Exhibit 10.1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

BIOPROCESSING SERVICES AGREEMENT

 

This Bioprocessing Services Agreement dated 26 February 2014 (this “Agreement”)
between Genocea Biosciences, Inc. (“Sponsor”), a Delaware corporation, with
offices at Cambridge Discovery Park, 100 Acorn Park Drive, Cambridge, MA 02140
and FUJIFILM Diosynth Biotechnologies U.S.A., Inc., a Delaware corporation
(“Fujifilm”), having its principal place of business at 101 J. Morris Commons
Lane, Morrisville, NC 27560, (each a “Party”, collectively, the “Parties”).

 

Sponsor desires Fujifilm to perform services in accordance with the terms of
this Agreement and the Scope (as hereinafter defined) related to the production
of the Drug Substance (as defined below) for research and development and/or
clinical trial uses; and Fujifilm desires to perform such services and supply
Substance to Sponsor;

 

In consideration of the above statements, which form part of this Agreement, and
other good and valuable consideration, the sufficiency and receipt of which are
hereby acknowledged, the Parties hereto agree as follows:

 

Definitions:

 

“Agreement” shall have the meaning set forth in the preamble.

 

“Alliance Manager” shall have the meaning set forth in Section 22(b).

 

“Batch” means a specific quantity of Drug Substance produced from a single Run.

 

“Batch Packet” shall mean [* * *].

 

“Batch Record” shall mean the Batch record instruction issued from the Master
Manufacturing Record for completion in production and/or completed Batch record
production instruction as the context dictates.

 

“Cell Line” shall mean the cell line for expression of the Drug Substance.

 

“Certificate of Analysis” shall mean a document prepared by Fujifilm in a
Fujifilm standard format certifying the Batch of the Drug Substance release
tests performed by Fujifilm, or Qualified Subcontractors, the specifications and
test results for each Batch, as further specified in the Quality Agreement.

 

“cGMP” shall mean the regulatory requirements for current good manufacturing
practices promulgated by the FDA under 21 C.F.R. Parts 210, 211, 600 and 610 and
ICH, Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, as the same may be amended from time to time.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

“cGMP Batch” shall mean a Batch intended to be manufactured in accordance with
cGMP.

 

“cGMP Run” shall mean a Run intended to be manufactured in accordance with cGMP.

 

“Change Order” shall have the meaning set forth in Section 7(a).

 

“Claim” shall have the meaning set forth in Section 16(a).

 

“Completion”, “Completed” and correlatives shall mean the completion by Sponsor
of Technology Transfer or the completion by Fujifilm of a Milestone, all as
defined in [* * *], Program or Scope.

 

“Completion Date” shall mean the date of Completion of a Milestone.

 

“Confidential Information” shall have the meaning set forth in Section 8(d).

 

“Conforming Product” means Drug Substance that conforms to all of the warranties
set forth in Section 17(g).

 

“Demonstration Batch” shall mean a Batch designated by Sponsor to demonstrate
scalability of the process in the Fujifilm non-cGMP process development
laboratory.

 

“Demonstration Run” shall mean a Run used to demonstrate scalability of the
process in the Fujifilm [* * *].

 

“Designated Equipment” shall mean equipment owned by Sponsor and located at the
Fujifilm Facility.

 

“Drug Substance” shall mean the active bulk component that is identified in the
applicable Scope to be manufactured by Fujifilm.

 

“Drug Product” shall mean the final dosage form which contains Drug Substance in
association with other active or inactive ingredients.

 

“Effective Date” shall mean the date of last signature.

 

“Engineering Batch” means a Batch produced from an Engineering Run, and which
may be used by Sponsor for Sponsor’s toxicology studies or otherwise in
accordance with this Agreement.

 

“Engineering Run” means a Run used for process demonstration and engineering of
some or all of the Manufacturing Process steps.

 

“Fujifilm Confidential Information” shall have the meaning set forth in
Section 8(b).

 

“Fujifilm Factor” shall mean [* * *].

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

“Fujifilm Facility” shall mean either the Fujifilm Diosynth facility in RTP,
North Carolina, USA or Billingham, UK, or both, as the context requires.

 

“Indemnified Party” shall have the meaning set forth in Section 16(c).

 

“Indemnity Claim” shall have the meaning set forth in Section 16(c).

 

“Initiation” shall mean the start of activities associated with a Milestone.

 

“Joint Steering Committee” shall have the meaning set forth in Section 22(a).

 

[* * *] means any [* * *] of a Drug Substance or Drug Product with [* * *] that
is attributed to Fujifilm’s Drug Substance(s) manufacturing activity and/or
release testing of Drug Product and [* * *] of the Batch Packet by Sponsor.

 

“Loss” shall have the meaning set forth in Section 16(a).

 

“Manufacturing Process” shall mean the process, or applicable
portion(s) thereof, for manufacturing the Drug Substances, including the
manufacture, analysis, documentation, quality evaluation, and storage of
components, intermediates and Drug Substances pursuant to this Agreement, as
mutually agreed and described in the Master Manufacturing Record, as such
process may be developed and/or changed from time to time in accordance with
this Agreement.

 

“Master Cell Bank” shall mean the [* * *] previously generated and to be
provided by Genocea.

 

“Master [* * *] Bank” shall mean the initial cGMP [* * *] stocks ([* * *]) being
generated for Genocea by a third party and to be provided to Fujifilm by
Genocea.

 

“Master Manufacturing Record”  shall mean for each Program the mutually agreed
document which sets out in detail the master production instructions for the
Manufacturing Process, as such instructions are defined in sections 6.4 and 6.5
of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Part II: Basic Requirements for Active Substances Used as Starting Materials.

 

“Milestone(s)” means any or all of the milestones set forth in the [* * *] for a
Scope.

 

“New IP” shall have the meaning set forth in section 10(a).

 

“Non-Conforming Batch” shall mean: [* * *].

 

“Non-Conforming Product” shall mean a Drug Substance which: (i) has not been
produced in accordance with cGMP; and/or (ii) does not meet the Product
Specification agreed jointly in

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

writing by Sponsor and Fujifilm in quality control documentation, and (iii) is
not in compliance with Fujifilm’s warranty in Section 17(g).

 

“Non-Manufacturing” shall mean activities that are not cGMP activities,
including Process Development Runs and Demonstration Batches.

 

“Party” or “Parties” shall have the meaning set forth in the preamble.

 

“Process Consumables” shall have the meaning set forth in the Scope and shall
include raw materials, resins and consumables.

 

“Process Development Batch” means a Batch produced from a Process Development
Run, including a Demonstration Batch.

 

“Process Development Run” means a Run used to demonstrate the transfer of
Sponsor’s then current production process to Fujifilm and/or development at
Fujifilm of the process, including a Demonstration Run.

 

“Product” shall mean any, some or all of the products listed in a Scope to be
manufactured by Fujifilm, including Drug Substances from [* * *].

 

“Product Specification” means the specifications for the Drug Product or Drug
Substance as applicable, each as set forth in quality control documentation.

 

“Production Batch” means a Batch produced from a Production Run, including an
Engineering Batch and/or cGMP Batch.

 

“Production Fee(s)” shall mean the following fees associated with a particular
Production Batch as set out in the applicable [* * *].

 

“Production Run” means a Run conducted in accordance with the Master
Manufacturing Record that is used to create Product for research and development
or for clinical use, including an Engineering Run and/or cGMP Run.

 

“Program” shall mean the services to be performed under this Agreement and the
supply of Product as more fully described in each Scope.

 

“Program Price and Payment Schedule” shall mean the schedule attached as
Appendix 3-A to this Agreement for the Scope, and additional schedules
identified as Appendix 3-B, Appendix 3-C and so on for any additional Scope.

 

“Qualified Subcontractor” shall mean a subcontractor that is a contract testing
laboratory or a cell bank manufacturer with whom Fujifilm has a signed
agreement, with provisions that protect Sponsor Confidential Information at
least as stringent as the provisions of this Agreement, and

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

that has been audited and approved as a supplier by Fujifilm’s quality assurance
department to provide the services to be subcontracted.

 

“Quality Agreement” shall mean the quality agreement attached as Appendix 2 to
this Agreement.

 

“Reservation Fee” shall mean [* * *] of the associated Production Fee(s) set
forth in the Program Price and Payment Schedule [* * *], as applicable in
accordance with Section 5(b) and/or Section 21(b)(7).

 

“Run” shall mean the activity for single complete operation of all, or a
discreet portion of (if appropriate from the context), the process (including,
if applicable, [* * *].

 

“Scope” shall mean the scope of work attached as Appendix 1-A to this Agreement
for the initial Scope, and additional schedules identified as Appendix 1-B,
Appendix 1-C and so on for any additional Scopes, each to be signed by each
Party and including the Sponsor Deliverables, Milestones, the final schedule of
stages [* * *], and timelines for the activities, as may be amended from time to
time through Change Orders.

 

“Sponsor” shall have the meaning set forth in the preamble.

 

“Sponsor Deliverables” shall have the meaning set forth in the Scope.

 

“Sponsor’s Confidential Information” shall have the meaning set forth in
Section 8(a).

 

“Start Date” shall mean the start date for a particular Milestone or Run set
forth in the [* * *] for a Scope (as may be amended by mutual agreement from
time to time as set forth in this Agreement).

 

“Technology Transfer” means, for each Scope, the transfer from Sponsor to
Fujifilm of information, data and technology as set forth in Section 2(c).

 

“Work Output” shall have the meaning set forth in Section 9(a).

 

“Working Cell Bank” shall mean the [* * *] to be generated directly from the
Master Cell Bank by Fujifilm.

 

“Working [* * *] Bank” shall mean the cGMP [* * *] stocks ([* * *]) being
generated for Genocea by a third party and to be provided to Fujifilm by
Genocea.

 

Section 1.

 

Scope of Work/Performance of Program/Acceptance of Milestones

 

a)             Fujifilm will perform the Program for Sponsor in accordance with
the terms and conditions of this Agreement, the Scope (attached as Appendix 1-A)
and the Quality

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Agreement (attached as Appendix 2).  Fujifilm shall not engage in any negligent
act or omission, which may reasonably be expected to prevent or delay the
successful execution of the Program.

 

b)             Terms defined in the terms and conditions of this Agreement shall
have same meaning when used in the Scope or Quality Agreement.  In the event of
any conflict among the components of this Agreement, the following order of
precedence shall apply:

 

1.              the terms and conditions;

2.              the Quality Agreement; and

3.              the Scope.

 

c)              As further set forth in the Scope, Fujifilm will timely provide
Sponsor with Milestones, Drug Substances and other deliverables, including Drug
Product testing, without a delay within the time periods specified in the
Program Price and Payment Schedule. Fujifilm will not deliver Product that does
not meet the applicable Product Specifications.  Delays in providing Drug
Substance solely attributable to Fujifilm will result in liquidated damages as
specified in Section 5(d) and are subject to the provisions of Section 14(a).

 

d)             Sponsor shall perform its obligations as set forth in the Scope
and Quality Agreement, shall support and cooperate with the execution of the
Program and shall not engage in any negligent act or omission, which may
reasonably be expected to prevent or delay the successful execution of the
Program.

 

(1)                                  All Non-Manufacturing deliverables listed
in the Scope and other documents that, according to Fujifilm quality systems,
require Sponsor’s approval either in a form of a signature on a document
(qualification protocols, reports, etc.) or in another format shall be reviewed
and approved [* * *] by Sponsor without a delay within the time periods
specified in Scope or Quality Agreement. Such approval shall constitute
Sponsor’s acceptance [* * *]. If Sponsor’s review is [* * *], unless Fujifilm
shall notify Sponsor within [* * *].

