Exhibit 10.1

Certain identified information has been excluded from the exhibit because it is
both (i) not

material and (ii) would likely cause competitive harm to the Company, if
publicly disclosed.

Double asterisks denote omissions.

Execution Version

SUITE RETENTION AND DEVELOPMENT AGREEMENT

This SUITE RETENTION AND DEVELOPMENT AGREEMENT (the “Agreement”) is made this
9th day of September, 2019 (the “Effective Date”), by and between Albany
Molecular Research, Inc. (“AMRI”), with a place of business at 26 Corporate
Circle, Albany, NY 12203 and Translate Bio, Inc. (“Translate Bio”), with a place
of business at 29 Hartwell Avenue, Lexington, MA 02421. For purposes of this
Agreement, AMRI and Translate Bio are each a “Party” and collectively, the
“Parties.”

WHEREAS, AMRI provides contract pharmaceutical development and manufacturing to
the pharmaceutical industry;

WHEREAS, Translate Bio is developing mRNA therapeutics to treat diseases caused
by protein or gene dysfunction and wants AMRI to assist in the development of
its Drug Substance, as provided in this Agreement and the attachments hereto;
and

WHEREAS, Translate Bio and AMRI desire to build a series of cleanroom suites at
AMRI’s manufacturing facility in [**] (the “Facility”) for use in development of
the Drug Substance and each Party shall provide resources in connection
therewith, pursuant to the terms and conditions set forth in this Agreement;

NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions
set forth below, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

The following terms have the following meanings in this Agreement:

 

1.1

“AAA” is as defined in Section 15.9.

 

1.2

“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.

 

1.3

“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.

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1.4

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

 

1.5

“AMRI Indemnitees” is as defined in Section 10.2.

 

1.6

“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).

 

1.7

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

 

1.8

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

 

1.9

“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.

 

1.10

“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.

 

1.11

“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.

 

1.12

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

 

1.13

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

 

1.14

“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.

 

1.15

“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.

 

2

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1.16

“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.

 

1.17

“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.

 

1.18

“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.

 

1.19

“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”.

 

1.20

“Cleanroom Suites” is as defined in Section 2.1.

 

1.21

“Confidential Information” is as defined in Section 8.1.

 

1.22

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

 

1.23

“Delivery” is as defined in Section 5.1.

 

1.24

“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.

 

1.25

“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.

 

3

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1.26

“Disclosing Party” is as defined in Section 8.1.

 

1.27

“Dispute” is as defined in Section 15.9.

 

1.28

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

 

1.29

“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.

 

1.30

“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.

 

1.31

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

 

1.32

“Effective Date” is as defined in the preamble.

 

1.33

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

 

1.34

“Facility” is as defined in the recitals.

 

1.35

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

 

1.36

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

 

1.37

“Indemnified Party” is as defined in Section 10.3.

 

1.38

“Indemnifying Party” is as defined in Section 10.3.

 

1.39

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

 

1.40

“Initial Term” is as defined in Section 12.1.

 

1.41

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

 

4

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1.42

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

 

1.43

“Losses” is as defined in Section 10.1.

 

1.44

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

 

1.45

“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.

 

1.46

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

 

1.47

“MSDS” is as defined in Section 4.1.

 

1.48

“Overage” is as defined in Section 2.5.

 

1.49

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

 

1.50

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

 

1.51

“Personal Data” is as defined in Section 15.16.

 

1.52

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

 

1.53

“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.

 

1.54

“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.

 

1.55

“Quality Agreement” is as defined in Section 6.1.

 

1.56

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

 

1.57

“Receiving Party” is as defined in Section 8.1.

 

1.58

“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.

 

5

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1.59

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

 

1.60

“Renewal Term” is as defined in Section 12.1.

 

1.61

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

 

1.62

“SDS” is as defined in Section 4.1.

 

1.63

“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.

 

1.64

“Suite Retention” is as defined in Section 2.7.

 

1.65

“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.

 

1.66

“Term” is as defined in Section 12.1.

 

1.67

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

 

1.68

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

 

1.69

“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.

 

1.70

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

 

1.71

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

 

1.72

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

 

1.73

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

 

6

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1.74

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

 

1.75

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

ARTICLE 2

BUILD-OUT, GOVERNANCE AND FEE STRUCTURE

 

2.1

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.

 

2.2

Equipment.

 

  (a)

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.

 

  (b)

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

 

7

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  such calibration, maintenance and repairs during the Term, including without
limitation any replacement parts or new Translate Bio Equipment, shall be the
sole responsibility of Translate Bio, except that AMRI shall be liable for any
repair to the Translate Bio Equipment to remedy damage caused by AMRI’s gross
negligence or willful misconduct. All replacement parts added or incorporated
into the Translate Bio Equipment shall become the property of Translate Bio.

 

  (c)

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.

 

  (d)

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.

 

2.3

Governance.

 

  (a)

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.

 

8

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  (b)

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.

 

  (c)

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.

 

2.4

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.

 

2.5

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.

 

9

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2.6

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.

 

2.7

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.

 

2.8

Translate Bio Payments.

 

  (a)

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.

 

  (b)

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.

