Suite Retention and Development Agreement, dated September 9, 2019, by and between Albany Molecular Research Inc. and the Registrant

“AAA” is as defined in Section 15.9.

“Affiliate(s)” means any corporation, firm, partnership or other entity which controls, is controlled by or is under common control with a Party for as long as such control exists. For purposes of this definition, “control” shall mean the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest, provided that Affiliates of AMRI shall be limited to its direct and indirect subsidiaries.

“AMRI Background Technology” means any Technology (i) owned or controlled by AMRI or any of its Affiliates as of the Effective Date; or (ii) developed or obtained by or on behalf of AMRI or any of its Affiliates after the Effective Date independent of this Agreement, and all intellectual property rights in any of the foregoing.

“AMRI Equipment” is as defined in Section 2.2(d).

“AMRI Indemnitees” is as defined in Section 10.2.

“AMRI Program Technology” means Program Technology that (i) consists of improvements to AMRI Background Technology, (ii) is developed using Confidential Information of AMRI, or (iii) consists of improvements to the manufacturing process that are generally applicable to multiple products (and for each of the foregoing clauses (i), (ii) and (iii)) which does not incorporate Translate Bio Confidential Information), and all intellectual property rights in any of the foregoing clauses (i), (ii) and (iii).

“AMRI-Supplied Raw Materials” means Raw Materials supplied by AMRI pursuant to Section 4.2.

“AMRI Technology” means AMRI Background Technology and AMRI Program Technology.

“Applicable Laws” means all laws, ordinances, rules and regulations applicable to the particular Development Services and the other obligations of AMRI or Translate Bio, as the context requires under this Agreement, including, without limitation, (i) all applicable federal, state and local laws and regulations; and (ii) the U.S. Federal Food, Drug and Cosmetic Act; and (iii) cGMPs.

“Batch” means a specific quantity of Drug Substance comprised of a number of units mutually agreed upon between the Parties, and that (i) is intended to have uniform character and quality within specified limits, and (ii) is Processed according to a single manufacturing order during the same cycle of Processing.

“Batch Documentation” means, with respect to a Batch, a copy of the executed batch record (including Batch disposition), a certificate of GMP compliance, and a TSE/BSE statement.

“Build-Out” is as defined in Section 2.1.

“Build-Out Cap” is as defined in Section 2.5.

“Build-Out Completion” means the receipt by Translate Bio of a copy of AMRI’s certificate of occupancy sufficient for AMRI to legally commence using the Cleanroom Suites for their intended use issued by the appropriate governmental authority.

“Business Day” shall mean any day (other than a Saturday, Sunday or a legal holiday) on which banks are open for general business in the United States.

“Calendar Quarter” means a period of three (3) consecutive months commencing on January 1, April 1, July 1 or October 1 of any calendar year.

“Certificate of Analysis” means (i) with reference to a Batch of Drug Substance, the certificate that accompanies each shipment of a Batch of Drug Substance, as applicable, and which lists the test methods, acceptance limits and release test results for that specific Batch of Drug Substance, and (ii) with reference to the Raw Materials, the certificate(s) that accompanies each shipment of Raw Materials and which lists the test methods, acceptance limits and release test results for that specific batch of Raw Materials, as applicable.

“Certificate of Compliance” shall mean (i) with reference to a Batch of Drug Substance, a certificate attesting that the particular Batch of Drug Substance was Processed in accordance with the Master Batch Record and cGMP (if applicable as per intended use of the Drug Substance) and in conformance with Drug Substance Specifications, as applicable, and (ii) with reference to Raw Materials, a certificate(s) attesting that the Raw Materials were manufactured in accordance with cGMP and conform to the Specifications and applicable regulatory requirements, as applicable.

“cGMP” means the Current Good Manufacturing Practices for the manufacture, control and storage of human pharmaceutical products, as set forth in 21 C.F.R. 210 and 21 C.F.R. 211, as may be amended or supplemented, and the related regulations and FDA guidance documents in effect from time to time, and as set forth in Directive 2001/83/EC (as amended by Directive 2004/27/EC), Directive 2003/94/EC and EudraLex – Volume 4 of the Rules Governing Medicinal Products in the European Union entitled “EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use”.

“Cleanroom Suites” is as defined in Section 2.1.

“Confidential Information” is as defined in Section 8.1.

“Construction Contract” means the written agreement by and between AMRI and a third-party general contractor for the construction of the Cleanroom Suites.

“Delivery” is as defined in Section 5.1.

“Detailed Design Contract” means the written agreement by and between AMRI and a third-party design firm for the development of detailed design drawings relating to the Build-Out.

“Development Services” means, collectively, formulation development, Master Batch Record creation and revision, Raw Materials management (ordering, receipt, storage), Raw Materials identification testing,]engineering Batches, registration and validation Batches, and in or developmental manufacture of the Drug Substance, including all Batches manufactured prior to the establishment of a validated manufacturing process, generation of engineering protocols for demo Batches, creation of Specifications, Equipment SOPs, cleaning verification and supporting documentation, analytical methods,, cGMP Batches, and storage of Drug Substance.

