a particular country in the Territory, as evidenced by the fact that
the distributor holds (A) sales and distribution rights for the Product in that
country, coupled with (B) pricing authority or government pricing negotiation
authority with respect to wholesalers or sub-distributors in that country.
If Janssen or any of its Related Parties makes any transfer of a Product to a
Third Party as part of a multiproduct transaction, Net Sales of each unit of the
Product transferred will be determined on a country-by-country basis, and will
be equal to [***]
1.78
"NON-INCURRED AMOUNT" SHALL HAVE THE MEANING SET FORTH IN SECTION
3.4.3.
1.79
"NON-PUBLISHING PARTY" SHALL HAVE THE MEANING SET FORTH IN SECTION
11.3.
1.80
[***]
1.81
(A)
"NORTH AMERICA" MEANS THE UNITED STATES, CANADA AND MEXICO, AND
THE TERRITORIES AND POSSESSIONS OF EACH OF THEM.
(B)
"NORTH AMERICA PRODUCT MATERIALS" SHALL HAVE THE MEANING SET FORTH IN
SECTION 5.5(A).
1.82
[***]
1.83
"PACKAGING" MEANS IMPORTATION, QUALITY CONTROL, TESTING, PRIMARY AND
SECONDARY PACKAGING (INCLUDING ALL LABELING), QUALIFIED PERSON RELEASE, STORAGE
AND SHIPPING AND HANDLING.
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this exhibit has been filed separately with the
Commission.
9
1.84
"PACKAGING REGULATORY APPROVAL" MEANS ALL REQUISITE APPROVALS OF
APPLICABLE REGULATORY AUTHORITIES NECESSARY FOR THE PACKAGING OF A PRODUCT.
1.85
"PARTY" MEANS JANSSEN OR VERTEX, AND "PARTIES" MEANS JANSSEN AND
VERTEX.
1.86
"PATENT COSTS" SHALL MEAN ALL REASONABLE COSTS AND EXPENSES INCURRED BY
VERTEX IN PREPARING, FILING, PROSECUTING AND/OR MAINTAINING VERTEX PATENT
RIGHTS, INCLUDING, WITHOUT LIMITATION, OUT-OF-POCKET COSTS AND REASONABLE TIME
SPENT BY VERTEX'S PROFESSIONAL PERSONNEL IN PATENT PREPARATION AND PROSECUTION,
MEASURED AT THE FTE RATE THEN IN EFFECT.
1.87
"PERMITTED SUBLICENSEE" MEANS A SUBLICENSEE OF EITHER PARTY UNDER A
SUBLICENSE PERMITTED UNDER ARTICLE 7 OF THIS AGREEMENT.
1.88
"PERSON" MEANS ANY INDIVIDUAL, CORPORATION, PARTNERSHIP, LIMITED
LIABILITY COMPANY, ASSOCIATION, JOINT-STOCK COMPANY, TRUST, UNINCORPORATED
ORGANIZATION OR GOVERNMENT OR POLITICAL SUBDIVISION THEREOF.
1.89
"PHASE I CLINICAL TRIAL" MEANS A HUMAN CLINICAL TRIAL FOR A PRODUCT
CANDIDATE OR PRODUCT, IN ANY COUNTRY, THAT WOULD SATISFY THE REQUIREMENTS OF 21
CFR §312.21(A).
1.90
"PHASE II CLINICAL TRIAL" MEANS A HUMAN CLINICAL TRIAL IN ANY COUNTRY
THAT WOULD SATISFY THE REQUIREMENTS OF 21 CFR §312.21(B) AND IS INTENDED TO
EXPLORE ONE OR MORE DOSES, DOSE RESPONSE, AND DURATION OF EFFECT, AND TO
GENERATE INITIAL EVIDENCE OF CLINICAL ACTIVITY AND SAFETY, FOR A PRODUCT
CANDIDATE OR PRODUCT IN THE TARGET PATIENT POPULATION
1.91
"PHASE III CLINICAL TRIAL" MEANS A HUMAN CLINICAL TRIAL IN ANY COUNTRY
THAT WOULD SATISFY THE REQUIREMENTS OF 21 CFR §312.21(C) AND IS INTENDED TO
CONFIRM WITH STATISTICAL SIGNIFICANCE THE EFFICACY AND SAFETY OF THE PRODUCT
CANDIDATE OR PRODUCT, AND IS PERFORMED TO OBTAIN REGULATORY APPROVAL.
1.92
"PHASE IV CLINICAL TRIAL" MEANS A STUDY OR DATA COLLECTION EFFORT FOR
THE PRODUCT THAT IS INITIATED AFTER RECEIPT OF REGULATORY APPROVAL FOR THE
PRODUCT AND IS NOT PRINCIPALLY INTENDED TO SUPPORT OR MAINTAIN A REGULATORY
APPROVAL, MAINTAIN A LABEL OR OTHERWISE OBTAIN A LABELING CHANGE. PHASE IV