 

  (c)

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.

 

10

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  (d)

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.

AMRI may implement an increase in the Translate Bio Monthly Fee once annually,
on January 1 of each calendar year following the first anniversary of Build-Out
Completion, in an amount equal to three percent (3%) of the then-current
Translate Bio Monthly Fee. AMRI shall provide Translate Bio with written notice
of any such increase at least [**] prior to its effective date.

 

  (e)

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.

 

  (f)

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.

 

  (g)

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.

 

2.9

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).

 

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ARTICLE 3

DEVELOPMENT SERVICES

 

3.1

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.

 

3.2

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.

 

3.3

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.

 

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ARTICLE 4

MATERIALS

 

4.1

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.

 

4.2

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.

 

4.3

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.

 

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ARTICLE 5

DELIVERY; STORAGE

 

5.1

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.

 

5.2

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.

ARTICLE 6

QUALITY AND REGULATORY MATTERS

 

6.1

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.

 

6.2

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.

 

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6.3

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.

Translate Bio shall provide this information, and AMRI shall review, in
accordance with the following:

 

  (a)

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.

 

  (b)

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.

 

6.4

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.

 

6.5

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

 

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  Substance, Translate Bio shall immediately notify AMRI in writing and AMRI
shall provide all necessary cooperation and assistance to Translate Bio, at
Translate Bio’s expense. Translate Bio shall bear the expenses of any recall of
Drug Substance or any finished dosage form pharmaceutical product containing the
Drug Substance, and in no event shall AMRI or its Affiliates be financially
responsible for the costs of, or associated with, any such recall.

ARTICLE 7

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

7.1

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

 

  (a)

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;

 

  (b)

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;

 

  (c)

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”);

 

  (d)

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);

 

  (e)

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);

 

  (f)

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

 

  (g)

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.

 

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7.2

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

 

  (a)

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;

 

  (b)

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;

 

  (c)

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;

 

  (d)

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;

 

  (e)

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);

 

  (f)

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

 

  (g)

(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).

 

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7.3

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

 

  (a)

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.

 

  (b)

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.

 

  (c)

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.

 

  (d)

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

 

  (e)

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.

 

7.4

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.

ARTICLE 8

CONFIDENTIAL INFORMATION

8.1 Confidential Information. As used in this Agreement, the term “Confidential
Information” means any confidential or proprietary scientific, technical, trade,
business and/or financial information of a Party (the “Disclosing Party”)
provided to the other Party (the “Receiving Party”) or to which the Receiving
Party has access under this Agreement, whether such information is in oral,
written or in electronic form and whether or not it is identified as
confidential. Confidential Information of Translate Bio includes, but is not
limited to Translate Bio Existing Technology, Drug Substance-specific Program
Technology, the Master Batch Record and the Drug Substance Specifications.
Confidential Information of AMRI includes, but is not limited to AMRI Background
Technology, AMRI Program Technology, and the pricing information set forth in
this

 

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Agreement and AMRI-specific portions of Translate Bio’s Regulatory Filings.
Notwithstanding the other provisions of this Agreement, a Party’s Confidential
Information does not include information which the Receiving Party can establish
by competent proof (i) is otherwise readily available to the public through no
fault of the Receiving Party; (ii) has been rightfully received by the Receiving
Party from a third party without restrictions on disclosure and other than in
breach of any obligation to the Disclosing Party; (iii) has been independently
developed by the Receiving Party without use of the Disclosing Party’s
Confidential Information; or (iv) was known to the Receiving Party prior to its
first receipt from the Disclosing Party.

8.2 Confidentiality Obligation. The Receiving Party agrees to hold the
Confidential Information of the Disclosing Party in trust and confidence and not
to disclose such Confidential Information except (i) to those of its employees
(including employees of its Affiliates) who have a need to know such information
for purposes of performing such Party’s obligations or exercising such Party’s
rights under this Agreement and who are under obligations of confidentiality at
least as protective as those contained in this Agreement that would apply to
such information, (ii) by AMRI to third parties who are involved in performing
services under this Agreement (including, without limitation, contractors and
vendors who are providing services in connection with the Build-Out) and who are
bound by written confidentiality restrictions at least as protective as those
contained in this Agreement, (iii) by either Party to Regulatory Authorities in
connection with regulatory filings related to the Facility or to Drug Substance
Processed under this Agreement, or (iv) as otherwise approved by the Disclosing
Party in writing. The Receiving Party shall be liable for any failure by any
person or entity to whom it discloses the Disclosing Party’s Confidential
Information to comply with the restrictions on disclosure and use imposed on the
Receiving Party in this Section 8.2 and in Section 8.3, respectively.
Notwithstanding the foregoing limitations on disclosure, the Receiving Party may
disclose such Confidential Information of the Disclosing Party as is required by
any law, rule, regulation, order, decision, decree, subpoena or other legal
process to be disclosed provided that the Receiving Party shall, if legally
permitted, notify the Disclosing Party of such request promptly prior to any
disclosure so as to permit the Disclosing Party to oppose or limit such
disclosure by appropriate legal action.