“Disclosing Party” is as defined in Section 8.1.

“Dispute” is as defined in Section 15.9.

“Drug Substance” means the Raw Materials after Processing by AMRI in accordance with the Master Batch Record.

“Drug Substance-specific Program Technology” means any Program Technology that constitutes an improvement, modification, derivative, or new use of the Raw Materials proprietary to Translate Bio or a Translate Bio partner or Drug Substance, including without limitation the manufacturing process for Drug Substance as set forth in the Master Batch Record, but which is not an improvement of general applicability to the manufacturing process, and all intellectual property rights in any of the foregoing.

“Drug Substance Specifications” means the written specifications and quality standards, including tests, analytical procedures and acceptance criteria, that are established to confirm the characteristics and quality of the Drug Substance as set forth in the mutually agreed upon Master Batch Record, and as amended from time to time, by written agreement of the Parties when applicable, in accordance with the procedures set forth in this Agreement and the Quality Agreement.

“Drug Substance Warranty” is as defined in Section 7.1(c).

“Effective Date” is as defined in the preamble.

“EMA” means the European Medicines Agency, and any successor agency thereto.

“Facility” is as defined in the recitals.

“FDA” means the United States Food and Drug Administration, and any successor agency thereto.

“JSC” is as defined in Section 2.3(b).

“Indemnified Party” is as defined in Section 10.3.

“Indemnifying Party” is as defined in Section 10.3.

“Initial Deliverables and Services” is as defined in Section 2.8(b).

“Initial Term” is as defined in Section 12.1.

“Initial Three Year Period” is as defined in Section 12.3.

“Letter Agreement” means the Letter Agreement by and between the Parties, dated April 29, 2019.

“Losses” is as defined in Section 10.1.

“Make-Whole Payment” is as defined in Section 12.4.

“Master Batch Record” shall mean the document approved in writing by both Parties, and as may be amended from time to time in accordance with this Agreement and the Quality Agreement, specifying or referencing the complete set of formal instructions agreed upon by the Parties for the Processing of Drug Substance, including, but not limited to material descriptions, the formula, processing procedures, in-process testing specifications, Drug Substance Specifications and shipping specifications.

“MHRA” means Medicines and Healthcare Products Regulatory Agency, and any successor agency thereto.

“MSDS” is as defined in Section 4.1.

“Overage” is as defined in Section 2.5.

“Partnership Executive Committee” is as defined in Section 2.3(a).

“Party” or “Parties” is as defined in the preamble.

“Personal Data” is as defined in Section 15.16.

“Prepayment” is as defined in Section 2.8(a).

“Process”, “Processed”, or “Processing” means the conversion of the Raw Materials into Drug Substance in accordance with the Master Batch Record and the terms and conditions set forth in this Agreement and the Quality Agreement.

“Program Technology” means Technology developed by or on behalf of either Party or any of its Affiliates in the course of the Processing of the Drug Substance.

“Quality Agreement” is as defined in Section 6.1.

“Raw Materials” means all raw materials, supplies, components and packaging necessary to manufacture and ship the Drug Substance.

“Receiving Party” is as defined in Section 8.1.

“Regulatory Authority” means any governmental regulatory authority involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Drug Substance. Unless otherwise agreed by the Parties in writing, Regulatory Authority shall mean the FDA, EMA, and/or MHRA for purposes of this Agreement.

“Regulatory Filing” shall have the meaning set forth in Section 6.3.

“Renewal Term” is as defined in Section 12.1.

“Representative” is as defined in Section 2.3(b).

“SDS” is as defined in Section 4.1.

“Specifications” means, as applicable, the specifications relating to the Raw Materials and the specifications for other materials, consumables and shipping components used in Processing of Drug Substance, as mutually agreed by the Parties in writing, and as may be amended from time to time by written agreement of the Parties in accordance with the procedures set forth in this Agreement and the Quality Agreement.

“Suite Retention” is as defined in Section 2.7.

“Technology” means all discoveries, inventions, know-how, developments, methods, techniques, trade secrets, innovations, updates, modifications, enhancements, improvements, copyrights, data, documentation, processes, procedures, specifications and other intellectual property of any kind, whether or not protectable under patent, trademark, copyright or similar laws.

“Term” is as defined in Section 12.1.

“Translate Bio Capital Investment” is as defined in Section 2.5.

“Translate Bio Equipment” is as defined in Section 2.2(a).

“Translate Bio Existing Technology” means (i) the Translate Bio Materials, (ii) any intermediates and derivatives of the Translate Bio Materials; (iii) any other Technology owned or controlled by Translate Bio or any of its Affiliates as of the Effective Date; or (iv) any Technology, other than Program Technology, developed or obtained by or on behalf of Translate Bio or any of its Affiliates after the Effective Date, and all intellectual property rights in any of the foregoing.

