Document:

exv10w42

 

Exhibit 10.42

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.

Execution Copy

AMENDED AND RESTATED

RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT

AMONG

NEOSE TECHNOLOGIES, INC.

AND

NOVO NORDISK A/S

AND

NOVO NORDISK HEALTH CARE AG

DATED AS OF OCTOBER 31, 2006

 

			
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Table of Contents

	 	 	 	 	 
	 	 	Page	 
	1. DEFINITIONS
	 	 	1	 
	2. CONDUCT OF THE PROJECT AND COMMERCIALIZATION EFFORTS
	 	 	8	 
	3. FEES AND DEVELOPMENT PAYMENTS
	 	 	10	 
	4. PRODUCT PAYMENTS AND ROYALTIES
	 	 	13	 
	5. INTELLECTUAL PROPERTY GRANTS AND RIGHT OF NEGOTIATION
	 	 	15	 
	6. OWNERSHIP OF INTELLECTUAL PROPERTY
	 	 	17	 
	7. BLOCKING PATENTS
	 	 	27	 
	8. SUPPLY AGREEMENT
	 	 	28	 
	9. CONFIDENTIALITY
	 	 	28	 
	10. REPRESENTATIONS AND WARRANTIES
	 	 	30	 
	11. INDEMNIFICATIONS AND LIMITED LIABILITY
	 	 	31	 
	12. TERM AND TERMINATION
	 	 	33	 
	13. DISPUTE RESOLUTION
	 	 	35	 
	14. GOVERNMENT APPROVAL
	 	 	35	 
	15. NEGATIVE COVENANTS
	 	 	36	 
	16. MUTUAL COOPERATION
	 	 	37	 
	17. MISCELLANEOUS
	 	 	37	 

 
 

			
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AMENDED AND RESTATED

RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT

     This AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT (“Agreement”), is dated
as of October 31, 2006 (the “Restatement Date”), among Neose Technologies, Inc., a Delaware
corporation (“Neose”), and Novo Nordisk A/S, a Danish corporation, and Novo Nordisk Health Care AG,
a Swiss Corporation (collectively, “Novo”).

BACKGROUND

     Neose and Novo are parties to two Research, Development and License Agreements, dated
September 30, 2002 and October 28, 2002, respectively, relating to the use of Neose’s technologies
on Novo’s recombinant human Factor VII and Factor VIIa. Additionally, Novo and Neose entered into
a Research, Development and License Agreement dated November 17, 2003, as amended by letter
agreements dated December 18, 2003 and October 12, 2004 and by Amendment Number 3 dated December
15, 2005 (collectively, the “Amendments”), respectively (as so amended, the “Original Agreement”),
pursuant to which Novo and Neose are collaborating to develop a long-acting Factor VII compound.

     Novo and Neose desire to amend and restate the Original Agreement to further amend the
Original Agreement and to incorporate all of the Amendments into one document.

     Contemporaneously with the execution and delivery of the Original Agreement, Neose and Novo
entered into another Research, Development and License agreement regarding coagulation Factors VIII
and IX.

TERMS

     NOW, THEREFORE, in consideration of the premises and of the mutual agreements and covenants
contained in this Agreement, and intending to be legally bound hereby, Novo and Neose agree as
follows:

     1. DEFINITIONS. Capitalized terms not otherwise defined shall have the meaning set forth in
this Section 1.

          1.1 “******” means any New Product that incorporates a ******.

          1.2 “Affiliate” means, with respect to any Person, any other Person that directly or
indirectly controls, is controlled by, or is under common control with, such Person. Without
limiting the foregoing, a Person shall be regarded as in control of another Person if it owns, or
directly or indirectly controls, more than fifty percent (50%) of the voting stock or other
ownership interest of the other Person.

          1.3 “Blocking Patent” means any Patent Rights claimed to be owned or Controlled by a Third
Party with respect to which Patent Rights an assertion is being made
by or on behalf of the Third Party that the use of the Neose Technology under this Agreement infringes
such Person’s Patent Rights.

 
 

			
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          1.4 “Calendar Quarter” means any of the respective periods of three (3) consecutive
calendar
months ending on March 31, June 30, September 30 or December 31 during the Term.

          1.5 “Calendar Year” shall mean the respective periods of twelve (12) consecutive
calendar
months ending on December 31 during the Term.

          1.6 “Carved Factor VII Claims” shall mean any Potential Carved Factor VII Claim with respect
to which the parties have filed, in accordance with Section 6.4.2, a separate patent
application.

          1.7 “Commercially Reasonable Efforts” shall mean efforts and resources normally used by a
Party in similar undertakings, taking into account the proprietary position of the product or
technology involved, the regulatory structure involved, the profitability of such undertaking, the
competitiveness of the relevant marketplace, and other relevant factors.

          1.8 “Commercial Sale” means any sale of a New Product by Novo, its Affiliates, or
Sublicensees
to a Person other than their respective Affiliates or Neose.

          1.9 “Confidential Information” shall mean any of the Disclosing Party’s proprietary or
confidential information, technical data, trade secrets or know-how, including, but not limited to,
research, product plans, products, the identity of the Novo Materials, information relating to the
Novo Materials, service plans, services, customer lists and customers, markets, software,
developments, inventions, processes, formulas, technology, designs, drawings, engineering,
marketing, distribution and sales methods and systems, sales and profit figures, finances and other
business information disclosed to the Recipient by or on behalf of the Disclosing Party, either
directly or indirectly, in writing, orally or by drawings or inspection of documents or other
tangible property.

          1.10 “Control” or “Controlled” means possession of the ability of
one party to grant the
licenses or sublicenses to the other party as provided for herein without violating the terms of an
agreement or other arrangement with a Third Party existing before or after the Effective Date.

          1.11 “Designated Representative” means, in the case of Neose, its President and Chief
Executive Officer, or such other person designated by Neose in writing from time to time to Novo,
and, in the case of Novo, its Executive Vice President and Chief Science Officer, or other such
other person designated by Novo in writing from time to time to Neose.

          1.12 “Disclosing Party” is used as defined in Section 9.1.

          1.13 “Effective Date” shall mean the date of execution of the Original Agreement by both
Parties.

 
 

			
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          1.14 “Factor VIII and IX Agreement” means the Research, Development and License Agreement
between Neose and Novo with respect to coagulation Factor VIII and IX, entered into
contemporaneously with the execution of the Original Agreement.

          1.15 “FDA” means the United States Food and Drug Administration and any successor agency.

          1.16 “Field of Use” means the development and commercial manufacture of New Product for
******.

          1.17 “GMPs” shall mean current good manufacturing practices for the methods to be used in,
and
the facilities and controls to be used for, the manufacture, processing, packing and holding of
biological products, all as set forth from time to time by the FDA, including all amendments and
supplements thereto throughout the term of this Agreement.

          1.18 “HSR Act” shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, and the rules and regulations promulgated thereunder.

          1.19 “Improvements” means any and all developments, discoveries, inventions, additions,
amendments, modifications, ideas, processes, methods, compositions, formulae, techniques,
information and data, whether or not patentable, conceived, developed or reduced to practice, that
improve or beneficially change, or enhance the economic and technical attributes of, any Know-How
or Patent Rights or any process, device or composition.

          1.20 “IND” means an application for an Investigational Exemption for a New Drug filed with
the
FDA, or any comparable filing made with a regulatory authority outside the United States.

          1.21 “Joint Improvements” means any and all Improvements made, conceived or reduced to
practice jointly by Neose and Novo in the conduct of the Work Plan under this Agreement, whether
patentable or not, other than Neose Improvements and Novo Improvements.

          1.22 “Know-How” means any and all formulae, procedures, processes, methods, designs,
know-how,
show-how, trade secrets, discoveries, inventions (whether or not patentable), patent applications,
licenses, software and source code, programs, prototypes, designs, discoveries, techniques,
methods, ideas, concepts, data, engineering and manufacturing information, electronic control
circuits, specifications, diagrams, drawings, schematics, blueprints and parts lists and other
proprietary information, rights and works of authorship, whether or not reduced to writing.

          1.23 “M1 Profile for the New Product” means the parameters for candidate selection required
for PEG-F7a set forth on Exhibit 1.23, as amended from time to time in accordance with
Section 2.2.

          1.24 “Mutual Nondisclosure Agreement” means the Amended and Restated Mutual Nondisclosure
Agreement between the Parties dated November 25, 2002.

          1.25 “Neose Exclusive Compounds” shall mean any and all forms of ****** including,
but not
limited to, with respect to either of the foregoing: full length
proteins, truncated proteins, fusion proteins, analogs, mutants, splice variants, and conjugates with other molecular entities
such as proteins, peptides, organic or inorganic substances.

