THE TERRITORY PURSUANT TO
THE PROVISIONS OF A SUPPLY AGREEMENT FOR BULK DRUG SUBSTANCE FOR COMMERCIAL
PURPOSES (THE "COMMERCIAL SUPPLY AGREEMENT"), INCLUDING SUCH CUSTOMARY
REPRESENTATIONS, WARRANTIES, COVENANTS AND CONDITIONS AS ARE NECESSARY OR
APPROPRIATE FOR TRANSACTIONS OF THIS TYPE, NOT INCONSISTENT WITH THE TERMS AND
CONDITIONS HEREOF AND SATISFACTORY IN FORM AND SUBSTANCE TO THE PARTIES AND
THEIR LEGAL ADVISORS.
PROMPTLY AFTER THE START OF THE FIRST PHASE III CLINICAL
TRIAL BY MITSUBISHI, THE PARTIES WILL COMMENCE GOOD FAITH NEGOTIATIONS AND
SEPARATELY ENTER INTO THE COMMERCIAL SUPPLY AGREEMENT.
MITSUBISHI SHALL
PURCHASE SUCH BULK DRUG SUBSTANCE FROM VERTEX IN ACCORDANCE WITH THE TERMS OF
SECTION 6.3 HEREOF.
VERTEX MAY CONTRACT WITH ANY THIRD PARTY AS A MANUFACTURING
SUBCONTRACTOR.
4.3
LIMITATION ON SUPPLY OBLIGATION.
NOTWITHSTANDING SECTIONS 4.1 OR 4.2 HEREOF, VERTEX SHALL HAVE NO OBLIGATION TO
SUPPLY BULK DRUG SUBSTANCE OR INVESTIGATIONAL DRUG PRODUCT TO MITSUBISHI WITH
RESPECT TO A DRUG PRODUCT UNLESS VERTEX IS DEVELOPING OR COMMERCIALIZING SUCH
DRUG PRODUCT; PROVIDED, HOWEVER, THAT IF VERTEX HAS SO SUPPLIED BULK DRUG
SUBSTANCE TO MITSUBISHI FOR COMMERCIAL PURPOSES BEFORE VERTEX CEASED DEVELOPMENT
OR COMMERCIALIZATION OF THE CORRESPONDING DRUG PRODUCT, THEN VERTEX SHALL BE
OBLIGATED TO CONTINUE THE SUPPLY OF SUCH BULK DRUG SUBSTANCE TO MITSUBISHI
PURSUANT TO THE TERMS SET FORTH
21
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this
exhibit has been filed separately with the Commission.
IN SECTION 6.4 HEREOF; PROVIDED FURTHER, HOWEVER, THAT IN ANY OTHER CASE WHERE
MITSUBISHI WISHES TO DEVELOP OR COMMERCIALIZE A DRUG PRODUCT THAT VERTEX IS NOT
ITSELF DEVELOPING OR COMMERCIALIZING,
VERTEX SHALL GRANT TO MITSUBISHI A
NONEXCLUSIVE LICENSE (OR SUBLICENSE, AS APPROPRIATE) UNDER THE VERTEX
TECHNOLOGY, WITH THE RIGHT TO SUBLICENSE, TO MANUFACTURE AND HAVE MANUFACTURED
BULK DRUG SUBSTANCE WITH RESPECT TO SUCH DRUG PRODUCT TO THE EXTENT REQUIRED TO
USE, SELL, HAVE SOLD, OFFER TO SELL AND IMPORT SUCH DRUG PRODUCT IN THE
TERRITORY IN THE FIELD OF USE.
IN SUCH EVENT, AT MITSUBISHI'S EXPENSE, VERTEX
WILL ALSO DELIVER TO MITSUBISHI SUCH VERTEX TECHNOLOGY AS MAY THEN EXIST (IF
ANY) AND PROVIDE TO MITSUBISHI ANY APPLICABLE TECHNICAL SUPPORT IN CONNECTION
THEREWITH THAT IS REASONABLY NECESSARY TO ENABLE MITSUBISHI TO MANUFACTURE BULK
DRUG SUBSTANCE IN COMPLIANCE WITH ANY AND ALL CURRENT REGULATORY APPROVALS IN
THE TERRITORY.
SUCH VERTEX TECHNOLOGY SHALL BE DELIVERED TO MITSUBISHI IN SUCH
A WAY AS TO COMMUNICATE IT TO MITSUBISHI PROMPTLY, EFFECTIVELY AND ECONOMICALLY.
4.4
SECOND SOURCE OF SUPPLY FOR BULK DRUG
SUBSTANCE.
WITHIN TWO (2) YEARS AFTER THE RECEIPT OF REGULATORY APPROVAL FOR A
DRUG PRODUCT IN THE UNITED STATES, VERTEX AGREES TO HAVE AT LEAST
[***]MANUFACTURING SITES, IN DIFFERENT GEOGRAPHICAL LOCATIONS, APPROVED BY THE
REGULATORY AUTHORITIES FOR THE SUPPLY OF THE CORRESPONDING BULK DRUG SUBSTANCE
TO MITSUBISHI PURSUANT TO THE COMMERCIAL SUPPLY AGREEMENT.
4.5
MANUFACTURING TECHNOLOGY.
MANUFACTURING
TECHNOLOGY WHICH IS CONTROLLED BY ONE PARTY AND WHICH WOULD BE USEFUL TO THE
OTHER PARTY IN DISCHARGING ITS MANUFACTURING OBLIGATIONS HEREUNDER SHALL BE MADE
AVAILABLE TO THE MANUFACTURING PARTY FOR THAT PURPOSE, SUBJECT TO NEGOTIATION