WHICH HAS
RECEIVED APPROVAL FROM A GOVERNMENTAL AUTHORITY IN ONE OR MORE COUNTRIES OF THE
TERRITORY.
1.18.
"INITIAL INDICATION" MEANS THE PRODUCT'S FIRST INDICATION RECEIVING
APPROVAL IN ONE OR MORE COUNTRIES OF THE TERRITORY.
1.19.
"INTERNATIONAL EMPLOYEE" MEANS ANY NYCOMED EMPLOYEE WHOSE EMPLOYEE
FUNCTION IS THE PERFORMANCE OF AN INTERNATIONAL SERVICE.
1.20.
"INTERNATIONAL SERVICES" HAS THE MEANING SET FORTH IN SECTION
2.1(A).
1.21.
"LAUNCH" MEANS THE DATE OF ANNOUNCEMENT TO PRESCRIBERS OF
PHARMACEUTICALS, OF THE AVAILABILITY OF PRODUCT UPON PRESCRIPTION TO TREAT AN
INITIAL INDICATION OR A SUBSEQUENT INDICATION IN ANY COUNTRY IN TERRITORY.
1.22.
"MARKETING PLAN" MEANS THE WRITTEN PLANS PREPARED BY NYCOMED FOR
CONDUCTING THE SERVICES. THE MARKETING PLAN IN EFFECT OF THE EFFECTIVE DATE IS
ATTACHED HERETO AS EXHIBIT F.
1.23.
"NYCOMED EMPLOYEE" MEANS EACH EMPLOYEE OF NYCOMED OR ONE OF
NYCOMED'S AFFILIATES WHO IS PERFORMING SERVICES PURSUANT TO THIS AGREEMENT, AS
SET FORTH IN SCHEDULE 4.1.
1.24.
"PACKAGING AGREEMENT" MEANS THE QUALITY (GMP) AGREEMENT FOR THIRD
PARTY CONTRACT MANUFACTURE, ENTERED INTO AS OF APRIL 24, 2002, BETWEEN TMC AND
NYCOMED.
1.25.
"PHARMACOVIGILANCE AGREEMENT" MEANS THE PHARMACOVIGILANCE AGREEMENT
ON BIVALIRUDIN®, ENTERED INTO AS OF SEPTEMBER 16, 2004, BETWEEN TMC AND NYCOMED.
4
1.26.
"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.
1.27.
"PHARMACOVIGILANCE QP SERVICES" MEANS THE SERVICES NYCOMED IS
OBLIGATED TO PERFORM UNDER THE PHARMACOVIGILANCE QP AGREEMENT.
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 LABELING" MEANS ALL PRODUCT LABELS AND OTHER WRITTEN,
PRINTED, OR GRAPHIC MATTER APPROVED BY THE RELEVANT GOVERNMENTAL AUTHORITY, WITH
RESPECT TO THE PRODUCT, INCLUDING THE FOREGOING DISPLAYED UPON ANY CONTAINER OR
WRAPPER OF A PRODUCT AND ANY WRITTEN MATERIAL ACCOMPANYING A PRODUCT, INCLUDING
WITHOUT LIMITATION PRODUCT PACKAGE INSERTS.
1.31.
"PRODUCT PROMOTIONAL MATERIALS" MEANS ALL PRINTED OR GRAPHIC
MATERIAL, OTHER THAN PRODUCT LABELING, INTENDED FOR USE BY SALES REPRESENTATIVES
DURING DETAILS, INCLUDING VISUAL AIDS, FILE CARDS, PREMIUM ITEMS, CLINICAL
STUDIES, REPRINTS, DRUG INFORMATION UPDATES AND ANY OTHER PROMOTIONAL SUPPORT
ITEMS THAT TMC DEEMS NECESSARY WITH RESPECT TO THE PROMOTIONAL ACTIVITIES
HEREUNDER.
1.32.
"PTC" MEANS THE PRODUCT TRANSITION COMMITTEE, AS DEFINED IN THE
TRANSITION AGREEMENT.
1.33.
"QA AGREEMENTS" MEANS, COLLECTIVELY, THE AQRPA, THE RELEASE
AGREEMENT AND THE PACKAGING AGREEMENT.
1.34.
"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.,