(2)                                  All documentation related to manufacturing
activities and cGMP testing that, according to Fujifilm quality systems, require
Sponsor’s approval either in a form of a signature on a document or in another
format shall be set forth in the Quality Agreement or otherwise communicated in
advance to Sponsor by [* * *] of the quality control documentation and shall be
reviewed by Sponsor for approval by [* * *]. If Sponsor’s review is [* * *] or
they shall constitute Sponsor delay subject to provisions of Sections 19 and
14(b).

 

e)              Following Completion of Technology Transfer, Fujifilm shall
perform the Process Development services as set forth in the applicable Scope,
and develop, confirm and/or refine processes to produce the Product and/or to
develop and/or scale-up a Manufacturing Process suitable for cGMP manufacture of
the Product. One or more Process Development Runs and one or more Engineering
Runs shall be conducted if and as mutually agreed in writing by the Parties in
Scope.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

f)               Fujifilm shall provide Sponsor with [* * *] as requested by
Sponsor. Sponsor’s representative may be present on the floor during execution
of the Engineering Run. After Completion of the Process Development Run(s), the
Parties shall mutually agree on [* * *] for [* * *] for Completion [* * *] of
the results of Engineering Batches, which shall be documented in a [* * *]
Change Order and/or manufacturing documentation. If the empirical results from
the Engineering Batches point to the need for additional work prior to
initiation of cGMP manufacturing, Fujifilm shall propose a Change Order in
accordance with Section 7(c), including a reasonable timeline for such work and
the Start Dates and Completion Dates for all subsequent Milestones. Sponsor
shall have the right to make whatever lawful use of such [* * *] as it shall
determine, providing that Product from such Batches must not be used in human
trials.

 

g)              For each Non-Manufacturing Milestone, Fujifilm shall provide
Sponsor with [* * *] at the times and as otherwise specified in the Scope and
Program timelines jointly agreed by Sponsor and Fujifilm’s Program teams in the
[* * *] and [* * *] at the Completion of each Milestone or as mutually agreed in
a Change Order.

 

(1)                                 All Non-Manufacturing deliverables that are
provided by Fujifilm require [* * *] provided to Fujifilm Alliance Manager.  If
within the [* * *] period after Sponsor’s receipt of each deliverable, or [* *
*], such deliverable will be deemed accepted by Sponsor; provided that Fujifilm
provides timely answers to information requests and resolution of issues arising
from Sponsor’s review of such deliverables so that Sponsor is able to reasonably
respond within the applicable time frame. If Fujifilm answers are not timely,
the time for Sponsor review and approval shall be extended for a reasonable
period. If Sponsor requests, [* * *] and Sponsor shall have the right to make
whatever lawful use of such [* * *] as it shall determine, providing that [* *
*] must not be used in human trials.  Fujifilm shall have the right to [* * *]
and shall notify Sponsor of this [* * *] as soon as practicable but no later
than [* * *] from Sponsor notification. Such written notice shall explain why [*
* *] with Sponsor’s findings.  Any disagreement whether [* * *] or not shall be
resolved in good faith according to the mechanism described in Section 15.

 

(2)                                  For each [* * *], Fujifilm shall use
commercially reasonable efforts to reform the deliverable and shall re-submit
the deliverable to Sponsor within [* * *], or if not reasonably possible to
complete the deliverable within [* * *], Fujifilm shall initiate the reforming
procedures within such [* * *] period and notify Sponsor of the procedures
Fujifilm has taken and will take and [* * *] and [* * *] to Sponsor as soon as
reasonable possible using commercially reasonable efforts to resubmit within [*
* *].

 

(3)                              In case of breach of warranties (including for
Non-Conforming Deliverable), under this Agreement, Sponsor may terminate in
accordance with Section 14 and

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

[* * *] shall follow the procedure in [* * *].  The terms of this
Section 1(g) are subject to Section 14.

 

h)             Fujifilm shall not subcontract, sublicense, or otherwise delegate
all or any portion of its obligation under this Agreement related directly to
handling or manipulation of Drug Substance, Drug Product or Working Cell Bank,
Master Cell Bank, Working [* * *] Bank or Master [* * *] Bank, without prior
written approval from Sponsor. For clarity, the limitation does not apply to
subcontracting by Fujifilm any activities related to upkeep of its facilities,
testing of raw materials, or testing of Product to the extent agreed in writing
in Scope or a Change Order.  Any subcontractor that would perform contract work
must be a “Qualified Subcontractor.” Fujifilm shall remain responsible and
liable for all activities of all subcontractors as if performed by Fujifilm
under this Agreement.

 

i)                 All Process Consumables used in the Manufacturing Process
shall comply with any applicable materials specifications.

 

j)                Fujifilm shall generate and/or maintain all portions of each
Master Cell Bank, Working Cell Bank, Master [* * *] Bank and/or Working [* * *]
Bank in safe and secure storage under its control in the Fujifilm Facility in
accordance with the mutually agreed storage guidelines. Fujifilm shall not use
any Master Cell Bank, Working Cell Bank, Master [* * *] Bank and/or Working [* *
*] Bank for any purpose except as authorized by this Agreement.  On Sponsor’s
request from time to time, all or any specified portion of the Cell Banks and/or
[* * *] Banks shall be returned to the Sponsor or a designee as directed by
Sponsor, at Sponsor expense.  At the conclusion of the Scope, any retained
portion of the Cell Banks and [* * *] Banks shall be returned to the Sponsor or
a designee as directed by Sponsor, at Sponsor expense.

 

Section 2.

 

Sponsor Deliverables

 

a)             As further set forth in the Scope, Sponsor will use commercially
reasonable efforts to timely provide Fujifilm with Sponsor Deliverables (as
defined in the Scope).  Failure by Sponsor to provide Sponsor Deliverables
within the timeframe set forth in the Scope may result in additional charges to
Sponsor pursuant to a Change Order or a delay in meeting Program objectives as
further described in Section 19.

 

b)             Title to Sponsor Deliverables shall remain with Sponsor. 
Fujifilm shall not sell, pledge, hypothecate, dispose of, or otherwise transfer
any interest in Sponsor Deliverables except as otherwise provided in this
Agreement, and shall use Sponsor Deliverables solely for purposes of performing
the Program in accordance with the particular Scope.  Fujifilm shall provide
safe and secure storage conditions for Sponsor Deliverables while they are at
Fujifilm’s location.

 

c)              For each Scope, Sponsor shall use commercially reasonable
efforts to transfer to Fujifilm all material information and technology
reasonably necessary for Fujifilm to

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

perform process development related to and subsequently to manufacture Product
for Sponsor (“Technology Transfer”). Specifically, Sponsor shall use
commercially reasonable efforts to (i) provide reasonable access to Sponsor’s
scientists who developed and/or are familiar with the Product and the Sponsor’s
processes, and (ii) supply Fujifilm with all Product-specific controls,
specifications, raw materials, assays, SOPs and standards.  Fujifilm shall
assign a project team of appropriately trained and experienced technical staff,
and shall use commercially reasonable efforts to accept and implement the
transferred information and materials provided by Sponsor.

 

Section 3.

 

Compliance with Government Regulations

 

a)             Fujifilm shall operate a compliant current cGMP facility located
at RTP, NC and Billingham, UK (each a “Fujifilm Facility”) pursuant to (a) the
U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.),
(b) U.S. regulations in Title 21 of the U.S. Code of Federal Regulations Parts
210, 211, 600 and 610, and (c) the EC Guide to Good Manufacturing Practice for
Medicinal Products, v.4, including relevant sections of DIR 2003/94/EC
International Conference on Harmonization (ICH) , in each case including
successor laws, regulations or guides. All Product requested by Sponsor under
this Agreement shall be manufactured solely by Fujifilm at the Fujifilm Facility
in RTP, NC.  [* * *]  In addition, Fujifilm shall perform each Program in
compliance in all respects with statutory and regulatory guidelines applicable
to the Product’s clinical phase. Fujifilm shall not permit debarred persons to
participate in any Program. Fujifilm shall undertake reasonable steps to prevent
such participation.

 

b)             Sponsor and Fujifilm each acknowledges that it has consulted with
the other Party in designing the Program in a manner consistent with current US
and EU regulatory guidelines. Notwithstanding the foregoing, neither Party
warrants that the Program and/or the Program results will satisfy the
requirements of any regulatory agencies at the time of submission of Program
results to such agencies.  Sponsor shall have the right and responsibility for
determining regulatory strategy, decision and actions to the extent relating to
the Product and Fujifilm shall have the right and responsibility for determining
regulatory strategy, decision and actions to the extent relating to (i) the
Fujifilm Facility; (ii) Fujifilm’s quality systems; (iii) any requirement
imposed on Fujifilm by a Regulatory Authority or (iv) any other commitments made
by Fujifilm prior to, on or after the Effective Date of this Agreement. 
Fujifilm shall monitor and maintain reasonable records respecting its compliance
with cGMPs, including the process of establishing and implementing the operating
procedures, equipment files, and the training of personnel as are reasonably
necessary to assure such compliance. Fujifilm hereby represents that, to
Fujifilm’s knowledge, no requirement imposed on Fujifilm by a Regulatory
Authority as of the Effective Date or any other commitments made by Fujifilm
prior to the Effective Date of this Agreement shall delay or prevent Fujifilm
from performing the Program or otherwise complying with its obligations
hereunder, and Fujifilm shall immediately notify Sponsor during the term of this
Agreement if that representation is no longer accurate on

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

an ongoing basis, in reasonable detail with a plan to immediately correct such
delay or non-compliance.

 

c)              Should such U.S. government or European Medicines Agency (“EMA”)
regulatory requirements change, Fujifilm will use reasonable efforts to satisfy
the new requirements.  In the event that compliance with such new U.S. or EMA
regulatory requirements necessitates a change in the Scope, Fujifilm will submit
to Sponsor a Change Order, as herein after defined, in accordance with Section 7
of this Agreement.

 

d)             Sponsor shall provide Fujifilm with information in Sponsor’s
possession concerning any health hazards or potential health hazards associated
with exposure to or the handling, storage, use or disposal of raw materials
and/or Product, including, without limitation, a Material Safety Data Sheet for
Product, if one exists.  In the event that any such information is updated or
corrected, Sponsor shall promptly notify Fujifilm thereof and provide Fujifilm
with the updated or corrected information.

 

e)              Subject to this Section 3, in the event of a conflict in
government regulations, the Party primarily responsible for compliance shall
determine in good faith which regulations shall be followed by Fujifilm in its
performance of the Program to comply with regulatory requirements and advance
the Program.

 

Section 4.

 

Facility Visits

 

The terms and conditions of Sponsor audits and other visits are provided in the
Quality Agreement.

 

Section 5.

 

Compensation

 

a)             Sponsor shall make the payments set forth in the [* * *] as
follows for all activities, which duration is not expected to exceed [* * *]
months: (i) on [* * *] Fujifilm will invoice Sponsor for [* * *]  of the
Milestone payment applicable to such Milestone, and (ii) on [* * *], Fujifilm
will invoice Sponsor for the remaining [* * *]  of the Milestone payment
applicable to such Milestone. Unless otherwise agreed in Scope or a Change
Order, for activities expected to last longer than six months, Fujifilm shall
issue interim invoices as follows: (1) on [* * *] Fujifilm will invoice Sponsor
for [* * *]  of the Milestone payment applicable to such Milestone, (2i) on [* *
*], Fujifilm will invoice Sponsor for [* * *] for each Milestone payment
applicable to such Milestone, and (3) on [* * *], Fujifilm will invoice Sponsor
for the remaining [* * *]  of the Milestone payment applicable to such
Milestone.

 

b)             (1)  Fujifilm shall [* * *] for Production Batch(es) in the [* *
*] in the Scope or [* * *].

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(2) For clarification, Fujifilm shall [* * *] for Non-Manufacturing Batch(es) in
the timeframe agreed in the Scope or Program Price and Payment Schedule, [* *
*].

