SUPPLY AGREEMENT, TOGETHER WITH A WORK
ORDER SPECIFICALLY RELATED TO THE SUPPLY OF CLINICAL MATERIALS.
FURTHER, THE
PARTIES SHALL EXECUTE SUCH ADDITIONAL AGREEMENTS RELATED TO GMP, QUALITY AND
TECHNICAL TERMS AS ARE NECESSARY FOR REGULATORY PURPOSES.
3.
DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS
3.1
RESPONSIBILITY FOR DEVELOPMENT AND COMMERCIALIZATION.
ON AND
AFTER THE EFFECTIVE DATE, SANOFI-AVENTIS SHALL HAVE THE SOLE RIGHT, AT ITS SOLE
EXPENSE, FOR ALL ASPECTS OF THE DEVELOPMENT AND COMMERCIALIZATION OF LICENSED
PRODUCTS IN THE FIELD IN THE TERRITORY, INCLUDING, WITHOUT LIMITATION, THE
CONDUCT OF: (A) ALL IND-ENABLING NON-CLINICAL STUDIES; (B) ALL ACTIVITIES
RELATED TO HUMAN CLINICAL TRIALS; (C) ALL ACTIVITIES RELATING TO THE MANUFACTURE
AND SUPPLY OF LICENSED PRODUCTS (INCLUDING ALL REQUIRED PROCESS DEVELOPMENT AND
SCALE UP WORK WITH RESPECT THERETO); AND (D) ALL PRE-MARKETING, MARKETING,
PROMOTION, SALES, DISTRIBUTION, IMPORT AND EXPORT ACTIVITIES (INCLUDING SECURING
REIMBURSEMENT, SALES AND MARKETING AND CONDUCTING ANY POST-MARKETING TRIALS OR
DATABASES AND POST-MARKETING SAFETY SURVEILLANCE).
WITHOUT LIMITING THE
GENERALITY OF THE FOREGOING, SANOFI-AVENTIS SHALL HAVE THE SOLE RIGHT, AT ITS
SOLE EXPENSE, FOR (I) MAKING ALL REGULATORY FILINGS FOR LICENSED PRODUCTS AND
FILING ALL DRUG APPROVAL APPLICATIONS AND OTHERWISE SEEKING ALL REGULATORY
APPROVALS FOR LICENSED PRODUCTS, AS WELL AS ALL CORRESPONDENCE AND
COMMUNICATIONS WITH REGULATORY AUTHORITIES REGARDING SUCH MATTERS, AND (II)
REPORTING OF ALL ADVERSE EVENTS TO REGULATORY AUTHORITIES IF AND TO THE EXTENT
REQUIRED BY APPLICABLE LAWS.
THE PARTIES HEREBY AGREE THAT SUBJECT TO SECTION
2.3, [***] SHALL [***]ALL DATA, RESULTS AND ALL OTHER INFORMATION ARISING FROM
ANY SUCH ACTIVITIES UNDER THIS AGREEMENT SPECIFICALLY RELATING TO LICENSED
PRODUCTS, INCLUDING, WITHOUT LIMITATION, ALL [***] [***] AND [***] [***]
RELATING TO LICENSED PRODUCTS, AND ALL OF THE FOREGOING INFORMATION,
DOCUMENTATION AND MATERIALS SHALL BE CONSIDERED CONFIDENTIAL
INFORMATION OF [***].
3.2
DILIGENCE.
SANOFI-AVENTIS SHALL USE COMMERCIALLY REASONABLE
EFFORTS DURING THE TERM TO DEVELOP AND COMMERCIALIZE LICENSED PRODUCTS IN THE
FIELD IN THE TERRITORY.
3.3
UPDATES AND REPORTS.
SANOFI-AVENTIS SHALL PROVIDE IMMUNOGEN WITH
BRIEF WRITTEN REPORTS NO LESS FREQUENTLY THAN ANNUALLY DURING THE TERM
(COMMENCING WITH THE FIRST ANNIVERSARY OF THE EFFECTIVE DATE) SUMMARIZING
SANOTI-AVENTIS' EFFORTS TO DEVELOP AND COMMERCIALIZE LICENSED PRODUCTS
HEREUNDER.
IN ADDITION, SANOFI-AVENTIS SHALL PROVIDE IMMUNOGEN WITH PROMPT
WRITTEN NOTICE OF THE OCCURRENCE OF THE FIRST COMMERCIAL SALE OF ANY LICENSED
PRODUCT IN ANY COUNTRY.
3.4
REPORTABLE EVENTS.
SANOFI-AVENTIS SHALL PROMPTLY PROVIDE
IMMUNOGEN WITH NOTICE OF ANY REPORTABLE EVENT WITHIN TIME FRAMES CONSISTENT WITH
ANY REPORTING OBLIGATIONS UNDER APPLICABLE LAWS.
3.5
MANUFACTURE OF LICENSED PRODUCTS FOR COMMERCIAL SALE.
UNLESS
OTHERWISE AGREED TO BY THE PARTIES IN THE SUPPLY AGREEMENT, SANOFI-AVENTIS SHALL
HAVE THE SOLE OBLIGATION
A-13
AND RESPONSIBILITY, AT ITS SOLE COST AND EXPENSE, FOR THE MANUFACTURE OF ALL
LICENSED PRODUCTS (INCLUDING WITHOUT LIMITATION THE ACTIVE PHARMACEUTICAL
INGREDIENTS IN ANY LICENSED PRODUCT) FOR COMMERCIAL SALE.
3.6
PRODUCT RECALLS.
IN THE EVENT THAT ANY REGULATORY AUTHORITY
ISSUES OR REQUESTS A RECALL OR TAKES SIMILAR ACTION IN CONNECTION WITH A
LICENSED PRODUCT THAT SANOFI-AVENTIS REASONABLY BELIEVES IS ATTRIBUTABLE TO OR
OTHERWISE RELATES TO THE LICENSED TECHNOLOGY OR LICENSED PATENT RIGHTS, OR IN