COMMERCIALIZATION OF THE PRODUCT IN THE GSK TERRITORY AND WHICH WILL BE
INITIATED IN A COUNTRY AFTER MARKETING APPROVAL OF THE PRODUCT IN SUCH COUNTRY.
SUCH STUDIES MAY INCLUDE, BUT SHALL NOT BE LIMITED TO, "MARKETING STUDIES" TO
SUPPORT MARKET UPTAKE, ACCEPTANCE AND DIFFERENTIATION OF THE PRODUCT,
EPIDEMIOLOGICAL STUDIES, MODELING AND PHARMACOECONOMIC STUDIES, AND STUDIES IN
SUPPORT OF MODIFICATIONS OR ADDITIONAL SLEEP DISORDER RELATED INDICATIONS.
COMMERCIALIZATION STUDIES SHALL NOT INCLUDE STUDIES DESIGNED TO GENERATE DATA IN
SUPPORT OF NEW INDICATIONS UNRELATED TO SLEEP DISORDERS, OR STUDIES
INVESTIGATING THE SAFETY OR EFFICACY OF THE PRODUCT IN A MODIFIED RELEASE
FORMULATION OR A COMBINATION PRODUCT. FOR THE AVOIDANCE OF DOUBT,
COMMERCIALIZATION STUDIES SHALL NOT INCLUDE REQUIRED STUDIES, INVESTIGATOR
SPONSORED CLINICAL STUDIES, SEPRACOR STUDIES, STUDIES SEPRACOR INITIATED PRIOR
TO THE EFFECTIVE DATE IN SUPPORT OF THE PRODUCT, ANY STUDIES RELATING TO THE
PRODUCT THAT SEPRACOR MAY INITIATE IN THE SEPRACOR TERRITORY OR ANY OTHER
STUDIES THAT SEPRACOR MAY INITIATE ANYWHERE IN THE WORLD WHICH DO NOT RELATE TO
THE PRODUCT.
1.13.
"COMMERCIALLY REASONABLE EFFORTS" MEANS THOSE DILIGENT EFFORTS AND
RESOURCES, WITH RESPECT TO A PARTICULAR PARTY, AT THE RELEVANT POINT IN TIME,
THAT ARE COMPARABLE TO THOSE GENERALLY USED BY THAT PARTY, IN GOOD FAITH, IN THE
EXERCISE OF ITS REASONABLE AND PRUDENT SCIENTIFIC AND BUSINESS JUDGMENT RELATING
TO OTHER PRESCRIPTION PHARMACEUTICAL PRODUCTS OWNED OR LICENSED BY IT OR TO
WHICH IT HAS EXCLUSIVE RIGHTS, WHICH HAVE MARKET POTENTIAL AND ARE AT A STAGE OF
DEVELOPMENT OR PRODUCT LIFE SIMILAR TO THE PRODUCT, TAKING INTO ACCOUNT MEASURES
OF RELATIVE SAFETY AND EFFICACY, PRODUCT PROFILE, THE COMPETITIVENESS OF THE
MARKETPLACE, THE PROPRIETARY
CONFIDENTIAL
POSITION OF THE COMPOUND OR PRODUCT, THE REGULATORY STRUCTURE INVOLVED, THE
RELATIVE PROFITABILITY OF THE PRODUCTS, AND OTHER RELEVANT FACTORS, INCLUDING
WITHOUT LIMITATION COMPARATIVE TECHNICAL, LEGAL, SCIENTIFIC, AND/OR MEDICAL
FACTORS. SUCH COMMERCIALLY REASONABLE EFFORTS SHALL INCLUDE, WITHOUT LIMITATION,
COMPARABLE EFFORTS WITH RESPECT TO (I) PROMPTLY ASSIGNING RESPONSIBILITY FOR
DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES TO SPECIFIC EMPLOYEES WHO ARE HELD
ACCOUNTABLE FOR PROGRESS AND MONITORING SUCH PROGRESS ON AN ON-GOING BASIS,
(II) SETTING AND CONSISTENTLY SEEKING TO ACHIEVE SPECIFIC AND MEANINGFUL
OBJECTIVES AND TIMELINES FOR CARRYING OUT SUCH DEVELOPMENT AND COMMERCIALIZATION
ACTIVITIES, (III) CONSISTENTLY MAKING AND IMPLEMENTING DECISIONS AND ALLOCATING
RESOURCES DESIGNED TO ADVANCE PROGRESS WITH RESPECT TO SUCH OBJECTIVES AND
TIMELINES, AND (IV) EMPLOYING COMPENSATION SYSTEMS FOR ITS EMPLOYEES WORKING
WITH THE PRODUCT THAT ARE SIMILAR TO THE COMPENSATION SYSTEMS THE APPLICABLE
PARTY APPLIES WITH RESPECT TO ITS OTHER PROGRAMS WITH PRODUCTS OF SIMILAR
POTENTIAL.
1.14.
"CONFIDENTIALITY AGREEMENT" SHALL MEAN THAT CERTAIN LETTER
AGREEMENT DATED JANUARY 11, 2005 ENTERED INTO BY AND BETWEEN SEPRACOR AND
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED.
1.15.
"CONTROL" (INCLUDING ANY VARIATIONS SUCH AS "CONTROLLED" AND
"CONTROLLING"), IN THE CONTEXT OF INTELLECTUAL PROPERTY RIGHTS AND KNOW-HOW,
SHALL MEAN RIGHTS TO INTELLECTUAL PROPERTY SUFFICIENT TO GRANT THE APPLICABLE
LICENSE UNDER THIS AGREEMENT, WITHOUT VIOLATING THE TERMS OF AN AGREEMENT WITH A
THIRD PARTY.
1.16.
"CORE CAMPAIGN PRODUCT STRATEGIES" SHALL MEAN THOSE MATERIALS
PROPOSED BY THE GSK EUROPEAN MARKETING GROUP