the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
44
5.7
PHARMACOVIGILANCE; ADVERSE EVENT REPORTS.
WITHIN [***] DAYS OF
THE EFFECTIVE DATE, THE PARTIES WILL ENTER INTO THE PHARMACOVIGILANCE AGREEMENT,
SETTING FORTH GUIDELINES AND PROCEDURES FOR THE RECEIPT, INVESTIGATION,
RECORDING, REVIEW, COMMUNICATION, REPORTING AND EXCHANGE BETWEEN THE PARTIES OF
ADVERSE EVENT REPORTS (WHICH, FOR PURPOSES OF INFORMATION EXCHANGE BETWEEN THE
PARTIES, SHALL INCLUDE ADVERSE EVENTS, AS WELL AS CLAIMS OF LACK OF EFFICACY),
TECHNICAL COMPLAINTS AND ANY OTHER INFORMATION CONCERNING THE SAFETY OF THE
PRODUCT.
NOTWITHSTANDING THE FOREGOING, IT IS CONTEMPLATED THAT SYNTA SHALL
MAINTAIN A UNIFIED WORLDWIDE ADVERSE EVENT DATABASE FOR THE PRODUCT, AND BE
PRIMARILY RESPONSIBLE FOR REPORTING ADVERSE EVENTS TO THE APPLICABLE REGULATORY
AUTHORITIES UNTIL SUCH TIME AS THE REGULATORY FILINGS, DRUG APPROVAL
APPLICATIONS, REGULATORY APPROVALS AND COMMERCIALIZATION REGULATORY APPROVALS
FOR THE U.S. TERRITORY ARE TRANSFERRED TO GSK PURSUANT TO THE REGULATORY FILINGS
TRANSFER PLAN AND THIS AGREEMENT, AND THEREAFTER, GSK SHALL MAINTAIN THE UNIFIED
WORLDWIDE ADVERSE EVENT DATABASE FOR THE PRODUCT, UNLESS OTHERWISE AGREED BY THE
PARTIES.
COSTS ASSOCIATED WITH DESIGNING, MAINTAINING AND INSTALLING THE SYSTEM
SUPPORTING SUCH DATABASE SHALL NOT BE INCLUDED IN DEVELOPMENT COSTS AND SHALL BE
THE RESPONSIBILITY OF SYNTA.
5.8
LABELING.
ALL PRODUCT LABELS AND PROMOTIONAL MATERIALS FOR
CO-COMMERCIALIZED PRODUCTS SHALL INCLUDE, IN EQUAL PROMINENCE, THE NAMES AND
LOGOS OF BOTH SYNTA AND GSK TO THE EXTENT FEASIBLE UNDER APPLICABLE LAWS.
GSK
AGREES THAT, TO THE EXTENT FEASIBLE UNDER APPLICABLE LAWS AND TO THE EXTENT SUCH
STATEMENTS ARE ACCURATE AT THE TIME OF THE SALE OF THE PRODUCT, PRODUCT LABELS
FOR CO-COMMERCIALIZED PRODUCT WILL IDENTIFY SYNTA AS CONDUCTING PROMOTIONAL
EFFORTS FOR SUCH CO-COMMERCIALIZED PRODUCT WITH GSK.
THE JCC SHALL HAVE THE
RESPONSIBILITY OF DECIDING WHETHER CHANGES IN THE PARTICULAR APPEARANCE IN
LABELING OF PACKAGING AND CONTAINERS OF CO-COMMERCIALIZED PRODUCTS OR IN THE
PRODUCT INFORMATION IS REQUIRED.
6.
PAYMENTS
6.1
UP-FRONT FEE.
AS PARTIAL CONSIDERATION FOR THE LICENSES GRANTED
TO GSK BY SYNTA UNDER THE TERMS OF THIS AGREEMENT, GSK WILL PAY TO SYNTA A
NON-REFUNDABLE, NON-CREDITABLE UP-FRONT FEE EQUAL TO EIGHTY MILLION DOLLARS (US
$80,000,000) WITHIN [***] BUSINESS DAYS OF THE EFFECTIVE DATE, AND UPON RECEIPT
OF AN INVOICE FROM SYNTA, PAYABLE BY WIRE TRANSFER OF IMMEDIATELY AVAILABLE
FUNDS IN ACCORDANCE WITH WIRE TRANSFER INSTRUCTIONS OF SYNTA THAT SHALL BE
PROVIDED IN WRITING TO GSK PRIOR TO THE EFFECTIVE DATE.
6.2
EQUITY PURCHASES.
6.2.1
INITIAL EQUITY PURCHASE OBLIGATION.
IN PARTIAL CONSIDERATION OF
THE RIGHTS GRANTED BY SYNTA TO GSK HEREUNDER, ON THE INITIAL EQUITY PURCHASE
OBLIGATION DATE, GSK SHALL HAVE THE [***] (THE "INITIAL EQUITY PURCHASE
OBLIGATION") TO PURCHASE FROM SYNTA, PROVIDED, THAT SYNTA MAY OPT TO [***] TO
GSK IN ITS [***], A NUMBER OF SHARES OF COMMON STOCK, $.0001 PAR VALUE PER
SHARE, OF SYNTA ("SYNTA COMMON STOCK"), AS SHALL EQUAL THE APPLICABLE SHARE
PURCHASE NUMBER FOR THE AGGREGATE EQUITY PURCHASE PRICE, PURSUANT TO THE TERMS
AND SUBJECT TO THE CONDITIONS SET FORTH IN A STOCK PURCHASE AGREEMENT