DURING THE APPLICABLE THIRTY (30) OR SIXTY (60) DAY PERIOD, THAT THE NDA OR HRD
IS NOT ACCEPTABLE FOR REVIEW.
1.2
"ACTIVITY CRITERIA" SHALL MEAN THE THRESHOLD
CRITERIA TO BE AGREED UPON BY THE PARTIES FOR IDENTIFYING COMPOUNDS HAVING
ACTIVITY AGAINST THE RELEVANT SCREENING TARGET.
1.3
"AFFILIATE" SHALL MEAN ANY INDIVIDUAL OR
ENTITY DIRECTLY OR INDIRECTLY CONTROLLING, CONTROLLED BY OR UNDER COMMON CONTROL
WITH, A PARTY TO THIS AGREEMENT.
FOR PURPOSES OF THIS AGREEMENT, THE DIRECT OR
INDIRECT OWNERSHIP OF FIFTY PERCENT (50%) OR MORE OF THE OUTSTANDING VOTING
SECURITIES OF AN ENTITY, OR THE RIGHT TO RECEIVE FIFTY PERCENT (50%) OR MORE OF
THE PROFITS OR EARNINGS OF AN ENTITY SHALL BE DEEMED TO CONSTITUTE CONTROL, OR
IF NOT MEETING THE PRECEDING REQUIREMENTS, ANY COMPANY OWNED OR CONTROLLED BY OR
OWNING OR CONTROLLING PHARMACOPEIA OR SCHERING AT THE MAXIMUM
1
CONTROL OR OWNERSHIP RIGHT PERMITTED IN A COUNTRY WHERE SUCH COMPANY EXISTS.
SUCH OTHER RELATIONSHIP AS IN FACT RESULTS IN ACTUAL CONTROL OVER THE
MANAGEMENT, BUSINESS AND AFFAIRS OF AN ENTITY SHALL ALSO BE DEEMED TO CONSTITUTE
CONTROL.
*
1.4
"AGREEMENT COMPOUND" SHALL MEAN ANY LEAD
COMPOUND OR DERIVATIVE COMPOUND, AS WELL AS *
1.5
"AGREEMENT PRODUCT" SHALL MEAN ANY PRODUCT
CONTAINING AN AGREEMENT COMPOUND, INCLUDING, WITHOUT LIMITATION, PRODUCTS FOR
THE THERAPEUTIC OR PROPHYLACTIC TREATMENT OR PREVENTION OF DISEASES AND
CONDITIONS IN HUMAN BEINGS OR ANIMALS.
1.6
"CARRYOVER PROGRAMS" SHALL HAVE THE MEANING
SET FORTH IN SECTION 2.02.
1.7
"COLLABORATION" SHALL MEAN THE OPTIMIZATION
PROGRAMS AND SCREENING PROGRAMS TO BE PERFORMED AT PHARMACOPEIA'S FACILITIES BY
SCHERING OR PHARMACOPEIA UNDER THIS AGREEMENT TO DISCOVER AGREEMENT COMPOUNDS
FOR FURTHER DEVELOPMENT BY SCHERING.
1.8
"COLLABORATION COMMITTEE" SHALL HAVE THE
MEANING SET FORTH IN SECTION 3.1.
1.9
"COLLABORATION RESEARCH PLAN" SHALL HAVE THE
MEANING SET FORTH IN SECTION 2.1.
1.10
"COLLABORATION TARGET-SPECIFIC TECHNOLOGY" SHALL
MEAN COLLABORATION TECHNOLOGY RELATING TO ASSAYS, COMPOUND SCREENING METHODS AND
BIOLOGICAL RESEARCH TOOLS, IN EACH CASE WHICH ARE DISCOVERED AND DEVELOPED
THROUGH COLLABORATION RESEARCH DIRECTED TO A SPECIFIC TARGET, OR A SMALL NUMBER
OF CLOSELY RELATED TARGETS (E.G. A FAMILY OF BIOLOGICAL RECEPTOR SUBTYPES), AND
ARE NOT READILY APPLICABLE TO OTHER TYPES OF TARGETS; PROVIDED, HOWEVER, THAT
COLLABORATION TARGET-SPECIFIC TECHNOLOGY SHALL NOT INCLUDE ANY RIGHTS IN OR TO
ANY SCHERING TECHNOLOGY (INCLUDING, WITHOUT LIMITATION, SCHERING'S PROPRIETARY
TARGETS) OR ANY AGREEMENT COMPOUNDS.
1.11
"COLLABORATION TECHNOLOGY" SHALL MEAN
COLLABORATION PATENT RIGHTS AND COLLABORATION KNOW-HOW.
1.11.1
"COLLABORATION PATENT RIGHTS" SHALL MEAN: (I) ALL
PATENTS AND PATENT APPLICATIONS CLAIMING ANY INVENTION OR DISCOVERY MADE BY OR
ON BEHALF OF PHARMACOPEIA IN PERFORMANCE OF THE COLLABORATION (INCLUDING,
WITHOUT LIMITATION, THE SYNTHESIS AND COMPOSITION OF MATTER OF ANY AGREEMENT
COMPOUND, OR METHOD OF USE THEREOF); AND (II) ANY DIVISIONS, CONTINUATIONS,
CONTINUATIONS-IN-PART, REISSUES, REEXAMINATIONS, EXTENSIONS OR OTHER
GOVERNMENTAL ACTIONS WHICH EXTEND ANY OF THE SUBJECT MATTER OF THE PATENT
APPLICATIONS OR PATENTS IN (I) ABOVE, AND ANY SUBSTITUTIONS, CONFIRMATIONS,
REGISTRATIONS, REVALIDATIONS, OR ADDITIONS OF ANY OF THE FOREGOING, IN EACH
CASE, WHICH IS OWNED OR CONTROLLED, IN WHOLE OR PART, BY LICENSE, ASSIGNMENT OR
OTHERWISE