 
 

			
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          1.26 “Neose Improvements” means any and all Improvements relating to the Neose Technology
made, conceived, or reduced to practice by (i) either Neose or Novo or both in the conduct of the
Work Plan under this Agreement, (ii) either Neose or Novo or both under this Agreement, (iii) Novo
in the practice of any Neose Technology under the licenses granted to Novo in Section 5.1,
or (iv) Novo in the conduct of any activity using any Ownership Rights assigned to Novo pursuant to
Section 6.4.1, in each case of (i), (ii), (iii) or (iv), other than the Novo Materials, the
Novo Materials modified using the Neose Technology and New Product. Specifically excluded from
“Neose Improvements” are (1) formulations, combinations and methods of treatment to the extent
relating to Novo Materials, the Novo Materials modified using the Neose Technology and New Products
and (2) analytical techniques and purification methods invented, developed or reduced to practice
solely by Novo that did not originate from or are not derived from Neose (collectively, the
“Techniques”)

          1.27 “Neose Improvement Claim” shall mean any Neose License Claim that relates to a Neose
Improvement.

          1.28 “Neose Intellectual Property” means Neose Technology and the Neose Improvements.

          1.29 “Neose License Claim” shall mean a claim in or supportable by Patent Rights listed in
Section 16.2 (including any Patent Rights claiming priority to such listed rights) and Controlled
by Novo encompassing within its scope: (i) any methods of ******; (ii) any compositions-of-matter
or methods of treatment specifically naming Neose Exclusive Compounds derived from or used in the
practice of such methods described in clause (i) above; (iii) any compositions-of-matter or methods
of treatment related to any compound other than the Neose Exclusive Compounds, any and all forms of
******, or Novo Materials derived from or used in the practice of such methods described in clause
(i) above; wherein any claim encompassed by clauses (i), (ii) or (iii) must also be encompassed
within the scope of a claim supportable by any Patent Right listed in the listing of patents and
patent applications dated October 13, 2006 which has been certified by Neose and delivered to Novo
prior to the date hereof; or (iv) any Neose Improvements made or reduced to practice by Novo.

          1.30 “Neose Patents” means (a) all Patent Rights relating to methods and processes for
glycosylation design and remodeling of proteins, peptides and antibodies that are Controlled by
Neose, including, but not limited to: (i) the Patent Rights listed in Exhibit 1.30, (ii)
the Patent Rights developed by Neose in the conduct of the Work Plan during the Term of this
Agreement, and (iii) any later acquired Patent Rights Controlled by Neose and used to develop any
New Product, and (b) all Patent Rights Controlled by Neose that would be infringed by the research,
development (including clinical development), manufacture, making, use, marketing, promotion, sale,
offer for sale, distribution, import and export of New Products in the Territory.

 
 

			
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          1.31 “Neose Project-Related Costs” means Neose’s costs of conducting the Work Plan,
which
shall be determined in accordance with this Agreement and calculated as follows: (i) with respect
to personnel, at the rate of ******; and (ii) with respect to materials, at the ******.

          1.32 “Neose Technology” means the Neose Patents and any Know-How Controlled by Neose
relating
to methods and processes for the ******, including, without limitation, its GlycoAdvance®,
GlycoPEGylationTM and GlycoConjugationTM technologies, and other ****** processes, and all Know-How
resulting from work conducted by Neose during the Term.

          1.33 “Net Sales” means proceeds from Commercial Sales of New Products by Novo, its Affiliates
or Sublicensees to Third Parties, after deducting (to the extent actually incurred or reasonably
estimated and accrued in accordance with Generally Accepted Accounting Principles in the United
States and to the extent not already deducted in the amount invoiced): (i) reasonable trade, cash
and quantity discounts or rebates (other than price discounts granted at the time of sale),
reasonable service allowances and reasonable required agent’s commissions, if any, allowed or paid,
(ii) credits or allowances actually given or made for rejection or return of previously sold
products or for retroactive price reductions (including Medicare, Medicaid, and/or discounts and
similar types or rebates and/or discounts), (iii) taxes, duties or other governmental charges
levied on or measured by the billing amount (excluding income and franchise taxes), as adjusted for
rebates and refunds, and (iv) charges actually incurred for freight and insurance directly related
to the distribution of New Products (excluding amounts reimbursed by Third Party customers). A
“Commercial Sale of a New Product” is deemed to occur when the invoice is issued, or if no invoice
is issued, upon the earlier of shipment or transfer of title in the New Product to a Third Party.
In the event that New Product is sold or distributed for use in combination with or as a component
of another product or products (a “Combination Product”), the calculation of Net Sales from such
Combination Product shall be determined as set forth below:

If all of the active ingredient components of a Combination Product are also sold separately
and in identical strengths to those contained in the Combination Product, then the following
shall apply: Net Sales shall be calculated as set forth above on the basis of the gross
invoice price of a New Product containing the same weight of the licensed active ingredient
constituent sold independently [A], divided by the sum of the gross invoice price of all of
the active ingredient constituents sold independently [B + A], multiplied by the gross
invoice price of the Combination Product, as shown by the following formula:

	 	 	 	 	 	 	 
	 

	 	Net Sales =
	 	[A]
	 	x [gross invoice price of the Combination Product]
	 

	 	 	 	 	 	 
	 

	 	 	 	[B + A]	 	 

The distribution costs associated with any Combination Product will be allocated in the same
proportion among the licensed active ingredient components and all other active ingredient
components.

 
 

			
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If the active ingredient components of a Combination Product are not sole separately in
identical strengths to those contained in the Combination Product, then the parties agree to
negotiate in good faith the calculation of Net Sales with regard to such Combination
Product.

          1.34 “New Product” shall mean the following: (a) any of the Novo Materials modified
using
either (i) the Neose Technology, (ii) any Neose Improvements, or (iii) any combination of all or
some of (i) and (ii) above, and (b) any Novo Materials covered by any Carved Factor VII Claims
(except to the extent such claims constitute Novo Improvements) .

          1.35 “Novo Improvements” means any and all Improvements that are related to the Novo
Materials
and/or any of the New Products made, conceived or reduced to practice by Novo or Neose or both,
other than Neose Improvements.

          1.36 “Novo Materials” means any and all forms of Factor VII and Factor VIIa, including, but
not limited to, full length rFVII, truncated rFVII, ****** such as ****** substances.

          1.37 “Novo Technology” means the Patent Rights and Know-How Controlled by Novo relating to
the
Novo Materials .

          1.38 “Ownership Rights” means any and all right, title and interest under patent, copyright,
trade secret and trademark law, or any other intellectual property or other law, in and to any
Know-How, Patent Rights, or Improvements.

          1.39 “Parties” means Neose and Novo, collectively.

          1.40 “Party” means Neose or Novo, as the context requires, or each of Neose and Novo,
individually.

          1.41 “Patent Rights” shall mean individually and collectively any and all patents and/or
patent applications and provisional applications, all inventions disclosed therein, and any and all
continuations, continuations-in-part, continued prosecution applications, divisions, renewals,
patents of addition, reissues, confirmations, registrations, revalidations, revisions and
re-examinations thereof, utility models, petty patents, design registrations and any and all
patents issuing therefrom and any and all foreign counterparts thereof and extensions of any of the
foregoing including without limitation extensions under the U.S. Patent Term Restoration Act,
extensions under the Japanese Patent Law, and Supplementary Protection Certificates (SPCs)
according to Counsel Regulation (EEC) No. 1768/92 and similar extensions for other patents under
any applicable law in any country of the world.

          1.42 “Permit” means any governmental or regulatory filing, submission, approval, permit or
license that is required by applicable law in any jurisdiction worldwide for clinical trials,
Commercial Sales or other use of any of the New Products.

          1.43 “Person” means an individual, corporation, partnership, trust, business trust,
association, joint stock company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, government, governmental agency, authority or instrumentality, or any other form
of entity not specifically listed in this Agreement.

 
 

			
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          1.44 “Potential Carved Factor VII Claims” shall mean ******.

          1.45 “Product-Candidate” means any new ****** product-candidate Controlled by
Neose during the
Term.

          1.46 “Project” means the project to be conducted hereunder by the Parties in accordance with
the Work Plan.

          1.47 “Project Manager” means the project managers described in Section 2.4.1.

          1.48 “Reagents” means the enzymes and sugar nucleotides required to use the Neose Technology
in the manufacture of New Products.

          1.49 “Recipient” is used as defined in Section 9.1.

          1.50 “Regulated Market” means any jurisdiction worldwide that requires a Permit for clinical
trials, Commercial Sales or any other use of a New Product.

          1.51 “Regulatory Approval” means any marketing authorization (including authorizations
approving a Biologics License Application) required for a New Product, exclusive of any pricing or
third-party reimbursement approval.

          1.52 “Required Agreement” means any agreement with a Sublicensee required under Section
5.1.3.

          1.53 “******”******.

