PARTIES, BUT NO
LESS THAN ONCE EACH QUARTER. SUCH MEETINGS MAY BE IN-PERSON, VIA VIDEO
CONFERENCE, OR VIA TELEPHONE CONFERENCE. AT LEAST FIVE (5) BUSINESS DAYS PRIOR
TO EACH SCWT MEETING, EACH PARTY WILL PROVIDE WRITTEN NOTICE TO THE OTHER PARTY
OF AGENDA ITEMS PROPOSED BY SUCH PARTY FOR DISCUSSION OR DECISION AT SUCH
MEETING, TOGETHER WITH APPROPRIATE INFORMATION RELATED THERETO. WRITTEN MINUTES
WILL BE KEPT OF ALL SCWT MEETINGS AND WILL REFLECT, WITHOUT LIMITATION, MATERIAL
DECISIONS MADE AT SUCH MEETINGS. RESPONSIBILITY FOR KEEPING MINUTES WILL
ALTERNATE BETWEEN THE PARTIES.
2.3
QUALITY GOVERNANCE. THE PARTIES HAVE
ESTABLISHED AN ALLIANCE QUALITY WORKING TEAM (THE "QWT") THAT MEETS ON A REGULAR
BASIS TO DISCUSS AND RESOLVE QUALITY-RELATED ISSUES AND TO REVIEW DATA AND/OR
PERFORM THE ACTIVITIES OUTLINED IN THE QUALITY AGREEMENT. PURSUANT TO THE
QUALITY AGREEMENT, THE PARTIES HAVE ALSO ESTABLISHED AN ALLIANCE QUALITY LEAD
TEAM (THE "QLT") RESPONSIBLE FOR STRATEGIC QUALITY ISSUES THAT ARISE WITH
RESPECT TO THE EQW PRODUCT. IN THE EVENT THAT THE QWT IS UNABLE TO RESOLVE ANY
QUALITY-RELATED DISPUTES, THE QWT SHALL REFER SUCH DISPUTE TO THE QLT. FURTHER,
IF THE QLT IS UNABLE TO RESOLVE SUCH DISPUTE, THE QLT SHALL REFER SUCH DISPUTE
TO THE HEAD OF EACH PARTY'S QUALITY
9
DEPARTMENT FOR RESOLUTION. IF DESPITE THEIR BEST EFFORTS, THE HEAD OF EACH
PARTY'S QUALITY DEPARTMENT ARE UNABLE TO RESOLVE SUCH DISPUTE, THEY SHALL REFER
SUCH DISPUTE TO THE MSC FOR RESOLUTION.
ARTICLE 3
PAYMENT OF DEVELOPMENT EXPENSES, PURCHASE AND SUPPLY OF EQW PRODUCT AND
COMPONENTS AND LIMITATION OF AGREEMENT
3.1
EQW Manufacturing Development Costs.
Notwithstanding anything to the contrary in the Collaboration Agreement or any
previous formal or informal agreements between the Parties, the Parties agree
that Lilly shall be responsible for [***]% of EQW Manufacturing Development
Costs incurred up until commercial Manufacture of EQW product commences and
Amylin shall be responsible for [***]% of EQW Manufacturing Development Costs
incurred up until commercial Manufacture of EQW product commences. Going
forward, the MSC shall determine if EQW Development Costs relate to developing
capabilities to Manufacture for the U.S. and OUS markets or solely for either
the US or OUS market.
3.2
Purchase of EQW Product Requirements. Subject
to the terms and conditions of this Agreement, Amylin will Manufacture EQW
Product for worldwide distribution; provided, however, that Amylin will not have
any responsibility to package EQW Product for the territory outside of the U.S.
Lilly shall purchase from Amylin, and Amylin shall supply and deliver to Lilly,
Lilly's requirements for the EQW Product for sale by Lilly in the territory
outside the U.S. in accordance with Article 5 of this Agreement. If at any time
Amylin is not able to provide Lilly with the quantity of EQW Lilly desires to
purchase in accordance herewith because of the capacity limitations of the
Facility, the Parties agree to discuss in good faith how best to provide such
additional quantities of EQW Product including, without limitation, increasing
the capacity of the Facility and/or securing a Third Party manufacturer
(including,