exv10w43



 





Exhibit 10.43



Portions of this exhibit were omitted and filed separately with the Secretary of the
Commission pursuant to an application for confidential treatment filed with the Commission pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934. Such portions are marked by a series of
asterisks.




Bioprocessing Services Agreement




     This Bioprocessing Services Agreement dated this 7th day of December, 2006
(the “Effective Date”) is between Neose Technologies, Inc., a Delaware corporation (“Neose”) having
its principal place of business at 102 Witmer Road, Horsham, PA, 19044 and Diosynth RTP 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”).



Background




     Whereas, Neose 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
known as bulk GlycoPEGylated erythropoietin, NE-180 drug substance (“Product”) along with any
intermediate bulk erythropoietin (“Intermediate”) and Diosynth desires to perform such services;



     Whereas, Neose and Diosynth executed a Letter Agreement dated September 7, 2006
(“Letter Agreement”) that provided for certain activities relating to the joint development of the
Scope (as defined below); and,



     Whereas, the Parties agree that this Agreement shall replace and supersede the
provisions of the Letter Agreement, and that upon execution of this Agreement the Letter Agreement
shall be of no further effect.



     Now, therefore, in consideration of the mutual covenants and promises contained
herein and intending to be legally bound, the Parties agree as follows:



1. Definitions.





	 	1.1	 	“Agreement” shall mean this Bioprocessing Services Agreement, including
the attached Appendices, effective as of the date first written above and any
Approved Change Orders effective as of the dates written therein.
	 
	 	1.2	 	“Approved Change Order” shall mean any Change Order that has been
approved, or that is deemed to be approved, pursuant to Section 3.3 of this
Agreement.
	 
	 	1.3	 	“Assumptions” shall mean (i) assumptions that relate to the Program
design and objectives, manpower requirements, timing, capital expenditure
requirements, if any and other matters relating to the







 




			
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	 	 	 	completion of the Program as set forth in the Scope, and (ii) the assumption
that there will be no changes in Law that affect the Program.
	 
	 	1.4	 	“Change Order” shall mean either a Process Modification Request, a Scope
Modification Request, or a Neose Requested Change Order as the context requires.
	 
	 	1.5	 	“Claim” shall mean any third party lawsuit, action, claim, demand,
assessment or proceeding.
	 
	 	1.6	 	“Confidential Information” shall mean any information provided by one
party to the other party that would be included in the definition of “Information”
in the Confidentiality Agreement.
	 
	 	1.7	 	“Confidentiality Agreement” shall mean that certain Confidentiality
Agreement by and between Neose and Diosynth dated July 6, 2004, as amended, a copy
of which is attached hereto as Appendix 4 to this Agreement.
	 
	 	1.8	 	“Diosynth” shall have the meaning set forth in the preamble.
	 
	 	1.9	 	“Documentation” shall mean materials, documents, information, programs,
experimental records, experimental descriptions, data, results, syntheses, and
suggestions of any kind and description generated as a result of the performance of
the Program wherever located including, but not limited to, within laboratory
notebooks. Copies of any of the items listed above shall also be considered to be
Documentation.
	 
	 	1.10	 	“Field” shall mean the research, manufacture, development and
commercialization of GlycoPEGylated erythropoietin expressed in ****** cells using a
baculovirus expression system.
	 
	 	1.11	 	“Impasse Notice” shall have the meaning set forth in Section 3.4.1.
	 
	 	1.12	 	“Impasse Termination” shall have the meaning set forth in Section 3.4.1.
	 
	 	1.13	 	“Indemnifiable Event” shall mean an event or occurrence that causes a
party (to this Agreement or otherwise) to incur Losses and which is indemnified
under Section 8.1, 8.2 or 8.3.
	 
	 	1.14	 	“Indemnified Party” shall mean a party seeking indemnification.
	 
	 	1.15	 	“Indemnifying Party” shall mean a party other than the Indemnified Party.







 




			
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	 	1.16	 	“Indemnity Claim” shall mean a demand in writing by an Indemnified Party
seeking indemnification for a Loss or Losses incurred as a result of an
Indemnifiable Event or a potential Loss or Losses as a result of a Claim.
	 
	 	1.17	 	“Intermediate” shall have the meaning set forth in the Background
section.
	 
	 	1.18	 	“Invention” shall mean any Process Improvement or Product Invention.
	 
	 	1.19	 	“Irrevocable Commitments” shall mean irrevocable commitments entered into
by Diosynth for Process Consumables that cannot be reallocated or applied to other
Diosynth operations in the event of the termination of the Program.
	 
	 	1.20	 	“Law” shall mean any and all federal, state and local laws, regulations,
ordinances, rules, judicial and administrative orders, injunctions, decrees or other
legal requirements applicable to the Program or the Product or applicable to Neose
due to its undertaking of the Program. Law shall include all U.S., EU, and
Switzerland current good manufacturing practice regulations.
	 
	 	1.21	 	“Loss” shall mean any third party loss, claim, damage, liability or
expense. Reasonable attorney’s fees, disbursements and other expenses incurred in
connection with investigating, preparing, settling and defending any pending or
threatened action, claim or proceeding brought by a third party resulting from an
Indemnifiable Event, shall also be considered to be Losses for the purposes of
indemnification under this Agreement.
	 
	 	1.22	 	“Neose” shall have the meaning set forth in the preamble.
	 
	 	1.23	 	“Neose Deliverables” shall mean materials to be provided by Neose
pursuant to the Scope including, but not limited to, process and analytical
information, technical data, reports, documents as well as information related to
cell line, virus stock and banks, process material, Intermediate and Product, and
Neose-Supplied Raw Materials as specified in the Scope.







 




			
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	 	1.24	 	“Neose Process” shall mean the process described and delivered by Neose for the
production of GlycoPEGylated erythropoietin in ****** cells using a baculovirus
expression system, including but not limited to all Neose Deliverables and
intellectual property associated with the creation or implementation of such
process.
	 
	 	1.25	 	“Neose Requested Change Order” shall have the meaning set forth in
Section 3.2.
	 
	 	1.26	 	“Neose-Supplied Raw Materials” shall mean ****** which will be supplied
to Diosynth from Neose.
	 
	 	1.27	 	“Non-Owning Party” shall mean the Party who is not an Owning Party in
relation to a particular Invention.
	 
	 	1.28	 	“Owning Party” shall mean Neose in the case of Product Inventions and
Diosynth in the case of Process Improvements.
	 
	 	1.29	 	“Party” or “Parties” shall have the meaning set forth in the preamble.
	 
	 	1.30	 	“Process Consumables” shall have the meaning set forth in the Scope.
	 
	 	1.31	 	“Process Modification” shall mean a material change to the Scope or
Program that is identified by Diosynth, but which is not necessary for the
successful completion of the Program pursuant to the Scope. The definition of
Process Modification shall include, but not be limited to, any Process Improvements
Diosynth desires to implement during the course of the Program and any changes to
analytical methods applied to the Program.
	 
	 	1.32	 	“Process Improvement” shall mean any idea, invention, discovery,
technique, method, process, trade secret or other know-how, whether patentable or
not, related to the manufacture of biological compounds and arising out of the
conduct by Diosynth of, or as a result Diosynth’s performance of the Program except
any process improvement that relates specifically to the Product that is invented by
Neose.
	 
	 	1.33	 	“Process Modification Request” shall mean a written request for a Process
Modification sent by Diosynth to Neose.
	 
	 	1.34	 	“Product Invention” shall mean any idea, invention, discovery, trade
secret or other know-how, whether patentable or not, related to (i) the Product and
arising out of the conduct of, or as a result of, the Program or (ii) the manufacture of biological materials related specifically to the Product and invented by Neose.







 




			
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	 	1.35	 	“Program” shall mean the services performed by Diosynth under this Agreement.
	 
	 	1.36	 	“Raw Materials” shall mean any ingredient intended for use in the
manufacture of an Intermediate or Product, including those that may not appear in
the final formulation and any chemicals used directly or indirectly in the
manufacturing process.
	 
	 	1.37	 	“Scope” shall mean the Program design, information desired, estimated
duration of the Program and all other matters pertinent to the completion of the
Program as set forth in Appendix 1, as may be amended or modified from time
to time by any Approved Change Orders.
	 
	 	1.38	 	“Scope Modification” shall mean a change to the Scope or Program required
as a result of the determination by Diosynth that its ability to complete the
Program as originally set forth is materially hindered absent such change, including
as a result of a change in Assumptions.
	 
	 	1.39	 	“Scope Modification Request” shall mean a written request for a Scope
Modification sent by Diosynth to Neose.
	 
	 	1.40	 	“******” shall mean ******.
	 
	 	1.41	 	“Work Output” shall mean all documentation, reports or technical
summaries, Intermediate, Product and samples provided or generated by Diosynth
pursuant to the Scope.





2. Scope of Work and Performance of the Program.





	 	2.1	 	Diosynth will perform the Program for Neose 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 shall have the same meaning when used in the Scope or
Quality Agreement. In the event of any conflict among the components of this
Agreement, the following order of precedence shall apply:






	 	2.1.1	 	the terms and conditions of this Agreement;
	 
	 	2.1.2	 	the Quality Agreement (except capitalized terms defined
in the Quality Agreement shall have such meanings as assigned in the Quality
Agreement); and
	 
	 	2.1.3	 	the Scope.







 




			
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	 	2.2	 	Diosynth shall use commercially reasonable efforts to dedicate adequate
resources to the performance of the Program as set forth in the Scope.
	 
	 	2.3	 	Neose shall use commercially reasonable efforts to perform its
obligations as set forth in the Scope and Quality Agreement and shall cooperate with
the execution of the Program.
	 
