OF SUCH COMPOUNDS.
1.8.
"IND" MEANS (A) AN INVESTIGATIONAL NEW DRUG APPLICATION (AS DEFINED
IN THE U.S. FEDERAL FOOD, DRUG AND COSMETIC ACT, AS AMENDED, AND THE REGULATIONS
PROMULGATED THEREUNDER) THAT IS REQUIRED TO BE FILED WITH THE FDA BEFORE
BEGINNING CLINICAL TESTING OF AN IDENTIFIED PRODUCT IN HUMAN SUBJECTS, OR ANY
SUCCESSOR APPLICATION OR PROCEDURE OR (B) ANY COUNTERPART OF AN INVESTIGATIONAL
NEW DRUG APPLICATION THAT IS REQUIRED IN ANY OTHER COUNTRY OR REGION IN THE
LICENSED TERRITORY BEFORE BEGINNING CLINICAL TESTING OF AN IDENTIFIED PRODUCT IN
HUMAN SUBJECTS IN SUCH COUNTY OR REGION.
1.9.
"LICENSEE" MEANS AVI BIOPHARMA, INC., AN OREGON CORPORATION, AND
ANY AFFILIATES THEREOF.
1.10.
"LICENSEE FACILITY" MEANS AND IS LIMITED TO THE FACILITIES OF
LICENSEE AND ITS AFFILIATES LOCATED AT THE LOCATIONS SPECIFIED IN EXHIBIT B.
LICENSEE MAY ADD ADDITIONAL LOCATIONS TO THIS LIST WITH PRIOR WRITTEN NOTICE TO
CHIRON.
1.11.
"LICENSED COMPOSITION" MEANS ANY COMPOSITION, THE MAKING, USING,
SELLING, KEEPING, OFFERING FOR SALE, IMPORTING OR EXPORTING THEREOF WOULD, BUT
FOR THE LICENSE GRANTED HEREIN, INFRINGE ANY VALID CLAIM WITHIN CHIRON PATENT
RIGHTS, IF PRACTICED IN A REFERENCE COUNTRY.
1.12.
"LICENSED METHOD" MEANS ANY METHOD OR PROCESS, THE PRACTICE OF WHICH
WOULD, BUT FOR THE LICENSE GRANTED HEREIN, INFRINGE A VALID CLAIM OF THE CHIRON
PATENT RIGHTS, (INCLUDING THE MANUFACTURE, USE, SALE, KEEPING, OFFER FOR SALE,
IMPORTATION OR EXPORTATION OF A PRODUCT WHICH WOULD INFRINGE ANY SUCH VALID
CLAIM), IF PRACTICED IN A REFERENCE COUNTRY.
1.13.
"LICENSED PROCESSES" MEANS ANY PROCESS THAT INVOLVES THE USE,
PRACTICE OR MANUFACTURE OF A LICENSED COMPOSITION AND/OR LICENSED METHOD,
INCLUDING:
(A) THE DESIGN, SYNTHESIS, SCREENING, IDENTIFICATION, SELECTION OR
IMPROVEMENT OF COMPOUNDS (INCLUDING MIXTURES THEREOF), BIOACTIVE "HITS" OR
RESEARCH LEADS DURING DRUG DISCOVERY RESEARCH; AND (B) THE OPTIMIZATION,
FORMULATION, CHARACTERIZATION OR EVALUATION OF LEAD COMPOUNDS OR DEVELOPMENT
CANDIDATES DURING PRECLINICAL RESEARCH OR DEVELOPMENT.
3
1.14.
"LICENSED TERRITORY" MEANS (A) FOR PURPOSES OF USE OF THE LICENSED
PROCESSES, ANY COUNTRY IN THE WORLD WHERE LICENSEE HAS A LICENSEE FACILITY AND
(B) FOR PURPOSES OF DEVELOPMENT AND COMMERCIALIZATION OF IDENTIFIED PRODUCTS
MEANS WORLDWIDE.
1.15.
"NDA" MEANS A NEW DRUG APPLICATION OR A BIOLOGICS LICENSE
APPLICATION, EACH AS DEFINED IN THE U.S. FEDERAL FOOD, DRUG, AND COSMETICS ACT,
AS AMENDED, AND THE REGULATIONS PROMULGATED THEREUNDER, AND ANY CORRESPONDING
FOREIGN OR DOMESTIC MARKETING AUTHORIZATION APPLICATION, REGISTRATION OR
CERTIFICATION, NECESSARY OR REASONABLY USEFUL TO MARKET A IDENTIFIED PRODUCT IN
THE LICENSED TERRITORY, BUT NOT INCLUDING PRICING OR REIMBURSEMENT APPROVALS.
1.16.
"NET SALES" SHALL BE CALCULATED IN ACCORDANCE WITH U.S. GENERALLY
ACCEPTED ACCOUNTING PRINCIPLES AND, FOR EACH CALENDAR YEAR DURING THE TERM,
MEANS THE GROSS AMOUNT BILLED OR INVOICED FOR SALES OR OTHER DISPOSITIONS OF ALL
IDENTIFIED PRODUCTS BY LICENSEE OR A THIRD PARTY BENEFICIARY HEREUNDER (OTHER
THAN SALES OR OTHER DISPOSITIONS TO AFFILIATES UNLESS SUCH AFFILIATE IS THE END
USER) LESS THE FOLLOWING DEDUCTIONS ACTUALLY PAID OR INCURRED (TO THE EXTENT
THEY ARE NOT ALREADY REFLECTED IN THE AMOUNT INVOICED AND TO THE EXTENT THEY ARE
NOT OTHERWISE COVERED OR REIMBURSED) DURING SUCH CALENDAR