8.3 Restrictions on Use. The Receiving Party agrees that it shall not use the
Disclosing Party’s Confidential Information except for purposes of fulfilling
its obligations or exercising its rights under this Agreement or as otherwise
expressly contemplated by this Agreement.

8.4 Protective Measures. In protecting the confidentiality of and avoiding
disclosure and unauthorized use of Disclosing Party’s Confidential Information,
the Receiving Party shall take at least those measures that it uses to protect
its own confidential information; however, in no event, shall less than a
reasonable standard of care be used. The Receiving Party shall immediately
notify the Disclosing Party in the event of any unauthorized use or disclosure
of the Disclosing Party’s Confidential Information of which the Receiving Party
is or becomes aware, provided that in no event shall such notification be deemed
an admission for evidentiary purposes.

8.5 Return of Confidential Information. Upon and in accordance with the written
request of the Disclosing Party, except as required by law (including any
regulatory requirements), the Receiving Party shall promptly return to
Disclosing Party or destroy all of the tangible Confidential Information of the
Disclosing Party in its possession or control, except that one (1) copy may be
retained by Receiving Party solely for record-keeping purposes and neither Party
shall have any obligation to return or destroy computer files that are created
during automatic system back-up.

 

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ARTICLE 9

INTELLECTUAL PROPERTY

9.1 Translate Bio Pre-Existing Technology. AMRI agrees that Translate Bio has
and shall retain sole and exclusive rights of ownership in and to any
Confidential Information of Translate Bio and Translate Bio Existing Technology.
AMRI does not acquire any license or other right to Confidential Information of
Translate Bio or Translate Bio Existing Technology except that Translate Bio
hereby grants AMRI a non-exclusive, fully paid-up license thereunder during the
Term for the limited purpose of carrying out its obligations under this
Agreement.

9.2 AMRI Background Technology. Translate Bio agrees that AMRI has and shall
retain sole and exclusive rights of ownership in and to any Confidential
Information of AMRI and AMRI Background Technology whether or not incorporated
into the Development Services provided under this Agreement. AMRI hereby grants
to Translate Bio a perpetual, irrevocable, fully paid-up (subject to Translate
Bio’s compliance with the payment terms set forth herein), worldwide,
sublicensable, non-exclusive license under the Confidential Information of AMRI
and the AMRI Background Technology (and any improvements thereto included in the
AMRI Program Technology) to use, sell, offer for sale and import the Drug
Substance Processed under this Agreement for any and all purposes. Except as set
forth in the preceding sentence, Translate Bio does not acquire any license or
other right to Confidential Information of AMRI or AMRI Background Technology.

9.3 Program Technology. All Drug Substance-specific Program Technology shall be
the exclusive property of Translate Bio, and AMRI shall and hereby does assign
all of its rights, title and interest in and to in Drug Substance-specific
Program Technology to Translate Bio, and to take such actions as are reasonably
requested by Translate Bio, at Translate Bio’s expense, to effect the foregoing
assignment and in connection with Translate Bio’s efforts to secure patent
protection for such Drug Substance-specific Program Technology. All AMRI Program
Technology shall be the exclusive property of AMRI, and Translate Bio agrees to
assign its rights in AMRI Program Technology to AMRI, and to take such actions
as are reasonably requested by AMRI, at AMRI’s expense, to effect the foregoing
assignment and in connection with AMRI’s efforts to secure patent protection for
such AMRI Program Technology. Each Party shall ensure that each of its employees
and contractors performing activities under this Agreement assign to such Party
all rights, title and interests that he or she acquire in any Technology arising
under this Agreement.

9.4 No Other Licenses. Except as expressly set forth in this Agreement, nothing
in this Agreement shall be deemed to grant to either Party any right or license
under any Technology of the other Party.

 

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ARTICLE 10

INDEMNIFICATION

10.1 Indemnification by AMRI. AMRI shall defend (upon Translate Bio’s written
request), indemnify and hold harmless Translate Bio, its Affiliates, and their
respective directors, officers, employees and agents (“Translate Bio
Indemnitees”) from and against any and all suits, claims, losses, demands,
liabilities, damages, costs and expenses (including reasonable attorneys’ fees)
resulting from or arising out of any suit, demand or action by any third party
(“Losses”) to the extent (i) caused by the gross negligence or willful
misconduct of any AMRI Indemnitee; (ii) arising from a claim by a third party
that AMRI Technology used in the performance of the Development Services or
Process (on its own and not in combination with any Translate Bio Materials or
Translate Bio Technology) infringes such third party’s intellectual property
right; or (iii) caused by the breach of any of AMRI’s representations,
warranties (including without limitation the Drug Substance Warranty) or
obligations under this Agreement, in each case relating to the Development
Services only; except to the extent of the amount of any Losses arising out of
claims for which Translate Bio is obligated to indemnify AMRI hereunder.