          1.54 “Steering Committee” means the steering committee established pursuant to Section
2.4.2, or any successor group appointed by the Parties.

          1.55 “Sublicensee” means a sublicensee of Novo’s rights under Section 5.

          1.56 “Supply Agreement” means the supply agreement to be entered into between Neose and Novo
in accordance with Section 8.

          1.57 “Territory” means the world.

          1.58 “Term” means the term of this Agreement, which shall commence on the Restatement Date
and
shall expire or terminate as described in Section 12.

          1.59 “Third Party” means any Person other than Novo, Neose, or their respective Affiliates.

          1.60 “Valid Patent Claim” means a claim of an issued and unexpired patent forming part of
the
Neose Patents or the Carved Factor VII Claims that has not been held revoked, unenforceable or
invalid by a decision of a court or other government agency of competent jurisdiction, or
unappealable or unappealed within the time allowed for appeal, or which has not been admitted to be
invalid or unenforceable through reissue or disclaimer or otherwise. For the purposes
of determining royalties due and payment obligations under this Agreement, any claim being
prosecuted in a pending patent application included in the Neose Patents or the Carved Factor VII
Claims shall be deemed a Valid Patent Claim, provided that such claim is not pending, other

 
 

			
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than because of any action taken by Novo or Affiliate of Novo, ****** in which the subject matter of the
claim is disclosed, after which period it shall cease to be considered a Valid Patent Claim until
the patent issues.

          1.61 “Work Plan” means the Work Plan attached hereto as Exhibit 2.2, and, unless
otherwise specified, as amended from time to time in accordance with Section 2.2.

     2. CONDUCT OF THE PROJECT AND COMMERCIALIZATION EFFORTS

          2.1 Conduct. Commencing promptly after the Restatement Date, Neose and Novo will continue to
use Commercially Reasonable Efforts to carry out their respective obligations under the Work Plan.

          2.2 Creation and Modification of Work Plan. Attached hereto as Exhibit 2.2 is the Work Plan,
setting forth a project summary and timetable for the research and development, scale-up and
technology transfer activities to be conducted under this Agreement. Neose shall be responsible
for the development of validated, GMP processes for the production of Reagents for use in the
manufacture of New Products and protocols for the use of the Reagents in the manufacture of New
Products by Novo, all as set forth in Exhibit 2.2. The Work Plan may be amended or
modified from time to time, but only in a writing signed by each Party’s Designated Representative
and specifying the Parties’ estimate of any additional Neose Project-Related Costs that will be
paid by Novo as a result of such amendment.

          2.3 Funding.

               2.3.1 Estimate. The Neose Project-Related Costs are estimated to be ******,
plus the cost of
materials. This estimate is based upon the Work Plan set forth in Exhibit 2.2. If the Parties
amend the Work Plan in a manner that requires any new product or service to be provided by Neose
(e.g., a new Reagent, expression system, scale up activity) which is not currently incorporated in
the Work Plan, the Parties shall agree in writing on any increase in the Neose Project-Related
Costs that are authorized in connection with such amendment.

               2.3.2 Payment. Novo will pay for the Neose Project-Related Costs ******. No
earlier than
thirty (30) days before the beginning of each Calendar Quarter following the Restatement Date,
Neose will invoice Novo for such amount based on a budgeted estimate of Neose Project-Related Costs
for such Calendar Quarter. Within thirty (30) days after the end of each Calendar Quarter, Neose
shall submit to Novo a written report setting forth the actual Neose Project-Related Costs for such
Calendar Quarter, and shall, as applicable, pay to Novo any amounts paid by Novo for such Calendar
Quarter in excess of the actual Neose Project-Related Costs shown in such report, or invoice Novo
for any additional amounts owed hereunder. Novo will pay all invoices delivered under this
Section 2.3 within ****** days after receipt.

 
 

			
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          2.4 Management of Project

               2.4.1 Project Managers. The Project Managers existing as of the Restatement Date are Henning
Stennicke for Novo and Megan Townsend for Neose and each shall remain the Project Managers
immediately following the Restatement Date. The Project Managers shall keep each other reasonably
informed of the progress under the Work Plan and shall be responsible for maintaining appropriate
records of the deliberations and decisions of the Project Managers and the Steering Committee. The
Project Managers shall be responsible for overseeing and directing the day-to-day activities
conducted at their respective sites in accordance with the Work Plan and suggesting changes for
consideration by the Steering Committee. A Party may change its Project Manager at any time, and
from time to time, effective upon notice to the other Party of such change.

               2.4.2 Establishment and Responsibilities of Steering Committee. As of the Restatement Date
the Steering Committee will consist of Søren Bjørn, Peter Nielsen and Ulla Grove Sidelman
representing Novo and David A. Zopf, M.D., Kathryn J. Gregory and Elliot Morales, Jr. representing
Neose. The responsibilities of the Steering Committee are to monitor the progress of the Work
Plan, to evaluate and recommend to the Parties any proposed amendments or modifications to the Work
Plan and the costs thereof, to approve and monitor compliance with any publication policy provided
to it by Novo, and to carry out all other obligations assigned to it under this Agreement or by the
Parties. Each Party may designate a co-chairperson and secretary of the Steering Committee.

               2.4.3 Action by Steering Committee and Dispute Resolution. The Steering Committee shall
consist of such number of members and alternate members as the Parties may determine from time to
time. Each Party shall appoint fifty percent (50%) of the permanent and alternate members of the
Steering Committee. The members of the Steering Committee shall include members of senior
management of each Party. The members of the Steering Committee representing a Party and present
at a meeting shall have one vote, collectively. If the Steering Committee cannot reach agreement
on any matter, ****** shall be entitled to ******; provided, however, that if the Steering
Committee cannot reach agreement on any matter involving a change in the scope of work to be
conducted by ****** under the Work Plan, the schedule of the work to be conducted by ****** under
the Work Plan, or the ******, such dispute shall resolved in accordance with Section 13.

               2.4.4 Changes to Steering Committee. Each Party may remove and replace its representatives on
the Steering Committee at any time, without cause, upon written notice to the other Party. An
alternate member designated by a Party shall be entitled to participate in the absence of a
permanent member designated by such Party. All references to “members” in this Agreement refer to
the then permanent members of the Steering Committee and any alternate member acting in the place
of a permanent member.

               2.4.5 Meetings. Regular meetings of the Steering Committee shall be scheduled by the Project
Managers or the secretary of the Steering Committee designated by either Party. Special meetings
of the Steering Committee may be called by the Project Managers or by

 
 

			
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any two or more members, at least one of whom represents each Party. Meetings may be in person or
by teleconference or videoconference, and notice of meetings may be by email. Each Party will bear
its own costs in connection with the management of the Project and the Steering Committee.

               2.4.6 No Waiver. No action, nor any failure to act, by the Steering Committee shall alter,
amend, waive or otherwise affect the obligations of the Parties under this Agreement. The Parties
may amend this Agreement only in accordance with Section 15.6, and a Party may waive any of
its rights under this Agreement only in accordance with Section 15.9.

          2.5 Cooperation. Throughout the Project, each Party shall cooperate with the other in the
conduct of the Work Plan, and will provide such information in its possession or under its Control
to the other Party as is reasonably necessary for the other Party to comply with and satisfy the
requirements of any and all international, national, state, local or other laws, treaties, rules,
procedures or regulations for purposes of this Agreement, or to carry out its obligations under
this Agreement.

          2.6 Permits. Prior to the commencement of any clinical trials, Commercial Sales or other use
of any New Product in a Regulated Market, Novo shall obtain at its expense all Permits required for
such activity in the applicable jurisdictions. Novo shall submit all applications for Permits for
the New Products in the name of Novo or its Affiliates. Novo shall hold all such Permits, if and
when granted, in its name alone. Neose, at Novo’s expense, shall provide reasonable assistance and
technical support to Novo in obtaining the Permits for the New Products. Novo shall pay all
expenses with respect to obtaining the Permits for the New Products including, without limitation,
the cost of clinical trials and preparation and prosecution of permit applications. Novo shall be
solely responsible for renewing any Permits at its expense. Neose shall supply Novo, at Novo’s
expense, with Reagents for producing New Products under the terms and conditions of the Supply
Agreement.

          2.7 Additional Development and Commercialization Activities. Except as set forth in the Work
Plan or the Supply Agreement, Neose shall not have any obligation to perform any further research,
development, technology transfer, technical support, improvements, modifications, or other
activities. Novo shall use Commercially Reasonable Efforts to obtain Regulatory Approvals for, and
Commercial Sales of, each New Product.

     3. FEES AND DEVELOPMENT PAYMENTS

          3.1 License Fee. In consideration of the licenses granted by Neose under this Agreement and
the Factor VIII and IX Agreement, Novo paid Neose a one-time, nonrefundable upfront fee of ******
within ten (10) days after the Effective Date.

