IN
DISCHARGING ITS MANUFACTURING OBLIGATIONS HEREUNDER SHALL BE MADE AVAILABLE TO
THE MANUFACTURING PARTY FOR THAT PURPOSE, SUBJECT TO NEGOTIATION OF A REASONABLE
COMPENSATION ARRANGEMENT.
IF EITHER PARTY (A "CONTRACTING PARTY") ENGAGES AN
AFFILIATE OR A THIRD PARTY TO PROVIDE ASSISTANCE TO THE CONTRACTING PARTY IN THE
DEVELOPMENT OF PROCESSES USEFUL FOR THE MANUFACTURE OF BULK DRUG SUBSTANCE OR
DRUG PRODUCT, THE CONTRACTING PARTY WILL MAKE REASONABLE EFFORTS TO PROVIDE THAT
ANY PROCESSES BELONGING TO THAT AFFILIATE OR THIRD PARTY AND MADE AVAILABLE TO
THE CONTRACTING PARTY WILL ALSO BE MADE AVAILABLE TO THE OTHER PARTY ON THE SAME
TERMS OFFERED TO THE CONTRACTING PARTY.
4.6
PACKAGING.
MITSUBISHI WILL BE RESPONSIBLE FOR PACKAGING THE DRUG
PRODUCT AND INVESTIGATIONAL DRUG PRODUCT FOR DEVELOPMENT PURPOSES AND FOR
COMMERCIAL SALE IN THE TERRITORY.
[***]
Information redacted pursuant to a confidential treatment request.
An unredacted version of this exhibit has been filed separately with the
Commission.
22
ARTICLE V - COMMERCIALIZATION
5.1
GLOBAL MARKETING AND SALES.
MITSUBISHI WILL PREPARE A MARKETING
PLAN IN REASONABLE DETAIL FOR THE LAUNCH OF ANY DRUG PRODUCT IN EACH COUNTRY OF
THE TERRITORY, AND WILL PROVIDE THE PLAN TO VERTEX NOT LATER THAN NINETY (90)
DAYS AFTER SUBMISSION OF THE INITIAL APPLICATION FOR REGULATORY APPROVAL OF THE
DRUG PRODUCT TO A REGULATORY AUTHORITY IN SUCH COUNTRY OF THE TERRITORY.
5.2
CO-LABELING.
THE LABELS, PACKAGING AND INSERTS FOR THE DRUG
PRODUCT PACKAGED FOR SALE IN THE TERRITORY, AND ANY PROMOTIONAL MATERIALS
THEREFOR, WILL BEAR THE COMPANY NAMES AND LOGOS OF BOTH MITSUBISHI AND VERTEX
WITH SUCH RELATIVE PROMINENCE AND IN SUCH LANGUAGE AS ARE PERMITTED BY THE
APPLICABLE LAWS, RULES, REGULATIONS AND CUSTOM OF SUCH COUNTRY, WITH THE
PREFERENCE THAT WHEREVER POSSIBLE SUCH NAMES AND LOGOS SHALL BE OF EQUAL
PROMINENCE AND VERTEX'S NAME SHALL BE WRITTEN IN THE ENGLISH LANGUAGE.
MITSUBISHI WILL PERMIT VERTEX TO REVIEW ALL MATERIAL REGULATORY FILINGS IN THE
TERRITORY THAT RELATE TO PRODUCT LABELING, AND ALL PROPOSED LABELS, PACKAGING,
PACKAGE INSERTS AND PROMOTIONAL MATERIALS REQUIRED UNDER THE FOREGOING
PROVISIONS TO BEAR VERTEX'S NAME AND LOGO, PRIOR TO THE FILING OF ANY SUCH
MATERIAL WITH ANY REGULATORY AUTHORITY.
5.3
TRADEMARKS.
EACH PARTY SHALL HAVE THE RIGHT TO REGISTER AND USE
ITS OWN TRADEMARK FOR A DRUG PRODUCT, RESPECTIVELY.
NOTWITHSTANDING THE
FOREGOING, IN THE EVENT MITSUBISHI WISHES TO USE VERTEX'S TRADEMARK FOR A DRUG
PRODUCT, VERTEX HEREBY GRANTS TO MITSUBISHI AN EXCLUSIVE, ROYALTY-FREE LICENSE
TO USE VERTEX'S TRADEMARK FOR A DRUG PRODUCT FOR THE ADVERTISING, PROMOTION,
MARKETING, DISTRIBUTION AND SALE OF THE DRUG PRODUCT IN THE FIELD OF USE IN THE
TERRITORY.
MITSUBISHI SHALL HAVE THE RIGHT TO GRANT SUBLICENSES UNDER THE
FOREGOING EXCLUSIVE LICENSE TO ITS SUBLICENSEES PURSUANT TO SECTION 2.1.2
HEREOF.
5.4
DUE DILIGENCE.
FOLLOWING THE FIRST COMMERCIAL SALE OF A DRUG
PRODUCT AND UNTIL THE EXPIRATION OF THIS AGREEMENT, MITSUBISHI SHALL USE
DILIGENT AND COMMERCIALLY REASONABLE EFFORTS TO KEEP THE DRUG PRODUCT REASONABLY
AVAILABLE TO THE PUBLIC IN THE TERRITORY, DEVOTING THE SAME DEGREE OF ATTENTION
AND DILIGENCE TO SUCH EFFORTS THAT