	 	2.4	 	As further set forth in the Scope, Neose will timely provide Diosynth
with Neose Deliverables (as defined in the Scope). Failure by Neose to provide
Neose Deliverables within the timeframe set forth in the Scope to execute the
program without delay may result at Diosynth’s reasonable discretion in additional
charges to Neose and a delay in meeting Program objectives.
	 
	 	2.5	 	Diosynth will perform the Program in compliance in all material respects
with applicable Law (including, but not limited to, those regulations of the FDA,
the EMEA and Swissmedic applicable to the manufacture of biological materials as
therapeutic compounds for use in human beings). Diosynth shall prevent any debarred
persons from participating in the Program.
	 
	 	2.6	 	Neose acknowledges that Diosynth has consulted with Neose in designing
the Program in a manner consistent with current U.S. regulatory guidelines.
Notwithstanding the foregoing, Diosynth does not warrant that the Program and/or the
Program results will satisfy the requirements of any regulatory agencies at the time
of submission of Program results to such agencies. Neose shall have responsibility
for determining regulatory strategy and for all regulatory decisions except for
those matters that Diosynth, in its sole discretion, deems contrary to regulatory
requirements or commitments made by Diosynth to regulatory authorities.
	 
	 	2.7	 	Neose shall have the right to audit Diosynth’s facilities in accordance
with the terms of the Quality Agreement and in accordance with the Standard
Operating Procedure entitled “Requirements for Facility Access by Client
Representations”, a copy of which has been provided to Neose (the “Facility Access
SOP”). Neose shall also have the right to otherwise visit Diosynth’s facilities in
accordance with the Facility Access SOP. Further, Neose shall have the right to
additional audits, agreed by Diosynth, which shall be arranged and compensated via a
Change Order.






	3.	 	Change Orders.






	 	3.1	 	Change Order Requests by Diosynth. If Diosynth identifies a
Scope Modification or a Process Modification, Diosynth shall notify Neose as







 




			
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	 	 	 	soon as is reasonably possible. Diosynth shall thereafter provide
Neose’s Alliance Manager or designee with a Change Order as soon as it is
reasonably possible, but in no event more than ten business days following the
identification of the requested Scope Modification or Process Modification.
Neose, through its Alliance Manager or designee, shall respond in writing to any
Change Order within five business days after receipt of such Change Order
indicating whether or not it approves the proposed Change Order.
	 
	 	3.2	 	Change Order Request by Neose. If Neose requests any
commercially reasonable modifications of the Scope activities during performance of
the Program, Neose shall notify Diosynth in writing of such request. Diosynth shall
use commercially reasonable efforts to accommodate Neose’s request through a Change
Order (a “Neose Requested Change Order”). In the event that Diosynth believes such
request can be accommodated based on Diosynth’s then existing resources and
capacity, Diosynth shall draft a Change Order as soon as reasonably possible but in
no event more than 10 business days after receipt of the request from Neose. Neose,
through its Alliance Manager or designee, shall respond in writing to any such
Change Order within five business days after receipt of such Change Order indicating
whether or not it approves the proposed Change Order.
	 
	 	3.3	 	Approved Change Orders. If a Change Order is approved, Diosynth
shall work on the Program as modified by the Approved Change Order and the Approved
Change Order shall serve as an amendment to this Agreement with respect to any other
obligations of the Parties modified by the Approved Change Order.
	 
	 	3.4	 	Unapproved Change Orders.






	 	3.4.1	 	Scope Modification Requests. If the
Change Order proposed pursuant to Section 3.1 is a Scope
Modification Request and Neose does not approve such Change Order,
Neose and Diosynth shall negotiate in good faith to agree on a
Change Order that is mutually acceptable. If the Parties cannot
agree on a mutually acceptable Change Order within 30 days after
the issuance of the initial Change Order and it would not be
commercially reasonable for Diosynth to continue the Program
without the requested Scope Modification, then Diosynth shall
deliver to Neose a written notice of its inability to perform in
the absence of the requested Scope Modification (an “Impasse Notice”). If Neose does not give
notice to Diosynth of its approval of such Change Order on or
before the tenth day following Neose’s







 




			
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	 	 	 	receipt of an Impasse Notice, this Agreement shall automatically
terminate (an “Impasse Termination”).
	 
	 	3.4.2	 	Process Modification Requests and Neose Requested Change
Orders. If the Change Order proposed pursuant to Section 3.1 is a Process
Modification Request or if the Change Order is a Neose Requested Change
Order and Neose does not approve such Change Order, Diosynth shall continue
the work on the Program without regard to the unapproved Change Order.






	 	3.5	 	To the extent possible, Diosynth shall continue work on the Program
without regard to any proposed Change Order during the course of any negotiations or
waiting periods pursuant to this Section 3, provided that Diosynth will not enter
into any Irrevocable Commitments during negotiations by the Parties pursuant to
Section 3.4.1 without the prior consent of Neose.
	 
	 	3.6	 	In the event of an Impasse Termination, this Agreement shall terminate
immediately, and the parties shall have no further obligation to each other except
as set forth in this Section 3 and Section 14. The foregoing notwithstanding, Neose
shall have no obligation to Diosynth with regard to Section 14.5 if the Impasse
Termination is the result of:






	 	3.6.1	 	a Change Order initiated by Diosynth in bad faith;
	 
	 	3.6.2	 	an Impasse Notice initiated by Diosynth in bad faith;
	 
	 	3.6.3	 	Diosynth’s failure to negotiate the terms of any Change
Order in good faith;
	 
	 	3.6.4	 	Diosynth’s bad faith in negotiating any Change Order;
	 
	 	3.6.5	 	the inclusion of commercially unreasonable terms in any
Change Order.





4. Compensation.





	 	4.1	 	Neose shall make payments to Diosynth in such amounts as are set forth in
the “Program Price and Payment Schedule” attached hereto as Appendix 3. In
addition, Neose shall make payments to Diosynth for Process Consumables and Raw
Materials purchased by Diosynth for this program in the amounts set forth in Section
4.3 below.
	 
	 	4.2	 	Neose shall supply Diosynth with Neose-Supplied Raw Materials required
for implementation of the Program.







 




			
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	 	4.3	 	Process Consumables and Raw Materials purchased for the Program will be invoiced
separately as such costs are incurred by Diosynth. Neose agrees to pay Diosynth’s
purchase price for the Process Consumables and Raw Materials purchased for the
Program plus a fee equal to ****** of such purchase price.
	 
	 	4.4	 	Invoices related to Process Consumables and Raw Materials purchased by
Diosynth shall be issued after Diosynth takes possession of the Process Consumables
and/or Raw Materials purchased and shall include an accounting, in reasonable
detail, of such Process Consumables and Raw Materials and their intended use.
	 
	 	4.5	 	Payments are due 30 days from the date of any invoice issued by Diosynth
unless the payment set forth in the invoice is subject to a good faith dispute. In
the event that Neose has a good faith basis for disputing a particular invoice,
Neose shall notify Diosynth immediately and payment shall not be due until 15 days
after resolution of the dispute. Except for those invoices that are the subject of
a good faith dispute, failure to pay an invoice within 90 days from the date of
invoice shall, for the purposes of Section 14.4, constitute a default of a material
obligation of Neose.
	 
	 	4.6	 	Late payments are subject to an interest charge of ****** per month.
	 
	 	4.7	 	Diosynth has allocated resources to the Program that may be difficult or
impractical to reallocate to other programs in the event of a delay attributable to
Neose. In recognition of this, Neose agrees to pay the amounts set forth in and in
accordance with the estimated dates set forth in Program Price and Payment Schedule
during such delay. Such amounts shall apply to completion of any components of the
Program that are delayed. In addition to the payment of the amounts set forth in
the Program Price and Payment Schedule, Neose and Diosynth shall negotiate a Change
Order to compensate Diosynth for any idled personnel or capacity not reallocated.
Diosynth shall use commercially reasonable efforts to mitigate its losses by moving
forward existing programs or securing new programs to minimize idled personnel and
capacity.






	5.	 	Confidential Information. All Confidential Information will be governed by,
and subject to, the terms and conditions of Confidentiality Agreement. Attached to this
document as Appendix 4. If the Confidentiality Agreement should expire or is terminated
prior to the expiration or termination of this Agreement, the terms and conditions of the
Confidentiality Agreement shall automatically be incorporated herein by reference effective upon such expiration or termination of the
Confidentiality Agreement.







 




			
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	6.	 	Work Output






	 	6.1	 	All Work Output documents, reports or technical summaries and other cGMP
documentation will be prepared using Diosynth’s standard format(s) unless otherwise
specified in the Scope.
	 
	 	6.2	 	Diosynth agrees to grant and hereby grants to Neose an exclusive,
worldwide, perpetual, non-revocable, fully-paid, royalty-free license to use the
reports with the right to sublicense for uses reasonably related to Neose’s
business.
	 
	 	6.3	 	Neose will be supplied with copies of all Work Output documents, reports
or technical summaries, all other documentation generated as a result of the Program
as set forth in the Scope or Quality Agreement and all other items generated by
Diosynth as a result of the Program and reasonably requested by Neose. Unless
instructed by Neose to destroy or return all Work Output, all Work Output will be
archived by Diosynth for a period of five years following completion of the Program.
Five years after completion of the Program, Work Output will be destroyed at
Neose’s cost, or, at Neose’s request and expense, sent to Neose. Neose may elect to
have the Work Output retained in the Diosynth archives for an additional period of
time not to exceed an additional five years at a cost to Neose. Notwithstanding the
foregoing, if required by Law, Diosynth will retain such Work Output, without charge
to Neose, for such a period as is required by the applicable Law (which period may
be more than 10 years). In addition, Diosynth may retain one copy of documentation
for archival purposes.






