ARRAY SHALL TRANSFER TO
AMGEN OR ITS DESIGNEE THE QUANTITIES OF ARRY-403 SET FORTH IN THE INVENTORY
LETTER (AS DEFINED IN SECTION 10.2(F) BELOW) (THE "ARRY-403 INVENTORY") IN THE
TIME FRAMES REASONABLY REQUESTED BY AMGEN IN WRITING (WHICH SHALL BE WITHIN A
REASONABLE TIME AFTER THE EFFECTIVE DATE AND, IN NO EVENT, LATER THAN [***]);
PROVIDED, HOWEVER, THAT ARRAY SHALL RETAIN SUCH QUANTITIES OF ARRY-403 AS ARE
REASONABLY NECESSARY FOR ARRAY TO CONDUCT ITS ACTIVITIES UNDER THE DISCOVERY
PLAN AND GLOBAL DEVELOPMENT PLAN, INCLUDING CLINICAL TRIAL SUPPLIES OF ARRY-403
THAT ARE REASONABLY NECESSARY FOR THE CONDUCT OF THE 403 MAD OR THE 403
BIOEQUIVALENCE TRIAL.
ARRAY WARRANTS TO AMGEN THAT THE PORTION OF THE ARRY-403
INVENTORY IDENTIFIED IN SECTION B OF THE INVENTORY LETTER, AT THE TIME OF
DELIVERY TO AMGEN, WILL MEET THE SPECIFICATIONS FOR ARRY-403 IN EFFECT AS OF THE
EFFECTIVE DATE (THE "SPECIFICATIONS"); PROVIDED, HOWEVER, THAT WITH RESPECT TO
TABLETS OF ARRY-403 FOR WHICH ARRAY HAS NOT COMPLETED TESTING AS OF THE
EFFECTIVE DATE ("ARRY-403 TABLETS"), SUCH WARRANTY IS MADE ONLY TO THE KNOWLEDGE
OF ARRAY.
IN THE EVENT THAT PORTIONS OF THE ARRY-403 TABLETS DO NOT MEET THE
SPECIFICATIONS, THEN ARRAY SHALL, AT ARRAY'S EXPENSE, PROVIDE TECHNICAL
ASSISTANCE TO AMGEN TO DETERMINE THE CAUSE OF SUCH FAILURE TO MEET
SPECIFICATIONS, AND REASONABLY COOPERATE WITH AMGEN, AS AMGEN MAY REQUEST, TO
EXERCISE ARRAY'S RIGHTS UNDER ITS CONTRACT WITH THE MANUFACTURER OF SUCH
ARRY-403 TABLETS, TO SEEK REMEDIES FOR SUCH FAILURE OF THE ARRY-403 TABLETS TO
MEET SPECIFICATIONS INCLUDING, IF APPLICABLE, SEEKING TO HAVE SUCH MANUFACTURER
MANUFACTURE REPLACEMENT QUANTITIES ARRY-403 TABLETS THAT MEET THE
SPECIFICATIONS.
AT THE TIME OF DELIVERY OF ARRY-403 INVENTORY, ARRAY SHALL
DELIVER ALL CERTIFICATES OF ANALYSIS RELATED TO SUCH ARRY-403 INVENTORY.
ARRAY
SHALL PROVIDE TO AMGEN OR ITS DESIGNEE SUCH OTHER MANUFACTURING INFORMATION
RELATED TO ARRY-403 OR OTHER COMPOUNDS MANUFACTURED BY ARRAY PRIOR TO THE
EFFECTIVE DATE THAT AMGEN REASONABLY REQUESTS, INCLUDING INFORMATION EVIDENCING
WHETHER THE CURRENT ANALYTICAL METHODS ARE SUITABLE UNDER FDA REGULATIONS TO
SUPPORT RELEASE TESTING FOR PHASE II CLINICAL TRIALS, AND SHALL COOPERATE WITH
AMGEN TO OBTAIN ANY SUCH REQUESTED INFORMATION AND/OR DOCUMENTATION FROM ARRAY'S
CONTRACTORS.
IF THE CURRENT ANALYTICAL METHODS ARE [***], THEN UPON REQUEST
FROM AMGEN [***], ARRAY WILL CONDUCT AGREED UPON WORK WITH THE GOAL OF MAKING
SUCH ANALYTICAL METHODS [***], AT AMGEN'S EXPENSE.
UNLESS OTHERWISE REQUESTED
BY AMGEN, ARRAY SHALL (I) CONDUCT [***] FOR THE ARRY-403 INVENTORY, AND
(II) CONDUCT [***] FOR THE ARRY-403 TABLETS AND BULK ARRY-403 TO OBTAIN, [***]
DATA TO [***].
IN CONNECTION WITH THE TRANSFER OF THE ARRY-403 INVENTORY, ARRAY
SHALL PROVIDE AMGEN WITH ANALYTICAL METHODS ASSOCIATED THEREWITH.
- 15 -
[ * ] = 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.
ADDITIONALLY, UPON AMGEN'S REQUEST, ARRAY SHALL PROMPTLY PROVIDE AMGEN WITH ANY
RETAINED SAMPLES AND REFERENCE STANDARDS OF ARRY-403.
PROMPTLY AFTER THE
EFFECTIVE DATE, ARRAY WILL ALSO PROVIDE TO