          3.2 Milestone Payments Relating to Development of the New Product. In consideration of the
development efforts of Neose under the Work Plan, Novo shall pay Neose the amount of each milestone
payment set forth in this Section 3.2 with respect to the development of the New Product.
With respect to the milestone payment described in Section 3.2.1 the Parties agree that
Neose shall have earned the right to receive a milestone payment solely as a result of the
achievement of the milestone event. With respect to the milestone payments described in
Sections 3.2.2 through 3.2.8, the Parties agree that Neose shall have earned the right to
receive a milestone

 
 

			
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payment, and Novo shall be obligated to pay the milestone payment and shall have met its diligence
obligations with respect to the milestone, in each case, as a result of either (i) the achievement
of the milestone event prior to the occurrence of the corresponding anniversary date or (ii) the
occurrence, alone, of the corresponding anniversary date.

               3.2.1
****** for the achievement of In Vivo Biological Success, defined as improved
pharmacokinetics of New Product (modified) in dogs when compared to Novo Materials (unmodified) as
follows: ******, using the assay attached hereto as Exhibit 3.2.1. The New Product and
Novo Materials will be administered in equi-molar concentrations.

               3.2.2 ****** upon the earlier to occur of: (i) the first date on which there
shall be a
candidate which has been shown to meet the ****** for the New Product, and Neose shall have
delivered to Novo ****** for the production of such candidate; and (ii) the ****** anniversary of
the Effective Date.

               3.2.3 ****** upon the earlier to occur of ****** of an ******
with respect to the New Product
or the ****** anniversary of the achievement of the milestone (or occurrence of the date) described
in Section 3.2.2 above.

               3.2.4 ****** upon the earlier of ****** of the ****** of
the New Product ****** or the ******
anniversary of the achievement of the milestone (or occurrence of the date) described in
Section 3.2.3 above.

               3.2.5 ****** upon the earlier to occur of ****** of the ******
of the New Product or the
****** anniversary of the achievement of the milestone (or occurrence of the date) described in
Section 3.2.4 above.

               3.2.6 ****** upon the earlier to occur of the first ****** for the New
Product or the ******
anniversary of the achievement of the milestone (or occurrence of the date) described in
Section 3.2.5 above.

               3.2.7 ****** upon the ****** of the New Product in ******.

               3.2.8 ****** upon the ****** of the New Product in ******.

          3.3 Restriction on Multiple Milestone Payments. The Parties acknowledge and agree that at
anytime prior to the ****** for the New Product, the Steering Committee may decide to continue the
development of the New Product solely with a back-up candidate if a candidate initially taken into
development should fail for ****** reasons, including, but not limited to, ******, or the
occurrence of ******. In the event that the Steering Committee makes such a decision, this
Agreement shall be amended to reflect, among other things, the resulting changes to the Work Plan
and the Neose Project-Related Costs mutually agreed upon by the Parties. In such event, Novo
****** be required to ****** each of the milestone payments set forth in Sections 3.2.2 through
3.2.5.

          3.4 Coordination with Factor VIII and IX Agreement. The Parties agree that it may be
appropriate to adjust one or more of the anniversary dates set forth in Sections 3.2.2 through
3.2.5 as a result of ****** limitations (e.g., ******) that may be encountered by Novo
if the

 
 

			
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New Product and either or both of the products being developed under the Factor VIII and IX
Agreement are scheduled to pass through the same ****** at the same time. Novo may request such an
adjustment at any time, and from time to time, by providing notice of the proposed adjustment to
Neose. Promptly after receipt of such a notice, the Steering Committee shall meet to evaluate the
request. Within thirty (30) days after Novo provides such notice, the Steering Committee shall
provide a written recommendation to both Parties with respect to such request. Within fifteen (15)
days after receipt of any such recommendation, the Steering Committee shall meet to discuss the
recommendation and, if mutually agreeable, to negotiate and propose to the Parties the terms of
amendment(s) to the Work Plan and this Agreement which would permit Novo to continue developing the
New Product and the ****** Factor VIII and IX ****** in a practical and efficient manner, with the
goal of minimizing the aggregate time to market for the New Product and the ****** Factor VIII and
IX ******.

          3.5 Milestone Payments Relating to Development of the ******. In consideration of the
development efforts of Neose under the Work Plan related to the ******, Novo shall pay Neose the
amount of each milestone payment set forth in this Section 3.5. The Parties agree that
Neose shall have earned the right to receive each respective milestone payment set forth in this
Section 3.5, and Novo shall be obligated to pay such milestone payment, in each case, as a
result of either (i) the achievement of the milestone set forth for such payment, or (ii) the
failure by Novo to inform Neose within 30 days after the receipt of the material, results or data
provided by Neose that the applicable milestone set forth in Sections 3.5.1 or 3.5.2 was
not achieved. For each milestone set forth in Sections 3.5.1 and 3.5.2, upon the occurrence
of (i) or (ii) above, Neose shall issue an invoice to Novo and payment of the respective milestone
payment shall be due upon the later of (a) 30 days following the receipt of such invoice by Novo
and (b) January 1, 2006.

               3.5.1 Novo will pay Neose ****** upon delivery of approximately ******
of ****** (******)
meeting the ****** criteria set forth in Exhibit 3.5 or as provided in clause (i) of
Section 3.5. The Parties acknowledge that the amount set forth in this Section
3.5.1 has been paid prior to the Restatement Date.

               3.5.2 Novo will pay Neose ****** upon the delivery of approximately ****** of
****** meeting
the ****** criteria set forth in Exhibit 3.5 or as provided in clause (ii) of Section
3.5.

               3.5.3 In the event that, notwithstanding good faith efforts on the part of Neose to meet the
milestones set forth in Section 3.5.1 and 3.5.2, neither milestone has been met by Neose,
Novo will pay the milestone payments provided for in Sections 3.5.1 and 3.5.2 upon delivery
by Neose to Novo of ****** for use in the production by Novo of ******.

 
 

			
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     4. PRODUCT PAYMENTS AND ROYALTIES

          4.1 Royalties on Net Sales. Novo will pay to Neose royalties as a percentage of annual Net
Sales of each New Product during the Term at the applicable rates set forth in this Section
4.1 and in accordance with this Section 4:

               4.1.1 ****** of annual Net Sales of the New Product up to ******.

               4.1.2 ****** of annual Net Sales of the New Product over ******.

          4.2 Minimum Royalties. Commencing with the first ****** of the ******
full Calendar Year
following the First Commercial Sale of New Product, Novo will pay minimum royalties in respect of
the New Product for such Calendar Year and ****** during the Term, in the amounts set forth in this
Section 4.2 and in accordance with this Section 4:

               4.2.1 For the ****** Calendar Year following the First Commercial Sale of the
New Product:
******.

               4.2.2 For the ****** Calendar Year following the First Commercial Sale of the
New Product:
******.

               4.2.3 For the ****** Calendar Year following the First Commercial Sale of the
New Product and
****** thereafter: ******.

All minimum royalty payments made in accordance with this Section 4.2 shall be ******
against royalties payable under Section 4.1 in respect of the New Product in the same or
any subsequent Calendar Quarter during the same Calendar Year.

          4.3 Competitive Product(s). If a Competitive Product (as defined below in this Section
4.3) reaches a ****** equal to or greater than ****** percent (******%) of the market for a New
Product marketed by Novo, then the royalties otherwise payable in accordance with Section
4.1, and the minimum royalties otherwise payable in accordance with Section 4.2, with
respect to the New Product shall be ****** by the applicable percentage set forth below:

     Market
Share of Competitive Product ****** Royalty Rate Otherwise Payable

          More than ******

          More than ******

          More than ******

          More than ******

For purposes of this Section 4.3, “Competitive Product” means any product marketed by a
Third Party that is not a Sublicensee of Novo, which product is a ****** Factor VIIa with a ******
substantially equivalent to or better than the ****** of the New Product marketed by Novo.

          4.4 Royalty Payments. Novo shall make royalty payments to Neose on a quarterly basis, within
forty-five (45) days after the end of each Calendar Quarter.
Royalty payments due under Section 4.1 shall commence, with respect to each New Product in each
country, on the date of first Commercial Sale in such country.

 
 

			
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          4.5 Currency Conversion. If any currency conversion from a foreign currency into United
States Dollars shall be required in connection with the calculation of Net Sales, such conversion
shall be made using the average exchange rate for the applicable Calendar Quarter, as reported by
the Wall Street Journal.

          4.6 Payment Reports. Within forty-five (45) days after the close of each Calendar Quarter,
Novo shall furnish to Neose a written report showing in reasonably specific detail, on a
country-by-country basis for each New Product:

               4.6.1 All Net Sales of the New Product during such quarter expressed in United States
Dollars.

               4.6.2 The exchange rates used in determining Net Sales of the New Product in United States
Dollars in accordance with Section 4.5.