“Translate Bio Indemnitees” is as defined in Section 10.1.

“Translate Bio Initial Services and Deliverables Payment” is as defined in Section 2.8(b).

“Translate Bio Materials” is as defined in Section 4.1.

“Translate Bio Monthly Fee” is as defined in Section 2.8(c).

“Translate Bio Technology” means Translate Bio Existing Technology and Drug Substance-Specific Program Technology.

“Translate Bio Termination Payment” is as defined in Section 12.2(c).

Cleanroom Suites. In connection with this Agreement, AMRI and Translate Bio shall arrange for the design and construction of a series of cleanroom suites at the Facility, as more specifically described in Exhibit A (the “Cleanroom Suites”). Title to, and risk of loss of, the Cleanroom Suites shall be retained by AMRI. AMRI shall enter into the Detailed Design Contract and the Construction Contract, pursuant to which the design and construction, respectively, of the Cleanroom Suites (the “Build-Out”) shall be conducted in conformance with Translate Bio’s requirements (as mutually agreed by the Parties) and the terms and conditions of this Agreement. The Parties agree that the Build-Out, and specifically the design of the Cleanroom Suites, shall be a joint effort between the Parties who shall share responsibility in ensuring that the Cleanroom Suites satisfy Translate Bio’s objectives.

Equipment.

Translate Bio shall procure the equipment described in Exhibit B, and the services related thereto (the “Translate Bio Equipment”) for installation in the Cleanroom Suites. The Parties may update Exhibit B from time to time by written, dated instrument signed by both Parties. All such Translate Bio Equipment shall be the sole property of Translate Bio, and title to, and risk of loss of, all such Translate Bio Equipment shall be retained by Translate Bio during the Term, except that AMRI shall be liable for any loss of, damage to, or theft of such the Translate Bio Equipment that is attributable to AMRI’s gross negligence or willful misconduct. Translate Bio shall be responsible for all freight, insurance and other costs of transporting the Translate Bio Equipment to the Facility and shall arrange insurance coverage for such Translate Bio Equipment while at the Facility. AMRI shall ensure that the Translate Bio Equipment is kept free and clear of any security interest (except as may be applied by Translate Bio’s other business partners or lenders), lien or any other encumbrance while in AMRI’s possession.

AMRI shall allow each item of Translate Bio Equipment to be installed in the Cleanroom Suites. Translate Bio shall be responsible for managing and coordinating the validation and qualification services relating to such installation, which shall be performed by a third-party vendor selected by Translate Bio, in accordance with the terms and conditions set forth in an agreement to be entered into by Translate Bio and such third-party vendor. For the avoidance of doubt, Translate Bio shall be responsible for the costs and expenses relating to such validation and qualification services and shall make direct payments to such third-party vendor. AMRI shall be responsible for maintaining the Translate Bio Equipment in good working order through regular calibration, maintenance and repairs in accordance with AMRI’s quality and standard operating procedures. All costs relating

Following expiration or termination of the Agreement and unless otherwise agreed in writing by the Parties, the Translate Bio Equipment shall be sent back to Translate Bio, at its sole cost and expense.

AMRI shall procure and install in the Cleanroom Suites certain additional equipment that is needed for the operation of the Cleanroom Suites, and services related thereto as set forth on Exhibit B (the “AMRI Equipment”) and shall be responsible for validation and qualification services relating to such installation, as appropriate. Title to, and risk of loss of, the AMRI Equipment shall be retained by AMRI. AMRI shall be responsible for maintaining the AMRI Equipment in good working order through regular calibration, maintenance and repairs in accordance with AMRI’s quality and standard operating procedures. Except as set forth in the immediately following sentence, all costs relating to the AMRI Equipment shall be funded through the Translate Bio Capital Investment or in the case of an Overage, as set forth in Section 2.5. AMRI shall be liable for any repair to the AMRI Equipment to remedy damage caused by AMRI’s gross negligence or willful misconduct.

Governance.

Partnership Executive Committee. Promptly following the Effective Date, the Parties shall establish an executive committee (a “Partnership Executive Committee”), consisting of [**] representatives from each Party. The Partnership Executive Committee shall meet not less than [**] during the Term, including to review the progress of the Build-Out. These meetings shall be in person, by video-conference or by telephone conference. The chair of the meeting shall alternate each meeting, with a representative of [**] acting as chair for the first meeting. Within [**] after each meeting, the Partnership Executive Committee shall memorialize in writing all key decisions made and circulate such summary to all members of the Partnership Executive Committee and JSC. Each Party shall bear its own expenses with respect to the activities conducted by the Partnership Executive Committee. In the event that the Partnership Executive Committee cannot reach agreement on any matter, the matter shall be referred promptly to the Chief Executive Officer of AMRI and the Chief Executive Officer of Translate Bio for resolution. The Partnership Executive Committee shall be responsible for (i) general oversight of the relationship between AMRI and Translate Bio during the Term; (ii) prompt resolution and mediation of any issues that cannot be resolved by the JSC; and (iii) decision-making for material changes in scope for either the design or construction of the Build-Out, based on the recommendation of the JSC.