	7.	 	Intellectual Property.






	 	7.1	 	The Neose Process, Work Output, Neose Deliverables, all other
documentation generated as a result of the Program as set forth in the Scope or
Quality Agreement and all other Documentation generated by Diosynth as a result of
the Program and any Documentation that has been provided by Neose shall be the sole
and exclusive property of Neose. Nothing contained herein shall constitute the
grant of a license to Diosynth for any use of the Neose Process, Work Output and
Neose Deliverables other than such uses as are necessary to allow Diosynth to
complete the Program.
	 
	 	7.2	 	Product Inventions.






	 	7.2.1	 	All Product Inventions shall be the sole and exclusive
property of Neose, and Diosynth hereby assigns and agrees to take all action
necessary to assign or cause to be assigned all rights thereto to Neose.
Diosynth shall notify Neose of the discovery of any







 




			
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	 	 	 	Product Invention as promptly as possible, but in no event later than
within 30 days following such discovery.
	 
	 	7.2.2	 	In consideration of the foregoing, Neose agrees to grant
to Diosynth a non-exclusive, non-assignable, royalty-free license, without
right to sublicense, to any of the Product Inventions necessary for the
completion of the Program for the term of this Agreement.






	 	7.3	 	Process Improvements.






	 	7.3.1	 	All Process Improvements shall be the sole and exclusive
property of Diosynth. Diosynth shall notify Neose of the discovery of any
Process Improvement as promptly as possible, but in no event later than
within 30 days following such discovery.
	 
	 	7.3.2	 	In consideration of the foregoing, for each Process
Improvement, Diosynth agrees to grant and hereby grants to Neose an
exclusive, worldwide, perpetual, non-revocable, fully-paid, royalty-free
license to use such Process Improvements, with the right to sublicense, in
the Field. Diosynth agrees to grant and hereby grants to Neose a
non-exclusive, worldwide, perpetual, non-revocable, fully-paid, royalty-free
license to use such Process Improvements outside the Field, solely for
research purposes. Upon Neose’s request, Diosynth agrees to grant to Neose
a non-exclusive, worldwide, license to use such Process Improvements outside
the Field for clinical development and commercialization purposes, on
commercially reasonable financial terms to be negotiated in good faith.
	 
	 	7.3.3	 	Diosynth may not abandon any Process Improvement without
notifying Neose in writing of the decision to do so and giving Neose the
exclusive right to assume ownership of such Process Improvement for a period
of 90 days following Neose’s receipt of such notice.






	 	7.4	 	For each Invention, the Owning Party shall be responsible for and shall
have sole control over the preparation and prosecution of all patent applications
(including, without limitation, all substitutions, divisionals, reissues,
reexaminations, continuations, continuations-in-part, inventors’ certificates,
renewals, extensions of additions to any such patent or patent application, and all
foreign counterparts thereof) that claim priority to any of the patent applications
or patents of Invention and the maintenance of all such patent applications, patents
and equivalents in the United States and in any foreign country related to the
Invention.







 




			
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	 	 	 	The Non-Owning Party shall cooperate, and shall use all reasonable efforts to
cause its affiliates, officers, directors and employees to cooperate, with the
Owning Party in taking all steps which the Owning Party believes necessary or
desirable to secure its rights in and to the Invention, at the expense of the
Owning Party. Furthermore, the Non-Owning Party shall provide access to, or
copies of, any of the items listed in Section 7.1 which the Owning Party believes
necessary or desirable to secure its rights in and to the Invention.






	8.	 	Indemnification.






	 	8.1	 	Each Party shall indemnify the other and its affiliates, officers,
directors and employees from any Loss as a result of Indemnifying Party’s
negligence, gross negligence, intentional misconduct or inaction (including
violation or non-performance of this Agreement).
	 
	 	8.2	 	Neose shall indemnify Diosynth and its affiliates, officers, directors
and employees from any Loss arising from (i) Neose’s breach of any of its
representations and warranties set forth in Section 12; and (ii) the infringement,
or alleged infringement, of the intellectual property rights of a third party
resulting from the use by Diosynth in accordance with the Scope, of the Neose
Deliverables, the Neose Process, Intermediate, or the Product as described or
delivered by Neose for application to the Program; and (iii) personal injury or
other Losses caused directly or indirectly by Neose or by the proper use by Diosynth
of the Neose Deliverables, Neose-Supplied Raw Materials, Intermediate, Product or
the Neose Process.
	 
	 	8.3	 	Diosynth shall indemnify Neose and its affiliates, officers, directors
and employees from any Loss arising from Diosynth’s breach of any of its
representations and warranties set forth in Section 12.
	 
	 	8.4	 	If any Claim for which an Indemnified Party is seeking indemnification
pursuant to this Section 8 arises in whole or in part from the Indemnified Party’s
negligence, gross negligence or intentional misconduct or inaction, then the amount
of such Loss shall be reduced by an amount in proportion to the percentage of the
Indemnified Party’s responsibilities for such Loss.
	 
	 	8.5	 	Upon receipt of notice of any Claim from a third party which may give
rise to a right of indemnification pursuant to this Section 8, the Indemnified Party
shall make an Indemnity Claim. Any delay or failure to give notice shall not
discharge the duty of the Indemnifying Party to indemnify except to the extent it is
prejudiced by such delay or failure. Such Claim for indemnity shall indicate the
nature of the Claim and the basis therefor.







 




			
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	 	8.6	 	Promptly after an Indemnity Claim is made the Indemnified Party shall
permit the Indemnifying Party, at its option and expense, to assume the complete
defense of the underlying Claim, provided that (i) the Indemnified Party will have
the right to participate in the defense of any such Claim at its own cost and
expense, (ii) the Indemnifying Party will conduct the defense of any such Claim with
due regard for the business interests and potential related liabilities of the
Indemnified Party, (iii) the Indemnifying Party will consult with the Indemnified
Party prior consenting to the entry of any judgment or entry into any settlement of
such Claim and (iv) the Indemnifying Party will obtain the written consent of the
Indemnified Party prior to consenting to the entry of any judgment or entry into any
settlement of such Claim that does not include as an unconditional term thereof, the
giving by the claimant or plaintiff to the Indemnified Party of a release from all
liability in respect thereof. After notice to the Indemnified Party of the
Indemnifying Party’s election to assume the defense of such Claim, the 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. The Indemnified Party shall have
complete control over the defense of any Claim that the Indemnifying Party does not
elect to assume control of the defense.
	 
	 	8.7	 	Section 8.6 notwithstanding, the Indemnified Party shall have the right,
at its election, to release and hold harmless the Indemnifying Party from its
obligations under this Section 8 with respect to a Claim underlying an Indemnity
Claim and assume the complete defense of such Claim in return for payment by the
Indemnifying Party to the Indemnified Party of the amount of the Indemnifying
Party’s settlement offer.






	9.	 	Insurance.






	 	9.1	 	Prior to commencement of any work under this Agreement, Diosynth shall,
at its sole expense, maintain the following insurance on its own behalf, with
insurance companies having an A. M. Best Rating of “A-, VII” or better and furnish
to Neose, certificates of insurance evidencing same and reflecting the effective
date of such coverage as follows:






	 	9.1.1	 	Workers Compensation (Statutory Benefits) and Employers
Liability in the state in which the work is to be performed and elsewhere as
may be required and shall include coverage for:







 




			
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	 	(a)	 	Bodily injury by accident:
****** per accident;
	 
	 	(b)	 	Bodily injury by disease:
****** per occurrence; and
	 
	 	(c)	 	Employee bodily injury by disease:
****** policy limit.






	 	9.1.2	 	Commercial General Liability (including premises
operations, products/completed operations and modified professional
liability) with the following limits:






	 	(a)	 	Each occurrence: ******;
	 
	 	(b)	 	General aggregate: ******;
	 
	 	(c)	 	Product completed operations aggregate:
******; and
	 
	 	(d)	 	Personal & advertising injury:
******.






	 	 	 	The policy or a specific coverage within the policy may be on a claims
made policy form and must be kept in force at least 2 years following
the termination of this agreement.






	 	9.1.3	 	Commercial Automobile Liability for all owned, hired and
non-owned vehicles with a per accident limit of ******.






	 	 	 	The amount of insurance required above shall not be construed to be a limitation
of the liability on the part of Diosynth. The policies will not be cancelled,
materially changed or non-renewed without at least 30 days advance written notice
to Neose.
	 
	 	9.2	 	Neose shall secure and maintain in full force and effect throughout the
performance of the Program a policy of insurance for general liability and product
liability having policy limits, deductibles and other terms appropriate to the
conduct of Neose’s business in Neose’s reasonable judgment.






	10.	 	Limitation of Warranty.






	 	10.1	 	Not withstanding anything herein to the contrary, under no circumstances
shall either party, or their respective affiliates, officers, directors, employees
or other representatives, 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. Diosynth’s maximum liability for damages in connection with a
claim







 




			
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	 	 	 	related to this Agreement (other than the Claim of a third party for which
Diosynth is responsible for pursuant to Section 8.3), regardless of the cause of
action, will not exceed the fees paid and/or due hereunder. Diosynth’s maximum
liability for a Claim of a third party for which Diosynth is responsible for
pursuant to Section 8.3 shall not exceed ******.
	 
	 	10.2	 	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. Diosynth makes no warranties that the execution of
the Scope will result in any specific quantity or quality of Product. Diosynth does
not guarantee the availability of future manufacturing capacity for the Product or
any other product.






	11.	 	Dispute Resolution.






	 	11.1	 	Except as provided in the Confidentiality Agreement with respect to
Confidential Information, in the event any dispute shall arise between Neose and
Diosynth with respect to any of the terms and conditions of this Agreement or the
Program, senior executives of Neose and Diosynth shall meet as promptly as
practicable after notice of such dispute to resolve in good faith such dispute.
	 
