EXECUTION COPY

Exhibit 10.1

BIOPROCESSING SERVICES AGREEMENT

This Bioprocessing Services Agreement dated January 22, 2013 (this “Agreement”)
between Synageva BioPharma Corp., a Delaware corporation (“Sponsor”) having its
principal place of business at 128 Spring Street, Suite 520, Lexington,
Massachusetts 02421 and FUJIFILM Diosynth Biotechnologies U.S.A., Inc., a
Delaware corporation (“Diosynth”), having its principal place of business at 101
J. Morris Commons Lane, Morrisville, NC 27560, (each a “Party”, collectively,
the “Parties”).

Sponsor desires Diosynth to perform services in accordance with the terms of
this Agreement and the Scope (as hereinafter defined) related to the production
of the material as described in the relevant Scope of Work (“Product”) and
Diosynth desires to perform such services;

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

Definitions:

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

“Alliance Manager” shall have the meaning set forth in Section 21(b).

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

“Batch Packet” shall mean a compilation of records, including but not limited
to, executed process records, genealogy, certificate of analysis (“COA”) and
associated Quality Control data, [*] Deviation Reports, Disposition of Product
form, Restriction Summary and Facility Assessment memo.

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

“Change Order” shall have the meaning set forth in Section 6(b).

“Claim” shall have the meaning set forth in Section 15(a).

“Confidential Information” shall have the meaning set forth in Section 7(d).

“Diosynth Confidential Information” shall have the meaning set forth in
Section 7(b).

“Diosynth Factor” shall mean (a) Diosynth’s negligence or willful default or
inaction, (b) Diosynth’s failure to comply with cGMP, or (c) the failure of the
GMP Facility to comply with applicable laws.

“Facilities” shall mean Diosynth’s facilities located in North Carolina,
including the GMP manufacturing plant (“GMP Facility”), the process development
laboratories, the GMP warehouse, and the administrative building.

“Impasse Notice” shall have the meaning set forth in Section 6(b).

 

[*] =   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 Securities and Exchange Commission.

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“Indemnified Party” shall have the meaning set forth in Section 15(c).

“Indemnity Claim” shall have the meaning set forth in Section 15(c).

“Joint Steering Committee” shall have the meaning set forth in Section 21(a).

“Loss” shall have the meaning set forth in Section 15(a).

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

“Non-Conforming Batch” shall mean a cGMP Batch which: (i) has not been produced
in accordance with cGMP; and/or (ii) does not meet the Product specification set
out in the Product item specification.

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

“Process Consumables” shall have the meaning set forth in the Scope.

“Process Invention” shall have the meaning set forth in Section 9(b).

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

“Product Invention” shall have the meaning set forth in Section 9(b).

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

“Program Invention” shall have the meaning set forth in Section 9(a).

“Program Price and Payment Schedule” shall mean the schedule attached as
Appendix 3 to this Agreement.

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

“Regulatory Authority” shall mean any national, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental
entity with authority over the Manufacture, production, use or storage,
transport, clinical testing, marketing, pricing or sale of Product, including
the United States Food and Drug Administration (the “FDA”) or any successor
agency or authority thereto, and the European Medicines Agency (the “EMA”), or
any successor agency or authority thereto.

“Scope” shall mean the scope of work attached as Appendix 1 to this Agreement.

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

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

“Sponsor Confidential Information” shall have the meaning set forth in
Section 7(a).

“Term” shall have the meaning set forth in Section 20(a).

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

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    2

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Section 1.

Scope of Work/Performance of Program

 

  a) Diosynth will perform the Program for Sponsor in accordance with the terms
and conditions of this Agreement, the Scope (attached as Appendix 1) and the
Quality Agreement (attached as Appendix 2). Terms defined in the terms and
conditions of this Agreement and the Scope and/or Quality Agreement shall have
same meaning when used in the Scope or Quality Agreement. In the event of any
conflict among the components of this Agreement and the Scope and/or Quality
Agreement, the following order of precedence shall apply:

 

  1. the terms and conditions of this Agreement;

 

  2. the Quality Agreement; and

 

  3. the Scope.

 

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

Section 2.

Sponsor Deliverables

 

  a) As further set forth in the Scope, Sponsor will timely provide Diosynth
with Sponsor Deliverables (as defined in the Scope) at the Facilities. Sponsor
acknowledges that the failure by Sponsor to provide Sponsor Deliverables within
the timeframe set forth in the Scope may result in additional charges to Sponsor
and a delay in meeting Program objectives.

 

  b) Title to Sponsor Deliverables shall remain with Sponsor. Diosynth shall not
sell, pledge, hypothecate, dispose of, or otherwise transfer any interest in
Sponsor Deliverables except as otherwise provided in this Agreement, and shall
use Sponsor Deliverables solely for purposes of performing the Program. Diosynth
shall provide safe and secure storage conditions at the Facilities for Sponsor
Deliverables while they are at the Facilities, shall store the Sponsor
Deliverables in accordance with all applicable statutory and regulatory
requirements and any storage guidelines provided by Sponsor and agreed upon by
Diosynth and, upon termination of this Agreement, at the instruction of Sponsor,
either return or destroy any unused Sponsor Deliverables at Sponsor’s expense.

Section 3.

Compliance with Government Regulations

 

  a)

Diosynth shall operate the GMP Facility as a compliant current Good
Manufacturing Practices (“cGMP”) facility in accordance with 21 CFR Parts 11,
210, 211, 600, & 610, ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients,
and the EU GMP Guide, including any requirements provided for in the Quality
Agreement for all aspects of manufacturing, testing, holding, packaging,
labeling and delivery of the Product and/or intermediates produced for Sponsor.
In addition, Diosynth shall perform the Program in compliance with statutory and
regulatory requirements applicable to the Product’s clinical phase, including
any other applicable regulations and/or guidance documents promulgated by any
applicable Regulatory Authority. Diosynth shall not permit debarred

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    3

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  persons to participate in the Program. Diosynth shall undertake reasonable
steps to prevent such participation. If Diosynth becomes aware of the debarment
or threatened debarment of any person participating in the Program, Diosynth
shall promptly so notify Sponsor.

 

  b) Sponsor acknowledges that Diosynth has consulted with Sponsor in designing
the Program in a manner consistent with current applicable regulatory
guidelines. Notwithstanding the foregoing, except as set forth in Section 3(a),
Diosynth does not warrant that the Program and/or the Program results will
satisfy the requirements of any Regulatory Authority at the time of submission
of Program results to such Regulatory Authority. As between the Parties,
(i) Sponsor shall have the sole right and responsibility for determining
regulatory strategy, decision and actions relating to the Program and the
Product and, (ii) subject to each Party’s contractual obligations under this
Agreement, Diosynth shall have the sole right and responsibility for determining
regulatory strategy, decision and actions to the extent relating to (A) the
Facilities; (B) Diosynth’s quality systems; or (iii) any requirement imposed on
Diosynth by a Regulatory Authority. Diosynth hereby represents that, to
Diosynth’s knowledge, as of the Effective Date, no requirement imposed on
Diosynth by a Regulatory Authority or any other commitments made by Diosynth
shall delay or prevent Diosynth from performing the Program or otherwise
complying with its obligations hereunder.

 

  c) Should such applicable regulatory requirements change, Diosynth will
promptly notify Sponsor of such change and the effect on the Program and
Diosynth will use reasonable efforts to satisfy the new requirements. In the
event that compliance with such new applicable regulatory requirements
necessitates a change in the Scope, Diosynth will submit to Sponsor a Change
Order, as herein after defined, in accordance with Section 6 of this Agreement.

 

  d) Subject to this Section 3, in the event of a conflict in government
regulations applicable to the performance of the Program, Sponsor and Diosynth
will agree in good faith as to which regulations shall be followed by Diosynth
in its performance of the Program.

 

  e) If Diosynth receives any contact or communication from any Regulatory
Authority relating in any way to the Program, Diosynth will (i) notify Sponsor
and provide Sponsor with copies of any such communication within two
(2) business days of its 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. Diosynth will promptly
inform Sponsor in the event that any such Regulatory Authority takes any action
against Diosynth for any reason that could be reasonably be expected to have an
effect on Diosynth’s performance of the Program. Unless required by applicable
laws or regulations, Diosynth 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.

 

  f) Diosynth 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 in order for Diosynth to perform its
obligations under this Agreement.

 

  g) If Diosynth receives notice of action or threat of action with respect to
its debarment during the Term of this Agreement (i) Diosynth shall so notify
Sponsor immediately and (ii) Sponsor shall have the right to terminate this
Agreement upon not less than ten (10) days’ written notice.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    4

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Section 4.

Facility Visits

The terms and conditions of Sponsor audit rights and rights to visit and inspect
the Facilities are provided in the Quality Agreement.

Section 5.

Compensation

 

  a) Sponsor shall make the payments to Diosynth set forth in, and in accordance
with, the Program Price and Payment Schedule. In addition, pursuant to the
Scope, Sponsor agrees to pay Diosynth [*] for any Process Consumables purchased
for the Program pursuant to the terms set forth in the Scope plus a fee equal
[*] of such [*]. These amounts will be invoiced separately as they are incurred
by Diosynth. Within thirty (30) days of completion of all Manufacturing under
this Agreement, Sponsor will provide Diosynth with written notice specifying its
preferred method of disposition for any remaining Process Consumables, the costs
for which shall be borne solely by Sponsor. In specifying its preferred method
for such disposition, Sponsor may choose from the following three options:

 

  1. having Diosynth deliver remaining Process Consumables to Sponsor or a
designated storage site;

 

  2. having Diosynth deliver remaining Process Consumables to a destruction
site; or

 

  3. assigning ownership of remaining Process Consumables to Diosynth at no
cost.

In the event that Sponsor fails to provide written notice of its preferred
method of disposition to Diosynth within the above thirty (30) day period,
Diosynth will implement the second option specified above, the costs for which
shall be borne solely by Sponsor.

 

  b) Subject to Section 5(d), payments are due thirty (30) calendar days from
the date any invoice issued by Diosynth is received by Sponsor consistent with
the Program Price and Payment Schedule. Unless Sponsor has advised Diosynth in
good faith and in writing the specific basis for disputing an invoice, failure
to pay an invoice within [*] from the date of invoice receipt may, at Diosynth’s
election, constitute a material breach of this Agreement. Invoices will include
a summary of all activities completed during the invoice period and a
description of all Process Consumables purchased during the invoice period.

