[*] = Certain confidential information contained in this document, marked by
brackets, is omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

Exhibit 10.5

 

AMENDED AND RESTATED AMENDMENT NO. 2 TO DEVELOPMENT AND MANUFACTURING SERVICES
AGREEMENT

This Amended and Restated Amendment No. 2 to the Development and Manufacturing
Services Agreement (“Amended and Restated Second Amendment”) is made and entered
into, effective as of November 4, 2018 (the “Amended and Restated Second
Amendment Effective Date”), by and between Cognate BioServices, Inc., a Delaware
corporation with an office at 7513 Connelly Drive, Suite I, Hanover, MD 21076
(“Manufacturer”), and Atara Biotherapeutics, Inc., a Delaware corporation
located at 611 Gateway Boulevard, Suite #900, South San Francisco, CA 94080
(“Atara”). Each of Atara and Manufacturer are referred to in this Amended and
Restated Second Amendment as a “party” and together, the “parties.”

Background

WHEREAS, the Parties have entered into that certain Development and
Manufacturing Services Agreement (the “Original Services Agreement”) effective
as of August 10, 2015 (the “Effective Date”), pursuant to which Atara engaged
Manufacturer to perform certain process development and manufacturing services
in relation to Atara’s products, as further described in individual work orders
entered into thereunder (the “Services”, as further defined in the Services
Agreement);

WHEREAS, the Parties entered into the First Amendment to the Services Agreement
effective December 21, 2017 (the “First Amendment”) to provide for Atara’s [ * ]
of certain Services at Manufacturer’s facility;

WHEREAS, the Original Services Agreement, as amended by the First Amendment, is
referred to in this Amended and Restated Second Amendment as the “Services
Agreement”; and

WHEREAS, as of May 4, 2018 (the “Second Amendment Effective Date”), the Parties
entered into the Second Amendment to the Services Agreement (the “Second
Amendment”) to further revise certain terms of the Services Agreement;

WHEREAS, the Parties have agreed to amend and restate the Second Amendment in
its entirety to revise certain other terms of the Services Agreement as of the
Amended and Restated Second Amendment Effective Date; and

WHEREAS, Section 15.7 of the Services Agreement provides that the Services
Agreement may only be modified by a writing signed by authorized representatives
of each Party.

NOW, THEREFORE, the Parties desire, for good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, to amend and restate
the Second Amendment in its entirety as set forth in this Amended and Restated
Second Amendment.

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214261683 v1

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Article 1
DEFINITIONS

1.1Capitalized Terms. Capitalized terms used in this Amended and Restated Second
Amendment shall have the meanings set forth in the Services Agreement, as
amended, unless otherwise defined in in this Amended and Restated Second
Amendment. Except as expressly modified by this Amended and Restated Second
Amendment, the remainder of the Services Agreement shall remain in force in
accordance with its terms and without further modification.

Article 2
AMENDMENTS

2.1Amendment of Section 1.10. Section 1.10 “Batch” of the Services Agreement is
hereby amended in its entirety as follows:

1.10 “Batch” means a specific quantity of Product that is intended to be of
uniform character and quality, within specified limits, and is produced during
the same cycle of Manufacture as defined by the applicable Batch record. For
clarity, the terms Product and Batch include [ * ] (in each case as specified in
the applicable Work Order).

2.2Amendment of Section 1.14. Section 1.14 “cGMP” of the Services Agreement is
hereby amended in its entirety as follows:

1.14 “cGMP” means current good manufacturing practices and regulations
applicable to the Manufacture of Product that are promulgated by the applicable
Authority, as are applicable to the Product, (a) [ * ]and (b) [ * ][ * ].

2.3Addition of New Section 2.4. Article 2 of the Services Agreement is hereby
amended by adding new Section 2.4 (Commercial Supply Agreement) immediately
following Section 2.3, as follows:

2.4Commercial Supply Agreement. [ * ] following the Second Amendment Effective
Date, the parties will negotiate in good faith a manufacture and supply
agreement for the commercial production and supply of Product (the “CSA”).

2.4Amendment of Section 3.2. Section 3.2 (Communications) of the Services
Agreement is hereby amended in its entirety as follows:

3.2

Communications.

(a)Operations Meetings; Production Forecasts. The parties will hold plant
leadership team meetings via teleconference or in person, on a periodic basis as
agreed upon by the Representatives. Notwithstanding the foregoing, the parties
will hold a monthly meeting of the plant leadership team members from each party
which shall be held in person, unless the parties mutually agree to hold such
meeting by teleconference (“Operations Meeting”). In each Operations Meeting,
Atara will provide a rolling written [ * ] Batch production demand forecast
(such [ * ] forecast, the “Demand Forecast”) so that Manufacturer can prepare a
production schedule and plan for the purchase of the necessary raw materials and
consumables to be provided by Manufacturer under the applicable Work Order.
Subject to

.