               4.6.3 Royalties payable in United States Dollars based upon such Net Sales of the New Product
during such quarter.

          4.7 Payment Method. Novo shall make all payments under this Agreement in United States
Dollars by bank wire transfer in immediately available funds to Hudson United Bank, ABA #******,
Acct Name: Neose Technologies, Inc., Acct # ******, or to such other account as Neose shall
designate to Novo in writing before such payment is due.

          4.8 Records; Audits. Novo shall, and shall cause its Affiliates and Sublicensees, if any, to
keep complete, true, and accurate books of account and records in connection with the production
and Commercial Sales of New Products in sufficient detail to permit accurate determination of all
figures necessary for verification of payments required to be made by Novo under this Agreement.
Novo shall, and shall cause its Affiliates and Sublicensees, if any, to, maintain such records for
at least ****** years following the end of the quarter to which such books and records pertain.
Neose shall have the right, at its expense, through a certified public accounting firm reasonably
acceptable to Novo, to examine the records required to be maintained by Novo, its Affiliates and
Sublicensees under this Section 4.8 upon reasonable notice and during regular business
hours prior to the termination or expiration of this Agreement and for ****** years thereafter for
the purpose of verifying the reports delivered pursuant to Section 4.6 provided that such
examination shall not take place more often than once a year. Novo may require such certified
public accounting firm to sign a confidential disclosure agreement prior to permitting such
certified public accounting firm to have access to its books, records or facilities. Such
accounting firm shall report to Neose only whether or not the reports submitted by Novo are
accurate for the period covered and the details concerning any identified discrepancies. If any
such audit uncovers an underpayment, Novo shall promptly pay to Neose the amount of such
underpayment. If any such underpayment exceeds ****** of the amount due, Novo shall pay the entire
expense of such audit within ****** after invoice.

 
 

			
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          4.9 Taxes. Novo may deduct the amount of any taxes imposed on Neose which are required to be
withheld or collected by Novo or its Sublicensees under the laws of any country from amounts owing
to Neose hereunder to the extent Novo, its Affiliates or Sublicensees pay such withholding taxes to
the appropriate governmental authority on behalf of Neose and promptly deliver to Neose a receipt
or other proof of payment of such taxes.

     5. INTELLECTUAL PROPERTY GRANTS AND RIGHT OF NEGOTIATION

          5.1 Neose Technology. Subject to the terms and conditions of this Agreement, Neose hereby
grants, and agrees to grant, to Novo, as of the Effective Date, the following rights and licenses:

               5.1.1 Exclusive License. As of the Effective Date, Neose hereby grants, and agrees to grant,
to Novo an exclusive (even as to Neose), royalty-bearing license under the Neose Intellectual
Property in the Field of Use during the Term, (i) to conduct research, sample, develop (including
clinical development), manufacture, make, use, market, promote, sell, offer for sale, have sold,
distribute, import and export New Products in the Territory, and (ii) to use the Reagents in the
Territory solely for the purpose of making New Products. Such license does not permit Novo (x) to
practice or use the Neose Intellectual Property outside the Field of Use or (y) to sublicense any
of its rights without the prior written approval of Neose, except as provided in Section
5.1.2.

               5.1.2 Limited Sublicense Rights. Novo shall be entitled to grant full sublicenses to its
Affiliates and limited sublicenses to its distribution, marketing and/or sales partners, in each
case, in compliance with the provisions of this Section 5.1.2 and Section 5.1.3.
In any sublicense granted under this Section 5.1.2 to a Third Party that is not an
Affiliate of Novo, Novo may grant the Sublicensee only the following rights: to market, promote,
sell, offer for sale, have sold, distribute, import and export New Products for Novo. Novo shall
not be entitled to disclose any Confidential Information of Neose to a non-Affiliate Sublicensee
under a sublicense permitted to be granted under this Section 5.1.2. Novo shall include in
each sublicense granted under this Section 5.1.2 all of the terms and conditions necessary
to ensure Novo’s compliance with this Agreement, and the provisions of Section 5.1.4 shall
apply to each sublicense granted under this Section 5.1.2.

               5.1.3 Required Agreement for Certain Proposed Sublicensees. Prior to entering into
discussions with any proposed sublicensee, Novo shall identify the proposed sublicensee to Neose.
If the proposed sublicensee is not an Affiliate of Novo, Novo shall obtain the approval of Neose
prior to entering into such discussions and shall obtain the proposed sublicensee’s execution and
delivery to Neose of a non-disclosure and non-use agreement substantially in the form attached
hereto as Exhibit 5.1.3. If the proposed sublicensee is an Affiliate of Novo, Novo may
enter into the proposed sublicense without obtaining the approval of Neose if: (i) the sublicense
between Novo and the Sublicensee/Affiliate provides that Neose is a third-party beneficiary of the
Sublicense, and (ii) Neose receives an original fully executed copy of the sublicense between Novo
and the Sublicensee/Affiliate within five (5) business days after its execution.

 
 

			
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               5.1.4 Liability. Novo shall remain primarily liable to Neose for the performance by each
Affiliate and Sublicensee in accordance with the terms and conditions of this
Agreement, and each sublicense shall terminate upon the termination of this Agreement or any
breach by the Sublicensee of the Required Agreement between Neose and the Sublicensee, if any.

               5.1.5 Reservation of Rights. Neose hereby reserves to itself all right, title and interest in
and to the Neose Intellectual Property not expressly granted in Section 5.1. Without
limiting the foregoing, in no event shall this Agreement be construed to prohibit Neose from
engaging in any of the following activities: (a) practicing the processes, methods and Know-How of
the Neose Intellectual Property outside of the Field of Use, including, without limitation, with
proteins that may be considered competitive with any of the New Products, subject, however, to
Novo’s rights with respect to Product-Candidates under Section 5.3; (b) developing, making,
using or selling proteins or Reagents, whether in conjunction with the Neose Intellectual Property
or otherwise, outside of the Field of Use; or (c) entering into and performing agreements with
Third Parties regarding any of the foregoing including, without limitation, research agreements,
development agreements and licensing agreements.

               5.1.6 Carved Factor VII Claim Licenses. Neose hereby grants, and agrees to grant, to Novo a
worldwide, exclusive (even as to Neose), perpetual, irrevocable, and royalty-bearing (subject only
to the payment of royalties in accordance with Section 4) license, with the right to sublicense, to
any Carved Factor VII Claims that do not constitute Novo Improvements for any and all purposes.
The royalties due with regard to the foregoing license shall be determined in accordance with
Section 4 of this Agreement. In addition to the foregoing, Neose hereby grants, and agrees to
grant, to Novo a worldwide, exclusive (even as to Neose), perpetual, irrevocable, and royalty-free
license, with the right to sublicense, to any Carved Factor VII Claims that constitute Novo
Improvements for any and all purposes.

          5.2 Novo Technology. Subject to the terms and conditions of this Agreement, and solely to the
extent necessary to enable Neose to carry out its obligations under the Work Plan, Novo hereby
grants to Neose, for the term of the Work Plan, a non-exclusive, royalty free, license under the
Novo Technology to use such Novo Technology for the sole purpose of carrying out its obligations
under the Work Plan. Novo shall retain at all times all of its rights, title and interest to the
Novo Technology.

          5.3 Licenses to Neose. Novo hereby grants, and agrees to grant, to Neose, a worldwide,
exclusive (even as to Novo) as to Neose Exclusive Compounds and non-exclusive as to all other
compounds, perpetual, irrevocable and royalty free license, with the right to sublicense, to Neose
License Claims as defined in clauses (i)-(iii) of Section 1.29, for any and all purposes, except in
connection with any and all forms of insulin or Novo Materials. Novo hereby grants, and agrees to
grant, to Neose, a worldwide, exclusive (even as to Novo), perpetual, irrevocable and royalty free
license, with the right to sublicense, to Neose License Claims as defined in clause (iv) of Section
1.29, for any and all purposes.

          5.4
Option and Right of First Negotiation

               5.4.1 Option. Neose hereby grants to Novo an option
to negotiate a worldwide license under the Neose Technology to conduct research,

 
 

			
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sample, develop (including clinical development), manufacture, make, use, market, promote, sell, offer for sale, have
sold, distribute, import and export each and every Product-Candidate. The option granted under
this Section 5.4.1 shall be exercisable by Novo, from time to time during the Term with
respect to each Product-Candidate, within fifteen (15) days after Novo receives notice of the
Product-Candidate from Neose.

