\ 4l -D1- SO q- f3 February 15 2018 US Securities & Exchange Commission RECEIVED Office of FOIA and Privacy Act Operations 100 F Street, NE Mail Stop 5100 FEB 15 2018 Washington, DC 20549-5100 Office of Dear FOIA Office: Under the Freedom of Information Act (FOIA), please send a copy of the following: A copy of: Exhibit 10.1 to the form 10-Q filed by SYNTA PHARMACEUTICALS CORP on May 5, 2011 In the event confidential treatment has not expired provide the specific date for which confidential treatment is still in effect. I do not need a copy of the order. We authorize up to $61.00 in processing fees. Thank You, Paul D'Souza Editor - Deals Clarivate Analytics Friars House, 160 Blackfriars Road London, UK SEl 8EZ Phone:+44-2074334789 [email protected]13
Transcript
\ 4l -D1- SO q- f3 February 15 2018
US Securities & Exchange Commission RECEIVED Office of FOIA and Privacy Act Operations
100 F Street, NE Mail Stop 5100 FEB 15 2018 Washington, DC 20549-5100
Office of
Dear FOIA Office:
Under the Freedom of Information Act (FOIA), please send a copy of the following:
A copy of: Exhibit 10.1 to the form 10-Q filed by SYNTA PHARMACEUTICALS CORP on May 5, 2011
In the event confidential treatment has not expired provide the specific date for which
confidential treatment is still in effect. I do not need a copy of the order. We authorize up to
$61.00 in processing fees. Thank You,
Paul D'Souza
Editor - Deals
Clarivate Analytics Friars House, 160 Blackfriars Road London, UK SEl 8EZ
Mr. Paul D’Souza Clarivate Analytics160 Blackfriars Road London, UK SE18EZ
RE: Freedom of Information Act (FOIA), 5 U.S.C. § 552Request No. 18-02509-E
Dear Mr. D’Souza:
This letter is in response to your request, dated andreceived in this office on February 15, 2018, for Exhibit 10.1to the Form 10-Q filed by Synta Pharmaceuticals Corp. on May 5,2011.
The search for responsive records has resulted in theretrieval of eight pages of records that may be responsive toyour request. They are being provided to you with this letter.
If you have any questions, please contact me [email protected] or (202) 551-8312. You may also contact me at [email protected] or (202) 551-7900. You also have the right toseek assistance from Jeffery Ovall as a FOIA Public Liaison orcontact the Office of Government Information Services (OGIS) fordispute resolution services. OGIS can be reached at 1-877-684-6448 or Archives.gov or via e-mail at [email protected].
SECOND AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT
This Second Amendment (the "Second Amendment") executed on February 3,2011 is made and effective as ofthe first (1st
) day ofJanuary 2011 (the "Second Amendment Effective Date") and amends the Collaboration and License Agreement dated as ofDecember 23, 2008 (as previously amended on February 5, 2010 (the "First Amendment"}, between SYNTA PHARMACEUTICALS CORP., a Delaware corporation having a principal office at 45 Hartwell Avenue, Lexington, MA 02421, U.S.A. ("SYNTA"), and F. HOFFMANN-LA ROCHE LTD, a Swiss corporation having a principal office located at Grenzacherstrasse 124, CH-4070 Basel, Switzerland ("ROCHE BASEL") and HOFFMANN-LA ROCHE INC., a New Jersey corporation having a principal office at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A. ("ROCHE NUTLEY"; ROCHE BASEL and ROCHE NUTLEY together referred to as "ROCHE") (the "Agreement"). Capitalized terms shall have the meaning set forth in the Agreement.
INTRODUCTION
WHEREAS, SYNTA and ROCHE have reached agreement with respect to ROCHE having the right to continue Research related to Licensed Compounds and Potential Licensed Compounds until June 30, 2011;
WHEREAS, the deadline for the JSC approving Licensed Compounds for advancement into Development shall remain June 30, 2011, pursuant to Section 2.3.4(a) of the Agreement, thus the full scope ofLicensed Compounds advancing into Development will be known by the end of the day June 30, 2011, and any use of these approved Licensed Compounds will be permitted under the Development and Commercialization License under Section 6.2 ofthe Agreement;
WHEREAS, SYNT A and ROCHE have reached agreement with respect to ROCHE having the right to conduct all pre-IND Development;
WHEREAS, SYNT A and ROCHE have reached agreement with respect to amending the definition ofLicensed Compound to exclude constitutional and geometric isomers;
WHEREAS, SYNTA and ROCHE have reached agreement with respect to ROCHE returning certain Licensed Compounds to SYNT A;
WHEREAS, the Parties wish to amend the Agreement, as described herein.