 

c)               In addition to the Milestone amounts set forth in the Program
Price and Payment Schedule, Process Consumables purchased for the Program will
be invoiced separately as such costs are incurred by Fujifilm.  For Process
Consumables, the bill of materials for manufacturing and estimated procurement
budget shall be prepared by the Program team as specified in Scope and shall be
approved by Sponsor in writing. Sponsor agrees to pay [* * *].  Fujifilm shall
use commercially reasonable efforts to procure materials at the lowest available
price and only in the quantity necessary for program performance, unless
otherwise agreed by Sponsor. These amounts will be invoiced as they are incurred
by Fujifilm.  Within thirty (30) days of completion of all Manufacturing under
this Agreement under a Scope or early termination, Sponsor will provide Fujifilm
with written notice specifying its preferred method of disposition for any
remaining, unused raw materials and other Program Consumables, the reasonable
third party costs for which shall be borne solely by Sponsor.  In specifying its
preferred method for such disposition, Sponsor may choose from the following
three options:

 

1.              Having Fujifilm deliver remaining raw materials to Sponsor or a
designated storage site.

2.              Having Fujifilm deliver remaining raw materials to a destruction
site; or

3.              Assign ownership of remaining materials to Fujifilm at no cost,
which request Fujifilm, in its sole discretion can choose to accept or reject

 

In the event that Sponsor fails to provide written notice of its preferred
method of disposition to Fujifilm within the above thirty (30) day period,
Fujifilm will select the method of disposition, the reasonable third party costs
for which shall be borne solely by Sponsor.

 

d)              Fujifilm recognizes the importance of [* * *]. Fujifilm shall [*
* *] of the timeframe specified in the [* * *] as updated as described in
Section 5(a).  In the event that the [* * *] is not completed [* * *], in
addition to all other remedies of Sponsor under this Agreement, in equity and at
law, at Sponsor’s discretion, Sponsor may cancel all or a portion of the
affected manufacturing campaign without incurring manufacturing termination fees
under Section 21 and shall be entitled to initiate the dispute resolution
mechanism under Section 15 or terminate the Agreement in accordance with
Section 14, provided, however, that [* * *].

 

e)               All raw materials, resins and other Process Consumables used in
the Manufacturing Process shall comply with any applicable materials
specifications.

 

f)                Payments or notice that Sponsor may dispute the invoice are
due thirty (30) days from the date of receipt of invoice issued by Fujifilm
consistent with the Program Price and Payment Schedule.  Unless disputed as
provided below, late payments are subject to an interest charge of [* * *] per
annum above the prime rate on the due date as posted by the Bank of America (or
its successor). Unless within sixty (60) days of the receipt of invoice, Sponsor
has advised the Alliance Manager at Fujifilm in good faith and in writing

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

the specific basis for disputing an invoice, failure to pay an invoice within
ninety (90) days from the date of invoice may, at Fujifilm’s election,
constitute a material breach of this Agreement.  Invoices will include a summary
of activities completed during the invoice period, including activities
completed and an indication of Process Consumables purchased. For purposes of
this Section 5(f), “notice” and “in writing” includes email notification sent to
Alliance Manager at Fujifilm.

 

g)               If Sponsor is more than ninety (90) days late in paying any
undisputed amount due greater than $[* * *] (“Late Payment”), Sponsor hereby
grants a purchase money security interest to Fujifilm in an amount equivalent to
the Late Payment in material produced hereunder, Process Consumables and/or
proceeds thereof to secure payment of the Late Payment by Sponsor in favor of
Fujifilm.

 

Section 6.

 

Quality Review; Batch Packet; Acceptance; Non-Conforming Batch

 

a)              Fujifilm shall disposition cGMP Batches following internal
standard operating procedures and procedures that are set forth in the Quality
Agreement.  Upon disposition of a cGMP Batch determined by Fujifilm to conform
to cGMP and Product Specifications, Fujifilm shall provide Sponsor’s quality
assurance department with a Batch Packet and a recommendation for such Batch to
be released.  Within [* * *] after Sponsor’s receipt of such documentation,
Sponsor shall review the Batch Packet to determine, to the extent ascertainable
from such documentation, whether or not Sponsor agrees that the Product covered
by such Batch Packet is Conforming Product. Upon Sponsor’s written acceptance of
the Batch Packet, the Product shall be delivered as provided in Section 13. 
Product [* * *] shall also be treated as [* * *] for purposes of this Agreement,
provided that the Sponsor’s notice shall specify both the basis for its
assertion of a [* * *] and also reasonable information to indicate that the
asserted [* * *] was attributed to Fujifilm’s manufacturing activity and/or
release testing and was not or could not reasonably have been expected to have
been revealed by the Sponsor Approval process above or by reasonable delivery
inspection by Sponsor.  Sponsor shall report any [* * *] following Fujifilm’s
complaint procedure no later than [* * *] following the manufacturing date.

 

b)              In the event Sponsor’s review of Batch Packet indicates that the
Batch may be a Non-Conforming Batch, Sponsor shall immediately notify Fujifilm’s
quality assurance department in writing and Fujifilm shall initiate an
investigation.  The Parties shall cooperate in good faith in analyzing and
investigating the Batch.  The Parties shall use good faith efforts to mutually
determine if the Batch is a [* * *] or if [* * *] shall be investigated and if
it is ascertained that it has [* * *], it will be treated as [* * *] for
purposes of this Agreement. If the Parties cannot come to mutual agreement
within [* * *] after Sponsor’s notice, or longer if reasonably required to
complete the investigation, then the Parties shall revert to the dispute
resolution procedure set forth in Section 6(f).

 

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c)               The following provisions shall apply if during disposition of
the cGMP Batch or as a result of Sponsor’s review of the applicable Batch Packet
and followed investigation or through dispute resolution set forth in
Section 6(f) and [* * *], it is ascertained that such cGMP Batch is a
Non-Conforming Batch:

 

(i)                                     The Non-Conforming Batch shall not be
delivered to Sponsor, except as provided in Section 6(e).

 

(ii)                                  The following provisions shall apply if
the Non-Conforming Batch arose other than as a result of a Fujifilm Factor:

 

(1)                                 Sponsor shall be obliged to make payment for
activities under the Manufacturing heading in respect of such [* * *] in the
applicable [* * *].

 

(2)                                 If Sponsor wishes Fujifilm to carry out
additional work under the Program, such additional work, including further
manufacture, shall be carried out at a time to be agreed and subject to
agreement of the price payable in respect of such further manufacture, such
agreement to be recorded in a Change Order.

 

(iii)          If the Non-Conforming Batch arose as a result of a Fujifilm
Factor, manufacture of a further cGMP Batch that is a Conforming Batch shall be
undertaken at [* * *], and Fujifilm shall promptly (a) acquire all raw materials
and other Process Consumables necessary for conducting the required Production
Run(s) to produce the replacement product, (b) prepare the documentation for
such Production Run(s), (c) conduct appropriate quality investigation of the
non-conformity and resolve and/or correct as appropriate, in consultation with
Sponsor and with appropriate sign-off by Fujifilm and Sponsor for any changes
deemed necessary for such Production Run(s), and (d) within [* * *] following
completion of item “(c)” schedule the Production Run(s) in a cGMP manufacturing
suite at the very next available time period.

 

d)              Notwithstanding anything to the contrary in this Agreement, the
remedies set out in Section 6(c)(iii) shall be Sponsor’s sole remedies in
relation to a Non-Conforming Batch; provided that Sponsor shall also have the
right to exercise its termination rights under Section 14.

 

e)               For the avoidance of doubt, the Parties will follow the
mutually agreed quality procedures set forth in the Quality Agreement while
accepting or rejecting the disputed Batch; provided that in the event of a
conflict, the applicable provisions of this Agreement shall control. [* * *]
Fujifilm shall dispose of any Non-Conforming Batch [* * *] with all Applicable
Laws with respect to such disposal, at [* * *].  Shipment of the Non-Conforming
batch through interstate or international commerce may be subject to limitation
by law or cGMP and must be approved by Fujifilm Quality Assurance.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

f)                The Parties shall resolve any dispute between them under this
Section 6 as follows:

 

(i) regarding decision whether or not a Batch is a Non-Conforming Batch and
whether or not a Batch shall be rejected or accepted for human use, a dispute
shall be resolved jointly by heads of Sponsor’s and Fujifilm’s Quality Assurance
organizations and if not so resolved, through the dispute procedures according
to Section 15;

 

g)               (ii) regarding allocation of financial responsibility for a
Non-Conforming batch, dispute shall be resolved through the Joint Steering
Committee, but if the Parties are unable to resolve a dispute within [* * *]
business days, despite their good faith efforts, either Party may refer the
dispute to the Chief Executive Officer (or other designee) of each Party.  In
the event that no agreement is reached by the Chief Executive Officers (or other
designees) with respect to such dispute within [* * *] days after its referral
to them, the actions outlined in Section 15 will come into effect.

 

Section 7.

 

Change Orders

 

a)             “Change Order” means a document to support a meaningful deviation
from a Scope mutually approved in writing by both Parties that (i) describes in
reasonable detail an amendment and/or modification to the Program and/or the
Scope, and (ii) that is required:  (a) to meet new or unforeseen applicable
regulatory or quality assurance requirements; (b) to address unforeseen issues
which arise from the empirical results related to the biology of the molecule;
and/or (c) as a result of a change in the written assumptions for the Scope
agreed upon by the Parties in relation to the Program design and objectives,
manpower requirements, timing, and capital expenditure requirements, if any;
(d) to perform activities that meaningfully deviate from the Scope but requested
by Sponsor. After duly executed by both Parties, a Change Order is hereby deemed
to be incorporated into the applicable Scope.

 

b)             Sponsor shall have the right to request reasonable modifications
to the Program and/or the Scope by providing notice thereof to Fujifilm.  Upon
receipt of such notice, Fujifilm shall generate a Change Order, and submit such
Change Order to Sponsor for Sponsor’s review and approval.  If Sponsor approves
the Change Order notwithstanding Fujifilm’s notice of any resulting cost
increase, Sponsor shall reimburse Fujifilm for the cost of such changes as
detailed in the Change Order, provided that pricing shall be based upon similar
underlying assumptions as used in the Scope Pricing. Upon Sponsor’s approval of
such Change Order, the Change Order will be implemented as soon as it is
commercially practical to do so in a commercially reasonable effort to meet the
development and manufacturing timelines as set forth in the Scope or as
described in the Change Order.  For the avoidance of doubt, if Sponsor requests
a reduction in the Scope, for example, fewer batches in a manufacturing campaign
or removal of other Program elements, cancellation charges shall be applicable
equivalent to the charges set out in Section 21(c) below [* * *].

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

c)              Fujifilm may only initiate a Change Order if it reasonably
determines that a meaningful deviation from the Scope is required in order to
successfully and timely complete any Milestone in the Scope that could not
reasonably have been anticipated at the time when the Scope and/or [* * *] was
prepared and mutually agreed by the Parties.  Before Fujifilm may amend the
Scope, Fujifilm shall prepare a Change Order describing in reasonable detail the
nature of such change(s), and propose such Change Order to Sponsor for Sponsor’s
review and written approval.  All approved Change Orders shall be signed by the
Alliance Manager of each Party or by such other authorized representatives of
Fujifilm and Sponsor that the Party may designate.  If any changes contemplated
by a Change Order will have a financial, timing and/or other impact on the
Scope, Fujifilm shall provide Sponsor with a written description of such impacts
in the Change Order.  If Sponsor approves the Change Order notwithstanding
Fujifilm’s notice of any resulting cost increase, Sponsor shall reimburse
Fujifilm for the cost of such changes as detailed in the Change Order, provided
that pricing shall be based upon similar underlying assumptions as used in the
Scope Pricing.  Upon Fujifilm and Sponsor’s approval of the Change Order, the
Change Order will be implemented as soon as it is commercially practical to do
so in a commercially reasonable effort to meet the development and manufacturing
timelines as set forth in the Scope. Fujifilm shall continue work on the Program
during any such negotiations, but shall not commence work with respect to the
Change Order unless authorized in writing by Sponsor. [* * *].  If lack of
timely review by Sponsor is the principal cause of delay of Fujifilm’s
manufacturing activities, it shall constitute Sponsor delay subject to
provisions of Sections 15, 19 and 21.  If Sponsor rejects a Change Order, the
dispute resolution procedures set out in Section 15 shall apply.