               5.4.2 Negotiations. If Novo duly exercises its option under Section 5.4.1 with
respect to a Product-Candidate, the Parties shall enter into negotiations to consummate an
agreement, which would grant to Novo the license described in Section 5.4.1 with respect to
such Product-Candidate, upon commercially reasonable terms, to be negotiated promptly, diligently
and in good faith by the Parties. If the Parties shall not have entered into such a license within
****** after Novo’s exercise of its option with respect to such Product-Candidate, Neose shall be
free to proceed with the development and/or commercialization of the Product-Candidate, whether
alone or with a Third Party or Third Parties, without any further obligation to Novo with respect
to such Product-Candidate, except as provided in Section 5.4.3.

               5.4.3 Right of First Negotiation. During the Term, Neose shall not enter into an agreement
with a Third Party relating to the use of the Neose Technology for the further development and
commercialization of a Product-Candidate without first allowing Novo to enter into an agreement
with respect to such Product-Candidate upon substantially the same terms. If Neose shall not have
already offered (and Novo shall not have already refused) substantially the same terms to Novo
under Section 5.4.2, Neose shall provide notice to Novo of the proposed terms and
conditions of any such agreement, and Novo may exercise its right of first refusal under this
Section 5.4.3 by notice to Neose within ****** after receiving the proposed terms and
conditions from Neose. If Novo does not exercise its right of first refusal with respect to the
terms proposed by Neose, or exercises its right of first refusal but does not enter into an
agreement with Neose upon substantially the proposed terms within ****** after receipt thereof,
Neose shall be free to proceed with the further development and/or commercialization of such
Product-Candidate with a Third Party or Third Parties, upon terms no more favorable to the Third
Party or Third Parties than those offered to Novo, without any further obligation to Novo with
respect to such Product-Candidate.

          5.5 No Other Right or Licenses. Except for the rights and licenses expressly granted in this
Agreement, nothing in this Agreement shall be deemed to grant to any Party any other rights or
licenses, including, without limitation, any implied licenses.

     6. OWNERSHIP OF INTELLECTUAL PROPERTY

          6.1 No Transfer of Title. All Ownership Rights in and to the Neose Intellectual Property and
the Reagents shall remain at all times with Neose. All Ownership Rights in the Novo Materials, any
New Product, and the Novo Technology shall remain at all times with Novo, subject to Novo’s
obligation to assign certain Ownership Rights to Neose under Section 6.3.

          6.2 Improvements

               6.2.1 Neose Improvements. Subject to Section 6.3.1, any and all Neose Improvements shall
be
owned by Neose and shall be deemed to be part of the Neose Intellectual
Property for all purposes, including, without limitation, the license granted in Section
5.1. Except as provided in Section 6.4, any and all Improvements made, conceived, or
reduced to practice solely by Neose shall be owned solely by Neose.

 
 

			
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               6.2.2 Novo Improvements. Subject to Section 6.4.1, except as otherwise provided in
Section 6.3, any and all Novo Improvements shall be owned by Novo for all purposes. Except
as set forth in Section 6.3, any and all Improvements made, conceived, or reduced to
practice, solely by Novo shall be owned solely by Novo.

               6.2.3 Joint Improvements. Each of Neose and Novo shall own a one-half undivided interest in
any and all Joint Improvements. Neither Party shall be permitted to license or sublicense its
one-half undivided interest in any Joint Improvement(s) to a Third Party that is not an Affiliate
of Novo for use in connection with any blood factor products VII, VIII or IX, except with the prior
written approval of the other Party.

               6.2.4 Other Improvements. If any Improvements, other than Neose Improvements, Novo
Improvements and Joint Improvements, are made, conceived or reduced to practice jointly by Neose
and Novo under this Agreement, each Party shall own a one-half undivided interest in and to any and
all such Improvements and the Parties shall not have any restriction with respect to the use
thereof or any requirement to report or account to the other Party with respect to any such use,
unless and except to the extent that the Parties may agree otherwise in writing.

          6.3 Assignment by Novo.

               6.3.1 Neose Improvements. To the extent that Novo may retain any Ownership Rights in any
Neose Improvements during the Term, Novo hereby irrevocably assigns and transfers, and agrees to
assign and transfer, to Neose, at the request of Neose, any and all such Ownership Rights that have
not been licensed to Neose under Section 5.3, in perpetuity or for the longest period otherwise
permitted by law, without the necessity of further consideration, and Neose shall be entitled to
receive and hold in its own name all such Ownership Rights, subject to Neose’s obligations to
assign certain rights to Novo under Section 6.4.

               6.3.2 Joint Improvements. If and when Novo terminates the development of New Product during
the Term, Novo hereby irrevocably assigns and transfers, and agrees to assign and transfer to
Neose, in perpetuity or for the longest period otherwise permitted by law, without the necessity of
further consideration, and Neose shall be entitled to receive and hold in its own name all
Ownership Rights in and to the Joint Improvements. With respect to any Ownership Rights and
licenses that Novo is required to assign and transfer to Neose under this Section 6.3.2, at
the request of Neose, and at Neose’s expense, either before or after termination of the Term, Novo
shall assist Neose in acquiring and maintaining patent, copyright, trade secret and trademark
protection upon, and confirming Neose’s title in and to, any such respective Ownership Rights, and
Novo shall provide Neose appropriate documentation evidencing the licenses to which Neose is
entitled. Novo’s assistance shall include, but shall not be limited to, signing all applications,
and any other documents and instruments for patent, copyright and any other proprietary rights,
providing executed license documents, cooperating in legal proceedings, and taking any other
actions considered necessary or desirable by Neose. For the purpose of facilitating the above

 
 

			
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assignments, Novo agrees that any and all employees and contractors employed or engaged by Novo and
providing any service in connection with the Project, prior to providing such service, shall have
agreed in writing to covenants consistent with Novo’s covenants set forth in this Section
6.3.

          6.4
Assignment by Neose.

               6.4.1 Ownership Rights. To the extent that Neose may retain any
Ownership Rights in any Novo Improvements during the Term, Neose hereby irrevocably assigns and
transfers, and agrees to assign and transfer, to Novo, at the request of Novo, any and all such
Ownership Rights that have not been licensed to Novo in accordance with Section 5.1.6, in
perpetuity or for the longest period otherwise permitted by law, without the necessity of further
consideration, and Novo shall be entitled to receive and hold in its own name all such Ownership
Rights, subject to Novo’s obligations to assign or license certain rights to Neose under
Section 6.3. With respect to any Ownership Rights that Neose is required to assign and
transfer to Novo under this Section 6.4.1, at the request of Novo, and at Novo’s expense,
either before or after the Term, Neose shall assist Novo in acquiring and maintaining patent,
copyright, trade secret and trademark protection upon, and confirming Novo’s title in and to, any
such respective Ownership Rights. Neose’s assistance shall include, but shall not be limited to,
signing all applications, and any other documents and instruments for patent, copyright and any
other proprietary rights, cooperating in legal proceedings, and taking any other actions considered
necessary or desirable by Novo. For the purpose of facilitating the above assignments, Neose
agrees that any and all employees and contractors employed or engaged by Neose and providing any
service in connection with the Project, prior to providing such service, shall have agreed in
writing to covenants consistent with Neose’s covenants set forth in this Section 6.4.1.

               6.4.2 Carved Factor VII Claims. The parties will cooperate in good faith with each other in
identifying Potential Carved Factor VII Claims, and in drafting, filing and prosecuting Carved
Factor VII Claims.

                    6.4.2.1 The parties will each appoint a patent representative
(“Patent Representative”) for
the purpose of communicating with the other party regarding this Section 6.4.2 and Section 6.4.3,
and carrying out the purposes of these Sections. The Patent Representatives as of the Restatement
date are Carsten Hansen, Karin Nilsson, and Reza Green for Novo, and Rachel Rondinelli, Ph.D. for
Neose. The Patent Representatives will meet in person or by phone at least quarterly and will
attend Steering Committee meetings as appropriate.

                    6.4.2.2 Each party shall, at least once in each Calendar Year,
during the Term of this
Agreement, provide the other party with a list of public Patent Rights (Neose Patent Rights or
Patent Rights within Novo Technology supporting Neose License Claims, as the case may be) providing
relevant filing, priority, and status information (the “Patent Report”).

                    6.4.2.3 Each party shall provide the other party with timely
notification regarding any
information it becomes aware of during the Term of this Agreement that may reasonably considered to
impact the validity, enforceability, scope or term of any Neose Patent Rights
or Patent Rights within Novo Technology supporting Neose License Claims. Nothing in this

 
 

			
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Section 6.4.2.3 shall impose an obligation on either party to search, investigate or actively
discover any such information nor shall it obligate either party to perform any investigation or
inquiry with regard to any information it does become aware of.