10.2 Indemnification by Translate Bio. Translate Bio shall defend, indemnify and
hold harmless AMRI, its Affiliates, and their respective directors, officers,
employees and agents (“AMRI Indemnitees”) from and against all Losses to the
extent (i) related to the marketing, sale, distribution or use of Drug
Substance, including, but not limited to, use in clinical trials (if
applicable), or any side effects, contraindications, illness, and/or death
resulting from use of the Drug Substance (whether based on strict liability,
inherent design defect, negligence, failure to warn, breach of contracts or any
other theory of liability), including, in each case, any finished dosage form
pharmaceutical product containing the Drug Substance; (ii) caused by the gross
negligence or willful misconduct of any Translate Bio Indemnitees; (iii) arising
from a claim by a third party that AMRI’s use of the Translate Bio Materials or
the Drug Substance or other intellectual property provided to AMRI by Translate
Bio infringes such third party’s intellectual property right; (iv) related to
any Drug Substance produced for a Translate Bio partner hereunder (including,
without limitation, as set forth in clauses (i)-(iii) and (v) herein); or
(v) caused by the breach of any of Translate Bio’s representations, warranties
or obligations under this Agreement, except to the extent of the amount of any
Losses arising out of claims for which AMRI is obligated to indemnify Translate
Bio hereunder.

10.3 Indemnification Procedures. In the event that either Party seeks
indemnification under the terms of Sections 10.1 or 10.2 (the “Indemnified
Party”), it shall inform the other Party (the “Indemnifying Party”) of the claim
within [**] after receipt of notice of such claim, provided that failure to
provide notice shall not eliminate the Indemnifying Party’s indemnification
obligation under this Article except to the extent the Indemnifying Party has
been prejudiced by such failure. Except as expressly set forth herein, if
(a) Translate Bio is the Indemnifying Party or (b) AMRI is the Indemnifying
Party and Translate Bio has requested in writing that AMRI defend against such
claim, then the Indemnifying Party shall have the right to assume sole direction
and control of the defense and settlement of any indemnified claim, provided
that if the Indemnifying Party does not assume direction and control of the
defense and settlement, the Indemnified Party shall do so, provided that such
defense and settlement shall be, in both cases, solely at the Indemnifying
Party’s cost. The Indemnified Party shall cooperate as requested by, and at the
expense of, the

 

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Indemnifying Party, in the defense of the claim. The Indemnifying Party shall
not settle or otherwise compromise any claim or suit in any manner which
requires the Indemnified Party to provide any consideration, admit fault or take
any other action that would be binding on such Indemnified Party without the
prior written consent of the Indemnified Party. The Indemnifying Party shall not
have any obligation to the Indemnified Party under this Article 10 for any claim
settled by the Indemnified Party without the Indemnifying Party’s prior written
consent.

10.4 Patent Litigation. Notwithstanding the provisions of Section 10.3,
Translate Bio shall have the exclusive right and obligation to defend and
control any patent litigation that is initiated or pursued relating to the
manufacture, use, sale or marketing of the Drug Substance (including any
finished dosage form pharmaceutical product containing the Drug Substance), or
to bring and control any declaratory judgment action with respect thereto.
Translate Bio shall pay the costs and expenses associated with any such patent
litigation defended, brought or controlled by Translate Bio.

10.5 Litigation Support. In the event a subpoena or other court order requiring
personal appearance or production of documents is received by a Party (the
“Subpoenaed Party”) in respect of litigation that the other Party is involved in
and to which the Subpoenaed Party is not a party, the other Party agrees that
the Subpoenaed Party shall obtain its own counsel and the other Party agrees to
indemnify the Subpoenaed Party from and against any and all costs and expenses
(including reasonable legal fees and expenses) reasonably relating to responding
to such subpoena and any required internal investigations. In the event a Party
(the “Litigating Party”) requests the other Party’s assistance in any litigation
that such Litigating Party is involved in and to which the other Party is not a
party (which assistance may include, without limitation, production of
documents), the Litigating Party all pay the other Party for any agreed-to
assistance at the other Party’s then-current rates as determined based on timing
of the request, resource demand, and any business disruption that may be caused
by such request.

ARTICLE 11

INSURANCE

11.1 AMRI. AMRI shall, at its own cost and expense, obtain and maintain in full
force and effect the following insurance during the Term: (i) Commercial General
Liability insurance with per-occurrence and general aggregate limits of not less
than $[**]; (ii) Products and Completed Operations Liability Insurance with
per-occurrence and general aggregate limits of not less than $[**]; (iii)
Workers’ Compensation and Employer’s Liability Insurance with statutory limits
for Workers’ Compensation and Employer’s Liability insurance limits of not less
than $[**]; and (iv) Professional Services Errors & Omissions Liability
Insurance with per claim and aggregate limits of not less than $[**] covering
sums that AMRI becomes legally obligated to pay as damages resulting from claims
made by Translate Bio for errors or omissions committed in the conduct of the
services outlined in the Agreement. In the event that any of the required
policies of insurance are written on a claims made basis, then such policies
shall be maintained during the entire Term and for a period of not less than
[**] following the termination or expiration of this Agreement. AMRI shall
furnish evidence of insurance for all of the above noted policies to Translate
Bio within a reasonable time following written request by Translate Bio. Each
insurance policy that is required under this Article shall be obtained from an
insurance carrier with an A.M. Best rating of at least A- VII. For clarity, the
limits of any insurance coverage shall not limit any liability AMRI may have
under this Agreement.

