EXTENSIONS, CONTINUATIONS AND CONTINUATIONS-IN-PART THEREOF AND PATENT
EXTENSIONS WITH RESPECT TO THE PRODUCT IN THE TERRITORY.
1.26.
"PHARMACOVIGILANCE AGREEMENT" MEANS THE PHARMACOVIGILANCE AGREEMENT
ON BIVALIRUDIN®, ENTERED INTO AS OF SEPTEMBER 16, 2004, BETWEEN TMC AND NYCOMED.
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1.27.
"PHARMACOVIGILANCE QP AGREEMENT" MEANS THE AGREEMENT BETWEEN THE
MEDICINES COMPANY AND NYCOMED DENMARK A/S ON THE ROLE OF THE QUALIFIED PERSON
FOR PHARMACOVIGILANCE IN THE EUROPEAN UNION FOR ANGIOX, ENTERED INTO AS OF
AUGUST 16, 2004, BETWEEN TMC AND NYCOMED.
1.28.
"PHV AGREEMENTS" MEANS THE PHARMACOVIGILANCE AGREEMENT AND THE
PHARMACOVIGILANCE QP AGREEMENT.
1.29.
"PRODUCT" MEANS BIVALIRUDIN, BEING A HIGHLY SPECIFIC AND REVERSIBLE
DIRECT THROMBIN INHIBITOR, WHICH OPERATES BY SPECIFIC BINDING TO BOTH THE
CATALYTIC SITE AND TO THE ANION-BINDING EXOSITE OF CIRCULATING AND CLOT-BOUND
THROMBIN. THE ACTIVE SUBSTANCE IS A SYNTHETIC, TWENTY (20)-AMINO ACID PEPTIDE,
WHOSE CHEMICAL NAME IS
(SALT) HYDRATE. ITS MOLECULAR WEIGHT IS 218.19 DALTONS (ANHYDROUS FREE BASE
PEPTIDE). PRODUCT SHALL ALSO INCLUDE IMPROVEMENTS.
1.30.
"PRODUCT CONFIGURATION" MEANS AND INCLUDES ANY MODIFICATIONS TO THE
PACKAGE INSERT, LABELING, OR PACKAGING OF THE PRODUCT REQUIRED BY GOVERNMENTAL
AUTHORITY(S) OF ONE OR MORE COUNTRIES OF THE TERRITORY.
1.31.
"PTC" MEANS THE PRODUCT TRANSITION COMMITTEE, AS DEFINED IN THE
TRANSITION AGREEMENT.
1.32.
"QA AGREEMENTS" MEANS, COLLECTIVELY, THE AQRPA, THE RELEASE
AGREEMENT AND THE PACKAGING AGREEMENT.
1.33.
"QUALITY AGREEMENTS" MEANS, COLLECTIVELY, THE QA AGREEMENTS AND THE
PHV AGREEMENTS. FOR THE SAKE OF CLARITY, WITH RESPECT TO EACH QUALITY AGREEMENT,
ALL REFERENCES TO SUCH QUALITY AGREEMENT WITH RESPECT TO ACTIVITIES PURSUANT TO
THE FORMER DISTRIBUTION AGREEMENT (I.E., PRIOR TO THE EFFECTIVE DATE) SHALL MEAN
SUCH QUALITY AGREEMENT UNAMENDED BY THE TRANSACTION AGREEMENTS, AND ALL
REFERENCES TO SUCH QUALITY AGREEMENT WITH RESPECT TO ACTIVITIES ON OR AFTER THE
EFFECTIVE DATE SHALL MEAN SUCH QUALITY AGREEMENT AS AMENDED BY THE TRANSACTION
AGREEMENTS.
1.34.
"RELEASE AGREEMENT" MEANS THE QUALITY (GMP) AGREEMENT FOR THIRD
PARTY CONTRACT QUALITY RELEASE, ENTERED INTO AS OF FEBRUARY 24, 2004, AMONG TMC,
NYCOMED AND NYCOMED AUSTRIA GMBH.
1.35.
"THROMBIN INHIBITOR" MEANS ANY PHARMACEUTICAL WITH A MECHANISM OF
ACTION INVOLVING THE PARTIAL OR COMPLETE INHIBITION OF THROMBIN IN THE CLOTTING
CASCADE. THROMBIN INHIBITORS SHALL INCLUDE DIRECT ACTING COMPOUNDS INCLUDING BUT
NOT LIMITED TO LEPIRUDIN, DESIRUDIN AND OTHER
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MEMBERS OF THE HIRUDIN FAMILY AS WELL AS MELAGATRAN AND SMALL MOLECULE DIRECT
THROMBIN INHIBITORS SUCH AS ARGATROBAN. THROMBIN INHIBITORS SHALL ALSO INCLUDE
INDIRECT ACTING THROMBIN INHIBITORS WHICH INHIBIT THROMBIN IN CONJUNCTION WITH A
CO-FACTOR SUCH AS AT-III. SUCH INDIRECT THROMBIN INHIBITORS SHALL INCLUDE BUT
NOT BE LIMITED TO UNFRACTIONATED HEPARINS AND LOW MOLECULAR WEIGHT HEPARINS SUCH
AS ENOXAPARIN SODIUM, DALTEPARIN SODIUM, FONDAPARINUX AND REVIPARIN SODIUM BUT
SHALL EXCLUDE WARFARIN.
1.36.
"TMC-UK" MEANS THE MEDICINES COMPANY UK LIMITED, A LIMITED
LIABILITY CORPORATION LOCATED AT SUITE B, PARK HOUSE, 11 MILTON PARK, ABINGDON,
OXFORDSHIRE OX14 4RS, OR SUCH OTHER EU INCORPORATED ENTITY OF TMC WHICH TMC MAY
DESIGNATE.
1.37.
"TRADEMARKS" MEANS TRADEMARKS, TRADE NAMES, SERVICE MARKS, AND
OTHER PROPRIETARY SYMBOLS OWNED OR CONTROLLED BY TMC AND AS DESIGNATED BY TMC IN
EXHIBIT C HERETO.
1.38.
"TRANSACTION