 

  c)

Diosynth has allocated resources to the Program that may be difficult or
impractical to reallocate to other programs in the event of a material delay in
the conduct of the Program that is reasonably attributable to Sponsor (a
“Sponsor Delay”). In recognition of this, upon the occurrence of a Sponsor
Delay, (i) Sponsor shall provide Diosynth with prompt written notice of same,
(ii) Diosynth shall use reasonable efforts to reallocate resources to other
programs and Sponsor and Diosynth shall negotiate in good faith a Change Order
to compensate Diosynth for any idled personnel or capacity it is unable to
reasonably reallocate to such other programs; and (iii) subject to subsection
(ii), Sponsor agrees to pay the amounts set forth in and in accordance with the
Change Order during such Sponsor Delay, including for completion of any
components of the Program that are so delayed and not reallocated, for a period
of [*]. Notwithstanding the foregoing, if Sponsor provides a notice of the
occurrence of a Sponsor Delay within [*] prior to the scheduled commencement
date for manufacturing activities and Diosynth is unable to reasonably
reallocate the resources to be used in the Program to other programs, then
(i) as

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    5

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  Diosynth’s sole remedy for such Sponsor Delay, Sponsor shall pay Diosynth,
upon receipt of Diosynth’s invoice, the following amounts: (A) if the notice of
the occurrence of the Sponsor Delay is delivered by Sponsor on or between [*]
and [*] days from the scheduled commencement date for manufacturing activities,
an amount equal to [*] of the unbilled activities under the Manufacturing
heading in the Program Price and Payment Schedule; (B) if the notice of the
occurrence of the Sponsor Delay is delivered by Sponsor on or between [*] and
[*] days from the scheduled commencement date for manufacturing activities, an
amount equal to [*] of the unbilled activities under the Manufacturing heading
in the Program Price and Payment Schedule; and (C) if the notice of the
occurrence of a Sponsor Delay is delivered by Sponsor less than [*] from the
scheduled commencement date for manufacturing activities, an amount equal to [*]
of the unbilled activities under the Manufacturing heading in the Program Price
and Payment Schedule; and (ii) Diosynth shall prepare in good faith and promptly
provide to Sponsor a reasonable rescheduled date for the commencement of Sponsor
manufacturing activities. Notwithstanding the foregoing, Sponsor Delays
resulting in delays to commencement of manufacturing activities of [*] or more
from the originally scheduled commencement date for such manufacturing
activities shall be subject to the cancellation payments equal to [*] described
in [*], less any delay payments already made by Sponsor.

 

  d) Diosynth shall (i) use commercially reasonable efforts to complete
disposition of each cGMP batch of Product (each, a “Batch”) within the period
specified in the Quality Agreement, and (ii) provide Sponsor’s quality assurance
department with a Batch Packet within ten (10) days of completion of disposition
of each such Batch by Diosynth and (if appropriate) a recommendation for such
Batch to be released. Within thirty (30) days after Sponsor’s receipt of such
documentation, Sponsor shall review the Batch Packet to determine, to the extent
ascertainable from such documentation, whether or not the Batch of Product
covered by such Batch Packet conforms to the specifications set forth in the
agreed specifications.

 

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

 

  (i) Diosynth or Sponsor, as the case may be, shall provide written notice of
same to the other Party.

 

  (ii) The Non-Conforming Batch shall not be delivered to Sponsor.

 

  (iii) Diosynth shall use commercially reasonable efforts to manufacture a
further Batch to replace the Non-Conforming Batch.

 

  (1) If the Non-Conforming Batch arose other than as a result of a Diosynth
Factor:

 

  (A) Subject to Section 5(g), Sponsor shall be obliged to make payment for such
Non-Conforming Batch in accordance with Section 5 and the applicable Program
Price and Payment Schedule.

 

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

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    6

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  (2) If the Non-Conforming Batch arose as a result of a Diosynth Factor,
Diosynth shall undertake the manufacture of a further Batch under
Section 5(e)(iii) to replace the Non-Conforming Batch at Diosynth’s cost and
expense and as soon as reasonably practicable.

 

  (iv) Unless otherwise agreed by the Parties in writing, Diosynth shall dispose
of any Non-Conforming Batch that Diosynth is obligated to replace pursuant to
Section 5(e)(iii) in accordance with all applicable laws, and such disposal
shall be at Diosynth’s cost, if Diosynth was liable for the Non-Conforming Batch
in accordance with Section 5(e)(iii)(2), and at Sponsor’s cost otherwise.

Notwithstanding the foregoing, should any hidden or latent defects be discovered
after the delivery of a Batch but in no event after [*] from the date the Batch
is delivered, which defects could not reasonably be discovered during
disposition within that period, then Sponsor shall promptly inform Diosynth. In
the event that the Batch fails to comply with agreed upon specifications, and it
is agreed by the Parties or established under the mechanism set out in
Section 5(g) below that such failure was due to a Diosynth Factor, then Sponsor
shall be entitled to the remedies under Section 5(e)(iii)(2) and (iv).

Notwithstanding anything to the contrary in this Agreement, the remedies set out
in this Section 5(e) shall be Sponsor’s sole remedies in relation to a
Non-Conforming Batch.

For the avoidance of doubt, if the Parties agree that an [*] Batch under a Scope
of Work is to be carried out in accordance with cGMP, such [*] Batch shall not
be treated as a GMP Batch for the purposes of this Section 5.

 

  f) If following the review of Batch Packet, it is ascertained by agreement of
the Parties (or in the absence of such agreement, through arbitration pursuant
to Section 14) that the Batch conforms to the specifications set forth in the
agreed specifications and otherwise complies with the representations,
warranties and covenants in Section 16(d) (a “Conforming Batch”), then Sponsor
shall issue to Diosynth a certificate of compliance and Diosynth shall have no
liability to Sponsor pursuant to Section 5(e)(iii) with respect to such
Conforming Batch, and Sponsor shall pay for such Conforming Batch pursuant to
Section 5.

 

  g) In the event the Parties disagree in good faith as to whether a Batch of
Product is a Conforming Batch or Non-Conforming Batch, the Parties shall agree
to submit test samples for analysis to a mutually agreed upon independent third
party GMP laboratory which is able to provide laboratory equipment and personnel
that are qualified in the same manner as the Sponsor/ Diosynth facilities. The
Parties hereby agree that a formal method transfer and qualification/validation
must be completed by the third party laboratory prior to performing any testing
related to a dispute resolution under Section 14. The costs of such independent
laboratory shall be borne [*]; provided, however, that the Party that is
determined to be correct in the dispute, shall be reimbursed by the other Party
for its reasonable costs so incurred. The decision of such independent
laboratory shall be in writing and shall be binding on both Parties unless there
has been a manifest error on the face of the decision whereupon the Parties
shall revert to the arbitration procedure set forth in Section 14. For the
avoidance of doubt, the Parties will follow Diosynth quality procedures while
accepting or rejecting the disputed Batch.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    7

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  h) The Parties hereby agree following the production of a certain number of
Batches to be determined in good faith by the Parties, to discuss in good faith
an amendment to the definition of Diosynth Factor to account for Diosynth’s
increased level of understanding with respect to the manufacturing process
necessary to produce such Batches.

Section 6.

Change Orders

 

  a) The total budget for the Program specified in the Program Price and Payment
Schedule, the individual budget components and the estimated durations specified
in the Scope are subject to the Assumptions (as defined below) as well as the
accuracy, timeliness and completeness of Sponsor’s Deliverables. Such
Assumptions relate to the Program design and objectives, manpower requirements,
timing, capital expenditure requirements, if any and other matters relating to
the completion of the Program and are set forth in the Scope (“Program
Assumptions”). Diosynth also assumes that Sponsor will cooperate and perform its
obligations under this Agreement and the Scope in a timely manner, that no Force
Majeure event will occur, and that there are no changes to any applicable laws,
rules or regulations which materially affect the performance of the Program (the
foregoing assumptions, together with the Program Assumptions, collectively, the
“Assumptions”). In the event that any of the Assumptions require modification to
this Agreement or the Program objectives cannot reasonably be achieved as a
result of one or more of the Assumptions being materially incorrect (each being
a “Modification”), the Scope may be amended as provided in paragraph b) of this
Section 6.

 

  b) In the event a Modification is identified by Sponsor or by Diosynth, the
identifying Party shall notify the other Party in writing as soon as is
reasonably possible. Diosynth shall provide Sponsor with a change order
containing an estimate of the additional cost to Sponsor of such Modifications
including any changes that may be necessary to the Program budget, activities
and/or estimated duration as specified in the Scope (“Change Order”) within ten
(10) business days of receiving such notice or providing such notice to Sponsor.
Sponsor shall respond in writing to such Change Order within ten (10) business
days of receiving such Change Order indicating whether or not it approves the
proposed Change Order. Sponsor shall be deemed to have not approved the Change
Order if Diosynth does not receive a written indication from Sponsor during such
ten (10) day period. If Sponsor does not approve such Change Order, then Sponsor
and Diosynth shall negotiate in good faith to agree on a Change Order that is
mutually acceptable. If practicable, Diosynth shall continue work on the Program
during any such negotiations, but shall not commence work with respect to the
Change Order unless authorized in writing by Sponsor. If the Parties are unable
to agree upon a Change Order within forty-five (45) days after issuance of the
relevant Change Order, then Diosynth shall, if reasonably possible, perform the
Scope without regard to the unresolved Change Order; provided, however, that the
estimated timelines shall be adjusted to reflect any delay during the
negotiation period. In the event that in Diosynth’s reasonable judgment such
performance in not possible in accordance with the current Scope and Program
Price and Payment Schedule, then Diosynth shall provide written notice to
Sponsor of its inability to perform in the absence of an agreed upon Change
Order (the “Impasse Notice”). Upon issuance of an Impasse Notice, either Party
shall have the right to terminate this Agreement or the Program affected by such
Change Order within thirty (30) days following the date of delivery of such
Impasse Notice.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    8

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Section 7.

Confidential Information/Legal Proceedings

 

  a) During the Term of this Agreement and for five (5) years following the
termination of this Agreement, Diosynth will hold in confidence and will not
disclose, without Sponsor’s prior written permission, any Confidential
Information pertaining to the Program or otherwise disclosed by Sponsor to
Diosynth in connection with the Program (“Sponsor Confidential Information”)
unless: (i) such disclosure is to an affiliate of Diosynth that is under an
obligation to keep such information confidential comparable in scope to
Diosynth’s obligation under this Section 7; (ii) such information is or becomes
publicly available through no fault of Diosynth; (iii) such information is
disclosed to Diosynth by a third party entitled to disclose it; (iv) such
information is already known to Diosynth as shown by its prior written records;
or, (v) such information is required by any law, rule, regulation, order
decision, decree, subpoena or other legal process to be disclosed. If such
disclosure is requested by legal process, Diosynth will use reasonable efforts
to notify Sponsor of this request promptly prior to any disclosure to permit
Sponsor to oppose such disclosure by appropriate legal action. Diosynth shall
use reasonable precautions to protect the confidentiality of Sponsor
Confidential Information comparable to precautions taken to protect its own
proprietary information.

 

  b) During the Term of this Agreement and for five (5) years following the
termination of this Agreement, Sponsor will hold in confidence and not disclose,
without Diosynth’s prior written permission, any Confidential Information
pertaining to Diosynth’s performance of the Program disclosed by Diosynth to
Sponsor (“Diosynth Confidential Information”) unless: (i) such disclosure is to
an affiliate of Sponsor that is under a similar obligation to keep such
information confidential; (ii) such information is or becomes publicly available
through no fault of Sponsor; (iii) such information is disclosed by a third
party entitled to disclose it; (iv) such information is already known to Sponsor
as shown by its prior written records; or, (v) such information is required by
any law, rule, regulation, order decision, decree, subpoena or other legal
process to be disclosed. If such disclosure is requested by legal process,
Sponsor will use reasonable efforts to notify Diosynth of this request promptly
prior to any disclosure to permit Diosynth to oppose such disclosure by
appropriate legal action. Sponsor shall use reasonable precautions to protect
the confidentiality of Diosynth Confidential Information comparable to
precautions taken to protect its own proprietary information.

