Exhibit 10.1

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement EXECUTION COPY

COMMERCIAL SUPPLY AGREEMENT

This Commercial Supply Agreement (this “Agreement”) dated January 28, 2015 (the
“Effective Date”) between Synageva BioPharma Corp., a Delaware corporation
(“Sponsor”), having its principal place of business at 33 Hayden Avenue,
Lexington, Massachusetts 02421 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”,
and together, the “Parties”).

WHEREAS, Sponsor and Fujifilm entered into a Bioprocessing Services Agreement
dated January 22, 2013 that was subsequently amended with change orders (“BSA”),
pursuant to which Fujifilm agreed to perform certain process development
services including process validation and Conformance Campaign (as defined
below) with respect to sebelipase alfa on behalf of Sponsor;

WHEREAS, Sponsor wants Fujifilm to Manufacture (as defined below) in accordance
with the terms of this Agreement the Product (as defined below) for the
anticipated initial commercial launch and, after receiving Market Authorization
(as defined below), for routine commercial supply of the Drug Product (as “Drug
Product” is defined below); and

WHEREAS, Fujifilm wants to Manufacture the Product.

NOW THEREFORE, 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:

“2015 Lack of Approval Event” shall have the meaning set forth in
Section 2(c)(ii).

“Actual Batch Yield” shall mean the quantity of Product resulting from
Manufacturing for a Batch, without reduction for sampling performed by Fujifilm
pursuant to this Agreement or the Quality Agreement. Quantity of Product shall
be determined by the following calculation: [**].

“Adverse Event” shall mean any untoward medical occurrence in a patient or
clinical trial subject administered a human medicinal product irrespective of
whether there is a causal relationship with the Product or the Drug Product or
not. An Adverse Event can therefore be any unfavorable and unintended sign
(e.g., abnormal laboratory finding), symptom, or disease temporally associated
with the use of the Product or the Drug Product in humans, whether or not
considered related to the Product or the Drug Product.

“Affiliate” shall mean any corporation or other business entity directly or
indirectly controlled by, controlling, or under common control with a Party or
its parent corporation. The term “control” (including, with correlative meaning,
the terms “controlled by,” “controlling” and “under common control with”) shall
mean the legal power to direct or cause the direction of the general management
and policies of such entity whether through the ownership of at least 50% of
voting securities or capital stock of such business entity or any other
comparable equity or ownership interest with respect to a business entity other
than a corporation.

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

 

CONFIDENTIAL   1   

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

“Annual Program Fee” shall have the meaning set forth in Section 6(b).

“Anti-Bribery Laws” shall have the meaning set forth in Section 33.

“Applicable Law” shall mean all laws, statutes, directives, ordinances, codes,
regulations, rules, by-laws, judgments, decrees or orders of any governmental or
regulatory authority (including any Regulatory Authority, as defined below),
department, body or agency or any court, tribunal, bureau, commission or other
similar body, whether foreign, federal, state, provincial, county or municipal,
applicable to the manufacture and production (including the Manufacture, as
defined below), processing, testing, packaging, use, storage, sale, and
distribution (including transport, import and export) of the Product and/or the
Drug Product, including, without limitation all applicable cGMPs.

“Batch” shall collectively refer to [**] Batches and [**] Batches.

“Batch Packet” shall mean a compilation of records identified in the Quality
Agreement for a Batch, including but not limited to, [**].

“Batch Price” shall have the meaning set forth in Section 6(a)(i).

“Binding Order” shall mean a non-cancellable order of specified number of
Batches in the [**] to be delivered to Sponsor by Fujifilm in accordance with
Section 2(f), which order shall be submitted to Fujifilm according to the
process specified in Section 2 and which shall be binding on Fujifilm to
fulfill.

“Binding Period” shall mean the forecast for [**] of each Rolling Forecast and
shall be the [**] starting with the first day of the [**] ending on the last day
of the [**]. For clarity, if Sponsor submits a Rolling Forecast on [**] the
Binding Period for such Rolling Forecast would be from [**].

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

“Bulk Fill” shall mean, with respect to a Batch, the point in time when Product
comprising that Batch is filled into bags and stored in cold temperature
storage.

“Campaign” shall mean the Manufacture of a Batch or a series of Batches operated
in succession for the production of Product, including in each case, set-up of
the GMP Facility, inter-Batch cleaning and a final clean-out of the GMP
Facility.

“cGMP” shall have the meaning set forth in Section 4(a).

“Change Order” shall have the meaning set forth in Section 10(b).

“Claim” shall have the meaning set forth in Section 19(a).

“COA” shall mean certificate of analysis, as described in the Quality Agreement.

“[**] Batch” shall mean a specific quantity of Product that is Manufactured by
Fujifilm during the same cycle of Manufacture and that is intended to have
uniform character and quality within specified limits, with an [**] according to
the Specifications.

 

CONFIDENTIAL 2

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

“Confidential Information” shall have the meaning set forth in Section 11(c).

“Conformance Campaign” shall mean the [**] manufacturing campaign at Fujifilm
under the [**].

“Consumable Price” shall have the meaning set forth in the Section 6(a).

“Delivery Date” shall have the meaning set forth in Section 2(f)(iii).

“Disposition Date” shall mean the date of Batch disposition by Fujifilm in
accordance with and as contemplated by the Quality Agreement.

“Disposition of Product Statement” shall have the meaning set forth in the
Quality Agreement.

“Drug Product” shall mean the filled and finished final dosage form of the
Product in association with other active or inactive ingredients intended for
commercial or clinical use.

“Drug Product Complaint” shall mean any verbal, written, or electronic
communication received that suggests dissatisfaction with the identity, quality,
stability, reliability, safety, efficacy, performance, or usage of the Drug
Product after it is released for distribution to the clinic or to the market.

“Effective Date” shall have the meaning set forth in the preamble.

“EMA” shall mean the European Medicines Agency, or any successor agency or
authority thereto.

“Facilities” shall mean the GMP Facility, Fujifilm’s process development
laboratories located at 3000 Weston Parkway, Cary, NC 27513, and Fujifilm’s
administrative building located at 101 J. Morris Commons Lane, Morrisville, NC
27560.

“Facility Assessment Memo” shall have the meaning set forth in the Quality
Agreement.

“FDA” shall mean the United States Food and Drug Administration, or any
successor agency or authority thereto.

“First Shipment” shall have the meaning set forth in Section 2(d)(i).

“Frustration of Purpose Event” shall have the meaning set forth in
Section 2(c)(iii).

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

“Fujifilm Confidential Information” shall have the meaning set forth in
Section 11(b).

“Fujifilm Indemnitees” shall have the meaning set forth in Section 19(b).

“GMP Facility” shall mean Fujifilm’s manufacturing plant located at 6051 George
Watts Hill Drive, Durham, NC 27709 that is operated in compliance with cGMP.

[**]

 

CONFIDENTIAL 3

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

“Indemnified Party” shall have the meaning set forth in Section 19(c).

“Indemnifying Party” shall have the meaning set forth in Section 19(c).

“Indemnity Claim” shall have the meaning set forth in Section 19(c).

“Index Figure” shall mean [**] index [**].

“Initial Binding Order” shall have the meaning set forth in Section 2(d).

“Initial Term” shall have the meaning set forth in Section 23(a).

“Joint Steering Committee” shall have the meaning set forth in Section 24(a).

“Key Manufacturing Assumption” shall have the meaning set forth in
Section 10(a).

“Late Delivery Credit” shall have the meaning set forth in Section 9(b).

“Loss” shall have the meaning set forth in Section 19(a).

“Manufacture”, “Manufactured” or “Manufacturing” shall mean the manufacture of
Product by Fujifilm and all related activities, including but not limited to
quality assurance, quality control, testing, storage and packaging for shipment,
in accordance with this Agreement and the Quality Agreement.

“Manufacturing Price” shall have the meaning set forth in Section 6(a)(i).

“Manufacture Start Date” shall mean the thaw date of the Starting Material.

“Market Authorization” shall mean approval by one or more Regulatory Authorities
to market, sell and distribute the Drug Product in any part of the world.

“Maximum Annual Order” shall mean the maximum number of Batches that Fujifilm
shall be obligated to Manufacture and Sponsor shall be obligated to purchase
within a twelve (12) month period, as further defined in Section 2(c)(v).

“Maximum Binding Order” shall mean the maximum number of Batches that Fujifilm
shall be obligated to Manufacture and Sponsor shall be obligated to purchase
pursuant to a Binding Order, as determined according to Section 2(c)(iv).

“Minimum Binding Order” shall mean the minimum number of Batches that Sponsor
shall be obligated to purchase and Fujifilm shall be obligated to Manufacture
pursuant to a Binding Order, as determined according to Section 2(c)(i).

“Modifications” shall have the meaning set forth in Section 10(b).

“[**] Batch” shall mean a Batch which [**] Manufactured in accordance with or
[**] the requirements of: cGMPs, this Agreement or the Quality Agreement
(including the Specifications).

 

CONFIDENTIAL 4

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

“Order Expansion” shall have the meaning set forth in Section 2(e).

“[**] Batch” shall mean a specific quantity of Product that is Manufactured by
Fujifilm during the same cycle of Manufacture and that is intended to have
uniform character and quality within specified limits, [**], provided that it is
releasable according to the Specifications.

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

“PIP” shall have the meaning set forth in Section 5.

“Process” shall mean the process for Manufacture of the Product, as initially
determined during the Conformance Campaign and as subsequently updated by the
process detailed in the Quality Agreement and changes thereto implemented
pursuant to Section 10.

“Process Consumables” shall mean materials required to Manufacture Product
(excluding [**]). For the purpose of this Agreement, this definition includes
[**].

“Process Consumables LOA” shall have the meaning set forth in Section 6(e).

“Process Inventions” shall have the meaning set forth in Section 13(b).

“Product” shall mean the product described in the Specifications that is
Manufactured by Fujifilm under this Agreement.

“Product Inventions” shall have the meaning set forth in Section 13(b).

“Program” shall mean the Manufacturing services to be performed under this
Agreement.

“Program Inventions” shall have the meaning set forth in Section 13(a).

“Program Manager” shall have the meaning set forth in Section 24(b).

“Quality Agreement” shall mean the quality agreement executed by the Parties
dated as of January 28, 2015, as may be amended from time to time.

“[**] Deviation Reports” shall have the meaning set forth in the Quality
Agreement.

“Recall” shall have the meaning set forth in Section 8(a).

“Receiving Date” shall mean the date indicated in the Receiving Schedule as the
date by when Fujifilm will receive a shipment of Starting Material from Sponsor,
provided that, unless the Parties agree otherwise in writing (which may be via
email) such date shall be no more than [**] before the target Manufacture Start
Date for the applicable Batches identified by Fujifilm pursuant to Section 2(f)
and provided further that the Receiving Date shall be [**] after Sponsor’s
receipt of the Receiving Schedule.

“Receiving Schedule” shall mean a schedule issued by Fujifilm in accordance with
Section 2(g) for receiving Starting Material at GMP Facility for a specific
Binding Order, which schedule must include the receiving quantity of the
Starting Material and Receiving Dates, subject to Section 2(g).

