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”)

 

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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 SELL A
GENERIC EQUIVALENT.

 

(I)            SCHERING AND SEPRACOR AGREE THAT THE TERM “FINAL COURT DECISION”
SHALL MEAN A DECISION OF A COURT FROM WHICH NO APPEAL HAS BEEN OR CAN BE TAKEN,
EXCLUDING ANY WRIT OF CERTIORARI OR OTHER PROCEEDINGS BEFORE THE UNITED STATES
SUPREME COURT.

 

2.             SCHERING AND SEPRACOR AGREE THAT SCHERING MAY GRANT A SUBLICENSE
UNDER THE SEPRACOR PATENTS TO ANY EXEMPTED SUBLICENSEE.  THE GRANTING OF ANY
SUCH SUBLICENSE SHALL BE WITHOUT ANY FURTHER OBLIGATION OR RESPONSIBILITY BY
SCHERING TO SEPRACOR UNDER THE AGREEMENT WITH RESPECT TO SUCH SUBLICENSE OTHER
THAN AS SET FORTH IN THIS AMENDMENT.

 

3.             SCHERING AND SEPRACOR AGREE THAT THE PAYMENT OF ROYALTIES
PURSUANT TO THE AGREEMENT SHALL BE AS FOLLOWS:

 

(A)           PRESCRIPTION NDA PRODUCTS

 

(1)           SCHERING AGREES, ON A PRODUCT-BY-PRODUCT BASIS, TO PAY A ROYALTY
OF [**] PERCENT ([**]%) ON NET SALES OF EACH PRESCRIPTION NDA PRODUCT UNTIL THE
EARLIER OF:  (I) THE EXPIRATION OF U.S. PATENT NOS. [**]; OR (II) A FINAL COURT
DECISION FINDING THAT ALL CLAIMS OF U.S. PATENT NOS. [**] IN DISPUTE ARE
INVALID, UNENFORCEABLE OR NOT INFRINGED BY A GENERIC EQUIVALENT OF SUCH
PRESCRIPTION NDA PRODUCT; OR (III) A LAUNCH OF A GENERIC EQUIVALENT OF SUCH
PRESCRIPTION NDA PRODUCT BEFORE [**]; OR (IV) THE DATE THAT SALES BY AN EXEMPTED
SUBLICENSEE OR EXEMPTED SUBLICENSEES OF A [**] OF SUCH PRESCRIPTION NDA PRODUCT
ACHIEVE A MARKET SHARE OF [**] PERCENT ([**]%) OR MORE OF [**] SUCH PRESCRIPTION
NDA PRODUCT IN THE UNITED STATES; OR (V) THE DATE THAT SALES BY ONE OR MORE
THIRD PARTIES THAT IS NOT AN EXEMPTED SUBLICENSEE OR SUBLICENSEE OF [**] OF SUCH
PRESCRIPTION NDA PRODUCT ACHIEVE A MARKET SHARE OF [**] PERCENT ([**]%) OR MORE
OF [**] SUCH PRESCRIPTION NDA PRODUCT IN THE UNITED STATES.

 

(2)           NOTWITHSTANDING ANYTHING ELSE IN SECTION 3(A) OF THIS AMENDMENT,
SHOULD SECTION 3(A)(L)(III) BE TRIGGERED BY A LAUNCH OF A PARTICULAR
PRESCRIPTION NDA PRODUCT BEFORE [**], SCHERING AGREES TO PAY A ROYALTY OF [**]
PERCENT ([**]%) ON NET SALES OF SUCH PRESCRIPTION NDA PRODUCT FOR A [**] PERIOD
COMMENCING FROM THE FINAL FDA APPROVAL OF THE FIRST GENERIC EQUIVALENT THAT HAD
SUCH A LAUNCH; AND AFTER SUCH [**] PERIOD, SCHERING SHALL HAVE NO FURTHER
OBLIGATION TO PAY ANY ROYALTY ON SUCH PRESCRIPTION NDA PRODUCT.

 

(3)           NOTWITHSTANDING ANYTHING ELSE IN SECTION 3(A) OF THIS AMENDMENT,
SHOULD SECTION 3(A)(L)(IV) BE TRIGGERED BY SALES BY AN EXEMPTED SUBLICENSEE OR
EXEMPTED

 

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SUBLICENSEES OF A GENERIC EQUIVALENT OR GENERIC EQUIVALENTS OF A PARTICULAR
PRESCRIPTION NDA PRODUCT, SCHERING AGREES TO PAY A ROYALTY OF [**] PERCENT
([**]%) ON NET SALES OF SUCH PRESCRIPTION NDA PRODUCT FOR A [**] PERIOD
COMMENCING FROM THE FINAL FDA APPROVAL OF [**]THAT CONTRIBUTED TO THE [**]
PERCENT ([**]%) OR MORE MARKET SHARE DESCRIBED IN SECTION 3(A)(L)(IV); AND AFTER
SUCH [**] PERIOD, SCHERING SHALL PAY [**] PERCENT ([**]%) ON NET SALES OF SUCH
PRESCRIPTION NDA PRODUCT.

