Transition Services Agreement, dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT PASSAGE BIO, INC. TREATS AS PRIVATE OR CONFIDENTIAL.
TRANSITION SERVICES AGREEMENT
This Transition Services Agreement (this “Agreement”) is entered into as of July 31, 2024 (the “Effective Date”), by and between Passage Bio, Inc., a corporation organized under the laws of Delaware (“Passage”) with offices at 2005 Market St, 39th Floor, Philadelphia, PA 19103, and Gemma Biotherapeutics, Inc., a Delaware corporation (“Gemma”) with offices at 1831 Delancey Place, Philadelphia, PA 19103. Passage and Gemma may be referred to in this Agreement individually as a “Party” or collectively as the “Parties.” Capitalized terms used but not defined herein will have the meanings ascribed to them in the applicable License Agreement (as defined below).
RECITALS
WHEREAS, Passage owns and controls a drug development program for the treatment of GM1 gangliosidosis (the “GM1 Program”), pursuant to which it is currently conducting a study of safety, tolerability and efficacy of PBGM01 in pediatric participants with GM1 gangliosidosis (Imagine-1) (the “GM1 Study”);
WHEREAS, Passage additionally owns and controls drug development programs for the treatment of Krabbe disease (the “Krabbe Program”) and metachromatic leukodystrophy (the “MLD Program,” and together with the GM1 Program and Krabbe Program, the “Programs”), pursuant to which it manages the clinical supply for the Programs (the “Clinical Supply”);
WHEREAS, the Parties have entered into those certain Exclusive License Agreements dated as of the Effective Date (each a “License Agreement”) pursuant to which Passage agreed to license to Gemma certain intellectual property rights owned or controlled by Passage to develop, manufacture and commercialize certain Licensed Products related to the Programs; and
WHEREAS, in connection with the License Agreements, Gemma wishes to obtain from Passage and Passage wishes to provide to Gemma certain Services (as defined below) pursuant to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants, conditions, and provisions contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
SERVICES
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collectively, the “Services”). The Parties acknowledge the transitional nature of the Services and Gemma agrees to use Commercially Reasonable Efforts to transition each Service to its own internal organization or to obtain alternate third-party sources to provide the Services as promptly as practicable following the execution of this Agreement. This Agreement imposes no obligation on Passage to perform any services other than the Services set forth on Exhibit A. The provision of the Services by Passage hereunder shall be subject in all cases to Gemma fulfilling its obligations under this Agreement and providing sufficient information, resources (including funding), and access as reasonably necessary for Passage to satisfy its obligations under this Agreement. For the purposes of this Agreement, “Commercially Reasonable Efforts” shall mean [*]. The Parties will use reasonable efforts to cooperate with each other in matters relating to the provision and receipt of the Services; provided [*].
TRANSFER OF MATERIALS/TRANSITION
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“CTA”) related to such Licensed Product triggering a transfer of sponsorship as set forth in Exhibit C.
COOPERATION
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Affiliates and subcontractors to, comply in all material respects with the other Party’s corporate information and physical security policies (including policies with respect to protection of proprietary information and other policies regarding the use of computing resources) as in effect from time to time and provided to that Party in writing. Gemma will not attempt to gain access to or use any information or systems of Passage and its Affiliates except as expressly authorized by Passage. The Parties acknowledge that the use and disclosure of each Party’s confidential information under this Agreement will be governed by the confidentiality terms of the License Agreement. If reasonably requested by Passage based on the nature of the Services, Gemma will enter into a data processing addendum with Passage prior to the performance of the applicable Services. For clarity, the confidentiality terms of this Agreement supersede the terms of that certain Mutual Confidentiality Agreement between the Parties effective as of December 1, 2022 with respect to any Confidential Information disclosed hereunder.
FEES AND PAYMENT
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value-added, goods and services and similar taxes, duties, charges, or levies (and any related interest and penalties) imposed on, or in connection with the provision of the Services hereunder, but excluding any taxes measured by or imposed on Passage’s net income. All payments made by or on behalf of Gemma under this Agreement shall be made without deduction or withholding for any taxes, unless Gemma is required to deduct or withhold such taxes under Law. If Gemma is required by any Law or regulation to withhold any amount for taxes from any payment due to Passage under this Agreement, then Gemma shall (i) make such withholdings as are required by Law, (ii) timely pay the full amount deducted or withheld to the appropriate governmental entity, and (iii) pay such additional amounts to Passage as may be necessary so that the net amount received by Passage after such withholding will not be less than the amount Passage would have received if such amounts had not been paid. At Passage’s request, Gemma shall provide Passage with reasonably satisfactory documentation evidencing the payment to the appropriate governmental entity of any amounts so withheld or deducted.
TERM AND TERMINATION
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for [*] (or [*] with respect to any payment breach) following receipt of written notice of such breach by the non-breaching Party.
COMPLIANCE
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substitute for Gemma’s performance of any such compliance obligation or the engagement of appropriate advisors to assist with any such compliance obligation.
INTELLECTUAL PROPERTY
INDEMNIFICATION AND LIABILITY
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GENERAL
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If to Passage: |
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With a copy to (which shall not constitute notice) to:
Passage Bio, Inc.
2005 Market St
39th Floor
Philadelphia, PA 19103
ATTN: General Counsel
If to Gemma: |
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Philadelphia, PA 19103
Attention: Chief Executive Officer
With a copy to (which shall not constitute notice) to:
McDermott Will & Emery LLP
200 Clarendon St. 57th Floor
Boston, MA 02116
Attention: Brian M. Bunn
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Delivery as a defense to the formation of a contract, and each Party forever waives any such defense, except to the extent that such defense relates to lack of authenticity.
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upon them by the terms of the License Agreements, including the representations, warranties, covenants, agreements, and other provisions set forth in the License Agreements. In the event of any conflict between the provisions of this Agreement (including the exhibits hereto) and the provisions of a License Agreement, the provisions of the applicable License Agreement will control.
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives effective as of the Effective Date.
Passage Bio, Inc. | Gemma Biotherapeutics, Inc. |
By: _/s/ Will Chou_______________ | By: _/s/ Annalisa Jenkins__________ |
Name: Will Chou, M.D. | Name: Annalisa Jenkins |
Title: Chief Executive Officer | Title: President |
[Signature Page to Transition Services Agreement]
EXHIBIT A
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EXHIBIT B
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EXHIBIT C
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EXHIBIT D
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EXHIBIT E
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EXHIBIT F
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