 

CONFIDENTIAL 5

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

“Regulatory Authority” shall mean foreign, national, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental
entity in any country or region listed in Attachment 1 hereto with authority
over the manufacture and production (including the Manufacture, as defined
above), processing, testing, packaging, use, storage, sale, pricing, and
distribution (including transport, import and export) of the Product, including,
without limitation, the FDA and the EMA and any successor entities thereto. The
definition may be expanded to other regulatory authorities upon mutual written
agreement.

“Reservation Fee” shall have the meaning set forth in Section 6(a)(i).

“Resin Cost” shall have the meaning set forth in Section 6(a)(ii).

“Restriction Summary” shall have the meaning set forth in the Quality Agreement.

“Rolling Forecast” shall have the meaning set forth in Section 2(b).

“Safety Information” shall mean all information relating to known or potential
risk to humans, obtained or otherwise received from any source, including
information derived from clinical investigations, commercial marketing
experience, post-authorization, post-authorization epidemiological/surveillance
studies, reports in the scientific literature, unpublished scientific papers,
animal or in vitro studies, electronic communications and reports. Safety
Information may include Adverse Events/experiences, lack of efficacy, suspected
transmission of infectious agents, overdose, abuse, misuse, medication errors,
pregnancy/breastfeeding exposure, and off-label use.

“Safety Stock” shall have the meaning set forth in Section 6(e).

“Second Shipment” shall have the meaning set forth in Section 2(d)(ii).

“Specifications” shall mean the specifications for the Product, as set forth in
and/or attached to the Quality Agreement.

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

“Sponsor Confidential Information” shall have the meaning set forth in
Section 11(a).

“Sponsor Deliverables” shall have the meaning set forth in Section 3(a).

“Sponsor Indemnitees” shall have the meaning set forth in Section 19(a).

“Starting Material” shall mean [**] provided from Sponsor to Fujifilm as the
starting material for Manufacturing.

“Starting Material Failure” shall have the meaning set forth in
Section 7(b)(vii)(A).

“Term” shall have the meaning set forth in Section 23(a).

“Third Shipment” shall have the meaning set forth in Section 2(d)(iii).

“Work Output” shall have the meaning set forth in Section 12(a).

 

CONFIDENTIAL 6

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 1. Manufacture of Product

 

  a) Manufacture of Product. Fujifilm will Manufacture the Product for Sponsor
at the GMP Facility, based on Binding Orders submitted by Sponsor, in accordance
with the terms and conditions of this Agreement, the Quality Agreement and
Applicable Law (including cGMPs). Terms defined in this Agreement shall have the
same meaning when used in Quality Agreement. In the event of any conflict
between this Agreement and the Quality Agreement, the terms of this Agreement
shall have the precedence except with respect to matters of quality, in which
case the terms of the Quality Agreement shall govern. Fujifilm may change the
site of Manufacture for the Product only with the prior written consent of
Sponsor and any such change will be at Fujifilm’s sole cost and expense, unless
the Parties agree otherwise in writing.

 

  b) Process Surveillance. Fujifilm will perform process surveillance on all
Batches Manufactured under this Agreement, which will include the surveillance
listed below, in addition to any surveillance detailed in the Quality Agreement:

 

  i. Trending process yield and release testing data in accordance with the
mutually agreed process surveillance plan, including per [**] and Step Yields
will also be trended;

 

  ii. Statistical analysis of surveillance parameters at the end of [**] once a
minimum of [**] are available; and

 

  iii. Preparation of surveillance parameter data report after [**] after the
Disposition Date of the last Batch of the Binding Order), not to exceed [**].

 

  c) Regulatory Support. Fujifilm will provide routine regulatory support to
Sponsor for the Program at Sponsor’s request that will include:

[**]

Any additional regulatory support, which in Fujifilm’s reasonable opinion,
exceeds reasonable expectations of the Parties established upon Agreement
execution will be provided by Fujifilm based on a Change Order or separate
agreement.

 

  d) Sponsor Obligations. Sponsor shall:

 

  i. Perform its obligations as set forth in this Agreement and the Quality
Agreement; and

 

  ii. Support and cooperate with the execution of each Binding Order.

 

  e) [**]

 

  f)

Purchasing Commitment. Sponsor shall order at least [**] supply from Fujifilm
[**] during the Term. Within [**], Sponsor shall send Fujifilm a written, signed
certification of [**] ordered from Fujifilm [**]. In the event Sponsor ordered
[**] from Fujifilm [**], it shall add the difference between the actual amount
ordered and the minimum required order (i.e., [**]) to the Binding Orders for
[**]. If such additional Batches result in Batches in excess of

 

CONFIDENTIAL 7

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  [**] obligation to order and purchase such additional Batches shall apply only
to the extent [**]. In addition to the foregoing, in the event [**] willfully
misrepresents the amount ordered on an [**]. The obligations set forth in this
Section 1(f) shall not apply in the event of a Frustration of Purpose Event
described in Section 2(c)(iii)(C), in the event of [**], until such time as such
[**], but in no event longer than[**] after such events have ended, at which
time the purchasing commitment described in this Section 1(f) shall recommence.
[**] compliance with the commitment [**] shall be calculated based on the [**]
effect and, for clarity, not [**]. In the event of (i) [**] pursuant
Section 7(b)(vii)(B) [**] (by way of clarification, [**] for purposes of this
Section 1(f)(ii)), or (iii) [**], the purchasing commitment described in this
Section 1(f) shall not apply to the [**] nor until such time as [**], but in no
event later than [**].

 

  g) Subcontractors. With respect to this Agreement and the Quality Agreement,
Fujifilm shall not delegate its responsibilities to, or perform any of its
obligations through, any third party unless (i) such third party is not involved
in processing, testing or handling Product, or (ii) expressly permitted
hereunder or thereunder or approved in writing in advance by Sponsor, such
approval not to be unreasonably withheld or delayed. Fujifilm’s delegation of
any such responsibility to, or performance of any of such obligation through,
any third party shall not in any way relieve Fujifilm of its duties and
responsibilities under this Agreement and the Quality Agreement and Fujifilm
shall remain primarily obligated and liable for the performance thereof.

 

  h) Process Improvements. Parties agree that during the course of the
Agreement, the Parties may identify and implement Process improvements that can
benefit both Parties. In the case one of the Parties identifies an opportunity
for improvements related to raw materials, such Party will notify the other
Party and the Parties will [**] to these opportunities. Any cost-related
improvements resulting from these projects will be [**]. Such improvements must
be within the validated parameters of the Process and shall not be effective
unless mutually agreed in writing by the Parties pursuant to Section 10.

 

  i) Periodic Inventory Reporting. Fujifilm shall furnish the following
information to Sponsor at the end of each Binding Period: Product, Starting
Material and [**] quantities remaining, lot numbers and sub lots, and expiry
dates as applicable.

Section 2. Rolling Forecast and Binding Orders; Scheduling; Starting Material
and [**]

 

  a) General. The Initial Binding Order meeting the Sponsor’s Product
requirements for year 2015 is described in Section 2(d). Future orders for the
year 2016 and the following years will be based on a Rolling Forecast (as
defined below) according to the mechanism described below.

 

  b) Rolling Forecast. No later than August 31, 2015, Sponsor shall provide
Fujifilm with a good-faith rolling forecast, and every [**] months thereafter
(by the following [**], respectively), that projects the number of Batches
needed for the following [**] beginning on [**] (the “Rolling Forecast”).
Fujifilm shall use the Rolling Forecast to plan capacity and resources. The
Rolling Forecast shall indicate the number of Batches to be provided during [**]
period and shall cover the Binding Period, the semi-binding period and the
non-binding periods, as follows:

 

  i. Period 1 (months [**]) – notice period;

 

CONFIDENTIAL 8

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  ii. Period 2 (months [**] ordered);

 

  iii. Period 3 (months [**]

 

  iv. Periods 4-7 [**].

When applying the percentages set forth in this Section 2(b), the Parties will
[**], as applicable.

 

  c) Binding Orders. The forecast for Period 2 of each Rolling Forecast (i.e.,
the Binding Period) shall constitute a Binding Order and shall be subject to the
following limitations:

 

  i. “Minimum Binding Order” shall be for [**] Batches.

 

  ii. If Sponsor has not received [**] (“2015 Lack of Approval Event”), Sponsor
(i) will purchase all [**] and (ii) all [**] will no longer be in effect as of
such date. The Parties will use [**].

 

  iii. Each of the following events constitute a “Frustration of Purpose Event”:

 

  (A) [**]

 

  (B) [**]

 

  (C) [**]

If a Frustration of Purpose Event occurs, Sponsor shall purchase [**].
Otherwise, all current and future [**], provided, however that such requirements
shall [**]. In addition, with respect to a Frustration of Purpose Event
described in Section 2(c)(iii)(A) or (B), the Parties will [**] the system of
forecasting and ordering (including any applicable [**] unless otherwise agreed
by the Parties.

 

  iv. “Maximum Binding Order” shall be for [**].

 

  v. Total number of Batches ordered within [**] (“[**]”).

 

  d) Initial Binding Order for 2015. During calendar year 2015, Fujifilm shall
Manufacture and Sponsor shall [**] Batches of Product (“Initial Binding Order”)
according to the following schedule:

 

  i. The first Batch of the initial [**] shall have a Manufacturing Start Date
no later than [**], with the remaining [**] in the Campaign having a targeted
[**] than [**] (“First Shipment”);

 

  ii. The first Batch of the [**] shall have a Manufacturing Start Date no later
than [**], with the remaining [**] in the Campaign having a targeted [**] than
[**] (“Second Shipment”); and

 

  iii. The first Batch of the [**] shall have a Manufacturing Start Date no
later than [**], with the remaining [**]in the Campaign having a targeted [**]
than [**] (“Third Shipment”).

Notwithstanding anything in Section 2(f) to the contrary, Fujifilm will perform
[**]. Fujifilm shall provide Sponsor at least [**] prior written notice of the
[**]. The Delivery Date for such Batches shall follow the requirements of
Section 2(f)(iii).

 

CONFIDENTIAL 9

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  Sponsor shall have the right to order additional Batches for delivery in
calendar year 2015 by notifying Fujifilm not later than [**] for the Second
Shipment and not later than [**] for the Third Shipment, and Fujifilm shall
[**]. Such additional Batches shall be purchased by Sponsor [**] as the Batches
of the original Binding Order and Sponsor shall [**]. For the Initial Binding
Order, Fujifilm shall provide Sponsor with Receiving Schedules for the
corresponding Campaigns [**] of the Effective Date for the First Shipment, [**]
for the Second Shipment and [**] for the Third Shipment.

 

  e) Batches in excess of Maximum Binding Order. Sponsor may request shipment of
additional Batches in excess of Maximum Binding Order or [**] (“Order
Expansion”) and Fujifilm shall make [**] to accommodate such request. In the
event Sponsor requests an Order Expansion, Fujifilm shall notify Sponsor in
writing within [**] of receipt of such request whether Fujifilm will be able to
accommodate such request. In the event Fujifilm confirms its ability to
accommodate Sponsor’s Order Expansion request, the quantity of additional
Batches in excess of the Maximum Binding Order or [**] indicated in the Order
Expansion shall become a Binding Order. Such additional Batches shall be
purchased by Sponsor [**] and Sponsor acknowledges and agrees that Sponsor [**].

