TO BE USED TOGETHER WITH ONE OR MORE OTHER ANTI-HEPATITIS
C VIRUS (HCV) AGENTS, SUCH AS INTERFERON PRODUCTS.
1.5
"COMMERCIAL SUPPLY 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
2
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this
exhibit has been filed separately with the Commission.
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