 

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11.2 Translate Bio Insurance. Translate Bio shall, at its own cost and expense,
obtain and maintain in full force and effect the following insurance during the
Term: (i) Products Liability Insurance with per-occurrence and general aggregate
limits of not less than $[**]; (ii) Workers’ Compensation and Employer’s
Liability Insurance with statutory limits for Workers’ Compensation and
Employer’s Liability insurance limits of not less than $[**]; (iii) All Risk
Property Insurance, including transit coverage, in an amount equal to full
replacement value covering Translate Bio’s property (including, without
limitation, the Translate Bio Equipment and the Translate Bio Materials) while
it is at the Facility or in transit to or from the Facility. In the event that
any of the required policies of insurance are written on a claims made basis,
then such policies shall be maintained during the entire Term and for a period
of not less than [**] following the termination or expiration of this Agreement.
Translate Bio shall cause AMRI to be named as an additional insured under such
policies and shall provide AMRI proof of such upon request. Translate Bio shall
furnish certificates of insurance for all of the above noted policies to AMRI
within a reasonable time following written request by AMRI. Each insurance
policy that is required under this Article shall be obtained from an insurance
carrier with an A.M. Best rating of at least A- VII. For clarity, the limits of
any insurance coverage shall not limit any liability Translate Bio may have
under this Agreement.

ARTICLE 12

TERM AND TERMINATION

12.1 Term. This Agreement shall commence on the Effective Date and, unless
terminated in accordance with this Article 12, shall continue in effect for five
(5) years after Build-Out Completion (the “Initial Term”). In addition,
Translate Bio shall have the right to extend the Term for an additional three
(3) year period (the “Renewal Term,” and together with the Initial Term, the
“Term”) upon at least one year’s notice prior to the expiration of the Initial
Term at prevailing commercially reasonable rates mutually agreed between the
Parties during such notice period.

12.2 Termination by Either Party.

(a) Material Breach. Either Party may terminate this Agreement effective upon
[**] prior written notice to the other Party, if the other Party commits a
material breach of this Agreement and fails to cure such breach (if it is
curable) or make commercially reasonable progress towards a timely resolution
(if it is curable) by the end of such [**] period; provided, however, that
failure to pay amounts due under this Agreement within [**] after such payments
are due (as set forth in Section 2.8) shall constitute cause for termination of
this Agreement [**] after AMRI furnishes Translate Bio with a written demand, or
at AMRI’s discretion, AMRI shall be relieved of any further obligation to
perform under this Agreement (including the Suite Retention obligation) until
all outstanding payments are brought current.

(b) Bankruptcy. Either Party may terminate this Agreement effective upon written
notice to the other Party, if the other Party becomes insolvent or admits in
writing its inability to pay its debts as they become due, files a petition for
bankruptcy, has a petition for bankruptcy filed against it that has not been
dismissed or stayed within [**] after filing, makes an assignment for the
benefit of its creditors or has a receiver, trustee or other court officer
appointed for its properties or assets.

 

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12.3 Termination for Convenience. Except as set forth in Section 12.7, following
the date that is thirty-six (36) months from payment by Translate Bio of the
first Translate Bio Monthly Fee hereunder (the “Initial Three Year Period”),
Translate Bio may elect to terminate this Agreement at any time during the
remaining Term. In the event that Translate Bio elects to terminate pursuant to
the foregoing sentence, Translate Bio shall pay a lump-sum payment to AMRI in
the amount of six million U.S. dollars ($6,000,000) within [**] of such
termination election, in addition to all other applicable termination payment
obligations set forth in Section 12.4 below (other than the Make-Whole Payment).

12.4 Translate Bio Obligations Upon Termination. In the event of a termination
by AMRI pursuant to either Section 12.2(a) or 12.2(b) and/or in the event that
this Agreement is rejected by Translate Bio pursuant to section 365 of the
United States Bankruptcy Code, AMRI shall be entitled (as liquidated damages for
loss of a bargain and not as a penalty) to a lump-sum payment from Translate Bio
equivalent to (i) the Translate Bio Monthly Fee, multiplied by the remaining
months in the Initial Three Year Period, plus (ii) six million U.S. dollars
($6,000,000) (the “Make-Whole Payment”). For the avoidance of doubt, in the
event termination occurs after the Initial Three Year Period, the Make-Whole
Payment shall equal six million U.S. dollars ($6,000,000). In addition,
Translate Bio shall make payment for any other outstanding invoices, work in
progress or unused Raw Materials (in each case, which is not covered by the
Translate Bio Monthly Fee) (together with the Make-Whole Payment, the “Translate
Bio Termination Payment”). In the event of any such termination by AMRI or
Translate Bio, Translate Bio have no further right to the Suite Retention. The
Translate Bio Termination Payment shall constitute part of Translate Bio’s
obligations under this Agreement for all purposes, and is intended by the
Parties hereto to be taken into account and included in any calculation of the
value of the claim represented by such obligations in any plan of reorganization
or other definitive determination of distributable value in any proceeding under
the bankruptcy code of the United States or any other liquidation,
conservatorship, receivership, insolvency, reorganization, or similar debtor
relief laws of the United States or other applicable jurisdictions.

