ARE UNABLE TO REACH AN
AGREEMENT ON COST SHARING TO CONDUCT SUCH TERRITORY SPECIFIC STUDY, CHIRON SHALL
HAVE NO FURTHER OBLIGATION TO CONDUCT SUCH TERRITORY SPECIFIC STUDY.
(B)
PROPOSED INDICATIONS.
CHIRON MAY, FROM TIME TO TIME, PROPOSE TO CUBIST
THROUGH THE JCT THAT CUBIST CONSIDER PURSUING DEVELOPMENT FOR A NEW INDICATION
(THE "PROPOSED INDICATION").
SUCH PROPOSAL SHALL BE IN WRITING AND CONTAIN SUCH
INFORMATION AS MAY BE READILY GATHERED WHICH WILL ASSIST CUBIST TO EVALUATE THE
PROPOSAL ON ITS MERITS.
IF AFTER DUE CONSIDERATION BY CUBIST AND CHIRON AT THE
JCT, CONSENSUS IS REACHED TO PURSUE DEVELOPMENT FOR SUCH NEW INDICATION, CUBIST
SHALL ADD THE PROPOSED INDICATION TO THE CUBIST DEVELOPMENT PLAN.
IN THE EVENT
THAT THE PARTIES ARE UNABLE TO REACH CONSENSUS ON ADDING THE PROPOSED INDICATION
THEN CHIRON SHALL BE FREE TO PURSUE, AT ITS OWN EXPENSE, DEVELOPMENT OF SUCH
PROPOSED INDICATION.
(C)
MEDICAL AFFAIRS STUDIES.
CHIRON MAY CONDUCT MEDICAL AFFAIRS STUDIES OF
THE LICENSED PRODUCTS AT ITS SOLE COST AND EXPENSE.
CHIRON SHALL PROVIDE TO
CUBIST VIA THE JCT ITS PROPOSAL FOR ANY MEDICAL AFFAIRS STUDY IT WISHES TO
CONDUCT, FOR REVIEW AND DISCUSSION PURPOSES ONLY.
CUBIST SHALL SUPPLY LICENSED
PRODUCTS TO BE USED IN MEDICAL AFFAIRS STUDIES (I) AT A
* CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE
COMMISSION
25
purchase price equal to the Transfer Price, and (ii) in an amount not to exceed
[*], during the first complete calendar year (and any part thereof) after
Commercial Launch, and for any calendar year thereafter, [*] by Chiron for the
corresponding period as reflected in the forecasts of purchase quantities
delivered by Chiron to Cubist pursuant to the Supply Agreement.
(D)
CHIRON DEVELOPMENT PLAN.
CHIRON WILL PREPARE AND UPDATE ANNUALLY A
DEVELOPMENT PLAN FOR CHIRON'S DEVELOPMENT ACTIVITIES PURSUANT TO THIS
SECTION 4.3 (THE "CHIRON DEVELOPMENT PLAN"). CHIRON SHALL UPDATE THE CHIRON
DEVELOPMENT PLAN EACH YEAR TO REFLECT THE ACTIVITIES THAT CHIRON EXPECTS TO
CONDUCT DURING THE FOLLOWING CALENDAR YEAR AND CHIRON SHALL PROVIDE THE UPDATED
CHIRON DEVELOPMENT PLAN TO CUBIST PRIOR TO THE JCT'S LAST SCHEDULED MEETING
DURING THE THEN CURRENT YEAR.
CUBIST SHALL HAVE THE RIGHT TO REVIEW AND
COMMENT, VIA THE JCT, ON THE CHIRON DEVELOPMENT PLAN AND ANY AND ALL REVISIONS
OR UPDATES THERETO AND CHIRON SHALL, IN GOOD FAITH, CONSIDER ALL COMMENTS MADE
BY CUBIST. SUBJECT TO THE PROVISIONS SET FORTH BELOW IN THIS SECTION 4.3(D),
CHIRON SHALL USE COMMERCIALLY REASONABLE EFFORTS TO CARRY OUT AND PERFORM DURING
EACH CALENDAR YEAR THE ACTIVITIES SET FORTH IN THE CHIRON DEVELOPMENT PLAN, AS
MAY BE IN EFFECT FOR SUCH CALENDAR YEAR, THAT ARE MATERIALLY SIGNIFICANT FOR
OBTAINING REGULATORY APPROVAL IN THE TERRITORY.
WITH THE EXCEPTION OF THE
TERRITORY SPECIFIC STUDIES (WHICH CHIRON MAY DECLINE TO PERFORM IN ACCORDANCE
WITH THE PROVISIONS OF SECTION 4.3(A) ABOVE), CHIRON RESERVES THE RIGHT AT ANY
TIME TO CHANGE OR MODIFY THE CHIRON DEVELOPMENT PLAN OR ANY OF THE PRECLINICAL
STUDIES OR CLINICAL TRIALS DESCRIBED IN THE CHIRON DEVELOPMENT PLAN, OR TO
ABANDON