 

  f) Manufacturing Scheduling and Product Shipment Schedule. Once Fujifilm
receives a Binding Order from Sponsor ([**] after receiving a Binding Order),
Fujifilm will provide Sponsor with a written confirmation of the [**] for the
Batches ordered pursuant to such Binding Order. Fujifilm shall [**], provided
that, unless mutually agreed to in writing, which may be via email:

 

  i. The actual Manufacture Start Date [**] by Fujifilm for such Binding Order;

 

  ii. Fujifilm will use commercially reasonable efforts to ensure the actual
Disposition Date [**] from the completion of Bulk Fill for the Batch, as
reflected in the Batch Records for that Batch; and

 

  iii. Fujifilm shall provide Sponsor with good-faith estimated date on which
Fujifilm anticipates providing possession of a Batch to Sponsor [**] before such
estimated date. The actual date of transfer of possession of a Batch from
Fujifilm to Sponsor shall ultimately be subject to the Parties’ mutual agreement
and shall [**] after the Disposition Date unless otherwise requested by Sponsor
and agreed by Fujifilm in writing, which may be via email (such agreement not to
be unreasonably withheld or delayed) (the “Delivery Date”).

 

  g) Starting Material Receiving Schedule. Within [**] of receiving a Binding
Order, Fujifilm shall prepare and deliver to Sponsor a Receiving Schedule.

 

  i. Based on the Receiving Schedule, Sponsor shall use commercially reasonable
efforts to deliver the Starting Materials to the GMP Facility in the quantity
listed on the Receiving Schedule (i) no later than on the [**], but (ii) no
earlier than [**]. Parties shall agree in writing, which may be via email, on
specific shipment dates for Starting Material. Sponsor acknowledges that the
failure by Sponsor to provide Starting Material within the timeframe agreed by
the Parties may result in postponed Manufacture Start Date or Delivery Date
equal to Sponsor delay.

 

  ii. Sponsor shall ship Starting Material so that [**] batches of such Starting
Material are received [**].

 

CONFIDENTIAL 10

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  iii. In the Receiving Schedule, Fujifilm shall not request a quantity of
Starting Material greater than the quantity of Starting Material required (based
on the Specifications) for the number of Batches indicated in Binding Order,
[**] in the amount sufficient for [**] unless Fujifilm already has [**].

 

  iv. Starting Material received by Fujifilm shall have [**] for each batch of
Starting Material received.

 

  v. Starting Material delivered by Sponsor to Fujifilm shall meet quality
requirements specified in the Specifications. Upon receipt of a batch of
Starting Material, Fujifilm shall review the accompanying documentation and
examine such shipment to confirm the quantity received is consistent with the
quantity specified in the Receiving Schedule. Fujifilm shall also perform
identification testing and any other testing required by the Quality Agreement
to confirm that the Starting Material meets the quality requirements specified
in the Specifications. In the event Fujifilm notifies Sponsor of non-conformity
of any Starting Material received by Fujifilm, Sponsor shall promptly
investigate Fujifilm’s claim of non-conformity in the Starting Material and
shall provide Fujifilm with instructions on how to handle such Starting Material
and any return of such Starting Material shall at Sponsor’s sole cost and
expense if Sponsor elects for the return of such Starting Material in lieu of
destruction. Notwithstanding the results of Sponsor investigation, Fujifilm
shall [**].

 

  vi. Fujifilm shall use commercially reasonable effort to apply the
“first-expired-first-out” principles to processing of Starting Material.

 

  h) [**]. During the Term, [**]. Concurrently with providing [**] shall provide
[**] of its requirements for [**]. Based on the feedback from [**] with
lead-time required by the [**] required to Manufacture a Batch as specified in
the Specifications, including appropriate [**] agreed by the Parties. Sponsor’s
[**]. The Parties acknowledge and agree that [**] in accordance with this
Section shall be made under the [**]. Fujifilm will be responsible for [**] and
agrees to comply with the [**] shall review the accompanying documentation and
perform incoming identification testing and perform any other tests required in
the Quality Agreement to confirm the [**] conforms with the Specifications and
was received in the quantity indicated in the shipment-related documentation,
including confirmation that the [**]. In the event the [**] shall be responsible
for the [**].

Section 3. Sponsor Deliverables

 

  a) Sponsor will use commercially reasonable efforts to timely provide Fujifilm
with Sponsor Deliverables (as defined below). Sponsor acknowledges that the
failure by Sponsor to provide Sponsor Deliverables within the timeframe set
forth below or otherwise agreed by Parties may result in postponed Manufacture
Start Date or Delivery Date equal to Sponsor delay. “Sponsor Deliverables” means
the following:

 

  i. For each Binding Order, Sponsor shall deliver the quantity of Starting
Material as specified in the Receiving Schedule.

 

  ii. Sponsor shall provide documentation review and approval within timeframes
specified in Quality Agreement, provided that Sponsor received such
documentation on a timely basis from Fujifilm.

 

CONFIDENTIAL 11

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  iii. Sponsor shall review the Batch Packet within the period specified in the
Quality Agreement to determine, to the extent ascertainable from such
documentation, whether or not the Batch covered by such Batch Packet conforms to
the Specifications and shall issue a Certificate of Compliance. For clarity,
Sponsor’s issuance of a Certificate of Compliance shall [**].

 

  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 and shall use Sponsor Deliverables solely for purposes of
performing the Program. Fujifilm shall provide safe and secure storage
conditions at the GMP Facility for Sponsor Deliverables while they are at the
GMP Facility and shall store the Sponsor Deliverables [**] at the GMP Facility,
unless otherwise agreed with Sponsor in writing, in accordance with all
Applicable Law and any storage guidelines provided by Sponsor and agreed upon
with Fujifilm.

Section 4. Compliance with Government Regulations

 

  a) Fujifilm shall operate the GMP Facility in compliance with Applicable Law
and any requirements provided for in the Quality Agreement for all aspects of
Manufacturing (including but not limited to testing, holding, packaging,
labeling and delivery of the Product and/or intermediates produced for Sponsor).
For clarity, this shall include the obligation for Fujifilm to operate the GMP
Facility as compliant with (i) the U.S. Federal Food, Drug and Cosmetics Act, as
amended (21 U.S.C. et seq.), (ii) U.S. regulations found at 21 CFR Parts 11,
210, 211, 600, & 610, (iii) ICH Q7 GMP Guidance for Active Pharmaceutical
Ingredients, (iv) EC Directive 2003/94/EC, (v) the EC Guide to Good
Manufacturing Practice for Medicinal Products and Division 2 of the Food and
Drug Regulations (Canada), (vi) the latest Health Canada, FDA and EMA guidance
documents all pertaining to manufacturing and quality control practice and
(vii) the good manufacturing practices required by any other Regulatory
Authority to the extent such required practices do not contradict or negate the
requirements or guidance documents issued by FDA or EMA, all as updated, amended
and revised from time to time (collectively, “cGMP”). Fujifilm shall not permit
debarred persons to participate in the Program or persons for whom debarment is
pending or threatened. Fujifilm shall undertake commercially reasonable steps to
prevent such participation.  

 

  b) Sponsor shall have the sole right and responsibility for determining
regulatory strategy, decision and actions relating to the Program and the
Product. Subject to each Party’s contractual obligations under this Agreement,
Fujifilm shall have the sole right and responsibility for determining regulatory
strategy, decision and actions to the extent relating to (i) the Facilities;
(ii) Fujifilm’s quality systems; or (iii) any requirement imposed directly on
Fujifilm by a Regulatory Authority, provided that a Regulatory Authority
requirement shall not be considered to be “a requirement imposed directly on
Fujifilm by a Regulatory Authority” if it is applicable to or imposed on Sponsor
regarding the services provided by Fujifilm with respect to the Product, but is
not applicable to other Fujifilm’s client in respect to Fujifilm’s services
provided to them. Fujifilm hereby [**], as of the Effective Date, [**] Sponsor
with commercial supply of Product or otherwise complying with its obligations
hereunder. Notwithstanding the foregoing, [**] Sponsor will consult with
Fujifilm in respect to and prior to any action that may be reasonably expected
to impact Fujifilm’s obligations with respect to the Product.

 

CONFIDENTIAL 12

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  c) Should such applicable requirements of Regulatory Authorities change or
should the mutually agreed upon expansion of the definition of Regulatory
Authorities impact Fujifilm’s regulatory obligations hereunder, Fujifilm will
promptly notify the other Party of such change and the effect on the Program,
and Fujifilm will use reasonable efforts to satisfy the new requirements. In the
event that compliance with such new applicable regulatory requirements
necessitates performing additional studies or other work not reasonably expected
and anticipated as part of routine commercial manufacturing, Fujifilm will
submit to Sponsor a Change Order in accordance with Section 10 of this
Agreement.

 

  d) Subject to this Section 4, in the event of a conflict in government
regulations applicable to the performance of the Program, Sponsor and Fujifilm
will [**] in its performance of the Program; provided, however, that Fujifilm
shall not be required to [**].

 

  e) If Fujifilm receives any contact or communication from any Regulatory
Authority governing commercial licensing of the Product, Fujifilm will
(i) notify Sponsor and provide Sponsor with copies of any such communication (to
the extent the communication relates to the Program) within [**] of Fujifilm’s
determination that such communication relates to the Program (but not to exceed
[**] of Fujifilm’s receipt of such communication) and (ii) comply with all
reasonable requests by Sponsor with respect to any actions to be taken or
responses to be made to any such Regulatory Authority. Fujifilm will promptly
inform Sponsor in the event that any such Regulatory Authority takes any action
against Fujifilm for any reason that could be reasonably expected to have an
effect on Fujifilm’s performance of the Program. Unless required by Applicable
Law, Fujifilm will have no contact or communication with any such Regulatory
Authority regarding the Product without the prior written consent of Sponsor,
which consent will not be unreasonably withheld. If Fujifilm is required by
Applicable Law to contact or communicate with any Regulatory Authority regarding
the Product, Fujifilm shall provide Sponsor with reasonable prior notice to
allow Sponsor the opportunity to participate in any such contact or
communication, to the maximum extent permitted by law. In the event of an
inspection of Fujifilm by a Regulatory Authority that pertains to Product,
Fujifilm shall allow Sponsor and its representatives to attend and participate
in such inspection. The Quality Agreement shall govern with respect to
obligations related to the Parties’ notifications and submissions to a
Regulatory Authority governing the commercial license of the Product.

 

  f) Fujifilm shall secure and maintain in good order, at its sole cost and
expense, such current governmental registrations, permits and licenses as are
required by any Regulatory Authority or otherwise required by any Applicable Law
in order for Fujifilm to perform its obligations under this Agreement.