 

d)             If a Change Order is not agreeable to both Parties, the Parties
shall resolve the dispute in accordance with Section 22 and Section 15.  If
reasonably possible, the Parties shall continue to perform the Scope as modified
by previously executed Change Orders, if any, without regard to the unresolved
Change Order until resolution of the dispute.

 

Section 8.

 

Confidential Information/Legal Proceedings

 

a)             For the duration of this Agreement and any successor agreement
and for three (3) years thereafter, Fujifilm will not disclose, without
Sponsor’s written permission, any Sponsor’s Confidential Information unless such
disclosure:  (i) is necessary to disclose for purposes of this Agreement to an
affiliate of Fujifilm that is under a similar obligation to keep such
information confidential; (ii) is or becomes publicly available through no fault
of Fujifilm; (iii) is disclosed by a third party entitled to disclose it;
(iv) is already known to Fujifilm as shown by its prior written records.
Fujifilm shall furnish only that portion of Confidential Information that is
legally required by any law, rule, regulation, order decision, decree, subpoena
or other legal process to be disclosed.  If such disclosure is requested by
legal process, Fujifilm will make all reasonable efforts to notify Sponsor of
this request promptly prior to any disclosure to permit Sponsor to oppose such
disclosure by appropriate legal action.  Fujifilm shall use reasonable
precautions to

 

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protect the confidentiality of Sponsor’s Confidential Information comparable to
precautions taken to protect its own proprietary information.

 

b)             For the duration of this Agreement and any successor agreement
and for three (3) years thereafter, Sponsor will not disclose, without
Fujifilm’s written permission, any Fujifilm Confidential Information unless such
disclosure:  (i) is necessary to disclose for purposes of this Agreement to an
affiliate of Sponsor that is under a similar obligation to keep such information
confidential, (ii) is to a regulatory authority in connection with making
regulatory filings and maintaining regulatory approvals for the Product(s), or
potential or actual partners, sublicensees, acquirers, investors or otherwise in
connection with obtaining financing; (ii) is or becomes publicly available
through no fault of Sponsor; or (iii) is disclosed by a third party entitled to
disclose it; (iv) is already known to Sponsor as shown by its prior written
records. Sponsor shall furnish only that portion of Confidential Information
that is legally required by any law, rule, regulation, order decision, decree,
subpoena or other legal process to be disclosed.  If such disclosure is
requested by legal process, Sponsor will make all reasonable efforts to notify
Fujifilm of this request promptly prior to any disclosure to permit Fujifilm to
oppose such disclosure by appropriate legal action. Sponsor shall use reasonable
precautions to protect the confidentiality of Fujifilm Confidential Information
comparable to precautions taken to protect its own proprietary information.

 

c)              If either Party shall be obliged to provide testimony or records
Confidential Information of the other in any legal or administrative proceeding,
then Party to whom the Confidential Information belongs shall reimburse the
other Party for its out-of-pocket costs therefore plus an hourly fee for its
employees or representatives equal to the internal fully burdened costs of such
employee or representative.

 

d)             For both Parties, “Confidential Information” shall mean and
include without limitation the existence and terms and conditions of this
Agreement, inventions, methods, plans, processes, specifications,
characteristics, raw data, analyses, equipment design, trade secrets, costs,
marketing, sales, and performance information, including patents and patent
applications, grant applications, notes, and memoranda, whether in writing or
presented, stored or maintained electronically, magnetically or by other means,
which are disclosed by the disclosing Party to the recipient Party in writing or
in other tangible form and marked “confidential” or, if [* * *] of such
disclosure, or that is reasonably recognizable as confidential or proprietary
either by the nature of the information or in the form or circumstances
transmitted. Sponsor Confidential Information shall include without limitation
the Drug Substances, Master Cell Bank, Working Cell Bank, Master [* * *]Banks,
Working [* * *] Banks, any Manufacturing Process documentation provided by
Sponsor to Fujifilm, and all elements of the Manufacturing Process (other than
Fujifilm intellectual property pre-existing on the Effective Date). Each
Manufacturing Process developed by Fujifilm for Sponsor and specific portions of
documents and records describing or relating to the Manufacturing Process shall
be deemed to be Sponsor Confidential Information, including the Master
Manufacturing Record and all Batch Packet and Batch Records and Work Product.

 

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

e)              Each recipient Party shall use the Confidential Information only
for purposes of this Agreement, and shall disclose Confidential Information only
to employees, consultants, subcontractors or agents who are bound in written
agreements by similar obligations of confidentiality and nonuse and who have a
need to know such information in order to perform their duties or services in
connection with recipient Party’s obligations under this Agreement.

 

f)               The Mutual Non-Disclosure Agreement between the Parties dated
August 23, 2011 (as amended) (“CDA”), is superseded by this Agreement effective
as of the date of this Agreement, and the Parties agree that all Confidential
Information provided on or after the date of this Agreement will be subject to
this Agreement and not the CDA.

 

g)              All Confidential Information shall remain the property of the
disclosing Party and shall be returned to the disclosing Party on termination or
expiration of this Agreement. However, each Party may retain one copy of the
disclosing Party’s Confidential Information, as defined on section 8(d) for
record keeping and legal purposes in a secure environment, provided such copy is
maintained as Confidential Information.

 

Section 9.

 

Work Output

 

a)             All reports specified in the Scope and other cGMP documentation,
including the Batch Record, Certificate of Analysis, and the Batch Packet (“Work
Output”) will be prepared using Fujifilm’s standard format(s) unless otherwise
specified in the Scope.

 

b)             Sponsor will be supplied with copies of Work Output generated as
a result of the Program as set forth in the Scope or Quality Agreement.  All
Work Output and Product samples will be archived by Fujifilm for a period of [*
* *] years following completion of the Program unless otherwise defined by the
Program or required by applicable U.S. laws or regulations.  [* * *] after
completion of the Program, Work Output and Product samples will be sent to
Sponsor and a return fee will be charged.  Sponsor may elect to have the
materials retained in the Fujifilm archives for an additional period of time at
additional cost to Sponsor.  If Sponsor chooses to have Fujifilm dispose of Work
Output and Product samples, a disposal fee will be charged.  Notwithstanding the
foregoing, Fujifilm will continue to retain such written materials and Product
samples as required by regulations and as may be required by law, pertaining to
such activities as well as for archival purposes.

 

Section 10.

 

Inventions and Patents

 

a)             “New IP” means any and all intellectual property that is made,
created, conceived and/or reduced to practice (1) in the course of performing
under this Agreement; and/or (2) which utilizes Sponsor Confidential Information
and/or is specifically related thereto;

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

and/or (3) which utilizes Drug Substance and/or Drug Product, and/or is
specifically related thereto; and/or (4) is specifically related to the
manufacture or uses of the Drug Substance and/or Drug Product, in any of cases
(1), (2), (3) or (4) whether made, created, conceived and/or reduced to practice
solely by Fujifilm or jointly by Fujifilm and Sponsor or others, and excluding
Fujifilm Project IP.  Fujifilm shall promptly disclose to Sponsor any and all
New IP reported to Fujifilm by its employees, Subcontractors and agents or which
Fujifilm otherwise becomes aware of.  New IP is deemed to be Sponsor
Confidential Information.  Sponsor shall solely own all right, title and
interest in any and all New IP.  Fujifilm hereby assigns all right, title and
interest in the New IP to Sponsor free and clear of all liens, claims and
encumbrances. If Sponsor requests and at Sponsor’s expense, Fujifilm will
execute any and all applications, assignments or other instruments and give
testimony which shall be necessary to apply for and obtain Letters of Patent of
the US or of any foreign country with respect to the New IP and Sponsor shall
compensate Fujifilm for the time devoted to such activities and reimburse it for
expenses incurred. For New IP assigned pursuant to this section, Sponsor shall
provide Fujifilm a royalty-free license necessary to perform each Program for
the term of this Agreement.  Subject to the terms and conditions of this
Agreement, Sponsor hereby grants to Fujifilm an irrevocable, fully paid,
non-exclusive license, under any New IP that is related to and/or capable of
being applied to products and/or processes other than the Manufacturing Process,
Drug Substance, Drug Product and/or the manufacture thereof, to practice such
New IP: (i) for Fujifilm’s internal research purposes, and (ii) with the prior
written consent of Sponsor, which may be granted or withheld in its sole
discretion, on request from time to time by Fujifilm, in connection with third
party products and/or processes; provided that for clarification, in no case may
Fujifilm use New IP in connection with products and processes that are
competitive with, and/or for the same indication as, Manufacturing Process, Drug
Substances, Drug Products and/or the manufacture thereof.

 

b)             With respect to any Manufacturing Process or portion thereof that
is developed by Fujifilm hereunder, whether made, created, conceived and/or
reduced to practice solely by Fujifilm or jointly by Fujifilm and Sponsor or
others, Sponsor shall own such Manufacturing Process in accordance with
Section 10(a); provided that Fujifilm retains the right to use any pre-existing
Fujifilm intellectual property in any underlying process, protocol, technology,
know-how or the like in conducting its laboratory and manufacturing operations
and activities, and all rights, title and interest in and to any Fujifilm
intellectual property rights therein.  Fujifilm hereby grants to Sponsor an
irrevocable, fully paid, non-exclusive license, with the right to grant and
authorize sublicenses, under any and all Fujifilm intellectual property that
Fujifilm incorporates into any Manufacturing Process, and/or that is necessary
to the practice of the Manufacturing Process, and/or to the generation of the
Working Cell Bank, to practise such Fujifilm intellectual property for the sole
and limited purpose of using Product produced hereunder for research and
development and/or clinical trial purposes, and/or the practise of the
Manufacturing Process by or on behalf of Sponsor or a Sponsor sublicensee for
the manufacture of Drug Substance and Drug Product for use and/or sale by or on
behalf of Sponsor or its sublicensee.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

c)              “Fujifilm Project IP” means any and all intellectual property
that is made and/or created in the course of performing under this Agreement,
whether made and/or created solely by Fujifilm or jointly by Fujifilm and
Sponsor or others, which utilizes, relates generally to or is based on Existing
Fujifilm IP (and not utilizing or specifically related to Sponsor Confidential
Information, Drug Substance, Drug Product, and/or the Manufacturing Process
and/or not otherwise specifically related to the manufacture or uses of the Drug
Substance and/or Drug Product).  “Existing Fujifilm IP” means Fujifilm’s current
and/or future business and operating intellectual property for conducting
laboratory and/or GMP or non-GMP manufacturing services (but such Fujifilm
Project IP and Existing Fujifilm IP is included in Fujifilm intellectual
property and so shall be subject to the license granted in Section 10(b). 
Fujifilm shall solely own all right, title and interest in any and all Fujifilm
Project IP.

 

d)             Fujifilm will advise Sponsor in writing in reasonable detail of
the technical processes it will use in the Manufacturing Process, including any
Third Party rights and/or in-licenses that, to Fujifilm’s knowledge, are
required.

 

e)              In the event Fujifilm must purchase any Designated Equipment
required specifically for Sponsor’s Program and Sponsor reimburses Fujifilm for
the cost of such Designated Equipment, Sponsor shall own all right, title and
interest in and to any and all such Designated Equipment.  All Designated
Equipment shall be maintained by Fujifilm per Fujifilm’s maintenance program.

