7.01
MANUFACTURE AND SUPPLY BY SONUS.
UNTIL SUCH TIME (IF ANY) AS SCHERING SHALL EXERCISE ITS OPTION TO ASSUME
RESPONSIBILITY FOR MANUFACTURE AND SUPPLY OF PRODUCT PURSUANT TO SECTION 7.05
BELOW, SONUS SHALL BE RESPONSIBLE FOR CMC/MANUFACTURING OF PRODUCT (INCLUDING
MANAGEMENT OF THIRD PARTY CONTRACTORS AND SUPPLIERS) BUT SUBJECT TO ALL OTHER
PROVISIONS OF THIS AGREEMENT.
FROM THE EXECUTION DATE OF THIS AGREEMENT, SONUS
SHALL MANUFACTURE, OR ARRANGE FOR MANUFACTURE OF PRODUCT AND SUPPLY PRODUCT TO
SCHERING OR TO SCHERING'S DESIGNEE FOR USE IN CONNECTION WITH DEVELOPMENT AND
FOR THE COMMERCIALIZATION OF THE PRODUCT IN EACH APPLICABLE COUNTRY OF THE
TERRITORY.
SONUS WILL NOT ENTER INTO ANY THIRD PARTY CONTRACT RELATING TO THE
MANUFACTURE OF THE PRODUCT WITHOUT SCHERING'S CONSENT, WHICH SHALL NOT BE
UNREASONABLY WITHHELD OR DELAYED.
ALL CMC/MANUFACTURING PLANS, THE
IMPLEMENTATION OF SUCH PLANS, AND ALL CHANGES TO MANUFACTURING PLANS AND
PROCESSES SHALL BE SUBJECT TO THE APPROVAL OF THE STEERING COMMITTEE.
REGARDLESS OF WHETHER SCHERING EXERCISES ITS OPTION TO MANUFACTURE OR HAVE
MANUFACTURED THE PRODUCT PURSUANT TO SECTION 7.05 BELOW, SCHERING SHALL BE
RESPONSIBLE, AT ITS OWN COST, FOR ALL CAPITAL EXPENDITURES INCURRED BY SCHERING
IN SCALING UP MANUFACTURE OF THE PRODUCT OR ESTABLISHING NEW MANUFACTURING
FACILITIES FOR THE PRODUCT TO THE EXTENT SUCH ACTIVITIES ARE NOT INCLUDED IN THE
CMC/MANUFACTURING PLAN AND BUDGET.
[*]
CONFIDENTIAL PORTIONS OMITTED AND FILED
SEPARATELY WITH THE COMMISSION
24
SECTION 7.02
MANUFACTURING AND SUPPLY AGREEMENT.
WITHIN THREE (3) MONTHS OF THE EXECUTION DATE, THE PARTIES SHALL ENTER INTO A
MANUFACTURING AND SUPPLY AGREEMENT TO COVER THE SUPPLY OF PRODUCT TO SCHERING BY
SONUS HEREUNDER, SUCH AGREEMENT TO INCLUDE A QUALITY ASSURANCE AGREEMENT.
SECTION 7.03
APPROVALS FOR MANUFACTURING.
SCHERING SHALL BE RESPONSIBLE FOR PREPARING ALL APPROVAL APPLICATIONS TO OBTAIN,
OR CAUSING A THIRD PARTY MANUFACTURER TO MAKE ALL NECESSARY FILINGS TO OBTAIN,
APPROVAL FOR THE MANUFACTURE OF THE PRODUCT AS PART OF THE APPROVAL APPLICATION
FOR THE PRODUCT.
AT THE REASONABLE REQUEST OF SCHERING, SONUS WILL PROVIDE
DRAFT SUBMISSIONS FOR FILING TO SCHERING AND WILL PROVIDE, OR HAVE PROVIDED TO
SCHERING, WHATEVER OTHER TECHNICAL SUPPORT AND EXPERTISE SCHERING REASONABLY
DEEMS NECESSARY TO EFFECTIVELY OBTAIN APPROVAL FOR THE MANUFACTURE OF THE
PRODUCT AS PART OF THE APPROVAL FOR THE PRODUCT.
SCHERING SHALL HAVE AUTHORITY
AND CONTROL WITH RESPECT TO ALL FILINGS TO OBTAIN APPROVAL FOR THE MANUFACTURE
OF THE PRODUCT.
SUBJECT TO THE FOREGOING, SCHERING SHALL PROVIDE SONUS AND
SONUS SHALL PROVIDE SCHERING WITH REASONABLE ADVANCE NOTICE OF ANY SCHEDULED
MEETING WITH THE FDA, EMEA OR OTHER GOVERNMENTAL AUTHORITY IN A MAJOR REGULATORY
JURISDICTION RELATING TO ANY FILING TO OBTAIN APPROVAL FOR THE PRODUCT, AND
SONUS OR SCHERING, AS APPLICABLE, SHALL HAVE THE RIGHT TO PARTICIPATE IN ANY
SUCH MEETING.
ONCE APPROVAL APPLICATIONS HAVE BEEN SUBMITTED, SONUS SHALL NOT
MAKE OR PERMIT TO BE MADE ANY MANUFACTURING PROCESS CHANGES WITH RESPECT TO THE
PRODUCT UNLESS SUCH MANUFACTURING PROCESS CHANGES ARE APPROVED IN ADVANCE BY
SCHERING IN WRITING.
SECTION 7.04
PRICING.
UNTIL SUCH TIME, IF ANY,
AS SCHERING SHALL EXERCISE ITS OPTION