WHICH CEPHALON HAS BROUGHT SUIT, MYLAN MAY THEN MARKET AND SELL MYLAN GENERIC
MODAFINIL IN THE UNITED STATES. IF SUCH FINAL JUDGMENT IS BASED ON A FINDING OF
THE INVALIDITY OF THE PATENT IN SUIT, NO ROYALTY WILL THEREAFTER BE DUE TO
CEPHALON. OTHERWISE, MYLAN SHALL PAY TO CEPHALON A ROYALTY OF [**] MYLAN GENERIC
MODAFINIL IN THE UNITED STATES MADE BY MYLAN AND/OR ITS AFFILIATES.
3.2
MYLAN SHALL HAVE THE RIGHT TO COMMENCE MANUFACTURING ACTIVITIES IN
PREPARATION OF LAUNCH A REASONABLE PERIOD OF TIME PRIOR TO THE AGREED UPON
EFFECTIVE DATE OF THE NON-EXCLUSIVE GENERIC RIGHTS GRANTED TO MYLAN HEREUNDER,
PROVIDED HOWEVER, THAT MYLAN SHALL NOT HAVE THE RIGHT TO LAUNCH IN ADVANCE OF
SUCH EFFECTIVE DATE, NOR TO COMMUNICATE ITS ABILITY TO DO SO TO THIRD PARTIES
EARLIER THAN [**] PRIOR TO THE ANTICIPATED LAUNCH DATE, WITHOUT PRIOR WRITTEN
CONSENT OF CEPHALON.
3.3
ON MYLAN'S REQUEST, CEPHALON SHALL SUPPLY MYLAN WITH FINISHED
MODAFINIL PRODUCT ON TERMS TO BE MUTUALLY AGREED, FOR SALE BY MYLAN OF MYLAN
GENERIC MODAFINIL IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT.
**Portions of the Exhibit have been omitted and have been filed separately
pursuant to an application for confidential treatment filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
11
3.4
IN ORDER FOR MYLAN TO EXERCISE THE RIGHTS UNDER THE LISTED PATENTS
AS CONTEMPLATED BY THIS SECTION 3, CEPHALON AGREES TO PROVIDE APPROPRIATE
WAIVERS OF EXCLUSIVITIES OR EVIDENCE OF PATENT LICENSES AS REASONABLY NECESSARY
FOR MYLAN TO OBTAIN REGULATORY APPROVAL OF MYLAN GENERIC MODAFINIL IN THE UNITED
STATES.
3.5
NOTWITHSTANDING THE TERMS OF THIS SECTION 3, CEPHALON COVENANTS
THAT IT WILL NOT SUE MYLAN FOR INFRINGEMENT UNDER THE LISTED PATENTS, OR ANY
OTHER PATENTS NOW OWNED OR SUBSEQUENTLY ACQUIRED BY CEPHALON, OR ANY OTHER
PATENTS TO WHICH CEPHALON NOW HAS OR SUBSEQUENTLY ACQUIRES LICENSE RIGHTS, FOR
ANY SALES BY MYLAN IN THE UNITED STATES OF A PRODUCT THAT IS MANUFACTURED OR
SOLD PURSUANT TO AN ANDA FOR WHICH THE REFERENCE LISTED DRUG IS PROVIGIL®,
PROVIDED THAT ANY SUCH SALES ARE IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT.
MYLAN AGREES THAT IT WILL NOT CHALLENGE THE VALIDITY OR ENFORCEABILITY OF THE
LISTED PATENTS.
3.6
(A)
MYLAN SHALL HAVE THE ONE TIME RIGHT, TO BE EXERCISED
UPON THIRTY (30) DAYS' WRITTEN NOTICE FROM MYLAN TO CEPHALON, AND AT ANY TIME
FOLLOWING MYLAN'S FIRST COMMERCIAL MARKETING OF MYLAN GENERIC MODAFINIL IN
ACCORDANCE WITH THE TERMS OF THIS AGREEMENT, TO REQUEST THAT CEPHALON PROVIDE TO
A MUTUALLY AGREEABLE INDEPENDENT THIRD-PARTY ACCOUNTING FIRM [**]. THE [**]
PROVIDED BY CEPHALON TO THE THIRD-PARTY ACCOUNTING FIRM [**], AND CEPHALON SHALL
TAKE ANY OTHER STEPS NECESSARY TO FACILITATE COMPLIANCE WITH ANY CONFIDENTIALITY
OBLIGATIONS OWED BY CEPHALON AND THE REQUIREMENTS OF APPLICABLE LAWS, WHILE
STILL PROVIDING SUFFICIENT INFORMATION ABOUT [**]. THESE [**] SHALL NOT BE
DISCLOSED TO MYLAN, EXCEPT TO THE EXTENT CONTEMPLATED IN SECTION 3.6(D) BELOW.
(b)
The information provided to the third-party accounting firm shall