ANY GOVERNMENT OR OF ANY
SUBDIVISION, AUTHORITY OR REPRESENTATIVE OF ANY SUCH GOVERNMENT.
1.28
"GENERIC PRODUCT" MEANS A PHARMACEUTICAL PRODUCT THAT (A) CONTAINS
THE SAME ACTIVE INGREDIENT AS A LICENSED PRODUCT; (B) IS BIOEQUIVALENT TO SUCH
LICENSED PRODUCT; AND (C) IS DIRECTED AGAINST THE SAME TARGET AS A LICENSED
PRODUCT.
A-4
1.29
"GLP" MEANS THE THEN CURRENT GOOD LABORATORY PRACTICE STANDARDS
PROMULGATED OR ENDORSED BY THE FDA OR IN THE CASE OF FOREIGN JURISDICTIONS,
COMPARABLE REGULATORY STANDARDS PROMULGATED OR ENDORSED BY THE APPLICABLE
REGULATORY AUTHORITY, INCLUDING THOSE PROCEDURES EXPRESSED OR IMPLIED IN THE
REGULATORY FILINGS.
1.30
"GMP" MEANS ALL GOOD MANUFACTURING PRACTICES UNDER TITLE 21 OF THE
UNITED STATES CODE OF FEDERAL REGULATIONS, AS AMENDED FROM TIME TO TIME.
1.31
"HATCH-WAXMAN ACT" MEANS THE DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984, AS AMENDED.
1.32
"IMPROVEMENT" MEANS ANY ENHANCEMENT, IMPROVEMENT OR MODIFICATION TO
THE LICENSED TECHNOLOGY OR THE LICENSED PATENT RIGHTS.
1.33
"IND" MEANS: (A) AN INVESTIGATIONAL NEW DRUG APPLICATION (AS DEFINED
IN THE FDCA AND REGULATIONS PROMULGATED THEREUNDER) OR ANY SUCCESSOR APPLICATION
OR PROCEDURE REQUIRED TO INITIATE CLINICAL TESTING OF A LICENSED PRODUCT IN
HUMANS IN THE UNITED STATES; (B) A COUNTERPART OF AN INVESTIGATIONAL NEW DRUG
APPLICATION THAT IS REQUIRED IN ANY OTHER COUNTRY OR REGION IN THE TERRITORY
BEFORE BEGINNING CLINICAL TESTING OF A LICENSED PRODUCT IN HUMANS IN SUCH
COUNTRY OR REGION; AND (C) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE
FOREGOING.
1.34
"INITIATION" MEANS, WITH RESPECT TO ANY CLINICAL TRIAL, THE FIRST
DATE THAT A HUMAN SUBJECT IS DOSED IN SUCH CLINICAL TRIAL.
1.35
"LICENSED PATENT RIGHTS" MEANS ANY OF THE PATENTS AND PATENT
APPLICATIONS DESCRIBED IN SCHEDULE 1 ATTACHED HERETO, AND ANY DIVISIONALS,
CONTINUATIONS, CONTINUATIONS-IN-PART (TO THE EXTENT THAT ANY
CONTINUATIONS-IN-PART ARE ENTITLED TO THE PRIORITY DATE OF AN INITIAL PATENT OR
PATENT APPLICATION WHICH IS THE SUBJECT OF THIS AGREEMENT), REISSUES,
REEXAMINATIONS, CONFIRMATIONS, REVALIDATIONS, REGISTRATIONS, PATENTS OF
ADDITION, RENEWALS, EXTENSIONS OR SUBSTITUTES THEREOF, OR ANY PATENTS ISSUING
THEREFROM OR ANY SUPPLEMENTARY PROTECTION CERTIFICATES RELATED THERETO,
INCLUDING ANY IMPROVEMENT RELATED THERETO THAT IS CONCEIVED OR REDUCED TO
PRACTICE BY IMMUNOGEN OR ITS THIRD PARTY COLLABORATORS, THAT ARE CONTROLLED BY
IMMUNOGEN AND THAT INCLUDE ONE OR MORE CLAIMS THAT COVER LICENSED TECHNOLOGY.
1.36
"LICENSED PRODUCT" MEANS ANY PRODUCT DIRECTED AGAINST THE LICENSED
TARGET (A) THAT IS COMPRISED OF, INCORPORATES OR IS DERIVED FROM AN AB-MAY
PRODUCT, OR (B) THE MANUFACTURE, USE OR SALE OF WHICH WOULD, ABSENT THE LICENSE
GRANTED TO SANOFI-AVENTIS HEREUNDER, INFRINGE ANY VALID CLAIM INCLUDED IN THE
LICENSED PATENT RIGHTS.
1.37
"LICENSED TARGET" MEANS THE TARGET SET FORTH ON EXHIBIT A ATTACHED
HERETO AND INCORPORATED HEREIN BY REFERENCE.
1.38
"LICENSED TECHNOLOGY" MEANS ANY TECHNOLOGY CONTROLLED BY IMMUNOGEN AS
OF THE EFFECTIVE DATEORTHAT IS CONTROLLED BY IMMUNOGEN AT ANY TIME DURING THE
TERM INCLUDING, WITHOUT LIMITATION, ANY IMPROVEMENT RELATED THERETO THAT IS
CONCEIVED OR REDUCED TO PRACTICE BY IMMUNOGEN OR ITS THIRD PARTY COLLABORATORS
AND THAT IS, IN ANY CASE, NECESSARY OR USEFUL FOR SANOFI-AVENTIS TO EXERCISE THE
LICENSES