 

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

 

  d) 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.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    9

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  e) Upon the expiration or termination of this Agreement, to the extent
requested by the disclosing Party, each recipient Party shall use all 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.

Section 8.

Work Output

 

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

 

  b) Sponsor will be supplied with copies of Work Output generated as a result
of the Program as set forth in the Scope or Quality Agreement. Notwithstanding
the foregoing, Diosynth 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 Diosynth for a period of five (5) years following
completion of the Program unless otherwise defined by the Program or required by
applicable U.S. laws or regulations. Five (5) years after completion of the
Program, Work Output and Product samples will be disposed by Diosynth or sent by
Diosynth to Sponsor and a return fee will be charged, as specified in writing by
Sponsor. Sponsor may elect to have the Work Output retained in the Diosynth
archives for an additional period of time at additional cost to Sponsor. If
Sponsor chooses to have Diosynth dispose of Work Output and Product samples, a
disposal fee will be charged. Notwithstanding the foregoing, Diosynth will
continue to retain such Work Output and Product samples as required by
regulations and as may be required by law, pertaining to such activities as well
as for archival purposes. In the absence of notice at the end of the applicable
period, Diosynth shall send the Work Product to Sponsor at Sponsor’s cost and
expense.

Section 9.

Inventions and Patents

 

  a) Diosynth 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 Diosynth in the course of the performance of the Program
(collectively, “Program Inventions”).

 

  b)

All Program Inventions that relate to Diosynth’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,
Diosynth (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. Diosynth
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, Diosynth will execute any and all applications, assignments
or other instruments

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    10

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  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 compensate Diosynth for the time devoted to such
activities and reimburse it for expenses incurred. For Product Inventions
assigned pursuant to this section, Sponsor shall provide Diosynth a royalty-free
license necessary to perform the Program for the Term of this Agreement.

Diosynth agrees to grant and hereby grants to Sponsor a perpetual, world-wide,
royalty-free, sublicensable, exclusive license under all Process Inventions for
use in connection with the Product. If Diosynth requests and at Diosynth’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 Diosynth shall compensate Sponsor for the time devoted to
such activities and reimburse it for expenses incurred.

 

  c) Diosynth 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 Diosynth is required to keep
confidential under this Agreement is disclosed in any such application,
assignment, or other instrument. Diosynth 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 request that any Sponsor Confidential
Information contained in any such application, assignment or other instrument be
deleted therefrom.

Section 10.

Independent Contractor

Diosynth 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 Diosynth 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.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    11

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Section 11.

Insurance

 

  a) Diosynth 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 $5,000,000 per occurrence and $5,000,000 in the aggregate, (c) product
liability with combined single limits of not less than $5,000,000 per occurrence
and $5,000,000 in the aggregate and (d) property damage (including business
interruption coverage) with limits equal to replacement value, and, in each
case, having deductibles and other terms appropriate to the conduct of
Diosynth’s business in Diosynth’s reasonable judgment.

 

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

Section 12.

Delivery

Diosynth shall package for shipment and deliver Product, samples or other
materials at Sponsor’s expense and in accordance with Sponsor’s full written and
reasonable instructions with Sponsor bearing all packaging, shipping and
insurance charges. Freight terms shall be Ex Works (Incoterms 2010) the GMP
Facility. Title, possession, risk of loss, risk of damage and all forward costs
and expenses shall pass to and be borne by Sponsor upon delivery. Diosynth shall
retain representative samples of Product for record keeping, testing and
regulatory purposes. Sponsor shall provide for shipping of each Batch of Product
within thirty (30) calendar days of its issuance of certificate of compliance in
accordance with Section 5(f), unless otherwise agreed between the Parties. In
the event of any delay by Sponsor in issuance of the certificate of compliance
or shipping of Product in accordance with this Section 12, the Parties
acknowledge and agree that liability and risk of loss for each such shipment of
Product shall automatically transfer to (and be assumed by) Sponsor effective
upon expiration of sixty (60) days period since completion of manufacturing.

Section 13.

Default/Limitation of Warranty

 

  a) If Diosynth is in default of its material obligations under this Agreement,
Sponsor shall promptly notify Diosynth in writing of any such default. Diosynth
shall have a period of forty-five (45) days from the date of receipt of such
notice within which to cure or, if a cure cannot reasonably be effected within
such forty-five (45) day period, to deliver to Sponsor a plan for curing such
breach that is reasonably sufficient to effect a cure as soon as practicable
thereafter and to commence in good faith to cure such default in accordance with
the plan within such forty-five (45) day period; provided, that, if the cure
involves the supply to Sponsor of a replacement shipment of Product, the Parties
will agree in good faith on a reasonable date by which Diosynth shall supply
such Product. If Diosynth fails to so cure, or commence to cure, such breach,
then this Agreement shall, at Sponsor’s option, immediately terminate.

 

  b)

If Sponsor is in default of its material obligations under this Agreement,
Diosynth shall promptly notify Sponsor in writing of any such default. Sponsor
shall have a period of forty-five (45) days from the date of receipt of such
notice within which to cure such default

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    12

--------------------------------------------------------------------------------

  or, if a cure cannot reasonably be effected within such forty-five (45) day
period, to deliver to Diosynth a plan for curing such breach that is reasonably
sufficient to effect a cure as soon as practicable thereafter and to commence in
good faith to cure such default in accordance with the plan within such
forty-five (45) day period. If Sponsor fails to so cure, or commence to cure,
such breach within the specified cure period, this Agreement may, at Diosynth’s
option, immediately terminate.

 

  c) Not withstanding anything herein to the contrary, EXCEPT AS SET FORTH IN
SECTION 15, UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE ENTITLED TO INCIDENTAL,
INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES ARISING IN CONNECTION WITH THE
DEFAULT OR BREACH OF ANY OBLIGATION OF THE OTHER PARTY UNDER THIS AGREEMENT, THE
SCOPE OR ANY DOCUMENTS OR APPENDICES RELATED THERETO. EXCEPT FOR THE OBLIGATIONS
OF DIOSYNTH UNDER SECTION 15(a), THE MAXIMUM LIABILITY OF DIOSYNTH FOR DAMAGES
IN CONNECTION WITH A CLAIM RELATED TO THIS AGREEMENT, REGARDLESS OF THE CAUSE OF
ACTION, [*].

 

  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. SUBJECT TO DIOSYNTH’S OBLIGATIONS
WITH RESPECT TO THE QUALITY OF THEIR SERVICES AS DESCRIBED HEREIN, INCLUDING THE
APPLICABLE SCOPE OF WORK, QUALITY AGREEMENT OR OTHER AGREEMENT BETWEEN THE
PARTIES, DIOSYNTH MAKES NO WARRANTIES THAT THE EXECUTION OF THE SCOPE WILL
RESULT IN ANY SPECIFIC QUANTITY OR QUALITY OF PRODUCT.

Section 14.

Dispute Resolution

 

  a) In the event any dispute shall arise between Sponsor and Diosynth with
respect to any of the terms and conditions of this Agreement or the Program the
senior executives of Sponsor and Diosynth shall meet as promptly as practicable
after notice of such dispute to resolve in good faith such dispute.

 

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

 

  c)

If mediation fails to resolve the dispute within forty-five (45) days of the
initial meeting pursuant to Section 14 a) above, then such dispute shall be
finally settled by an arbitrator in accordance with this Section 14. 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 agreeable to both Parties. If the Parties do
not agree on an arbitrator within thirty (30) days of the termination of the
mediation as indicated by at least one of the Parties, the American Arbitration
Association shall appoint an arbitrator to hear the case in accordance with its
rules. The arbitrator shall have no

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    13

--------------------------------------------------------------------------------

  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.

 

  d) 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 15.

Indemnification

 

  a) Diosynth shall indemnify 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 material breach of any representation or warranty by Diosynth under
this Agreement; (ii) the failure of Diosynth to perform the Services in
accordance with the Scope; (iii) the material breach by Diosynth of any
applicable statute or regulation relating to the Program; or (iv) Diosynth’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 Diosynth shall indemnify Sponsor
Indemnitees for pursuant to this Section 15 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 Diosynth and its affiliates and their respective
officers, directors and employees (“Diosynth Indemnitees”) from any Claim or
Loss arising from or related to: (i) the use by Sponsor of Sponsor Deliverables,
Process Consumables, or the Product; (ii) the material breach of any
representation or warranty by Sponsor under this Agreement; (iii) the
infringement or alleged infringement of the intellectual property rights of a
third party arising out of Diosynth’s use of any technical information,
materials or know-how provided by Sponsor to Diosynth for Diosynth’s conduct of
the Program in accordance with the Scope; 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 Diosynth’s negligence, gross negligence or intentional
misconduct or inaction, then the amount of such Loss that Sponsor shall
indemnify the Diosynth Indemnitees for pursuant to this Section 15 shall be
reduced by an amount in proportion to the percentage of Diosynth’s
responsibilities for such Loss as determined by a court of competent
jurisdiction in a final and non-appealable decision or in a binding settlement
between the Parties.

 

  c)

Upon receipt of notice of any Claim which may give rise to a right of indemnity
from the other Party hereto, the Party seeking indemnification (the “Indemnified
Party”) shall give written notice thereof to the other Party, (the “Indemnifying
Party”) with a Claim for indemnity (“Indemnity Claim”). Any delay or failure to
give notice shall not discharge the duty of the Indemnifying Party to indemnify
except to the extent it is prejudiced by such delay or failure. Such Indemnity
Claim shall indicate the nature of the Indemnity Claim and the basis therefore.
Promptly after an Indemnity Claim is made for which the Indemnified Party seeks
indemnity, the Indemnified Party shall permit the Indemnifying Party, at its
option and expense, to assume the complete defense of such Indemnity

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    14

--------------------------------------------------------------------------------

  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 approval thereof, not to be unreasonably
withheld. The Indemnified Party shall have the right, at its election, to
release and hold harmless the Indemnifying Party from its obligations hereunder
with respect to such Indemnity Claim and assume the complete defense of the same
in return for payment by the Indemnifying Party to the Indemnified Party of the
amount of the Indemnifying Party’s settlement offer. The Indemnifying Party will
not, in defense of any such Indemnity Claim, except with the consent of the
Indemnified Party, consent to the entry of any judgment or enter into any
settlement which does not include as an unconditional term thereof, the giving
by the claimant or plaintiff to the Indemnified Party of a release from all
liability in respect thereof. After notice to the Indemnified Party of the
Indemnifying Party’s election to assume the defense of such Indemnity Claim, the
Indemnifying Party shall be liable to the Indemnified Party for such legal or
other expenses subsequently incurred by the Indemnified Party in connection with
the defense thereof at the request of the Indemnifying Party. As to those
Indemnity Claims with respect to which the Indemnifying Party does not elect to
assume control of the defense, the Indemnified Party will afford the
Indemnifying Party an opportunity to participate in such defense at the
Indemnifying Party’s own cost and expense, and will not settle or otherwise
dispose of any of the same without the consent of the Indemnifying Party.

Section 16.