                    6.4.2.4 Within thirty (30) days after the Restatement
Date, the Patent Representatives will
hold a meeting (in person or otherwise) to discuss the timing, logistics and other details
regarding the identification, in Neose Patents, of any Potential Carved Factor VII Claims and, as
soon as is practicable thereafter, will agree on any Carved Factor VII Claims to be filed and the
language therefor (the “Carved Claim Meeting”), and will hold such other meetings as appropriate at
the request of either party to agree upon future Carved Factor VII Claims. Unless otherwise
requested by Novo, Neose will notify Novo in a timely manner of the publication of any new patent
application containing subject matter supporting Potential Carved Factor VII Claims. Nothing in
this Section 6.4.2 creates an obligation for Neose to disclose any inventions to Novo other
than as would be required by other terms of this Agreement.

                    6.4.2.5 As soon as commercially practicable following the
Carved Claim Meeting and the
agreement upon Carved Factor VII Claims, Neose will, at Novo’s sole cost and expense, with respect
to any agreed-upon Carved Factor VII Claim, subject to this Section 6.4.2, file, prosecute,
maintain, and extend, in the jurisdictions chosen by Novo, one or more new or
continuation/divisional applications consisting of only composition-of-matter claims explicitly and
solely reciting and claiming Novo Materials with respect to the agreed-upon Carved Factor VII
Claims, claiming priority (each a “Carved Factor VII Claim Application”), as appropriate, to one or
more pending Neose patent applications.

                    6.4.2.6 Each Carved Factor VII Claim Application will be owned
by Neose and licensed to Novo
pursuant to Section 5.1.6 and, subject to Neose’s obligations in this Sections
6.4.2, managed by Neose throughout its prosecution and prosecuted by patent counsel appointed
by Neose.

                    6.4.2.7 With respect to all Carved Factor VII Claims, the
parties shall agree on the scope and
language of the claims to be filed. Neose will, within fourteen (14) calendar days after receipt,
provide Novo with copies of all correspondence from any patent authority or regulatory agency, and
any proceedings (including, but not limited to, opposition proceedings, interference proceedings,
protests in re-examination proceedings, and inter partes re-examination proceedings, and the like),
relating to filed Carved Factor VII Claims, and shall notify Novo in writing of any oral
communications regarding filed Carved Factor VII Claims within fourteen (14) days of any such
communications. Notwithstanding this Section 6.4.2 and 6.4.3, with respect to Restriction
Requirements, Neose will provide Novo with a copy of the patent authority communication and Neose’s
proposed response as soon as is commercially reasonable.

                    6.4.2.8 In connection with any proceedings before a patent
authority regarding any Carved
Factor VII Claims, Neose shall use Commercially Reasonable Efforts to (i)
provide Novo with a copy of any proposed filing with such patent authority regarding any
Carved

 
 

			
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Factor VII Claims, and, (ii) inform Novo of any planned, non-written substantive
communication to such patent authority in connection with any Carved Factor VII Claims, at least
fourteen (14) calendar days before the submission thereof or, where applicable, at least fourteen
(14) calendar days from the close of the initial (non-extended) response period therefor. The
Parties agree that notifications under this Section shall be subject to receipt of information from
outside patent counsel, and that Neose shall use Commercially Reasonable Efforts to effectuate
these notifications, but in no case shall Novo be notified less than fourteen (14) calendar days
before the final non-extendable response deadline.

                    6.4.2.9 Novo may provide to Neose proposals for
(i) additions, modifications, or deletions in
Neose’s proposed responses and (i) adoption of a strategy in prosecution, such as acceleration of
prosecution, with respect to Carved Factor VII Claims. Neose will include, in any future-filed
patent applications that could support Potential Carved Factor VII Claims, any general Factor
VII-related disclosure provided and periodically updated by Novo.

                    6.4.2.10 Neose shall provide Novo with copies of all written
submissions to Patent Authorities
in connection with Carved Factor VII Claims in a timely manner and shall provide, upon Novo’s
reasonable request, any or all materials previously filed with any patent authority in connection
with the subject matter of Carved Factor VII Claims.

                    6.4.2.11 Neose shall not disclaim any subject matter in any
Patent Right solely and
specifically reciting Carved Factor VII Claims without Novo’s written consent, which shall not be
unreasonably withheld.

                    6.4.2.12 Neose and Novo will continue to cooperate during the
prosecution of each Carved
Factor VII Claim Application, and endeavor to agree on prosecution strategy. The Patent
Representatives will discuss, consider and agree on additions, modifications or deletions with
respect to filed Carved Factor VII Claims. All of the activities undertaken by the parties
pursuant to this Section 6.4.2, including the prosecution of all Carved Factor VII Claim
Applications, shall be at Novo’s sole expense. Neose shall invoice Novo for any expenses incurred
in the conduct of any activity and Novo shall pay Neose within thirty (30) days after the date of
such invoice.

                    6.4.2.13 Novo may, at its sole discretion, seek, or direct
Neose (at the sole cost and expense
of Novo) to seek where appropriate, an extension of the term of any Carved Factor VII Claim
covering a New Product (including, without limitation, filing for patent term restoration under the
U.S. Patent Statutes (35 U.S.C. §§1-376) and seeking supplementary protection certificates in the
member states of the European Union or European Economic Area, or Switzerland). Neose will not
seek an extension of the term of any Carved Factor VII Claims without Novo’s prior written consent.

                    6.4.2.14 Novo hereby authorizes Neose to act as its agent
before any patent authority in
connection with seeking an extension under Section 6.4.2.13 and agrees that Neose is
entitled to rely on any activities of Novo as a marketing applicant before any regulatory

 
 

			
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agency in any seeking of an extension of any patent for a New Product. The Parties shall, at Novo’s sole
cost and expense, cooperate with any efforts to extend the term of such patent for a New Product,
including diligently supplying all information relating to such extension, and executing supporting
documents required to comply with all laws pertaining to the extension of patent term.

                    6.4.2.15 In the event the Patent Representatives are unable to
agree upon (i) a Carved Factor
VII Claim, (ii) the scope, language or prosecution strategy therefor, or (iii) any other matter
under this Section 6.4.2, the parties will do the following to resolve the dispute:

                         (a) Any disagreement will be
referred to the Steering Committee for a period of 15 business
days.

                         (b) If the Steering Committee is
unable to resolve the dispute within such 15 business day
period, the dispute will be referred to the Designated Representatives of the parties for
resolution. If the dispute is not resolved by the Designated Representatives within 15 business
days, the dispute may be referred to arbitration in accordance with Section 13.2.

               6.4.3 Neose License Claims. The parties will cooperate in good faith with each other in
identifying Neose License Claims, and in drafting, filing and prosecuting Neose Improvement Claims.

                    6.4.3.1 Novo will notify Neose of any Patent Rights containing
Neose License Claims not
constituting Neose Improvement Claims (each an “Other Neose License Claim”) promptly upon
publication of any patent application containing Neose License Claims. Novo’s Patent
Representative will keep Neose’s Patent Representative fully-informed about the status of any
filing containing Other Neose License Claims.

                    6.4.3.2 The Patent Representatives will meet in person or by
phone at least quarterly, but
more often if necessary, (each such meeting a “Neose Improvement Meeting”) to discuss the timing,
logistics and other details regarding the identification, of any Neose Improvement Claims and, as
soon as is practicable thereafter, will agree on the specific claims to be filed and the language
therefor.

                    6.4.3.3 As soon as commercially practicable following each
Neose Improvement Meeting and the
agreement upon Neose Improvement Claims to be filed, Novo will, at Neose’s sole cost and expense,
with respect to any agreed-upon Neose Improvement Claim, subject to this Section 6.4.3,
file, prosecute, maintain, and extend, in the jurisdictions chosen by Neose, one or more new or
continuation/divisional applications consisting only of the agreed-upon Neose
Improvement Claims, claiming priority (each a “Neose Improvement Claim Application”), as
appropriate, to one or more pending Novo patent applications.

 
 

			
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                    6.4.3.4 Each Neose Improvement Claim Application will be owned
by Novo and licensed to Neose
pursuant to Section 5.3 and, subject to Novo’s obligations in this Section 6.4.,
managed by Novo throughout its prosecution and prosecuted by patent counsel appointed by Novo.

                    6.4.3.5 With respect to all Neose License Claims, the parties
shall agree on the scope and
language of the claims to be filed. Novo will, within fourteen (14) calendar days after receipt,
provide Neose with copies of all correspondence from any patent authority or regulatory agency, and
any proceedings (including, but not limited to, opposition proceedings, interference proceedings,
protests in re-examination proceedings, and inter partes re-examination proceedings, and the like),
relating to filed Neose Improvement Claims, and shall notify Neose in writing of any oral
communications regarding filed Neose License Claims within fourteen (14) days of any such
communications. Notwithstanding this Section 6.4.2 and 6.4.3, with respect to Restriction
Requirements, Novo will provide Neose with a copy of the patent authority communication and Novo’s
proposed response as soon as is commercially reasonable.

