PARTY ACQUIRER (WHICH SHALL NOT BE
ANY TRUSTEE OR OTHER FIDUCIARY HOLDING SECURITIES UNDER AN EMPLOYEE BENEFIT PLAN
OF SUCH PERSON, OR ANY CORPORATION OWNED DIRECTLY OR INDIRECTLY BY THE
STOCKHOLDERS OF SUCH PERSON, IN SUBSTANTIALLY THE SAME PROPORTION AS THEIR
OWNERSHIP OF STOCK OF SUCH PERSON), TOGETHER WITH ANY OF THE THIRD PARTY
ACQUIRER'S "AFFILIATES" OR "ASSOCIATES", AS SUCH TERMS ARE USED IN THE EXCHANGE
ACT, BECOMING THE BENEFICIAL OWNER OF FIFTY PERCENT (50%) OR MORE OF THE
COMBINED VOTING POWER OF THE OUTSTANDING SECURITIES OF SUCH PERSON OR BY
CONTRACT OR OTHERWISE HAVING THE RIGHT TO CONTROL THE BOARD OF DIRECTORS OR
EQUIVALENT GOVERNING BODY OF SUCH PERSON OR THE ABILITY TO CAUSE THE DIRECTION
OF MANAGEMENT OF SUCH PERSON.
1.44
"CLINICAL DATA" SHALL MEAN ANY AND ALL DATA
(TOGETHER WITH THE RESULTS OF ANALYSIS THEREOF) DERIVED OR GENERATED FROM ANY
CLINICAL TRIAL OF A PHARMACEUTICAL PRODUCT OR FROM
5
TESTING OR ANALYSIS OF SUBJECTS OR SAMPLES FROM SUCH A CLINICAL TRIAL (E.G. IN
VITRO TESTING OF TISSUE SAMPLES FROM SUBJECTS ENROLLED IN SUCH A CLINICAL
TRIAL), IN EACH CASE WHERE SUCH CLINICAL TRIAL INVOLVES EITHER OR BOTH OF (I)
ANY SINGLE AGENT PRODUCT OR DOUBLE AGENT PRODUCT, WHETHER ALONE OR IN
COMBINATION WITH ANY OTHER PRODUCT, AND (II) THE COMBINATION PRODUCT, WHETHER
ALONE OR IN COMBINATION WITH ANY OTHER PRODUCT.
1.45
"CLINICAL TRIAL REGISTRY" SHALL HAVE THE MEANING
SET FORTH IN SECTION 3.11(B).
1.46
"CLINICAL TRIAL RESULTS DATABASE" SHALL HAVE THE
MEANING SET FORTH IN SECTION 3.11(B).
1.47
"CMC DATA" SHALL MEAN ANY AND ALL INFORMATION
CONTAINED IN, AS WELL AS DATA SUPPORTING, THE "CHEMISTRY, MANUFACTURING AND
CONTROL" AND FACILITIES SECTIONS (OR SECTIONS CORRESPONDING THERETO) OF AN NDA,
INCLUDING, WITHOUT LIMITATION, ANY DRUG MASTER FILES REFERENCED IN THE NDA.
1.48
"CO-FUNDED CLINICAL TRIAL" SHALL HAVE THE MEANING
SET FORTH IN SECTION 3.2(B).
1.49
"COLLABORATION PRINCIPLES" SHALL HAVE THE MEANING
SET FORTH IN SECTION 2.9.
1.50
"COMBINATION PRODUCT" SHALL MEAN THE FIXED-DOSE
CO-FORMULATED PRODUCT DEVELOPED PURSUANT TO THIS AGREEMENT CONTAINING, AS ITS
ONLY ACTIVE PHARMACEUTICAL INGREDIENTS PER SINGLE DAILY DOSE, 300 MG TDF, 200 MG
FTC AND 600 MG EFV.
1.51
"COMBINATION PRODUCT REGULATORY DOCUMENTATION"
SHALL MEAN ALL REGULATORY DOCUMENTATION APPLICABLE TO THE COMBINATION PRODUCT
THAT IS DEVELOPED BY OR ON BEHALF OF ANY PARTY PURSUANT TO, AND DURING THE TERM
OF, THIS AGREEMENT, BUT EXCLUDING ALL BMS REGULATORY DOCUMENTATION AND ALL
GILEAD REGULATORY DOCUMENTATION.
1.52
"COMBINATION PRODUCT TRADEMARKS" SHALL MEAN THE
TRADEMARK OR TRADEMARKS SELECTED BY THE JCC FOR THE COMBINATION PRODUCT, ALL
PACKAGING DESIGNS AND OTHER TRADE DRESS USED IN CONNECTION WITH THE COMBINATION
PRODUCT, OTHER TRADEMARKS RELATING THERETO AND ANY REGISTRATIONS THEREOF OR ANY
PENDING APPLICATIONS RELATING THERETO.
FOR THE AVOIDANCE OF DOUBT, THE
FOLLOWING SHALL NOT BE CONSIDERED COMBINATION PRODUCT TRADEMARKS: (A) BMS
LICENSED TRADEMARKS, (B) GILEAD LICENSED TRADEMARKS AND (C) THE NAMES, LOGOS AND
OTHER TRADEMARKS OF THE MEMBER PARTIES.
1.53
"COMMERCIALIZATION ACTIVITIES" SHALL MEAN
MARKETING AND OTHER ACTIVITIES FOR THE COMMERCIALIZATION OF THE COMBINATION
PRODUCT INCLUDING THOSE SET FORTH IN THE