Representations and Warranties

 

  a) Each Party represents and warrants to the other that it has the full right
and authority to enter into this Agreement and to perform this Agreement in
accordance with the terms and conditions set forth herein; 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; 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) Each Party represents and warrants to the other Party that it has obtained
and will at all times during the term of this Agreement, hold and comply with
all licenses, permits and authorizations necessary to perform this Agreement as
now or hereafter required under any applicable statutes, laws, ordinances, rules
and regulations of the United States and any applicable foreign, state, and
local governments and governmental entities.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    15

--------------------------------------------------------------------------------

  c) Sponsor hereby represents and warrants to Diosynth that it has legal title
and/or a valid license to the Sponsor Deliverables necessary to conduct the
Program in accordance with the Scope.

 

  d) Diosynth hereby represents and warrants to Sponsor that (i) Diosynth will
operate the GMP Facility in compliance with cGMP in all aspects of
manufacturing, testing, holding, packaging, labeling and preparation for
shipping of the Product and will perform the Program in compliance with cGMP and
that the Products will conform to the packaging instructions provided by Sponsor
and agreed upon by Diosynth; (ii) Diosynth owns or lawfully controls the GMP
Facility, and the GMP Facility shall be maintained in accordance with cGMP and
in such condition as will allow Diosynth to manufacture the Product in
compliance with cGMP; (iii) Diosynth has written agreements with all its
employees involved in the performance of the Services, which agreements shall
require that all discoveries and inventions conceived or reduced to practice by
such employees in the conduct of the Services shall be promptly disclosed and
assigned to Diosynth; and Diosynth has the right to assign to Sponsor its rights
in and to all Product Inventions as provided in this Agreement; (iv) Diosynth is
under no contractual or other obligation or restriction that is inconsistent
with Diosynth’s performance of this Agreement; and (v) in performing this
Agreement, Diosynth will comply with all applicable laws and perform the Program
in compliance with applicable cGMP regulations, except as specified otherwise in
this Agreement.

Section 17.

Force Majeure

Either Party shall be excused from performing its respective obligations under
this Agreement if its performance is delayed or prevented by any event beyond
such Party’s reasonable control, including, but not limited to, acts of God,
fire, explosion, weather, disease, war, insurrection, civil strife, riots,
government action, acts of terrorism or power failure; provided, that, such
performance shall be excused only to the extent of and during such disability.
The Party subject to such event shall promptly notify the other Party of the
occurrence thereof and, if known, the expected duration. Any time specified or
estimated for completion of performance in the Scope falling due during or
subsequent to the occurrence of any or such events shall be automatically
extended for a period of time to recover from such disability. Diosynth will
promptly notify Sponsor if, by reason of any of the events referred to herein,
Diosynth is unable to meet any such time for performance specified or estimated
in the Scope. If any part of the Program is invalid as a result of such
disability, Diosynth will, upon written request from Sponsor, but at Sponsor’s
sole cost and expense, repeat that part of the Program affected by the
disability.

Section 18.

Allocation of Resources

If delays in the agreed commencement or performance of the Program occur because
of Sponsor’s request or inability to supply Diosynth with agreed Sponsor
Deliverables or any information required to begin or perform the Program within
thirty (30) days of such agreed time, Diosynth may reallocate resources being
held for performance of the Program. In such event, Diosynth shall be relieved
of its obligation to perform the Program as set forth in the Scope except that
upon such delay being removed or remedied, Diosynth will use commercially
reasonable efforts to allocate resources to performance of the Program as set
forth in the Scope.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    16

--------------------------------------------------------------------------------

Section 19.

Use of Names

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

Section 20.

Term/Termination

 

  a) This Agreement shall take effect on the date first written above and
continue in effect, unless earlier terminated pursuant to this Section 20, until
the completion of the Program (the “Term”).

 

  b) In addition to the termination rights set forth in Section 13, Sponsor may
at any time terminate this Agreement by giving forty-five (45) days written
notice to Diosynth. In the event Sponsor elects to terminate for reasons other
than pursuant to Section 13 or in the event that Diosynth terminates this
Agreement pursuant to Section 13, then, as Diosynth’s sole remedy under this
Agreement, Sponsor shall pay Diosynth upon receipt of Diosynth’s invoice, the
following amounts:

 

  (i) All amounts owed for services completed but not yet invoiced; plus

 

  (ii) All unpaid costs incurred or committed for Process Consumables; plus

 

  (iii) A termination fee to be paid on or before forty-five (45) days of the
effective date of termination, calculated as follows:

(A) [*] of any unbilled amounts set forth in the Program Price and Payment
Schedule under all headings, other than “Manufacturing”; plus

(B) (1) If the effective date of termination is within [*] of the scheduled
commencement date for manufacturing activities, but prior to the date that is
[*] prior to the scheduled commencement for manufacturing activities, an amount
equal to [*] of the unbilled activities under the Manufacturing heading in the
Program Price and Payment Schedule (as amended to include any executed Change
Orders); or

(B) (2) If the effective date of termination is within [*] of the scheduled
commencement date for manufacturing activities, but prior to the date that is
[*] prior to the scheduled commencement for manufacturing activities, an amount
equal to [*] of the unbilled activities under the Manufacturing heading in the
Program Price and Payment Schedule (as amended to include any executed Change
Orders); or

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    17

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(B) (3) If the effective date of termination is within [*] of the scheduled
commencement date for manufacturing activities, but prior to the date that is
[*] prior to the scheduled commencement for manufacturing activities, an amount
equal to [*] of the unbilled activities under the Manufacturing heading in the
Program Price and Payment Schedule (as amended to include any executed Change
Orders); or

(B) (4) If the effective date of termination is within [*] of the scheduled
commencement date for manufacturing activities, an amount equal to [*] of the
unbilled activities under the Manufacturing heading in the Program Price and
Payment Schedule (as amended to include any executed Change Orders).

 

  c) For the avoidance of doubt, the provisions of this Section 20 shall not
apply to delays, including without limitation, Sponsor Delays, which are
addressed in Section 5(c). For the avoidance of doubt, in the event of
termination of this Agreement for any reason, (i) Diosynth will terminate all
services in progress under the Program in an orderly manner as soon as practical
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) Diosynth will deliver to Sponsor any Sponsor Deliverables and Work Output
in its possession or control and all Product Inventions developed through the
date of termination or expiration, and (iii) Sponsor will pay Diosynth any
monies due and owing Diosynth, up to the time of termination or expiration, for
services actually performed and all authorized expenses actually incurred
pursuant to Section 20(b). The termination of this Agreement for any reason
shall relieve neither Party of its obligation to the other for obligations in
respect of: (i) confidentiality of information; (ii) consents for advertising
purposes and publications; (iii) indemnification; (iv) inventions and patents;
(v) compensation for services performed and (vi) dispute resolution.

Section 21.

Program Management.

a) Joint Steering Committee. Effective on the Effective Date, Sponsor and
Diosynth shall establish a Joint Steering Committee (the “Joint Steering
Committee”) comprised of an equal number of representatives designated by
Sponsor and Diosynth.

 

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

 

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

 

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

 

  (i) monitoring the performance of the Program;

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    18

--------------------------------------------------------------------------------

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

 

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

 

  e) Meetings. The Joint Steering Committee shall meet at such times as the
Joint Steering Committee determines to resolve issues arising hereunder and to
perform its responsibilities under this Agreement; provided, that, the Joint
Steering Committee shall meet not less than four (4) times per calendar year
unless otherwise mutually agreed. Such meetings may be in person or by telephone
as agreed by the Joint Steering Committee. To the extent that meetings are held
in person, they shall alternate between the offices of the Parties unless the
Parties agree otherwise. The Alliance Managers shall attend all meetings of the
Joint Steering Committee. All decisions of the Joint Steering Committee shall be
unanimous. The first meeting shall be held on or before January     , 2013.

 

  f) Administration. The chairperson of the Joint Steering Committee shall be
designated every six (6) months on an alternating basis between the Parties. The
initial chairperson will be selected by Diosynth. The chairperson shall be
responsible for calling meetings, sending notices of meetings and for leading
such meetings.

 

  g) Minutes. Within fifteen (15) days after each Joint Steering Committee
meeting, the Alliance Manager for the party whose representative chaired the
Joint Steering Committee meeting shall prepare and distribute minutes of the
meeting, which shall provide a description in reasonable detail of the
discussions had at the meeting and a list of any actions, decisions or
determinations approved by the Joint Steering Committee. Minutes shall be
approved or disapproved and revised, as necessary, at the next meeting. Final
minutes shall be distributed to the members of the Joint Steering Committee.

 

  h) Dispute Resolution. In the event that the Joint Steering Committee cannot
reach agreement with respect to any material issue, then the issue shall be
resolved in accordance with the dispute resolution provisions in Section 14.

 

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

Section 22.

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. 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.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    19

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Section 23.

Notice

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

If to Sponsor:

Synageva BioPharma Corp.

128 Spring Street, Suite 520

Lexington, MA 02421

P: 781-357-9900

F: 781-357-9901

Attention: Legal Department

If to Diosynth:

President

Fujifilm Diosynth Biotechnologies

101 J. Morris Commons Lane

Morrisville, NC 27560

P: 919-337-4404

F: 919-337-0899

With copies to:

General Counsel

Fujifilm Diosynth Biotechnologies

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 24.

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.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    20

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Section 25.

Waiver/Severability

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

Section 26.

Nonsolicitation

For the term of this Agreement, and for twelve (12) months following termination
of this Agreement, for any reason, neither Sponsor nor Diosynth nor any of their
employees or agents shall, directly or indirectly, solicit, hire, or attempt to
solicit or hire, any employees of the other who were involved in the Program,
unless otherwise approved by the other Party. This provision shall not restrict
either Party or its affiliates from advertising employment opportunities in any
manner that does not directly target the other Party or its Affiliates.

Section 27.

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 Diosynth for Sponsor 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.

 

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

[Remainder of page intentionally left blank.]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    21

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

/s/ Stephen Mahoney

    By:  

/s/ Henrik Edeback

Name:  

Stephen Mahoney

    Name:  

Henrik Edeback

Title:  

VP, General Counsel

    Title:  

VP Finance

Date:  

1/22/13

    Date:  

1/22/13

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

/s/ Stephen Spearman

      Name:  

Stephen Spearman

      Title:  

President

      Date:  

22 Jan 2013

[Signature page to Bioprocessing Services Agreement]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    22

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SOW Technology Transfer and Manufacture of SBC-102

APPENDIX 1

 

 

Scope of Work for Technology Transfer

and cGMP Manufacture of SBC-102

Drug Substance

 

 

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 1 of 20

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TABLE OF CONTENTS

 

1.0

 

PROGRAM DEFINITIONS

     3   

2.0

 

ACRONYMS

     5   

3.0

 

INTRODUCTION

     6   

4.0

 

SCOPE ASSUMPTIONS

     7   

5.0

 

SPONSOR DELIVERABLES

     8   

6.0

 

PROGRAM MANAGEMENT

     9   

7.0

 

[*]

     10   

8.0

 

TECHNOLOGY TRANSFER

     11   

9.0

 

PRODUCT RECOVERY AND PURIFICATION PROCESS TRANSFER

     11   

10.0

 

ANALYTICAL METHOD

     13   

11.0

 

DEMONSTRATION RUN

     14   

12.0

 

[*] AND FACILITY PREPARATION

     15   

13.0

 

[*]

     16   

14.0

 

CGMP MANUFACTURING

     17   

15.0

 

CURRENT PROCESS FLOW DIAGRAM

     19   

16.0

 

CURRENT CERTIFICATE OF ANALYSIS FOR EGG WHITES

     20   

 

[*] =   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 Securities and Exchange Commission.

