DEVELOP, USE OR COMMERCIALIZE IL13 AND/OR THE
PRODUCT IN THE TERRITORY IN THE FIELD OF USE AND SHALL INCLUDE THE LICENSED
PATENT RIGHTS AND ANY NEOPHARM DATA.
1.29
"LICENSOR" SHALL MEAN, FOR EACH PATENT OR APPLICATION INCLUDED IN
THE LICENSED PATENT RIGHTS LISTED ON EXHIBIT A HERETO, THE LICENSOR TO NEOPHARM
DESIGNATED ON EXHIBIT A FOR SUCH PATENT ESTATE.
1.30
"MHLW" SHALL MEAN THE JAPANESE MINISTRY OF HEALTH, LABOR AND
WELFARE, AND ANY SUCCESSOR AGENCY.
1.31
"MILESTONE PAYMENTS" SHALL MEAN THE PAYMENTS TO BE MADE BY NK TO
NEOPHARM UPON OCCURRENCE OF CERTAIN EVENTS AS SET FORTH IN SECTION 4.2.
5
1.32
"NEOPHARM DATA" SHALL MEAN CLINICAL, TECHNICAL, SCIENTIFIC AND
MEDICAL INFORMATION, KNOWLEDGE, KNOW-HOW, METHODS, AND PRACTICES INCLUDING, BUT
WITHOUT LIMITATION, PHARMACOLOGICAL, TOXICOLOGICAL AND CLINICAL TEST DATA AND
RESULTS HAVING APPLICATION TO IL13 AND/OR THE PRODUCTS IN THE FIELD OF USE.
1.33
"NEOPHARM TERRITORY" SHALL MEAN THE ENTIRE WORLD EXCLUDING THE
TERRITORY.
1.34
"NET SALES" SHALL MEAN [*] PERCENT [*]% OF THE JAPANESE NHI
REIMBURSEMENT PRICE FOR THE PRODUCT SOLD BY NK AND ITS AFFILIATES TO THIRD
PARTIES (OTHER THAN FOR THE PURPOSE OF CLINICAL STUDIES); PROVIDED, HOWEVER,
THAT IN CASE THE JAPANESE PRICING SYSTEM CHANGES FROM THE JAPANESE NHI
REIMBURSEMENT PRICE TO ANOTHER SYSTEM, THE PARTIES SHALL NEGOTIATE WITH EACH
OTHER ABOUT HOW TO EQUITABLY DETERMINE NET SALES OF PRODUCT.
1.35
"NEW DRUG APPLICATION" OR "NDA" SHALL MEAN (A) THE SINGLE
APPLICATION OR SET OF APPLICATIONS FOR APPROVAL AND/OR PRE-MARKET APPROVAL TO
MAKE AND SELL COMMERCIALLY A PHARMACEUTICAL OR BIOLOGICAL THERAPEUTIC PRODUCTS
OR DELIVERY SYSTEMS OR DEVICE FILED WITH THE FDA OR GOVERNMENTAL AUTHORITIES IN
THE TERRITORY, AS APPLICABLE, OR ANY SUCCESSOR AGENCY HAVING THE ADMINISTRATIVE
AUTHORITY TO REGULATE THE APPROVAL FOR MARKETING OF NEW HUMAN PHARMACEUTICAL OR
BIOLOGICAL THERAPEUTIC PRODUCTS, DELIVERY SYSTEMS AND DEVICES IN THE UNITED
STATES OR THE TERRITORY, AS APPLICABLE, INCLUDING ALL INFORMATION IN DRUG MASTER
FILES RELATED TO SUCH APPLICATION(S), AND (B) ANY RELATED REGISTRATIONS WITH OR
NOTIFICATIONS TO THE FDA OR GOVERNMENTAL AUTHORITIES IN THE TERRITORY, AS
APPLICABLE.
1.36
"NHI" SHALL MEAN THE JAPANESE NATIONAL HEALTH INSURANCE.
1.37
"NK DATA" SHALL MEAN ANY INFORMATION, INCLUDING, BUT NOT LIMITED
TO, PRE-CLINICAL AND CLINICAL DATA, OBTAINED BY NK OR ITS AFFILIATES IN SUPPORT
OF THE DEVELOPMENT AND COMMERCIALIZATION.
1.38
"NK TECHNOLOGY" SHALL MEAN ANY TECHNOLOGY, TRADE SECRETS, KNOW-HOW
AND OTHER INTELLECTUAL PROPERTY (OTHER THAN TRADEMARKS) DIRECTED TO IL13 AND/OR
PRODUCTS, FORMULATIONS AND/OR METHODS AND ANY BIOLOGICAL MATERIALS CONTROLLED ON
THE EFFECTIVE DATE OR TO BE CONTROLLED THEREAFTER BY NK OR ITS AFFILIATES WHICH
ARE NECESSARY OR USEFUL TO RESEARCH, DEVELOP, USE AND COMMERCIALIZE THE PRODUCT
AND/OR IL13 AND SHALL INCLUDE ANY NK DATA.
1.39
"PARTY" SHALL MEAN NEOPHARM OR NK, AS THE CASE MAY BE, AND
"PARTIES" SHALL MEAN NEOPHARM AND NK.
1.40
"PERSON" SHALL MEAN AN INDIVIDUAL, A PARTNERSHIP, A JOINT VENTURE,
A CORPORATION, A TRUST, AN ESTATE, AN UNINCORPORATED ORGANIZATION, OR ANY OTHER
ENTITY, OR A GOVERNMENT OR ANY DEPARTMENT OR AGENCY THEREOF.
1.41
"PHASE I STUDY" SHALL MEAN A PHASE I