BY PHARMACOPEIA DURING THE TERM OF THIS AGREEMENT; PROVIDED, HOWEVER,
THAT COLLABORATION PATENT RIGHTS SHALL NOT INCLUDE ANY PATENTS OR PATENT
APPLICATIONS WHICH ARE SCHERING TECHNOLOGY OR PHARMACOPEIA TECHNOLOGY.
1.11.2
"COLLABORATION KNOW-HOW" SHALL MEAN ALL PROPRIETARY
IDEAS, INVENTIONS, DATA, KNOW-HOW, INSTRUCTIONS, PROCESSES, FORMULAS, MATERIALS,
EXPERT OPINION AND INFORMATION (INCLUDING, WITHOUT LIMITATION, (I) BIOLOGICAL,
CHEMICAL, PHYSICAL AND ANALYTICAL DATA AND INFORMATION RELATING TO AGREEMENT
COMPOUNDS, AND (II) ANY STRUCTURE-FUNCTION DATA RELATED TO LEAD COMPOUNDS OR
DERIVATIVE COMPOUNDS), IN EACH CASE WHICH IS DEVELOPED BY PHARMACOPEIA IN
PERFORMANCE OF THE COLLABORATION; PROVIDED, HOWEVER, THAT COLLABORATION KNOW-HOW
SHALL NOT INCLUDE COLLABORATION PATENT RIGHTS, SCHERING TECHNOLOGY OR
PHARMACOPEIA TECHNOLOGY.
1.12
"COMBINATION PRODUCT" SHALL MEAN AN AGREEMENT
PRODUCT WHICH COMPRISES TWO (2) OR MORE ACTIVE THERAPEUTIC INGREDIENTS AT LEAST
ONE (1) OF WHICH IS AN AGREEMENT COMPOUND.
1.13
"DERIVATIVE COMPOUND" SHALL MEAN ANY COMPOUND
DERIVED BY PHARMACOPEIA IN THE PERFORMANCE OF THE COLLABORATION, IN EACH CASE
FROM ONE OR MORE LEAD COMPOUNDS, AND HAVING ACTIVITY AGAINST THE SAME TARGET AS
SUCH LEAD COMPOUND(S).
AS USED HEREIN, A COMPOUND SHALL BE DEEMED TO HAVE BEEN
"DERIVED FROM" A LEAD COMPOUND IF IT *
2
1.14
"DEVELOPMENT CANDIDATE" SHALL MEAN A LEAD
COMPOUND, DERIVATIVE COMPOUND OR SCHERING DERIVATIVE WHICH POSSESSES THE
DESIRABLE PROPERTIES OF A THERAPEUTIC AGENT FOR THE PREVENTION OR TREATMENT OF A
CLINICAL CONDITION, IN THE ABSENCE OF REQUIRED SAFETY TRIALS NECESSARY TO BEGIN
HUMAN TESTING.
1.15
"EFFECTIVE DATE" SHALL HAVE THE MEANING SET FORTH
IN SECTION 2.01.
1.16
"EXCLUDED COMPOUND" SHALL HAVE THE MEANING SET
FORTH IN SECTION 2.9.3.
1.17
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG
ADMINISTRATION OR ANY CORRESPONDING FOREIGN REGISTRATION OR REGULATORY
AUTHORITY.
1.18
"FIRST COMMERCIAL SALE" SHALL MEAN, WITH RESPECT
TO ANY AGREEMENT PRODUCT, THE FIRST SALE FOR END USE OF SUCH AGREEMENT PRODUCT
IN THE TERRITORY AFTER RECEIPT OF THE REQUISITE REGULATORY APPROVAL.
1.19
"FTE" SHALL MEAN A FULL-TIME EMPLOYEE DEDICATED
TO THE CONDUCT OF THE COLLABORATION OR, IN THE CASE OF LESS THAN FULL-TIME
DEDICATION, A FULL-TIME EQUIVALENT PERSON-YEAR, BASED ON A TOTAL OF FORTY-SIX
AND ONE-FOURTH (46.25) WEEKS OR ONE THOUSAND EIGHT HUNDRED FIFTY (1,850) HOURS
PER YEAR, OF WORK ON OR DIRECTLY RELATED TO THE COLLABORATION.
1.20
"HIT" SHALL MEAN A PHARMACOPEIA COMPOUND
IDENTIFIED BY PHARMACOPEIA DURING THE TERM AND IN PERFORMANCE OF THE
COLLABORATION AS MEETING THE ACTIVITY CRITERIA WITH RESPECT TO THE GIVEN
SCREENING TARGET.
1.21
"HRD" SHALL MEAN A HEALTH REGISTRATION DOSSIER OR
ITS EQUIVALENT COVERING AN AGREEMENT PRODUCT FILED IN ANY COUNTRY OUTSIDE THE
UNITED STATES AND WHICH IS ANALOGOUS TO AN NDA AND INCLUDING, WHERE APPLICABLE,
APPLICATIONS FOR PRICING, PRICING REIMBURSEMENT APPROVAL, LABELING AND
REGULATORY APPROVAL.
1.22
"IND" SHALL MEAN AN INVESTIGATIONAL NEW DRUG
APPLICATION, AS DEFINED IN THE U.S. FOOD, DRUG AND COSMETIC ACT AND THE
REGULATIONS PROMULGATED THEREUNDER FOR INITIATING CLINICAL TRIALS IN THE UNITED
STATES, OR ANY CORRESPONDING FOREIGN APPLICATION, REGISTRATION OR CERTIFICATION.
1.23
"INTERNATIONAL AGREEMENT" SHALL MEAN THAT CERTAIN
COLLABORATION AND LICENSE AGREEMENT ENTERED INTO BY AND BETWEEN PHARMACOPEIA AND
SCHERING-PLOUGH, LTD. OF EVEN