USE IN THE FIELD IN SUCH COUNTRY OR REGION.
1.95
"REGULATORY AUTHORITY" MEANS THE FDA IN THE
UNITED STATES, THE EMEA IN THE EU, THE MINISTRY OF HEALTH, LABOR AND WELFARE IN
JAPAN, OR ANY COUNTERPART OF ANY OF THE FOREGOING IN ANY OTHER JURISDICTION, OR
ANY OTHER NATIONAL, SUPRA-NATIONAL, REGIONAL, STATE OR LOCAL REGULATORY AGENCY,
DEPARTMENT, 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.
1.96
"REGULATORY FILINGS" MEANS, COLLECTIVELY: (A) ALL
INDS, ESTABLISHMENT LICENSE APPLICATIONS, DRUG MASTER FILES, 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.
18
§ 355(B)(4)(B)), NDAS AND BLAS 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.
1.97
"RESEARCH COLLABORATION PERIOD" MEANS THE PERIOD
BEGINNING ON THE EFFECTIVE DATE AND ENDING ON THE * ANNIVERSARY THEREOF, AS SUCH
PERIOD MAY BE EXTENDED BY THE MUTUAL WRITTEN AGREEMENT OF THE PARTIES; PROVIDED,
THAT, (A) DS SHALL HAVE THE RIGHT TO EXTEND THE RESEARCH COLLABORATION PERIOD BY
* (*) * (*) * BY PROVIDING WRITTEN NOTICE TO ARQULE NOT LESS THAN * (*) * PRIOR
TO THE EXPIRATION OF THE THEN-APPLICABLE RESEARCH COLLABORATION PERIOD AND
(B) IF THIS AGREEMENT IS TERMINATED PRIOR TO THE END OF THE RESEARCH
COLLABORATION PERIOD, THE EFFECTIVE DATE OF SUCH EARLY TERMINATION SHALL BECOME
THE LAST DAY OF THE RESEARCH COLLABORATION PERIOD.
1.98
"RESEARCH PROGRAM" MEANS THE RESEARCH PROGRAM TO
BE CONDUCTED BY THE PARTIES DURING THE RESEARCH COLLABORATION PERIOD PURSUANT TO
THE ANNUAL RESEARCH PLANS WHICH SHALL INVOLVE THE IDENTIFICATION AND PRECLINICAL
DEVELOPMENT OF COLLABORATION COMPOUNDS THROUGH ALL RESEARCH STAGES.
FOR
PURPOSES OF CLARITY, THE RESEARCH PROGRAM DOES NOT INCLUDE ANY DEVELOPMENT
ACTIVITIES PERFORMED IN THE COURSE OF THE DEVELOPMENT PROGRAM.
1.99
"RESEARCH STAGE" MEANS EACH STAGE OF THE RESEARCH
PROGRAM DESCRIBED MORE FULLY ON SCHEDULE 1 ATTACHED HERETO AND INCORPORATED
HEREIN BY REFERENCE.
FOR PURPOSES OF CLARITY, THE RESEARCH STAGES SHALL CONSIST
OF (A) ASSAY DEVELOPMENT AND HIT GENERATION ; (B) HIT TO LEAD; (C) LEAD
OPTIMIZATION AND (D) PRECLINICAL STUDIES.
1.100
"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 VALID CLAIM
OF THE LICENSED PATENT RIGHTS OR JOINT PATENT RIGHTS IN SUCH COUNTRY THAT COVERS
SUCH LICENSED PRODUCT OR ITS IDENTIFICATION, MANUFACTURE, USE, IMPORT, OFFER FOR
SALE OR SALE OR (B) * (*) YEARS FROM THE DATE OF THE FIRST