MATERIAL ACTIVITIES WITH RESPECT TO THE
COMMERCIALIZATION OF SUCH PRODUCT BY GSK IN THE MAJOR MARKET COUNTRIES IN THE
ROYALTY-BEARING TERRITORY.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
9
1.58
"GSK PATENT RIGHTS" MEANS ANY PATENT RIGHTS CONTROLLED BY GSK IN
THE TERRITORY DURING THE TERM THAT COVER ANY ASPECT OF THE MANUFACTURE, USE,
SALE, OFFER FOR SALE OR IMPORTATION OF A COLLABORATION COMPOUND OR PRODUCT,
INCLUDING WITHOUT LIMITATION ANY PATENT RIGHTS THAT CLAIM GSK TECHNOLOGY.
1.59
"GSK TECHNOLOGY" MEANS ANY TECHNOLOGY, INCLUDING PROGRAM TECHNOLOGY
OTHER THAN JOINT TECHNOLOGY, CONTROLLED BY GSK IN THE TERRITORY DURING THE TERM
THAT IS NECESSARY OR USEFUL FOR THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY
COLLABORATION COMPOUND OR PRODUCT.
1.60
"HATCH-WAXMAN ACT" MEANS THE DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984, AS AMENDED.
1.61
"HSR ACT" MEANS THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF
1976, AS AMENDED.
1.62
"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 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 PRODUCT IN HUMANS IN SUCH COUNTRY OR REGION; AND (C) ALL
SUPPLEMENTS AND AMENDMENTS TO ANY OF THE FOREGOING.
1.63
"INDICATION" MEANS ANY HUMAN DISEASE OR CONDITION WHICH CAN BE
TREATED, PREVENTED, CURED OR THE PROGRESSION OF WHICH CAN BE DELAYED.
FOR
PURPOSES OF THE PAYMENT OF MILESTONES PURSUANT TO SECTION 6.4.1, WITH RESPECT TO
SYNTA'S DEVELOPMENT OPT-OUT RIGHT (EXCEPT AS PROVIDED IN SECTION 3.1.3(D)) AND
WITH RESPECT TO THE DEFINITION OF NEW INDICATION, THE [***] FOR A PRODUCT FOR A
PARTICULAR INDICATION, FOR EXAMPLE, THE [***] OF THE USE OF A PRODUCT FROM
TREATING [***] TO USE AS [***] TREATMENT FOR [***] AND/OR THE APPROVAL OF A
PRODUCT AS A [***] THERAPY AFTER BEING APPROVED AS A [***] THERAPY FOR TREATMENT
OF THE SAME DISEASE OR CONDITION SHALL NOT BE DEEMED TO BE SEPARATE INDICATIONS.
1.64
"INITIAL EQUITY PURCHASE OBLIGATION DATE" MEANS THE [***] OF
(A) THE DATE OF DETERMINATION BY THE JDC THAT THE ONGOING CLINICAL TRIAL HAS
ACHIEVED ITS [***], OR (B) THE DATE OF DETERMINATION BY THE JDC TO FILE FOR
REGULATORY APPROVAL IN THE U.S. TERRITORY FOR STA-4783 FOR METASTATIC MELANOMA
DESPITE NOT MEETING THE [***] IN THE ONGOING[***]CLINICAL TRIAL.
FOR PURPOSES
OF THIS DEFINITION, THE DATE OF DETERMINATION SHALL MEAN THE DATE OF ANY MEETING
AT WHICH THE APPLICABLE DECISION IS MADE BY THE JDC PURSUANT TO
SECTION 2.2.3(B) (OR IF SUCH DECISION WAS A DISPUTED MATTER, THEN THE DATE ON
WHICH THE APPLICABLE DECISION WAS FINALLY DECIDED).
1.65
"INITIATION" MEANS, WITH RESPECT TO A CLINICAL TRIAL, THE FIRST
DATE THAT A SUBJECT OR