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the remainder of this Section 3.2, the Demand Forecast will be binding on Atara
with respect to (i) [ * ]for production of the full number of Batches of Product
set forth in such Demand Forecast (the “Committed Materials Costs”), and (ii) [
* ]. Atara will also provide to Manufacturer at each Operations Meeting, where
reasonably practicable, a non-binding rolling estimated Batch demand forecast
covering an additional [ * ](i.e. so that the total forecast covers a period of
[ * ]). Atara will be required to (A) pay, [ * ]following delivery by
Manufacturer of an invoice therefor, all Committed Materials Costs (i.e. all raw
materials necessary to Manufacture [ * ]set forth in such Demand Forecast), less
any amounts already paid by Atara (or that are the subject to invoices already
issued by Manufacturer) for Prepaid Materials Costs and (B) execute work orders
for the Manufacture of, and purchase [ * ]of the quantity (by number of Batches)
of Product requested in each such Demand Forecast. For clarity, for any
Committed Materials Costs that are also Prepaid Materials Costs that have been
approved at an Operations Meeting, the payment terms applicable to Prepaid
Materials Costs will govern. If Atara orders [ * ]set forth in the Demand
Forecast, then any raw materials and supplies purchased by Manufacturer that
have been paid for by Atara as Committed Materials Costs shall be held by
Manufacturer and used for Manufacture of Batches ordered by Atara in subsequent
periods (and covered by subsequent Demand Forecasts), provided that Manufacturer
may, upon prior written notice to Atara, dispose of or destroy any such raw
materials that are outside their shelf life, or are otherwise unsuitable for use
in Manufacture of subsequent Batches, [ * ] with respect to [ * ]. Manufacturer
shall provide an update at each Operations Meeting of the quantity of raw
materials and supplies that have been paid for by Atara as Committed Materials
Costs and are being held for application against subsequent production. The
Updated Financial Terms in Section 2 of Exhibit F sets forth the price and
payment terms applicable to each of such Batches of Product Manufactured on and
after the Second Amendment Effective Date (each such Batch for which Manufacture
is commenced after the Second Amendment Effective Date, a “Price Adjusted
Batch”).

(b)Manufacturer Operations Meeting Reports. In each Operations Meeting,
Manufacturer will provide (i) a report identifying the number of (A) Final Batch
Dispositions and any (B) [ * ]Batches produced in the preceding calendar
month(s), (ii) a [ * ], (iii) a [ * ] forecast of expected costs of raw
materials to be provided by Manufacturer under the applicable Work Order (the
“Raw Materials Cost Forecast”), (iv) operational and quality metrics as may be
mutually agreed to by the parties, and (v) as set forth in the applicable Work
Order, such other reports as Atara may reasonably request from time to time.
Each party will cover its own expenses with respect to the attendance of all
Operations Meetings. Manufacturer will make written reports to Atara to the
extent and as specified in the applicable Work Order and as required in
connection with any Operations Meeting (including for the purposes of reporting
on (i) through (v) of this Section 3.2(b)).

2.5Production Forecasts. Without limiting Atara’s obligations to provide the
Demand Forecast (and the rolling non-binding forecast of production) at each
Operations Meeting, as set forth above, within [ * ]following the Second
Amendment Effective Date, Atara will provide to Manufacturer a non-binding
forecast of its estimated production requirements for Product on a [ * ]during
the [ * ]period immediately following the Second Amendment Effective Date,
prepared in good faith and on reasonable grounds, and reflecting Atara’s
commercially reasonable estimate of its needs for Product over the applicable
period.

 

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2.6Amendment of Section 4.1. Section 4.1 (Supply of Materials) of the Services
Agreement is hereby amended in its entirety as follows:

4.1Supply of Materials. Manufacturer will supply, in accordance with the payment
schedule(s) included in the applicable Work Order and in accordance with the
relevant approved raw material specifications, all materials to be used by
Manufacturer in the performance of Services under a Work Order other than the
Atara Materials specified in such Work Order. Without limiting the foregoing,
any such materials that the parties, at an Operations Meeting, mutually agree
require prepayment will be subject to the Updated Financial Terms set forth in
Section 2 of Exhibit F. Atara or its designees will provide Manufacturer with
the Atara Materials in accordance with the schedule established at the
applicable Operations Meeting. Manufacturer agrees (a) to acknowledge receipt of
all Atara Materials received; (b) not to provide Atara Materials to any third
party without the express prior written consent of Atara; (c) not to use Atara
Materials for any purpose other than conducting the Services, and without
limiting the generality of the foregoing, will not analyze, characterize, modify
or reverse engineer any Atara Materials or take any action to determine the
structure or composition of any Atara Materials unless required pursuant to a
signed Work Order (or necessary to confirm that all applicable standards are
met, solely in connection with an Investigational Process and with Atara’s prior
written consent); and (d) to destroy or return to Atara all unused quantities of
Atara Materials according to Atara’s written directions and at Atara’s sole cost
and expense.