Joint Steering Committee. Promptly following the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) to meet not less than [**] during the Build-Out and each [**] during the remainder of the Term. The JSC shall be responsible for (i) the daily execution of the Build-Out, including monitoring the progress of the Build-Out against established timelines, making necessary amendments to the Build-Out plans, setting priorities, allocating tasks and coordinating activities between the Parties, and reviewing the budget and any budget overruns for the Build-Out, (ii) overseeing the Development Services and Processing, (iii) addressing improvements, changes and any other items that pertain to the Processing and related testing and shipping of Raw Materials and Drug Substance, and (iv) communicating with and updating the relevant parties, including the Partnership Executive Committee as to such matters. Within [**] after each meeting of the JSC, the JSC shall memorialize in writing all key decisions made and circulate such summary to all members of the Partnership Executive Committee and JSC. To the extent the JSC is unable to reach resolution on a particular matter or it determines that material changes in scope are required, it shall refer such matter to the Partnership Executive Committee, making recommendations and providing all necessary supporting information. In addition, each Party shall appoint a representative having primary responsibility for day-to-day interactions with the other Party relating to the Build-Out (each, a “Representative”). Both Parties shall use reasonable efforts to provide the other with at least [**] prior written notice of any change in its Representative other than in the event of a termination of employment.

Person-In-Plant. The Representative from Translate Bio and his/her designees (who shall be employees or contractors of Translate Bio or a Translate Bio partner) shall be permitted to be present during the period of the Build-Out and during the performance of the Development Services to assess progress and monitor work as Translate Bio deems necessary. With respect to the observation of Development Services, Translate Bio shall be limited to [**] people at any given time. Such Translate Bio personnel shall comply with any and all confidentiality, security, safety, quality or similar guidelines that apply to persons present in the Facility and that are communicated in advance by AMRI, and such other terms and conditions as further set forth in Exhibit C.

Translate Bio Capital Investment. Translate Bio agrees to provide six million U.S. dollars ($6,000,000) (the “Translate Bio Capital Investment”) to finance the costs of the Build-Out. AMRI shall invoice Translate Bio on a monthly basis for the goods and services provided by the third-party contractors and vendors in connection with the Build-Out as they are incurred by AMRI, and Translate Bio shall make payment to AMRI within [**] of receipt of such invoices. AMRI shall provide Translate Bio with [**] updates, tracking the Build-Out spend against the Translate Bio Capital Investment.

Overage. In the event that the aggregate Build-Out cost exceeds six million U.S. dollars ($6,000,000) (an “Overage”), the Parties shall work together in good faith to eliminate or minimize such Overage. In the event there continues to be an Overage following such good faith efforts, AMRI and Translate Bio shall each pay 50% of every dollar of Overage, up to a total Build-Out cost of eleven million U.S. dollars ($11,000,000) (the “Build-Out Cap”). Translate Bio shall be solely responsible for any cost over the Build-Out Cap, provided that AMRI agrees to notify Translate Bio in writing and provide Translate Bio with a reasonable opportunity to modify the plan for the Build-Out to reduce costs before any costs over the Build-Out Cap are incurred.

Delays and Disputes. AMRI will use commercially reasonable efforts to ensure that its counterparties to the Detailed Design Contract and the Construction Contract perform their obligations diligently in accordance with written timelines. AMRI shall not be responsible for any delays in the Build-Out or disputes with any of the contractors, vendors or suppliers it engages. Any losses or other expenses resulting from any such disputes or delays, including expediting, rescheduling, cancellation and/or legal fees, shall be financed from the Translate Bio Capital Investment. In the event that there are insufficient funds remaining in the Translate Bio Capital Investment, the provisions set forth in Section 2.5 relating to Overage shall apply.

Translate Bio Rights to Cleanroom Suites. During the Term and in exchange for the Translate Bio Capital Investment and Translate Bio Monthly Fee, AMRI agrees that the Cleanroom Suites shall be for the exclusive use of Translate Bio, pursuant to the terms and conditions set forth in this Agreement (the “Suite Retention”). The Parties acknowledge and agree that Translate Bio may utilize the Cleanroom Suites for the manufacture of products on behalf of its partners, provided that any such services will be subject to the terms and conditions of this Agreement and Translate Bio shall remain responsible for any such use.

Translate Bio Payments.

Build-Out Payments. Translate Bio shall be responsible for payment to AMRI of the Translate Bio Capital Investment, as set forth in Section 2.4 herein.