12.5 AMRI Obligations Upon Termination or Expiration. In the event of any
termination of this Agreement, AMRI shall, subject to receipt of applicable
payments in full from Translate Bio, including without limitation those set
forth in Section 12.4, deliver to Translate Bio, in accordance with Translate
Bio’s written request, any Drug Substance, Raw Materials, work-in-process and
deliverables in AMRI’s possession. In addition, and subject to receipt of
applicable payments in full from Translate Bio, including without limitation
those set forth in Section 12.4, AMRI shall make available to Translate Bio any
data generated in the course of performing the Development Services up to the
effective date of termination.

12.6 Effect of Termination on Cleanroom Suites. Following the expiration or
termination of this Agreement and the removal of the Translate Bio Equipment,
nothing shall restrict or prevent AMRI from using the Cleanroom Suites for other
parties, in its sole discretion, subject to Article 8.

 

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12.7 Change of Control of Translate Bio. In the event of a change of control of
Translate Bio or any assignment of this Agreement by Translate Bio without
AMRI’s prior written consent, (a) the rights set forth under Section 12.3
(Termination for Convenience) shall be null and void, and (b) the Make-Whole
Payment set forth in Section 12.4 shall be revised to equal (i) the Translate
Bio Monthly Fee, multiplied by the remaining months in the initial 5-year period
following Build-Out Completion, plus (ii) six million U.S. dollars ($6,000,000).
For purposes of this Section 12.7, change of control shall mean the sale of all
or substantially all of the assets of Translate Bio (or any of its Affiliates);
or any merger, consolidation or acquisition of Translate Bio effecting any
change in the ownership of more than fifty percent (50%) of the voting capital
stock of Translate Bio in one or more related transactions, including without
limitation, an initial public offering.

ARTICLE 13

LIMITATIONS OF LIABILITY

13.1 EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 3.1 AND 4.1 OF THIS AGREEMENT,
AMRI SHALL HAVE NO LIABILITY FOR THE COST OF, OR LOSS OR DAMAGE TO, TRANSLATE
BIO MATERIALS, AT ANY TIME, WHETHER OR NOT SUCH TRANSLATE BIO MATERIALS ARE
INCORPORATED INTO DRUG SUBSTANCE.

AMRI EXPRESSLY DISCLAIMS AND MAKES NO WARRANTY OR REPRESENTATION, EXPRESS OR
IMPLIED, OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR OTHERWISE
WITH RESPECT TO THE NEW CLEANROOM SUITES. AMRI IS NOT RESPONSIBLE NOR LIABLE FOR
ANY DIRECT, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR LOSSES OF
TRANSLATE BIO OR ANY THIRD PARTY RESULTING FROM INSTALLATION OF THE CLEANROOM
SUITES.

13.2 PRIOR TO PAYMENT OF THE FIRST TRANSLATE BIO MONTHLY FEE, AMRI SHALL HAVE NO
LIABILITY TO TRANSLATE BIO PURSUANT TO THIS AGREEMENT. FOLLOWING PAYMENT OF THE
FIRST TRANSLATE BIO MONTHLY FEE, AMRI’S AGGREGATE LIABILITY UNDER THIS AGREEMENT
SHALL IN NO EVENT EXCEED [**] PERCENT ([**]%) OF THE TOTAL FEES PAID BY
TRANSLATE BIO TO AMRI, MINUS ANY THIRD-PARTY PASS THROUGH EXPENSES, FOR THE
TWELVE (12) MONTHS IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO THE LIABILITY.

13.3 NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES OF THE OTHER PARTY OR ITS RELATED INDEMNIFIED
PARTIES ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, INCLUDING WITHOUT
LIMITATION, LOSS OF REVENUES, PROFITS OR DATA, OR PENALTIES ARISING UNDER THIRD
PARTY CONTRACTS, WHETHER IN CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING WAIVER SHALL IN NO
EVENT LIMIT A PARTY’S INDEMNITY OBLIGATIONS HEREUNDER.

 

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13.4 THE LIMITATIONS OF LIABILITY CONTAINED IN THIS ARTICLE 13 SHALL IN NO EVENT
LIMIT A PARTY’S LIABILITY FOR ITS GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

13.5 THE LIMITATIONS SET FORTH IN THIS ARTICLE SHALL APPLY NOTWITHSTANDING ANY
FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

ARTICLE 14

NOTICE

All notices and other communications hereunder shall be in writing and shall be
deemed given: (A) when delivered personally; (B) when received or refused, if
mailed by registered or certified mail (return receipt requested), postage
prepaid; or (C) when delivered if sent by express courier service with delivery
confirmation, to the Parties at the following addresses (or at such other
address for a Party as shall be specified by like notice; provided, that notices
of a change of address shall be effective only upon receipt thereof):

 

To Translate Bio:   Translate Bio, Inc.   29 Hartwell Avenue   Lexington, MA
02421   Attn: Ronal Renaud With a copy to:   Translate Bio, Inc.   29 Hartwell
Avenue   Lexington, MA 02421   Attn: General Counsel To AMRI:   Albany Molecular
Research, Inc.   26 Corporate Circle   Albany, New York 12212   Attn: Dave
Stevens With a copy to:   Albany Molecular Research, Inc.   26 Corporate Circle
  Albany, New York 12212   Attn: Legal Department

