not otherwise defined shall have
the meanings and definitions ascribed to them as listed below.
1.1.
"ADVERSE EVENT" MEANS ANY UNTOWARD MEDICAL OCCURRENCE IN A PATIENT
ADMINISTERED A MEDICINAL PRODUCT AND WHICH DOES NOT NECESSARILY HAVE TO HAVE A
CAUSAL RELATIONSHIP WITH THIS TREATMENT. AN ADVERSE EVENT CAN THEREFORE BE ANY
UNFAVORABLE AND UNINTENDED SIGN (FOR EXAMPLE, AN ABNORMAL LABORATORY FINDING),
SYMPTOM, OR DISEASE TEMPORALLY ASSOCIATED WITH THE USE OF A MEDICINAL PRODUCT,
WHETHER OR NOT CONSIDERED RELATED TO SUCH MEDICINAL PRODUCT.
1.2.
"AFFILIATE" MEANS ANY CORPORATION, COMPANY, JOINT VENTURE,
PARTNERSHIP OR OTHER ENTITY WHICH, DIRECTLY OR INDIRECTLY, CONTROLS, IS
CONTROLLED BY, OR IS UNDER COMMON CONTROL WITH A PARTY TO THIS AGREEMENT.
"CONTROL" MEANS THE OWNERSHIP OF AT LEAST 50% OF THE ISSUED SHARE CAPITAL OR
BUSINESS ASSETS OF ANOTHER ENTITY, THE POWER TO EXERCISE AT LEAST 50% OF THE
VOTING RIGHTS OF ANOTHER ENTITY, OR THE POWER TO APPOINT MORE THAN 50% OF THE
BOARD OF DIRECTORS OF ANOTHER ENTITY.
1.3.
"ANGIOMAX" MEANS ANGIOMAX®, ANGIOX®, ANGIONAX® OR ANY OTHER
TRADEMARK SELECTED BY TMC FOR THE PRODUCT IN THE TERRITORY.
1.4.
"APPROVALS" MEANS AND INCLUDES ALL FILINGS, APPROVALS,
REGISTRATIONS, PERMITS, LICENSES AND AUTHORIZATIONS RELATED TO THE PRODUCT WHICH
ARE NECESSARY OR WHICH, IN THE REASONABLE OPINION OF TMC, ARE DESIRABLE, TO BE
MADE WITH OR OBTAINED FROM ANY GOVERNMENTAL AUTHORITY FOR THE IMPORTATION, SALE,
MARKETING AND PROMOTION OF THE PRODUCT IN THE TERRITORY OR ANY PART THEREOF,
INCLUDING PRIMARILY, BUT WITHOUT LIMITATION, AUTHORIZATIONS OF MEDICINAL
PRODUCTS FOR HUMAN USE AND APPROVAL OF RELATED LABELS AND PACKAGING, AS WELL AS
PRICING AND SOCIAL HEALTH SYSTEM REIMBURSEMENT APPROVALS.
2
1.5.
"AQRPA" MEANS THE ANALYSIS, QUALITY RELEASE AND PACKAGING
AGREEMENT, ENTERED INTO AS OF MARCH 24, 2004, BETWEEN TMC AND NYCOMED.
1.6.
"BUSINESS DAY" MEANS ANY DAY ON WHICH THE BANKS IN THE KINGDOM OF
DENMARK ARE OPEN FOR BUSINESS.
1.7.
"COMBINATION PRODUCT" MEANS A PRODUCT CONTAINING ONE OR MORE
ACTIVE INGREDIENTS OR COMPONENTS IN ADDITION TO THE PRODUCT.
1.8.
"DISTRIBUTOR" MEANS A PERSON OR ENTITY IN A COUNTRY WHO (I)
PURCHASES PRODUCT FROM NYCOMED OR ONE OF ITS AFFILIATES, AND (II) ASSUMES
RESPONSIBILITY FOR A PORTION OF THE SALES EFFORT RELATED TO PRODUCT IN THAT
COUNTRY, AND (III) UNDER AN IMPLIED OR EXPRESS SUBLICENSE, SELLS PRODUCT IN THAT
COUNTRY.
1.9.
"EEA" MEANS ANY CURRENT MEMBER COUNTRIES OF THE EUROPEAN UNION AND
NORWAY, ICELAND, AND LIECHTENSTEIN.
1.10.
"EXISTING INVENTORY" MEANS ALL LABELED AND UNLABELED VIALS OF
PRODUCT HELD BY NYCOMED OR NYCOMED'S AFFILIATES IN INVENTORY ON THE EFFECTIVE
DATE UNTIL SOLD OR SUPPLIED BY NYCOMED PURSUANT TO SECTION 9.
1.11.
"EXISTING SUBDISTRIBUTORS" MEANS THOSE NYCOMED AFFILIATES APPOINTED
BY NYCOMED PRIOR TO THE EFFECTIVE DATE, IN ACCORDANCE WITH THE FORMER
DISTRIBUTION AGREEMENT, AS DISTRIBUTORS OF THE PRODUCT IN THE TERRITORY, AND
SUCH ADDITIONAL NYCOMED AFFILIATES AND OTHER THIRD PARTIES APPOINTED AS
DISTRIBUTORS OF THE PRODUCT IN THE TERRITORY IN ACCORDANCE WITH SECTION 2.1.
1.12.
"FIRST LAUNCH DATE" MEANS THE DATE OF LAUNCH OF THE INITIAL
INDICATION(S) IN ANY COUNTRY OF THE TERRITORY.