 

  g) If Fujifilm receives notice of action or threat of action with respect to
its debarment or debarment of any individual involved in the performance of
Fujifilm’s obligations hereunder during the Term of this Agreement: (i) Fujifilm
shall so notify Sponsor immediately and (ii) Sponsor shall have the right to
terminate this Agreement immediately upon written notice.

 

  h)

If Sponsor receives notice of action or threat of action with respect to its
debarment or debarment of any individual involved in the performance of
Sponsor’s obligations hereunder during the Term of this Agreement (i) Sponsor
shall so notify Fujifilm immediately and (ii) in the event of Sponsor’s actual
debarment, Fujifilm shall have the

 

CONFIDENTIAL 13

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  right to terminate this Agreement immediately upon written notice. In the
event of actual debarment of any Sponsor employee involved in the performance of
Sponsor’s obligations hereunder, provided Sponsor has not terminated the
employment of such individual within [**] after debarment, Fujifilm shall have
the right to terminate this Agreement immediately upon written notice.

 

  i) In the event that Fujifilm receives notification of an Adverse Event or
other Safety Information pertaining to the Product as Manufactured by Fujifilm
under this Agreement, Fujifilm shall notify Sponsor within one (1) business day
by sending all relevant information to pharmacogivilance@synageva.com. In the
event that Fujifilm receives a Drug Product Complaint, Fujifilm shall notify
Sponsor within one (1) business day by sending all relevant information to
QA@synageva.com.

 

  j) In the event that Sponsor receives a Drug Product Complaint, Adverse Event
or other Safety Information pertaining to the Product as Manufactured by
Fujifilm under this Agreement, Sponsor shall notify Fujifilm within one
(1) business day by sending all relevant information to the Quality Assurance
contact specified in the Quality Agreement.

Section 5. Facility Visits

The terms and conditions of Sponsor audit rights and rights to inspect the GMP
Facility are provided in the Quality Agreement. Sponsor’s person-in-the-plant
(“PIP”) shall have the right to access [**]. The PIP shall follow Fujifilm
policies and operating procedures while in the GMP Facility. The PIP [**].

Section 6. Compensation

 

  a) Reservation Fee and Batch Price; Resins.

 

  i. Upon placement of a Binding Order, Fujifilm shall invoice Sponsor a
reservation fee in the amount of [**] of the aggregate Batch Price (as defined
below) for all the Batches ordered under such Binding Order (“Reservation Fee”).
[**] of the aggregate Batch Price for all the Batches ordered under such Binding
Order shall be invoiced to Sponsor upon Manufacture Start Date of the First
Batch under the Binding Order and [**] of the aggregate Batch Price for the all
the Batches ordered under such Binding Order shall be invoiced [**] upon
shipment of each of the Batches under the Binding Order. The “Batch Price” shall
mean the price for [**] (“Manufacturing Price”) together with the price for [**]
allocated to Manufacturing of such Batch [**] and shall be calculated as set
forth in, and in accordance with, Attachment 2. Notwithstanding the foregoing,
[**].

 

  ii. In addition to the Batch Price, Sponsor shall [**] purchased and used by
Fujifilm in Manufacturing the Product pursuant to a Binding Order, provided the
[**].

 

  b) [**] Fee. In addition to fees for Product delivered under Binding Orders,
Sponsor shall [**] (“[**] Fee”). The [**] Fee shall be subject to [**], provided
that Sponsor shall receive at least [**] written notice of any such [**].

 

  c)

[**] Batch Price Adjustment. Batch Price specified in Attachment 2 shall be
adjusted [**] according to the following mechanism, provided that Sponsor must
receive at least [**]

 

CONFIDENTIAL 14

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  prior written notice of any such adjustment before it may take effect and such
notice shall include the details on any changes to the [**]:

 

  i. Manufacturing Price shall [**], in which case the [**]. Notwithstanding the
foregoing, if the [**].

 

  ii. Initial Consumable Price is specified in Attachment 2. The Consumable
Price will be [**], Fujifilm will issue Sponsor [**] to Fujifilm by Sponsor for
the prior [**].

 

  iii. The adjusted Manufacturing Price and [**] Price shall together constitute
the new Batch Price, which shall be included in a revised Attachment 2 to this
Agreement together with new Annual Program Fee.

 

  d) [**]:

[**]

[**]

 

  e) Safety Stock. Fujifilm shall carry sufficient safety stock of Process
Consumables to help ensure uninterrupted Manufacturing of Product (“Safety
Stock”) and timely delivery of Product according to Binding Orders. Fujifilm and
Sponsor have jointly determined the required initial level of Safety Stock
before the first Campaign under this Agreement ([**]) pursuant to that certain
Letter of Agreement between the Parties dated October 30, 2014 (“Process
Consumables LOA”), and shall review the level of Safety Stock and adjust, as
needed, at least [**] upon receiving updated Rolling Forecasts. The cost of an
increase in Safety Stock shall be borne by Sponsor, except of Process
Consumables that are regularly stocked by Fujifilm, or if otherwise agreed in
writing. Fujifilm shall invoice Sponsor for Process Consumables purchased for
the increase in Safety Stock other than Process Consumables that are regularly
stocked by Fujifilm, including [**], after receiving the invoices from its
vendors, provided that except as set forth in Section 2(h) with [**], Sponsor
shall not have an obligation to pay for any Process Consumables that do not meet
the Specifications, the Bill of Materials or Fujifilm’s order placed with the
third party supplier. Fujifilm shall use such Process Consumables (other than
those Process Consumables that are regularly stocked by Fujifilm) solely for
purposes of performing the Program. Fujifilm shall use commercially reasonable
efforts to use “first-to-expire-first-out” principles for managing the Safety
Stock. If the Parties agree to reduce the Safety Stock, Fujifilm shall make a
commercially reasonable effort to use the Process Consumables from the Safety
Stock in the upcoming Campaigns, until the Safety Stock is reduced to the
desired level, and shall credit Sponsor for the purchase cost of used
consumables. Any unused expired materials from the Safety Stock shall be
disposed as described in Section 6(g).

 

  f) Invoices. Fujifilm shall issue invoices separately for (i) each [**] and
(ii) the [**] and (iii) any additional [**]. Invoices for any work performed
under a Change Order shall be issued as specified in the applicable Change
Order. All invoices shall be submitted and payable in U.S. Dollars. Payments are
due [**] from the date an invoice issued by Fujifilm is received by Sponsor. If
Sponsor disputes an invoice, Sponsor shall pay the undisputed amount and notify
Fujifilm of the dispute within [**] of receipt of invoice and advise Fujifilm in
good faith and in writing the specific basis for disputing an invoice. In
addition to all other remedies available to Fujifilm, in the event [**],
Fujifilm may [**] deliveries of Product or provision of reports until [**].

 

CONFIDENTIAL 15

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  g) Disposal of Expired or Unused Starting Materials and Process Consumables.
Fujifilm shall be responsible for disposal of expired or unused Process
Consumables. The cost of such Consumables and their disposal shall be borne by
Fujifilm except of Process Consumables from Safety Stock not regularly stocked
by Fujifilm, disposal cost of which shall be borne by Sponsor unless such [**].
Fujifilm shall invoice Sponsor for [**], except as set forth in the preceding
sentence. Sponsor shall be responsible for an [**], Fujifilm shall provide
Sponsor with remaining inventory of Starting Material including expiry dates.
For any expired Starting Material, Sponsor may request Fujifilm to deliver
remaining Starting Material to Sponsor or a designated storage site in lieu of
destruction by incineration.

 

  h) Sponsor-dedicated Process Equipment. In anticipation of Market
Authorization for the Drug Product, Fujifilm shall perform evaluation of the
equipment used in Manufacturing of Product in respect to the risk posed to
uninterrupted supply of Product under this Agreement and shall propose to
Sponsor appropriate countermeasures that may include dedication of equipment to
the Program. If Sponsor elects to have any equipment dedicated solely to
Sponsor’s Process, Sponsor shall carry the cost of procurement, installation and
qualification of such equipment, which shall be set forth in a Change Order.

Section 7. Non-Conforming Batches

 

  a) Fujifilm shall [**] ensure that it will only deliver Batches to Sponsor
that (i) are Manufactured in accordance with, and meet the requirements of, this
Agreement, the Quality Agreement (including the Specifications) and Applicable
Laws (including cGMPs) [**].

 

  b) The following provisions shall apply if it is ascertained by either Party
that a Batch is a Non-Conforming Batch during disposition of a Batch or as a
result of Sponsor’s review of the applicable Batch Packet [**]:

 

  i. If Fujifilm is the first to discover the non-conformity, Fujifilm shall
[**] provide written notice of same, including an explanation of the
non-conformity, to Sponsor within [**] from discovery, but not to exceed [**]
from discovery. If Sponsor is the first to discover the non-conformity, Sponsor
shall [**] provide written notice, including an explanation of the
non-conformity, to Fujifilm within [**] from discovery, but not to exceed [**]
from Sponsor’s receipt of Batch, or in the case of [**] from Sponsor’s receipt
of the Batch.

 

  ii. The Non-Conforming Batch shall not be delivered to Sponsor if it is still
located at the GMP Facility as of the date of Fujifilm’s issuance or receipt (as
applicable) of the notice of non-conformity.

 

  iii. If Sponsor has provided the notice of a Non-Conforming Batch to Fujifilm,
within [**] of receiving such notice, Fujifilm shall investigate the presence
and source of defect following the Fujifilm complaint procedure and notify
Sponsor in writing as to whether Fujifilm agrees or disagrees in good faith with
Sponsor’s determination of the existence or cause of the non-conformity and the
reasons therefor. [**].

 

CONFIDENTIAL 16

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  iv. If Fujifilm has provided the notice of a Non-Conforming Batch to Sponsor,
within [**] of receiving such notice, Sponsor shall notify Fujifilm whether
Sponsor agrees or disagrees in good faith with Fujifilm’s determination of the
existence or cause of the non-conformity and the reasons therefor. If Sponsor
does not provide a written notice within such period, Sponsor shall be deemed to
have accepted the existence and cause of non-conformity as stated by Fujifilm.

 

  v. In the event the Parties do not agree as to the existence or cause of a
Non-Conforming Batch, then within [**] of Fujifilm’s written notice pursuant to
Section 7(b)(iii) or Sponsor’s written notice pursuant to Section 7(b)(iv), the
authorized Quality Assurance representative(s) of each Party will [**] to
evaluate the existence and the cause of non-conformity and [**]. This evaluation
will be [**] for purposes of determining respective financial liability pursuant
to Section 7(b)(vii). The Party [**] shall bear the costs of the evaluation.

 

  vi. Fujifilm shall [**] start Manufacture of a further Batch to replace the
Non-Conforming Batch [**] after it is determined that the Batch was a
Non-Conforming Batch).

 

  vii. The cost of replacing a Non-Conforming Batch shall be allocated as
follows:

 

  (A) If a Non-Conforming Batch results from the Starting Material’s failure to
comply with the applicable Specifications as of the date of delivery to Fujifilm
and such failure could not have been reasonably detected during Fujifilm’s
proper performance of its review and testing obligations of the Starting
Material (a “Starting Material Failure”), Fujifilm will manufacture a conforming
replacement Batch pursuant to Subsection (vi) above and [**].