	 	11.2	 	If Neose and Diosynth are unable to satisfactorily resolve the dispute,
then such dispute shall be finally settled by a panel of three arbitrators in
accordance with this Section 11. The arbitration will be held in or around New York
City, in the State of New York, 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. The panel of arbitrators shall consist of one
arbitrator selected by each Party and a third arbitrator selected mutually by each
of the other two arbitrators. If the a third arbitrator is not selected within 30
days of the selection of the first two, the American Arbitration Association shall
appoint an arbitrator to hear the case in accordance with its rules. The arbitrators
shall have no authority to award consequential, punitive or exemplary damages or to
vary from or ignore the terms of this Agreement and shall be bound by controlling
law.






	12.	 	Representations and Warranties.






	 	12.1	 	Neose hereby represents and warrants to Diosynth that, to the best of its
knowledge, the delivery and use of the Neose Process will not constitute







 




			
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	 	 	 	infringement of the patents, or a violation of trademarks, trade names, service
marks or copyrights, of any other party.
	 
	 	12.2	 	Neose hereby represents and warrants to Diosynth that it has legal title
and/or a valid license to the cell line (****** (“******”) and viral bank (******),
Neose-Supplied Raw Materials, Intermediate and the Product necessary to conduct the
Program and that Diosynth’s use of the foregoing will not violate or infringe on the
patents, trademarks, trade names, service marks or copyrights of any other party.
	 
	 	12.3	 	Diosynth hereby represents and warrants to Neose that, to the best of its
knowledge, the acquisition and use of any Process Consumable or Raw Material
(excluding Neose-Supplied Raw Materials) not received from Neose, the application of
any process other than, or in addition to, the Neose Process in connection with the
performance of the Program and the delivery and use of Work Output provided by
Diosynth to Neose pursuant to this Agreement will not constitute infringement of the
patents, or a violation of trademarks, trade names, service marks or copyrights, of
any other party, except to the extent any such infringement results from the use of
bulk intermediate erythropoietin.
	 
	 	12.4	 	Diosynth represents and warrants that it will notify Neose prior to
implementing any process modification hereunder that to its knowledge would infringe
on the patents or violate the trademarks, trade names, service marks or copyrights
of any other party.
	 
	 	12.5	 	Neose represents and warrants that the Intermediate and the Product
produced or manufactured as part of the Program will be used solely in clinical
trials, in support of clinical trials and in all other activities required for, or
contemplated by, the process of attaining regulatory approval to commercialize the
Product.






	13.	 	Allocation of Resources. If delays in the agreed commencement or performance of the
Program occur because of Neose’s request or inability to supply Diosynth with agreed Neose
Deliverables required to begin or perform the Program, Diosynth may, after 30 days prior
notice to Neose and if Neose does not cure such delay following the receipt of such notice,
reallocate resources being held for performance of the Program without incurring liability to
Neose. In addition, in such event Diosynth shall be relieved of its obligation to perform the
Program as set forth in the Scope until the cause of such delay has been removed or remedied
or the Program has been modified so as to no longer require the Neose Deliverables or
information that caused the delay. After the elimination of the delay, Diosynth will use
commercially reasonable efforts to allocate resources to performance of the Program as set
forth in the Scope.






	14.	 	Term/Termination.







 




			
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	 	14.1	 	This Agreement shall take effect on the date first written above and,
unless terminated earlier pursuant to an Impasse Termination or this Section 14,
shall automatically terminate upon the completion of the Program.
	 
	 	14.2	 	If Diosynth is in default of its material obligations under this
Agreement, then Neose shall promptly notify Diosynth in writing of any such default.
Diosynth shall have a period of 45 days from the date of receipt of such notice
within which to cure or to commence to cure such default. If Diosynth fails to so
cure or commence to cure, then this Agreement shall, at Neose’s option, immediately
terminate.
	 
	 	14.3	 	In addition to the rights set forth in Section 14.2, Neose may at any
time terminate this Agreement prior to completion of the Program by giving 45 days
written notice to Diosynth.
	 
	 	14.4	 	If Neose is in default of its material obligations under this Agreement,
Diosynth shall promptly notify Neose in writing of any such default. Neose shall
have a period of 45 days from the date of receipt of such notice within which to
cure such default; provided that if Neose fails to cure such breach within the
specified cure period, this Agreement may, at Diosynth’s option, immediately
terminate.
	 
	 	14.5	 	In the event (i) Neose elects to terminate this Agreement or any
particular manufacturing Scope activity for reasons other than pursuant to Section
14.2, (ii) Diosynth terminates this Agreement pursuant to Section 14.4 or, subject
to Section 3.6, (iii) of an Impasse Termination, Neose shall pay Diosynth upon
receipt of Diosynth’s invoice (i) all amounts owed for work completed but not yet
invoiced; plus (ii) all unpaid costs incurred or committed for Process Consumables
and Raw Materials; plus (iii) a termination fee calculated as follows:






	 	14.5.1	 	******;
	 
	 	14.5.2	 	******;
	 
	 	14.5.3	 	******;
	 
	 	14.5.4	 	******.




The termination of this Agreement shall not relieve either Party of its obligation to the other for
obligations contained in Sections 5, 6, 7, 8 and 15 (along with those terms defined in Section 1
and used in the listed sections).





	 	14.6	 	Within 10 days following the termination of this Agreement for any reason
and subject to Section 6.3 and the Quality Agreement, Diosynth







 




			
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	 	 	 	shall, at Neose’s option, return or destroy all Work Output and all other
documentation generated that (i) is, (ii) as a result of the Program is, or (iii)
would become in its final form, the property of Neose under this Agreement and
provide Neose with a written certification that such return or destruction has
occurred.






	15.	 	Use of Names and Disclosures.






	 	15.1	 	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, provided that,
Neose may (i) disclose a redacted copy of this Agreement and Diosynth’s role to any
party and (ii) to the extent the following parties have entered into a
non-disclosure agreement with Neose, disclose this Agreement and Diosynth’s role to
investors, prospective partners who are not competitors of Diosynth, and to
prospective partners who are competitors of Diosynth and with whom a letter or
intent or term sheet has been produced.
	 
	 	15.2	 	Nothing in this Agreement shall prevent or restrict either Party’s
ability (i) to make any announcement or public disclosure which includes the name of
the other Party; or (ii) to include in any of its filings with the Securities and
Exchange Commission (“SEC”) any information related to the Program or this Agreement
that it is required to disclose (including the name of the other Party) pursuant to
its obligations as a public company in the United States under the Exchange Act.
Neose shall provide Diosynth with the opportunity to comment on the proposed
redactions from the Agreement to be filed with the SEC.
	 
	 	15.3	 	Neither Party may include any Confidential Information in any disclosure
or public announcement made pursuant to this Section 15 unless the other Party has
consented to such disclosure in writing.






	16.	 	Force Majeure. Either Party shall be excused from performing its respective
obligations under this Agreement if its performance is delayed or prevented by any
unforeseeable 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 or acts of terrorism, 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 Neose if, by
reason of any of the events referred to in this Section 16, Diosynth is unable to







 




			
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	 	 	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
Neose repeat that part of the Program affected by the disability at Neose’s expense.






	17.	 	Shipping. Diosynth shall package for shipment and ship Product, samples or other
materials at Neose’s expense and in accordance with Neose’s full written and reasonable
instructions with Neose bearing all packaging, shipping and insurance charges. Freight terms
shall be Ex Works according to INCO terms 2000. Diosynth shall retain representative samples
of Product for record keeping, testing and regulatory purposes.






	18.	 	Program Management.






	 	18.1	 	Joint Steering Committee. Effective on the Effective Date, Neose
and Diosynth shall establish a Joint Steering Committee (the “Joint Steering
Committee”) comprised of 3 representatives designated by Neose and 3 representatives
designated by Diosynth, each of whom shall have experience and seniority sufficient
to enable him or her to make decisions on behalf of the party he or she represents.
	 
	 	18.2	 	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.
	 
	 	18.3	 	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.
	 
	 	18.4	 	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:






	 	18.4.1	 	Monitoring the performance of the Program; and
	 
	 	18.4.2	 	Resolving disagreements that arise under the Agreement.







 




			
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	 	18.5	 	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 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.
	 
	 	18.6	 	Administration. A chairperson of the Joint Steering Committee
shall be designated every six months on an alternating basis between the parties.
The initial chairperson will be selected by Diosynth. The chairperson shall be
responsible for calling meetings, sending notices of meetings and for leading such
meetings. The position of chairperson is an administrative position and the
chairperson shall have no more authority than any other member of the Joint Steering
Committee.
	 
	 	18.7	 	Minutes. Within 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 distributed and revised, as necessary, prior
to the next meeting. At the next meeting, the minutes of the immediately prior
meeting shall be approved or disapproved. Final minutes shall be distributed to the
members of the Joint Steering Committee.
	 
	 	18.8	 	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
11.
	 
	 	18.9	 	Limitations. The Joint Steering Committee is not empowered to
amend the terms of this Agreement.






	19.	 	Miscellaneous.






	 	19.1	 	Notice. All notices to be given as required in this Agreement
shall be in writing and shall be delivered personally, sent by e-mail, 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







 




			
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	 	 	 	notice shall be effective on the date sent, if delivered personally, by e-mail or
sent by telecopier, the date after delivery if sent by overnight carrier and on
the date received if mailed first class.





	 	 	 	 	 
	 

	 	If to Neose:
	 	Neose Technologies, Inc.
	 

	 	 	 	102 Witmer Road
	 

	 	 	 	Horsham, PA 19044
	 

	 	 	 	Attention: General Counsel
	 

	 	 	 	Phone: 215-315-9000
	 

	 	 	 	Fax: 215-315-9100
	 

	 	 	 	E-Mail: dpoul@neose.com
	 
	 	 	 	 
	 

	 	If to Diosynth:
	 	Chief Operating Officer
	 

	 	 	 	Diosynth RTP Inc.
	 

