PRICING, DISTRIBUTION, COSTS, AND SALES DATA, MANUFACTURING
INFORMATION, AND PATENT AND LEGAL DATA OR DESCRIPTIONS (TO THE EXTENT THAT
DISCLOSURE THEREOF WOULD NOT RESULT IN LOSS OR WAIVER OF PRIVILEGE OR SIMILAR
PROTECTION) AND (II) COMPOSITIONS OF MATTER, INCLUDING BUT NOT LIMITED TO
COMPOUNDS, BIOLOGICAL MATERIALS AND ASSAYS.
AS USED HEREIN, "CLINICAL TEST
DATA" SHALL BE DEEMED TO INCLUDE ALL INFORMATION RELATED TO THE CLINICAL OR
PRECLINICAL TESTING OF A CANDIDATE DRUG OR LICENSED PRODUCT, INCLUDING WITHOUT
LIMITATION, PATIENT REPORT FORMS, INVESTIGATORS' REPORTS, BIOSTATISTICAL,
PHARMACO-ECONOMIC AND OTHER RELATED ANALYSES, AND THE LIKE.
4
1.32
"JOINT CHEMICAL PATENT" SHALL HAVE THE MEANING
SET OUT IN SECTION 8.2.2(K).
1.33
"JOINT INTELLECTUAL PROPERTY" SHALL HAVE THE
MEANING SET OUT IN SECTION 8.2.3.
1.34
"JOINT PATENT" SHALL HAVE THE MEANING SET OUT IN
SECTION 8.2.3.
1.35
"JOINT RESEARCH COMMITTEE" (OR "JRC") SHALL MEAN
THE COMMITTEE ESTABLISHED UNDER SECTION 2.2.
1.36
"KNOW HOW" SHALL MEAN EITHER OR BOTH OF ARRAY
KNOW HOW AND/OR AZ KNOW HOW.
1.37
"LICENSED PRODUCT" SHALL MEAN A PHARMACEUTICAL
PREPARATION FOR HUMAN USE INCORPORATING ARRY-142886 OR INCORPORATING ANOTHER
CANDIDATE DRUG AS AN ACTIVE INGREDIENT.
FOR PURPOSES OF CLARITY, THE TERM
"LICENSED PRODUCT" INCLUDES A PHARMACEUTICAL PREPARATION FORMULATED AND FIRST
USED IN A CLINICAL TRIAL.
1.38
"LICENSED TECHNOLOGY" SHALL MEAN ARRAY EXISTING
TECHNOLOGY, AZ EXISTING TECHNOLOGY AND COLLABORATION TECHNOLOGY.
1.39
"MAJOR EUROPEAN COUNTRY" SHALL MEAN FRANCE,
GERMANY, ITALY, SPAIN, OR THE UNITED KINGDOM.
1.40
"MARKETING APPROVAL" SHALL MEAN ALL APPROVALS,
LICENSES, REGISTRATIONS OR AUTHORIZATIONS OF ANY FEDERAL, STATE OR LOCAL
REGULATORY AGENCY, DEPARTMENT, BUREAU OR OTHER GOVERNMENTAL ENTITY, NECESSARY
FOR THE MANUFACTURING, USE, STORAGE, IMPORT, TRANSPORT AND SALE OF LICENSED
PRODUCTS IN A REGULATORY JURISDICTION.
FOR COUNTRIES WHERE GOVERNMENTAL
APPROVAL IS REQUIRED FOR PRICING OR REIMBURSEMENT FOR THE LICENSED PRODUCT TO BE
REIMBURSED BY NATIONAL HEALTH INSURANCE (I.E., OTHER THAN THE UNITED STATES),
"MARKETING APPROVAL" SHALL NOT BE DEEMED TO OCCUR UNTIL SUCH PRICING OR
REIMBURSEMENT APPROVAL IS OBTAINED;
PROVIDED, THAT IF A PARTY HAS NOT ACCEPTED
THE PRICING OFFERED BY THE GOVERNMENTAL AUTHORITY OF A PARTICULAR COUNTRY WITHIN
EIGHTEEN (18) MONTHS AFTER THE DATE THE FIRST MAA IS APPROVED IN SUCH COUNTRY,
THEN MARKETING APPROVAL SHALL BE DEEMED TO HAVE OCCURRED IN SUCH COUNTRY.
1.41
"MARKETING APPROVAL APPLICATION" OR "MAA" SHALL
MEAN A NEW DRUG APPLICATION (AS DEFINED IN 21 C.F.R. § 314.50 ET. SEQ.), OR A
COMPARABLE FILING FOR MARKETING APPROVAL (NOT INCLUDING PRICING OR REIMBURSEMENT
APPROVAL) IN A COUNTRY, IN EACH CASE WITH RESPECT TO A LICENSED PRODUCT IN THE
TERRITORY.
1.42
"MEK" SHALL MEAN (MITOGEN ACTIVATED PROTEIN
KINASE / EXTRACELLULARLY REGULATED PROTEIN KINASE) KINASE.
1.43
"NET SALES" SHALL MEAN THE GROSS INVOICED AMOUNT
ON SALES OF THE LICENSED PRODUCTS BY AZ OR ITS AFFILIATES (THE "SELLING PARTY")
TO THIRD PARTIES (INCLUDING DISTRIBUTORS), LESS DEDUCTIONS ALLOWED
5
TO THE THIRD PARTY CUSTOMER BY THE SELLING PARTY, AND WITH RESPECT ONLY TO (A)
AND (B) BELOW TO THE EXTENT ACTUALLY TAKEN BY THE THIRD PARTY CUSTOMER, ON SUCH
SALES FOR:
(A)
TRADE, QUANTITY, AND CASH DISCOUNTS;
(B)
CREDITS,