WOULD APPLY EFFORTS AND RESOURCES FOR A COMPOUND IN ITS OWN PIPELINE,
AT A [***] AS COMPARED TO THE COLLABORATION COMPOUND OR LICENSED PRODUCT IN
QUESTION.
1.45.3
A PARTY THAT IS REQUIRED TO USE DILIGENT EFFORTS WITH RESPECT TO AN
OBLIGATION SHALL, CONSISTENT WITH THE STANDARD DESCRIBED ABOVE: (A) PROMPTLY
ASSIGN RESPONSIBILITY FOR SUCH OBLIGATION TO SPECIFIC EMPLOYEE(S) OR PERMITTED
CONTRACTORS WHO ARE HELD ACCOUNTABLE FOR PROGRESS AND MONITOR SUCH PROGRESS ON
AN ON-GOING BASIS, (B) ESTABLISH AND CONSISTENTLY SEEK TO ACHIEVE SPECIFIC,
MEANINGFUL AND MEASURABLE OBJECTIVES FOR CARRYING OUT SUCH OBLIGATION, AND
(C) CONSISTENTLY MAKE AND IMPLEMENT DECISIONS AND ALLOCATE REASONABLY SUFFICIENT
PERSONNEL AND FINANCIAL RESOURCES DESIGNED TO ADVANCE PROGRESS WITH RESPECT TO
SUCH OBJECTIVE.
1.46
"DISCLOSING PARTY" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 9.1.
1.47
"DISCOVERY MILESTONE" SHALL MEAN, ON A PROGRAM-BY-PROGRAM BASIS, THE
MILESTONE EVENT THAT IS ACHIEVED HEREUNDER UPON THE LATER OF (I) DEMONSTRATION
OF [***] CONFIRMED BY THE JSC (SUBJECT TO THE DISPUTE RESOLUTION PROVISIONS IN
SECTION 2.1.7, IF NECESSARY) OR (II) [***] FOR A GIVEN PROGRAM.
1.48
"EARLY DEVELOPMENT PLAN" SHALL MEAN AN OVERALL DEVELOPMENT PLAN (INCLUDING
ALL SUBSEQUENT AMENDMENTS OR UPDATES THERETO) FOR THE DEVELOPMENT OF A
DEVELOPMENT CANDIDATE THROUGH TO COMPLETION OF THE POC TRIAL.
8
1.49
"EARLY DEVELOPMENT PROGRAM" SHALL HAVE THE MEANING SET FORTH IN
SECTION 3.5.1.
1.50
"EARLY DEVELOPMENT PROGRAM TERM" SHALL DEFINE THE DURATION OF EACH EARLY
DEVELOPMENT PROGRAM HEREUNDER AND SHALL BE DETERMINED ON AN EARLY DEVELOPMENT
PROGRAM-BY-EARLY DEVELOPMENT PROGRAM BASIS AS FOLLOWS:
THE PERIOD COMMENCING
UPON THE EARLIER OF (A) THE EXPIRATION OF THE [***] EXERCISE PERIOD WITHOUT
GSK'S EXERCISE OF THE [***] FOR SUCH PROGRAM, OR (B) GSK'S NOTICE TO REGULUS OF
ITS DECISION NOT TO EXERCISE SUCH [***], AND ENDING UPON [***]; PROVIDED,
HOWEVER, THAT SUCH PERIOD SHALL TERMINATE WHEN GSK EXERCISES THE RELEVANT [***]
UNLESS SUCH PROGRAM IS TERMINATED EARLIER.
1.51
"EFFECTIVE DATE" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN THE
RECITALS.
1.52
"EMEA" SHALL MEAN THE EUROPEAN MEDICINES EVALUATION AGENCY, AND ANY
SUCCESSOR ENTITY THERETO.
1.53
"ENABLING STUDIES" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 3.8.
1.54
"EUROPEAN UNION" OR "EU" SHALL INCLUDE AUSTRIA, BELGIUM, DENMARK, FINLAND,
FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, THE NETHERLANDS, PORTUGAL,
SPAIN, SWEDEN, UNITED KINGDOM, CYPRUS, CZECH REPUBLIC, ESTONIA, HUNGARY, LATVIA,
LITHUANIA, MALTA, POLAND, SLOVAKIA, SLOVENIA, AND ANY SUCH OTHER COUNTRY OR
TERRITORY THAT MAY OFFICIALLY BECOME PART OF THE EUROPEAN UNION AFTER THE
EFFECTIVE DATE.
1.55
"EXECUTIVE OFFICERS" SHALL MEAN THE CHIEF EXECUTIVE OFFICER OF REGULUS (OR
A SENIOR EXECUTIVE OFFICER DESIGNATED BY SUCH PERSON) AND EITHER THE CHIEF
EXECUTIVE OFFICER OR THE CHAIRMAN OF R&D AT GSK (OR ANOTHER SENIOR EXECUTIVE
OFFICER DESIGNATED BY SUCH PERSONS).
1.56
"EXISTING IN-LICENSE AGREEMENTS" SHALL HAVE THE MEANING ASSIGNED TO SUCH
TERM IN SECTION 10.3.3.
1.57
"EXPERT PANEL" SHALL HAVE THE MEANING ASSIGNED TO SUCH TERM IN
SECTION 2.4.
1.58
"FDA" SHALL MEAN THE U.S. FOOD AND DRUG ADMINISTRATION, AND ANY SUCCESSOR
ENTITY THERETO.
1.59
"FIELD" SHALL MEAN (A)