 

(4)           NOTWITHSTANDING ANYTHING ELSE IN SECTION 3(A) OF THIS AMENDMENT,
SHOULD SECTION 3(A)(L)(V) BE TRIGGERED BY SALES BY ONE OR MORE THIRD PARTIES
THAT IS NOT AN EXEMPTED SUBLICENSEE OR SUBLICENSEE OF A GENERIC EQUIVALENT OR
GENERIC EQUIVALENTS OF A PARTICULAR PRESCRIPTION NDA PRODUCT, SCHERING AGREES TO
PAY A ROYALTY OF [**] PERCENT ([**]%) ON NET SALES OF SUCH PRESCRIPTION NDA
PRODUCT FOR A [**] PERIOD COMMENCING FROM THE FINAL FDA APPROVAL OF [**] THAT
CONTRIBUTED TO THE [**] PERCENT ([**]%) OR MORE MARKET SHARE DESCRIBED IN
SECTION 3(A)(L)(V); AND AFTER SUCH [**] PERIOD, SCHERING SHALL HAVE NO FURTHER
OBLIGATION TO PAY ANY ROYALTY ON SUCH PRESCRIPTION NDA PRODUCT.

 

(5)           FOR THE PURPOSES OF CLARITY AND THE AVOIDANCE OF DOUBT, THE
OBLIGATION OF SCHERING TO PAY A ROYALTY ON NET SALES OF EACH PRESCRIPTION NDA
PRODUCT PER SECTION 3(A) OF THIS AMENDMENT SHALL APPLY NOTWITHSTANDING AN
EXEMPTED SUBLICENSEE RECEIVING APPROVAL TO MARKET A GENERIC EQUIVALENT FROM THE
FDA WITH OR WITHOUT SCHERING’S CONSENT.

 

(B)           [**] NDA PRODUCTS

 

(1)           SCHERING AGREES, ON A PRODUCT-BY-PRODUCT BASIS, TO PAY A ROYALTY
OF [**] PERCENT ([**]%) ON NET SALES OF EACH [**] NDA PRODUCT UNTIL THE EARLIER
OF:  (I) EXPIRATION OF U.S. PATENT NOS. [**]; OR (II) A FINAL COURT DECISION
FINDING THAT ALL CLAIMS OF U.S. PATENT NOS. [**] IN DISPUTE ARE INVALID,
UNENFORCEABLE OR NOT INFRINGED BY A GENERIC EQUIVALENT OF SUCH [**] NDA PRODUCT;
OR (III) A LAUNCH OF A GENERIC EQUIVALENT OF SUCH [**] NDA PRODUCT BEFORE [**].

 

(2)           FOR THE PURPOSES OF CLARITY AND THE AVOIDANCE OF DOUBT, THE
OBLIGATION OF SCHERING TO PAY A ROYALTY ON NET SALES OF EACH [**] NDA PRODUCT
PER SECTION 3(B) OF THIS AMENDMENT SHALL APPLY NOTWITHSTANDING AN EXEMPTED
SUBLICENSEE RECEIVING APPROVAL TO MARKET A GENERIC EQUIVALENT FROM THE FDA WITH
OR WITHOUT SCHERING’S CONSENT.

 

(C)           FOR THE AVOIDANCE OF DOUBT, THE ROYALTIES OF SECTION 3(A) AND
3(B) ABOVE SHALL BE ON A PRODUCT-BY-PRODUCT BASIS; FOR EXAMPLE, THE LAUNCH OF A
GENERIC EQUIVALENT TO THE 2.5 MILLIGRAM, DESLORATADINE /120 MILLIGRAM
PSEUDOEPHEDRINE TABLET SHALL NOT REDUCE OR REMOVE SCHERING’S ROYALTY
OBLIGATION(S) TO SEPRACOR ON NET SALES OF ANY PRESCRIPTION OR NON-PRESCRIPTION
DESLORATADINE 5 MILLIGRAM TABLET PRODUCT.

 

4.             SALES BY AN EXEMPTED SUBLICENSEE OF A GENERIC EQUIVALENT MADE
UNDER A SUBLICENSE GRANTED BY SCHERING SHALL BE EXCLUDED FROM THE DEFINITION OF
NET SALES UNDER ARTICLE I, SECTION 1.17 OF THE AGREEMENT.

 

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5.             IN THE EVENT OF ANY INCONSISTENCY BETWEEN THIS AMENDMENT AND THE
AGREEMENT, THE TERMS OF THIS AMENDMENT SHALL CONTROL AND THE AGREEMENT SHALL BE
DEEMED AMENDED SO THAT IT IS IN FULL COMPLIANCE WITH, AND GIVES EFFECT TO, ALL
THE TERMS AND CONDITIONS OF THIS AMENDMENT.

 

6.             THE PARTIES HEREBY REPRESENT AND WARRANT THAT THEY HAVE APPROVED
THE EXECUTION OF THIS AMENDMENT AND HAVE AUTHORIZED AND DIRECTED THE SIGNATORY
OFFICERS BELOW TO EXECUTE AND DELIVER THIS AMENDMENT.

 

Agreed to and Acknowledged

 

Agreed to and Acknowledged

This 10th day of November, 2008, by:

 

This 7th day of November, 2008, by:

 

 

 

SCHERING-PLOUGH LTD.

 

SEPRACOR INC.

 

 

 

By:

/s/ David Piacquad

 

By:

/s/ Andrew I. Koven

Name:

David Piacquad

 

Name:

Andrew I. Koven

Title:

Managing Officer

 

Title:

EVP, General Counsel & Corporate Secretary

 

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