WITH THIS AGREEMENT UP TO AND INCLUDING THE
OBTAINING OF COMMERCIALIZATION REGULATORY APPROVAL OF SUCH PRODUCT, INCLUDING
WITHOUT LIMITATION, TOXICOLOGY, PHARMACOLOGY AND OTHER DISCOVERY AND PRECLINICAL
EFFORTS, ALL ACTIVITIES RELATING TO MANUFACTURING DEVELOPMENT, CLINICAL TRIALS
(INCLUDING REQUIRED PHASE 4 CLINICAL TRIALS), STATISTICAL ANALYSIS AND ALL
ACTIVITIES RELATING TO OBTAINING COMMERCIALIZATION REGULATORY APPROVAL.
WHEN
USED AS A VERB, "DEVELOPING" MEANS TO ENGAGE IN DEVELOPMENT AND "DEVELOPED" HAS
A CORRESPONDING MEANING.
FOR PURPOSES OF CLARITY, DEVELOP AND DEVELOPMENT SHALL
NOT INCLUDE THE CONDUCT OF OPTIONAL PHASE 4 CLINICAL TRIALS OR COLLABORATIVE
RESEARCH TRIALS.
1.33
"DEVELOPMENT COSTS" MEANS THE REASONABLE OUT-OF-POCKET COSTS AND
INTERNAL COSTS INCURRED BY A PARTY (OR FOR ITS ACCOUNT BY AN AFFILIATE OR A
THIRD PARTY) AFTER THE EFFECTIVE DATE THAT ARE CONSISTENT WITH THE RESPECTIVE
DEVELOPMENT ACTIVITIES OF SUCH PARTY IN THE APPLICABLE GLOBAL DEVELOPMENT PLAN
AND BUDGET AND ARE DIRECTLY ATTRIBUTABLE TO THE DEVELOPMENT OF A PRODUCT AND
DETERMINED IN ACCORDANCE WITH SCHEDULE 7 ATTACHED HERETO.
FOR PURPOSES OF THIS
DEFINITION (A) [***] MEANS THE ACTUAL AMOUNTS PAID TO A [***] FOR SPECIFIC
EXTERNAL DEVELOPMENT ACTIVITIES APPLICABLE TO A PRODUCT, INCLUDING, WITHOUT
LIMITATION ALL [***] REQUIRED FOR AND OTHER COSTS ASSOCIATED WITH, ANY [***] AND
ALL EXPENSES (INCLUDING [***]) RELATED TO THE [***] APPLICABLE TO A PRODUCT AS
PROVIDED IN [***] UNTIL COMMERCIALIZATION REGULATORY APPROVAL IS OBTAINED;
(B) INTERNAL COSTS MEANS THE APPLICABLE FTE RATE MULTIPLIED BY THE NUMBER OF FTE
HOURS UTILIZED IN THE RELEVANT PERIOD ON ACTIVITIES DIRECTLY RELATING TO
DEVELOPMENT IN ACCORDANCE WITH THE GLOBAL DEVELOPMENT PLAN; AND (C) THE
REASONABLE OUT-OF-POCKET AND INTERNAL COSTS SHALL INCLUDE THE COST OF [***] FOR
USE IN THE ACTIVITIES DESCRIBED IN CLAUSE (A) OR (B).
1.34
"DEVELOPMENT PROGRAM" MEANS, WITH RESPECT TO EACH PRODUCT, THE
DEVELOPMENT ACTIVITIES (INCLUDING THE MANUFACTURING DEVELOPMENT ACTIVITIES) TO
BE CONDUCTED BY THE PARTIES DURING THE TERM WITH RESPECT TO SUCH PRODUCT AS SET
FORTH IN THE GLOBAL DEVELOPMENT PLAN.
1.35
"DRUG APPROVAL APPLICATION" MEANS, WITH RESPECT TO EACH PRODUCT IN
A PARTICULAR COUNTRY OR REGION, AN APPLICATION FOR COMMERCIALIZATION REGULATORY
APPROVAL FOR SUCH PRODUCT IN SUCH COUNTRY OR REGION, INCLUDING WITHOUT
LIMITATION: (A) AN NDA, SNDA, MAA OR JNDA; (B) A COUNTERPART OF THE FOREGOING IN
ANY COUNTRY OR REGION IN THE TERRITORY; AND (C) ALL SUPPLEMENTS AND AMENDMENTS
TO ANY OF THE FOREGOING.
1.36
"DMF" MEANS A DRUG MASTER FILE MAINTAINED WITH THE FDA OR ITS
EQUIVALENT MAINTAINED WITH A REGULATORY AUTHORITY IN OTHER COUNTRIES WITHIN THE
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.
6
1.37
"EFFECTIVE DATE" MEANS THE DATE OF SATISFACTION OF THE HSR
CONDITIONS WITH RESPECT TO THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, OR
IF THE PARTIES DETERMINE THAT AN HSR FILING IS NOT REQUIRED, THEN THE EXECUTION
DATE.
1.38
"EMEA" MEANS THE EUROPEAN MEDICINES AGENCY OR ANY SUCCESSOR AGENCY
OR AUTHORITY THERETO.
1.39
"EXECUTION DATE" MEANS THE