WHICH OUTLINE THE CORE MARKETING
MATERIALS TO BE USED IN RELATION TO THE PRODUCT AND TO SPECIFICALLY INCLUDE
TRADE DRESS, CORE CLAIMS AND VISUALS.
1.17.
"DATA" SHALL MEAN, SUBJECT TO THE PROVISIONS OF SECTION 5.10, ANY
AND ALL RESEARCH DATA, PHARMACOLOGY DATA, PRECLINICAL DATA, CLINICAL DATA,
MANUFACTURING DATA AND/OR ALL REGULATORY DOCUMENTATION, INFORMATION AND
SUBMISSIONS PERTAINING TO, OR MADE IN ASSOCIATION WITH, AN IND OR A MARKETING
AUTHORIZATION APPLICATION FOR THE PRODUCT, IN EACH CASE WHICH ARE CONTROLLED BY
A PARTY AS OF THE EFFECTIVE DATE OR DURING THE TERM OF THIS AGREEMENT, INCLUDING
BUT NOT LIMITED TO THE DEVELOPMENT DATA.
1.18.
"DEVELOPMENTAL STUDIES" MEANS ANY (I) REQUIRED STUDIES OR
(II) COMMERCIALIZATION STUDIES, BOTH AS SET FORTH IN THE DEVELOPMENT PLAN. FOR
THE AVOIDANCE OF DOUBT, DEVELOPMENTAL STUDIES SHALL NOT INCLUDE INVESTIGATOR
SPONSORED CLINICAL STUDIES OF THE PRODUCT IN THE GSK TERRITORY.
1.19.
"EFFECTIVE DATE" SHALL MEAN THE LATER OF: (I) THE DATE ON WHICH AN
AUTHORIZED REPRESENTATIVE OF SEPRACOR EXECUTES THIS AGREEMENT, AND (II) THE DATE
ON WHICH AN AUTHORIZED REPRESENTATIVE OF GSK EXECUTES THIS AGREEMENT.
1.20.
"EMEA" SHALL MEAN THE EUROPEAN MEDICINES AGENCY, OR ANY OTHER
SUCCESSOR AGENCY THAT IS RESPONSIBLE FOR APPROVING THE SALE OF PHARMACEUTICAL
PRODUCTS ACROSS THE EUROPEAN UNION.
CONFIDENTIAL
1.21.
"EUROPEAN UNION" SHALL MEAN THE MEMBER COUNTRIES OF THE EUROPEAN
UNION AT THE RELEVANT POINT IN TIME.
1.22.
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG ADMINISTRATION, OR
ANY SUCCESSOR ENTITY THERETO PERFORMING SIMILAR FUNCTIONS.
1.23.
"GSK COMPETING PRODUCT" SHALL HAVE THE MEANING STATED IN
SECTION 9.1(E) OF THIS AGREEMENT. FOR THE AVOIDANCE OF DOUBT, GSK COMPETING
PRODUCTS MAY INCLUDE, BUT SHALL NOT BE LIMITED TO, COMPOUNDS, OTHER THAN
ACQUIRED COMPETING PRODUCTS, ACQUIRED BY GSK (BY LICENCE, PURCHASE OR OTHERWISE)
DURING THE TERM OF THIS AGREEMENT.
1.24.
"GSK TERRITORY" SHALL MEAN ALL COUNTRIES AND TERRITORIES OF THE
WORLD EXCLUDING THE SEPRACOR TERRITORY.
1.25.
"IMPROVEMENTS" SHALL MEAN ANY NEW OR USEFUL PROCESS, TECHNIQUE,
FORMULA, INVENTION OR KNOW-HOW, FORMULATION, OR COMPOSITION OF MATTER RELATING
TO OR COMPRISING THE PRODUCT, OR ANY SEPRACOR TECHNOLOGY, WHETHER PATENTABLE OR
UNPATENTABLE, OR ANY IMPROVEMENT, ENHANCEMENT, MODIFICATION OR DERIVATIVE WORK
THEREOF, THAT IS CONCEIVED OR FIRST REDUCED TO PRACTICE OR FIRST DEMONSTRATED TO
HAVE UTILITY DURING THE TERM OF THIS AGREEMENT IN CONNECTION WITH THE PARTIES'
ACTIVITIES UNDER THIS AGREEMENT.
1.26.
"IND" SHALL MEAN AN INVESTIGATIONAL NEW DRUG APPLICATION (INCLUDING
ANY AMENDMENTS THERETO) FILED WITH THE FDA PURSUANT TO 21 C.F.R. §312 BEFORE
COMMENCEMENT OF CLINICAL TRIALS OF A PHARMACEUTICAL PRODUCT, OR ANY COMPARABLE
FILINGS WITH ANY REGULATORY AUTHORITY IN ANY OTHER JURISDICTION, INCLUDING, BUT
NOT LIMITED TO, CLINICAL TRIAL APPLICATIONS.
1.27.
"INTERNATIONAL FINANCIAL REPORTING STANDARDS" SHALL MEAN THE
INTERNATIONAL FINANCIAL REPORTING STANDARDS AND INTERNATIONAL ACCOUNTING
STANDARDS ISSUED BY THE INTERNATIONAL ACCOUNTING STANDARDS BOARD ("IASB") AND
INTERPRETATIONS ISSUED BY THE INTERNATIONAL FINANCIAL REPORTING INTERPRETATIONS
COMMITTEE OF THE IASB.
1.28.
"MAJOR MARKET" SHALL MEAN EACH OF THE U.K., GERMANY, ITALY, FRANCE,
SPAIN, CHINA, AUSTRALIA, BRAZIL AND SOUTH KOREA, PROVIDED, HOWEVER, WITH RESPECT
TO SECTIONS 6.1, 6.3(L), 6.4(B), 14.4(C) AND 16.2(E),