SECTION 505(A) OF THE U.S. FEDERAL FOOD, DRUG, AND
COSMETIC ACT (21 U.S.C. § 355(A)).
1.12
"SHELF STOCK ADJUSTMENT" MEANS THE CUSTOMARY PRACTICE OF PROVIDING
A PURCHASER OF ACTIQ LICENSED PRODUCT AN ADJUSTMENT TO THE NET PURCHASE PRICE
FOR ON-HAND INVENTORY IN RESPONSE TO AN OFFER FROM A SUPPLIER OF A COMPETING
GENERIC SUBJECT OTFC PRODUCT,.
1.13
"SUBJECT OTFC PRODUCT" MEANS [**].
2.
GRANT OF RIGHTS
2.1
EXCLUSIVITY; LICENSE. IF, AND ONLY IF, THE EXISTING LICENSE
EFFECTIVE DATE HAS NOT OCCURRED ON OR PRIOR TO DECEMBER 6, 2006, THEN THE
FOLLOWING TERMS AND CONDITIONS SHALL APPLY:
(A)
EXCLUSIVE AUTHORIZED GENERIC. DURING THE EXCLUSIVITY PERIOD,
CEPHALON SHALL NOT MARKET OR SELL, NOR SHALL IT LICENSE OR AUTHORIZE ANY ENTITY
OTHER THAN BARR TO MARKET OR SELL, GENERIC SUBJECT OTFC PRODUCTS IN THE UNITED
STATES.
(B)
GRANT OF LICENSES. CEPHALON GRANTS TO BARR AN IRREVOCABLE,
NON-TRANSFERABLE, EXCLUSIVE (EVEN AS TO CEPHALON) LICENSE, WITHOUT THE RIGHT TO
SUBLICENSE, TO DEVELOP, USE, SELL, OFFER FOR SALE, DISTRIBUTE OR HAVE
DISTRIBUTED, PROMOTE OR ADVERTISE, IMPORT OR HAVE IMPORTED ACTIQ LICENSED
PRODUCT SOLELY IN THE UNITED STATES AND SOLELY DURING THE EXCLUSIVITY PERIOD, IN
EACH CASE, UNDER:
(I)
THE LICENSED PATENTS; AND
(II)
(A) THE U.S. TRADEMARK REGISTRATION NO. 2,622,734 AS NEEDED FOR A
SINGLE DOSE ENTITY OF AN ACTIQ LICENSED PRODUCT (B) ANY TRADEMARK OR TRADE DRESS
COVERING THE SIZE, SHAPE AND COLOR OF A SINGLE DOSE ENTITY OF ACTIQ LICENSED
PRODUCT, TO THE EXTENT BARR DESIRES; AND (C) THE APPEARANCE, STRUCTURE, TEXTUAL
OR GRAPHICAL CONTENT AND/OR COLOR SCHEME OF ANY LABELING, DOSING INFORMATION,
PRODUCT INSERTS, SKEEPER OR OTHER MATERIALS, AND ANY RISK MANAGEMENT PROGRAM, AS
MAY BE NECESSARY FOR THE MARKETING AND SALE OF ACTIQ LICENSED PRODUCT.
The Parties acknowledge Barr's rights to certain manufacturing know-how,
technology and material with respect to ACTIQ Licensed Product under Sections
2.1(a)(iii) and 2.2(a)(ii) of the Existing License and Supply Agreement entered
into effect as of July 7, 2004.
**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.
4
(C)
PEDIATRIC EXCLUSIVITY. IF, AND ONLY IF, THE EXISTING LICENSE
EFFECTIVE DATE HAS NOT OCCURRED ON OR PRIOR TO DECEMBER 6, 2006, THEN, DURING
THE EXCLUSIVITY PERIOD, CEPHALON SHALL GRANT A LICENSE TO BARR WITH RESPECT TO
ANY SUCH PEDIATRIC EXCLUSIVITY THAT MAY EXIST DURING SUCH PERIOD WITH RESPECT TO
ACTIQ OR ACTIQ SF. CEPHALON SHALL REASONABLY COOPERATE WITH BARR IN NOTIFYING
THE FDA THAT CEPHALON HAS WAIVED PEDIATRIC EXCLUSIVITY WITH RESPECT TO BARR,
INCLUDING, BUT NOT LIMITED TO, BY FILING WITH THE FDA A DATED AND EXECUTED COPY
OF THE LETTER ATTACHED AS EXHIBIT H TO THE EXISTING LICENSE AND SUPPLY
AGREEMENT.
(D)
EXPIRATION. BARR'S RIGHTS UNDER SECTION 2.1(A), 2.1(B) AND 2.1(C)
SHALL EXPIRE AS OF THE EXISTING LICENSE EFFECTIVE DATE. IT IS UNDERSTOOD AND
AGREED BY THE PARTIES THAT THE TERMS OF THE FTC CONSENT