Prepayment. On [**], pursuant to the Letter Agreement, Translate Bio paid AMRI [**] U.S. dollars ($[**]) (the “Prepayment”) to fund the purchase of certain AMRI Equipment while this Agreement was being negotiated. For the avoidance of doubt, this Prepayment and the other payments made by Translate Bio pursuant to the Letter Agreement represent part of the Translate Bio Capital Investment and shall not be credited against any other amounts due by Translate Bio hereunder.

Initial Deliverables and Services Payment. As soon as practical following Translate Bio’s request after execution of this Agreement, AMRI shall deliver to Translate Bio the following services: (i) [**] (collectively, the “Initial Deliverables and Services”). Payment in the amount of one million U.S. dollars ($1,000,000) for the Initial Deliverables and Services is due within five (5) Business Days after execution of this Agreement (the “Translate Bio Initial Deliverables and Services Payment”). The Translate Bio Initial Deliverables and Services Payment is not refundable or transferrable, and is not creditable to any other services or costs associated with this Agreement.

Monthly Payment. On the first Business Day of each calendar month during the Term, beginning with the month immediately following the Build-Out Completion, Translate Bio shall make payment to AMRI in the amount of one million U.S. dollars ($1,000,000) (as may be increased pursuant to the immediately following paragraph, the “Translate Bio Monthly Fee”). Translate Bio shall make a pro-rated payment for the month during which the Build-Out Completion occurs, equivalent to: the Translate Bio Monthly Fee (i) divided by the number of days in such month, and (ii) multiplied by the number of days remaining in such month following the day of the month that Build-Out Completion occurred. The Parties agree that the Translate Bio Monthly Fee shall be made to AMRI in exchange for the Suite Retention and the Development Services (excluding any services expressly set forth in Exhibit D, which shall be subject to the charges set forth therein). Notwithstanding the foregoing, the Parties agree that Translate Bio shall be obligated to pay the Translate Bio Monthly Fee, irrespective of whether AMRI is providing Development Services during the relevant monthly period. Furthermore, the Translate Bio Monthly Fee is not refundable or transferrable, and is not creditable to any future services or periods covered by this Agreement.

Additional Charges. In addition to the Translate Bio Initial Services and Deliverables Payment and the Translate Bio Monthly Fee, Translate Bio shall pay additional costs and expenses as set forth on Exhibit D hereto. In the event that Translate Bio requests any other services that are not set forth in this Agreement, AMRI shall provide a written quote with the fee for such additional services and Translate Bio shall advise AMRI in writing whether it wishes to have such additional services performed by AMRI.

Payment Terms. All payments required to be made by Translate Bio hereunder shall be paid in United States dollars in immediately available funds to an account designated by AMRI. In the event payment is not received by AMRI on or before the [**] after (i) the date specified in Sections 2.8(d), or (ii) the date of the invoice for purposes of Section 2.8(e), then such unpaid amount shall accrue interest at the rate of [**] percent ([**]%) per annum above the prime rate published by the Wall Street Journal as of the original due date, compounded monthly, until paid in full.

Setoff. Without limiting Translate Bio’s rights under law or in equity, Translate Bio shall have the right to set off against any amount payable to AMRI hereunder any amount for which AMRI is responsible for payment or credit to Translate Bio pursuant to the terms of Section 3.1, 4.1, or 10.1 (in the event that Translate Bio elects to defend) that has not previously been paid by AMRI.

Audits. AMRI will permit Translate Bio to audit AMRI’s relevant records with at least [**] advance prior notice, during normal business hours, no more than [**] solely to permit Translate Bio to confirm the accuracy of reported Build-out expenditures, amounts charged to Translate Bio for AMRI-Supplied Raw Materials pursuant to Section 4.2 and any additional charges pursuant to Section 2.8(e), and that all such amounts are in compliance with this Agreement. For the avoidance of doubt, Translate Bio’s rights pursuant to this Section 2.9 shall be limited to (i) the expenditures funded by the Translate Bio Capital Investment, (ii) any expenditures funded by Overages, and (iii) documentation of pass-through expenses, with respect to Sections 4.2 and 2.8(e).

