AUTHORITIES REGARDING THE FOREGOING.
WHEN USED AS A VERB, "COMMERCIALIZING" MEANS TO ENGAGE IN COMMERCIALIZATION AND
"COMMERCIALIZED" HAS A CORRESPONDING MEANING.
1.13
"COMMERCIALLY REASONABLE EFFORTS" MEANS, WITH RESPECT TO
SANOFI-AVENTIS, THE EFFORTS AT LEAST EQUAL TO THOSE CUSTOMARILY USED BY
SANOFI-AVENTIS WITH RESPECT TO A PRODUCT OR POTENTIAL PRODUCT OF SIMILAR NATURE
AT A SIMILAR STAGE IN ITS DEVELOPMENT OR PRODUCT LIFE AND OF
A-2
SIMILAR MARKET POTENTIAL, IN VIEW OF CONDITIONS PREVAILING AT THE TIME, AND
EVALUATED TAKING INTO ACCOUNT ALL RELEVANT FACTORS, INCLUDING WITHOUT
LIMITATION, THE MECHANISM OF ACTION, EFFICACY, SAFETY, THE ANTICIPATED
REGULATORY AUTHORITY APPROVED LABELING, THE COMPETITIVENESS OF ALTERNATIVE
PRODUCTS THAT ARE IN THE MARKETPLACE OR UNDER DEVELOPMENT, THE PATENT AND OTHER
PROPRIETARY POSITION OF THE PRODUCT, THE LIKELIHOOD OF REGULATORY APPROVAL, THE
PROFITABILITY OF THE PRODUCT AND OTHER TECHNICAL, SCIENTIFIC, LEGAL, MEDICAL,
MARKETING AND COMPETITIVE FACTORS.
1.14
"COMMERCIALIZATION REGULATORY APPROVAL" MEANS, WITH RESPECT TO ANY
LICENSED PRODUCT, THE GRANTING OF APPROVAL BY A REGULATORY AUTHORITY OF (A) AN
NDA IN THE UNITED STATES, OR (B) THE EQUIVALENT OF AN NDA REQUIRED BY APPLICABLE
LAWS IN ANY COUNTRY OR REGION IN THE TERRITORY OUTSIDE OF THE UNITED STATES TO
SELL SUCH LICENSED PRODUCT FOR USE IN THE FIELD IN SUCH COUNTRY OR REGION.
1.15
"COMPARABLE PRODUCT" MEANS A PRODUCT, OTHER THAN ANY PRODUCT BEING
MARKETED AND/OR SOLD AS OF THE EFFECTIVE DATE, THAT (A) INCORPORATES OR IS
COMPRISED OF AN ANTIBODY-DRUG CONJUGATE, (B) IS DIRECTED AGAINST THE SAME TARGET
AS A LICENSED PRODUCT AND (C) IS MARKETED AND SOLD BY A THIRD PARTY FOR USE IN
THE FIELD.
1.16
"CONFIDENTIAL INFORMATION" MEANS (A) WITH RESPECT TO IMMUNOGEN, ALL
TANGIBLE EMBODIMENTS OF LICENSED TECHNOLOGY AND LICENSED PATENT; (B) WITH
RESPECT TO SANOFI-AVENTIS, ALL INFORMATION AND TECHNOLOGY RELATED TO THE
SANOFI-AVENTIS ANTIBODY AND OTHERWISE INCLUDED IN ANY REGULATORY FILINGS MADE,
AND REGULATORY APPROVALS RECEIVED, BY SANOFI-AVENTIS WITH RESPECT TO LICENSED
PRODUCTS; AND (C) WITH RESPECT TO EACH PARTY, ALL INFORMATION AND TECHNOLOGY
DISCLOSED OR PROVIDED BY OR ON BEHALF OF SUCH PARTY (THE "DISCLOSING PARTY") TO
THE OTHER PARTY (THE "RECEIVING PARTY") OR TO ANY OF THE RECEIVING PARTY'S
EMPLOYEES, CONSULTANTS, AFFILIATES OR SUBLICENSEES, PROVIDED, THAT, NONE OF THE
FOREGOING SHALL BE CONFIDENTIAL INFORMATION IF: (I) AS OF THE DATE OF
DISCLOSURE, IT IS KNOWN TO THE RECEIVING PARTY OR ITS AFFILIATES AS DEMONSTRATED
BY CREDIBLE CONTEMPORANEOUS WRITTEN DOCUMENTATION, OTHER THAN BY VIRTUE OF A
PRIOR CONFIDENTIAL DISCLOSURE TO SUCH RECEIVING PARTY; (II) AS OF THE DATE OF
DISCLOSURE IT IS IN THE PUBLIC DOMAIN, OR IT SUBSEQUENTLY ENTERS THE PUBLIC
DOMAIN THROUGH NO FAULT OF THE RECEIVING PARTY; (III) IT IS OBTAINED BY THE
RECEIVING PARTY FROM A THIRD PARTY HAVING A LAWFUL RIGHT TO MAKE SUCH DISCLOSURE
FREE FROM ANY OBLIGATION OF CONFIDENTIALITY TO THE DISCLOSING PARTY; OR (IV) IT
IS INDEPENDENTLY DEVELOPED BY OR FOR THE RECEIVING PARTY WITHOUT REFERENCE TO OR
USE OF ANY CONFIDENTIAL INFORMATION OF THE DISCLOSING PARTY AS DEMONSTRATED BY
CREDIBLE CONTEMPORANEOUS WRITTEN DOCUMENTATION.
FOR PURPOSES OF CLARITY, THE
TERMS