 

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1.0 PROGRAM DEFINITIONS

The definitions listed below reflect terms used in this Scope.

 

Sponsor:    Synageva BioPharm (Synageva) with a place of business at 128 Spring
Street Suite 520 Lexington, MA 02421 Fujifilm Diosynth:    Fujifilm Diosynth
Biotechnologies USA Inc. (Fujifilm Diosynth), with a place of business at 101 J.
Morris Commons Lane Morrisville, North Carolina 27560. Agreement:    The
Bioprocessing Services Agreement, of which this Scope document is considered an
attachment. (Also referred to herein as the “BSA”). Bulk Drug Substance:    Drug
Substance filled into bulk containers, using aseptic techniques, under a laminar
flow hood. cGMP:    Current Good Manufacturing Practices pursuant to (a) the
U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b)
U.S. regulations in Title 21 of the U.S. Code of Federal Regulations Parts 210,
211, 600 and 610 (c) the EC Guide to Good Manufacturing Practice for Medicinal
Intermediate Products, v.4, including relevant sections of DIR 2003/94/EC, and
(d) International Conference on Harmonization (ICH) Guidance for Industry Q7
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Drug
Product:    The dosage form of SBC-102 in the final immediate packaging intended
for clinical use. [*]:    [*] run intended to execute the series of unit
operations, in the specified order to evaluate whether or not the process for
manufacturing Product in its entirety meets Product / process draft
specifications. In-Process Control:    Analytical testing performed by Quality
Control during execution of the process to provide data for making process
decisions. The manufacturing process is on hold during testing until results are
obtained. In-Process Testing:   

Analytical testing performed on samples from the process, often after the
process is finished, to provide data about performance of the process.

 

The manufacturing process is not on hold until results are obtained. Results of
In-Process Testing are not used for making decisions during execution of the
process; but can be used for batch decisions after execution of the process.

Item Specification:    A set of criteria to which a material must conform to be
considered acceptable for its intended use. Intermediate    Process fraction
containing Product generated during the manufacturing prior to Bulk Drug
Substance. Manufacturing Process:    The detailed instructions used to produce
the Product, which have been agreed by Fujifilm Diosynth and the Sponsor.
Process Consumables:    Process Consumables include any Process Consumable or
Raw Material used in the manufacture of an intermediate or Drug Substance that
do not by themselves participate in a chemical or biological reaction. Such
other materials include: [*] Process:    The manufacturing process consisting of
three sub-processes: fermentation, product recovery, and purification.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 3 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

Product:    Recombinant form of the human Lysosomal Acid Lipase (LAL) enzyme
known as SBC-102 Program:    The services to be performed with respect to
Product by Fujifilm Diosynth under the Agreement as more particularly detailed
in this Scope. Raw Materials:    Any ingredient intended for use in the
manufacture of an intermediate or API, including those that may not appear in
the final formulation. These include chemicals used directly and/or indirectly
in the manufacturing process. Reference Standard:    A substance that has been
shown by an extensive set of analytical tests to be authentic material
representative of the Product and process. Scope:    This Appendix 1 – Scope of
work, which the Parties acknowledge is part of the Agreement. The scope is a
component of the legal Agreement that specifies the Program design, information
desired, estimated duration of the Program and all other matters pertinent to
the completion of the Program. Scope Assumptions:    Assumptions relating to the
Program design, objectives, process assumptions, deliverables, resource
requirements, timing, capital expenditure requirements (if any) and other
matters relating to the completion of the Program as set forth in the Scope.

Technical

Summary

Report:

   Detailed reports to be provided to Synageva upon completion of the different
sections of the Scope of work as detailed in Appendix 1 describing the
experimental methods and justification for the process description, to include
data from all experiments, and a preliminary rationale for each unit operation.
The reports will also outline any additional work that needs to be performed to
complete the Process and Product characterization and recommendations for the
next stages, as appropriate. Third Party:    Any organization other than
Fujifilm Diosynth and Sponsor, selected by Fujifilm Diosynth or Sponsor to
perform services related to manufacture and testing of the Product.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 4 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

2.0 ACRONYMS

 

API    Active Pharmaceutical Ingredient BDS    Bulk Drug Substance BLA   
Biologics License Application BOM    Bill of Materials BSA    Bioprocessing
Services Agreement C of A    Certificate of Analysis cGMP    current Good
Manufacturing Practice CMC    Chemistry, Manufacturing and Controls CPL   
Customer Project Leader DNA    Deoxyribonucleic Acid ELISA    Enzyme Linked
Immuno-Sorbent Assay FDA    Food and Drug Administration HCP    Host Cell
Protein HPLC    High Pressure Liquid Chromatography ICH    International
Conference on Harmonization IPC    In-Process Control IPT    In-Process Test L
   Liters QA    Quality Assurance QC    Quality Control SDS-PAGE    Sodium
Dodecyl Sulfate Polyacrylamide Gel Electrophoresis SEC    Size Exclusion
Chromatography SOP    Standard Operating Procedure STM    Standard Test Method
TOC    Total Organic Carbon UF/DF    Ultrafiltration and Diafiltration

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 5 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

3.0 INTRODUCTION

The Sponsor has requested that Fujifilm Diosynth transfer the process and
associated analytics for manufacture of SBC-102. SBC-102 is an enzyme
replacement therapy for Lysosomal Acid Lipase (LAL) Deficiency, a lysosomal
storage disorder. SBC-102 is a recombinant form of the human LAL enzyme. SBC-102
contains glycan structures that are specifically recognized and internalized by
specific receptors into key target cells. In 2010, SBC-102 received orphan drug
designation in both the US and EU.

SBC-102 is produced in the egg white of transgenic hens. SBC-102 will be
recovered from the egg whites and purified. Synageva would like to establish a
process that is capable of processing approximately [*] of egg whites containing
Lysosomal Acid Lipase (rhLAL) at Fujifilm Diosynth. At this time, Synageva is
requesting [*] manufacturing runs at the scale of [*] egg whites. The first
manufacturing run may be executed as [*]

 

Note: The ability to execute the [*] run is subject to business and quality
agreement. An assessment of whether the [*] will be [*] run will be performed
after the conclusion of the [*].

This Scope outlines activities for this program.

TECHNOLOGY TRANSFER

Process Transfer

 

  •  

Product recovery process transfer

 

  •  

Purification process transfer

Analytical

 

  •  

Qualified method transfer to support technology transfer and manufacturing

Demonstration Runs

 

  •  

[*] product recovery and purification runs to be executed at approximately [*]
of egg whites containing rhLAL in the process development laboratories. The
actual volume of egg whites containing rhLAL will be determined based upon
equipment and process scale factors.

MANUFACTURING

[*]

 

  •  

Procurement and testing of raw materials and process consumables

 

  •  

[*] and facility set-up, including qualification of necessary equipment, if
required.

cGMP Manufacturing Runs

 

  •  

[*] at approximately [*] of egg whites containing rhLAL working scale.

 

  •  

Disposition of all lots of SBC-102 drug substance produced.

 

Note:

The ability to execute the [*] manufacturing run as a [*] run is subject to
business and quality agreement. After reviewing the results of the demonstration
runs, the feasibility of the [*] manufacturing run to be executed as a [*] will
be evaluated. If it is mutually agreed that the first manufacturing run will be
executed as a [*], prior to execution of the run, both parties will agree to
target success criteria for the run. In the event the target

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 6 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

  success criteria for the first are not met, the first run will be deemed an
[*] and the Sponsor will be charged the [*] rate. Adjustments to the Scope,
Price, and Payment Schedule will be managed via Change Order.

Summary Reports

 

  •  

Technology transfer activities summary report.

 

  •  

Manufacturing activities summary report.

 

4.0 SCOPE ASSUMPTIONS

Assumptions for this Scope are listed below. If these Scope Assumptions change
or prove to be invalid, the Program activities, Program price, and estimated
duration will be modified accordingly.

 

  1. Any timeline provided is for planning purposes only and exhibits estimated
durations for activities. Any delay to contract approval and/or Sponsor
deliverables may subsequently delay other activities, including milestone
completion dates.

 

  2. All technology transferred to Fujifilm Diosynth by Sponsor will perform as
represented by Sponsor and is suitable for its intended use.

 

  3. All analytical samples collected during manufacturing will be stable under
conditions recommended, to permit in process control testing.

 

  4. [*].

 

  5. Standard Fujifilm Diosynth cleaning procedures are capable of degrading
Product as demonstrated by [*].

 

  6. Any animal derived materials that are required for Product production have
been evaluated for TSE / BSE risk and deemed suitable for human use.

 

  7. The majority of the manufacturing process can be modified to fit equipment
currently available at Fujifilm Diosynth. Processing steps that may require
capital investment are the egg white thaw and the UFDF steps. A more detailed
review of the program’s equipment needs will be evaluated during the transfer.
[*], the program price and timeline may be impacted.

 

  8. Fujifilm Diosynth will employ [*] during performance of this Program as
long as the equipment meets process requirements and appropriate cleaning and
lack of carry-over from other products can be demonstrated. Where appropriate
Fujfilm Diosynth will employ [*] to support manufacturing of SBC-102. The final
equipment list is dependent on the manufacturing scale and will be established
during transfer and [*]. If Synageva wishes to employ equipment [*] the
manufacturing of SBC-102, or should [*] be required, the program price and
timeline may be impacted.

 

  9. [*] will be used for storage of buffers and in-process materials as
appropriate. Fujifilm Diosynth will leverage existing stability information
(e.g. bioburden, endotoxin) to support length of storage for process buffers
and/or solutions.

 

  10. Product recovery can be completed within [*], including cleaning.

 

  11. Purification can be completed within [*], including awaiting QC eluate
fraction results, cleaning and steaming.

 

  12. Low-pressure [*] chromatography columns will be used for purification.

 

  13. Sponsor will be responsible for performing any assays requiring the use of
tissue cultures or animals.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 7 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

  14. Whenever possible, Raw Materials will be sourced as [*] from Fujifilm
Diosynth approved vendors. Raw Materials will be released based on [*] C of A
and ID testing only, with the exception of Critical Raw Materials which will be
[*].

 

  15. [*] manufacturing runs at the [*] egg white scale are identified within
the Scope. [*] of egg whites contains approximately [*]. At least [*] of the [*]
manufacturing runs will be executed under [*] conditions.

Note: The ability to execute the first manufacturing run [*] run is subject to
business and quality agreement.

 

  16. The Sponsor will be responsible for all [*].

 

  17. Fujifilm Diosynth will use standard packing procedures for Product
shipments.

 

  18. Fujifilm Diosynth’s standard formats will be used for preparation of
transfer and manufacturing documentation.

 

5.0 SPONSOR DELIVERABLES

Sponsor will provide the following items at the following times:

Lysosomal Acid Lipase (rhLAL) Egg Whites

 

  1. All egg whites containing Lysosomal Acid Lipase (rhLAL) provided to
Fujifilm Diosynth must be tested and found negative for [*]. Documentation to
ensure that the material meets all agreed Certificate of Analysis specifications
no less than [*] prior shipment of the material to Fujifilm Diosynth.