2.7Amendment of Section 6.2. Section 6.2 (Provision of Records) of the Services
Agreement is hereby amended it its entirety as follows:

6.2Provision of Records. If, based upon such tests and documentation review, a
Batch of Product conforms to the Specifications and was Manufactured according
to cGMP

(if applicable) and the Manufacturing Process, then a Certificate of Compliance
(or other applicable disposition form) will be completed and approved by the
quality assurance department of Manufacturer. Batches for which Manufacture
commenced prior to the Second Amendment Effective Date will be invoiced in
accordance with the applicable Work Order and Price Adjusted Batches will be
invoiced in accordance with Sections 7 and 8 of the Updated Financial Terms in
Exhibit F. This Certificate of Compliance (or other applicable disposition
form), a Certificate of Analysis, the Specifications, and a complete and
accurate copy of the Batch records including those items set forth on Exhibit E
(collectively, the “Batch Documentation”) for each Batch of Product will be
delivered by Manufacturer to Atara electronically.

2.8Amendment of Section 6.3. (Review of Batch Documentation) of the Services
Agreement is hereby amended it its entirety as follows:

6.3Review of Batch Documentation. Each party will review the Batch Documentation
for each Batch of Product and may test samples of the Batch of Product against
the Specifications. Atara will notify Manufacturer in writing of its acceptance
or rejection of such Batch based on [ * ] commencing upon Atara’s receipt of the
Batch Documentation relating to such Batch. Each party will use commercially
reasonable efforts to review the Batch Documentation within [ * ] following
receipt. During this review

 

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period, the parties agree to respond promptly, but in any event within [ * ], to
any reasonable inquiry or request for a correction or change by the other party
with respect to such Batch Documentation.

2.9Amendment of Section 6.5. Section 6.5 (Disputes) of the Services Agreement is
hereby retitled as “Non-Conforming Product; Disputes” and is amended in its
entirety as follows:

 

6.5

Non-Conforming Product; Disputes.

(a)Upon Atara’s receipt and review of the Batch Documentation within the time
period set forth in Section 6.3, Atara shall in accordance with Section 6.3
notify Manufacturer in writing if Atara believes, in good faith and based on
reasonable grounds that any Batch (i) fails to conform to the Specifications,
(ii) was not Manufactured in compliance with cGMP (if applicable) or (iii) was
not Manufactured in compliance with the Manufacturing Process (as modified by
any Planned Deviations, if any, that were preapproved in writing by Atara) (such
Batch, a “Non-Conforming Batch”). Non-Conforming Batches shall be addressed in
accordance with the remainder of this Section 6.5 and Section 6.6.

(b)If a Batch is a Non-Conforming Batch, then a root cause analysis on such
Non-Conforming Batch will be undertaken in accordance with subsection (c) below
(the “Investigational Process”). [ * ] for Product that is a Non-Conforming
Batch within the time frame required under the applicable Work Order, with the
remainder of such invoiced amount held pending the determination of an
Investigational Process. Payment of an invoice by Atara will not constitute a
waiver of remedies available to Atara under Section 6.6, except for claims that
a Batch is or was a Non-Conforming Batch where Product in such Batch is or was
approved for Final Disposition (as defined in Exhibit E).

(c)Without limiting subsection (b) above, the parties agree that any
Non-Conforming Batch (or where the parties cannot agree, any Batch that either
party believes to be Non-Conforming) will first be reviewed through the
Investigational Process by a joint “Investigation Team” made up of [ * ]. If the
Investigation Team is unable to make a determination of the root cause within [
* ] following identification of the Non-Conforming Batch (or submission of a
disputed Batch to the Investigational Process for determination of whether it is
Non-Conforming), an analysis and review will be performed by the joint
“Materials Review Board.” The Materials Review Board shall [ * ]. Either Party
may make changes to their members on the Materials Review Board at any time on
written notice to the other party, provided that any such replacement shall be
of equivalent experience and seniority. This Materials Review Board shall be
responsible for making the determination of the root cause. If the Materials
Review Board cannot agree as to the root cause of the non-conformance in the
Non-Conforming Batch and believe that additional investigational processes are
needed to make such determination, the Parties may mutually agree to conduct
such additional investigations and to return such Non-Conforming Batch for
consideration by the joint Materials Review Board with the results of such
additional investigations, if any. If the Materials Review Board cannot agree on
the root cause (with or in absence of such additional investigations) within [ *
] following its first consideration (or such further consideration if additional
investigations are conducted), then any dispute shall be referred for final
binding resolution to a [ * ](the “Quality Expert”). The parties

