OR CORRESPONDENCE.
EACH PARTY WILL DISCLOSE TO THE OTHER PROPOSED AGENDA ITEMS REASONABLY IN
ADVANCE OF EACH MEETING OF THE STEERING COMMITTEE.
EACH PARTY SHALL BEAR ITS
OWN COSTS FOR PARTICIPATION IN THE STEERING COMMITTEE.
17
(D)
LIMITATION ON STEERING COMMITTEE AUTHORITY.
NOTWITHSTANDING THE CREATION OF THE STEERING COMMITTEE, EACH PARTY TO THIS
AGREEMENT SHALL RETAIN THE RIGHTS, POWERS AND DISCRETIONS GRANTED TO IT
HEREUNDER, AND THE STEERING COMMITTEE SHALL NOT BE DELEGATED OR VESTED WITH ANY
SUCH RIGHTS, POWERS OR DISCRETIONS UNLESS SUCH DELEGATION OR VESTING IS
EXPRESSLY PROVIDED FOR HEREIN OR THE PARTIES EXPRESSLY SO AGREE IN WRITING.
THE
STEERING COMMITTEE SHALL NOT HAVE THE POWER TO AMEND OR MODIFY THIS AGREEMENT,
WHICH MAY BE AMENDED OR MODIFIED ONLY AS PROVIDED IN SECTION 17.10.
(E)
RESOLUTION OF DISPUTES.
IF THE STEERING
COMMITTEE CANNOT REACH A UNANIMOUS DECISION WITH RESPECT TO THE DEVELOPMENT
MATTERS DELEGATED TO IT WITHIN TEN (10) BUSINESS DAYS, THEN THE DISPUTED MATTER
SHALL PROMPTLY BE REFERRED TO A SENIOR MANAGER OF EACH PARTY DESIGNATED BY SUCH
PARTY FOR RESOLUTIONS.
IF THE SENIOR MANAGERS ARE UNABLE TO RESOLVE SUCH MATTER
WITHIN TEN (10) BUSINESS DAYS AFTER ONE PARTY NOTIFIES THE OTHER OF ITS DESIRE
TO HAVE THE MATTER REFERRED TO SUCH SENIOR MANAGERS, THEN THE DECISION OF
SCHERING'S SENIOR MANAGER SHALL CONTROL, PROVIDED, HOWEVER, THAT THE FOLLOWING
DECISIONS MUST BE BY UNANIMOUS CONSENT OF THE PARTIES AND SHALL NOT BE SUBJECT
TO THE FINAL DECISION OF SCHERING'S SENIOR MANAGER: (I) ANY DECISION TO ADD OR
REMOVE A CORE INDICATION FROM THE CORE DEVELOPMENT PLAN; (II) ANY DECISION WHICH
WOULD HAVE THE EFFECT OF INCREASING THE CORE DEVELOPMENT COSTS AND/OR THE
CMC/MANUFACTURING COSTS BY AN AGGREGATE AMOUNT OF [*]; AND (III) ANY OTHER
DECISION WHICH WOULD INCREASE IN ANY MATERIAL RESPECT THE DUTIES, OBLIGATIONS,
OR RESPONSIBILITIES OF SONUS PURSUANT TO THE CORE DEVELOPMENT PLAN OR BUDGET OR
PURSUANT TO THE CMC/MANUFACTURING PLAN AND BUDGET.
SECTION 5.02
CORE DEVELOPMENT
(A)
EACH OF SONUS AND SCHERING AGREE TO
CO-OPERATE IN THE CORE DEVELOPMENT OF THE PRODUCT AND TO USE COMMERCIALLY
REASONABLE EFFORTS TO BRING THE PRODUCT TO MARKET IN THE US.
SONUS AND SCHERING
EACH AGREE TO USE COMMERCIALLY REASONABLE EFFORTS TO EXECUTE AND SUBSTANTIALLY
PERFORM THE OBLIGATIONS ASSUMED BY EACH OF THEM UNDER THE CORE DEVELOPMENT PLAN
AND BUDGET.
ALL PRECLINICAL AND CLINICAL DEVELOPMENT, INCLUDING ALL CLINICAL
TRIALS OTHER THAN THE PIVOTAL TRIAL, SHALL BE CONDUCTED BY THE PARTIES, AS
DETERMINED BY THE STEERING COMMITTEE.
ALL ISS ACTIVITIES SHALL BE CONDUCTED BY
SCHERING.
THE PIVOTAL TRIAL SHALL BE CONDUCTED BY SONUS UNDER THE SUPERVISION
OF THE STEERING COMMITTEE.
PROMPTLY FOLLOWING THE EXECUTION DATE, SONUS SHALL
TRANSFER LEGAL TITLE TO ALL DATA FROM COMPLETED STUDIES OF THE PRODUCT TO
SCHERING, PROVIDED HOWEVER, THAT (SUBJECT TO SECTION 5.08(A)), SONUS SHALL
ASSIGN AND TRANSFER TO SCHERING ALL OF SONUS' RIGHT, TITLE AND INTEREST IN AND
TO, AND SPONSORSHIP OF, U.S. IND 60,980 FOR THE PRODUCT AT THE TIME OF FIRST NDA
APPROVAL OF THE PRODUCT.
THE NDA WILL BE DEVELOPED