Exhibit 10.28
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
AMENDMENT TO DECEMBER 5, 1997 EXCLUSIVE
LICENSE AGREEMENT BETWEEN SCHERING AND SEPRACOR
This amendment to the December 5, 1997 Exclusive License Agreement between
Schering and Sepracor ("the Amendment") is made as of this 7th day of November,
2008 by Schering-Plough Ltd., a Swiss corporation having a place of business at
Topferstrasse 5, 6004 Lucerne, Switzerland ("Schering"), and Sepracor Inc., a
Delaware corporation having a place of business at 84 Waterford Drive,
Marlborough, Massachusetts 01752 ("Sepracor") (collectively, "the Parties").
WHEREAS, the Parties mutually desire to amend their December 5, 1997 Exclusive
License Agreement ("the Agreement") as set forth herein; and
WHEREAS, the Parties acknowledge that this Amendment conforms to Article IX,
Section 9.6 of the Agreement and is a permitted amendment to that Agreement.
NOW THEREFORE, in consideration of the rights and obligations set forth herein,
the sufficiency of which is hereby acknowledged, Schering and Sepracor agree as
follows.
1.
ALL CAPITALIZED TERMS NOT OTHERWISE DEFINED HEREIN SHALL HAVE THE
MEANING ASCRIBED TO SAME IN THE AGREEMENT.
(A)
SCHERING AND SEPRACOR AGREE THAT THE TERM "SEPRACOR ACTIONS" SHALL
INCLUDE ANY ACTION FOR INFRINGEMENT OF CERTAIN PATENTS LISTED IN SCHEDULE 1.18
OF THE AGREEMENT OR OTHERWISE INCLUDED IN THE DEFINITION OF "PATENT RIGHTS" IN
ARTICLE I, SECTION 1.18 OF THE AGREEMENT (THE "SEPRACOR PATENTS") BROUGHT BY
SEPRACOR AGAINST CERTAIN ABBREVIATED NEW DRUG APPLICATION ("ANDA") FILERS WITH
RESPECT TO ONE OR MORE OF NEW DRUG APPLICATION ("NDA") NOS. 021300, 021312,
021313, 021605, AND/OR 021165, SEVERAL OF WHICH ARE CURRENTLY PENDING IN THE
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY.
(B)
SCHERING AND SEPRACOR AGREE THAT THE TERM "EXEMPTED SUBLICENSEE"
SHALL MEAN ANY SUBLICENSEE WHERE:
[**].
(C)
SCHERING AND SEPRACOR AGREE THAT THE TERM "NDA PRODUCT" SHALL MEAN
A LICENSED PRODUCT UNDER THE AGREEMENT APPROVED FOR MARKETING IN THE UNITED
STATES PURSUANT TO A NEW DRUG APPLICATION.
(D)
SCHERING AND SEPRACOR AGREE THAT THE TERM "PRESCRIPTION NDA
PRODUCT" SHALL MEAN A NDA PRODUCT, AS DEFINED ABOVE, THAT REQUIRES A
PRESCRIPTION TO BE SOLD IN THE UNITED STATES.
(E)
SCHERING AND SEPRACOR AGREE THAT THE TERM "[**] NDA PRODUCT" SHALL
MEAN A NDA PRODUCT, AS DEFINED ABOVE, THAT DOES [**] IN THE UNITED STATES.
(F)
SCHERING AND SEPRACOR AGREE THAT THE TERM "GENERIC EQUIVALENT"
SHALL MEAN A PHARMACEUTICAL PRODUCT THAT HAS RECEIVED U.S. FOOD AND DRUG
ADMINISTRATION ("FDA")
1
APPROVAL FOR MARKETING IN THE UNITED STATES PURSUANT TO AN ANDA AS A GENERIC
EQUIVALENT TO A SPECIFIC NDA PRODUCT.
(G)
SCHERING AND SEPRACOR AGREE THAT THE TERM "LAUNCH" SHALL MEAN THE
COMMERCIAL LAUNCH OF A GENERIC EQUIVALENT OF A NDA PRODUCT BY ONE OR MORE THIRD
PARTIES OTHER THAN AN EXEMPTED SUBLICENSEE OR SUBLICENSEE WHILE SCHERING AND/OR
SEPRACOR IS PREPARING FOR OR INVOLVED IN LITIGATION REGARDING SUCH GENERIC
EQUIVALENT.
(H)
SCHERING AND SEPRACOR AGREE THAT THE TERM "FINAL FDA APPROVAL"
SHALL MEAN APPROVAL FROM THE FDA THAT WOULD ALLOW A PARTY TO MARKET AND