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Bluebird Bio, Inc. (Exhibit 10.14 to 10-Q)

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Bluebird Bio, Inc. (Exhibit 10.14 to 10-Q) foiapa ,-1£ .,_: ,,.....·,~ -•-· ,• From: Mark Edwards <[email protected]> RECle~\f~fQJ Sent: Saturday, June 02, 2018 6:43 PM To: foiapa JUN O4 2018 Subject: FOIA Request Office of FOIA Services I would like to request access to Exhibit 10.14 to the 6/30/15 10-Q, filed by bluebird bio, Inc. on 8/7/2015. Confidential treatment was sought as to certain portions when initially filed with the Commission. In the event that confidential treatment has not expired or has been extended, I further request that you send me the expiration date(s) from the relevant CT order(s) so I will know when I should resubmit my request. I authorize up to $61 in search and retrieval fees. Please send the exhibit(s) by PDF if possible. Sincerely, Mark Mark G Edwards Managing Director Bioscience Advisors 2855 Mitchell Dr., Suite 103 Walnut Creek, CA 94598 [email protected] 925 954-1397 UNITED STATES SECURITIES AND EXCHANGE COMMISSION STATION PLACE 100 F STREET, NE WASHINGTON, DC 20549-2465 Office of FOIA Services June 22, 2018 Mr. Mark G. Edwards Bioscience Advisors 2855 Mitchell Dr., Suite 103 Walnut Creek, CA 94598 RE: Freedom of Information Act (FOIA), 5 U.S.C. § 552 Request No. 18-04561-E Dear Mr. Edwards: This letter is in response to your request, dated June 02, 2018, and received in this office on June 04, 2018, for Exhibit 10.14 to the June 30, 2015, 10-Q, filed by bluebird bio, Inc., on August 7, 2015. The search for responsive records has resulted in the retrieval of 95 pages of records that may be responsive to your request. They are being provided to you with this letter. If you have any questions, please contact me at [email protected] or 202-551-8186. You may also contact me at [email protected] or (202) 551-7900. You also have the right to seek assistance from Lizzette Katilius as a FOIA Public Liaison or contact the Office of Government Information Services (OGIS) for dispute resolution services. OGIS can be reached at 1-877- 684-6448 or Archives.gov or via e-mail at [email protected]. Sincerely, Charlotte Fulton FOIA Research Specialist Enclosure (01 )2 I Execution CopT Amended and Restated Master Collaboration Agreement by and between bluebird bio, Inc., and Celgene Corporation and Celgene European Investment Company LLC June 3, 2015 BLUE-102 Table of Contents Page 1. Definitions.............................................................................................................................. 1 2. Collaboration Program....................................................................................................... 12 3. Governance.......................................................................................................................... 20 4. Third Party Licenses........................................................................................................... 23 5. Option for Licensed Candidates ........................................................................................ 31 6. Payments.............................................................................................................................. 37 7. Patent Prosecution and Maintenance................................................................................ 39 8. Confidentiality..................................................................................................................... 42 9. Warranties; Limitations of Liability; Indemnification .................................................... 46 10. Term and Termination....................................................................................................... 51 11. General Provisions .............................................................................................................. 53 BLUE-103 List of Exhibits Exhibit A Amended and Restated License Agreement Exhibit B Amended and Restated Co-Development, Co-Promote and Profit Share Agreement Exhibit C Pre-Existing In-Licenses Exhibit D Additional Definitions Exhibit E Collaboration Plan Exhibit F Bluebird Collaboration In-Licenses Exhibit G Additional Celgene Option Infonnation Exhibit H Press Release Exhibit I Bluebird Patents Exhibit J Bluebird Agreements BLUE-104 Amended and Restated Master Collaboration Agreement This Amended and Restated Master Collaboration Agreement (this "Agreement"), dated as of June 3, 2015 (the "Amendment Date"), is made by and between bluebird bio, Inc., a Delaware corporation ("Bluebird"), and Celgene Corporation, a Delaware corporation ("Celgene ~"), with respect to all