 

  (B) Fujifilm shall Manufacture a further Batch [**] if the Non-Conforming
Batch arose from any cause other than a Starting Material Failure. In addition,
disposal of the Non-Conforming Batch, if applicable pursuant to
Section 7(b)(viii), shall be [**]. Notwithstanding the foregoing, Sponsor [**]
unless the Non-Conforming Batch arose from [**], in which case [**] for the cost
of [**], as specified in Attachment 2 and [**] needed to produce the [**].

 

  viii. Unless otherwise requested by Sponsor in writing, Fujifilm shall dispose
of any Non-Conforming Batch that Fujifilm is obligated to replace pursuant to
Section 7(b)(vi) in accordance with Applicable Law.

 

  c) In the event of [**] Non-Conforming Batches within a Campaign, the root
cause of which is either not identifiable or is the same across the
Non-Conforming Batches and is not the result of [**], the parties will [**] a
plan for [**]) in an effort to reduce the number of Non-Conforming Batches. Such
[**] may result in Process changes or other changes, subject to Section 10 on
Modifications. The reasonable [**] shall be borne by [**]. In addition, to the
extent required for compliance with cGMP, Fujifilm may [**], provided that the
[**].

 

CONFIDENTIAL 17

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  d) [**], the remedies set out in this Section 7 shall be [**] in relation to a
Non-Conforming Batch. Notwithstanding the foregoing, this Section 7(d) shall not
limit Fujifilm’s obligations pursuant to Section 19 or Sponsor’s rights pursuant
to Section 1(f).

Section 8. Recalls

 

  a) Records and Notice. Fujifilm shall maintain records necessary to permit a
Recall (as defined below). Each Party will promptly notify the other by
telephone (to be promptly confirmed in writing) of any information which might
affect the marketability, safety or effectiveness of the Product or Drug Product
or which might result in a Recall. Upon receiving this notice or upon this
discovery, Sponsor may elect by written notice for Fujifilm to stop making any
further shipments of any Product in its possession or control until a decision
has been made whether a Recall or some other corrective action is necessary. The
decision to initiate a Recall or to take some other corrective action, if any,
will be made and implemented by Sponsor. “Recall” will mean any action (i) by or
at the request of Sponsor to recover title to or possession of quantities of the
Product shipped to third parties or Drug Product sold or shipped to third
parties (including, without limitation, the voluntary withdrawal of Drug Product
from the market); or (ii) by any Regulatory Authorities to seize, detain or
destroy any of the Product or Drug Product. Recall will also include any action
by either Party to refrain from selling or shipping quantities of the Product or
Drug Product to third parties which would have been subject to a Recall if sold
or shipped.

 

  b) Recalls. If (i) any Regulatory Authority issues a directive, order or,
following the issuance of a safety warning or alert about a Product or Drug
Product, a written request that any Product or Drug Product be Recalled,
(ii) any Regulatory Authority threatens to prohibit the delivery or use of any
Product or Drug Product or any other regulatory reportable event for the Product
or Drug Product occurs, (iii) a court of competent jurisdiction orders a Recall,
or (iv) Sponsor determines that a Recall should be instituted or that a “Dear
Doctor” letter or its equivalent is required relating to the restrictions on the
use of any Drug Product, Fujifilm will notify Sponsor as within the period
specified in the Quality Agreement (in the event it is the Party that becomes
first aware of such event) or Sponsor will notify Fujifilm within the period
specified in the Quality Agreement (in the event it is the Party that becomes
first aware of such event) and, in any case, Fujifilm and Sponsor will
co-operate as reasonably required by each Party, having regard to all Applicable
Law.

 

  c) Responsibility for Costs of Recall. If a Recall results from the Product’s
deviation from the Quality Agreement (including the Specifications), this
Agreement, cGMPs or other Applicable Law, to the extent such deviation arose
from the items for which [**] responsible thereunder(other than [**]), [**] will
be responsible for the cost of the replacement Product [**] provided, that [**]
the expenses related to such Recall and provided that if the [**]. For clarity,
the foregoing limit on Fujifilm’s liability for Recall expenses [**]
responsibility for the cost of any replacement Product or, to the extent such
Recall results from [**] responsibility for [**] of the [**] and the Starting
Material needed to produce any replacement Batches. [**] Products involved in
the Recall with new Products, contingent upon the receipt from [**].

 

CONFIDENTIAL 18

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 9. Late Delivery

 

  a) Late Delivery of Starting Material. If Sponsor delivers the required amount
of Starting Material more than [**] after the Receiving Date, Fujifilm [**] and
Sponsor shall [**] if, despite [**] Fujifilm is [**] provided however that if
Fujifilm is [**] Sponsor’s Binding Order [**].

 

  b) [**] Manufacture Start Date. [**] The amount of the [**] will vary based on
the [**] and will equal the following [**]:

 

[**] [**]

Section 10. Change Orders

 

  a) Key Manufacturing Assumption. The Parties have agreed upon certain
analytical methods for Product release being transferred by Sponsor to Fujifilm
and the Parties intend for such release testing to be performed by Fujifilm,
provided the requisite Regulatory Authority approval is received (“Key
Manufacturing Assumption”).

 

  b) Sponsor Change Orders. Sponsor shall inform Fujifilm in writing of any
proposed modifications to the Key Manufacturing Assumption, equipment, systems,
GMP Facility, Process, Process Consumables, Starting Materials, Specifications
or other changes relating to the Manufacture (collectively, “Modifications”).
Once a Modification has been requested by Sponsor, and agreed with by Fujifilm
(to the extent Fujifilm’s agreement is explicitly required per this Section 10),
Fujifilm shall provide Sponsor with a change order containing an estimate of the
increase or decrease, as applicable, in Batch Price or any other costs to
Sponsor as well as the activities, deliverables, estimated duration, and payment
schedule (“Change Order”) within [**] of receiving such notice from Sponsor.
Sponsor shall be deemed to have not approved the Change Order if Fujifilm does
not receive a written approval of the Change Order from Sponsor within [**] of
Sponsor’s receipt of the Change Order. If Sponsor does not approve such Change
Order, then Sponsor and Fujifilm shall negotiate in good faith to agree on a
Change Order that is mutually acceptable. Any Modification proposed by Sponsor
that would [**].

 

  c) Fujifilm Change Orders. Fujifilm may not make any Modifications without the
prior written consent of Sponsor, other than a Modification required by a
Regulatory Authority that would not affect the Product’s Biologic License
Application (or foreign equivalent) or Product validation. If such a
Modification required by a Regulatory Authority would affect the Product’s
Biologic License Application or Product validation, the Parties shall discuss
such proposed Modification in good faith and such Modification shall require
Sponsor’s prior written consent, which consent shall not be unreasonably
withheld or delayed. Fujifilm shall promptly notify Sponsor in writing of any
Modification after becoming aware of the need for such Modification. If a
Modification is expected to have an impact on Process or Fujifilm obligations
under this Agreement, Parties shall discuss the feasibility of such Modification
in good faith. [**]. Fujifilm shall request Modifications in writing from
Sponsor by issuing a Change Order to Sponsor for review and approval. Sponsor
shall be deemed to have not approved the Change Order if Fujifilm does not
receive a written approval of the Change Order from Sponsor within [**] of
Sponsor’s receipt of the Change Order. If Sponsor does not approve such Change
Order, then Sponsor and Fujifilm shall negotiate in good faith to agree on a
Change Order that is mutually acceptable.

 

CONFIDENTIAL 19

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
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Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  d) Cost of Change Orders. If Modifications are requested by or from Fujifilm
as a result of [**] then Sponsor and Fujifilm will review such requirements and
use good faith efforts to agree on the reasonable costs associated therewith,
[**]. If Modifications are requested by or from Fujifilm as a result of
requirements set forth by a Regulatory Authority and such Modifications apply
generally to the Product as well as other products produced by Fujifilm (for
itself or for third parties) or the general operation of the Facilities, then
Fujifilm shall bear the reasonable costs associated therewith. Except as set
forth above, the reasonable costs associated with Modifications requested by
Fujifilm which exclusively benefit Fujifilm and/or its other customers shall be
borne by Fujifilm, and the reasonable costs associated with Modifications
requested by Sponsor shall be borne by Sponsor, if such costs have been accepted
by Sponsor pursuant to Section 10(b) above. When Fujifilm provides a proposed
Change Order to Sponsor for any reason, Fujifilm shall provide reasonable
detailed explanation of activities to be performed to enable Sponsor to
understand and evaluate the source of such changes in price.

 

  e) Regulatory Authority Approval of Modifications. Sponsor shall have sole
responsibility for obtaining any and all necessary approvals from any Regulatory
Authority for implemented Modifications and for reporting any implemented
Modifications to any Regulatory Authority as appropriate, except if
Modifications are requested by or from Fujifilm as a result of requirements set
forth by a Regulatory Authority and such Modifications apply generally to the
Product as well as other products produced by Fujifilm (for itself or for third
parties) or the general operation of the Facilities, in which case Fujifilm
shall have the responsibility for the aforementioned actions. Upon request by a
Party, the other Party [**].

Section 11. Confidential Information/Legal Proceedings

 

  a)

During the Term of this Agreement and for five (5) years following the
expiration or earlier termination of this Agreement, Fujifilm will hold in
confidence and will not disclose, without Sponsor’s prior written permission,
any Confidential Information pertaining to the Drug Product, the Product, the
Program or otherwise disclosed by Sponsor to Fujifilm in connection with the
Program (“Sponsor Confidential Information”) unless: (i) such disclosure is to
an Affiliate of Fujifilm that is under an obligation to keep such information
confidential comparable in scope to Fujifilm’s obligation under this Section 11;
(ii) such information is or becomes publicly available through no fault of
Fujifilm; (iii) such information became known to Fujifilm through disclosure by
sources other than Sponsor, having no duty of confidentiality with respect to
such information, whether to Sponsor or another party, and having the legal
right to disclose such information; (iv) such information is already known to
Fujifilm, without restriction, at the time of disclosure, as shown by its prior
written records; or (v) such information was independently developed by Fujifilm
without reference to or reliance upon Sponsor Confidential Information. In the
event Sponsor Confidential Information rises to the level of a trade secret
under law, the obligations of this Section 11 shall continue with respect to
such Sponsor Confidential Information for so long as such Sponsor Confidential
Information retains its status as a trade secret. Notwithstanding the
obligations of confidentiality specified in this Section 11, disclosure of
Sponsor Confidential Information shall not be prohibited to the extent required
to be disclosed by any law, rule, regulation, order decision, decree, subpoena
or other legal process, provided that, to the extent possible, Fujifilm provides
prior written notification to Sponsor of such disclosure promptly prior to any
disclosure to permit Sponsor to oppose and/or minimize the extent of such
disclosure by appropriate legal

 

CONFIDENTIAL 20

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Fujifilm – Synageva Agreement

EXECUTION COPY

 

  action. Fujifilm shall use reasonable precautions to protect the
confidentiality of Sponsor Confidential Information comparable to precautions
taken to protect its own proprietary information but in no event shall Fujifilm
use less than a reasonable degree of care.