 

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ARTICLE 15

MISCELLANEOUS

15.1 Entire Agreement; Amendments. This Agreement, the attachments, exhibits and
any amendments thereto constitute the entire understanding between the Parties
and supersede any contracts, agreements or understanding (oral or written) of
the Parties with respect to the subject matter hereof, including without
limitation the Master Services Agreement dated February 25, 2017 between AMRI
and Translate Bio (as the successor to RaNA Development, Inc.) and the Letter
Agreement. No term of this Agreement may be amended except upon written
agreement of both Parties, unless otherwise provided in this Agreement.

15.2 Captions. The captions in this Agreement are for convenience only and are
not to be interpreted or construed as a substantive part of this Agreement.

15.3 Further Assurances. The Parties agree to execute, acknowledge and deliver
such further instruments and to take all such other incidental acts as may be
reasonably necessary or appropriate to carry out the purpose and intent of this
Agreement.

15.4 No Waiver. Failure by either Party to insist upon strict compliance with
any term of this Agreement in any one or more instances will not be deemed to be
a waiver of its rights to insist upon such strict compliance with respect to any
subsequent failure.

15.5 Severability. If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining
terms of this Agreement will continue in full force and effect.

15.6 Independent Contractors. The relationship of the Parties is that of
independent contractors, and neither Party will incur any debts or make any
commitments for the other Party except to the extent expressly provided in this
Agreement. Nothing in this Agreement is intended to create or will be construed
as creating between the Parties the relationship of joint ventures, co-partners,
employer/employee or principal and agent.

15.7 Successors and Assigns. This Agreement will be binding upon and inure to
the benefit of the Parties, their successors and permitted assigns. Neither
Party may assign this Agreement, in whole or in part, without the prior written
consent of the other Party, except (i) that either Party may, without the other
Party’s consent, assign this Agreement to an Affiliate or to a successor to
substantially all of its business or assets, subject to Section 12.7. No
assignment of this Agreement shall be effective unless (a) such assignment
complies with the preceding sentence and (b) the assignee agrees in a writing
furnished to the other Party within [**] after such assignment to be bound by
the terms of this Agreement.

15.8 Governing Law. This Agreement shall be governed by and construed under the
laws of the Commonwealth of Massachusetts, excluding its conflicts of law
provisions.

15.9 Dispute Resolution/ Arbitration. Any claim or controversy between the
Parties that arises out of this Agreement or breach thereof (a “Dispute”) shall
be resolved in accordance with the procedures specified in this Section 15.9,
which shall be the sole and exclusive procedures for the resolution of any such
Disputes (except for disputes relating to the Build-Out which shall initially be
addressed through the procedure set forth in Section 2.3 and shall follow the
procedure set forth herein when such dispute is escalated to the Chief Executive
Officer of each Party). The Parties shall first attempt in good faith to resolve
any Dispute promptly by negotiations between the Chief Executive Officer of each
Party. Any Dispute that has not been resolved by negotiation as provided

 

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in the foregoing sentence within [**] after escalation to the Chief Executive
Officer of each Party (which escalation shall be documented in writing) will be
resolved by binding arbitration, unless the Parties mutually agree to an
extended period of negotiation. The arbitration will be conducted by one
arbitrator, who will be appointed pursuant to the agreement of the Parties
within [**] after filing, or if the Parties are unable to agree on an arbitrator
within [**] after filing, pursuant to the Commercial Arbitration Rules and
Mediation Procedures of the American Arbitration Association (“AAA”). The
arbitration will be held in New York, New York and will be conducted in
accordance with the Commercial Arbitration Rules and Mediation Procedures of the
AAA, except that the rules set forth in this Section 15.9 will govern such
arbitration to the extent they conflict with the rules of the Commercial
Arbitration Rules and Mediation Procedures of the AAA. Time is of the essence
for any arbitration under this Agreement and arbitration hearings shall take
place within [**] after filing and awards rendered within [**] after filing. The
arbitrator shall agree to these limits prior to accepting appointment. In the
arbitration, Massachusetts law will govern, except to the extent that those laws
conflict with the Commercial Arbitration Rules and Mediation Procedures of the
AAA and the provisions of this Section 15.9. The disclosure rules provided for
in the AAA Commercial Arbitration Rules shall govern. The arbitrator shall not
award damages in any arbitration initiated under this Section 15.9 that conflict
with the limitations set forth in Article 13. The arbitrator may award to the
prevailing Party, if any, as determined by the arbitrator, all of their costs
and fees. “Costs and fees” mean all reasonable pre-award expenses of the
arbitration, including the arbitrators’ fees, administrative fees, travel
expenses, out-of-pocket expenses such as copying and telephone, court costs,
witness fees, and reasonable attorneys’ fees. Except as may be required by law
or regulation, neither a Party nor an arbitrator may disclose the existence,
content, or results of any arbitration hereunder without the prior written
consent of both Parties. In the event a person fails to comply with the
procedures in any arbitration in a manner deemed material by the arbitrator, the
arbitrator will fix a reasonable period of time for compliance and, if the
person does not comply within said period, a remedy deemed just by the
arbitrator, including an award of default, may be imposed. The determination of
the arbitrator will be final and binding on Translate Bio and AMRI. Judgment
upon the award rendered by the arbitrator may be entered in any court having
jurisdiction thereof.

