INVENTOR'S CERTIFICATES AND
UTILITY MODELS) IN ANY COUNTRY OR JURISDICTION WITHIN THE TERRITORY, INCLUDING
ALL PROVISIONALS, SUBSTITUTIONS, CONTINUATIONS, CONTINUATIONS-IN-PART,
DIVISIONALS, SUPPLEMENTARY PROTECTION CERTIFICATES, RENEWALS, ALL LETTERS PATENT
GRANTED THEREON, AND ALL REISSUES, REEXAMINATIONS, EXTENSIONS, CONFIRMATIONS,
REVALIDATIONS, REGISTRATIONS, PATENTS OF ADDITION THEREOF, PCTS AND FOREIGN
COUNTERPARTS.
1.47
"PERSON" MEANS AN INDIVIDUAL, SOLE PROPRIETORSHIP, PARTNERSHIP,
LIMITED PARTNERSHIP, LIMITED LIABILITY PARTNERSHIP, CORPORATION, LIMITED
LIABILITY COMPANY, BUSINESS TRUST, JOINT STOCK COMPANY, TRUST, INCORPORATED
ASSOCIATION, JOINT VENTURE OR SIMILAR ENTITY OR ORGANIZATION, INCLUDING A
GOVERNMENT OR POLITICAL SUBDIVISION, DEPARTMENT OR AGENCY OF A GOVERNMENT.
A-7
1.48
"PHASE I STUDY" MEANS A CLINICAL STUDY IN SUBJECTS TO EVALUATE THE
PHARMACOKINETIC AND PHARMACODYNAMIC PROPERTIES, MAXIMUM TOLERATED DOSE, DOSING
INTERVAL, AND ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION (ADME) OF A
LICENSED PRODUCT.
1.49
"PHASE IIB STUDY"MEANS A CONTROLLED DOSE RANGING CLINICAL TRIAL TO
EVALUATE FURTHER THE EFFICACY AND SAFETY OF A LICENSED PRODUCT IN THE TARGETED
PATIENT POPULATION AND TO DEFINE THE OPTIMAL DOSING REGIMEN.
1.50
"PHASE III STUDY" MEANS, AS TO A PARTICULAR LICENSED PRODUCT FOR A
PARTICULAR INDICATION, A CONTROLLED AND LAWFUL STUDY IN HUMANS OF THE SAFETY AND
EFFICACY OF SUCH PRODUCT FOR SUCH INDICATION, WHICH IS PROSPECTIVELY DESIGNED TO
DEMONSTRATE STATISTICALLY WHETHER SUCH LICENSED PRODUCT IS SAFE AND EFFECTIVE
FOR USE IN SUCH INDICATION IN A MANNER SUFFICIENT TO FILE A DRUG APPROVAL
APPLICATION TO OBTAIN REGULATORY APPROVAL TO MARKET AND SELL THAT LICENSED
PRODUCT FOR THE INDICATION UNDER INVESTIGATION IN SUCH STUDY.
1.51
"PRECLINICAL MATERIALS" MEANS ANY SUPPLIES OF MAY COMPOUND OR
LICENSED PRODUCT MANUFACTURED BY IMMUNOGEN IN ACCORDANCE WITH APPLICABLE LAWS
AND ALL APPLICABLE SPECIFICATIONS FOR USE IN PRECLINICAL TESTING.
1.52
"REGULATORY APPROVAL" MEANS, WITH RESPECT TO ANY COUNTRY OR REGION IN
THE TERRITORY, ANY APPROVAL, PRODUCT AND ESTABLISHMENT LICENSE, REGISTRATION OR
AUTHORIZATION OF ANY REGULATORY AUTHORITY REQUIRED FOR THE MANUFACTURE, USE,
STORAGE, IMPORTATION, EXPORTATION, TRANSPORT OR SALE OF A LICENSED PRODUCT FOR
USE IN THE FIELD IN SUCH COUNTRY OR REGION.
1.53
"REGULATORY AUTHORITY" MEANS THE FDA OR ANY COUNTERPART OF THE FDA
OUTSIDE THE UNITED STATES, OR 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.
1.54
"REGULATORY FILINGS" MEANS, COLLECTIVELY: (A) ALL INDS, NDAS,
ESTABLISHMENT LICENSE APPLICATIONS, DRUG MASTER FILES, APPLICATIONS FOR
DESIGNATION AS AN "ORPHAN PRODUCT" 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)) OR ALL OTHER SIMILAR FILINGS (INCLUDING MAAS AND, COUNTERPARTS
OF ANY OF THE FOREGOING IN ANY COUNTRY OR REGION IN THE TERRITORY) AS MAY BE
REQUIRED BY ANY REGULATORY AUTHORITY FOR THE DEVELOPMENT OR COMMERCIALIZATION OF
A LICENSED PRODUCT 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