AGREEMENT" SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.2 HEREOF.
1.6
"COMPETING PRODUCT" SHALL MEAN ANY PHARMACEUTICAL PRODUCT IN
FINISHED DOSAGE FORM THAT CONTAINS [***] (I) THAT FALLS WITHIN ONE OR MORE OF
THE CLAIMS OF THE PUBLISHED PATENT APPLICATIONS [***] IN THE TERRITORY AS OF THE
EFFECTIVE DATE, OR (II) THAT FALLS WITHIN ONE OR MORE OF THE CLAIMS OF A PATENT
APPLICATION FILED [***] HAVING THE PRIORITY DATE OF [***].
1.7
"COMPLETION" WITH RESPECT TO A PHASE II CLINICAL TRIAL OR A PHASE
III CLINICAL TRIAL SHALL MEAN THE FINALIZATION OF THE FINAL REPORT WITH RESPECT
TO SUCH CLINICAL TRIAL.
1.8
"COMPOUND" SHALL MEAN EITHER OF VX-950 OR VX-905.
1.9
"CONFIDENTIAL INFORMATION" SHALL HAVE THE MEANING SET FORTH IN
SECTION 9.1.
1.10
"CONTROLLED" SHALL MEAN THE LEGAL AUTHORITY OR RIGHT OF A PARTY TO
GRANT A LICENSE OR SUBLICENSE OF INTELLECTUAL PROPERTY RIGHTS TO ANOTHER PARTY,
OR TO OTHERWISE DISCLOSE PROPRIETARY OR TRADE SECRET INFORMATION TO SUCH OTHER
PARTY, WITHOUT BREACHING THE TERMS OF ANY AGREEMENT WITH A THIRD PARTY,
MISAPPROPRIATING THE PROPRIETARY OR TRADE SECRET INFORMATION OF A THIRD PARTY OR
INCURRING ANY FINANCIAL OBLIGATION OR POTENTIAL FINANCIAL OBLIGATION TO A THIRD
PARTY.
1.11
"CORE DEVELOPMENT ACTIVITIES" SHALL MEAN:
[***]
1.12
"CORE DEVELOPMENT PLAN" SHALL HAVE THE MEANING SET FORTH IN SECTION
3.2.3
[***]
Information redacted pursuant to a confidential treatment
request.
An unredacted version of this exhibit has been filed separately with
the Commission.
2
HEREOF.
1.13
"CORE DEVELOPMENT COSTS" SHALL MEAN [***]
1.14
"DEVELOPMENT SUPPLY AGREEMENT" SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.1 HEREOF.
1.15
"DRUG PRODUCT" SHALL MEAN A COMPOUND IN FINISHED DOSAGE FORM THAT
IS PREPARED FROM BULK DRUG SUBSTANCE AND IS READY FOR ADMINISTRATION TO THE
ULTIMATE CONSUMER AS A PHARMACEUTICAL PRODUCT.
1.16
"EFFECTIVE DATE" SHALL MEAN THE EFFECTIVE DATE OF THIS AGREEMENT AS
SET FORTH ON THE FIRST PAGE HEREOF.
1.17
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
1.18
"FIELD OF USE" SHALL MEAN THE TREATMENT OF ANY HUMAN CONDITION,
DISORDER OR DISEASE.
1.19
"FIRST COMMERCIAL SALE" SHALL MEAN THE FIRST SALE OF A DRUG PRODUCT
BY MITSUBISHI OR AN AFFILIATE OR SUBLICENSEE OF MITSUBISHI IN A COUNTRY IN THE
TERRITORY FOLLOWING REGULATORY APPROVAL OF THE DRUG PRODUCT IN THAT COUNTRY, OR
IF NO SUCH REGULATORY APPROVAL OR SIMILAR MARKETING APPROVAL IS REQUIRED, THE
DATE UPON WHICH THE DRUG PRODUCT IS FIRST SOLD IN SUCH COUNTRY BY MITSUBISHI OR
AN AFFILIATE OR SUBLICENSEE OF MITSUBISHI PURSUANT TO A PLAN OF COMMERCIAL
LAUNCH.
1.20
"IND" SHALL MEAN THE INVESTIGATIONAL NEW DRUG APPLICATION RELATING
TO THE DRUG PRODUCT FILED WITH THE FDA PURSUANT TO 21 C.F.R. PART 312, INCLUDING
ANY AMENDMENTS THERETO, AND EQUIVALENT APPLICATIONS WITH SIMILAR REQUIREMENTS IN
COUNTRIES OTHER THAN THE UNITED STATES.
1.21
"INDICATION" SHALL MEAN A GENERALLY ACKNOWLEDGED DISEASE, DISORDER
OR CONDITION, A SIGNIFICANT MANIFESTATION OF A DISEASE, DISORDER OR CONDITION,
OR A SYMPTOM ASSOCIATED WITH A DISEASE, DISORDER OR CONDITION FOR WHICH USE OF A
DRUG PRODUCT IS INDICATED, AS