OF
SUCH PRODUCT OR THE PRACTICE OF SUCH TECHNOLOGY, PROCESS OR METHOD, BY SUCH
PERSON WOULD INFRINGE SUCH VALID CLAIM (OR, IN THE CASE OF A VALID CLAIM THAT
HAS NOT YET ISSUED, WOULD INFRINGE SUCH VALID CLAIM IF IT WERE TO ISSUE).
1.13
"CPI" MEANS THE CONSUMER PRICE INDEX - URBAN WAGE EARNERS AND
CLERICAL WORKERS, U.S. CITY AVERAGE, ALL ITEMS, 1982-84 = 100, PUBLISHED BY THE
UNITED STATES DEPARTMENT OF LABOR, BUREAU OF STATISTICS (OR ITS SUCCESSOR
EQUIVALENT INDEX).
1.14
"DETAIL" MEANS FACE-TO-FACE DISCUSSIONS OR OTHER DIRECT
COMMUNICATION (E.G. EDETAILING) WITH PHYSICIANS AND OTHER HEALTH CARE
PRACTITIONERS WHO ARE PERMITTED UNDER APPLICABLE LAWS TO PRESCRIBE A LICENSED
PRODUCT FOR THE PURPOSE OF PROMOTING A LICENSED PRODUCT TO SUCH PHYSICIANS OR
PRACTITIONERS.
1.15
"DEVELOPMENT" OR "DEVELOP" MEANS, WITH RESPECT TO A COMPOUND,
PRECLINICAL AND CLINICAL DRUG DEVELOPMENT ACTIVITIES, INCLUDING, AMONG OTHER
THINGS:
THE CONDUCT OF CLINICAL TRIALS, TEST METHOD DEVELOPMENT AND STABILITY
TESTING, TOXICOLOGY, FORMULATION AND DELIVERY SYSTEM DEVELOPMENT, PROCESS
DEVELOPMENT, PRE-CLINICAL AND CLINICAL DRUG SUBSTANCE AND CLINICAL DRUG PRODUCT
SUPPLY, MANUFACTURING SCALE-UP, DEVELOPMENT-STAGE MANUFACTURING, QUALITY
ASSURANCE/QUALITY CONTROL PROCEDURE DEVELOPMENT AND PERFORMANCE WITH RESPECT TO
CLINICAL MATERIALS, STATISTICAL ANALYSIS AND REPORT WRITING AND CLINICAL
STUDIES, REGULATORY AFFAIRS, AND ALL OTHER PRE-REGULATORY APPROVAL ACTIVITIES.
WHEN USED AS A VERB, "DEVELOP" MEANS TO ENGAGE IN DEVELOPMENT.
1.16
"DEVELOPMENT COSTS" MEANS THE COSTS AND EXPENSES INCURRED BY OR ON
BEHALF OF A PARTY ATTRIBUTABLE TO, OR REASONABLY ALLOCABLE TO, THE DEVELOPMENT
OF LICENSED PRODUCTS AND THAT ARE MATERIALLY CONSISTENT, AS APPLICABLE, WITH THE
DEVELOPMENT PLAN AND DEVELOPMENT BUDGET.
DEVELOPMENT COSTS SHALL NOT INCLUDE
***.
"DEVELOPMENT COSTS" SHALL INCLUDE (A) THE COSTS OF CLINICAL TRIALS, THE
PREPARATION, COLLATION AND/OR VALIDATION OF DATA FROM SUCH CLINICAL TRIALS AND
THE PREPARATION OF MEDICAL WRITING AND PUBLISHING; (B) THE FTE COSTS OF THE
RELEVANT PARTY OR ITS AFFILIATES; (C) ALL OUT-OF-POCKET COSTS INCURRED BY THE
PARTIES OR THEIR AFFILIATES, INCLUDING PAYMENTS MADE TO THIRD PARTIES WITH
RESPECT TO ANY OF THE FOREGOING (EXCEPT TO THE EXTENT THAT SUCH COSTS HAVE BEEN
INCLUDED IN FTE COSTS); (D) OUT-OF-POCKET COSTS INCURRED BY OR ON BEHALF OF A
PARTY IN CONNECTION WITH THE PREPARATION AND FILING OF REGULATORY SUBMISSIONS
FOR LICENSED PRODUCT AND OBTAINING OF REGULATORY APPROVALS; AND (E) THE COST OF
CONTRACT RESEARCH ORGANIZATIONS (CROS) AND CLINICAL SUPPLY, INCLUDING:
(I) COSTS, PACKAGING AND DISTRIBUTION OF LICENSED PRODUCTS USED IN CLINICAL
TRIALS; (II) EXPENSES INCURRED TO PURCHASE AND/OR PACKAGE COMPARATOR DRUGS; AND
(III) COSTS AND EXPENSES OF DISPOSAL OF CLINICAL SAMPLES.
1.17
"EMEA" MEANS THE EUROPEAN MEDICINES AGENCY, OR A SUCCESSOR AGENCY
THERETO.
3
*** Confidential material redacted and filed separately with the Commission.
1.18
"EXCHANGE ACT" MEANS THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
1.19
"EXCLUDED FIELD" MEANS ANY AND ALL INDICATIONS IN HUMANS AND
ANIMALS IN THE HEMATOLOGY FIELD AND THE ONCOLOGY FIELD.
1.20
"EXECUTIVE OFFICERS" MEANS THE CHIEF EXECUTIVE OFFICER OF INCYTE
(OR A SENIOR EXECUTIVE OFFICER OF INCYTE DESIGNATED BY INCYTE'S CHIEF EXECUTIVE
OFFICER) AND THE VICE PRESIDENT AUTOIMMUNE PRODUCT DEVELOPMENT OF LILLY