 

f)               Sponsor reserves the right to use data during the course of a
Program or Scope to support applications necessary to apply for and obtain
Letters of Patent of the U.S. or any foreign country with respect to New IP so
long as no information which Sponsor is required to keep confidential under this
Agreement is disclosed in any such application.

 

Section 11.

 

Independent Contractor

 

Fujifilm shall perform the Program as an independent contractor of Sponsor and
shall have complete and exclusive control over its facilities, equipment,
employees and agents. The provisions of this Agreement shall not be construed to
establish any form of partnership, agency or other joint venture of any kind
between Fujifilm and Sponsor, nor to constitute either Party as the agent,
employee or legal representative of the other. All persons furnished by either
Party to accomplish the intent of this Agreement shall be considered solely as
the furnishing Party’s employees or agents and the furnishing Party shall be
solely responsible for compliance with all laws, rules and regulations
involving, but not limited to, employment of labor, hours of labor, working
conditions, workers’ compensation, payment of wages, and withholding and payment
of applicable taxes, including, but not limited to income taxes, unemployment
taxes, and social security taxes.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Section 12.

 

Insurance

 

a)             Fujifilm shall secure and maintain in full force and effect
throughout the term of the Agreement and for a reasonable period thereafter
policies of insurance for (a) workmen’s compensation in statutory amounts, and
(b) general liability, automobile liability, and product liability having policy
limits, deductibles and other terms appropriate to the conduct of Fujifilm’s
business in Fujifilm’s reasonable judgment.

 

b)             Sponsor shall secure and maintain in full force and effect
throughout the term of the Agreement and for a reasonable period thereafter
policies of insurance for general liability and product liability, having policy
limits, deductibles and other terms appropriate to the conduct of Sponsor’s
business in Sponsor’s reasonable judgment.

 

Section 13.

 

Delivery

 

Within [* * *] following Sponsor approval (pursuant to Section 6(a) of the Batch
Packet for each Production Batch, Fujifilm shall notify Sponsor and make each
Batch available to Sponsor at Fujifilm’s Facility. Fujifilm shall package for
shipment and deliver Drug Substances, samples or other materials at Sponsor’s
expense and in accordance with Sponsor’s full written and reasonable
instructions with Sponsor bearing all packaging, shipping and insurance
charges.  Freight terms shall be Ex Works (Incoterms 2010). Fujifilm shall
retain representative samples of Drug Substances and raw materials for record
keeping, testing and regulatory purposes as mutually agreed in the Scope or
Quality Agreement.  Sponsor shall provide for shipping within sixty (60)
calendar days of completion of manufacturing.  In the event of any delay by
Sponsor in shipping one or more shipments of Drug Substances in accordance with
this Section 13, the Parties acknowledge and agree that liability and risk of
loss for each such shipment of Drug Substances shall automatically transfer to
(and be assumed by) Sponsor effective upon expiration of the applicable sixty
(60) day period. If Sponsor requires a longer period for shipping, Sponsor must
make arrangements with Fujifilm or a third party for storage on Sponsor’s behalf
and at Sponsor’s expense.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Section 14.

 

Default/Limitation of Warranty

 

a)             If Fujifilm is in default of its material obligations under this
Agreement and/or a Program and/or a Scope, then Sponsor shall promptly notify
Fujifilm in writing of any such default.  Fujifilm shall have a period of [* *
*]  from the date of receipt of such notice within which to cure such default;
provided that if such default is not capable of being cured within such [* * *]
period, on written request received within the [* * *] period with a detailed
explanation of efforts that have been made and will be made to cure, the cure
period shall be extended for such amount of time as may be reasonably necessary
to cure such breach [* * *], so long as Fujifilm is making diligent efforts to
cure.  If Fujifilm fails to cure such breach [* * *], then this Agreement shall,
at Sponsor’s option, immediately terminate.  Termination does not relieve
Sponsor from its payment obligation for work already performed or costs already
committed as described in Section 21(b)(i) and (ii).

 

b)             If Sponsor is in default of its material obligations under this
Agreement and/or a Program and/or a Scope, then, Fujifilm shall promptly notify
Sponsor in writing of any such default.  Sponsor shall have a period of [* * *]
from the date of receipt of such notice within which to cure such default;
provided that if such default is not capable of being cured within such [* * *]
period, on written request received within the [* * *] period with a detailed
explanation of efforts that have been made and will be made to cure, [* * *], so
long as Sponsor is making diligent efforts to cure.  If Sponsor fails to cure
such breach [* * *], this Agreement may, at Fujifilm’s option, immediately
terminate.

 

c)              Notwithstanding anything herein to the contrary, except for
damages included in a third party claim covered by the indemnification
obligations in this Agreement or arising out of, resulting from or relating to
breach of Section 8 Confidentiality or Article 10 IP or other unauthorized use
of the other Party’s intellectual property or Confidential information: (i) 
UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE ENTITLED TO INCIDENTAL, INDIRECT,
CONSEQUENTIAL OR SPECIAL DAMAGES ARISING IN CONNECTION WITH THE DEFAULT OR
BREACH OF ANY OBLIGATION OF THE OTHER PARTY UNDER THIS AGREEMENT, THE SCOPE OR
ANY DOCUMENTS OR APPENDICES RELATED THERETO, and (ii) EACH OF FUJIFILM’S AND
SPONSOR’S MAXIMUM LIABILITY FOR DAMAGES IN CONNECTION WITH A CLAIM RELATED TO
THIS AGREEMENT, REGARDLESS OF THE CAUSE OF ACTION, WILL NOT EXCEED AN AMOUNT
EQUAL TO [* * *].

 

d)             EXCEPT AS EXPRESSLY STATED HEREIN, NEITHER PARTY PROVIDES TO THE
OTHER PARTY HERETO ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
CONFIDENTIAL INFORMATION, MATERIALS AND SERVICES PROVIDED HEREUNDER, AND ALL
SUCH WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTIES OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE WAIVED. 
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT INCLUDING ANY SCOPE,
PROGRAM PRICE AND PAYMENT SCHEDULE OR

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

QUALITY AGREEMENT, INCLUDING THE WARRANTIES AND OTHER OBLIGATIONS OF FUJIFILM,
FUJIFILM MAKES NO OTHER WARRANTIES THAT THE EXECUTION OF THE SCOPE WILL RESULT
IN ANY SPECIFIC QUANTITY OR QUALITY OF DRUG SUBSTANCE OR DRUG PRODUCT.

 

Section 15.

 

Dispute Resolution

 

a)             In the event any dispute shall arise between Sponsor and Fujifilm
with respect to any of the terms and conditions of this Agreement or the Program
(whether or not cross-referencing or identifying this Section 15 as the dispute
procedure); then senior executives of Sponsor and Fujifilm shall meet as
promptly as practicable after notice of such dispute to resolve in good faith
such dispute.

 

b)             If Sponsor and Fujifilm are unable to satisfactorily resolve the
dispute within thirty (30) days following referral to the senior executives,
then such dispute shall be referred to mediation in accordance with the rules of
the American Arbitration Association.  The Parties shall participate in the
mediation in a good faith attempt to settle the dispute.  The mediation shall be
held in the location determined by the mediator.

 

c)              If mediation fails to resolve the dispute within forty-five (45)
days of the initial meeting pursuant to Section 15 a) above, then such dispute
shall be finally settled by an arbitrator in accordance with this Section 15;
provided that if the dispute relates to the scope, inventorship, validity and/or
infringement of any intellectual property rights, the Parties shall litigate the
dispute unless otherwise agreed in writing.  The arbitration will be held in the
location determined by the arbitrator, and except as noted below, shall be
conducted in accordance with the rules of the American Arbitration Association,
applying the applicable substantive laws in accordance with Section 25, by a
neutral arbitrator agreeable to both Parties if the dispute involves less than
$1,000,000, and by a panel of three (3) neutral arbitrators if greater than that
amount.  If the Parties do not agree on an arbitrator within thirty (30) days of
the end of the mediation period, the American Arbitration Association shall
appoint an arbitrator to hear the case in accordance with its rules. The
arbitrator shall have no authority to award consequential, punitive or exemplary
damages or to vary from or ignore the terms of this Agreement and shall be bound
by controlling law.  Finally, notwithstanding anything to the contrary in this
Agreement, at any time each of the Parties may seek judicial intervention for
emergency relief, such as restraining orders and injunctions where appropriate.

 

d)             Subject to Section 15(e), any decision by the arbitrator shall be
binding upon the Parties and may be entered as final judgment in any court
having jurisdiction. The cost of any arbitration proceeding shall be borne by
the Parties, as the arbitrator shall determine if the Parties have not otherwise
agreed.  The arbitrator shall render their final decision in writing to the
Parties.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

e)              Each Party agrees to the American Arbitration Association’s
Optional Appellate Arbitration Rules, and either Party may appeal an arbitration
award that has been rendered pursuant to the applicable Arbitration Rules and
has become final.  Such appeal must be filed with notice given to the other side
within ninety (90) days after the date of receipt by such Party of the
Arbitrator’s decision.  The cost of any appellate arbitration proceeding shall
be borne by the Parties, as the arbitrator shall determine if the Parties have
not otherwise agreed.  The appellate arbitrators shall render their final
decision in writing to the Parties.

 

Section 16.

 

Indemnification

 

a)             Fujifilm shall indemnify Sponsor and its affiliates and their
respective officers, directors and employees from any loss, cost, damage or
expense (“Loss”) from any lawsuit, action, claim, demand, assessment or
proceeding (“Claim”) arising from, related to or as a result of: (i) Fujifilm’s
violation of any applicable law, rule, regulation or ordinance in Fujifilm’s
performance of this Agreement;  (ii) Fujifilm’s negligence, gross negligence or
intentional misconduct or inaction in Fujifilm’s performance of this Agreement;
(iii) Fujifilm’s violation, non-compliance or non-performance of any of the
terms of this Agreement, (iv) the infringement or alleged infringement in the
United States arising from Fujifilm’s performance of the services to Sponsor
under this Agreement on the intellectual property rights of a third party [* *
*]; and/or (v) third party personal injury or property damage to [* * *];
provided that if such Loss or Claim arises in whole or in part from Sponsor’s
negligence, gross negligence or intentional misconduct or inaction, then the
amount of the Loss that Fujifilm shall indemnify Sponsor for pursuant to this
Section 16 shall be reduced by an amount in proportion to the percentage of
Sponsor’s responsibilities for such Loss determined by a court of competent
jurisdiction in a final and non-appealable decision or in a binding settlement
between the Parties.

 

b)             Sponsor shall indemnify Fujifilm and its affiliates and their
respective officers, directors and employees from any Claim and/or Loss arising
from or related to: (i) Fujifilm’s proper involvement with the Sponsor
Deliverables; (ii) Sponsor’s violation of any applicable law, rule, regulation
or ordinance in Sponsor’s performance of this Agreement; (iii) the negligence,
gross negligence or intentional misconduct or inaction of Sponsor in Sponsor’s
performance of this Agreement;  (iv) the infringement or alleged infringement in
the United States arising from [* * *] use of Sponsor Deliverables including the
Manufacturing Process provided by Sponsor to Fujifilm in accordance with this
Agreement, or the use, import, export or sale of the Drug Product in the United
States, on the intellectual property rights of a third party, except to the
extent falling within Section 16(a); or, (v) Sponsor’s violation, non-compliance
or non-performance of any of the terms of this Agreement; or (vi) third party
personal injury or property damage arising from Conforming Product or for [* *
*]; provided that if such Loss or Claim arises in whole or in part from
Fujifilm’s negligence, gross negligence or intentional misconduct or inaction,
then the amount of such Loss that Sponsor shall indemnify Fujifilm for pursuant
to this Section 16 shall be reduced by an amount in proportion to the

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

percentage of Fujifilm’s responsibilities for such Loss as determined by a court
of competent jurisdiction in a final and non-appealable decision or in a binding
settlement between the Parties.

