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.
22
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this
exhibit has been filed separately with the Commission.
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 IT DEVOTES TO SUCH
ACTIVITIES FOR OTHER OF ITS PRODUCTS OF COMPARABLE COMMERCIAL POTENTIAL.
MITSUBISHI SHALL PROMPTLY NOTIFY VERTEX IF IT SHALL