 

  2. Lysosomal Acid Lipase (rhLAL) containing egg whites, sufficient to
initiation transfer activities, will be delivered to Fujifilm Diosynth Process
Development laboratories at least [*] prior to the start date for activities
stated within the Scope.

 

  3. Lysosomal Acid Lipase (rhLAL) containing egg whites for cGMP production
will be delivered to Fujifilm Diosynth upon establishment of the receiving [*]
in support of manufacturing activities.

 

  4. Documentation to support receipt, acceptance, and release of Lysosomal Acid
Lipase (rhLAL) containing egg whites in accordance to the receiving [*] for use
in the manufacturing facility.

Analytical

 

  5. Analytical test methods, qualification or validation protocols and reports
for the methods to be transferred, and list of reagents required within [*] of
the effective date of the Agreement.

 

  6. Qualified reference standard to support process transfer and demonstration
run within [*] of the effective date of the Agreement.

Process

 

  7. Documentation to initiate transfer and establishment of the manufacturing
process (including process development reports, historical data, current process
specifications, list of materials and process consumables, and executed
formulation and batch records or production protocols) – not to exceed [*] of
the effective date of the Agreement.

 

  8. Bill of materials for GMP manufacturing with vendor catalogue numbers,
material grade, and quantities for all process consumables – not to exceed [*]
of the effective date of the Agreement.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 8 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

Other

 

  9. Appointment of Alliance Manager authorized to represent and communicate
with Fujifilm Diosynth on behalf of Sponsor.

 

  10. Timely review and approval of all Fujifilm Diosynth documents submitted to
Sponsor for approval, such as [*] and Sponsor-[*] (preferably within [*]).
Review of documentation will be [*]. Comments from [*], if applicable, are to be
provided cumulatively in one (1) document.

 

  11. MSDS and [*] regarding the Product in support of [*] of the Product [*]
prior to initiation of process transfer activities.

 

  12. Timely updates on any results of [*], or otherwise acquired knowledge that
might impact the [*].

 

6.0 PROGRAM MANAGEMENT

 

6.1 Objectives

 

  1. Fujifilm Diosynth will provide overall management of the Program according
to the Scope and Agreement.

 

6.2 Activities

 

  1. Fujifilm Diosynth will appoint a [*] to manage Program execution who will
continuously evaluate the Program performance and will initiate discussions with
Sponsor when Program-related issues arise.

 

  2. The [*] will:

 

  •  

Manage Program performance as defined in the Agreement.

 

  •  

Serve as primary contact for the Program and communications with Sponsor and
internal Fujifilm Diosynth project team members.

 

  •  

[*] work with Sponsor to determine what additional activities are required to
support Sponsor’s Program and/or regulatory submissions.

 

  •  

[*] work with Sponsor to identify [*] Scope as defined, and determine and agree
upon course of action according to the Agreement.

 

  •  

Conduct project meetings with Sponsor on a regular basis. Method of meeting
(face-to-face, teleconference, etc.) and timing will be [*] and may vary
depending on the needs of the Program and provide appropriate documentation and
reporting to the team [*].

 

  •  

Track Program progress against [*]

 

  •  

Facilitate the review and approve invoices with the Sponsor.

 

6.3 [*]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 9 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

7.0 [*]

 

7.1 Objective

 

  1. Perform [*].

 

  2. Establish requirements for [*].

 

  3. Perform [*]:

 

  •  

[*] requirements

 

  •  

[*] requirements

 

Note: [*] is required for all products [*]. [*] must be performed before any [*]

 

7.2 Activities

 

  1. Review Sponsor process of [*].

 

  2. Review Sponsor supplied MSDS and [*] data to [*].

 

  3. Establish [*].

 

  4. Review [*] procedures for [*] and establish [*] requirements, if
appropriate.

 

  5. Perform [*] to assess [*] of Product and [*].

 

Note: The joint project team will define the requirements of [*] for Product
samples from [*].

 

  6. Establish [*] requirements and recommend [*] solutions to ensure product
[*].

 

  7. Establish appropriate procedures and policies.

 

  8. Establish [*] requirements.

 

7.3 [*]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 10 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

TECHNOLOGY TRANSFER

 

8.0 TECHNOLOGY TRANSFER

 

8.1 Objective

 

  1. Prepare Fujifilm Diosynth personnel and [*] to support transfer of the
SBC-102 process into Fujifilm Diosynth’s [*].

 

8.2 Activities

 

  1. Receive and review existing process and analytical information from Sponsor
in the form of raw data, manufacturing instructions, historical data and process
development reports.

 

  2. Establish an initial process consumable list and order materials required
to support process development activities.

 

  3. Based on process documentation provided by Sponsor, prepare [*] Fujifilm
Diosynth’s manufacturing facility, including [*].

 

8.3 [*]

 

9.0 PRODUCT RECOVERY AND PURIFICATION PROCESS TRANSFER

 

9.1 Objectives

 

  1. Transfer the Sponsor’s product recovery and purification processes into
Fujifilm Diosynth’s [*].

 

  2. Adapt current processes, as necessary, to assure fit with Fujifilm Diosynth
manufacturing facilities and equipment.

 

9.2 Activities

 

  1. Perform [*] recovery and purification transfer runs using Lysosomal Acid
Lipase (rhLAL) containing egg whites supplied by the Sponsor. The target initial
volume for each transfer [*] of egg whites. The initial volume for each transfer
set will be finalized in the [*] to ensure that the [*] transfer runs yields
information suitable to use in assessing the process and transfer.

 

  •  

[*]

 

  2. Evaluate the suitability of the transferred process for scale-up and cGMP
manufacturing at Fujifilm Diosynth’s RTP manufacturing facility.

 

  3. Adapt, as necessary, unit operations to fit Fujifilm Diosynth’s
manufacturing facilities and equipment.

 

  4. Test [*].

 

  5. Determine [*] operations.

 

  6. Evaluate [*] in the analytical methods section.

 

  7. Test [*] to support cGMP manufacturing.

 

  8. Evaluate [*] during cGMP manufacturing.

 

  9. Generate [*] of transfer activities.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 11 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

9.3 [*]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 12 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

10.0 ANALYTICAL METHOD

In the case of method transfer, the Sponsor has completed qualification or
validation of product-specific methods to be used for cGMP purposes. Diosynth
Fujifilm will review and analyze Sponsor provided method
development/qualification/validation reports. Based upon the documentation,
Fujifilm Diosynth will [*] each method to be transferred. In the case of method
verification, Fujifilm Diosynth will [*] for each method to be verified.
Fujifilm Diosynth expects that no more than [*] runs are sufficient to
demonstrate that knowledgeable analysts can successfully execute a method [*].
[*] for each transfer/verification will be provided to the Sponsor and the
transfer of a method [*]. If target acceptance criteria are not met during the
execution of the [*] during or after the execution of the transfer protocol.
Once the method transfer/verification protocol is successfully executed, [*] for
verified methods) will be prepared to support cGMP activities.

Definitions used in this section include:

 

  •  

Verify: Demonstrating that an USP compendial method, general Fujifilm Diosynth
qualified or validated method or commercial testing kit (e.g., [*]) is
suitable for use with the intended product.

 

  •  

Implement: Application of a Sponsor’s method at Fujifilm Diosynth [*].
Successful implementation of the method will be documented in a [*] at the
completion of execution.

 

  •  

In-Process Control (IPC): Manufacturing decisions are based on the results of
in-process control assays (e.g. methods used to determine protein concentration
for column loading).

 

  •  

In-Process Test (IPT): [*]. This test provides a check that the process operates
[*], as identified by transfer package.

 

10.1 Objective

 

  1. Transfer Sponsor’s analytical methods and verify methods for use with
Product as outlined in Table 1.

 

10.2 Activities

 

  1. Transfer qualified analytical methods from Sponsor for cGMP In-Process
Testing, In-Process Control, and Drug Substance / Drug Product release testing.

 

  2. Implement analytical methods from Sponsor to [*].

 

  3. Verify that compendial methods are suitable for the intended purpose,
meeting USP requirements [*].

 

  4. Verify [*].

 

  5. Prepare Program specific [*].

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 13 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

Table 1. SBC-102 Analytical Methods

 

Assay

  

Purpose

  

Application

IPT: In Process Testing

IPC: In Process Control

DS: Drug Substance

PD: Process Development

  

Activity

[*]    Concentration    [*]    Transfer Qualified
Synageva Method [*]    Identity    [*]    Transfer Qualified
Synageva Method [*]    Potency    [*]    Transfer Qualified
Synageva Method [*]    Safety    [*]    Transfer Qualified
Synageva Method [*]    Quality    [*]    Verify Fujifilm Diosynth Method [*]   
Safety    [*]    Verify Fujifilm Diosynth Method [*]    Safety    [*]    Verify
Fujifilm Diosynth Method [*]    Purity    [*]    Implement Synageva Method [*]
   Purity    [*]    Implement Synageva Method

 

10.3 [*]

 

11.0 DEMONSTRATION RUN

 

11.1 Objectives

 

  1. To perform [*] product recovery and purification runs using Lysosomal Acid
Lipase containing egg whites supplied by the Sponsor. The target initial volume
for each demonstration run is [*] of egg whites. The initial volume for each
demonstration run will be finalized after the transfer runs to ensure that the
[*] demonstration runs yields information suitable for assessing the process and
scale-up.

 

11.2 Activities

 

  1. Perform Product recovery.

 

  2. Perform purification of Product.

 

  3. Provide [*].

 

  4. Analyze purified Product alongside the reference standard using a [*]
release methods.

 

  5. Develop [*] parameters such as [*] and [*], and [*] as well as [*] Product
specifications based on [*].

 

  6. Review demonstration run results and [*] determine the appropriate and
subsequent activities.

 

  7. Document demonstration run in [*]

 

11.3 [*]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 14 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

MANUFACTURING

 

12.0 [*] AND FACILITY PREPARATION

 

12.1 Objectives

 

  1. To [*].

 

  2. To procure and release Process Consumables to be used in the manufacture of
Product.

 

  3. To provide Quality Assurance and Quality Control support, as needed.

 

12.2 Activities

Documentation

 

  1. Prepare and approve all necessary documentation, [*] for the manufacture of
Product.

 

  2. Establish [*] for Product and prepare and approve Product [*].

 

  3. Complete [*] changeover activities.

Material Procurement and Testing

 

  4. Perform a quality audit of [*] suppliers of process materials including the
rhLAL containing egg whites.

 

  5. Procure, sample, test, and disposition Process Consumables to be utilized
according to existing [*].

 

  6. Test [*] from Fujifilm Diosynth-approved vendors as per Fujifilm Diosynth
procedures.

 

  7. Perform sampling and submission of samples for testing to be [*], if
necessary.

Notes:

 

•  

Fujifilm Diosynth will acquire and release Process Consumables for an
anticipated cGMP manufacturing campaign and [*]. Where possible, Fujifilm
Diosynth will purchase [*] of a Process Consumable from approved vendor to [*].
Fujifilm Diosynth will procure Process Consumables for:

 

  •  

[*] complete manufacturing runs ([*] egg white scale).