Development Services. In exchange for the Translate Bio Monthly Fee, Translate Bio shall have the right from time to time to request in writing that AMRI perform specified Development Services in accordance with a mutually agreed timeline, and AMRI shall perform such Development Services in accordance therewith. In case of Development Services, Translate Bio acknowledges and agrees that specific results for Development Services are unable to be guaranteed, and until a manufacturing process is optimized and validated under cGMP conditions, there is no assurance that the Drug Substance Specifications will be exactly as set forth in the Master Batch Record or that any manufactured Drug Substance will meet the Drug Substance Specifications. Translate Bio is obligated to pay for (via the Translate Bio Monthly Fee and any applicable additional costs per Section 2.8(e)), and AMRI shall have no liability for, all Development Services even if the Drug Substance produced does not conform to Drug Substance Specifications, unless such non-conformity is attributable to AMRI’s gross negligence or willful misconduct. In the event AMRI is responsible for non-conformance to Drug Substance Specifications per the immediately foregoing sentence, AMRI shall replace the non-conforming Drug Substance at no additional cost to Translate Bio provided Translate Bio supplies sufficient quantities of Translate Bio Materials, as necessary, for AMRI to complete such replacement. If AMRI replaces the non-conforming Drug Substance per the immediately foregoing sentence, AMRI shall credit Translate Bio for the cost of any replacement Translate Bio Materials up to $[**], per batch of Drug Substance. The remedy set forth in this Section 3.1 shall be Translate Bio’s sole remedy for non-conforming Drug Substance and lost or damaged Translate Bio Materials. Notwithstanding anything to the contrary herein, AMRI shall not be precluded or limited from providing to itself, its Affiliates or any third party any services that are identical to the Development Services, provided that such provision of services do not use the Cleanroom Suites (during the Term) and do not constitute a breach of confidentiality under Article 8 herein.

Monthly Batch Limit. The Parties agree that notwithstanding the Suite Retention and the Translate Bio Monthly Fee, the maximum number of Batches that AMRI shall be required to Process to completion pursuant to this Agreement in exchange for the Translate Bio Monthly Fee on a monthly basis is [**]. Translate Bio may request that AMRI Process additional Batches to completion in a given month at AMRI’s then-current standard rates, and AMRI shall use commercially reasonable efforts, including without limitation by increasing the number of hours the Cleanroom Suites are in operation, to accommodate any such request.

Rescheduling and Cancellation. For the avoidance of doubt, Translate Bio shall be responsible for payment of the Translate Bio Monthly Fee even if it delays, reschedules or cancels any Development Services scheduled for the applicable monthly period.

Translate Bio Materials. Translate Bio shall supply to AMRI for Processing, at Translate Bio’s sole cost, certain Raw Materials and any other materials (such as consumables) as agreed by the Parties (collectively, the “Translate Bio Materials”). Translate Bio shall ensure that all Raw Materials included in the Translate Bio Materials and provided under this Agreement meet applicable Specifications and have been manufactured in accordance with cGMP and applicable regulatory requirements, as applicable. Translate Bio (or Translate Bio’s applicable raw material supplier) shall supply a Certificate of Analysis and Certificate of Compliance confirming that the standards set forth in the preceding sentence have been met. Prior to delivery of any of the Raw Materials included in the Translate Bio Materials to AMRI for Processing, Translate Bio (or Translate Bio’s raw material supplier) shall provide to AMRI a copy of the Material Safety Data Sheet (“MSDS”) or Safety Data Sheet (“SDS”), as amended, and any subsequent revisions thereto. Translate Bio shall supply the Translate Bio Materials and accompanying documentation to AMRI no later than [**] before the scheduled date of Processing for which such Translate Bio Materials will be used by AMRI. Translate Bio shall retain title and risk of loss to the Translate Bio Materials during such times as they are located at the Facility, except as provided in the remainder of this Section 4.1. AMRI shall segregate the Translate Bio Materials from other materials at the Facility in a location where their confidentiality will be protected, store them in accordance with written instructions provided by Translate Bio (or Translate Bio’s applicable raw material supplier), handle them in accordance with the MSDS/SDS, and use the Translate Bio Materials solely and exclusively for Processing under this Agreement. AMRI shall have no liability with respect to the Translate Bio Materials, except for any loss or damage resulting from AMRI’s gross negligence or willful misconduct. In the event of loss or damage to the Translate Bio Materials caused by AMRI’s gross negligence or willful misconduct, AMRI shall provide a credit to Translate Bio equal to the value of the lost or damaged Translate Bio Materials up to $[**] (in the aggregate), per event.

AMRI-Supplied Raw Materials. AMRI shall be responsible for procuring AMRI-Supplied Raw Materials, as necessary and in appropriate quantities consistent with the Master Batch Record, and shall retain the risk of loss of the AMRI-Supplied Raw Materials. Translate Bio shall be financially responsible for the cost of the AMRI-Supplied Raw Materials plus a [**] percent ([**]%) handling charge, as set forth in Exhibit D. If Translate Bio requires a specific supplier for any AMRI-Supplied Raw Material, Translate Bio will be responsible for all costs associated with qualification of that supplier in accordance with the Quality Agreement, if not previously qualified by AMRI.

Reimbursement for Materials. In the event of (i) a Drug Substance Specification change for any reason, (ii) termination or expiration of this Agreement; or (iii) obsolescence of any Raw Material, Translate Bio shall bear the cost of any resulting unused AMRI-Supplied Raw Materials.