	 	 	 	101 J. Morris Commons Lane
	 

	 	 	 	Morrisville, NC 27560
	 

	 	 	 	Phone: 919-337-4404
	 

	 	 	 	Fax: 919-337-0899
	 

	 	 	 	E-Mail: chris.vaneekelen@diosynth-rtp.com
	 
	 	 	 	 
	 

	 	With a copy to:
	 	General Counsel
	 

	 	 	 	Diosynth RTP Inc.
	 

	 	 	 	101 J. Morris Commons Lane
	 

	 	 	 	Morrisville, NC 27560
	 

	 	 	 	Phone: 919-337-4415
	 

	 	 	 	Fax: 919-337-0911
	 

	 	 	 	E-Mail: anne.showalter@diosynth-rtp.com







	 	19.2	 	Independent Contractor. Diosynth shall perform the Program as an
independent contractor of Neose 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 Neose, nor to constitute either Party as
the agent, employee or legal representative of the other. All persons furnished by
either Party to accomplish the intent of this Agreement shall be considered solely
as the furnishing Party’s employees or agents and the furnishing Party shall be
solely responsible for compliance with all laws, rules and regulations involving,
but not limited to, employment of labor, hours of labor, working conditions,
workers’ compensation, payment of wages, and withholding and payment of applicable
taxes, including, but not limited to income taxes, unemployment taxes, and social
security taxes.







 




			
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	 	19.3	 	Choice of Law. This Agreement shall be construed and enforced in
accordance with the laws of and in the venue of the State of New York except for its
rules regarding conflict of laws.
	 
	 	19.4	 	Entire Agreement. This agreement, including the attached
Appendices, together with the Confidentiality Agreement, sets forth the entire
agreement between the Parties hereto with respect to the performance of the Program
by Diosynth for Neose and as such, supersedes all prior and contemporaneous
negotiations, agreements (including the Letter Agreement), 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.
	 
	 	19.5	 	Amendments. 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.
	 
	 	19.6	 	Assignment. This Agreement may not be assigned by either Party
without the prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed. Notwithstanding the foregoing, either Party shall
be entitled, without the prior written consent of the other Party, to assign all or
a part of its rights under this Agreement to a purchaser of all or substantially all
of its assets or business, or an entity with which it may merge 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 accrued prior to the date of assignment.
	 
	 	19.7	 	Nonsolicitation. For the term of this Agreement and for twelve
(12) months following termination of this Agreement for any reason, neither Neose
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 Party who
were involved in the Program, unless otherwise approved by the other Party.
	 
	 	19.8	 	Counterparts. This Agreement may be executed by facsimile and 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.





[signature page follows]






 




			
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          In witness whereof, the parties hereto have caused this Agreement to be signed as of
the Effective Date.



	 	 	 	 	 
	 	 	Neose Technologies, Inc.
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Kathryn J. Gregory
	 

	 	 	 	Name: Kathryn J. Gregory

Title: Vice President, Business

          Development and Licensing
	 
	 	 	 	 
	 	 	Diosynth RTP Inc.
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Chris van Eekelen
	 

	 	 	 	Name: Chris van Eekelen

Title: Chief Operating Officer
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Juliens
	 

	 	 	 	Name: Juliens
	 

	 	 	 	Title: President








 




			
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Appendix 1





Scope




*****






 




			
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Appendix 1-1









 








Appendix 2




Form of Quality Agreement




Clinical Material Quality Agreement




     This clinical material quality agreement (“Quality Agreement”) is dated December 7,
2006 (the “Effective Date”) and is by and between Neose Technologies, Inc., a Delaware corporation
(“Neose”) having its principal place of business at 102 Witmer Road, Horsham, PA, 19044 and
Diosynth RTP 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”).



Background




     Whereas, the Parties have entered into a certain Bioprocessing Services Agreement on
December 7, 2006 (the “BSA”) pursuant to which Diosynth will perform services related to the
production of the material known as bulk *GlycoPEGylated erythropoietin, NE-180 drug substance
(“Product”) along with any intermediate bulk erythropoietin (“Intermediate”).



     Whereas, this Quality Agreement shall govern the roles, responsibilities,
deliverables and time requirements with respect to the quality of the Intermediate and Product.



Terms




     Now, therefore, in consideration of the mutual covenants and promises contained
herein and intending to be legally bound, the Parties agree as follows:




	1.	 	Definitions






	 	1.1.	 	“Analytical Raw Data” shall have the meaning set forth in Section 12.1.
	 
	 	1.2.	 	“Approved Vendor” shall mean a vendor who has met minimum approval standards
and who has been approved to provide required items or services that may impact
product quality.
	 
	 	1.3.	 	“Authorized Quality Representative” shall have the meaning set forth in
Section 3.1.
	 
	 	1.4.	 	“Batch” shall mean a specific quantity of Intermediate or Product in a
process or fraction of a process. Batches are defined as the material represented at
the end of the intermediate processing steps and the material represented at the end
of the processing step for Product.







 




			
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	 	1.5.	 	“BPRs” shall have the meaning set forth in Section 9.2.1.
	 
	 	1.6.	 	“BSA” shall have the meaning set forth in the Background.
	 
	 	1.7.	 	“Certificate of Analysis,” “C of A” or “COA” shall mean an authentic document
that certifies that a specific batch of material has been evaluated in accordance with
the Item Specification for that material.
	 
	 	1.8.	 	“Certificate of Conformance” or “COC” shall mean a Neose supplied document
that certifies a specific lot of material has been evaluated by Neose and meets all
product and regulatory requirements for further manufacturing or release.
	 
	 	1.9.	 	“CMC” shall have the meaning set forth in Section 5.1.
	 
	 	1.10.	 	“Critical Change” shall mean any change that (i) impacts the quality of
Product; (ii) impacts the regulatory commitments or reporting requirements of the
Intermediate; (iii) requires re-qualification or re-validation of Neose’s methods,
process or reference standards; or (iii) results in changing or modifying Item
Specifications or test methods.
	 
	 	1.11.	 	“Critical Deviation” shall mean any departure that (i) impacts the
regulatory commitments and/or reporting requirements of the Intermediate; (ii)
requires re-qualification of methods, process or reference standards (where already
qualified); and (iii) results in changing or modifying the specifications or methods.
	 
	 	1.12.	 	“Critical Raw Materials” shall mean raw materials that are critical to a
Neose specific process which typically comprise final formulation components
(excipients) and raw materials that combine structurally or chemically with the
therapeutic protein. Critical raw materials should be defined in the scope of work.
	 
	 	1.13.	 	“Date of Manufacturing” shall mean the date of fill into final container or
packaging for Intermediate or Product.
	 
	 	1.14.	 	“Diosynth” shall have the meaning set forth in the First paragraph of this
Agreement.
	 
	 	1.15.	 	“Effective Date” shall have the meaning set forth in the First paragraph of
this Agreement.
	 
	 	1.16.	 	“Final Release” shall have the meaning set forth in Section 14.1.
	 
	 	1.17.	 	“Intermediate” shall have the meaning set forth in the Background.







 




			
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	 	1.18.	 	“Item Specification” shall mean a set of criteria to which a material must
conform to be considered acceptable for its intended use.
	 
	 	1.19.	 	“Master Batch Record” or “MBR” shall mean a detailed description of Neose
specific production process outlining the different actions an operator has to perform
to complete the drug substance production process. A scaled copy of the master batch
record is the batch production record.
	 
	 	1.20.	 	“Neose” shall have the meaning set forth in the First paragraph of this
Agreement
	 
	 	1.21.	 	“OOS” shall have the meaning set forth in Section 10.1.
	 
	 	1.22.	 	“Party” or “Parties” shall have the meaning set forth in the First paragraph
of this Agreement.
	 
	 	1.23.	 	“Product” shall have the meaning set forth in the Background.
	 
	 	1.24.	 	“Quality Agreement” shall have the meaning set forth in the First paragraph
of this Agreement.
	 
	 	1.25.	 	“Release Package” shall mean the relevant documentation to be transferred to
Neose to facilitate the release of a Batch. This package consists of copies of quality
assurance reviewed, executed processing batch records, deviation summaries, in-process
and release assay results, Certificate of Analysis or analytical results, QA
disposition of product statement and where applicable batch genealogy, and facility
deviations.
	 
	 	1.26.	 	“SSTM” shall have the meaning set forth in Section 7.1.
	 
	 	1.27.	 	“TSE” shall have the meaning set forth in the heading to Section 6.3.
	 
	 	1.28.	 	“Validation Master Plan” shall mean a document defining the scope of
validation work including equipment/systems or processes to be validated and the
overall validation approach.
	 
	 	1.29.	 	All capitalized terms not defined in the Quality Agreement shall have the
same meaning as is assigned to such terms in the BSA. Any terms not defined in this
Quality Agreement or in the BSA will be interpreted in accordance with, in the
following order of precedence: (i) the Diosynth Quality Policy, QMS 5 (a copy of which
has been provided to Neose prior to the Effective Date); (ii) ICH Q7 GMP Guidance for
Active Pharmaceutical Ingredients; and (iii) 21 CFR Parts 210, 211, 600, 601, & 610.
If (i) is amended after the Effective Date, Diosynth shall provide copies of such
amendments or amended documents to Neose.







 




			
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Appendix 2-3









 












	2.	 	General






	 	2.1.	 	This Quality Agreement sets forth the roles, responsibilities, deliverables
and time requirements with respect to the quality of the Intermediate and Product. If
any terms or conditions of this Quality Agreement conflict with the terms or
conditions of the BSA, such terms and conditions contained in the BSA shall control.
	 
	 	2.2.	 	Any amendments to this Quality Agreement must be in writing executed by both
Parties and reviewed and approved by Authorized Quality Representatives from each
Party.