 

  b) During the Term of this Agreement and for five (5) years following the
expiration or earlier termination of this Agreement, Sponsor will hold in
confidence and will not disclose, without Fujifilm’s prior written permission,
any Confidential Information pertaining to Fujifilm’s performance of the Program
disclosed by Fujifilm to Sponsor (“Fujifilm Confidential Information”) unless:
(i) such disclosure is to an Affiliate of Sponsor that is under an obligation to
keep such information confidential comparable in scope to Sponsor’s obligation
under this Section 11; (ii) such information is or becomes publicly available
through no fault of Sponsor; (iii) such information became known to Sponsor
through disclosure by sources other than Fujifilm, having no duty of
confidentiality with respect to such information, whether to Fujifilm or another
party, and having the legal right to disclose such information; (iv) such
information is already known to Sponsor, without restriction, at the time of
disclosure, as shown by its prior written records; or (v) such information was
independently developed by Sponsor without reference to or reliance upon
Fujifilm Confidential Information. In the event Fujifilm Confidential
Information rises to the level of a trade secret under law, the obligations of
this Section 11 shall continue with respect to such Fujifilm Confidential
Information for so long as such Fujifilm Confidential Information retains its
status as a trade secret. Notwithstanding the obligations of confidentiality
specified in this Section 11, disclosure of Fujifilm Confidential Information
shall not be prohibited to the extent required to be disclosed by any law, rule,
regulation, order decision, decree, subpoena or other legal process, provided
that, to the extent possible, Sponsor provides prior written notification to
Fujifilm of such disclosure promptly prior to any disclosure to permit Fujifilm
to oppose and/or minimize the extent of 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 but in no event shall Sponsor use less than a
reasonable degree of care. Notwithstanding anything to the contrary in this
Agreement, no provision of this Agreement shall be construed so as to preclude
Sponsor’s disclosure of Confidential Information, including Fujifilm
Confidential Information, as may be reasonably necessary to secure from any
Regulatory Authority or other governmental agency necessary approvals or
licenses, or, in the case of Sponsor’s Confidential Information, in a patent
application with respect to the Product or Drug Product. Disclosure of
Fujifilm’s Confidential Information in a patent application with respect to the
Product or Drug Product shall require written approval from Fujifilm.

 

  c) For both Parties, “Confidential Information” shall mean and include without
limitation 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 whether or not marked “confidential”; provided, that,
if disclosed orally (or in some other non-tangible form), the disclosing Party
shall use reasonable efforts to identify such information as confidential to the
recipient Party in writing within sixty (60) days of such oral disclosure but
the failure to so mark information shall not affect its treatment as
Confidential Information if it is reasonably clear that the information is
commercially sensitive.

 

CONFIDENTIAL 21

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

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Fujifilm – Synageva Agreement

EXECUTION COPY

 

  d) Upon the expiration or termination of this Agreement, to the extent
requested by the disclosing Party, each recipient Party shall use all
commercially reasonable efforts to collect and return to the disclosing Party
any and all data, notes, records, reports, and other electronic or written
information, including any and all copies that may have been made thereof, that
contain Confidential Information received from the disclosing Party; provided,
that, each recipient Party shall be entitled to keep one archival copy of
Confidential Information provided by the disclosing Party in its confidential
files, subject to ongoing obligations of confidentiality hereunder.

Section 12. Work Output

 

  a) All information, data, documentation and reports produced by Fujifilm in
the conduct of the Program and/or all other cGMP documentation (“Work Output”)
will be prepared by Fujifilm using Fujifilm’s standard format(s).

 

  b) Sponsor will be supplied with copies of Work Output as part of Batch Packet
and Campaign summary reports. Fujifilm shall not be obliged to supply all data
generated but instead will supply relevant data to Sponsor and Sponsor will have
access to all data generated in relation to the Program for on-site review
either (i) during any audits or (ii) upon Sponsor’s written request. All Work
Output and Product samples will be archived by Fujifilm as required by the
Quality Agreement or for a period of five (5) years, whichever is longer.
Sponsor may elect to have the Work Output 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 reasonable
disposal fee will be charged. Notwithstanding the foregoing, Fujifilm will
continue to retain such Work Output and Product samples as required by
Applicable Law pertaining to such activities as well as for archival purposes.
In the absence of such notice, at the end of the applicable period, Fujifilm
shall notify Sponsor of the expiration of such period and, upon notice from
Sponsor, Fujifilm shall send the Work Output to Sponsor at Sponsor’s cost and
expense.

Section 13. Inventions and Patents

 

  a) Fujifilm shall promptly and fully disclose to Sponsor any and all
inventions, improvements, developments, original works of authorship or other
intellectual property conceived, developed and/or reduced to practice, whether
in whole or in part, by Fujifilm in the course of the performance of the Program
(collectively, “Program Inventions”).

 

  b)

All Program Inventions that relate to Fujifilm’s general manufacturing and
analytical methods and that are not specific to the Product or Sponsor
Deliverables shall be Confidential Information of and shall be solely owned by
Fujifilm (collectively, “Process Inventions”). All other Program Inventions,
including without limitation, any Program Inventions that are specific to the
Product or the Sponsor Deliverables (collectively, “Product Inventions”) shall
be Confidential Information of, and shall be solely owned by, Sponsor. Fujifilm
hereby agrees to assign, and does hereby assign, to Sponsor and its successors
and assigns, without further consideration, its entire right, title and interest
in any Product Inventions, whether or not patentable. 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
any Product Inventions and Sponsor shall

 

CONFIDENTIAL 22

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

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Fujifilm – Synageva Agreement

EXECUTION COPY

 

  reimburse it for actual out-of-pocket expenses incurred. For Product
Inventions assigned pursuant to this section, Sponsor shall provide Fujifilm a
royalty-free license necessary to perform the Program for the Term of this
Agreement.

 

  c) Fujifilm agrees to grant and hereby grants to Sponsor a perpetual,
world-wide, fully paid-up, royalty-free, sublicensable, exclusive license under
all Process Inventions for use in connection with the Product. If Fujifilm
requests and at Fujifilm’s expense, Sponsor 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 any Process Inventions and Fujifilm shall reimburse it
for actual out-of-pocket expenses incurred.

 

  d) Fujifilm reserves the right to use data during the course of the Program to
support applications, assignments or other instruments necessary to apply for
and obtain Letters of Patent of the U.S. or any foreign country with respect to
Process Inventions so long as no information which Fujifilm is required to keep
confidential under this Agreement is disclosed in any such application,
assignment, or other instrument. Fujifilm shall notify Sponsor ninety (90) days
in advance of intent to file such application, assignment or other instrument
and Sponsor shall have the right to require that any Sponsor Confidential
Information contained in any such application, assignment or other instrument be
deleted therefrom.

 

  e) Sponsor shall retain all right, title and interest arising under applicable
laws, rules and regulations in and to all Sponsor Deliverables, Product, and
other intellectual property belonging to Sponsor (including ideas, concepts,
discoveries, inventions, developments, know-how, trade secrets, techniques,
methodologies, modifications, innovations, improvements, writings,
documentation, data and rights, whether or not protectable under state, federal
or foreign patent, trademark, copyright or similar laws or the like and whether
or not written or otherwise fixed in any form or medium). Neither Fujifilm nor
any third party shall acquire any right, title or interest in such intellectual
property of Sponsor by virtue of this Agreement. For the avoidance of doubt and
without limitation, Fujifilm shall have no right to use any of Sponsor’s
intellectual property or Confidential Information to produce or manufacture any
product(s) for or on behalf of itself or a third party.

Section 14. 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.

 

CONFIDENTIAL 23

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

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Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 15. Insurance

 

  a) Fujifilm shall secure and maintain in full force and effect throughout the
performance of the Program policies of insurance with companies with an AM Best
Rating of at least A-, VII or its equivalent for (a) workmen’s compensation with
statutory limits, (b) general liability with combined single limits of not less
than [**] per occurrence and [**] in the aggregate and (c) product liability
with combined single limits of not less than [**] per occurrence and [**] in the
aggregate.

 

  b) Sponsor shall secure and maintain in full force and effect throughout the
performance of the Program policies of insurance with an AM Best Rating of at
least A-, VII or its equivalent for the minimum of (a) workmen’s compensation
with statutory limits, (b) general liability with combined single limits of not
less than [**] per occurrence and [**] in the aggregate and (c) product
liability with combined single limits of not less than [**] per occurrence and
[**] in the aggregate. Such limits may be satisfied in part through umbrella
liability coverage.

Section 16. Delivery

Fujifilm shall package for shipment and deliver Product, samples or other
materials in accordance with Sponsor’s full written and reasonable instructions.
Freight terms shall be [**]. Sponsor shall be responsible for shipments. Title,
possession, risk of loss, risk of damage and all forward costs and expenses
shall [**]. Fujifilm shall retain representative samples of Product solely for
record keeping, testing obligations or testing in the event of an alleged Batch
non-conformity and regulatory purposes. Sponsor shall provide for shipping of
each Batch of Product on the Delivery Date, unless otherwise agreed between the
Parties. In the event of any delay by Sponsor in shipping of Product in
accordance with this Section 16, the Parties shall work together in good faith
to reschedule the Delivery Date and Fujifilm shall store such Batch in
accordance with the storage requirements provided by Sponsor and agreed to by
Fujifilm, provided that liability and risk of loss for such Batch shall
automatically transfer to (and be assumed by) Sponsor effective upon expiration
of [**] after the originally scheduled Delivery Date.

Section 17. Default/Limitation of Warranty

 

  a) If Fujifilm is in material default of its obligations under this Agreement,
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. If Fujifilm fails to so cure such breach, then this Agreement shall, at
Sponsor’s option, immediately terminate; provided, however, if a cure cannot
reasonably be effected within such [**], Fujifilm shall deliver to Sponsor a
plan for curing such breach that is reasonably sufficient to effect a cure as
soon as practicable thereafter,[**]. Fujifilm shall commence in good faith to
cure such default in accordance with the plan within such [**] period and if
Fujifilm fails to cure such default as set forth in accordance with the plan’s
deadlines, Sponsor may terminate this Agreement immediately upon written notice.
Any cure involving the supply to Sponsor of a replacement shipment of Product
must be agreed in advance by Sponsor, and if such cure is agreed by Sponsor, the
Parties will agree in good faith on a reasonable date by which Fujifilm shall
supply such Product.

 

CONFIDENTIAL 24

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

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Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  b) If Sponsor is in material default of its obligations under this Agreement,
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, however, if a cure cannot reasonably be effected
within such [**] period, Sponsor shall deliver to Fujifilm a plan for curing
such breach that is reasonably sufficient to effect a cure as soon as
practicable thereafter but in no more than [**] and to commence in good faith to
cure such default in accordance with the plan within such [**] period. If
Sponsor fails to so cure, or commence to cure, such breach within the specified
cure period, Fujifilm may terminate this Agreement immediately upon written
notice.

