Free Stipulation - District Court of Delaware - Delaware

Case 1:04-cv-00940-JJF Document 101 Filed 12/22/2006 Page 1 of 3
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
THE PROCTER & GAMBLE COMPANY,
Plaintiff,
v, Civil Action No. 04-940 (JJF)
TEVA PHARMACEUTICALS USA, iNC,,
Defendant,
STIPULATION
WHEREAS, Plaintiff The Procter 8.; Gamble Co. ("P&G") and Defendant Teva
Pharmaceuticals USA, inc. ("Teva") (collectively "the parties") are engaged in ongoing patent
litigation involving U.S. Pat. No. 5,583,122 ("tlie ’l22 patent") as it relates to risedronate;
WHEREAS, Teva has tiled Abbreviated New Drug Application ("ANI)A") No. 77-l32
seeking approval from the United Stated Food and Drug Administration ("FDA") to market
generic versions of P&G’s risedronate sodium products marketed under the trade name
Actonel®;
WHEREAS, the parties recognize that any approval of the ANDA cannot be made until
alter the expiration of the thirty-month period provided for under paragraph 21 USC, §
355(j)(5)(2)(B)(i) which will end on January 6, 2007 for ANDA No. 77-132;
NOW THEREFORE, the parties hereby stipulate to the following:
(1) lf Teva, or any parent, subsidiary, or other related entity of Teva, elects to
manufacture, sell, or rnarlcet in the United States, or import into the United States (other than in
accordance with 35 USC, section 271 (e)(l)), (l) a product that is the subject of ANDA Noi 77-
rtrrn-sooner-z

Case 1:04-cv-00940-JJF Document 101 Filed 12/22/2006 Page 2 of 3
132 and/or (2) risedronate, either alone or in combination with one or more pharniaceutically
acceptable carriers, before:
(a) A court issues a decision holding that the asserted claims ofthe ’122
patent are invalid, unenforceable or not infringed;
(b) The ’ 122 patent expires; or
(c) Any entity other than Teva, or any parent, subsidiary, or other related
entity of Teva, sells a generic version of an Actonel® product in the
United States, including any entity authorized by P&G to do so;
Teva shall provide thirty (30) days advance notice to P&G, so as to allow P&G, if it so chooses,
the opportunity to file a motion for a temporary restraining order and/or preliminary injunctive
relief against any such action.
(2) This stipulation contains and constitutes the entire understanding and agreement
among the parties with respect to the foregoing subject matter.
RICHARDS LAYTON & FINGER, PA. YOUNG CONAWAY STARGATT
& TAYLOR, LLP
/5/ Steven JY Finenzczn /s/Karen L. Pnscnle
Frederick L. Cottreil, Ill (#2555) Josy W. Ingersoll (#1088)
cottrell@rlfLco1n [email protected]
Steven J. Fineman (ti 4025) Karen L. Pascale (#2903)
iine1nan@rltYcon·1 l One Rodney Square The Brandywine Building
P.O. Box 551 1000 West Street, l"/lh Floor
Wilmington, DE 19899-039l P.O. Box .39l
Telephone: (302) 651-7700 Wilmington, DE l9899—055l
Telephone: (302) 57145600
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n1-.i=i·s0sv101~i

Case 1 :04-cv-00940-JJF Document 101 Filed 12/22/2006 Page 3 of 3
Of Cozmsels OfC01ur.seIr
William F. Lee James Galbraith
David B. Bassett Maria Luisa Palmese
Vinita Ferrera Antony Pfeffer
WILMER CUTLER PICKERING KENYON & KENYON LLP
HALE AND DORR LLP One Broadway
60 State Street New York, NY 10004
Boston, MA 02109 Telephone: (212) 425~7200
Telephone: (617) 526—6000
Attorneys for The Procter & Gamble Attorneys for Teva Pharmaceutical
Company USA, inc.
Dated: December 22, 2006 Dated: December 22, 2006
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RL.Fl—3097l0l-l