BUREAU, COMMISSION, COUNCIL OR
OTHER GOVERNMENTAL ENTITY WITH AUTHORITY OVER THE DISTRIBUTION, IMPORTATION,
EXPORTATION, MANUFACTURE, PRODUCTION, USE, STORAGE, TRANSPORT, CLINICAL TESTING
OR SALE OF A LICENSED PRODUCT.
1.122
"REGULATORY FILINGS" MEANS, COLLECTIVELY: (A) ALL INDS, NDAS, BLAS,
ESTABLISHMENT LICENSE APPLICATIONS, DMFS, APPLICATIONS FOR DESIGNATION AS AN
"ORPHAN PRODUCT(S)" UNDER THE ORPHAN DRUG ACT, FOR "FAST TRACK" STATUS UNDER
SECTION 506 OF THE FDCA (21 U.S.C. § 356) OR FOR A SPECIAL PROTOCOL ASSESSMENT
UNDER SECTION 505(B)(4)(B) AND (C) OF THE FDCA (21 U.S.C. § 355(B)(4)(B)) AND
ALL OTHER SIMILAR FILINGS (INCLUDING, WITHOUT LIMITATION, COUNTERPARTS OF ANY OF
THE FOREGOING IN ANY COUNTRY OR REGION IN THE TERRITORY); (B) ALL SUPPLEMENTS
AND AMENDMENTS TO ANY OF THE FOREGOING; AND (C) ALL DATA AND OTHER INFORMATION
CONTAINED IN, AND CORRESPONDENCE RELATING TO, ANY OF THE FOREGOING.
1.123
"ROW TERRITORY" MEANS ALL OF THE COUNTRIES AND TERRITORIES OF THE
WORLD OTHER THAN THE U.S. TERRITORY AND THE ASIAN TERRITORY.
1.124
"ROYALTY TERM" MEANS ON A LICENSED PRODUCT-BY-LICENSED PRODUCT AND
COUNTRY-BY-COUNTRY BASIS, THE PERIOD BEGINNING ON THE DATE OF FIRST COMMERCIAL
SALE OF A LICENSED PRODUCT IN A COUNTRY AND ENDING ON THE LATER TO OCCUR OF
(A) EXPIRATION OF THE LAST TO EXPIRE OF THE LICENSED PATENT RIGHTS OR JOINT
PATENT RIGHTS HAVING A VALID CLAIM IN SUCH COUNTRY THAT COVERS SUCH LICENSED
PRODUCT OR ITS MANUFACTURE, USE, IMPORT, OFFER FOR SALE OR SALE OR (B) * (*)
YEARS FROM THE DATE OF THE FIRST COMMERCIAL SALE OF SUCH LICENSED PRODUCT IN
SUCH COUNTRY, AND "COVER" AS USED HEREIN MEANS, WITH RESPECT TO A LICENSED
PRODUCT, COMPOSITION, TECHNOLOGY,
23
PROCESS OR METHOD THAT, IN THE ABSENCE OF OWNERSHIP OF OR A LICENSE GRANTED
UNDER A VALID CLAIM, THE MANUFACTURE, USE, OFFER FOR SALE, SALE OR IMPORTATION
OF SUCH LICENSED PRODUCT OR THE PRACTICE OF SUCH TECHNOLOGY, PROCESS OR METHOD
WOULD INFRINGE SUCH VALID CLAIM OF THE LICENSED PATENT RIGHTS OR JOINT PATENT
RIGHTS (OR, IN THE CASE OF A VALID CLAIM OF THE LICENSED PATENT RIGHTS OR JOINT
PATENT RIGHTS THAT HAS NOT YET ISSUED, WOULD INFRINGE SUCH VALID CLAIM IF IT
WERE TO ISSUE).
1.125
"SECOND CO-COMMERCIALIZATION OPTION PERIOD" MEANS, WITH RESPECT TO
EACH LICENSED PRODUCT, THE PERIOD COMMENCING ON THE DATE THAT THE NDA FILING
NOTICE IS RECEIVED BY ARQULE AND CONTINUING FOR A PERIOD OF * (*) DAYS
THEREAFTER.
1.126
"SHARED DEVELOPMENT COSTS" MEANS, WITH RESPECT TO A PARTY, * PERCENT
(*%) OF THE AGGREGATE AMOUNT OF THE EXTERNAL DEVELOPMENT COSTS INCURRED BY SUCH
PARTY IN THE CONDUCT OF DEVELOPMENT ACTIVITIES.
1.127
"SNDA" MEANS A SUPPLEMENTAL NEW DRUG APPLICATION, AS DEFINED IN THE
FDCA AND APPLICABLE REGULATIONS PROMULGATED THEREUNDER.
1.128
"SUBLICENSEE" MEANS ANY THIRD PARTY TO WHICH A PARTY GRANTS A
SUBLICENSE IN ACCORDANCE WITH SECTION 6.2.2.
1.129
"TARGETED INDICATIONS" MEANS (A) ALL HUMAN CANCER INDICATIONS AND
(B) ANY APPROVED NON-CANCER INDICATIONS.
1.130
"TECHNOLOGY" MEANS, COLLECTIVELY, INVENTIONS, DISCOVERIES,
IMPROVEMENTS, TRADE SECRETS AND PROPRIETARY METHODS, WHETHER OR NOT PATENTABLE,
INCLUDING WITHOUT LIMITATION: (A) METHODS OF MANUFACTURE OR USE OF, AND