ANY
COUNTRY IN THE WORLD, INCLUDING ANY CONTINUATIONS, CONTINUATIONS-IN-PART,
DIVISIONS, PROVISIONALS OR ANY SUBSTITUTE APPLICATIONS, ANY PATENT ISSUED WITH
RESPECT TO ANY SUCH PATENT APPLICATIONS, ANY REISSUE, REEXAMINATION, RENEWAL,
TERM ADJUSTMENT, RESTORATION, OR EXTENSION (INCLUDING ANY SUPPLEMENTAL
PROTECTION CERTIFICATE) OF ANY SUCH PATENT, AND ANY CONFIRMATION PATENT OR
REGISTRATION PATENT OR PATENT OF ADDITION BASED ON ANY SUCH PATENT, AND ALL
NON-UNITED STATES COUNTERPARTS OF ANY OF THE FOREGOING.
1.60
"PATENT TERM EXTENSION" MEANS ANY PATENT TERM EXTENSION, ADJUSTMENT
OR RESTORATION OR SUPPLEMENTAL PROTECTION CERTIFICATES.
1.61
"PERSON" MEANS ANY NATURAL PERSON, GENERAL OR LIMITED PARTNERSHIP,
CORPORATION, LIMITED LIABILITY COMPANY, LIMITED LIABILITY PARTNERSHIP, FIRM,
ASSOCIATION OR ORGANIZATION OR OTHER LEGAL ENTITY.
9
1.62
"PHASE I STUDY" MEANS A STUDY IN HUMANS WHICH PROVIDES FOR THE
FIRST INTRODUCTION INTO HUMANS OF A PRODUCT, CONDUCTED IN HEALTHY VOLUNTEERS OR
PATIENTS TO OBTAIN INFORMATION ON PRODUCT SAFETY, TOLERABILITY, PHARMACOLOGICAL
ACTIVITY OR PHARMACOKINETICS, AS MORE FULLY DEFINED IN 21 C.F.R. § 312.21(A) (OR
THE NON-UNITED STATES EQUIVALENT THEREOF).
1.63
"PHASE II STUDY" MEANS A STUDY IN HUMANS OF THE SAFETY, DOSE
RANGING AND EFFICACY OF A PRODUCT, WHICH IS PROSPECTIVELY DESIGNED TO GENERATE
SUFFICIENT DATA (IF SUCCESSFUL) TO COMMENCE PIVOTAL CLINICAL TRIALS, AS FURTHER
DEFINED IN 21 C.F.R. § 312.21(B) (OR THE NON-UNITED STATES EQUIVALENT THEREOF).
1.64
"PHASE IIB STUDY" MEANS A WELL-CONTROLLED, DOSE RANGING,
MULTICENTER PHASE II STUDY IN PATIENTS WITH THE DISEASE OR CONDITION UNDER STUDY
WHICH IS CONDUCTED AFTER A PROOF OF CONCEPT STUDY AND THAT IS ADEQUATELY POWERED
TO FURTHER EVALUATE EFFICACY AND SAFETY AND DEFINE THE DOSAGE REGIMEN OF A
PRODUCT IN THE TARGET INDICATION AND WHICH IS INTENDED TO BE AMONG THE LAST
CLINICAL TRIALS IN THE PATIENT POPULATION PERFORMED PRIOR TO THE INITIATION OF
PHASE III STUDIES.
A PHASE IIB STUDY COULD INCLUDE SEVERAL HUNDRED PATIENTS BUT
NOT TO THE EXTENT REQUIRED FOR REGISTRATION.
1.65
"PHASE III STUDY" MEANS A CONTROLLED STUDY IN HUMANS OF THE
EFFICACY AND SAFETY OF A PRODUCT, WHICH IS PROSPECTIVELY DESIGNED TO DEMONSTRATE
STATISTICALLY WHETHER SUCH PRODUCT IS EFFECTIVE AND SAFE FOR USE IN A PARTICULAR
INDICATION IN A MANNER SUFFICIENT TO FILE AN NDA TO OBTAIN REGULATORY APPROVAL
TO MARKET THE PRODUCT, AS FURTHER DEFINED IN 21 C.F.R. § 312.21(C) (OR THE
NON-UNITED STATES EQUIVALENT THEREOF).
1.66
"PHASE IV STUDY" MEANS A HUMAN CLINICAL TRIAL WHICH IS CONDUCTED ON
A PRODUCT AFTER REGULATORY APPROVAL OF THE PRODUCT HAS BEEN OBTAINED FROM AN
APPROPRIATE REGULATORY AUTHORITY, AND INCLUDES (A) TRIALS CONDUCTED VOLUNTARILY
FOR ENHANCING MARKETING OR SCIENTIFIC KNOWLEDGE OF AN APPROVED INDICATION OR
(B) TRIALS CONDUCTED AFTER REGULATORY APPROVAL DUE TO REQUEST OR REQUIREMENT OF
A REGULATORY AUTHORITY OR AS A CONDITION OF A PREVIOUSLY GRANTED REGULATORY
APPROVAL.
1.67
"PRIOR CONFIDENTIALITY AGREEMENT" MEANS THE CONFIDENTIALITY
AGREEMENT BETWEEN INCYTE AND LILLY, DATED APRIL 23, 2009.
1.68
"PUBLICATION" MEANS ANY PUBLICATION IN A SCIENTIFIC JOURNAL, ANY
ABSTRACT TO BE PRESENTED TO ANY SCIENTIFIC AUDIENCE, ANY PRESENTATION AT ANY
SCIENTIFIC CONFERENCE, INCLUDING SLIDES AND TEXTS OF ORAL OR OTHER PUBLIC
PRESENTATIONS, ANY OTHER SCIENTIFIC PRESENTATION