AND "RELATED PARTIES" MEANS ALL OF A PARTY'S AFFILIATES AND
PERMITTED LICENSEES.
1.102
"RESULTS" SHALL HAVE THE MEANING SET FORTH IN SECTION 11.3.
1.103
"SALES CALL" MEANS FACE-TO-FACE CONTACT (OR OTHER CONTACT WHICH IN THE
FUTURE IS EMPLOYED TO SUBSTITUTE, IN WHOLE OR IN PART, FOR FACE-TO-FACE CONTACT)
OF A SALES REPRESENTATIVE WITH A HEALTH CARE PROFESSIONAL WITH PRESCRIBING
AUTHORITY DURING WHICH SCIENTIFIC AND/OR MEDICAL INFORMATION IS DISCUSSED ABOUT
THE USE OF A PRODUCT FOR THE TREATMENT OF INDICATIONS FOR WHICH THE PRODUCT HAS
RECEIVED REGULATORY APPROVAL.
1.104
"SALES REPRESENTATIVE" MEANS AN INDIVIDUAL WHO ENGAGES IN OR MANAGES
SALES CALLS AND OTHER PROMOTIONAL EFFORTS WITH RESPECT TO A PRODUCT AND WHO IS
EMPLOYED BY A PARTY OR ITS RELATED PARTIES. FOR PURPOSES OF CLARITY, AN MSL IS
NOT A SALES REPRESENTATIVE.
Information redacted pursuant to a confidential treatment request.
An
unredacted version of this exhibit has been filed separately with the
Commission.
11
1.105
"SPECIFICATIONS" MEANS THE MANUFACTURING SPECIFICATIONS FOR THE PRODUCT
TO BE FILED WITH THE FDA IN THE NDA.
1.106
"SUPPLY AGREEMENT" SHALL HAVE THE MEANING SET FORTH IN SECTION 4.5.
1.107
"TABLET" MEANS THE FORM OF THE PRODUCT OR PRODUCT CANDIDATE THAT IS READY
FOR PACKAGING.
1.108
"TERRITORY" MEANS ALL OF THE COUNTRIES IN THE WORLD, AND THEIR
TERRITORIES AND POSSESSIONS, OUTSIDE OF THE EXCLUDED TERRITORY.
1.109
"TERRITORY PRODUCT MATERIALS" SHALL HAVE THE MEANING SET FORTH IN SECTION
5.5.
1.110
"THIRD PARTY" MEANS AN ENTITY OTHER THAN A PARTY OR ANY OF ITS RELATED
PARTIES.
1.111
"THIRD PARTY PRODUCT" SHALL HAVE THE MEANING SET FORTH IN SECTION 9.4.2.
1.112
"TRADEMARK" SHALL MEAN THE MARK OR MARKS USED TO PROMOTE AND SELL THE
PRODUCT.
1.113
"U.S." AND "UNITED STATES" AND "UNITED STATES OF AMERICA" SHALL MEAN THE
UNITED STATES OF AMERICA AND ITS TERRITORIES AND POSSESSIONS.
1.114
"VALID PATENT CLAIM" MEANS A CLAIM OF AN ISSUED AND UNEXPIRED PATENT
INCLUDED WITHIN THE VERTEX PATENT RIGHTS OR JOINT PATENT RIGHTS THAT (A) CLAIMS
(I) THE COMPOUND, A PRODUCT CANDIDATE OR A PRODUCT AS A COMPOSITION OF MATTER,
OR (II) THE FORMULATION, METHOD OF MANUFACTURE OR USE OF THE COMPOUND, A PRODUCT
CANDIDATE OR A PRODUCT; (B) HAS NOT BEEN REVOKED OR HELD UNENFORCEABLE,
UNPATENTABLE OR INVALID BY A DECISION OF A COURT OR OTHER GOVERNMENTAL AGENCY OF
COMPETENT JURISDICTION (WHICH DECISION IS NOT APPEALABLE OR HAS NOT BEEN
APPEALED WITHIN THE TIME ALLOWED FOR APPEAL); AND (C) HAS NOT BEEN DISCLAIMED,
DENIED OR ADMITTED TO BE INVALID OR UNENFORCEABLE THROUGH REISSUE,
RE-EXAMINATION OR DISCLAIMER OR OTHERWISE.
1.115
"VERTEX KNOW-HOW" MEANS ALL INFORMATION, MATERIALS, DISCOVERIES,
IMPROVEMENTS, PROCESSES, METHODS, PROTOCOLS, FORMULAS, DATA, INVENTIONS AND
TRADE SECRETS, PATENTABLE OR OTHERWISE, THAT DO NOT FALL WITHIN THE VERTEX
PATENT RIGHTS, AND (I) THAT ARE CONTROLLED BY VERTEX OR ANY OF ITS AFFILIATES AS
OF THE EFFECTIVE DATE OR (II) ARE DISCOVERED, CREATED OR DEVELOPED, AND
CONTROLLED, BY VERTEX OR ITS AFFILIATES IN THE COURSE OF VERTEX'S PERFORMANCE OF
THE DEVELOPMENT PROGRAM OR ADDITIONAL DEVELOPMENT ACTIVITIES, OR OF
MANUFACTURING ACTIVITIES, UNDER THIS AGREEMENT