILL
IDENTIFY THE REQUIREMENTS OF THIS
35
AGREEMENT OR SUCH OF ITS OBLIGATIONS AS MAY BE AFFECTED, AND, TO THE EXTENT SO
AFFECTED, SAID OBLIGATIONS WILL BE SUSPENDED DURING THE PERIOD OF SUCH
DISABILITY.
THE PARTY PREVENTED FROM PERFORMING HEREUNDER WILL USE COMMERCIALLY
REASONABLY EFFORTS TO REMOVE SUCH DISABILITY AS PROMPTLY AS POSSIBLE AND WILL
CONTINUE PERFORMANCE WHENEVER SUCH CAUSES ARE REMOVED.
THE PARTY SO AFFECTED
WILL GIVE TO THE OTHER PARTY A GOOD FAITH ESTIMATE OF THE CONTINUING EFFECT OF
THE FORCE MAJEURE CONDITION AND THE DURATION OF THE AFFECTED PARTY'S
NONPERFORMANCE.
IF THE PERIOD OF ANY PREVIOUS ACTUAL NONPERFORMANCE OF A PARTY
BECAUSE OF FORCE MAJEURE CONDITIONS PLUS THE ANTICIPATED FUTURE PERIOD OF SUCH
PARTY'S NONPERFORMANCE BECAUSE OF SUCH CONDITIONS WILL EXCEED AN AGGREGATE OF
ONE HUNDRED TWENTY (120) DAYS WITHIN ANY ONE YEAR PERIOD, THE OTHER PARTY MAY
TERMINATE THIS AGREEMENT BY PRIOR WRITTEN NOTICE TO THE NONPERFORMING PARTY.
16.15
Interpretation.
In the event of any conflict between this
Agreement and the Collaboration Agreement, the terms of this Agreement shall
control.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the
date first above written.
ELI LILLY AND COMPANY
By:
Pedro P. Granadillo
Senior Vice President
AMYLIN PHARMACEUTICALS, INC.
By:
Printed Name:
Title:
36
EXHIBIT A
DEFINITION OF ALLOCATION OF SERVICE FOR
ACTUAL MANUFACTURING COST CALCULATION
"Actual Manufacturing Cost" will include Lilly's costs for allocation of
service, in addition to other cost elements.
Calculation of the Actual
Manufacturing Cost will be consistent with the usual methodology utilized by
Lilly to calculate Lilly's Cost of Products Sold.
Allocation of services is the cost of the indirect materials, indirect labor and
all other expenses incurred in the support of production and for the acquisition
of materials related to production of the Devices.
The labor related charges
included in the Allocation of Services would be calculated using the then
current FTE Rate.
To the extent the costs above are not directly traceable to
production of the Device, Lilly in good faith will apply reasonable allocation
methods to such costs.
Examples of items that are incorporated as part of the
Allocation of Services include:
(1)
repair and maintenance;
(2)
on-going qualification/validation;
(3)
manufacturing equipment and manufacturing
support equipment calibration costs;
(4)
utilities;
(5)
depreciation and amortization;
(6)
raw material testing;
(7)
pre-inspection approval costs (including
validation costs), which consists of Lilly's internal labor and any
out-of-pocket costs on an actual dollar for dollar basis;
(8)
Prorated costs for manufacturing
administration such as complaint handling, customer service, technical
stewardship, logistics, production planning, regulatory support, training and
development, procedure coordination, procurement, finance and IT support, and
(9)
Other costs that are required to support
the manufacture of Device in