 

  •  

[*] complete [*] run.

 

•  

Where Fujifilm Diosynth [*] are not available, the assay methods for testing the
materials may require development and qualification [*].

 

•  

Development and qualification of additional test methods for Raw Materials, if
required, [*].

Set-up & Changeover

 

  8. Prepare facilities necessary for execution of the manufacturing processes
including [*].

 

  9. Confirm [*] status and perform [*] as necessary.

 

  10. Set-up all equipment necessary for execution of the process and testing.

 

  11. Prepare and set-up software, as necessary.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 15 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

12.3 [*]

 

13.0 [*]

 

13.1 Objectives

 

  1. To execute an [*] consisting of the product recovery, and purification
units of operation. These runs will verify [*] with manufacturing equipment.
This run will be performed using [*] Process Consumables and [*] manufacturing
suites, [*].

 

  2. To provide available purified Product to Sponsor

 

  3. To test and correct any documentation [*].

 

Note: The [*] is a critical element to confirm successful scale-up of the
process by providing the opportunity to execute all process steps on intended
[*] manufacturing equipment and to provide Fujifilm Diosynth manufacturing
personnel hands on experience with the process. [*] is performed using [*]
manufacturing documentation that is [*] operation. In the event of need for
process modifications during the [*], Fujifilm Diosynth will [*] and procedures,
then [*]. [*] to the process flow may be necessary. Fujifilm Diosynth will [*]
only for [*] of one or more of units of operations (e.g. a chromatography step.)
Fujifilm Diosynth will inform Sponsor of the modification as soon as possible.
[*].

 

13.2 Activities

Manufacturing

 

  1. Perform the product recovery of approximately [*] of Lysosomal Acid Lipase
(rhLAL) containing egg whites using [*].

 

  2. Perform the purification of Product recovered from the [*] of Lysosomal
Acid Lipase (rhLAL) containing egg whites using [*].

 

  3. Collect samples for in-process testing according to [*].

 

  4. Clean equipment and facilities, and [*].

 

  5. Perform analytical testing [*] as required by the process.

 

  6. Complete and review [*] production records.

 

  7. Modify and update production records and submit [*].

 

  8. Make equipment adjustments, if necessary, before [*] campaign.

Quality Control and [*]

 

  9. Perform in-process and release testing of Product produced from the [*]
using [*] analytical documents.

 

  10. Perform environmental monitoring and testing of cleaning samples.

[*]

 

  13. Provide [*] oversight and support.

 

  14. Perform [*], if necessary.

 

  15. Evaluate [*].

 

  16. Make [*] adjustments, if necessary, before [*] campaign.

 

  17. Host and provide [*].

[*]

 

  18. Provide [*], as needed.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 16 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

  19. Evaluate [*] manufacturing.

 

  20. Perform [*], if necessary.

Quality Assurance

 

  21. Provide compliance oversight for use of cGMP facility.

 

  22. Review and approve modified and updated manufacturing documentation.

 

13.3 [*]

 

14.0 cGMP MANUFACTURING

 

14.1 Objectives

 

  1. To manufacture [*] of Product in accordance with cGMP and [*] manufacturing
documentation.

 

  2. To provide Quality Assurance and Quality Control support as required.

 

  3. To support Sponsor’s regulatory filing by providing [*] pertaining to work
performed at Fujifilm Diosynth.

 

Note: The ability to execute the [*] is subject to business and quality
agreement. After reviewing the results of the [*], the feasibility of the [*]
will be evaluated. If it is mutually agreed that the [*], prior to execution of
the run, both parties will agree to [*]. In the event the [*] for the [*] will
be deemed an [*] and the Sponsor will be [*]. Adjustments to the Scope, Price,
and Payment Schedule will be managed via Change Order.

 

14.2 Activities

Manufacturing

 

  1. Perform [*] Product recoveries at [*] of Lysosomal Acid Lipase (rhLAL)
containing egg whites using [*].

 

  2. Perform [*] purification of Product using [*]

 

  3. Collect samples for in-process, release and stability testing according to
[*].

 

  4. Clean equipment and facilities, and [*].

 

  5. Perform In-Process Control testing and/or In-Process Testing [*] as
required by the process.

 

  6. Review executed production records.

 

  7. Participate in deviation closure and out-of-specification investigations,
if any.

Quality Control

 

  8. Perform In-Process Control testing for process steps according to [*].

 

  9. Perform release testing according to Product [*].

 

  10. Perform environmental monitoring and testing of cleaning samples.

[*]

 

  11. Provide [*] support as needed.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 17 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

  12. Perform [*], if necessary.

 

  13. Support [*] the process.

 

  14. Support [*].

 

  15. Host and provide [*].

 

  16. Prepare [*].

[*]

 

  17. Provide [*], as necessary.

 

  18. Support [*] the process.

 

  19. Support [*].

 

  20. Evaluate [*] in comparison to [*].

 

  21. Perform [*], if necessary

Quality Assurance

 

  22. Provide compliance oversight for cGMP manufacturing.

 

  23. Issue [*] records.

 

  24. Review [*] records.

 

  25. Lead deviation closure and out-of-specification investigations, if any.

 

  26. Disposition of Drug Substance to Sponsor in accordance with an established
Quality Agreement specifying [*].

 

  27. Issue a Certificate of Analysis for Drug Substance.

Regulatory support

 

  28. Prepare data and documents to support regulatory filing.

 

  29. Perform [*] Fujifilm Diosynth [*], defining Fujifilm Diosynth’s [*].

 

  30. Maintain a copy [*] and updates/changes at Fujifilm Diosynth.

 

14.3 [*]

Note - Quality Assurance will provide the batch packet to the client for release
as per quality procedures. The batch packet consists of, but is not limited to,
the following information.

 

•  

Completed disposition of manufactured product form

 

•  

Completed batch genealogy

 

•  

Completed and reviewed process records, including in-process results.

 

•  

Certificate of Analysis

 

•  

Facilities assessment memo

 

•  

Quest Trackwise deviation report

 

•  

Quest Trackwise restriction summary

 

•  

Copies of all closed deviations associated with the batch.

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 18 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

15.0 CURRENT PROCESS FLOW DIAGRAM

Attached is the Process Flow Diagram for the current process as represented by
the Sponsor

[*]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 19 of 20

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SOW Technology Transfer and Manufacture of SBC-102

 

 

16.0 CURRENT CERTIFICATE OF ANALYSIS FOR EGG WHITES

Attached is the current Certificate of Analysis for the rhLAL containing Egg
Whites.

[*]

 

[*] =   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 Securities and Exchange Commission.

 

  CONFIDENTIAL    Page 20 of 20

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FUJIFILM Diosynth Biotechnologies – Synageva BioPharma Corp.

Clinical Material Manufacturing Quality Agreement

 

Table of Contents

 

General Information

     2   

Signatures

     3   

Quality Responsibilities Table

     4   

Attachments

     9   

Attachment A – Release Documentation

     9   

Attachment B – Master Documents

     9   

Attachment C – Definitions

     9   

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      1 of 10

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FUJIFILM Diosynth Biotechnologies – Synageva BioPharma Corp.

Clinical Material Manufacturing Quality Agreement

 

General Information

This Quality Agreement outlines the roles, responsibilities and time
requirements with respect to the Quality Assurance of the Intermediate and/or
Drug Substance produced by FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
(referred to in this Quality Agreement as “Fujifilm Diosynth”) for Synageva
BioPharma Corp. (here within known as “Sponsor”) and fulfils the requirements as
outlined in ICH Q7 Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients. In addition, Fujifilm Diosynth may perform [*] as
outlined within the Agreement. The drug substance covered by this Quality
Agreement is <Sebelepase alfa SBC-102>.

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

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

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

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

 

For Sponsor:   Mark Hazard, Quality Responsible Head For Fujifilm Diosynth:  
David Patterson, Sr. Vice President, Quality Operations

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      2 of 10

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Signatures

Sponsor Authorized Quality Assurance Representative

 

By:  

 

      Date:  

 

        (Signature)         Name:   Mark Hazard     Tel.:   706-286-8932      
Email:   [*] Address:   Synageva BioPharma Corp.           150 Ben Burton Rd    
      Bogart, Ga. 30622        

Fujifilm Diosynth Authorized Quality Assurance Representative

 

By:  

 

    Date:  

 

        (Signature)       Name:   David Patterson     Tel.:   919-337-4408      
Email:   [*] Address:   FUJIFILM Diosynth Biotechnologies U.S.A., Inc.        
101 J. Morris Commons Lane         Morrisville, North Carolina, USA, 27560      

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      3 of 10

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Quality Responsibilities Table

The responsible party is denoted by ü

 

    

Description

  

Fujifilm Diosynth

(time frame)

  

Sponsor

(time frame)

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

ü

(at all times)

     Renegotiate the Quality Agreement   

ü

(as required)

  

ü

(as required)

  Appoint an Authorized Quality Representative for resolution of disputes   

ü

(prior to approval of Quality Agreement)

  

ü

(prior to approval of Quality Agreement)

  Give notification in event of Authorized Quality Representative change   

ü

(as required)

  

ü

(as required)

2   Regulatory   Prepare and update Regulatory applications       ü   Provide
information, as requested, to keep submissions current    ü      Provide copies
of [*] relevant to work Fujifilm Diosynth performs for review and comment prior
to submission to the [*]       ü   Provide comments on [*] section(s) prior to
submission [*]   

ü

([*] after receipt)

     Provide updates of [*]      

ü

(all [*] relevant to Fujifilm Diosynth process work)

  Responsible for all reporting requirements with regard to manufacturing site
registration that may be required to support Sponsor related activities    ü   
  Provide a Letter of Authorization (LOA) to reference site registration filing
  

ü

(when requested)

     For clients with LOAs, provide [*]    ü    3   Audits  
3.1        Regulatory Inspections         Provide notification of Regulatory
Audits with Sponsor product impact   

ü

[*]

     Provide all Sponsor related regulatory observation response   

ü

[*]

     3.2        Sponsor Audits – Entitled to one on-site GMP audit per [*]
period      Provide Notification to schedule audit – not to exceed [*]      

ü

[*]

  Schedule and support annual Sponsor Audits    ü   

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      4 of 10

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Description

  

Fujifilm Diosynth

(time frame)

  

Sponsor

(time frame)

  Provide written audit report      

ü

([*] from completion of audit)

  Provide written response to observations   

ü

([*] from receipt of observations)

     3.3        For Cause Audits         Provide notification to schedule For
Cause Audit      

ü

(as required)

  Schedule and support For Cause Audit   

ü

(scheduled at a mutually agreed upon time)

   4   Complaint handling         Notify other party of any information coming
into its possession concerning [*]   

ü

(within [*])

  

ü

(within [*])

  Participate in the development of investigation plans      

ü

([*] from Sponsor notification)

  Investigate the issue to the extent that it relates to Fujifilm Diosynth’s
activities and provide a written report   

ü

(Target [*] from date event observed)

    

Approve Complaints

[*]

  

ü

(Target [*] from date event observed)

