"PHASE III CLINICAL TRIAL" SHALL MEAN A HUMAN
CLINICAL TRIAL CONDUCTED FOR INCLUSION IN (I) THAT PORTION OF THE FDA SUBMISSION
AND APPROVAL PROCESS WHICH PROVIDES FOR THE CONTINUED TRIALS OF A COMPOUND ON
SUFFICIENT NUMBERS OF PATIENTS TO GENERATE SAFETY AND EFFICACY DATA TO SUPPORT
REGULATORY APPROVAL IN THE PROPOSED THERAPEUTIC INDICATION, AS MORE FULLY
DEFINED IN 21 C.F.R. § 312.21(C), AND (II) EQUIVALENT SUBMISSIONS WITH SIMILAR
REQUIREMENTS IN COUNTRIES OTHER THAN THE UNITED STATES.
1.46
"REGULATORY APPROVAL" SHALL MEAN, WITH RESPECT
TO ANY COUNTRY, ALL AUTHORIZATIONS BY A REGULATORY AUTHORITY OR OTHER
APPROPRIATE GOVERNMENTAL ENTITY OR ENTITIES NECESSARY FOR COMMERCIAL MARKETING
AND SALE OF A DRUG PRODUCT IN THAT COUNTRY INCLUDING, WHERE APPLICABLE, APPROVAL
OF LABELING, PRICE, REIMBURSEMENT AND MANUFACTURING.
1.47
"REGULATORY AUTHORITY" SHALL MEAN (I) THE FDA
OR (II) ANY REGULATORY BODY WITH SIMILAR REGULATORY AUTHORITY IN ANY OTHER
JURISDICTION ANYWHERE IN THE WORLD.
1.48
"START" SHALL MEAN THE FIRST DOSING OF THE
FIRST PATIENT WITH RESPECT TO A PHASE II CLINICAL TRIAL OR PHASE III CLINICAL
TRIAL, OR THE STARTING DATE SET FORTH IN THE FINAL PROTOCOL FOR THE APPLICABLE
STUDY WITH RESPECT TO NON-CLINICAL STUDIES.
1.49
"TERRITORY" SHALL MEAN ALL COUNTRIES IDENTIFIED
ON SCHEDULE 1.49 HERETO.
1.50
"THIRD PARTY" SHALL MEAN ANY PERSON THAT IS NOT
A PARTY OR AN AFFILIATE OF ANY PARTY.
7
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this
exhibit has been filed separately with the Commission.
1.51
"VALID PATENT CLAIM" SHALL MEAN EITHER (I) A
CLAIM OF AN ISSUED AND UNEXPIRED PATENT WHICH HAS NOT LAPSED, BEEN REVOKED OR
ABANDONED OR HELD PERMANENTLY UNENFORCEABLE OR INVALID BY A DECISION OF A COURT
OR OTHER GOVERNMENTAL AGENCY OF COMPETENT JURISDICTION, UNAPPEALABLE OR
UNAPPEALED WITHIN THE TIME ALLOWED FOR APPEAL, AND WHICH HAS NOT BEEN
DISCLAIMED, DENIED OR ADMITTED TO BE INVALID OR UNENFORCEABLE THROUGH REISSUE,
REEXAMINATION, DISCLAIMER OR OTHERWISE, OR (II) A CLAIM OF A PENDING PATENT
APPLICATION WHICH CLAIM WAS FILED IN GOOD FAITH AND HAS NOT BEEN ABANDONED OR
FINALLY DISALLOWED WITHOUT THE POSSIBILITY OF APPEAL OR REFILLING OF SAID
APPLICATION.
1.52
"VERTEX DEVELOPMENT ACTIVITIES" SHALL MEAN ALL
NON-CLINICAL AND CLINICAL ACTIVITIES PERFORMED BY OR ON BEHALF OF VERTEX OR A
VERTEX LICENSEE IN THE VERTEX TERRITORY WITH RESPECT TO BULK DRUG SUBSTANCE, A
COMPOUND, AND/OR DRUG PRODUCT, INCLUDING NON-CLINICAL STUDIES, CLINICAL TRIALS,
FORMULATION RESEARCH, FORMULATION DEVELOPMENT, PROCESS RESEARCH, PROCESS
DEVELOPMENT, MANUFACTURING SCALE-UP, ANALYTICAL METHOD DEVELOPMENT AND
VALIDATION, AND REGULATORY ACTIVITIES, IN ORDER TO OBTAIN REGULATORY APPROVAL
FROM A REGULATORY AUTHORITY FOR MARKETING THE CORRESPONDING DRUG PRODUCT IN THE
VERTEX TERRITORY FOR THE INDICATIONS SELECTED.
FOR THE AVOIDANCE OF DOUBT, THE
CORE DEVELOPMENT ACTIVITIES SET FORTH IN SECTION 1.11 SHALL BE INCLUDED IN THE
VERTEX DEVELOPMENT ACTIVITIES.
1.53
"VERTEX DEVELOPMENT PLAN" SHALL HAVE THE
MEANING SET FORTH IN SECTION 3.2.2 HEREOF.
1.54
"VERTEX KNOW-HOW" SHALL MEAN ALL KNOW-HOW
CONTROLLED BY VERTEX OR ANY OF ITS AFFILIATES, INCLUDING ANY SUCH KNOW-HOW
INVENTED, DISCOVERED OR DEVELOPED IN THE CONDUCT OF THE VERTEX DEVELOPMENT
ACTIVITIES.
1.55