eSAS 2 Instrument,
including without limitation pipettors, automated reagent addition stations,
automated target capture bays or automated incubation modules.
1.17
TIMELINE MEANS THE OVERALL DEVELOPMENT TIMELINE
INCLUDED WITHIN THE TECHNICAL PLAN.
4
2.
ESAS 2 DEVELOPMENT PROGRAM.
2.1
OBJECTIVE.
SUBJECT TO THE TERMS OF THE AGREEMENT, AS AMENDED BY
THIS ESAS 2 ADDENDUM, THE PARTIES EACH SHALL CONDUCT THEIR RESPECTIVE
OBLIGATIONS UNDER THE ESAS 2 DEVELOPMENT PROGRAM AS ESTABLISHED IN ACCORDANCE
WITH THE TERMS HEREOF, AND SHALL APPLY FOR AND ENDEAVOR TO OBTAIN SUCH
REGULATORY APPROVALS AS NECESSARY OR APPROPRIATE TO MAKE AND SELL THE ESAS 2
INSTRUMENT IN THE TERRITORY FOR USE IN THE BLOOD SCREENING FIELD.
2.2
GENERAL CONDUCT OF DEVELOPMENT.
THE PARTIES, USING COMMERCIALLY
REASONABLE EFFORTS, SHALL CONDUCT THEIR RESPECTIVE OBLIGATIONS UNDER THE ESAS 2
DEVELOPMENT PROGRAM IN COMPLIANCE IN ALL MATERIAL RESPECTS WITH ALL REQUIREMENTS
OF APPLICABLE LAWS AND REGULATIONS AND ALL APPLICABLE GOOD LABORATORY, CLINICAL
AND MANUFACTURING PRACTICES.
IN ADDITION, THE PARTIES EACH SHALL PROCEED
DILIGENTLY WITH THEIR RESPECTIVE OBLIGATIONS UNDER THE ESAS 2 DEVELOPMENT
PROGRAM AND SHALL USE THEIR RESPECTIVE COMMERCIALLY REASONABLE EFFORTS TO
ACHIEVE THE OBJECTIVES OF THE ESAS 2 DEVELOPMENT PROGRAM EFFICIENTLY AND
EXPEDITIOUSLY.
THE PARTIES EACH SHALL ALLOCATE SUCH PERSONNEL, EQUIPMENT,
FACILITIES AND OTHER RESOURCES TO THE ESAS 2 DEVELOPMENT PROGRAM TO CARRY OUT
THEIR RESPECTIVE OBLIGATIONS AND TO ACCOMPLISH THE OBJECTIVES THEREOF, ALL AS IS
MORE PARTICULARLY DESCRIBED IN THE ESAS 2 DEVELOPMENT PROGRAM, AS AMENDED FROM
TIME TO TIME DURING THE TERM OF THIS ESAS 2 ADDENDUM, IN ACCORDANCE WITH THE
PROVISIONS OF SECTION 3.
EACH PARTY SHALL HAVE THE RIGHT TO CONSULT WITH THE
OTHER PARTY REGARDING THE ESAS 2 DEVELOPMENT PROGRAM AND THE OBLIGATION TO
REASONABLY CONSIDER THE OTHER PARTY'S ADVICE.
2.3
NO LIABILITY IF COMMERCIALLY REASONABLE EFFORTS ARE EXPENDED.
NEITHER PARTY WILL BE IN BREACH OF ITS OBLIGATIONS TO THE OTHER HEREUNDER AND
SUCH PARTY SHALL BE DEEMED TO HAVE EXERCISED COMMERCIALLY REASONABLE EFFORTS, SO
LONG AS SUCH PARTY SHALL HAVE COMMITTED THE RESOURCES DESCRIBED IN THE ESAS 2
DEVELOPMENT PROGRAM.
THE PAYMENT OF ESAS 2 DEVELOPMENT COSTS BETWEEN THE
PARTIES SHALL BE DUE AND PAYABLE WITHOUT RESPECT TO THE ACHIEVEMENT OF ANY
PARTICULAR DELIVERABLE SPECIFIED IN THE ESAS 2 DEVELOPMENT PROGRAM.
2.4
PROJECT MANAGEMENT.
2.4.1
PRINCIPLES OF PROJECT MANAGEMENT.
THE PARTIES
AGREE THAT IN THE PROCESS OF EXERCISING THEIR RESPONSIBILITIES, THE PROJECT
MANAGEMENT (CONSISTING OF THE PROJECT MANAGER AND PROJECT LEADERS, AS SET FORTH
HEREIN) SHOULD HAVE ROUTINE ACCESS TO SUCH INFORMATION NEEDED TO ASSESS PROGRESS
UNDER AND COSTS OF THE ESAS 2 DEVELOPMENT PROGRAM.
SPECIFICALLY, THE PARTIES
AGREE THAT THE PROJECT LEADERS SHALL BE INVITED TO PARTICIPATE IN ALL TEAM
MEETINGS, AND WILL HAVE ACCESS TO TEAM MEETING MINUTES, TIMECARDS AND OTHER
EXPENSE RECORDS, EXCEPT TO THE EXTENT THE PROJECT LEADER FOR THE PARTY ASSIGNED
PRINCIPAL RESPONSIBILITY UNDER SECTION 2.5.3 OF THIS ESAS 2 ADDENDUM FOR AN
ACTIVITY DETERMINES IN ITS REASONABLE DISCRETION THAT ANY SUCH MEETINGS OR
MINUTES CONTAIN CONFIDENTIAL, PROPRIETARY INFORMATION OF THE RESPONSIBLE PARTY.
IN SUCH CASES, THE PROJECT MANAGER