TO PAY SUCH ADDITIONAL COSTS).
FOLLOWING THE EFFECTIVE
DATE, EXCEPT AS REQUIRED BY LAW, ARRAY WILL NOT MAKE OR INITIATE ANY FILING,
SUBMISSION OR CORRESPONDENCE WITH THE FDA OR OTHER GOVERNMENTAL AUTHORITY WITH
RESPECT TO THE PROGRAM, INCLUDING THE 403 MAD AND 403 BIOEQUIVALENCE TRIAL,
WITHOUT AMGEN'S PRIOR REVIEW AND CONSENT.
(D)
REGULATORY COMMUNICATIONS.
ADDITIONALLY, WITH RESPECT TO ADVERSE EVENTS OR
SERIOUS ADVERSE EVENTS IN CONNECTION WITH THE 403 MAD AND THE 403 BIOEQUIVALENCE
- 19 -
[ * ] = Confidential treatment of certain confidential information contained in
this document, marked by brackets, is being sought pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
TRIAL, ARRAY SHALL, PRIOR TO ANY COMMUNICATION WITH THE FDA, PROVIDE AMGEN WITH
AN OPPORTUNITY TO REVIEW SUCH SUSPECTED EVENTS AND DETERMINE WHETHER ANY SUCH
SUSPECTED EVENTS ARE IN FACT AN ADVERSE OR SERIOUS ADVERSE EVENT.
SUBJECT TO
ARRAY'S COMPLIANCE WITH LAW, ARRAY WILL HANDLE ANY SUCH ADVERSE EVENTS AND
SERIOUS ADVERSE EVENTS AS DIRECTED BY AMGEN.
ARRAY WILL PROMPTLY NOTIFY AN
AMGEN DESIGNATED CONTACT PERSON OF ANY PLANNED FILING, SUBMISSION OR
CORRESPONDENCE TO THE FDA WITH RESPECT TO THE PROGRAM OR ARRAY'S GLUCOKINASE
ACTIVATOR PROGRAM CONDUCTED PRIOR TO THE EFFECTIVE DATE.
AMGEN WILL HAVE THE
RIGHT TO PARTICIPATE IN ANY DISCUSSIONS BETWEEN ARRAY AND THE FDA RELATING TO
THE PROGRAM (OR ARRAY'S GLUCOKINASE ACTIVATOR PROGRAM CONDUCTED PRIOR TO THE
EFFECTIVE DATE) AT AMGEN'S OWN EXPENSE, AND ARRAY WILL GIVE AMGEN TEN BUSINESS
(10) DAYS PRIOR WRITTEN NOTICE THEREOF (OR PROMPT WRITTEN NOTICE, IF TEN
(10) BUSINESS DAYS NOTICE IS IMPRACTICAL); PROVIDED, THAT THE FOREGOING WILL NOT
APPLY TO UNSCHEDULED MEETINGS OR TELECONFERENCES THAT ARE INITIATED BY THE FDA
AND ARRAY CAN NOT PRACTICALLY INCLUDE AMGEN IN SUCH DISCUSSION, AND IN SUCH
CASE, ARRAY WILL THEREAFTER PROVIDE AMGEN PROMPT WRITTEN NOTICE OF SUCH
COMMUNICATION WITH A SUMMARY OF THE DISCUSSION.
NOTHING HEREIN SHALL BE
CONSTRUED TO PROHIBIT ARRAY FROM MAKING SUCH FILINGS, SUBMISSIONS OR
CORRESPONDENCE AS ARRAY IS REQUIRED TO MAKE UNDER LAW.
(E)
SAFETY AND REQUIREMENT OF LAW.
NOTWITHSTANDING THE OBLIGATIONS SET FORTH
IN THIS SECTION 3.2 FOR ARRAY TO PROVIDE NOTICE AND REVIEW CERTAIN MATTERS WITH
AMGEN, OR TO FOLLOW AMGEN'S DIRECTION AS TO CERTAIN MATTERS, IN THE EVENT THAT
ARRAY REASONABLY BELIEVES THAT IMMEDIATE ACTIONS ARE REQUIRED TO BE TAKEN (IN A
TIME FRAME THAT DOES NOT PERMIT THE FULL PERIOD OF NOTICE AND REVIEW
CONTEMPLATED IN THIS SECTION 3.2) FOR EXIGENT SAFETY CONCERNS RELATED TO
PATIENTS OR FOR COMPLIANCE WITH LAW, ARRAY MAY TAKE SUCH ACTION AND, IN SUCH
EVENT, SHALL PROMPTLY NOTIFY AMGEN; PROVIDED, HOWEVER, THAT ARRAY WILL FIRST USE
REASONABLE EFFORTS TO IMMEDIATELY NOTIFY AMGEN'S DESIGNATED CONTACT PERSON WITH
RESPECT TO ANY SUCH MATTER, INCLUDING SAFETY-RELATED MATTERS, TO DISCUSS SUCH
MATTER.
3.3
GLOBAL DEVELOPMENT PLANS.
3.3.1
GENERAL.
FOR EACH PRODUCT, [***], AMGEN SHALL PREPARE AND PRESENT TO
THE JDC A REASONABLY DETAILED, WRITTEN GLOBAL DEVELOPMENT PLAN (A "GLOBAL
DEVELOPMENT PLAN") PURSUANT TO WHICH THE GLOBAL DEVELOPMENT PROGRAM FOR SUCH
PRODUCT WILL BE PERFORMED.