 

c)              Upon receipt of notice of any Claim which may give rise to a
right of indemnity from the other Party hereto, the Party seeking
indemnification (the “Indemnified Party”) shall give written notice thereof to
the other Party, (the “Indemnifying Party”) with a Claim for indemnity
(“Indemnity Claim”). Any delay or failure to give notice shall not discharge the
duty of the Indemnifying Party to indemnify except to the extent it is
prejudiced by such delay or failure.  Such Claim for indemnity shall indicate
the nature of the Claim and the basis therefore.  Promptly after a Claim is made
for which the Indemnified Party seeks indemnity, the Indemnified Party shall
permit the Indemnifying Party, at its option and expense, to assume the complete
defense of such Claim, provided that (i) the Indemnified Party will have the
right to participate in the defense of any such Claim at its own cost and
expense, and (ii)  the Indemnifying Party will, prior to making any settlement,
consult with the Indemnified Party as to the terms of such settlement and
receive approval thereof, not to be unreasonably withheld.  The Indemnified
Party shall have the right, at its election, to release and hold harmless the
Indemnifying Party from its obligations hereunder with respect to such Claim and
assume the complete defense of the same in return for payment by the
Indemnifying Party to the Indemnified Party of the amount of the Indemnifying
Party’s settlement offer.  The Indemnifying Party will not, in defense of any
such Claim, except with the consent of the Indemnified Party, consent to the
entry of any judgment or enter into any settlement which does not include as an
unconditional term thereof, the giving by the claimant or plaintiff to the
Indemnified Party of a release from all liability in respect thereof.  After
notice to the Indemnified Party of the Indemnifying Party’s election to assume
the defense of such Claim, the Indemnified Party shall reasonably cooperate with
the Indemnifying Party, who shall be liable to the Indemnified Party for such
legal or other expenses subsequently incurred by the Indemnified Party in
connection with the defense thereof at the request of the Indemnifying Party. 
As to those Claims with respect to which the Indemnifying Party does not elect
to assume control of the defense, the Indemnified Party will afford the
Indemnifying Party an opportunity to participate in such defense at the
Indemnifying Party’s own cost and expense, and will not settle or otherwise
dispose of any of the same without the consent of the Indemnifying Party.

 

Section 17.

 

Representations and Warranties

 

a)             Each Party represents and warrants to the other that it has the
full right and authority to enter into this Agreement and to perform in
accordance with the terms and conditions set forth herein.

 

b)             Each Party represents and warrants to the other that neither it
nor any of its officers, directors, or its employees performing services under
this Agreement has been debarred, or convicted of a crime which could lead to
debarment, under the Generic

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Drug Enforcement Act of 1992, 21 United States Code §§335(a) and (b) or
Section 306(b)(1)(b) of the FDC Act.

 

c)              Each Party represents and warrants to the other Party that it
has obtained and will at all times during the term of this Agreement, hold and
comply with all licenses, permits and authorizations necessary to perform this
Agreement as now or hereafter required under any applicable statutes, laws,
ordinances, rules and regulations of the United States and any applicable
foreign, state, and local governments and governmental entities.

 

d)             Sponsor hereby represents and warrants to Fujifilm that to the
best of its knowledge, it has legal title and/or a valid license to the Cell
Line, Sponsor Confidential Information and the Drug Substance necessary to
conduct the Program and that to the best of its knowledge, the Sponsor
Deliverables and Drug Substance when used by Fujifilm in the United States in
the Manufacturing Process in accordance with this Agreement will not infringe on
the intellectual property rights of a third party.

 

e)              Sponsor hereby represents and warrants to Fujifilm that it has
the full right and authority to grant the purchase money security interest
indicated in Section 5 hereof.

 

f)               Fujifilm represents and warrants to Sponsor that to the best of
its knowledge, Fujifilm has legal title and/or a valid license to Existing
Fujifilm IP necessary to conduct the Program and that to the best of its
knowledge, the Existing Fujifilm IP when used in the United States will not
infringe on the intellectual property rights of a third party.

 

g)              Fujifilm represents and warrants to Sponsor that each Production
Batch of Drug Substance delivered to Sponsor hereunder: (i) was manufactured and
analyzed in conformance with the [* * *], the Product Specifications and Quality
Agreement; (ii) was manufactured in compliance with the requirements of cGMP and
all applicable laws and regulations; (iii) was [* * *]; (iv) is not subject to
[* * *]; and (v) was transferred free and clear of any liens or encumbrances of
any kind to the extent arising through or as a result of the acts or omissions
of Fujifilm, its Subcontractors, consultants or agents.

 

h)             Fujifilm represents and warrants that it lawfully controls
operations in the Fujifilm Facility, and will maintain the Fujifilm Facility and
ensure that any Subcontractor facility will be maintained, in accordance with
cGMP and in such condition as will allow Fujifilm to manufacture the Drug
Substance(s) in compliance with cGMP and in conformance with the applicable
Master Manufacturing Record, Quality Agreement and all applicable statutes,
laws, ordinances, rules and regulations of the United States and any applicable
foreign, state, and local governments and governmental entities.

 

i)                 Sponsor represents and warrants to Fujifilm that the Master
Cell Bank supplied to Fujifilm will, at the time of delivery, meet the
sterility, mycoplasma and [* * *] specifications in the quality control
documentation for such Master Cell Bank.  Provided that the foregoing
representation and warranty is satisfied, Fujifilm represents and warrants to
Sponsor that the Working Cell Bank generated by Fujifilm from the Master

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Cell Bank will, at the time of production and release, meet the sterility,
mycoplasma and [* * *] specifications included in the quality control
documentation for the Working Cell Bank.  Fujifilm represents and warrants that
it will store and handle the Working Cell Bank in accordance with mutually
agreed conditions to ensure that the sterility, mycoplasma and [* * *]
specifications continue to be met whilst the Working Cell Bank is in Fujifilm’s
possession.

 

Section 18.

 

Force Majeure

 

Either Party shall be excused from performing its respective obligations under
this Agreement if its performance is delayed or prevented by any event beyond
such Party’s reasonable control, including, but not limited to, acts of God,
fire, explosion, weather, disease, war, insurrection, civil strife, riots,
government action, acts of terrorism or power failure, provided that such
performance shall be excused only to the extent of and during such disability.
The Party subject to such event shall promptly notify the other Party of the
occurrence thereof and, if known, the expected duration.  Any time specified or
estimated for completion of performance in the Scope falling due during or
subsequent to the occurrence of any or such events shall be automatically
extended for a reasonable period of time to recover from such disability. 
Fujifilm will promptly notify Sponsor if, by reason of any of the events
referred to herein, Fujifilm is unable to meet any such time for performance
specified or estimated in the Scope, and Fujifilm will use commercially
reasonable efforts to overcome the event and [* * *].

 

Section 19.

 

Allocation of Resources

 

If delays in the agreed commencement or performance of the Program occur or are
anticipated because of Sponsor’s request or inability to supply Fujifilm with
agreed Sponsor Deliverables set forth in the applicable Program Scope required
to begin or perform the Program within twenty (20) days after such agreed time,
Fujifilm shall immediately notify Sponsor, and the Joint Steering Committee
shall convene to determine the reasonable course of action.  If the delay shall
continue for more than ten (10) business days after the Joint Steering Committee
meeting without resolution, the dispute shall be escalated as provided in
Section 15 and Fujifilm may reallocate resources being held for performance of
the Program without incurring liability to Sponsor for the period of any
anticipated delay.  In addition, upon such delay being removed or remedied,
Fujifilm will use commercially reasonable efforts to promptly allocate resources
to performance of the Program as set forth in the Scope.  The parties
acknowledge that Fujifilm has allocated resources to the Program that may be
difficult or impractical to reallocate to other programs in the event of a delay
solely attributable to Sponsor’s activities.  In recognition of this, Sponsor
and Fujifilm shall discuss a Change Order to compensate Fujifilm for any idled
personnel or capacity not reallocated despite Fujifilm’s diligent efforts to
reallocate personnel and capacity and to mitigate any loss.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Section 20.

 

Use of Names

 

The Parties anticipate opportunities for joint or independent press releases or
other announcements relating to the activities contemplated hereby. 
Notwithstanding the foregoing, neither Party shall use the name of the other
Party or the names of the employees of the other Party in any advertising or
sales promotional material or in any publication without prior written
permission of such Party.  Such consent may not be unreasonably withheld.

 

Section 21.

 

Term/Termination

 

a)             This Agreement shall take effect on the date first written above
and continue in effect for a period of ten (10) years.  Each Program and Scope
shall remain in effect from the date of its execution by both Parties until
Completion of the Program or Scope or termination of the Program or Scope as
provided in this Section 21.

 

b)             In addition to the termination rights set forth in Section 14,
Sponsor may at any time terminate this Agreement, or any Program, Scope or Run
prior to Completion by giving thirty (30) days written notice to Fujifilm. In
the event Sponsor elects to terminate for convenience under this
Section 21(b) or in the event that Fujifilm rightfully terminates this Agreement
pursuant to Section 14, Sponsor shall pay Fujifilm upon receipt of Fujifilm’s
invoice and Fujifilm’s compliance with Section 21(h), the following amounts:

 

(i)          All amounts owed for work Completed but not yet invoiced; plus

 

(ii)         All unpaid third party costs incurred, or committed and
non-cancelable, for Process Consumables, provided that Fujifilm shall use its
commercially reasonable efforts to cancel open orders or return any unused
Process Consumables; plus if applicable

 

(iii)        A termination fee calculated as follows, which shall be [* * *] for
any particular [* * *] based on the duration between the date of Sponsor’s
notice to Fujifilm and the Start Date of such Run, as follows:

 

(1)  For cancellation more than [* * *] in advance of [* * *];

 

(2)  For cancellation during the [* * *] period but more than [* * *] in advance
of [* * *]; and

 

(3) For cancellation during the [* * *] period but more than [* * *] in advance
of [* * *]; and

 

(4)  For cancellation during the [* * *] period but more than [* * *] in advance
of or during [* * *].

 

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(5) For cancellation during the [* * *] period in advance of or during [* * *].

 

(6)  [* * *] are due for cancellation of [* * *] or other [* * *] prior to
commencement of Demonstration Batch.  Following commencement of [* * *], the
cancellation fee for the [* * *] shall be [* * *]. Upon cancellation of all
other Non-Manufacturing activities, other than process characterization,
scheduled post [* * *], Sponsor shall pay [* * *] as set forth in the Scope or
[* * *], less in each case any prepaid fees and expenses for such activities,
unless otherwise specified in applicable Scope.

 

(7) [* * *], and the remaining after offset against payments as provided in [* *
*] shall be applied by Fujifilm against any [* * *] under Section 21(b)(iii).

 

c)              No cancellation fees are due in the event of any of the
following:

 

(i)                   [* * *].

(ii)              if Sponsor cancels for material breach by Fujifilm under
Section 14 or as the non-affected Party in Section 21(d) or under Section 21(e);
or

(iii)           [* * *]; or

(iv)            [* * *] for this reason.

 

d)             The non-affected Party shall have the right to terminate a
Program, Scope, Run or this Agreement without penalty, including without payment
of any termination fee, by providing written notice thereof to the affected
Party, such termination to be effective [* * *] from the date of such notice,
if, as a result of a force majeure event (as described in Section 18), an
affected Party is unable fully to perform its obligations under the Program,
Scope, Run or this Agreement for any consecutive period of [* * *].

 

e)              Further, if any change in circumstance occurs during the term to
make the warranty in [* * *] inaccurate, Fujifilm shall notify Sponsor in
writing immediately, including a reasonably detailed explanation, and Sponsor
shall have the right to immediately terminate this Agreement or the affected
Run, Scope or Program, without penalty.