rights and obligations under this Agreement in the United States (subject to Section 11.19), and Celgene European Investment Company LLC ("Celgene Europe"), a Delaware limited liability company, with respect to all rights and obligations under this Agreement outside of the United States (subject to Section 11.19) ("Celgene Europe" and Celgene Corp., together, "Celgene"). Each of Bluebird and Celgene may be referred to herein as a "£ill:!y" or together as the "Parties." WHEREAS, Bluebird has developed and owns or has rights to certain Patents and technology relating to developing innovative gene therapies for genetic disorders; WHEREAS, Celgene is a biopharmaceutical company focused on acquiring, Developing and Commercializing innovative anti-cancer agents; WHEREAS, the Bluebird and Celgene Corp. entered into that certain Master Collaboration Agreement, dated as of March 19, 2013 (the "Original Agreement Date"), pursuant to which such Parties entered into a global strategic collaboration to research, develop and commercialize therapeutic products in the Field (the "Original Agreement"); and WHEREAS, the Parties wish to amend and restate the Original Agreement as set forth herein in order to continue the research and development of Product Candidates, pursuant to the terms set forth therein. NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows: I. Definitions. The following terms and their correlatives will have the following meanings: 1. 1 "Affiliate" of a Person means any other Person which ( directly or indirectly) is controlled by, controls or is under common control with such Person. A Person will be deemed to "control" another Person if it: (a) with respect to such other Person that is a corporation, owns, directly or indirectly, beneficially or legally, at least fifty percent (50%) of the outstanding voting securities or capital stock ( or such lesser percentage which is the maximum allowed to be owned by such Person in a particular jurisdiction) of such other Person, or, with respect to such other Person that is not a corporation, has other comparable ownership interest; or (b) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of such other Person. 1.2 "Baylor" means Baylor College of Medicine. 1.3 . "Baylor Agreements" means (a) the Research and Collaboration Agreement (dated as of March 19, 2013) by and between Baylor and Celgene Corp. ("Baylor Research Agreement"), (b) the Platform Technology License Agreement (dated as of March 19, 2013) by and between Baylor and Celgene ("Baylor Platform License"), and ( c) any Product License Agreement ("Baylor Product License"), in each case ((a)- (c)) as may be amended or restated. BLUE-105 1.4 "Biologics License Application" or "BLA" means, with respect to a country or extra- national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S. 1.5 "Bluebird In-Licensed IP" means all Patents, Materials and Know-How in-licensed by Bluebird or its Affiliates during the Collaboration Program Term pursuant to Bluebird In­ Licenses that are necessary or useful to perform the Collaboration Program. 1.6 "Bluebird In-Licenses" means Pre-Existing In-Licenses and Bluebird Collaboration In-Licenses. 1.7 "Bluebird IP" means (a) Collaboration IP solely owned by Bluebird pursuant to Section 2.l(f), (b) Bluebird In-Licensed IP and (c) all Patents, Materials and Know-How Controlled by Bluebird or its Affiliates ( other than Bluebird In-Licensed IP), in each case that is necessary or useful to perform the Collaboration Program. For avoidance of doubt, Collaboration IP jointly owned by the Parties pursuant to Section 2.1 (f) will not be deemed Bluebird IP. [For clarity, the Bluebird IP shall not include any Patents, Materials or Know­ How relating to Gene Editing.} 1.8 "Bluebird New In-License" means a New In-License between Bluebird or any of its Affiliates and a Third Party. 1.9 "Business Combination" means with respect to a Party, any of the following events: (a) any Third Party (or group of Third Parties acting in concert as a "group" within the meaning of Section 13(d) of the Exchange Act) acquires (including by way of a tender or exchange offer or issuance by such Party), directly or indirectly, beneficial ownership or a right to acquire beneficial ownership of shares of such Party representing fifty percent ( 50%) or more of the voting shares ( where voting refers to being entitled to vote for the election of directors) then outstanding of such Party, but excluding for such purposes any transaction or series of transactions with Financial Investors made for bona fide equity financing purposes in which cash is received by Bluebird or indebtedness of
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