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.
[***]
Information redacted pursuant to a confidential treatment
request.
An unredacted version of this exhibit has been filed separately with
the Commission.
7
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UNEXPIRED PATENT WHICH HAS NOT LAPSED, BEEN REVOKED OR ABANDONED OR HELD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
"VERTEX LICENSEE" SHALL MEAN ANY PERSON OTHER THAN