 

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will mutually agree on the Quality Expert, or if unable to agree, each party
will [ * ]with which neither party has an existing or prior contractual
relationship, to serve as the Quality Expert and one of such candidates will be
selected, at random (in a blind drawing), to serve as the Quality Expert. Each
candidate proposed to serve as such Quality Expert shall have [ * ]. As
necessary or appropriate to permit the Quality Expert to evaluate the root cause
of the non-conformance and make a determination, the parties will provide the
Quality Expert with the defined terms, [ * ]), and the Batch Documentation. The
Quality Expert will make a determination as to [ * ]for the Batch.
Notwithstanding the foregoing, if the Quality Expert determines that [ *
]selected by the Quality Expert from among the approved or qualified vendors
utilized in the Manufacture of Product. The determination of the root cause by
such Quality Expert shall occur within [ * ]of receiving the necessary
information from the joint Materials Review Board[ * ]. The decision of the
Quality Expert will be final and binding on the parties absent manifest error,
provided that a failure by any Quality Expert to reach a determination within
such [ * ] shall not render such decision invalid or unenforceable. [ * ]. If,
however, the Quality Expert cannot establish the root cause of the
non-conformance ([ * ].

(d)Following Investigation Team and/or Materials Review Board review and/or
Quality Expert analysis set forth in subsection (c) above:

(i) A Non-Conforming Batch is a “Manufacturer Non-Conforming Batch” [ * ].

(ii)A Non-Conforming Batch is an “Atara Non-Conforming Batch” [ * ].

(e)If a Non-Conforming Batch is finally determined pursuant to this Section 6.5
(by agreement of the parties, through the Materials Review Board or the Quality
Expert, as applicable) to be (i) a Manufacturer Non-Conforming Batch, then
Section 6.6(a) shall apply or (ii) an Atara Non-Conforming Batch, then Section
6.6(b) shall apply.

(f)In addition to carrying out the Investigational Process, the parties will
meet to discuss, evaluate and analyze the implications of the failure to comply
with the Specifications, cGMP (if applicable) and/or the Manufacturing Process
and will decide whether to proceed with or to amend the applicable Work Order
via a Change Order, or to terminate such Work Order.

(g)Following the execution of this Amended and Restated Second Amendment, [ * ].
For clarity, in the absence of any other written agreement between the parties,
the parties will [ * ].

2.10Amendment of Section 6.6. Section 6.6 is hereby retitled as “Remedies for
Non-Conforming Product”, and is hereby amended in its entirety as follows:

 

6.6

Remedies for Non-Conforming Product.

(a)If the parties agree or if determined in accordance with Section 6.5 above
that a Batch of Product is a Manufacturer Non-Conforming Batch then,
Manufacturer will, [ * ]:

[ * ]

 

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For clarity, performance by Manufacturer, [ * ], of the remedy under (i) or (ii)
satisfies Manufacturer’s obligations in respect of any Manufacturer
Non-Conforming Batch.

(b)If the parties agree or if determined in accordance with Section 6.5 above
that a Batch of Product is an Atara Non-Conforming Batch, then Atara will [ * ],
and shall [ * ] after completion of the Investigational Process. Atara will pay
Manufacturer the fees, costs and expenses for such Atara Non-Conforming Batch [
* ], and Atara will not be entitled to the remedies set forth in Section 6.6(a).

(c)For clarity, unless the Non-Conforming Batch is determined to be a
Manufacturer Non-Conforming Batch pursuant to Section 6.5, and without limiting
Section 6.5(g), Manufacturer will not be responsible for [ * ]under clause
(a)(i) of this Section 6.6 [ * ]under clause (a)(ii) of this Section 6.6.