 

f)               The expiration or termination of a Scope or this Agreement for
any reason shall relieve neither Party of its obligation to the other for
obligations in respect of:  (i) confidentiality of information; (ii) consents
for advertising purposes and publications; (iii) indemnification;
(iv) inventions and patents; (v) compensation for services performed
(vi) dispute resolution, and (vii) the following provisions shall survive the
termination or expiration of this Agreement: Sections 1(h), 1(j), 3, 8, 9, 10
(except “New IP” for the provision of Section 10(a) with respect to the cases
set out in section 10(a)(3) and 10(a)(4) will not survive after the termination
or expiration of this Agreement so long as Fujifilm does not practice, infringe
or misappropriate Sponsor intellectual property rights; provided that Section 10
shall survive as to all New IP arising under Section 10(a)(3)

 

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and/or 10(a)(4) during the term of this Agreement), 11, 12, 15, 16, 17, 20,
21(f), and 25 through 28 (inclusive) and the Definitions.  In addition:

 

(i)                                     On expiration or termination of this
Agreement any advanced payments made by Sponsor shall be applied to the total
amounts then earned and due under the [* * *] (as amended to include any
executed Change Orders) and as listed in Section 21(b) and any prior unpaid,
undisputed invoice amounts.  Fujifilm shall provide a complete final accounting
within [* * *] after expiration or termination of this Agreement.  Any remaining
balance will be returned to Sponsor along with such accounting, and any balance
due shall be paid to Fujifilm within [* * *] after receipt of invoice, in each
case following Completion of the initiated or scheduled activities (if Sponsor
elects to continue such activities under the terms of this Agreement after
expiration or termination) and written reconciliation of Program activities and
wind-down plan subject to agreement in a Change Order that shall be prepared by
Alliance Managers upon termination or expiration.

 

(ii)                                  Unless otherwise agreed by the Parties in
writing, within [* * *] following expiration or termination of a Scope, Fujifilm
shall promptly (except as may be needed to complete any Runs that are in
process, if Sponsor elects to continue such activities under this Agreement
after expiration or termination of a Scope) at Sponsor’s sole cost and expense
(i) return (or, at Sponsor’s written election, destroy) all quantities of the
all quantities of the Master Cell Bank, Working Cell Bank, Master [* * *] Bank
and Working [* * *] Bank received or generated by Fujifilm under this Agreement,
and (ii) deliver to Sponsor all reference materials being held by Fujifilm or
its Subcontractors, (iii) deliver all remaining Process Consumables and
works-in-process to Sponsor, and (iv) deliver all Completed Product and other
deliverables.

 

(iii)                               Upon expiration or termination of a Scope or
at any time upon written request of Sponsor, within [* * *], Fujifilm
shall return to Sponsor any or all Sponsor Confidential Information received in
tangible form in connection with the Scope, except for a single copy and/or
sample which may be retained in a secure environment solely for purposes of
determining Fujifilm’s obligations hereunder and which shall remain subject to
the obligations of nonuse and confidentiality set forth in this Agreement.

 

(iv)                              Upon expiration or termination of a Scope or
at any time upon written request of Fujifilm, within [* * *], Sponsor
shall return to Fujifilm any or all Fujifilm Confidential Information, (for
clarity, Work Output is Sponsor Confidential Information), received in tangible
form in connection with the Scope, except for a single copy and/or sample which
may be retained in a secure environment solely for purposes of determining
Sponsor’s obligations hereunder and which shall remain subject to the
obligations of nonuse and confidentiality set forth in this Agreement.

 

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

(v)                                 Fujifilm shall make all Designated Equipment
associated with the Scope available for transfer to Sponsor, at Sponsor’s sole
cost and expense, within [* * *] following expiration or termination of this
Agreement.  Sponsor shall be responsible for making all arrangements to recover
the Designated Equipment.

 

(vi)                              Within [* * *] after termination or expiration
of a Scope or this Agreement as applicable, an officer of Fujifilm and an
officer of Sponsor shall certify compliance with this Section 21(f).

 

Section 22.

 

Program Management.

 

a)             Joint Steering Committee.  Effective on the Effective Date,
Sponsor and Fujifilm shall establish a Joint Steering Committee (the “Joint
Steering Committee”) comprised of three (3) representatives designated by
Sponsor and three (3) representatives designated by Fujifilm, each of whom shall
have experience and seniority sufficient to enable him or her to make decisions
on behalf of the party he or she represents.

 

b)             Alliance Managers.  Each party shall appoint one person to serve
as an Alliance Manager (each, an “Alliance Manager”) with responsibility for
overseeing the day-to-day activities of the parties with respect to the Program
and for being the primary point of contact between the parties with respect to
the Program.  The Fujifilm customer Project Leader will serve as the Fujifilm
Alliance Manager.  The Alliance Managers shall report to the Joint Steering
Committee.

 

c)              Replacement of Joint Steering Committee Representatives and
Alliance Managers.  Each party shall be free to replace its representative
members on the Joint Steering Committee or its Alliance Manager with new
appointees who have authority to act on behalf of such party, on notice to the
other party.

 

(d)         Responsibilities of Joint Steering Committee.  The Joint Steering
Committee shall be responsible for overseeing and directing the parties’
interaction and performance of their respective obligations under this
Agreement.  Without limiting the generality of the foregoing, its duties shall
include:

 

(i)             Monitoring the performance of the Program;

(ii)          Resolving disagreements that arise under the Agreement; and

(iii)       Determining the need for and terms of any Change Orders.

 

e)              Meetings.  The Joint Steering Committee shall meet at such times
as the Joint Steering Committee determines to resolve issues arising hereunder
and to perform its responsibilities under this Agreement, provided that the
Joint Steering Committee shall meet not less than four (4) times per calendar
year unless otherwise mutually agreed.  Such meetings may be in person or by
telephone as agreed by the Joint Steering Committee.  To the extent that
meetings are held in person, they shall alternate between

 

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REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

the offices of the parties unless the parties agree otherwise.  The Alliance
Managers shall attend all meetings of the Joint Steering Committee.  The
objective of the Joint Steering Committee is that all decisions shall be
unanimous.  In addition, the Vice President of Development for Sponsor and the
Vice President of Business Development of Fujifilm, or designated Fujifilm
Program sponsor, shall convene on a monthly basis in person or by teleconference
to discuss any issues, problems or other matters that cannot be resolved by the
Parties’ Alliance Managers as well as to monitor the general progress of the
Program.

 

f)               Administration.  The chairperson of the Joint Steering
Committee shall be designated every six months on an alternating basis between
the parties.  The initial chairperson will be selected by Fujifilm.  The
chairperson shall be responsible for calling meetings, sending notices of
meetings and for leading such meetings.

 

g)              Minutes.  Within [* * *]  after each Joint Steering Committee
meeting, the Alliance Manager for the party whose representative chaired the
Joint Steering Committee meeting shall prepare and distribute minutes of the
meeting, which shall provide a description in reasonable detail of the
discussions had at the meeting and a list of any actions, decisions or
determinations approved by the Joint Steering Committee.  Minutes shall be
approved or disapproved and revised, as necessary, at the next meeting.  Final
minutes shall be distributed to the members of the Joint Steering Committee.

 

h)             Dispute Resolution.  In the event that the Joint Steering
Committee cannot reach agreement with respect to any material issue, then the
issue shall be resolved in accordance with the dispute resolution provisions in
Section 15.

 

i)                 Limitations.  The Joint Steering Committee is not empowered
to amend the terms of this Agreement.

 

Section 23.

 

Assignment

 

This Agreement shall not be assigned in whole or in part by either Party without
the prior written consent of the other, which consent shall not be unreasonably
withheld or delayed.  Any attempt to assign this Agreement without such consent
shall be void and of no effect.  Notwithstanding the foregoing, either Party
shall be entitled, without the prior written consent of the other Party, to
assign all or a part of its rights under this Agreement to an affiliate, or to
assign all of its rights under this Agreement to a purchaser of all or
substantially all of its assets, or an entity with which it may merge where it
is not the surviving company, provided that in each case within [* * *]  after
the closing, the affiliate, purchaser or the assignee agrees in writing to
assume all obligations undertaken by its assignor in this Agreement.  No
assignment shall relieve the assigning Party of responsibility for the
performance of any of its obligations hereunder.  The terms of this Agreement
shall inure to the benefit of successors and assigns.

 

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Section 24.

 

Notice

 

All notices to be given as required in this Agreement shall be in writing and
shall be delivered personally, sent by telecopies, or mailed either by a
reputable overnight carrier or first class mail, postage prepaid to the Parties
at the addresses set forth below or such other addresses as the Parties may
designate in writing.  Such notice shall be effective on the date sent, if
delivered personally or sent by telecopier, the date after delivery if sent by
overnight carrier and on the date received if mailed first class.

 

If to Sponsor:

 

President

Genocea Biosciences, Inc.

Cambridge Discovery Park

100 Acorn Park Drive, 5th floor

Cambridge, MA 02140

Tel: 617-876-8191

Fax: 617-876-8192

 

If to Fujifilm:

 

President

Fujifilm Diosynth Biotechnologies

101 J. Morris Commons Lane

Morrisville, NC 27560

P:  919-337-4404

F:  919-337-0899

 

With copies to:

 

General Counsel

Fujifilm Diosynth Biotechnologies

Belasis Avenue, Billingham, TS23 1LH, United Kingdom

F: +44 1642 364463

 

Assistant General Counsel

FUJIFILM Holdings America Corporation

200 Summit Lake Drive

Valhalla, New York 10595-1356

F: 914-789-8514

 

Section 25.

 

Choice of Law

 

a)             This Agreement shall be construed and enforced in accordance with
the laws of and in the venue of the State of Delaware except for its rules
regarding conflict of laws. Subject to

 

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Section 15, all actions related to or arising out of this Agreement shall be
brought in the state or federal courts located in Delaware, and each Party
submits to the exclusive jurisdiction of such courts, except that the U.S. Court
of Appeals for the Federal Circuit, or similar non-U.S. tribunal for patent
matters outside the United States, shall have exclusive jurisdiction with regard
to the inventorship, scope or validity of any patent rights.

 

b)             Each recipient Party agrees that the disclosing Party might be
irreparably injured by an actual or threatened material breach of Section 8
and/or Section 10 of this Agreement by the recipient Party, and without
prejudice to any other rights and remedies otherwise available to the other
Party, the recipient Party agrees, upon proof of any such actual or threatened
material breach, to the granting of equitable relief, including injunctive
relief and specific performance, in the other Party’s favor without proof of
actual damages or posting of bond or other security, subject to the court’s
discretion.

 

Section 26.

 

Waiver/Severability

 

No waiver of any provision of this Agreement, whether by conduct or otherwise,
in any one or more instances shall be deemed to be or be construed as a further
or continuing waiver of any such provision, or of any other provision or
condition of this Agreement.  If any provisions hereof shall be determined to be
invalid or unenforceable, the validity and effect of the other provisions of
this Agreement shall not be affected thereby.

 

Section 27.

 

Nonsolicitation

 

For the term of this Agreement, and for [* * *] following termination of this
Agreement, for any reason, neither Sponsor nor Fujifilm nor any of their
employees or agents shall, directly or indirectly, solicit, hire, or attempt to
solicit or hire, any employees of the other who were involved in the Program,
unless otherwise approved by the other Party; provided that nothing herein shall
restrict either Party from indirectly soliciting any such employees or agents by
general employment advertising or third party employment agencies.

 

Section 28.

