PACKAGE (OR
HAVE SUPPLIED AND PACKAGED) PRODUCT PURSUANT TO THIS SECTION 4.8.
DEPOMED WILL
USE COMMERCIALLY REASONABLE EFFORTS TO ENTER INTO A LONG-TERM PRODUCT SUPPLY
AGREEMENT WITH [***] DAYS AFTER THE EFFECTIVE DATE (THE "DEPOMED SUPPLY
AGREEMENT") THAT WILL BE FREELY ASSIGNABLE TO SOLVAY OR ITS AFFILIATES,
SUCCESSORS OR ASSIGNS AT ANY TIME.
IN ADDITION, DEPOMED AND SOLVAY WILL
NEGOTIATE AND ENTER INTO A PRODUCT SUPPLY AGREEMENT WITH BUSINESS TERMS
SUBSTANTIALLY SIMILAR TO THE DEPOMED SUPPLY AGREEMENT CONCURRENTLY WITH THE
EXECUTION AND DELIVERY BY DEPOMED AND [***] OF THE DEPOMED SUPPLY AGREEMENT (THE
"SOLVAY SUPPLY AGREEMENT", AND, TOGETHER WITH THE DEPOMED SUPPLY AGREEMENT, THE
"SUPPLY AGREEMENTS").
THE SUPPLY AGREEMENTS WILL, TOGETHER, CONTAIN THE
FOLLOWING PROVISIONS (AMONG OTHERS MUTUALLY AGREEABLE TO THE PARTIES):
(I)
UNDER THE SOLVAY SUPPLY AGREEMENT,
DEPOMED WILL AGREE TO SUPPLY SOLVAY WITH ITS REQUIREMENTS OF FINISHED, PACKAGED
PRODUCT DURING THE SUPPLY PERIOD;
(II)
ALL MANUFACTURING AND RECORDS WILL BE
PERFORMED AND MAINTAINED IN ACCORDANCE WITH SPECIFICATIONS, CGMP AND APPLICABLE
LAW;
(III)
DEPOMED WILL PROVIDE REASONABLE ASSISTANCE TO
SOLVAY IN THE EVENT SOLVAY WISHES TO QUALIFY A BACKUP PRODUCT MANUFACTURER;
(IV)
DEPOMED SHALL [***];
(V)
SOLVAY WILL PAY DEPOMED THE FOLLOWING
AMOUNTS IN CONNECTION WITH ALL ACTIVITIES PERFORMED BY OR ON BEHALF OF DEPOMED
ASSOCIATED WITH PRODUCT MANUFACTURE AND SUPPLY (OTHER THAN ACTIVITIES SPECIFIED
ON EXHIBIT D) (A) [***]% OF DEPOMED'S OUT-OF-POCKET COSTS INCURRED IN CONNECTION
WITH SUCH MANUFACTURE AND SUPPLY OF PRODUCT TO SOLVAY, AND (B) A LABOR CHARGE
EQUAL TO THE FTE CHARGES FOR ALL DEPOMED EMPLOYEES ALLOCATED TO THE MANUFACTURE
AND SUPPLY OF PRODUCT TO SOLVAY, NOT TO EXCEED FTE CHARGES FOR AN AGGREGATE OF
[***] DURING ANY GIVEN CALENDAR QUARTER (AND DEPOMED SHALL PROVIDE TO SOLVAY
PERIODIC REPORTS DETAILING THE FTE CHARGES FOR WHICH SOLVAY MUST PAY DEPOMED
HEREUNDER);
17
Confidential Information, indicated by [***] has been omitted from this filing
and filed separately with the Securities Exchange Commission
(VI)
PAYMENTS FOR ACTIVITIES DESCRIBED IN
SUBSECTION (V) WILL BE MADE TO DEPOMED WITHIN TWENTY (20) DAYS AFTER SOLVAY'S
RECEIPT OF AN INVOICE FROM DEPOMED, WITH THE SOLVAY MANUFACTURING AGREEMENT TO
INCLUDE PROVISIONS SPECIFYING THE ALLOCATION OF COSTS BETWEEN THE PRODUCT FOR
USE WITHIN AND OUTSIDE THE FIELD AS APPLICABLE; AND
(VII)
DEPOMED AND SOLVAY WILL ESTABLISH A CMC
COMMITTEE INCLUDING QUALITY, REGULATORY AND MANUFACTURING PERSONNEL, WHICH
COMMITTEE WILL MEET ON A MONTHLY BASIS THROUGHOUT THE SUPPLY PERIOD TO
COORDINATE PRODUCT MANUFACTURING AND SUPPLY ACTIVITIES.
(C)
THE PARTIES ACKNOWLEDGE [***].
4.9
RIGHTS OF FIRST NEGOTIATION.
(A)
IF SOLVAY DEVELOPS AND OBTAINS REGULATORY
APPROVAL OF PRODUCT FOR A FIBROMYALGIA INDICATION, SOLVAY SHALL AND HEREBY DOES
GRANT TO DEPOMED A RIGHT OF FIRST NEGOTIATION TO CO-PROMOTE THE PRODUCT IN THE
FIELD IN THE TERRITORY SOLELY FOR THE FIBROMYALGIA INDICATION AND SOLELY TO
OBSTETRICIANS AND GYNECOLOGISTS.
SOLVAY SHALL NOTIFY DEPOMED IN WRITING NO
LATER THAN [***] PRIOR TO [***].
IF DEPOMED IS INTERESTED IN NEGOTIATING WITH
SOLVAY THE TERMS UNDER WHICH DEPOMED WOULD CO-PROMOTE THE PRODUCT FOR SUCH
INDICATION TO OBSTETRICIANS AND GYNECOLOGISTS IN THE TERRITORY, IT