TO INFLUENCE PHYSICIAN
PRESCRIBING PREFERENCES OF SUCH CO-COMMERCIALIZED PRODUCT FOR ITS APPROVED USES
WITHIN THE CO-COMMERCIALIZATION TERRITORY.
1.103
"PROOF OF CONCEPT CLINICAL TRIAL" MEANS A PHASE 2B CLINICAL TRIAL
THAT IS DESIGNED TO DETERMINE WHETHER A COLLABORATION COMPOUND SATISFIES THE
PROOF OF CONCEPT CRITERIA FOR A SPECIFIC INDICATION.
A PROOF OF CONCEPT
CLINICAL TRIAL SHALL BE DESIGNED TO BE IN KEEPING WITH INDUSTRY PRACTICES IN
TERMS OF NUMBER OF PARTICIPANTS, NUMBER OF SITES, DURATION OF THE STUDY, NUMBER
OF ARMS IN THE STUDY AND TOTAL ANTICIPATED COST OF THE STUDY.
1.104
"PROOF OF CONCEPT CRITERIA" MEANS THE CRITERIA THAT WILL BE
DETERMINED BY THE JDC AND USED TO DETERMINE IF A COLLABORATION COMPOUND
DEMONSTRATES A [***] IN TREATING A SPECIFIC INDICATION IN A PROOF OF CONCEPT
CLINICAL TRIAL.
PROOF OF CONCEPT CRITERIA MAY ALSO INCLUDE CERTAIN NON-CLINICAL
STUDIES AND ASSESSMENTS AS THE JDC MAY DETERMINE ARE APPROPRIATE.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
15
1.105
"REGULATORY APPROVAL" MEANS, WITH RESPECT TO ANY COUNTRY OR REGION
IN THE TERRITORY, ANY APPROVAL, PRODUCT AND ESTABLISHMENT LICENSE, REGISTRATION
OR AUTHORIZATION OF ANY REGULATORY AUTHORITY REQUIRED FOR THE MANUFACTURE, USE,
STORAGE, IMPORTATION, EXPORTATION, TRANSPORT OR DISTRIBUTION OF A PRODUCT IN
SUCH COUNTRY OR REGION, EXCLUDING PRICE AND REIMBURSEMENT APPROVAL.
1.106
"REGULATORY AUTHORITY" MEANS ANY NATIONAL, SUPRA-NATIONAL, REGIONAL,
STATE OR LOCAL REGULATORY AGENCY, DEPARTMENT, BUREAU, COMMISSION, COUNCIL OR
OTHER GOVERNMENTAL ENTITY WITH AUTHORITY OVER THE DISTRIBUTION, IMPORTATION,
EXPORTATION, MANUFACTURE, PRODUCTION, USE, STORAGE, TRANSPORT, CLINICAL TESTING,
PRICING OR SALE OF A PRODUCT, INCLUDING WITHOUT LIMITATION, THE FDA, EMEA,
EUROPEAN COMMISSION AND THE MHLW.
1.107
"REGULATORY FILINGS" MEANS, COLLECTIVELY: (A) ALL INDS, NDAS, MAAS,
JNDAS, BLAS, ESTABLISHMENT LICENSE APPLICATIONS, DMFS, APPLICATIONS FOR
DESIGNATION AS AN "ORPHAN PRODUCT(S)" UNDER THE ORPHAN DRUG ACT, FOR "FAST
TRACK" STATUS UNDER SECTION 506 OF THE FDCA (21 U.S.C. § 356) OR FOR A SPECIAL
PROTOCOL ASSESSMENT UNDER SECTION 505(B)(4)(B) AND (C) OF THE FDCA (21 U.S.C. §
355(B)(4)(B)) AND ALL OTHER SIMILAR FILINGS (INCLUDING, WITHOUT LIMITATION,
COUNTERPARTS OF ANY OF THE FOREGOING OR SCIENTIFIC ADVICE IN ANY COUNTRY OR
REGION IN THE TERRITORY); AND (B) ALL SUPPLEMENTS AND AMENDMENTS TO ANY OF THE
FOREGOING.
1.108
"REQUIRED PHASE 4 CLINICAL TRIAL" MEANS A POST-REGISTRATIONAL
CLINICAL TRIAL OF PRODUCTS IN HUMAN PATIENTS THAT IS REQUIRED AS A CONDITION TO,
OR FOR THE MAINTENANCE OF, A COMMERCIALIZATION REGULATORY APPROVAL FOR THE USE
OF PRODUCT IN A SPECIFIED INDICATION IN A COUNTRY.
1.109
"ROW TERRITORY" MEANS ALL OF THE COUNTRIES AND TERRITORIES OF THE
WORLD OTHER THAN THE U.S. TERRITORY.
1.110
"ROYALTY-BEARING PRODUCT" MEANS ANY PRODUCT THAT IS SOLD BY GSK IN
THE ROYALTY-BEARING TERRITORY.
1.111
"ROYALTY-BEARING TERRITORY" MEANS (A) THE ROW TERRITORY AND (B) THE
U.S. TERRITORY IN THE EVENT THAT SYNTA EXERCISES THE COMMERCIALIZATION OPT-OUT
RIGHT WITH RESPECT TO A PRODUCT OR OTHERWISE LOSES THE RIGHT TO CONDUCT SYNTA
CO-COMMERCIALIZATION ACTIVITIES WITH RESPECT