 

Entire Agreement; No implied Rights; Interpretation; Modification/Counterparts

 

a)             This instrument including the attached Appendices sets forth the
entire agreement between the Parties hereto with respect to the performance of
the Program by Fujifilm for Sponsor and the other subject matter hereof and as
such, supersedes all prior and contemporaneous negotiations, agreements,
representations, understandings, and commitments with respect thereto ,
including the CDA as to Confidential Information exchanged after the Effective
Date of this Agreement; and shall take precedence over all terms, conditions and
provisions on any purchase order form or form of order acknowledgment or other
document purporting to address the same subject matter.  Except as expressly
provided in Section 10 hereof, no right or license, either express or implied,
is granted under any intellectual property right or by virtue of the disclosure
of

 

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Confidential Information under this Agreement, or otherwise. Nothing in this
Agreement shall be construed to limit a Party’s remedies for use of its
intellectual property or materials by the other Party outside of the use
expressly permitted herein.  The terms of this Agreement Sections 1 through 28
shall prevail in the event of a conflict between this Agreement Sections 1
through 28 and any of its Appendices. All headings in this Agreement are for
convenience of reference only and shall not affect the interpretation of this
Agreement.  The term “includ(ing)(e/es)” and correlatives means
“includ(ing)(e/es) without limitation.” This Agreement shall not be waived,
released, discharged, changed or modified in any manner except by an instrument
signed by the duly authorized officers of each of the Parties hereto, which
instrument shall make specific reference to this Agreement and shall express the
plan or intention to modify same.

 

b)             This Agreement may be executed in one or more counterparts each
of which shall be deemed an original but all of which together shall constitute
one and the same instrument. A PDF signature document shall be deemed to be and
shall be as effective as an original signature document.

 

c)              This Agreement becomes effective and binding on both Parties on
and as of the last date that the Parties hereto have executed this Agreement. 
Should terms contained herein be at variance with the terms and conditions
specified in Sponsor’s written acceptance, then the terms and conditions
contained herein take precedence.

 

Genocea Biosciences, Inc.

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

 

 

By:

/s/ William D. Clark

 

By:

/s/ M.E. Meeson

 

 

 

 

 

Name:

William D. Clark

 

Name:

M.E. Meeson

 

 

 

 

 

Title:

President and CEO

 

Title:

Senior Vice President of Finance

 

 

 

 

 

Date:

2/28/14

 

Date:

2/26/14

 

 

 

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

 

 

 

By:

/s/ Stephen Spearman

 

 

 

 

Name:

Stephen Spearman

 

 

 

 

Title:

President

 

 

 

 

Date:

2/26/14

 

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APPENDICES:

 

Appendix 1-A: Scope of Work

Appendix 2: Quality Agreement

Appendix 3-A: Price and Payment Schedule

 

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APPENDIX 1-A

 

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Scope of Work for Phase 2 Manufacturing of

[* * *]

 

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Genocea Biosciences, Inc.

Cambridge Discovery Park, 100 Acorn Park Drive, 5th Floor, Cambridge, MA 02140

 

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

101 J. Morris Commons Lane Morrisville, North Carolina 27560

 

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WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.  WHERE THIRTY-SIX PAGES OF MATERIAL HAVE BEENOMITTED, THE
REDACTED MATERIAL IS MARKED WITH [†].

 

[†]

 

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Appendix 2

 

FUJIFILM Diosynth Biotechnologies — Genocea Biosciences, Inc.

Clinical Material Manufacturing Quality Agreement

 

Table of Contents

 

GENERAL INFORMATION

39

SIGNATURES

40

QUALITY RESPONSIBILITIES TABLE

41

ATTACHMENTS

42

ATTACHMENT A — BATCH PACKET DOCUMENTATION

42

ATTACHMENT B — MASTER DOCUMENTS

43

ATTACHMENT C — PRODUCT LIST

44

ATTACHMENT D — DEFINITIONS

45

 

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FUJIFILM Diosynth Biotechnologies — Genocea Biosciences, Inc.

Clinical Material Manufacturing Quality Agreement

 

General Information

 

This Quality Agreement outlines the roles, responsibilities and time
requirements with respect to the Quality Assurance of the Intermediate and/or
Drug Substance produced by FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
(referred to in this Quality Agreement as “Fujifilm”) or FUJIFILM Diosynth
Biotechnologies UK Limited (FDBK)  (collectively referred to as FFDB) for
Genocea Biosciences, Inc. (here within known as “Sponsor”) and fulfils the
requirements as outlined in ICH Q7 Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients.  In addition, Fujifilm may perform [* * *] as
outlined within the Agreement.  The product(s) covered by this Quality Agreement
are listed in Attachment C.

 

The Quality Agreement is an appendix to the Bioprocessing Services Agreement
(Agreement) executed by Sponsor and Fujifilm.

 

Unless otherwise defined specifically in this Quality Agreement, all general
terms used herein will be interpreted in accordance with the definitions
provided in the Agreement.  Any terms not so defined will be interpreted with
the definitions so stated in ICH Q7 or 21 CFR Parts 210, 211, 600, & 610.

 

The Authorized Quality Representatives will resolve any disputes or conflicts
relating to this Quality Agreement in a timely and equitable manner and in
compliance with all applicable quality and regulatory requirements.  Such
resolutions shall be [* * *] by the Authorized Quality Representatives of each
company.  If any issue remains unresolved for more than twenty (20) business
days, the senior corporate Quality officials from each company should be
contacted to resolve this issue.  In the event the parties fail to reach
agreement on such issue within thirty (30) calendar days after notice is
provided to the senior corporate Quality officials, then such dispute shall be
resolved according to the provisions as detailed in the Agreement.

 

All communication affecting the contents of this Quality Agreement will be
between the Authorized Quality Representatives, as set forth below:

 

For Sponsor:                                     Matthew Curtis, Director of
Regulatory Affairs

 

For FFDB:                                                 David Patterson, Sr.
Vice President, Quality Operations

 

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Signatures

 

Sponsor Authorized Quality Assurance Representative

 

By:

/s/ Matthew Curtis

 

Date:

2/28/14

 

(Signature)

 

 

 

Name:  Matthew Curtis

Tel.: [* * *]

 

Cell: [* * *]

 

Email: [* * *]

 

Address:

Genocea Biosciences

 

Cambridge Discovery Park

 

100 Acorn Park Drive, 5th Floor

 

Cambridge, MA 02140

 

FFDB Authorized Quality Assurance Representative

 

By:

/s/ David Patterson

 

Date:

2/26/14

 

(Signature)

 

 

 

 

Name:

David Patterson

Tel.:

[* * *]

 

Email:

[* * *]

 

 

Address:

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

 

 

101 J. Morris Commons Lane

 

 

Morrisville, North Carolina, USA, 27560

 

 

Confidential

 

40

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HAVE BEEN OMITTED, THE REDACTED MATERIAL IS MARKED WITH [·].

 

Quality Responsibilities Table

 

The responsible party is denoted by [g109551kk09i001.jpg]

 

 

 

Description

 

FFDB
(time frame)

 

Sponsor
(time frame)

 

 

 

[·]

 

 

 

 

 

 

41

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Attachments

 

Attachment A — Batch Packet Documentation

 

[* * *]

 

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Attachment B — Master Documents

 

Master Documents include:

 

[* * *]

 

Master Documents requiring Sponsor review and approval:

 

[* * *]

 

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Attachment C — Product List

 

Product

Site

[* * *]

 

 

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Attachment D — Definitions

 

API

 

Active Pharmaceutical Ingredient, may be used interchangeably with Drug
Substance.

 

 

 

Approved Supplier

 

A supplier who has met minimum approval standards and who has been approved to
provide required items or services that may impact product quality.

 

 

 

Authorized Quality Representatives

 

An individual named within the Quality Agreement with the authority to resolve
any disputes or conflicts relating to this Quality Agreement in a timely and
equitable manner and in compliance with all applicable quality and regulatory
requirements.

 

 

 

Batch

 

A specific quantity of material produced in a process or fraction of a process.
Batches are defined as the material represented at the end of the intermediate
processing steps or the material represented at the end of the processing step
for API.

 

 

 

cGMP

 

Current Good Manufacturing Practices pursuant to (a) the U.S. Federal Food, Drug
and Cosmetics Act as amended (21 USC 301 et seq.), (b) U.S. regulations in Title
21 of the U.S. Code of Federal Regulations Parts 210, 211, 600 and 610 (c) the
EC Guide to Good Manufacturing Practice for Medicinal Products, v.4, including
relevant sections of DIR 2003/94/EC, and (d) International Conference on
Harmonization (ICH) Guidance for Industry Q7 Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients.

 

 

 

Complaint

 

Any written, electronic, or oral communication by the Customer, Sponsor, or
other source (e.g. fill finish manufacturing site) outside of the FFDB which
expresses dissatisfaction related to the identity, strength, quality, purity,
safety or effectiveness of a product manufactured by FFDB after it is
dispositioned or released. This includes suspected tampering, counterfeiting or
diversion.

 

 

 

Critical Raw Materials

 

Raw materials that comprise final formulation components and / or that combine
structurally or chemically with the product (i.e. excipient), which has the
potential to influence the properties (safety, immunogenicity) of the product.

 

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Deviation

 

An unplanned event requiring investigation which 1) may affect the quality or
compliance status of the product, process materials, equipment or facility
involved or 2) may not be in alignment with regulatory submissions.

 

 

 

Disposition

 

A recommendation given by FFDB Quality on the suitability of the Intermediate or
Drug Substance for further processing.

 

 

 

Drug Product

 

The dosage form in the final immediate packaging intended for clinical use.

 

 

 

Drug Substance or DS

 

Any substance or mixture of substances intended to be used in the manufacture of
a drug (medicinal) product and that, when used in the production of a drug,
becomes an active ingredient of the Drug Product. Such substances are intended
to furnish pharmacological activity or other direct effect on the diagnosis,
cure mitigation, treatment, or prevention of disease or to affect the structure
and function of the body.

 

 

 

Process Consumables

 

Process Consumables include any disposable equipment or equipment parts or Raw
Material used in the manufacture of an intermediate or Drug Substance that do
not themselves participate in a chemical or biological reaction. Such other
materials include: [* * *].

 

 

 

Product

 

Any (a) API/Drug Substance, or (b) Drug Product comprised of API/Drug Substance,
or (c) intermediate(s) of (a) or (b) , in each case as specified in the
applicable Scope.

 

 

 

Raw Material

 

Any ingredient intended for use in the manufacture of an intermediate or API,
including those that may not appear in the final formulation. These include
chemicals used directly and/or indirectly in the manufacturing process.

 

 

 

Statement of Compliance

 

A FFDB QA Disposition of Product Statement stating that a specific Batch of Drug
Substance complies with all Product, GMP and regulatory requirements and is
signed by an authorized representative of FFDB.

 

 

 

Test Methods

 

Methods used for QC testing, including Standard Test Methods and Compendial
Methods.

 

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APPENDIX 3-A: PROGRAM PRICE AND PAYMENT SCHEDULE

 

PHASE II PROGRAM PRICE

 

Activities

 

Estimated Budget

 

[☼]

 

 

 

 

Pricing Assumptions:

 

·                  [* * *]

 

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ADDITIONAL SERVICES - ESTIMATES

 

Other Program Services - Activities

 

Estimated
Budget
1st Antigen

 

Estimated
Budget
2nd Antigen

 

[* * *]

 

[* * *]

 

 

 

 

Estimate for Raw Materials/Consumables (for budgetary purpose only)

 

·                  [* * *]

 

·                  [* * *]

 

If needed, the cost of any capital expenditures necessary to transfer the
process to Fujifilm will be communicated to Sponsor.  At this time no capital
expenditure is anticipated for this program.

 

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BEEN OMITTED, THE REDACTED MATERIAL IS MARKED WITH [*****].

 

PAYMENT SCHEDULE

 

Reservation Fee

 

Activity/Milestone

 

Payment

 

Reservation
Fee Credit

 

Net Payment

 

Estimated
Invoice
Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[*****]

 

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