	3.	 	Authorized Quality Representatives






	 	3.1.	 	Each Party shall designate an authorized representative of quality assurance
(“Authorized Quality Representative”). Neose’s initial Authorized Quality
Representative shall be Joan Gavaghan, Director, Quality Assurance. Diosynth’s
initial Authorized Quality Representative shall be Mark Zemler, Senior Director,
Quality Assurance.
	 
	 	3.2.	 	Each Party may change their Authorized Quality Representative at any time.
In the event of such a change, the Party changing their Authorized Quality
Representative shall notify the other Party in writing of such change.
	 
	 	3.3.	 	In addition to other duties set forth in this Quality Agreement, the
Authorized Quality Representatives will resolve any disputes or conflicts relating to
this Quality Agreement. Such resolutions shall be in writing, signed by each
Authorized Quality Representative, and shall not conflict with any applicable Law,
regulatory requirements of the Parties, or any quality requirements of Neose. If any
issue remains unresolved for more than twenty (20) business days, the most senior
officers of each Party with a responsibility for quality will be contacted to resolve
this issue. To the extent such senior officers cannot resolve the issue, the issue
shall be resolved pursuant to the dispute resolution provisions of the BSA.






	4.	 	Change Control






	 	4.1.	 	Change is controlled through Diosynth approved procedures. All changes to
approved manufacturing processes or Neose specific analytical methods shall be
communicated to Neose in writing and approved in writing by Neose, prior to
implementation. Critical Change control procedures are utilized for changes to
validated procedures, methods, facilities, utilities, equipment and Critical Raw
Materials. Document change control procedures are utilized to track documentation
changes to batch records, release specifications, or Neose specific test methods and
shall be subject







 




			
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Appendix 2-4









 









	 	 	 	to Neose’s prior approval. Neose initiated requests for changes shall be
communicated to Diosynth’s quality management in writing using Neose’s change
control documentation, and upon mutual agreement, shall be implemented by Diosynth
using Diosynth’s current approved change control procedure.
	 
	 	4.2.	 	Neose will review changes prior to implementation for conformance to
registration commitments, and advise Diosynth on any actions to take to assure
compliance.






	5.	 	Regulatory






	 	5.1.	 	All updates to regulatory applications related to Intermediate or Product are
the responsibility of Neose. Diosynth will provide Neose all necessary information
which it may possess, pertinent to Intermediate or Product, to keep the global
regulatory filings current and up-to-date. Prior to submitting, Neose will provide
copies of all of the Chemistry Manufacturing Control (“CMC”) sections or other
relevant sections submissions and regulatory applications to Diosynth related to
activities to be performed by Diosynth for review and opportunity to comment to
support compliance with filed regulatory requirements. Diosynth cannot assure
conformance to filings if (i) Diosynth is not notified of the applicable parts of
these documents or (ii) the applicable parts of such documents are determined to be
incorrect or (iii) is inconsistent with mutually agreed upon activities. Neose will
promptly provide copies to Diosynth of all communications about and updates to
regulatory applications as they pertain to manufacturing at Diosynth.
	 
	 	5.2.	 	Complaints and Adverse Event Reporting.






	 	5.2.1.	 	Diosynth shall promptly notify Neose of any information coming into its
possession concerning the quality of previously released Batch(es). Any
determinations on how to address the information impacting product quality and
safety including communication with regulatory authorities shall be the
responsibility of Neose.
	 
	 	5.2.2.	 	Neose shall promptly notify Diosynth of any complaint or adverse event
affecting the quality of Product made from previously released Batch(es).






	 	5.3.	 	Recalls.






	 	5.3.1.	 	In the event that either Party determines that Intermediate or Product
violates applicable laws, regulations, agreed upon specifications, or is
deemed unacceptable for some other reason, whether or not such action is
requested by any governmental







 




			
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Appendix 2-5









 









	 	 	 	agency, Diosynth and Neose have the responsibility to notify each other
within one (1) business day. Within two (2) business days after such
notice, the Parties’ representatives from business, medical, regulatory,
quality assurance, legal functions, and any others deemed necessary will
consult to determine if any Product should be withdrawn or recalled. The
final decision to recall or withdraw Product or to withdraw Intermediate
resides with Neose. Performance of all activities associated with recalls
and withdrawals are the responsibility of Neose. Diosynth shall be
responsible for the quarantine of any Intermediate or Product at any
Diosynth location or otherwise under Diosynth control at the time of any
recall.
	 
	 	5.3.2.	 	Diosynth will investigate the Intermediate or Product issue using its
deviation handling procedure to the extent the issue directly relates to
Diosynth’s activities. Neose will be responsible for formal notification of
the regulatory authorities as well as determining the impact of such decision
on any Neose Product.






	6.	 	Process Consumables and Raw Materials






	 	6.1.	 	Procurement and Delivery of Process Consumables and Raw Materials.






	 	6.1.1.	 	Diosynth is responsible for determining suitable source(s) of all Process
Consumables and Raw Materials (excluding Neose-Supplied Raw Materials).
Diosynth is responsible for procuring such materials and developing/approving
test methods and specifications. Diosynth will use commercially reasonable
efforts to obtain material that conforms to agreed-upon specifications from
approved vendors. Should the primary supply source become unavailable, Neose
agrees to cooperate with Diosynth in identifying an alternative supply. If a
satisfactory alternative supply can not be identified, the parties agree to
jointly determine in writing how to proceed.
	 
	 	6.1.2.	 	Diosynth vendor quality and raw material program requirements will apply to
all material sourced by Diosynth. Diosynth will maintain a process specific
complete list of materials to be utilized in Neose process and will notify
Neose of any Critical Raw Material vendor change prior to implementation.






	 	6.2.	 	Inspection and Testing of Critical Raw Materials.






	 	6.2.1.	 	Diosynth and Neose will agree upon which Raw Materials (including
Neose-Supplied Raw Materials) will be designated as critical. The testing
procedures for the Critical Raw Materials will







 




			
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Appendix 2-6









 









	 	 	 	be developed by Diosynth or may be provided by Neose as appropriate.
Changes to compendial methods are acceptable, if in accordance with
current compendia.
	 
	 	6.2.2.	 	Diosynth shall store retains of Critical Raw Material samples according to
Diosynth policy for each batch or lot of Critical Raw Materials for a minimum
of three (3) years. Upon the expiration of this period or any termination of
this Agreement, Diosynth shall offer such Critical Raw Material retains to
Neose.






	 	6.3.	 	Transmissible Spongiform Encephalopathy (“TSE”) Compliance.






	 	6.3.1.	 	Diosynth will source relevant Raw Materials from non-animal derived sources
whenever possible. If animal derived Raw Materials are necessary, then
Diosynth will 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) by obtaining Country of Origin
certification and verifying that the source country is not a known
BSE-contaminated country (in accord with 9CFR94.18) or by ensuring the
processing methods are know to inactivate TSE agents, per CHMP guidelines. If
required, Neose and Diosynth may make an application for a TSE Certificate of
Suitability in accordance with European Directive(s) and EMEA Notes for
Guidance.






	7.	 	Master Batch Records, Product Specification(s) and Analytical Test Methods






	 	7.1.	 	Master Batch Records and Sponsor Specific Test Methods (“SSTM”) will be
mutually agreed upon. Administrative revisions to batch records that improve clarity,
formatting, typos or other changes that do not change the sequence of events or
processing steps may be made by Diosynth without client approval of that revision.
Changes to operating parameters, process steps, or other instructions that impact how
the material is manufactured will be approved by both parties. It is expected that,
cycle time for document reviews and approvals will be limited to two rounds of
substantial re-drafts between Diosynth and Neose. Minor edits, typo corrections and
other non-substantive or non-material revisions shall not be considered to be a
“substantial re-draft” for the purpose of this Section 7.1. Neose is entitled to
copies of the approved MBRs, and SSTMs. Any other documentation is maintained by and
available for review on Diosynth premises. Notwithstanding the foregoing, any
Analytical Raw Data specifically set forth in the Scope shall be made available to
Neose. Diosynth shall address Neose’s comments on all MBRs and SSTMs within a
reasonable timeframe.







 




			
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Appendix 2-7









 











	 	7.2.	 	Intermediate and Product Specifications.






	 	7.2.1.	 	Neose and Diosynth will jointly agree upon specifications and/or procedures
for manufacturing, packaging, labeling and handling for the Intermediate and
Product. The Intermediate and Product will be manufactured, packaged, labeled
and handled in accordance with the written specification(s) and to written
procedures provided by Neose and agreed to by Diosynth. Where Neose provides
no written procedure, current Diosynth procedures and practices will be used.
	 
	 	7.2.2.	 	Neose will notify Diosynth in writing using Neose Change Control
documentation, or similar, of the intent to change a specification and provide
supporting documentation to Diosynth. Diosynth will initiate the change
control documentation and must agree on the achievability and practicality of
such specifications.
	 
	 	7.2.3.	 	Where no manufacturing history is available from early stage clinical
material, it will be appropriate to use “Target” specifications documented
with “Report Result”. If adequate data is available, Diosynth and Neose will
mutually agree upon appropriate specifications.






	 	7.3.	 	Analytical Methods/Standard Test Methods.






	 	7.3.1.	 	Analytical test methods for the Intermediate or Product will be transferred
from Neose to Diosynth using mutually agreed upon processes, or are developed
by Diosynth. Neose will be responsible for providing documentation to
facilitate effective transfer of analytical methods and will provide support
and clarification when necessary. Diosynth will perform qualification and
validation, when applicable, of any new test methods as required by the scope
of work. Diosynth will be responsible for generating mutually agreed upon
protocols to evaluate the methods. Diosynth will provide a final report to
Neose for any method transfer, qualification, or validation performed.
	 
	 	7.3.2.	 	Diosynth is responsible for performing any analytical method transfers to or
from other sites. Diosynth will not change any Neose specific test methods
without the appropriate approved change control documentation. Compendial
updates to methods are acceptable and will not require Neose pre-approval.
	 