2.11Amendment of Section 8.1. Section 8.1 (Price) of the Services Agreement is
hereby amended in its entirety as follows:

8.1Price. The price of Product and/or the fees and expenses for the performance
of Services will be set forth in the applicable Work Order; provided that for
all Price Adjusted Batches, the price of Product and the fees and expenses for
the performance of Services in connection with such Price Adjusted Batch will be
governed by Sections 7 and 8 of the Updated Financial Terms set forth in Exhibit
F, unless the applicable Work Order expressly states its intention to supersede
the Updated Financial Terms. All dollar ($) amounts specified in this Agreement
are United States dollar amounts and all payments to be made under this
Agreement will be made in United States dollars.

2.12Amendment to Section 14.1. Section 14.1 of the Services Agreement is hereby
amended in its entirety as follows:

14.1Term. This Agreement will take effect as of the Effective Date and, unless
earlier terminated pursuant to this Article 14 or superseded by a CSA, [ * ].

2.13Addition of Exhibit E. Exhibit E (“Batch Disposition Requirements”) added to
the Services Agreement in the form agreed as of the Second Amendment Effective
Date and attached as Appendix 1 to this Amended and Restated Second Amendment
remains in effect.

2.14Addition of Exhibit F. Exhibit F (“Updated Financial Terms”) added to the
Services Agreement in the form agreed as of the Second Amendment Effective Date
is amended and restated as set forth in the attached Appendix 2 to this Amended
and Restated Second Amendment. The Updated Financial Terms shall only apply to
Price Adjusted Batches. To the extent the Updated Financial Terms conflict with
the payment terms set forth in the Work Order by and between Atara and
Manufacturer with an effective date of August 7, 2015, as subsequently modified
by a Change Order effective as of March 21, 2016 and amended on June 20, 2016
(“Work Order 1”), the Updated Financial Terms shall govern with respect to all
payments for Price Adjusted Batches.

Article 3
MISCELLANEOUS

 

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3.1No Waiver. Nothing in this Amended and Restated Second Amendment is intended
to operate as a waiver of any claims either Party may have against the other
Party arising prior to the date of this Amended and Restated Second Amendment
with respect to the performance of the Services or otherwise under the Services
Agreement, provided that Atara shall have no right to make a claim for refund or
replacement under Section 6.6 (as amended by the Second Amendment and as amended
and restated herein) on the basis of Non-Conformance in connection with any
Batch approved by Atara for disposition or final disposition prior to the date
hereof, and all of such claims are waived and extinguished upon execution of
this Amended and Restated Second Amendment. For clarity, the waiver in the
preceding sentence does not affect the discount set forth in Section 4 of the
Updated Financial Terms set forth in Exhibit F. Any delay in enforcing a Party’s
rights under this Amended and Restated Second Amendment or the Services
Agreement, or any waiver as to a particular default or other matter, will not
constitute a waiver of such Party’s rights to the future enforcement of its
rights under this Amended and Restated Second Amendment or the Services
Agreement, except with respect to an express written waiver relating to a
particular matter for a particular period of time signed by an authorized
representative of the waiving Party, as applicable.

3.2Miscellaneous. This Amended and Restated Second Amendment is governed by and
interpreted in accordance with the laws of the State of New York, U.S.A.,
without reference to the principles of conflicts of laws. The United Nations
Convention on Contracts for the International Sale of Goods shall not apply to
the transactions contemplated by this Amended and Restated Second Amendment.
Except as specifically amended by this Amended and Restated Second Amendment,
the terms and conditions of the Services Agreement shall remain in full force
and effect. This Amended and Restated Second Amendment may be executed in two or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Except to the extent
expressly provided herein, the Services Agreement, as amended by the Second
Amendment, and this Amended and Restated Second Amendment, including all
appendices, exhibits and schedules to each of the foregoing, together with all
Work Orders executed by the Parties, constitute the entire agreement between the
Parties relating to the subject matter of the Services Agreement and supersede
all previous oral and written communications, including all previous agreements,
between the Parties.

[Remainder of Page Intentionally Left Blank]

IN WITNESS WHEREOF, Manufacturer and Atara have executed this Amended and
Restated Second Amendment by their respective officers hereunto duly authorized,
on the day and year hereinafter written. The Parties acknowledge and agree that
the signature date may not be the Amended and Restated Second Amendment
Effective Date.

 

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Cognate BioServices, Inc.

By:       /[ * ]

Name:      [ * ]

Title:    [ * ]

 

Atara Biotherapeutics, Inc.

By:       /[ * ]

Name:      [ * ]

Title:    [ * ]

 

 

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Appendix 1

Exhibit E (to Services Agreement)

[ * ]

 

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Appendix 2

Exhibit F (to Services Agreement)

[ * ]

 

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Schedule 1

[ * ]

 

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Schedule 2

[ * ]

 

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Schedule 3

[ * ]

 

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