Delivery of Drug Substance. Title and risk of loss of Drug Substance and other deliverables shall transfer from AMRI to Translate Bio upon delivery EXW Facility (Incoterms 2010) (“Delivery”). For manufactured Batches, Delivery shall occur upon the later of (a) the issuance to Translate Bio of the completed Batch Documentation, in accordance with to the Quality Agreement and (b) notification by AMRI to Translate Bio that the Batch is available for pick up at Facility. Translate Bio is responsible for transportation of the Drug Substance to Translate Bio’s final destination, at the sole risk and expense of Translate Bio. For avoidance of doubt, Translate Bio is responsible for arranging pick up by carrier and all shipping costs and risks. Should Translate Bio request AMRI to assist with any arrangements with the carrier, such arrangements will be made by AMRI on behalf of Translate Bio in accordance with Translate Bio’s applicable instructions and at the sole risk and expense of Translate Bio.

Storage. If Translate Bio does not pick up Drug Substance after AMRI has notified Translate Bio in writing that it is available, AMRI shall store such Drug Substance at the Facility. For all Drug Substance stored by AMRI following such notification, Translate Bio agrees that: (i) Translate Bio has title and risk of ownership, (ii) Translate Bio has made a fixed commitment to purchase such Drug Substance, (iii) Translate Bio is responsible for any decrease in market value of such Drug Substance that relates to factors and circumstances outside of AMRI’s control, and (iv) Translate Bio is responsible for obtaining insurance for such Drug Substance during the storage period, if desired.

Quality Agreement. No less than [**] prior to the manufacture of the first Batch of Drug Substance, including qualification, engineering or validation Batches, the Parties shall execute a quality agreement setting forth the roles and responsibilities of the Parties with respect to assuring the quality of the Drug Substance and conformance with cGMP requirements (the “Quality Agreement”). The Quality Agreement shall in no way determine liability or financial responsibility of the Parties for the responsibilities set forth therein, nor shall it control any commercial aspect of the Development Services provided hereunder. In the event of a conflict between the terms of this Agreement and the Quality Agreement, this Agreement shall control except with respect to matters relating to compliance with cGMP requirements and/or applicable regulatory laws and regulations, in which case, the Quality Agreement will control.

Regulatory Compliance. Translate Bio shall be solely responsible for all permits and licenses required by any Regulatory Authority with respect to the Drug Substance, including any product licenses, applications and amendments in connection therewith. AMRI will be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the Facility. During the Term, AMRI shall provide support to Translate Bio for any regulatory filings or submissions relating to the Drug Substance, which support services shall be invoiced at AMRI’s then current rates.

Regulatory Correspondence. Translate Bio shall make available to AMRI the AMRI-specific portions of all regulatory applications and amendments thereto and all correspondence with a Regulatory Agency, in each case relating to the Drug Substance, including without limitation, an IND, NDA, ANDA, 505(b)(2) and DMF or their equivalent applications in foreign jurisdictions (each, a “Regulatory Filing”). For purposes of the foregoing sentence, “AMRI-specific portions” shall mean those sections of a Regulatory Filing, amendments or correspondence regarding a Regulatory Filing, that reference AMRI’s systems, facilities or capabilities. Translate Bio agrees to incorporate all changes provided by AMRI which correct for factual inaccuracies and to reasonably consider all other comments.

Original Applications/ Amendments Not Requested by Regulatory Agency: Translate Bio shall provide [**] prior notice of its intent to file a Regulatory Filing. Within [**] after receipt of the AMRI-specific portions of the draft application or amendment, AMRI shall provide any comments on such portions to Translate Bio.

Amendments/ Responses Requested by a Regulatory Agency: Translate Bio shall notify AMRI of any request by a regulatory agency within [**] after receipt of request, if the request relates to an AMRI-specific portion of a Regulatory Filing. Within [**] after receipt of the AMRI-specific portion of the draft amendment or response, AMRI shall provide any comments to Translate Bio.

Audits. Following Build-Out Completion and during the Term, AMRI will permit Translate Bio and/or its designee to audit AMRI’s relevant non-financial records with at least [**] advance prior notice, during normal business hours, no more than [**] (except with respect to “for cause” audits) solely to permit Translate Bio to confirm that the Development Services are or have been performed in compliance with this Agreement. Except with respect to “for cause” audits, AMRI shall invoice Translate Bio, and Translate Bio shall pay AMRI, for any additional inspections and/or audits, including, without limitation, any EHS audits, supply chain audits and/or any pre-approval inspections by the FDA or other regulatory authority, at such rates as determined by AMRI based on timing of the audit, resource demand, and any production disruption that may be caused by such audit; provided that Translate Bio may only request [**]. As used herein, “for cause” audit means an audit conducted to investigate a specific quality failure at the Facility that directly relates to the performance of the Development Services.