	 	7.3.3.	 	Changes to test methods and procedures for the Intermediate or Product will
be consistent with Section 4 of this Quality Agreement. Deviations to the
test methods and procedures and







 




			
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Appendix 2-8









 









	 	 	 	OOS test results will be handled in a manner consistent with Section 10 of
this Quality Agreement.






	8.	 	Manufacturing and Packaging of Intermediate and Product






	 	8.1.	 	The manufacturing, packaging, and labeling of the Intermediate or Product
will be done according to the specific cGMP documentation as mutually agreed upon by
the parties.
	 
	 	8.2.	 	Neose and the Diosynth project team will provide an adequate process
description which will be used as the basis for batch record development and CMC
section development. Diosynth will manufacture the Intermediate or Product in
accordance with this description. As the process is developed and optimized, all
relevant documents will be revised by Diosynth in accordance with Section 4 of this
Quality Agreement.






	9.	 	Inspection and Testing of the Intermediate and Product






	 	9.1.	 	Diosynth will carry out the inspection and testing of the Intermediate or
Product as set forth by Neose in the anticipated or actual regulatory filings, and in
cGMP documentation mutually agreed upon by both Diosynth and by Neose.
	 
	 	9.2.	 	Inspection (Batch Production Record Review).






	 	9.2.1.	 	A Release Package will be transferred to Neose to facilitate the release of
each batch. Batch Production Records (“BPRs”) must be complete and have all
batch related deviation issues finalized and approved by Diosynth. Neose may
concurrently review batch records, pending the closure of outstanding
deviations, OOSs, or laboratory results to facilitate timely disposition of
material by Diosynth to Neose.
	 
	 	9.2.2.	 	Copies of all completed BPRs, all batch related documents identified above,
and the COA will be sent to Neose, targeting delivery within forty (40)
business days from batch completion. Neose shall respond with comments and
provide Diosynth with release documentation such as a Certificate of
Conformance, or similar, within twenty (20) business days after receipt of the
records.
	 
	 	9.2.3.	 	In addition to any retention requirements set forth in the BSA (including
without limitation Section 6.3), Diosynth will supply Neose with complete
copies of the Release Package. Diosynth will retain all original batch
production records and batch related documents for a minimum of
five (5) years from Date of







 




			
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Appendix 2-9









 









	 	 	 	Manufacture. These documents will be readily accessible for review and
inspection by Neose and/or regulatory authorities if requested. At the
end of the document retention period, Diosynth will notify Neose and offer
these records to Neose.






	 	9.3.	 	Analytical Testing to Support cGMP Manufacture.






	 	9.3.1.	 	Diosynth follows written procedures describing the identification,
quarantine, handling, sampling, testing and approval or rejection of
materials. Diosynth will perform testing per established methods/procedures
and review against defined specifications as detailed in regulatory
submissions. Changes to these methods and procedures will be consistent with
the Change Control section of this Quality Agreement. Deviations to the test
methods and procedures and OOS test results will be handled in a manner
consistent with the Deviation section.
	 
	 	9.3.2.	 	Neose will be responsible for characterizing and providing an adequate
supply of reference standards of the Intermediate and Product to Diosynth on a
timely basis. Diosynth will be responsible for proper maintenance and
inventory of reference standards in its possession, and for requesting
additional quantities of reference standards in a timely manner with adequate
notice to Neose.
	 
	 	9.3.3.	 	Analytical samples for testing to be performed by Neose, or a contract
laboratory, will be shipped by Diosynth within ten (10) days from the date of
sample collection and Diosynth shall notify Neose of its planned timing for
shipment. The foregoing notwithstanding, if the timing of the shipment
pursuant to this Section 9.3.3 will cause damage, sample degradation or
otherwise compromise the integrity of the samples, or as specified in the
Scope, the samples will be shipped as agreed to by the parties. Samples will
be packaged and shipped in accordance with mutually agreed upon procedures
approved by both parties.






	10.	 	Deviations and Out-of-Specification Results






	 	10.1.	 	Deviations and Out-of Specification (“OOS‘) results will be managed
according to Diosynth’s procedures for deviation control and the extent of
investigation and corrective action implementation is dependent on the stage of
process and product development at Diosynth.
	 
	 	10.2.	 	Diosynth will notify Neose of any Critical Deviations or suspected or
confirmed OOS within three (3) business days after Diosynth notification. Critical
Deviations will be investigated for product quality impact and







 




			
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Appendix 2-10









 









	 	 	 	fully documented by Diosynth, targeting completion within twenty (20) business days
after the date of Diosynth notification. Investigations will include appropriate
justification, scientific rationale and supporting data. In the event a Critical
Deviation cannot be resolved within the twenty (20) business day period, Diosynth
will provide Neose with written updates of the investigation’s progress and target
completion dates at mutually agreed upon intervals.
	 
	 	10.3.	 	Copies of all final completed and approved deviation reports will be
promptly supplied to Neose. In cases where Neose and Diosynth cannot agree to a
resolution of a Critical Deviation, provisions for conflict resolution per the Quality
Agreement and the Agreement shall apply.
	 
	 	10.4.	 	Non-critical deviations will be documented according to established Diosynth
procedures and will also be retained according to relevant SOPs. Summaries of all
completed and approved Non-Critical Deviations will be supplied to Neose with the
Release Package.






	11.	 	Audits






	 	11.1.	 	Regulatory Audits






	 	11.1.1.	 	Diosynth will notify Neose of any inspections, notifications, or actions by
a regulatory agency or other enforcement body that impacts Neose’s
Intermediate or Product. Notification should not be any later than next day of
an unannounced agency inspection or prior to a pre-announced, scheduled agency
inspection. Diosynth will provide support for all regulatory inspections and
regulatory filings, as appropriate. Neose may be present at a regulatory
inspection at Diosynth if the inspection pertains to Neose’s process.
Diosynth will provide Neose with the observations from such regulatory audits,
as they apply to Neose’s process, within ten (10) business days of the
occurrence of the audit observation.
	 
	 	11.1.2.	 	Neose is responsible for all reporting requirements to the respective
regulatory agency(ies) with regard to Neose registration documentation.
Diosynth is responsible for all reporting requirements with regard to
manufacturing site registration that may be required to support Neose related
activities, and will notify Neose upon doing so.






	 	11.2.	 	Neose Audits. Neose has the right to audit all Diosynth facilities
and systems as they relate to the manufacturing, testing and stability laboratories
supporting production of Intermediate or Product on an annual basis. Neose will
provide timely notification for scheduling an audit. The annual audit shall not exceed
two (2) auditors and three (3)







 




			
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Appendix 2-11









 









	 	 	 	business days in duration. Additional audits are referenced in the BSA, section
2.7.






	 	11.3.	 	For Cause Visit. Neose may visit particular functions/areas on a
“For Cause” basis for product quality reasons as they apply to product manufacturing.
Timing for a “for-cause” Visit must be mutually agreed upon.
	 
	 	11.4.	 	Vendor Audits. Where applicable, the auditing of the vendors of all
Critical Raw Materials utilized in the manufacture and packaging of Intermediate or
Product will be the responsibility of the party (Neose or Diosynth) that sources the
materials. Neose will share audit summaries with Diosynth for any audits of vendors
required to support Diosynth’s vendor qualification program.






	12.	 	Analytical Data Reporting Requirements






	 	12.1.	 	Analytical raw data (including chromatograms and gel scans) and reports
generated by Diosynth (collectively “Analytical Raw Data”) will be stored and retained
in accordance with cGMPs and internal Diosynth guidelines and will be made accessible
for on site review within a reasonable timeframe. Notwithstanding the foregoing, any
Analytical Raw Data specifically set forth in the Scope shall be made available to
Neose .






	13.	 	Person-in-the-Plant






	 	13.1.	 	When authorized by Neose, if the Person-in-the-Plant is granted quality
assurance oversight, they may make quality-related decisions and authorizations for
Neose. When observing activities in the manufacturing or testing areas, the
Person-in-the Plant must adhere to Section 2.7 of the BSA regarding access and
behavior while in the production areas.
	 
	 	13.2.	 	Diosynth shall provide adequate and reasonable workspace and facilities for
Person-in-the-Plant.






	14.	 	Release and Shipment of the Intermediate and Product






	 	14.1.	 	Diosynth has the responsibility for disposition of Intermediate or Product
Batches to Neose. The release for further processing or use in formulation of DP
(“Final Release”) is the responsibility of Neose.
	 
	 	14.2.	 	Neose will identify the destination to which Intermediate or Product Batches
are to be shipped. Diosynth will not ship any material to any destination until that
material has been released by Neose, unless prior written approval is received from
Neose to perform such a shipment.







 




			
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Appendix 2-12









 









	15.	 	Retained Samples of Intermediates






	 	15.1.	 	Diosynth agrees to store retained samples for all Intermediate or Product
Batches. The amount of retained samples must be of sufficient quantity to conduct at
least full specification analyses in duplicate.
	 
	 	15.2.	 	Diosynth agrees to store the retained samples under storage conditions
defined by Neose and in a secure area for a minimum of five (5) years from the Date of
Manufacture. Diosynth shall offer all such samples to Neose upon the expiration of
this period or any termination of this Quality Agreement.






	16.	 	Storage of Materials, the Intermediate and Product






	 	16.1.	 	Diosynth shall store all Raw Materials, Process Consumables, Intermediate
and Product under storage conditions set forth in the specifications related to such
materials.






	17.	 	Facilities, Equipment, and Utilities Validation and Qualification






	 	17.1.	 	Diosynth is responsible for maintaining the validated state of equipment,
facilities, and utilities. Documentation relevant to the client’s processes is
available for review during audits.






