SUCCESSOR ENTITY THERETO PERFORMING SIMILAR FUNCTIONS.
1.18
"FD&C ACT" SHALL MEAN THE UNITED STATES FEDERAL FOOD, DRUG, AND
COSMETIC ACT, AS AMENDED FROM TIME TO TIME, AND THE REGULATIONS PROMULGATED
THEREUNDER, AS AMENDED FROM TIME TO TIME.
1.19"
FTE" SHALL MEAN A FULL-TIME PERSON EMPLOYED BY ARRAY, DEDICATED
FULL-TIME TO THE DISCOVERY PROGRAM, OR IN THE CASE OF LESS THAN A FULL-TIME
DEDICATED PERSON, A FULL-TIME, EQUIVALENT
6
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
PERSON YEAR, BASED UPON A TOTAL OF ONE THOUSAND EIGHT HUNDRED EIGHTY (1,880)
HOURS PER YEAR OF WORK ON THE DISCOVERY PROGRAM.
1.20
"GAAP" SHALL MEAN GENERALLY ACCEPTED ACCOUNTING PRINCIPLES AS
APPLICABLE IN THE UNITED STATES OF AMERICA.
1.21
"IND" SHALL MEAN ANY INVESTIGATIONAL NEW DRUG APPLICATION FILED
WITH THE FDA PURSUANT TO 21 C.F.R. § 312 BEFORE THE COMMENCEMENT OF CLINICAL
TRIALS INVOLVING A DEVELOPMENT COMPOUND, A DEVELOPMENT BACK-UP COMPOUND, A
COLLABORATION COMPOUND OR A COLLABORATION BACK-UP COMPOUND (OR ANY LICENSED
PRODUCT INCORPORATING A COLLABORATION COMPOUND OR COLLABORATION BACK-UP
COMPOUND), OR ANY COMPARABLE FILINGS WITH ANY REGULATORY AUTHORITY IN ANY OTHER
JURISDICTION.
1.22
"INFORMATION" SHALL MEAN MATERIALS, DATA AND OTHER INFORMATION
RELATING TO THE SUBJECT MATTER OF THIS AGREEMENT AND INCLUDING: (A) TECHNIQUES
AND DATA, INCLUDING SCREENS, MODELS, INVENTIONS, METHODS, TEST DATA (INCLUDING,
PHARMACOLOGICAL, TOXICOLOGICAL AND CLINICAL TEST DATA), ANALYTICAL AND QUALITY
CONTROL DATA, MARKETING, PRICING, DISTRIBUTION, COSTS, AND SALES DATA,
MANUFACTURING INFORMATION, AND PATENT AND LEGAL DATA OR DESCRIPTIONS (TO THE
EXTENT THAT DISCLOSURE THEREOF WOULD NOT RESULT IN LOSS OR WAIVER OF PRIVILEGE
OR SIMILAR PROTECTION); (B) COMPOSITIONS OF MATTER, INCLUDING COMPOUNDS,
BIOLOGICAL MATERIALS AND ASSAYS; AND (C) THE SUBJECT MATTER AND CONTENT OF ALL
JRC, JDC, JMC AND JCC DISCUSSIONS AND MEETINGS.
AS USED HEREIN, "CLINICAL TEST
DATA" SHALL BE DEEMED TO INCLUDE ALL INFORMATION RELATED TO THE CLINICAL OR
PRECLINICAL TESTING OF A COMPOUND OR LICENSED PRODUCT, INCLUDING PATIENT REPORT
FORMS, INVESTIGATORS' REPORTS, BIOSTATISTICAL, PHARMACO-ECONOMIC AND OTHER
RELATED ANALYSES, REGULATORY FILINGS AND COMMUNICATIONS, AND THE LIKE.
1.23
"INITIATION" OF A PARTICULAR CLINICAL TRIAL SHALL BE DEEMED TO
OCCUR UPON THE DATE OF FIRST DOSING OF THE FIRST SUBJECT IN SUCH TRIAL.
1.24
"LICENSED PRODUCT" SHALL MEAN A PRODUCT THAT INCORPORATES A
COLLABORATION COMPOUND OR A COLLABORATION BACK-UP COMPOUND AS AN ACTIVE
INGREDIENT.
7
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
1.25
"MARKETING APPROVAL" SHALL MEAN ALL APPROVALS, LICENSES,
REGISTRATIONS OR AUTHORIZATIONS OF A REGULATORY AUTHORITY IN A COUNTRY NECESSARY
FOR THE MANUFACTURE, USE, STORAGE, IMPORT, MARKETING AND SALE OF A LICENSED
PRODUCT IN SUCH COUNTRY.
1.26
"MARKETING APPROVAL APPLICATION" OR "MAA" SHALL MEAN A NEW DRUG
APPLICATION (AS DEFINED IN 21 C.F.R. § 314.50