barter or counter trade, Net Sales
shall be calculated as above on the value of the consideration received or the
fair market value (if higher) of the Product in the country of sale or disposal.
1.32.
"NON-SEVERABLE IMPROVEMENTS" SHALL MEAN AN IMPROVEMENT TO THE
SEPRACOR TECHNOLOGY WHICH IS INCAPABLE OF EXPLOITATION INDEPENDENTLY OF THE
SEPRACOR TECHNOLOGY
CONFIDENTIAL
CONTROLLED BY SEPRACOR OR ITS AFFILIATES AS OF THE EFFECTIVE DATE AND DURING THE
TERM OF THIS AGREEMENT.
1.33.
"PARTY" SHALL MEAN SEPRACOR OR GSK INDIVIDUALLY, AND "PARTIES"
SHALL MEAN SEPRACOR AND GSK COLLECTIVELY.
1.34.
"PATENT(S)" SHALL MEAN PATENTS AND PATENT APPLICATIONS, TOGETHER
WITH ALL ADDITIONS, DIVISIONS, CONTINUATIONS, CONTINUATIONS-IN-PART,
PROVISIONALS, SUBSTITUTIONS, REISSUES, RE-EXAMINATIONS, EXTENSIONS,
REGISTRATIONS, PATENT TERM EXTENSIONS, SUPPLEMENTAL PROTECTION CERTIFICATES AND
RENEWALS OF A PATENT OR PATENT APPLICATION, AND ANY CONFIRMATION PATENT OR
REGISTRATION PATENT OR PATENT OF ADDITION BASED ON ANY SUCH PATENT.
1.35.
"PERSON" SHALL MEAN ANY INDIVIDUAL, CORPORATION, PARTNERSHIP,
LIMITED LIABILITY COMPANY, TRUST, GOVERNMENTAL ENTITY, OR OTHER LEGAL ENTITY OF
ANY NATURE WHATSOEVER.
1.36.
"PHASE III CLINICAL TRIAL" SHALL MEAN A HUMAN CLINICAL TRIAL, THE
PRINCIPAL PURPOSE OF WHICH IS TO GATHER SAFETY AND EFFICACY DATA FOR A PRODUCT
INDICATION OF ONE OR MORE PARTICULAR DOSES IN PATIENTS BEING STUDIED THAT IS
NEEDED TO EVALUATE THE OVERALL BENEFIT AND RISK RELATIONSHIP OF THE PRODUCT AND
TO PROVIDE ADEQUATE BASIS FOR LABELING, AS REQUIRED IN 21 C.F.R. §312(C), OR
SUCH SIMILAR CLINICAL STUDY IN A COUNTRY OTHER THAN THE UNITED STATES OF
AMERICA.
1.37.
"PRODUCT" SHALL MEAN THE ACTIVE INGREDIENT, IN THE FORM AND DOSAGES
APPROVED AS OF THE EFFECTIVE DATE BY THE FDA AS LUNESTA® (ESZOPICLONE), FOR ALL
INDICATIONS WHICH ARE OR MAY BE APPROVED BY REGULATORY AUTHORITIES IN THE GSK
TERRITORY FOR THOSE FORMS AND DOSAGES. THE PRODUCT SHALL ALSO INCLUDE ANY
ADDITIONAL IMMEDIATE RELEASE FORMS OR DOSAGES OF LUNESTA® (ESZOPICLONE) THAT
MAY BE DEVELOPED BY SEPRACOR OR GSK DURING THE TERM OF THE AGREEMENT.
FOR THE AVOIDANCE OF DOUBT, PRODUCT SHALL NOT MEAN, INTER ALIA: (I) ANY PRODUCT
CONTAINING ACTIVE INGREDIENT IN [**]; OR (II) ANY PRODUCT WITH THE ACTIVE
INGREDIENT USED [**]. ALL SUCH PRODUCTS TO BE REFERRED TO HEREIN AS "EXCLUDED
PRODUCTS".
1.38.
"PRODUCT INDICATION" SHALL MEAN, ON A COUNTRY-BY-COUNTRY BASIS, ANY
INDICATION FOR WHICH THE PRODUCT HAS MARKETING APPROVAL IN SUCH COUNTRY.
1.39.
"PRODUCT TRADEMARKS" SHALL MEAN THE TRADEMARK(S) OWNED BY SEPRACOR
WHICH ARE AVAILABLE FOR USE WITH THE PRODUCT, AS LISTED IN PART A OF
SCHEDULE 1.39.
1.40.
"REGULATORY AUTHORITY" SHALL MEAN THE EMEA AND ANY OTHER NATIONAL,
REGIONAL, STATE OR LOCAL REGULATORY AGENCY, DEPARTMENT, BUREAU, COMMISSION,
COUNCIL OR OTHER GOVERNMENTAL ENTITY WHOSE REVIEW AND/OR APPROVAL IS NECESSARY
FOR THE MANUFACTURE, PACKAGING, USE, STORAGE, IMPORT, EXPORT, DISTRIBUTION,
PROMOTION, MARKETING, OFFER FOR SALE AND SALE OF THE PRODUCT IN THE GSK
TERRITORY. FOR COUNTRIES WHERE GOVERNMENTAL APPROVAL IS REQUIRED FOR PRICING OR
REIMBURSEMENT FOR THE PRODUCT TO BE REIMBURSED BY NATIONAL HEALTH INSURANCE (OR
ITS LOCAL EQUIVALENT), "REGULATORY AUTHORITY" SHALL ALSO INCLUDE ANY NATIONAL,
REGIONAL, STATE OR LOCAL
CONFIDENTIAL
REGULATORY AGENCY, DEPARTMENT,