	18.	 	Use of Subcontractors






	 	18.1.	 	Diosynth may use Sub-contractors for any portion of the manufacturing,
testing, holding, packaging or labeling of the Intermediate or Product only with the
prior written approval by Neose. Sub-contractors will meet Diosynth requirements for
Approved Vendors. Neose recognizes Diosynth’s vendor compliance program.






	19.	 	Returned Goods






	 	19.1.	 	Diosynth uses a cGMP compliant system for handling returned goods and/or
rejected materials.






	20.	 	Product Testing






	 	20.1.	 	Where Diosynth is responsible for testing of Product, changes to test plans,
sampling plans, test methods, and other associated documentation will be managed
through Diosynth’s change control process. Neose initiates such change by providing
written notification through Neose change control system to Diosynth at least thirty
(30) days prior to the requested change.







 




			
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Appendix 2-13









 











	 	20.2.	 	Suspected or confirmed OOSs will be notified to Neose within three (3) days
of Diosynth notification and managed according to Diosynth standard operating
procedures.






	21.	 	Stability Testing






	 	21.1.	 	If any stability testing is carried out by Diosynth, Diosynth shall use
mutually agreed upon protocols in accordance with the international Committee on
Harmonization Stability Testing Guidelines. Neose receives copies of test results at
following each time point. Changes to test plans, sampling plans, test methods, and
other associated documentation will be managed through Diosynth’s change control
process. Neose initiates such change by providing written notification through Neose
change control system to Diosynth at least thirty (30) days prior to the requested
change.
	 
	 	21.2.	 	Suspected and/or confirmed OOSs will be notified to Neose within three (3)
days from Diosynth notification and managed according to Diosynth standard operating
procedures.







 




			
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Appendix 2-14









 










               In witness whereof, the parties hereto have caused this Quality Agreement to be
signed as of the Effective Date.



	 	 	 	 	 	 	 
	 	 	Neose Technologies, Inc.	 	 
	 
	 	 	 	 	 	 
	 

	 	By	 	 	 	 
	 

	 	 	 	 
Name:

Title:
	 	 
	 
	 	 	 	 	 	 
	 	 	Diosynth RTP Inc.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:	 	 	 	 
	 

	 	 	 	 

Name:

Title:	 	 
	 

	 	 	 		 	 








 




			
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Appendix 2-15









 








Appendix 3




Program Price and Payment Schedule




******






 




			
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Appendix 3-1









 










Appendix 4




Confidentiality Agreement






 




			
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Appendix 4-1









 








CONFIDENTIALITY AGREEMENT



Effective as of this 4th day of April, 2006, Neose Technologies, Inc. with offices at 102 Witmer
Road, Horsham, PA 19044 (Customer) and Diosynth RTP Inc. with offices at 101 J. Morris Commons
Lane, Morrisville, NC 27560 together with its affiliates, (Diosynth) agree that the following terms
apply when one of the parties (Discloser) discloses confidential information (Information) to the
other (Recipient). Customer and Diosynth agree that the objective is to provide appropriate
protection for Information while maintaining the ability to conduct their respective business
activities.





	1.	 	DISCLOSURE




Information to be disclosed is intended to assist in the evaluation of the provision by Diosynth to
Customer of the development, scale-up. and cGMP manufacturing of an EPO baculovirus program and
related matters, which may be disclosed :





	 	a)	 	in writing;
	 
	 	b)	 	by delivery of items;
	 
	 	c)	 	by access to Information, such as may be contained in a data base; or
	 
	 	d)	 	by oral and/or visual presentation.




Information disclosed in writing shall be marked with a restrictive legend of the Discloser.
Information that is not marked with such legend or is disclosed orally; (i) must be identified as
confidential at the time, and (ii) the Discloser must provide the Recipient with written
confirmation within thirty (30) days after its disclosure.





	2.	 	OBLIGATION OF CONFIDENTIALITY




The Recipient will maintain Information as confidential, using the same care and discretion to
avoid disclosure, publication or dissemination of Information as it uses with its own similar
information that it does not wish to disclose, publish or disseminate. The Recipient may use
Information solely for the purpose set forth in this Agreement. The Recipient may disclose
Information only to:





	 	a)	 	its employees, subcontractors and employees and its affiliate companies which have
a need to know; and
	 
	 	b)	 	any other party with the Discloser’s prior written consent.




Before disclosure to any of the above parties, the Recipient will have a written agreement with
such party sufficient to require that party to treat Information in accordance with this Agreement.
The Receiving Party shall be responsible for any breach of this Agreement by its Representatives.



The Recipient may disclose Information to the extent required by law if it provides the Discloser
with prompt notice and a reasonable opportunity to secure a protective order.





	3.	 	CONFIDENTIALITY PERIOD




Disclosed Information continues to be subject to this Agreement for five (5) years following the
disclosure date.





	4.	 	EXCEPTIONS




No obligation of confidentiality applies to Information that:





	 	a)	 	the Recipient possessed prior to disclosure without obligation of confidentiality to
Discloser;
	 
	 	b)	 	is required to be disclosed pursuant to applicable laws, rules, regulations,
government requirement or court order (provided, however, that Recipient shall promptly
advise Discloser of its notice of any such requirement or order and shall
cooperate with the Discloser’s reasonable efforts to limit such disclosure)
	 
	 	c)	 	the Recipient develops independently, as documented by it’s written records;
	 
	 	d)	 	the Recipient rightfully receives from a third party who is under no obligation of
confidentiality to the Disclosing Party to keep the same confidential.; or
	 
	 	e)	 	is or becomes publicly known through no fault of the Recipient.




Information that is combined with information that falls within one or more of these exceptions
shall remain confidential regardless of such combination.






 




			
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Appendix 4-1









 







Neither this Agreement nor any disclosure of Information grants the Recipient any license under any
patents, copyrights or other intellectual property rights.



5. Remedies. Both parties agree that it would be impossible or inadequate to measure and
calculate the other party’s damages from any breach of the covenants set forth in this Agreement.
Accordingly, the Recipient agrees that if it breaches any of such covenants, the Discloser will
have available, in addition to any other right or remedy available, the right to seek an injunction
from a court of competent jurisdiction restraining such breach or threatened breach and to seek
specific performance of any such provision of this Agreement. . Both parties further agree that
no bond or other security shall be required in obtaining such equitable relief.





	5.	 	DISCLAIMERS




THE DISCLOSER PROVIDES INFORMATION ON AN “AS IS” BASIS. The Discloser will not be liable for any
damages arising out of use of Information. Disclosure of Information containing business plans is
for planning purposes only. The Discloser may change or cancel its plans at any time. Therefore,
use of Information is at the Recipient’s own risk.





	6.	 	GENERAL




Neither party shall be required either to disclose or to receive Information.



Neither party may assign its rights or delegate its duties or obligations under this Agreement
without prior written consent. Any attempt to do so is void.



The Recipient will comply with all applicable United States and foreign export laws and
regulations.



Either party may terminate this Agreement by providing written notice to the other. Any provisions
of this Agreement which by their nature extend beyond its termination will remain in effect beyond
such termination until fulfilled and will apply to either party’s successors and assigns. Upon the
Discloser’s written request, the Recipient, at its option, will return or destroy and certify the
destruction of all Information, including copies.



The terms and conditions of this Agreement remain in full force and effect unless modified in
writing and signed by both parties.



Except as provided in paragraph 5, disputes hereunder shall be attempted to be resolved first
through mediation and then binding arbitration. This Agreement will be governed by the laws of the
State of New York, without regard to its conflicts of law provisions.



The parties acknowledge that they have read this Agreement, understand it, and agree to be bound by
its terms and conditions. Further they agree that this Agreement is the complete and exclusive
statement of the agreement between the parties relating to this subject, superseding all proposals
or other prior agreements, oral or written, and all prior communications between the parties
relating to this subject.




	 	 	 	 	 
	Neose Technologies, Inc.	 	 
	By:

	 	/s/ Jeremy Middleton
 

	 	 
	Name:

	 	Jeremy Middleton	 	 
	Title:

	 	Vice President	 	 
	 
	 	 	 	 
	DIOSYNTH RTP INC.	 	 
	By:

	 	/s/ Karen O’Malley
 

	 	 
	Name:

	 	Karen O’Malley	 	 
	Title:

	 	Director, Commercial Development	 	 
	 
	 	 	 	 
	DIOSYNTH RTP INC.	 	 
	By:

	 	/s/ Richard Basile
 

	 	 
	Name:

	 	Richard Basile	 	 
	Title:

	 	VP M&S	 	 








 




			
	******	 	— Material has been omitted and filed separately with the Commission.






Appendix 4-1









 








[AKZO NOBEL]




May 18, 2006




Neose Technologies, Inc.

102 Witmer Road

Horsham, PA 19044

Attn: Kathryn Gregory




By Facsimile:     215-315-9400




Dear Kathryn:



This letter confirms the agreement between Neose Technologies, Inc. and Diosynth RTP Inc.
to amend the Confidentiality Agreement (Mutual) between Neose Technologies, Inc. and
Diosynth RTP Inc. dated April 4. 2006 (“the Agreement”) to expand the purpose of exchange
of confidential information under the Agreement to include discussions concerning a
potential licensing, development and/or commercialization collaboration with Diosynth RTP
Inc. or one of its affiliates.




Sincerely,




/s/ Karen O’Malley




Karen O’Malley




Director, Commercial Development



Accepted and Agreed to by Neose Technologies, Inc.




	 	 	 
	By:

	 	/s/ Kathryn Gregory
	Title:

	 	V.P. Business Dev. & Lic.
	Date:

	 	May 23, 2006






Diosynth RTP Inc.

101 J Morris Commons Lane

Morrisville, NC 27560

Tel: (919) 337-4400

Fax: (919) 337-0900






 




			
	******	 	— Material has been omitted and filed separately with the Commission.





Appendix 4-2