NOW THEREFORE, for and in consideration of the mutual covenants contained in this Second Amendment, the Parties agree:
1. Research License. SYNTA hereby grants to ROCHE for the period beginning on the Second Amendment Effective Date and continuing through June 30, 2011, an exclusive, worldwide, paid-up right and license, without the right to grant sub licenses ( except in
l
EXECUTION COPYCONFIDENTIAL accordance with Section 6.4), under the SYNTA Intellectual Property to enable ROCHE to perform Research relating to Licensed Compounds and Potential Licensed Compounds.
2. Pre-IND Development. Notwithstanding anything to the contrary in the Agreement, Roche shall have the right to perform all pre-IND Development on Licensed Compounds.
3. Definitions. Unless otherwise defined or amended by the terms of this Second Amendment, all initial capitalized defined terms used have the meanings as defined in the Agreement. Section 1.42 of the Agreement is revised in its entirety to read as follows:
" 1.42. "Licensed Compound" means a Collaboration Compound, one form of which (a) is evidenced to directly or indirectly inhibit CRAC Channel activity by fifty percent (50%) or more at a concentration (CRAC IC50) of :S l µM, as measured by patch-clamp electrophysiology, and (b) either is (i) evidenced to be at least 30-fo ld more potent in modulating the activity ofCRAC Channels versus all tested ion channels that are not CRAC Channels, as tested against at least eight (8) ion channels that are not CRAC Channels, prior to or during the Research Term or prior to June 30, 2011 in the case ofPotential Licensed Compounds, or (ii) has completed all Stage 2a Research activities and has been mutually agreed by the Parties to be ready for initiation of Stage 2b Research activities as specified in Exhibit A of the First Amendment. For further clarity, if ROCHE terminates a Licensed Compound in one or more regions pursuant to Section 12.3, such Licensed Compound shall continue to be deemed a Licensed Compound except as provided in A11icle XII unless and until ROCHE terminates such Licensed Compound in all Regions pursuant to Section 12.3 (whether ROCHE so terminates such Licensed Compound in all Regions simultaneously or terminates such Licensed Compound in all Regions over time). For the sake of clarity, any Licensed Compound shall also include all pro-drugs, metabolites, regioisomers, stereoisomers including enantiomers and diastereoisomers, salt forms, hydrates, solvates and polymorphs of such Licensed Compound, all of which shall constitute a single Licensed Compound. As of the Amendment Effective Date, the compounds identified in Appendix A are deemed to be Licensed Compounds and the compounds identified in Appendix B as Potential Licensed Compounds shall be deemed to be Licensed Compounds if such compounds have met the criteria set forth above on or before June 30, 2011."
New Section 1.58 bis ofthe Agreement is added to the Agreement and reads as follows:
" 1.58 bis. "Potential Licensed Compound" means a Collaboration Compound identified in Appendix B."
4. Return ofCompounds. The Licensed Compounds identified in Appendix C shall be returned to Synta and treated as if Roche had terminated the Agreement with respect to such Licensed Compounds. For clarity, these returned Licensed Compounds will be subject to royalty obligations under Section 12.6.8 of the Agreement.
2
EXECUTION COPYCONFIDENTIAL 5. Effect on Agreement. Except as amended by this Second Amendment, the Agreement shall remain in full force and effect. After the date ofthis Second Amendment, every reference in the Agreement to the "Agreement" shall mean the Agreement as amended by the Amendment, the First Amendment, and this Second Amendment.
{Remainder ofpage intentionally left blank.)
3
CONFIDENTIAL EXECUTION COPY
IN WI1NESS WHEREOF, the Parties have entered into this Amendment as of the Amendment Execution Date.
SYNTA PHARMACEUTICALS CORP.
By: Isl Safi Bahcall
Name: Safi Bahcall
Title: President & CEO
F. HOFFMANN-LA ROCHE LTD
By: Isl Christophe Carissimo By: Isl Stefan Arnold
Name: Christophe Carissimo Name: Stefan Arnold
Title: Global Licensing Director Title: Head Legal Pharma