Recall. In the event AMRI believes a recall, field alert withdrawal or field correction may be necessary with respect to the Drug Substance provided under this Agreement or any finished dosage form pharmaceutical product containing the Drug Substance, AMRI shall immediately notify Translate Bio in writing. AMRI will not act to initiate a recall, field alert, withdrawal or field correction without the express prior written approval of Translate Bio, unless otherwise required by Applicable Laws. In the event Translate Bio believes a recall, field alert, withdrawal or field correction may be necessary with respect to Drug Substance provided under this Agreement or any finished dosage form pharmaceutical product containing the Drug

AMRI. AMRI represents, warrants and covenants to Translate Bio that:

it shall provide the Development Services in a professional and workmanlike manner, using personnel that have been trained by AMRI in the applicable regulations, and in accordance with such regulations and all Applicable Laws;

it has not engaged in any conduct which could lead to debarment actions by the FDA under 21 U.S.C. 335(a) (Section 306, Federal Food, Drug and Cosmetic Act) and has not and shall not employ, or knowingly contract with or retain any person directly or indirectly to perform Development Services if such a person is debarred by the FDA or, to AMRI’s knowledge, is under investigation by the FDA for debarment, and will promptly notify Translate Bio in writing if it or any person that has performed Development Services hereunder becomes debarred by the FDA or if it becomes aware that any such person is under investigation by the FDA for debarment;

all Drug Substance delivered hereunder shall be manufactured in accordance with cGMP, the then-current Master Batch Record and the Quality Agreement, and, if manufactured after establishment of a validated manufacturing process, shall conform to the Drug Substance Specifications upon Delivery (the “Drug Substance Warranty”);

AMRI has all necessary authority and all right, title and interest in and to any AMRI Background Technology that is used in the Development Services (alone and not in combination with any Translate Bio Materials or Translate Bio Technology, and for the avoidance of doubt, excluding the Drug Substance);

AMRI shall ensure that the Certificates of Analysis for AMRI-Supplied Raw Materials indicate that they comply with the applicable Specifications (which shall, for the avoidance of doubt, require no independent testing by AMRI);

AMRI will comply with all Applicable Laws relating to its performance under this Agreement and its use of any Translate Bio Materials and Translate Bio Equipment; and

AMRI will use commercially reasonable efforts to obtain all consent required for the Build-Out under the Lease Agreement for the Facility. In the event that AMRI is unable to obtain such consent or if the Lease Agreement is terminated during the Term, Translate Bio shall have the right to terminate this Agreement immediately upon written notice to AMRI and, in such event, shall have no obligation to make the Make-Whole Payment.

Translate Bio. Translate Bio represents, warrants and covenants to AMRI that:

the Translate Bio Materials will have been produced in compliance with the Applicable Laws and, upon delivery to AMRI, shall meet the applicable Specifications, if any;

it has all necessary authority and all right, title and interest (or in the case of any Drug Substance to be produced for a Translate Bio partner hereunder, legal right to use or provide to AMRI for production, manufacture or other related services in accordance with the terms of this Agreement) in and to any intellectual property related to the Drug Substance or that is otherwise provided by Translate Bio under this Agreement;

it has provided or will provide all safe handling instructions, health and environmental information and material safety data sheets applicable to the Drug Substance, in the time period specified in Section 4.1;

it will obtain and shall maintain in effect during the Term, all necessary approvals from applicable Regulatory Authorities, if any, relating to the use of the Drug Substance;

it will comply with all Applicable Laws relating to its performance under this Agreement and its use of any materials or Drug Substance provided by AMRI under this Agreement (including the use of any finished dosage form pharmaceutical product containing the Drug Substance);

it will not release the Drug Substance into the market if the completed Batch record for a particular Batch indicates that the Drug Substance does not comply with the Drug Substance Specifications or Applicable Laws; and

(i) Translate Bio will have sufficient net cash available to pay all amounts due and payable to AMRI hereunder when such amounts become due and payable, or (ii) to the extent Translate Bio expects that it will not have sufficient net cash to pay all amounts due and payable to AMRI hereunder when such amounts become due and payable, it will use commercially reasonable efforts to obtain financing for such amounts; (iii) Translate Bio will not assign this Agreement to an undercapitalized assignee for the purpose of avoiding its payment obligations hereunder; (iv) Translate Bio has no knowledge of any existing facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction; and (v) Translate Bio does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt).

Mutual. Each Party hereby represents and warrants to the other Party that:

Existence and Power. Such Party (i) is duly organized, validly existing and in good standing under the laws of the state in which it is organized, (ii) has the power and authority and the legal right to own and operate its property and assets, and to carry on its business as it is now being conducted, and (iii) is in compliance with all requirements of Applicable Laws, except to the extent that any noncompliance would not materially adversely affect such Party’s ability to perform its obligations under the Agreement.

Authorization and Performance of Obligations. Such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.

Execution and Delivery. This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

Consents. All necessary consents, approvals and authorizations of all Regulatory Authorities have been or will be obtained.

No Conflict. The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any requirement of Applicable Laws; and (ii) do not materially conflict with, or constitute a material default or require any consent under, any contractual obligation of such Party, except for (a) any permits required relating to the Build-Out, which AMRI shall obtain, and (b) the Lease Agreement relating to the Facility.

Limitations. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 7 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.