USER, WITH RESPECT TO A LICENSED PRODUCT IN A COUNTRY IN THE TERRITORY.
1.66
"FORCE MAJEURE" MEANS ANY OCCURRENCE BEYOND THE REASONABLE CONTROL
OF A PARTY THAT (A) PREVENTS OR SUBSTANTIALLY INTERFERES WITH THE PERFORMANCE BY
SUCH PARTY OF ANY OF ITS OBLIGATIONS HEREUNDER AND (B) OCCURS BY REASON OF ANY
ACT OF GOD, FLOOD, FIRE, EXPLOSION, EARTHQUAKE, STRIKE, LOCKOUT, LABOR DISPUTE,
CASUALTY OR ACCIDENT, OR WAR, REVOLUTION, CIVIL COMMOTION, ACT OF TERRORISM,
BLOCKAGE OR EMBARGO, OR ANY INJUNCTION, LAW, ORDER, PROCLAMATION, REGULATION,
ORDINANCE, DEMAND OR REQUIREMENT OF ANY GOVERNMENT OR OF ANY SUBDIVISION,
AUTHORITY OR REPRESENTATIVE OF ANY SUCH GOVERNMENT.
1.67
"GLOBAL DEVELOPMENT PLAN" MEANS, WITH RESPECT TO EACH COLLABORATION
COMPOUND AND LICENSED PRODUCT, THE WRITTEN PLAN FOR, AND BUDGET APPLICABLE TO,
THE DEVELOPMENT ACTIVITIES TO BE CONDUCTED FOR SUCH COLLABORATION COMPOUND AND
LICENSED PRODUCT FOR THE TERRITORY, AS SUCH WRITTEN PLAN MAY BE AMENDED,
MODIFIED OR UPDATED IN ACCORDANCE WITH SECTION 3.1.2.
1.68
"GLOBAL PRICING POLICY" MEANS THE ESTABLISHMENT OF THE RANGE OF
PUBLISHED PRICES FOR LICENSED PRODUCTS THROUGHOUT THE TERRITORY.
1.69
"GLP" MEANS THE THEN CURRENT GOOD LABORATORY PRACTICE STANDARDS
PROMULGATED OR ENDORSED BY THE FDA OR IN THE CASE OF FOREIGN JURISDICTIONS,
COMPARABLE REGULATORY STANDARDS PROMULGATED OR ENDORSED BY THE APPLICABLE
REGULATORY AUTHORITY, INCLUDING THOSE PROCEDURES CONTEMPLATED BY ANY REGULATORY
FILINGS.
1.70
"GMP" MEANS CURRENT GOOD MANUFACTURING PRACTICES THAT APPLY TO THE
MANUFACTURE OF API AND CLINICAL PRODUCT, INCLUDING, WITHOUT LIMITATION, THE
UNITED STATES REGULATIONS SET FORTH UNDER TITLE 21 OF THE UNITED STATES CODE OF
FEDERAL REGULATIONS, PARTS 210, 211 AND 600-680, AS MAY BE AMENDED FROM
TIME-TO-TIME, AS WELL AS ALL APPLICABLE GUIDANCE PUBLISHED FROM TIME-TO-TIME BY
THE FDA.
13
1.71
"HATCH-WAXMAN ACT" MEANS THE DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984, AS AMENDED.
1.72
"HSR ACT" MEANS THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF
1976, AS AMENDED.
1.73
"IND" MEANS: (A) AN INVESTIGATIONAL NEW DRUG APPLICATION AS DEFINED
IN THE FDCA AND REGULATIONS PROMULGATED THEREUNDER OR ANY SUCCESSOR APPLICATION
OR PROCEDURE REQUIRED TO INITIATE CLINICAL TESTING OF A LICENSED PRODUCT IN
HUMANS IN THE UNITED STATES; (B) A COUNTERPART OF AN INVESTIGATIONAL NEW DRUG
APPLICATION THAT IS REQUIRED IN ANY OTHER COUNTRY OR REGION IN THE TERRITORY
BEFORE BEGINNING CLINICAL TESTING OF A LICENSED PRODUCT IN HUMANS IN SUCH
COUNTRY OR REGION; AND (C) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE
FOREGOING.
1.74
"INDICATION" MEANS ANY HUMAN DISEASE OR CONDITION WHICH CAN BE
TREATED, PREVENTED, CURED OR THE PROGRESSION OF WHICH CAN BE DELAYED.
FOR
PURPOSES OF CLARITY, DISTINCTIONS BETWEEN HUMAN INDICATIONS, DISEASES OR
CONDITIONS WITH RESPECT TO A LICENSED PRODUCT SHALL BE MADE BY REFERENCE TO THE
WORLD HEALTH ORGANIZATION INTERNATIONAL CLASSIFICATION OF DISEASES, VERSION 10
(AS REVISED AND UPDATED, THE "ICD10").
1.75
"INITIATION" MEANS, WITH RESPECT TO A CLINICAL TRIAL, THE FIRST
DATE THAT A SUBJECT OR PATIENT IS DOSED IN SUCH CLINICAL TRIAL.
1.76
"JOINT DECISION" MEANS (A) ANY DECISION AS SET FORTH IN
SECTION 3.1.4(B); (B) ANY DECISION SET FORTH IN SECTION 3.14; (C) ANY