 

  c) Notwithstanding anything herein to the contrary, EXCEPT WITH RESPECT TO A
BREACH OF SECTION 11 OR A PARTY’S OBLIGATIONS PURSUANT TO SECTION 19 OR SECTION
33: (I) UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE ENTITLED TO INCIDENTAL,
INDIRECT , CONSEQUENTIAL OR SPECIAL DAMAGES ARISING IN CONNECTION WITH THIS
AGREEMENT OR THE QUALITY AGREEMENT AND (II) [**].

 

  d) EXCEPT AS EXPRESSLY STATED HEREIN, NEITHER PARTY PROVIDES TO THE OTHER
PARTY HERETO ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE MATERIALS
AND SERVICES PROVIDED HEREUNDER, AND ALL SUCH WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE ARE WAIVED.

Section 18. 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, and
such dispute has been discussed at a meeting of the Joint Steering Committee, or
such Joint Steering Committee was not able to meet within the time period
specified in Section 24(e), then the senior executives of the Parties shall meet
as promptly as practicable, but at least within [**] after notice of such
dispute to resolve in good faith such dispute.

 

  b) If the senior executives of the Parties fail to resolve the dispute within
[**] of the initial meeting pursuant to Section 18(a) above, then such dispute
shall be finally settled by an arbitrator in accordance with this Section 18(b).
The arbitration will be held in Washington, D.C., and except as noted below,
shall be conducted in accordance with the rules of the American Arbitration
Association by a neutral arbitrator who is experienced in arbitrating matters
related to commercial manufacturing of drugs or other health care products
agreeable to both Parties. If the Parties do not agree on an arbitrator [**] of
the failure of the senior executives of the Parties to resolve the dispute, the
American Arbitration Association shall appoint an arbitrator who is experienced
in arbitrating matters related to commercial manufacturing of drugs or other
health care products 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. The Parties may seek judicial intervention for emergency
relief, such as restraining orders and injunctions where appropriate.

 

CONFIDENTIAL 25

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Fujifilm – Synageva Agreement

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  c) 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
a final decision in writing to the Parties.

Section 19. Indemnification

 

  a) Fujifilm shall indemnify, defend and hold harmless Sponsor and its
Affiliates and their respective officers, directors and employees (“Sponsor
Indemnitees”) from any loss, cost, damage or expense (“Loss”) from any lawsuit,
action, claim, demand, assessment or proceeding made or brought by a third party
(“Claim”) arising from or related to (i) the breach of any representation,
covenant or warranty by Fujifilm under this Agreement; (ii) the failure of
Fujifilm to perform the Manufacturing in accordance with this Agreement, the
Quality Agreement (including Specifications) or cGMPs or other Applicable Law or
a failure of the Product to meet the Specifications or the requirements of this
Agreement or the Quality Agreement to the extent such failure did not arise from
a Starting Material Failure [**] (unless such failure could have been reasonably
discovered by Fujifilm through its review or [**] required by this Agreement or
the Quality Agreement); (iii) the material breach by Fujifilm of this Agreement;
(iv) the infringement or alleged infringement of the intellectual property
rights of a third party covering the use of any of Fujifilm’s methods, technical
information, materials, or know-how used in the Manufacturing; or (v) Fujifilm’s
negligence or intentional misconduct or inaction (including violation or
non-performance of this Agreement); provided, that, if such Loss or Claim arises
in whole or in part from Sponsor’s negligence or intentional misconduct or
inaction, then the amount of the Loss that Fujifilm shall indemnify, defend and
hold harmless Sponsor Indemnitees for pursuant to this Section 19 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, defend and hold harmless Fujifilm and its
Affiliates and their respective officers, directors and employees (“Fujifilm
Indemnitees”) from any Loss from any Claim arising from or related to:
(i) except to the extent of Fujifilm’s indemnification obligations pursuant to
Section 19(a) above, Starting Materials, [**] or the Drug Product; (ii) the
breach of any representation, covenant or warranty by Sponsor under this
Agreement; (iii) the infringement or alleged infringement of the intellectual
property rights of a third party covering the use of any of Sponsor’s methods,
technical information, materials (including the Starting Material), [**] or
know-how that, in each case, is provided by Sponsor to Fujifilm [**] and used by
Fujifilm in the Manufacturing for Fujifilm’s conduct of the Program in a manner
not in violation of this Agreement, except to the extent that the Claim arises
from the use of Fujifilm’s own general manufacturing and analytical methods; or
(iv) the negligence or intentional misconduct or inaction of Sponsor; provided,
that, if such Loss or Claim arises in whole or in part from Fujifilm’s
negligence or intentional misconduct or inaction, then the amount of such Loss
that Sponsor shall indemnify the Fujifilm Indemnitees for pursuant to this
Section 19 shall be reduced by an amount in proportion to the 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.

 

CONFIDENTIAL 26

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
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Fujifilm – Synageva Agreement

EXECUTION COPY

 

  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 prompt 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 Indemnity Claim shall indicate the nature of the Indemnity Claim
and the basis therefore. Promptly after notice of an Indemnity Claim is provided
to the Indemnifying Party, the Indemnified Party shall permit the Indemnifying
Party, at its option and expense, to assume the complete defense of such
Indemnity Claim; provided, that, (i) the Indemnified Party will have the right
to participate in the defense of any such Indemnity Claim at its own cost and
expense, (ii) the Indemnifying Party will conduct the defense of any such
Indemnity Claim with due regard for the business interests and potential related
liabilities of the Indemnified Party and (iii) the Indemnifying Party will,
prior to making any settlement, consult with the Indemnified Party as to the
terms of such settlement and receive written approval thereof, not to be
unreasonably withheld. The Indemnifying Party will not, in defense of any such
Indemnity Claim, except with the written 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.

Section 20. Representations and Warranties

 

  a) Each Party represents and warrants to the other that: (i) it has the full
right and authority to enter into this Agreement and to perform this Agreement
in accordance with the terms and conditions set forth herein; (ii) this
Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party
in accordance with its terms except as enforceability may be limited by
bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and
other laws relating to or affecting creditors’ rights generally and by general
equitable principles; and (iii) the execution, delivery and performance of this
Agreement does not breach, violate, contravene or constitute a default under any
contract or commitment to which such Party is a party or by which it is bound
nor does the execution, delivery and performance of this Agreement by such Party
violate any order, law or regulation of any court, governmental body or
administrative or other agency having authority over it. 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 Drug
Enforcement Act of 1992, 21 United States Code §§335(a) and (b).

 

  b) Fujifilm represents, warrants and covenants that it has obtained and will
at all times during the Term, hold and comply with all licenses, permits and
authorizations necessary to perform its obligations under this Agreement as now
or hereafter required under any Applicable Law.

 

  c) Sponsor hereby represents and warrants to Fujifilm that, to its knowledge,
(i) it has legal title and/or a valid license to the Starting Materials,
(ii) any methods, technical information, materials or know-how provided by
Sponsor and used by Fujifilm to perform the Manufacturing is Sponsor’s
unencumbered property, may be lawfully used by Fujifilm and does not infringe
and will not infringe the rights of any third party and (iii) the Product does
not infringe the rights of any third party.

 

CONFIDENTIAL 27

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

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Commission.

 

Fujifilm – Synageva Agreement

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  d) Fujifilm hereby represents, warrants and covenants to Sponsor that:
(i) Fujifilm will operate and maintain the GMP Facility in compliance with cGMP
in all aspects of Manufacturing; (ii) Fujifilm will perform the Manufacturing in
compliance with this Agreement, the Quality Agreement (including Specifications)
and cGMPs and all other Applicable Law and packaging instructions provided by
Sponsor and agreed upon by Fujifilm; (iii) to its knowledge, any of the methods,
technical information, materials or know-how used by Fujifilm to perform the
Manufacturing (other than those provided by Sponsor) is Fujifilm’s unencumbered
property, may be lawfully used by Fujifilm and does not infringe and will not
infringe the rights of any third party; (iv) to its knowledge, any other
Manufacturing activities by Fujifilm pursuant to this Agreement that are not
unique to the Product may lawfully be used by Fujifilm and do not infringe and
will not infringe the rights of any third party; (v) all Product, at the time of
shipment from Fujifilm, shall not be adulterated or misbranded within the
meaning of the Federal Food, Drug and Cosmetic Act, provided, however, this
warranty shall not be applicable in the event Sponsor requests shipment of
Product prior to completion of testing; (vi) Fujifilm owns or lawfully controls
the GMP Facility; (vii) Fujifilm has written agreements with all its employees
involved in the creation of intellectual property, which agreements shall
require that all discoveries and inventions conceived or reduced to practice by
such employees in the conduct of the Manufacturing shall be promptly disclosed
and assigned to Fujifilm, and Fujifilm has the right to assign to Sponsor its
rights in and to all Product Inventions as provided in this Agreement and to
license to Sponsor the rights in the Process Inventions as provided in this
Agreement and (viii) Fujifilm is under no contractual or other obligation or
restriction that is inconsistent with Fujifilm’s performance of this Agreement.

Section 21. 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 and shall take all
reasonable steps to mitigate the effect of such occurrence. Any time specified
or estimated for completion of performance falling due during or subsequent to
the occurrence of any such events shall be automatically extended for a 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. If any part of the Program is invalid as a
result of such disability, Fujifilm will, upon written request from Sponsor, but
at Sponsor’s sole cost and expense, repeat that part of the Program affected by
the disability. If, as a result of a force majeure event described in this
Section, Fujifilm is unable to Manufacture the Product ordered by Sponsor or
which Sponsor would have ordered but for such circumstances, then if such
circumstances continue or are reasonably likely to continue for more than one
hundred eighty (180) days, Sponsor may terminate this Agreement by providing
written notice to Fujifilm in writing.

 

CONFIDENTIAL 28

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 22. Use of Names

The Parties anticipate that there may be 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 nor disclose the
terms of this Agreement in any press releases, advertising or sales promotional
material or in any publication without prior written permission of such Party.
Such consent shall not be unreasonably withheld. This provision shall not
restrict a Party’s ability to use the other Party’s name and to disclose the
terms of this Agreement to the extent, in the reasonable opinion of such Party’s
legal counsel, required by law or by the requirements of any nationally
recognized securities exchange, quotation system or over-the-counter market on
which such Party has its securities listed or traded. In the event that such
disclosure is required as aforesaid, the disclosing Party shall make reasonable
efforts to provide the other Party with advance notice and to coordinate
reasonably with the other Party with respect to the wording and timing of any
such disclosure, subject to the requirements of such securities laws.

Section 23. Term/Termination

 

  a) This Agreement shall take effect on the Effective Date and continue in
effect for five (5) years (“Initial Term”). After the initial five (5) year
period the Agreement shall be automatically extended in two (2) year
installments, unless it is earlier terminated (the Initial Term and any
extensions thereof being collectively referred to herein as the “Term”).

 

  b) In addition to the termination rights set forth elsewhere in this Agreement
(including but not limited to Sections 4(g), 4(h), 17(a), 17(b), 21 and 23(c)),
either Party may terminate this Agreement after expiration of the Initial Term
by giving two (2) years’ written notice to the other Party prior to the end of
the then-current Term, without payment of any termination penalties. For
clarity, termination does not void any payments due under Binding Orders that
cannot be cancelled or terminated except that in the event of termination by
Sponsor pursuant to Section 4(g), Section 17(a), Section 21 or Section 23(c),
Sponsor may elect to cancel any outstanding Binding Orders and shall not be
obligated to make any payment to Fujifilm for such cancelled Binding Orders.