15.10 Equitable Relief. Each Party acknowledges and agrees that the other Party
would be damaged irreparably in the event any of the provisions of this
Agreement (including Article 8) are not performed in accordance with their
specific terms or otherwise are breached. Accordingly, notwithstanding
Section 15.9, each Party agrees that the other Party shall be entitled to an
injunction or other equitable relief to prevent breaches of the provisions of
this Agreement and to enforce specifically this Agreement and the terms and
provisions hereof (except if such specific enforcement would require AMRI to
violate any Applicable Laws) in any action instituted in any court of the United
States or any state thereof having jurisdiction over the Parties and the matter,
in addition to any other remedy to which it may be entitled, at law or in
equity.

15.11 Counterparts. This Agreement may be executed in one or more counterparts,
each of which will be deemed an original but all of which together will
constitute one and the same instrument. Any photocopy, PDF or electronic
reproduction of the executed Agreement shall constitute an original.

 

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15.12 Publicity. Neither Party will make any press release or other public
disclosure regarding this Agreement or the transactions contemplated hereby
without the other Party’s express prior written consent, except as required
under Applicable Law (including the U.S. federal securities laws) or by any
governmental agency, in which case the Party required to make the press release
or public disclosure shall use commercially reasonable efforts to obtain the
approval of the other Party as to the form, nature and extent of the press
release or public disclosure prior to issuing the press release or making the
public disclosure.

15.13 Setoff. Without limiting AMRI’s rights under law or in equity, AMRI and
its Affiliates, parent or related entities, collectively or individually, may
exercise a right of set-off against any and all amounts due to AMRI from
Translate Bio. For purposes of this Section 15.13, AMRI, its Affiliates, parent
or related entities shall be deemed to be a single creditor.

15.14 Survival. The rights and obligations of the Parties shall continue under
Articles 8 (Confidential Information), 9 (Intellectual Property), 10
(Indemnification), 11 (Insurance) to the extent expressly stated therein, 13
(Limitations of Liability), 14 (Notice), and 15 (Miscellaneous), notwithstanding
expiration or termination of this Agreement.

15.15 Force Majeure. Except as to payments required under this Agreement,
neither Party shall be liable in damages for, nor shall this Agreement be
terminable or cancelable by reason of, any delay or default in such Party’s
performance hereunder if such default or delay is caused by events beyond such
Party’s reasonable control including, but not limited to, acts of God,
regulation or law or other action or failure to act of any government or agency
thereof (excluding any action or failure to act which relates specifically to
the Drug Substance), war or insurrection, civil commotion, destruction of
production facilities or materials by earthquake, fire, flood or storm, labor
disturbances, epidemic, or failure of suppliers, public utilities or common
carriers; provided however, that the Party seeking relief hereunder shall
immediately notify the other Party of such cause(s) beyond such Party’s
reasonable control. The Party that may invoke this Section shall use all
reasonable endeavors to reinstate its ongoing obligations to the other Party. If
the cause(s) shall continue unabated for [**], then both Parties shall meet to
discuss and negotiate in good faith what modifications to this Agreement should
result from this force majeure.

15.16 Personal Data Protection. Each Party acknowledges and agrees, and hereby
expressly consents, as follows: (i) in the performance of this Agreement, and
the delivery of any documentation hereunder, Personal Data may be generated,
disclosed to a Party, and may be incorporated into files processed by either
Party or by the Affiliates of either Party; (ii) Personal Data will be stored as
long as such data is necessary for the performance of this Agreement, as well as
for maintaining historical records; (iii) it represents and warrants that it has
all legal right and authority to disclose any Personal Data of any Third Party
it discloses to the other Party, and that it has obtained the necessary consents
from the relevant Third Party data subjects to so disclose such Personal Data;
(iv) it has been informed of the existence of its right to request access to,
removal of or restriction on the processing of its Personal Data, as well as to
withdraw consent at any time; and (v) it acknowledges its right to file a
complaint with the Personal Data supervisory authority in the relevant
jurisdiction. As used herein, “Personal Data” shall be as defined in Article 4
of Regulation (EU) 2016/679 of the European Parliament and of the Council of
27 April 2016 on the protection of natural persons with regard to the processing
of personal data and on the free movement of such data, and repealing Directive
95/46/EC (General Data Protection Regulation) or any other applicable data
protection legislation.

 

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IN WITNESS WHEREOF, the Parties have caused their duly authorized representative
to execute this Agreement effective as of the date first written above.

 

Albany Molecular Research, Inc.     Translate Bio, Inc. By:   /s/ David Stevens
    By:   /s/ Ronald C. Renaud, Jr.

Name:   David Stevens     Name:   Ronald C. Renaud, Jr. Its:   Sr. Vice
President, Drug Product     Its:   CEO

 

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