Free Notice (Other) - District Court of Delaware - Delaware

Case 1:04-cv-00884-SLR

Document 59-2

Filed 08/29/2005

Page 1 of 4

EXHIBIT A

Case 1:04-cv-00884-SLR

Document 59-2

Filed 08/29/2005

Page 2 of 4

Dbtf !2 ;15 .dwl1995 .TNc!!!!!Epdvn f od68!!!llgrfie!19CB5CB116!!!!!Cbhf !2!pd 4

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWAR E --------------------------------- -----------------x PERRINO B .V., Plaintiff, Civil Action No, 04-884-SL R

TEVA PHARMACEUTICALS USA, INC . and TEVA PHARMACEUTICAL INDUSTRIES LIMITED, Defendants . . --------------------------------------------------- x
STIPULATION AND ORDE R

The parties, by their counsel, stipulate and agree subject to Order of this Court as Ibllows : WHEREAS, plaintiff Ferring has filed a patent infringement lawsuit, C .A. 04-884-SLR ("the Action"), in the United States District Court for the District of Delaware against defendants Teva, alleging that Teva infringed U .S . Patent No, 5,047,398 ("`398 patent') by filing Abbreviated New Drug Application No . 77-122 ("ANDA") and seeking marketing approval for 0 .1 mg and 0 .2 mg desmopressin acetate tablets ("ANDA Product') prior to the expiration of the `398 patent; and WHEREAS, Teva has fi led a counterclaim in the Action seeking a declaratory judgment that the `398 patent is invalid, not infringed and unenforceable ; and WHEREAS, Teva seeks final FDA approval to market and sell the ANDA Product manufactured as disclosed in its ANDA ; and WHEREAS final approval can not be granted by FDA since, as a result of the Action, an automatic 30-month stay of approval of the ANDA is currently in effect ; and

- NYA934 827 .4

Case 1:04-cv-00884-SLR

Document 59-2

Filed 08/29/2005

Page 3 of 4

Dbtf 12 ;15 .dwI l995 .T%,B!!!!!Epdvn f od68!!!!Kgfie! 19C85C8116! !!!!Cbhf 131p9 4

WHEREAS, Appeal No . 05-1284 is currently pending in the Court of Appeals for the Federal Circuit in the matter captioned Ferring BY and Aventts Pharmacewicals, Lm . V. Barr Laboratories, Inc . ("Appeal") : 1. Ferring agrees that the 30 month stay of final approval of Teva's ANDA Product

shall be terminated . The parties shall cause this stipulation to be filed with the Delaware District Court and, upon entry, the Order appended as Exhibit A hereto, will be submitted to the FDA by Teva. 2. Upon submission to the FDA of the Order appended as Exhibit A hereto pursuant

to Paragraph I above, Teva will withdraw its Motion to Lift the Stay of Proceedings now pending in this Action . Teva agrees that it will submit the Order appended as Exhibit A to the FDA within four business days of entry of said Order by the Court . The stay of proceedings currently in force shall remain in effect until the resolution of Appeal No . 05-1284 pursuant to the Order entered by the Court on April 27, 2005 . 3. Nothing in this Stipulation shall be construed as a waiver of any right of Ferring

to seek and obtain damages from Teva accruing from its market entry (if any) prior to the expiration of the `398 patent, or to seek any and all appropriate relief from the Court, including enjoining Teva from further infringing the `398 patent during the pendency of the Action, upon resolution of Appeal No . 05-1284 in Ferring's favor. 4. Nothing in this Stipulation shall be construed as a waiver of any right of Teva to

seek and obtain damages from Ferring (if any) based on a claim of antitrust or unfair competition . 5. Nothing in this Stipulation shall be construed as a license of any kind under or to

any Ferring patent or other form of intellectual property including but not limited to Unite d

I .NYl1934SZ7.4

Case 1:04-cv-00884-SLR

Document 59-2

Filed 08/29/2005

Page 4 of 4

Dbtf !2 ;15 .dwl1995 .TN8!!i!!Epdvn f od68!!!!!grhe!1985(8116!!!!!Cbhf !4!pd 4

States Patent Nos. 5,047,398, 5,500,413, 5,647,850 and 5,763,407 . If this case goes forward to a trial on the merits, neither the existence nor terms of this Stipulation and Order shall be usable for any evidentiary purpose on the issues ofpatent validity, enforceability or patent infringement . 6. Teva shall provide written notice of market entry of its ANDA Product to Ferring,

copy to its counsel at Morgan, Lewis & Bockius LLP, by certified mail . 7. Ferring shall provide notice and a copy of the Appeal Decision to Teva's counsel,

Sutherland, Asbill & Brennan, LLP within one business day of the entry of the Appeal Decision, & Teva may, with the express written approval of Ferring, transfer all of its interes t in this Stipulation to any party to whom Teva transfers all of its rights and interests in its ANDA, provided that any party to whom such transfer is made shall first enter into and execute an undertaking, in form and substance acceptable to Ferring, to be bound to this Stipulation as if a n original party hereto and agreeing to perform all duties and obligations of Teva hereunder . CONSENTED TO :

Isl Francis DiGiovanni

Is/ Josv W . Inaersol l

Francis DiGiovanni (# 3189) Connolly Bove Lodge & Hutz LLP The Nemours Buildin g 1007 No rt h Orange Street P .O . Box 2207 Wilmington, DE 19899 Telephone : (302) 658-9141 fdi u,inv a nni(~cblh .corn Atto rneys for Ferring B .V .

Josy W . Ingersoll (#1088 ) Young Conaway Stargatt & Taylor LLP The Brandywine Buildin g 1000 West Street, 17th Floor Wilmington, DE 19899-0391 Telephone : (302) 571-6600 iin eerso ll . .vcst .co m Attorneys for Teva Pharmaceuticals USA, Inc, and Teva Pharmaceutical Industries Limite d

SO ORDERED

Dated : Wilmington, Delaware August a3, 2005

United States Dist{'ct Judge

I-NYIID24'E27 .4

3