 

  c) Either Party may immediately terminate this Agreement upon written notice
to the other Party if (i) the other Party is declared insolvent or bankrupt by a
court of competent jurisdiction, (ii) a voluntary petition of bankruptcy is
filed in any court of competent jurisdiction by the other Party or (iii) this
Agreement is assigned by the other Party for the benefit of creditors.

 

  d)

For the avoidance of doubt, in the event of termination of this Agreement,
(i) Fujifilm will terminate all services in progress other than Manufacturing
under Binding Order, provided that if this Agreement is terminated by Sponsor
pursuant to Section 4(g), Section 17(a), Section 21 or Section 23(c) and Sponsor
has elected to cancel any outstanding Binding Orders, Fujifilm will terminate
all services in progress including Manufacturing under any Binding Order in an
orderly manner as soon as practicable and in accordance with a schedule agreed
to by Sponsor, unless Sponsor specifies in the notice of termination that such
services in progress should be completed, (ii) Fujifilm will deliver to Sponsor
any Sponsor Deliverables, Safety Stock, completed and in-process Product and
Work Output in its possession or control and all Product Inventions developed
through the date of

 

CONFIDENTIAL 29

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

termination or expiration, and (iii) Sponsor will pay Fujifilm any monies due
and owing Fujifilm, up to the time of termination or expiration, for services
actually performed and all expenses actually incurred for procurement and/or
disposal of Process Consumables for Batches cancelled by Sponsor, including any
Safety Stock. In the event of any termination by Sponsor under this Agreement
for reason other than termination pursuant to Section 23(b), Sponsor may request
that the effective date of the termination be a later date (not to exceed
twenty-four (24) months from the notice date), which if agreed to by Fujifilm,
such agreement not to be unreasonably withheld for the duration of then Binding
Period, Fujifilm shall continue to perform the Manufacturing and Sponsor shall
continue to perform all its obligations under this Agreement (other than
forecasting beyond the designated termination date) until the effective date of
the termination. The respective obligations of the Parties set forth in the
following sections shall survive expiration or earlier termination of this
Agreement: Sections 1(e), 3(b), 4(e), 4(i), 8, 11, 12, 13, 16, 17, 18, 19, 22,
23, 26, 27, 28, 29, 30, 31 and 33.

Section 24. Program Management

 

  a) Joint Steering Committee. Within thirty (30) days from the Effective Date,
Sponsor and Fujifilm shall establish a Joint Steering Committee (the “Joint
Steering Committee”) comprised of an equal number of representatives designated
by Sponsor and Fujifilm.

 

  b) Program Managers. Each Party shall appoint one (1) person to serve as a
Program Manager (each, a “Program 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 Program Managers shall report their activities to the Joint
Steering Committee. The Program Managers shall be responsible for calling
meetings, sending notices of meetings and preparing the agenda for such
meetings.

 

  c) Replacement of Joint Steering Committee Representatives and Program
Managers. Each Party shall be free to replace its representative members on the
Joint Steering Committee or its Program Manager with employees of such Party,
upon notice to the other Party.

 

  d) Responsibilities of Joint Steering Committee. The Joint Steering Committee
shall be responsible for overseeing 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) attempting to resolve disagreements that arise under the Agreement; and

 

  (iii) assisting in the evaluation as to whether there is a need for 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

 

CONFIDENTIAL 30

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

  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 the offices of the Parties unless the Parties agree otherwise.
The Program Managers shall attend all meetings of the Joint Steering Committee.
All decisions of the Joint Steering Committee must be unanimous. In the event of
a dispute, either Party may call a meeting of the Joint Steering Committee,
which must be held within seven (7) business days from the date of receipt of
written notice to the other Party.

 

  f) Minutes. The Program Managers shall alternate responsibility for keeping
minutes of the Joint Steering Committee Meeting, unless otherwise agreed. Within
fifteen (15) days after each Joint Steering Committee meeting, the applicable
Program Manager 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.

 

  g) Dispute Resolution. In the event that the Joint Steering Committee cannot
reach agreement with respect to any material issue, then the issue will be
resolved in accordance with the dispute resolution provisions in Section 18.

 

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

Section 25. 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 any part of its rights under this Agreement to a purchaser of all
or substantially all of its assets to which this Agreement relates, or an entity
with which it may merge or sell its capital stock where it is not the surviving
company; provided, that, the assignee agrees in writing to assume all
obligations undertaken by its assignor in this Agreement. In addition, Sponsor
may assign this Agreement in whole or in part to one of its Affiliates without
Fujifilm’s prior written consent. 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.

 

CONFIDENTIAL 31

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 26. Notice

All notices to be given as required in this Agreement shall be in writing and
shall be delivered personally, sent by fax, 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 after the date it was
sent if sent by fax, delivered personally or delivered by overnight carrier and
on the date received if mailed first class.

If to Sponsor:

Synageva BioPharma Corp.

33 Hayden Avenue

Lexington, MA 02421

P: 781-357-9900

F: 781-357-9901

Attention: General Counsel

If to Fujifilm:

President

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

101 J. Morris Commons Lane

Morrisville, NC 27560

P: 919-337-4404

F: 919-337-0899

With copies to:

General Counsel

Fujifilm Diosynth Biotechnologies

Hexagon Tower

Blackley, Manchester, M9 8ES, United Kingdom

Facsimile No.: +44 161 721 5801

Assistant General Counsel

FUJIFILM Holdings America Corporation

200 Summit Lake Drive

Valhalla, New York 10595-1356

Fax: 914-789-8514

Section 27. Choice of Law

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.

 

CONFIDENTIAL 32

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 28. Equitable Relief

Notwithstanding any provision of this Agreement, either Party may seek
injunctive or other equitable relief to enforce or protect its rights hereunder
with respect to a breach of confidentiality or intellectual property rights in
any court of competent jurisdiction.

Section 29. Waiver

No failure or delay by either Party in exercising or enforcing any right, power
or privilege hereunder shall operate as a waiver thereof, nor shall any single
or partial exercise thereof preclude any other or further exercise thereof. A
waiver by either Party in one or more instances shall not be construed as
constituting a continuing waiver or as a waiver in other instances.

Section 30. Severability

If any provisions herein are found to be invalid or unenforceable, it is the
intent of the Parties that such provisions be replaced, reformed or narrowed so
that their original business purpose can be accomplished to the extent permitted
by law. The invalidity or unenforceability of any provision of this Agreement
shall not affect the validity or enforceability of any other provisions of this
Agreement, which shall remain in full force and effect.

Section 31. Nonsolicitation

For the term of this Agreement, and for twelve (12) months following termination
of this Agreement, for any reason, each Party agrees not to solicit any employee
of the other Party with whom they have come in contact pursuant to the
performance of services under this Agreement. The foregoing sentence shall not
prohibit a Party from hiring an employee of the other who (i) responds to a
general advertisement, (ii) is found by a recruiter who was not asked to target
such employee, or (iii) has left the employment of the non-hiring Party.

Section 32. Entire Agreement; 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 as well as all of Sponsor’s obligations with
respect to the Program and the purchase of Product and as such, supersedes all
prior and contemporaneous negotiations, agreements, representations,
understandings, and commitments with respect thereto 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. 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.

 

CONFIDENTIAL 33

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

Section 33. Foreign Corrupt Practices Act; Anti-Bribery Laws

Fujifilm shall comply with the requirements of all applicable anti-bribery
legislation both national and foreign, including but not limited to the U.S.
Foreign Corrupt Practices Act and the U.K. Bribery Act (collectively,
“Anti-Bribery Laws”) and Fujifilm has not and will not make, promise or offer to
make any payment or transfer anything of value (directly or indirectly) to
(i) any individual, (ii) corporation, (iii) association, (iv) partnership, or
(v) public body, (including but not limited to any officer or employee of any of
the foregoing) who, acting in their official capacity or of their own accord,
are in a position to influence, secure or retain any business for and/or provide
any financial or other advantage to Sponsor by improperly performing a function
of a public nature or a business activity with the purpose or effect of public
or commercial bribery, acceptance of or acquiescence in extortion, kickbacks or
other unlawful or improper means of obtaining or retaining business. Fujifilm
shall indemnify, defend and hold harmless Sponsor and its Affiliates, and its
and their directors, officers, employees and agents, from and against any and
all losses resulting or arising from any third party claims, actions,
proceedings, investigations or litigation relating to or arising from any
violation of Anti-Bribery Laws, to the extent such losses resulted from
Fujifilm’s failure to comply with Anti-Bribery Laws.

[Remainder of page intentionally left blank. Signature page to follow.]

 

CONFIDENTIAL 34

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Fujifilm – Synageva Agreement

EXECUTION COPY

 

IN WITNESS WHEREOF, the duly authorized representatives of each Party have
executed this Agreement effective as of the Effective Date.

 

Synageva BioPharma Corp. FUJIFILM Diosynth Biotechnologies U.S.A., Inc. By:

/s/ Thomas W. Beetham

By:

/s/ M. Meeson

Name: Thomas W. Beetham Name: M. Meeson Title: Sr. Vice President, General
Counsel Title: SVP Finance FUJIFILM Diosynth Biotechnologies U.S.A., Inc. By:

/s/ Stephen Spearman

Name: Stephen Spearman Title: President

[Signature page to Commercial Supply Agreement]

 

CONFIDENTIAL 35

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

APPENDICES:

1. Attachment 1. List of Countries and Territories

2. Attachment 2: Price; Cost of Starting Material

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Attachment 1: List of Countries and Territories

United States of America

All countries in the European Union (as the European Union is constituted as of
the Effective Date)

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Attachment 2: Price; Cost of Starting Material

Cost of Starting Material: [**]

Price

[**]

Notes:

 

  1. [**]. All other [**] listed in the table are priced at the [**].

 

  2. One time exception: [**]

 

  3. [**].

 

Activities for Annual Program Maintenance

   Cost

Process Surveillance

 

  

•    Collection of surveillance parameters data for all Batches Manufactured at
Fujifilm. Surveillance parameters include but are not limited to Critical
Parameters and In-Process Controls

 

•    Trending of Surveillance Parameters

 

•    Statistical Analysis shall be performed on Critical Process and Quality
Attributes at a minimum

 

•    [**]

 

•    Preparation of surveillance parameter data report after completion of each
manufacturing campaign

 

Note: Surveillance review in compliance with regulatory requirements outside the
above listed may incur in additional costs

   [**]

 

Annual Product Quality Review (APR) Report

 

  

•    [**]

 

•    [**]

 

•    [**]

 

  

 

[**]

[**]

 

  

Annual Regulatory Support

 

   [**]   

•    [**]

 

•    [**]

  

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

•    [**]

 

•    [**]

  

Annual waste disposal fee

   [**]

•    [**]

  

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request.

An unredacted version of this exhibit has been filed separately with the
Commission.

 

Itemized Process Consumables Pricing

[**]