SUBSECTION 6.1(B);
(I)
"DEVELOPMENT PROGRAM" SHALL HAVE THE
MEANING SET OUT IN SECTION 2.1;
(J)
"FDA" SHALL MEAN THE UNITED STATES FOOD
AND DRUG ADMINISTRATION OR ANY SUCCESSOR AGENCY THEREOF;
(K)
"FIELD" SHALL MEAN THE USE OF A LICENSED
COMPOUND OR A LICENSED PRODUCT FOR THE DIAGNOSIS, PREVENTION AND/OR TREATMENT OF
ANY HUMAN DISEASE;
(L)
"FIRST COMMERCIAL SALE" SHALL MEAN THE
FIRST SALE OF A LICENSED PRODUCT BY NEORX OR AN AFFILIATE OR A SUBLICENSEE OF
NEORX IN A COUNTRY IN THE TERRITORY FOLLOWING THE RECEIPT OR ISSUANCE OF
REGULATORY
2
APPROVAL FOR THE LICENSED PRODUCT IN THAT COUNTRY OR, IF NO SUCH REGULATORY
APPROVAL OR SIMILAR MARKETING APPROVAL IS REQUIRED, THE DATE UPON WHICH THE
LICENSED PRODUCT IS FIRST COMMERCIALLY LAUNCHED IN SUCH COUNTRY.
FOR THE
PURPOSES OF THE DEFINITION OF "FIRST COMMERCIAL SALE", "CONTROL" IN THE
DEFINITION OF AFFILIATE SHALL MEAN DIRECT OR INDIRECT BENEFICIAL OWNERSHIP OF
[*] INTEREST IN THE INCOME OF A PERSON OR SUCH OTHER RELATIONSHIP AS, IN FACT,
CONSTITUTES ACTUAL CONTROL;
(M)
"GAAP" OR "GENERALLY ACCEPTED ACCOUNTING
PRINCIPLES" SHALL MEAN THE CONVENTIONS, RULES AND PROCEDURES THAT DEFINE
ACCOUNTING PRACTICES AS ESTABLISHED, AND REVISED OR AMENDED, BY THE FINANCIAL
ACCOUNTING STANDARDS BOARD;
(N)
"ICR" SHALL MEAN THE INSTITUTE OF CANCER
RESEARCH: ROYAL CANCER HOSPITAL, LONDON, UNITED KINGDOM;
(O)
"ICR AGREEMENT" MEANS THE [*];
(P)
"IND" SHALL MEAN AN INVESTIGATIONAL NEW DRUG
EXEMPTION UNDER 21 C.F.R. 355(I) PURSUANT TO THE RULES AND POLICIES OF THE FDA
AND SUCH EQUIVALENT REGULATIONS OR STANDARDS OF COUNTRIES OUTSIDE THE UNITED
STATES AS MAY BE APPLICABLE TO THE ACTIVITIES CONDUCTED HEREUNDER;
(Q)
"INTELLECTUAL PROPERTY" SHALL MEAN ANY
DISCOVERIES, IMPROVEMENTS, PATENTS, PATENT APPLICATIONS, COPYRIGHTS, COPYRIGHT
APPLICATIONS, INDUSTRIAL DESIGNS, INDUSTRIAL DESIGN APPLICATIONS, MASK WORKS,
TRADEMARKS, TRADEMARK APPLICATIONS AND TRADE SECRETS;
(R)
"KNOW-HOW" SHALL MEAN ANY AND ALL DATA,
RESULTS, INSTRUCTIONS, PROCESSES, FORMULAE, TRADE SECRETS, EXPERT OPINIONS,
REGULATORY SUBMISSIONS AND OTHER INFORMATION (IN WRITTEN OR OTHER TANGIBLE FORM)
INCLUDING, WITHOUT LIMITATION, ANY CHEMICAL, PHARMACOLOGICAL, TOXICOLOGICAL,
PRE-CLINICAL, CLINICAL, ASSAY, CONTROL AND MANUFACTURING DATA, BIOLOGICAL
MATERIALS, MANUFACTURING OR RELATED TECHNOLOGY, ANALYTICAL METHODOLOGY, CHEMICAL
AND QUALITY CONTROL PROCEDURES, PROTOCOLS, TECHNIQUES, IMPROVEMENTS, RESULTS AND
REPORTS OF EXPERIMENTATION AND TESTING;
(S)
"LICENSED COMPOUND" SHALL MEAN AMD473, AND
ANY ANALOGUES OR DERIVATIVES OR BACKUP COMPOUNDS OF AMD473, THE MAKING, HAVING
MADE, USING, SELLING, OFFERING FOR SALE OR IMPORTING OF WHICH WOULD, BUT FOR THE
LICENSE GRANTED HEREIN, INFRINGE A VALID CLAIM OF ONE OR MORE OF THE ANORMED
PATENTS;
(T)
"LICENSED PRODUCT"
SHALL MEAN ANY
PHARMACEUTICAL COMPOSITIONS APPROVED AS A DRUG IN THE TERRITORY IN DOSAGE FORM
IN ANY FORMULATION THAT CONTAINS A LICENSED COMPOUND AS AN ACTIVE INGREDIENT AND
THAT ARE PACKAGED AND LABELLED FOR SALE TO THE ULTIMATE CUSTOMER FOR USE IN THE
FIELD;
(U)
"NDA" MEANS A COMPLETE NEW DRUG APPLICATION
AND ALL SUPPLEMENTS THERETO FILED WITH THE FDA INCLUDING ALL DOCUMENTS, DATA,
AND OTHER INFORMATION CONCERNING A LICENSED PRODUCT WHICH ARE NECESSARY FOR, OR
INCLUDED IN, FDA APPROVAL TO MARKET SUCH LICENSED PRODUCT AS MORE FULLY DEFINED
IN 21 C.F.R. § 314.5 ET SEQ