  

ü

([*] from receipt of complaint summary)

  Determine how to address the information impacting the product quality and
safety       ü   Communicate with regulatory authorities       ü 5   Change
Management         Communicate need for change to approved master documents (as
defined in Attachment B)    ü    ü   Review proposed change for conformance to
any regulatory commitments      

ü

([*] from receipt of change summary)

  Use [*] in controlled documents to track changes (review and approval
according to Section 8)    ü      Use [*] for changes made to validated
processes and/or systems    ü    6   Facilities, Equipment, and Utilities
Validation and Qualification      Maintain the qualified and/or validated state
of equipment, facilities, and utilities including equipment supporting [*]   

ü

(on-going)

   7   Consumables and Raw Materials         Determine suitable Process
Consumables    ü    ü   Determine sources for identified Process Consumables   
ü      Develop and approve test methods for Raw Materials    ü   

ü

[*]

  Develop and approve [*] for Process Consumables    ü   

ü

[*]

  Approve suppliers of Process Consumables    ü   

ü

[*]

  Procure, store, sample and test Raw Materials according to approved [*]    ü
  

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      5 of 10

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Description

  

Fujifilm Diosynth

(time frame)

  

Sponsor

(time frame)

  Release Process Consumables prior to use    ü     

Audit supplier for [*] Process Consumables

Provide summary of supplier audit to Fujifilm Diosynth

     

ü

(prior to receipt of material at Fujifilm Diosynth)

  Use only the Process Consumables that are listed in the approved master
controlled documents [*]    ü      Review supplier changes for compliance with
regulatory filings and notify Sponsor    ü      7.1        Animal Derived
Materials         Source relevant Raw Materials from non-animal derived sources
whenever possible    ü      Comply with U.S. and European regulations (EP,
latest edition, Chapter 5.2.8, Minimizing the Risk of Transmitting Animal
Spongiform Encephalopathy Agents via Medicinal Products)    ü      Obtain
Country of Origin certification and confirm source country is not a known
BSE-contaminated country (in accord with 9CFR94.18) or by ensuring the
processing methods are known to inactivate TSE agents, per CHMP guidelines    ü
     Supply statement regarding process materials confirmed to be of animal
origin as regards to TSE/BSE compliance and provide updates, as needed   

ü

(when requested)

   8   Master Batch Records, Product Specification(s), Test Methods and
Qualification/Validation Documentation   Author master documents (as defined in
Attachment B)   

ü

(prior to start of first full scale run)

     Review master documents (as defined in Attachment B)    ü   

ü

(comments within [*] of receipt)

  Approve master documents (as defined in Attachment B)    ü   

ü

(approval within [*] of receipt)

  Revise master documents   

ü

(as required)

     Author transfer, qualification, and validations protocols    ü     

Review transfer, qualification, and validations protocols

[*]

   ü   

ü

(comments within [*] of receipt)

  Approve, transfer, qualification, and validations protocols    ü   

ü

(approval within [*] of receipt)

  Execute transfer, development, qualification and/or validation (as defined
within the Scope of Work)    ü      Author transfer, qualification, and
validations summary reports    ü     

Review transfer, qualification, and validations summary reports

[*]

   ü   

ü

(comments within [*] of receipt)

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      6 of 10

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Description

  

Fujifilm Diosynth

(time frame)

  

Sponsor

(time frame)

  Approve transfer, qualification, and validations summary reports    ü   

ü

(approval within [*] of receipt)

9   Manufacturing and Packaging of DS and/or Intermediates   The execution of
manufacture, packaging, holding and labeling of DS in accordance with approved
procedures    ü    10   Quality Control Testing to Support cGMP Manufacture  
Sample according to batch records or other approved document    ü      Test
material using approved methods    ü      Compare results against Approved
Specifications    ü    11   Deviations and Out-of-Specification Results  
Notification of Deviations with Potential Product Impact   

ü

([*] from Fujifilm Diosynth QA notification)

     Notification of Significant Deviations and/or confirmed Out of
Specification (OOS) Results    ([*] from Fujifilm Diosynth QA classification)   
  Participate in the development of investigation plans      

ü

([*] from Sponsor notification)

  Complete the investigation into Deviations or/and OOSs   

ü

([*] from date event observed, or prior to execution of next campaign)

     Approve Deviation and / or OOS   

ü

([*] from date event observed, or prior to execution of next campaign)

    

Approve Deviations with potential product impact and OOSs

[*]

     

ü

([*] from receipt of deviation summary)

12   Batch Disposition and Release   Prepare a Batch Packet (as defined in
Attachment A), providing [*] and OOSs are approved   

ü

([*] from date of manufacture)

     Disposition Intermediate and /or Drug Substance, providing [*] and OOSs are
approved   

ü

([*] from date of manufacture)

     Release Intermediate and /or Drug Substance. Issue a Certificate of
Conformance (COC), or similar      

ü

([*] from receipt of batch packet)

  Maintain original batch records   

ü

(minimum of [*])

     Make records [*]   

ü

(in a timeframe mutually agreed upon)

   13   Storage, Delivery and Shipment         Store materials under appropriate
conditions    ü      Provide information on required shipping conditions       ü

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      7 of 10

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Description

  

Fujifilm Diosynth

(time frame)

  

Sponsor

(time frame)

  Authorize delivery of released Intermediate and/or Drug Substance       ü  
Deliver released Intermediate and /or Drug Substance to Sponsor’s nominated
courier    ü    14   Person-in-the-Plant   Adhere to applicable Fujifilm
Diosynth procedures      

ü

(at all times)

15   QA Retain Samples of Intermediates and Drug Substance   Store sufficient
quantity ([*] amount needed for release testing, [*]) of QA Retain for the
purposes of fulfilling the regulatory reserve requirement   

ü

(minimum of [*] from date of manufacture)

   16   Use of Subcontractors   Use subcontractors that meet the requirements
for Approved Suppliers    ü      Approve the use of subcontractors, prior to
use, for testing [*]    ü    ü   Through the use of Fujifilm Diosynth Quality
systems, participate in any investigations and corrective actions that occur at
the subcontractor    ü    ü 17   Returned Goods   Handle return materials using
a cGMP compliant system    ü    18  

[*]

(when applicable, as detailed in the Scope)

        [*] using approved methods    ü      Compare results against approved
specifications    ü      Issue a Certificate of Analysis   

ü

([*] from receipt of samples)

   19  

Stability Testing and Expiration Period

(when applicable)

  Author stability protocols    ü      Review stability protocols    ü   

ü

(comments within [*] of receipt)

  Approve stability protocols    ü   

ü

(approval within [*] of receipt)

  Carry out stability program in accordance with approved protocols and ICH
guidelines    ü      Test stability samples using approved methods    ü     
Provide copies of results following each time point   

ü

([*] from completion of testing, not to exceed [*] from scheduled pull date)

     Establish Expiry or Retest Period       ü

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      8 of 10

--------------------------------------------------------------------------------

Attachments

Attachment A – Batch Packet Documentation

Relevant documentation to be transferred to Sponsor to facilitate the release of
a Batch. This packet consists of copies of: [*]

Attachment B – Master Documents

Master Documents include:

Master Batch Records

Master Formulation Records

Test Methods

Forms

Item Specifications

Stability Protocols

Qualification/Validation Documents

Master Documents requiring Sponsor [*]

Attachment C – Definitions

 

API    Active Pharmaceutical Ingredient, may be used interchangeably with Drug
Substance. Approved Supplier    A supplier who has met minimum approval
standards and who has been approved to provide required items or services that
may impact product quality. Authorized Quality Representatives    An individual
named within the Quality Agreement with the authority to resolve any disputes or
conflicts relating to this Quality Agreement in a timely and equitable manner
and in compliance with all applicable quality and regulatory requirements. Batch
   A specific quantity of material produced in a process or fraction of a
process. Batches are defined as the material represented at the end of the
intermediate processing steps or the material represented at the end of the
processing step for API. cGMP    Current Good Manufacturing Practices pursuant
to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et
seq.), (b) U.S. regulations in Title 21 of the U.S. Code of Federal Regulations
Parts 210, 211, 600 and 610 (c) the EC Guide to Good Manufacturing Practice for
Medicinal Products, v.4, including relevant sections of DIR 2003/94/EC, and (d)
International Conference on Harmonization (ICH) Guidance for Industry Q7 Good
Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      9 of 10

--------------------------------------------------------------------------------

Critical Raw Materials    Raw materials comprise final formulation components
and / or that combine structurally or chemically with the therapeutic protein.
Deviation    An unplanned event requiring investigation which 1) may affect the
quality or compliance status of the product, process materials, equipment or
facility involved or 2) may not be in alignment with regulatory submissions.
Disposition    A recommendation given by Fujifilm Diosynth Quality on the
suitability of the Intermediate or Drug Substance for further processing. Drug
Product    The dosage form in the final immediate packaging intended for
clinical use. Drug Substance or DS    Any substance or mixture of substances
intended to be used in the manufacture of a drug (medicinal) product and that,
when used in the production of a drug, becomes an active ingredient of the Drug
Product. Such substances are intended to furnish pharmacological activity or
other direct effect on the diagnosis, cure mitigation, treatment, or prevention
of disease or to affect the structure and function of the body. Process
Consumables    Process Consumables include any disposable equipment or equipment
parts or Raw Material used in the manufacture of an intermediate or Drug
Substance that do not themselves participate in a chemical or biological
reaction. Such other materials include: [*]. Product    Any (a) API/Drug
Substance, or (b) Drug Product comprised of API/Drug Substance, or (c)
intermediate(s) of (a) or (b) , in each case as specified in the applicable
Scope. Raw Material    Any ingredient intended for use in the manufacture of an
intermediate or API, including those that may not appear in the final
formulation. These include chemicals used directly and/or indirectly in the
manufacturing process. Statement of Compliance    A Fujifilm Diosynth QA
Disposition of Product Statement stating that a specific Batch of Drug Substance
complies with all Product, GMP and regulatory requirements and is signed by an
authorized representative of Fujifilm Diosynth. Test Methods    Methods used for
QC testing, including Standard Test Methods and Compendial Methods.

 

[*] =   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 Securities and Exchange Commission.

 

Confidential      10 of 10

--------------------------------------------------------------------------------

Appendix 3

Synageva SBC-102 Program Price

 

Activity

   Price  

Technology Transfer

     [ *] 

[*]

     [ *] 

[*]

     [ *] 

Analytical Method Transfer

     [ *] 

Demonstration Runs ([*])

     [ *] 

[*]

     [ *] 

[*] Manufacturing ([*])

     [ *] 

cGMP [*] ([*])

     [ *] 

[*]

     [ *] 

TOTAL

     [ *] 

 

Optional Activity

   Price  

[*]

     [ *] 

 

[*] =   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 Securities and Exchange Commission.

--------------------------------------------------------------------------------

Synageva SBC-102 Payment Schedule

 

Activity/Milestone

   Payment     Credit     Net Payment  

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]      [ *]      [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]      [ *]      [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]      [ *]      [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]        [ *] 

[*]

     [ *]      [ *]      [ *] 

[*]

     [ *]        [ *] 

TOTAL

       [ *]      [ *] 

 

[*] =   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 Securities and Exchange Commission.

-2-