AS
A RESULT OF SUCH TRANSFER BY IMMUNOGEN.
2.5.3
TRAINING.
IMMUNOGEN SHALL USE COMMERCIALLY REASONABLE EFFORTS TO
PROVIDE SANOFI-AVENTIS WITH SUCH TRAINING AS MAY BE REASONABLY NECESSARY TO
ENABLE SANOFI-AVENTIS TO PRACTICE THE LICENSED TECHNOLOGY AND LICENSED PATENT
RIGHTS TO HUMANIZE ANTIBODIES THROUGH CONFERENCE CALLS [***] [***] [***] [***]
TO THE [***] OF SANOFI-AVENTIS OR ITS AFFILIATES IN THE UNITED STATES AND
EUROPE.
ALL SUCH TRAINING CALLS [***] [***] SHALL BE REQUESTED IN ADVANCE
9
IN WRITING BY SANOFI-AVENTIS AND SHALL BE SCHEDULED BY IMMUNOGEN AT TIMES
MUTUALLY CONVENIENT TO THE PARTIES.
2.5.4
ADDITIONAL OBLIGATIONS OF IMMUNOGEN.
SUBJECT TO THE OTHER TERMS OF
THIS AGREEMENT (INCLUDING WITHOUT LIMITATION SECTION 4.3), IMMUNOGEN SHALL USE
COMMERCIALLY REASONABLE EFFORTS TO CONDUCT SUCH ACTIVITIES IN CONNECTION WITH A
RESURFACED ANTIBODY AS SANOFI-AVENTIS MAY REQUEST IN WRITING AT ANY TIME DURING
THE RESEARCH LICENSE TERM.
2.6
COMPLIANCE.
SANOFI-AVENTIS SHALL PERFORM ITS OBLIGATIONS TO
DEVELOP LICENSED PRODUCTS IN GOOD SCIENTIFIC MANNER AND IN COMPLIANCE IN ALL
MATERIAL RESPECTS WITH ALL APPLICABLE LAWS; PROVIDED THAT, WITH RESPECT TO EACH
ACTIVITY SO PERFORMED THAT WILL OR WOULD REASONABLY BE EXPECTED TO BE SUBMITTED
TO A REGULATORY AUTHORITY IN SUPPORT OF A REGULATORY FILING OR DRUG APPROVAL
APPLICATION, SANOFI-AVENTIS SHALL COMPLY IN ALL MATERIAL RESPECTS WITH THE
REGULATIONS AND GUIDANCE OF THE FDA THAT CONSTITUTE GOOD LABORATORY PRACTICE OR
GOOD MANUFACTURING PRACTICE (OR, IF AND AS APPROPRIATE UNDER THE CIRCUMSTANCES,
OR OTHER COMPARABLE REGULATION AND GUIDANCE OF ANY APPLICABLE REGULATORY
AUTHORITY IN ANY COUNTRY OR REGION IN THE TERRITORY).
2.7
MANUFACTURE OF LICENSED PRODUCTS FOR DEVELOPMENT.
SANOFI-AVENTIS
SHALL HAVE THE SOLE RESPONSIBILITY AND OBLIGATION, AT ITS SOLE COST AND EXPENSE,
TO MANUFACTURE ALL LICENSED PRODUCTS REQUIRED FOR THE CONDUCT OF DEVELOPMENT
ACTIVITIES UNDER THIS AGREEMENT (INCLUDING WITHOUT LIMITATION THE CONDUCT OF ALL
NECESSARY CLINICAL TRIALS IN THE TERRITORY) AND/OR THE MAKING OF ALL REGULATORY
FILINGS AND OBTAINING OF ALL REGULATORY APPROVALS.
3.
DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS
3.1
RESPONSIBILITY FOR DEVELOPMENT AND COMMERCIALIZATION.
EXCEPT FOR
THE ACTIVITIES CONDUCTED BY IMMUNOGEN IN ACCORDANCE WITH SECTION 2.5.4,
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