OR HAVE MANUFACTURED, THE PRODUCT ON BEHALF OF
DEPOMED, AT DEPOMED'S EXPENSE, INCLUDING EXPENSES RELATED TO THE TECHNICAL
TRANSFER OF THE PRODUCT, AND DEPOMED WILL PROVIDE REASONABLE ASSISTANCE TO KING
IN CONNECTION THEREWITH, INCLUDING BY TRANSFERRING OR LICENSING TO KING ALL
TECHNOLOGY NECESSARY OR USEFUL TO GIVE KING THE CAPABILITY OF MANUFACTURING THE
PRODUCT SO THAT KING CAN UNDERTAKE MANUFACTURE OF THE PRODUCT; PROVIDED,
HOWEVER, THAT DEPOMED SHALL NOT BE REQUIRED TO REIMBURSE KING FOR MORE THAN ***
PERCENT (***%) OF DEPOMED'S STANDARD COST FOR SUCH PRODUCT.
ANY SUCH PRODUCT
MANUFACTURED BY KING WILL BE SOLD BY DEPOMED IN ACCORDANCE WITH THIS AGREEMENT.
KING'S RIGHT TO USE THE TECHNOLOGY TO MANUFACTURE, OR HAVE MANUFACTURED, THE
PRODUCT UNDER THIS SECTION 6.6 SHALL TERMINATE UPON THE LATER TO OCCUR OF
(A) THE SECOND (2ND) ANNIVERSARY OF THE DATE UPON WHICH KING DELIVERED THE KING
MANUFACTURING NOTICE TO DEPOMED AND (B) THE SIX (6) MONTH ANNIVERSARY OF THE
DATE UPON WHICH DEPOMED SHALL HAVE DELIVERED TO KING A CERTIFICATION OF ITS CEO
AS TO DEPOMED'S ABILITY TO FULFILL ALL ORDERS FOR THE PRODUCT GENERATED BY KING
ACTIVITIES IN A TIMELY AND EFFICIENT MANNER, BUT IN ANY EVENT ON TERMINATION OF
THIS AGREEMENT.
SECTION 6.7
MANUFACTURE BY KING.
DEPOMED AGREES TO CONSIDER IN GOOD
FAITH ANY PROPOSAL BY KING TO MANUFACTURE THE 500MG FORMULATION OF THE PRODUCT
AT KING'S BRISTOL FACILITY THAT WOULD RESULT IN A REDUCTION IN THE SUPPLY PRICE
APPLICABLE TO THE PRODUCT RELATIVE TO DEPOMED'S THEN CURRENT CONTRACT
MANUFACTURER, AND WOULD BE SUITABLE TO DEPOMED'S OPERATIONS, REGULATORY AFFAIRS,
AND QUALITY ASSURANCE GROUPS.
ANY FIXED AND DETERMINABLE SAVINGS IN PRODUCT
MANUFACTURING COST TO DEPOMED REALIZED DURING THE TERM, AND DURING THE EIGHT
CALENDAR QUARTERS DURING WHICH A PAYMENT IS BEING PAID PURSUANT TO SECTION 7.4,
THAT RESULTS FROM ANY DEFINITIVE LONG-TERM SUPPLY ARRANGEMENT BETWEEN DEPOMED
AND KING RELATING TO THE PRODUCT RELATIVE TO DEPOMED'S THEN CURRENT LONG-TERM
SUPPLY ARRANGEMENT ***; PROVIDED THAT, IN THE EVENT KING CONTINUES TO
MANUFACTURE THE PRODUCT FOR DEPOMED, THE PARTIES WILL NEGOTIATE IN GOOD FAITH
WITH RESPECT TO ADJUSTING THE PRICING MECHANISM FOR THE MANUFACTURE OF SUCH
PRODUCT FOLLOWING THE TERM, AND SUCH EIGHT CALENDAR QUARTER PERIOD, IN ORDER TO
COMPENSATE KING FOR SUCH SAVINGS AND FOR ANY DISCOUNTS KING PROVIDED TO DEPOMED
AS A RESULT OF THE RELATIONSHIP OF THE PARTIES HEREUNDER.
ANY MANUFACTURE BY
KING OF THE PRODUCT WOULD BE SUBJECT TO REGULATORY APPROVAL OF A SUPPLEMENTAL
NDA PROVIDING FOR SUCH MANUFACTURE.
SECTION 6.8
1000MG FORMULATION.
(A)
THE PARTIES ACKNOWLEDGE THAT DEPOMED WILL USE COMMERCIALLY
REASONABLE EFFORTS TO SUBMIT A SUPPLEMENTAL NEW DRUG APPLICATION TO THE FDA AND
TO OBTAIN REGULATORY APPROVAL FOR A 1000MG FORMULATION USING METFORMIN AS THE
SOLE ACTIVE PHARMACEUTICAL INGREDIENT (THE "1000MG FORMULATION") TO WHICH
DEPOMED HAS CERTAIN RIGHTS PURSUANT TO THE BLS SUPPLY AGREEMENTS.
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(B)
THE PROVISIONS OF SECTION 6.1 THROUGH 6.6 WILL NOT APPLY TO THE
1000MG FORMULATION UNLESS AND UNTIL DEPOMED OBTAINS REGULATORY APPROVAL FOR THE
1000MG FORMULATION, AT WHICH TIME SUCH PROVISIONS WILL APPLY, EXCEPT