                    6.4.3.6 In connection with any proceedings before a patent
authority regarding any Neose
License Claims, Novo shall use Commercially Reasonable Efforts to (i) provide Neose with a copy of
any proposed filing with such patent authority regarding any Neose License Claims, and, (ii) inform
Neose of any planned, non-written substantive communication to such patent authority in connection
with any Neose License Claims, at least fourteen (14) calendar days before the submission thereof
or, where applicable, at least fourteen (14) calendar days from the close of the initial
(non-extended) response period therefor. The Parties agree that notifications under this Section
shall be subject to receipt of information from outside patent counsel, and that Novo shall use
Commercially Reasonable Efforts to effectuate these notifications but in no case shall Neose be
notified less than fourteen (14) calendar days before the final non-extendable response deadline.

                    6.4.3.7 Neose may provide to Novo proposals for
(i) additions, modifications, or deletions in
Novo’s proposed responses and (i) adoption of a strategy in prosecution, such as acceleration of
prosecution, with respect to Neose License Claims. Novo will include, in any future-filed patent
applications that could support Neose License Claims, any general Neose Technology-related
disclosure provided and periodically updated by Neose.

                    6.4.3.8 Novo shall provide Neose with copies of all written
submissions to Patent Authorities
in connection with Neose License Claims in a timely manner and shall provide, upon Neose’s
reasonable request, any or all materials previously filed with any patent authority in connection
with the subject matter of Neose License Claims.

                    6.4.3.9 Novo shall not disclaim any subject matter in any
Patent Right solely and specifically
reciting Neose Improvement Claims without Neose’s written consent, which shall not be unreasonably
withheld.

 
 

			
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                    6.4.3.10 Novo and Neose will continue to cooperate during the
prosecution of each Neose
Improvement Claim Application, and endeavor to agree on prosecution strategy. The Patent
Representatives will discuss, consider and agree on additions, modifications or deletions with
respect to filed Neose License Claims. All of the activities undertaken by the parties pursuant to
this Section 6.4.3, including the prosecution of all Neose Improvement Claim Applications,
shall be at Neose’s sole expense. Novo shall invoice Neose for any expenses incurred in the
conduct of any activity and Neose shall pay Novo within thirty (30) days after the date of such
invoice.

                    6.4.3.11 Neose may, at its sole discretion, seek, or direct
Novo (at the sole cost and expense
of Neose) to seek where appropriate, an extension of the term of any Other Neose License Claim
solely and specifically reciting a Neose Exclusive Compound or any Neose Improvement Claim
(including, without limitation, filing for patent term restoration under the U.S. Patent Statutes
(35 U.S.C. §§1-376) and seeking supplementary protection certificates in the member states of the
European Union or European Economic Area, or Switzerland). Novo will not seek an extension of the
term of any Neose License Claim to which Neose has an exclusive license under Section 5.3 without
Neose’s prior written consent.

                    6.4.3.12 Neose hereby authorizes Novo to act as its agent
before any patent authority in
connection with seeking an extension under Section 6.4.3.11 and agrees that Novo is
entitled to rely on any activities of Neose as a marketing applicant before any regulatory agency
in any seeking of an extension of any patent for a product containing a Neose Exclusive Compound.
The Parties shall cooperate, at Neose’s sole cost and expense, with any efforts to extend the term
of such patent for a product containing a Neose Exclusive Compound, including diligently supplying
all information relating to such extension, and executing supporting documents required to comply
with all laws pertaining to the extension of patent term.

                    6.4.3.13 In the event the Patent Representatives are unable to
agree upon (i) a Neose License
Claim, (ii) the scope, language or prosecution strategy therefor, or (iii) any other matter under
this Section 6.4.3, the parties will do the following to resolve the dispute:

                         (a) Any disagreement will be
referred to the Steering Committee for a period of 15 business
days.

                         (b) If the Steering Committee is
unable to resolve the dispute within such 15 business day
period, the dispute will be referred to the Designated Representatives of the parties for
resolution. If the dispute is not resolved by the Designated Representatives within 15 business
days, the dispute may be referred to arbitration in accordance with Section 13.2.

          6.5 Prosecution and Maintenance of Patent Rights

               6.5.1 Solely Owned Patent Rights. Subject to Sections 6.4.2 and 6.4.3, each Party shall,
in
its sole discretion, prepare, file, prosecute and maintain all patent applications

 
 

			
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and patents covering its Patent Rights and Improvements that the Party owns pursuant to Section 6.
Neose shall use reasonable commercial efforts to provide to Novo for review and comment, at least
ten (10) days prior to filing, all patent claims relating specifically to the New Product to be
filed by Neose, and Neose shall give due consideration to all comments thereon that are made by
Novo within the period ending two days before the proposed filing date.

               6.5.2 Patent Rights with Respect to Joint Improvements. With respect to Joint Improvements,
the Parties shall meet to determine whether patent protection is appropriate and, if so, in which
countries, if any, patent applications claiming such joint inventions and discoveries should be
filed. Novo shall file, prosecute, and maintain, at its expense, such joint patent applications.
Novo may at any time, in its sole discretion, discontinue the preparation, prosecution or
maintenance of such joint patent applications, in which case Novo will give Neose sufficient notice
to enable Neose to, and Neose may, file, prosecute and maintain such applications.

     6.6 Enforcement of Ownership Rights

               6.6.1 Reports of Infringement. Each Party shall promptly report in writing to the other
during the Term any infringement or misappropriation or suspected infringement or misappropriation
of any of the Neose Technology, Neose License Claims or Carved Factor VII Claims of which such
Party becomes aware and shall provide the other Party with its full cooperation in the protection
and enforcement of the affected intellectual property and all available evidence supporting said
infringement, misappropriation, suspected infringement or unauthorized use or misappropriation.
Neose shall reimburse Novo for its reasonable, documented costs of such cooperation with regard to
Neose Technology and Neose License Claims, unless such infringement or misappropriation is by an
Affiliate or Sublicensee of Novo and Novo shall reimburse Neose for its reasonable, documented
costs of such cooperation with regard to Carved Factor VII Claims, unless such infringement or
misappropriation is by an Affiliate or Sublicensee of Neose.

               6.6.2 Right to Institute Suit. Neose shall have the sole right to initiate an infringement or
other appropriate suit against any Third Party who at any time has infringed or is suspected of
infringing or misappropriating, the Neose Technology and any Neose Improvement Claims and Novo
shall have the sole right to initiate an infringement or other appropriate suit against any Third
Party who at any time has infringed or is suspected of infringing or misappropriating, the Carved
Factor VII Claims and any Other Neose License Claims. Prior to initiating any such suit, the
Designated Representatives shall consult with each other on an expedited basis, and the party
initiating such suit (as such the “Enforcing Party”) shall give due consideration to any reasonable
requests the other party may make relating to the advisability of bringing the suit. The Enforcing
Party shall not enter into any settlement, consent judgment or other voluntary final disposition of
such suit that would adversely affect the other party’s rights under this Agreement without the
other party’s prior written consent, which consent shall not be unreasonably withheld with the
proviso that no such consent will be required in the case of a settlement by Novo related to
Carved Factor VII Claims unless such settlement could have an adverse effect on any of Neose’s
Patent Rights. In the event that the Enforcing Party recovers any sums in such suit by way of damages or in settlement thereof, the Enforcing Party shall be entitled to retain the same.

 
 

			
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               6.6.3 Cooperation. In a suit initiated by one party, if it is legally required for the other
party to join any such suit, or if failure of the other party to join such suit would result in
dismissal thereof, the other party shall waive any objection to such joinder on the grounds of
personal jurisdiction, venue or forum non conveniens and shall execute all papers and perform such
other acts as may be reasonably required to permit the litigation to be conducted.

               6.6.4 Continued Infringement.

                    6.6.4.1 If Neose fails to either bring suit against or enter
into negotiations for settlement
with such Third Party within six (6) months after receipt of notice of such infringement and Novo
is of the opinion that the alleged infringement or misappropriation of Neose Technology is
occurring in the Field of Use then, upon Novo’s written request, the Parties shall seek the opinion
of patent counsel acceptable to both Parties as to whether there has been or continues to be a
misappropriation or infringement of the Neose Technology in the Field of Use by such Third Party.
If such patent counsel concurs with Novo’s opinion, Novo shall have the right, but not the
obligation, to bring suit against such Third Party under the Neose Technology and to join Neose as
a party plaintiff. Neose will cooperate with Novo in any such suit brought against a Third Party
and shall have the right to consult with Novo and to participate in and be represented by counsel
in such suit at its own expense. In the event that Novo recovers any sums in such suit by way of
damages or in settlement thereof, such sums shall be used first to reimburse each of Novo and Neose
for their documented, out-of-pocket legal expenses, with Novo retaining any remaining amounts.

                    6.6.4.2 If Novo fails to either bring suit against or enter
into negotiations for settlement
with such Third Party within six (6) months after receipt of notice of such infringement and Neose
is of the opinion that the alleged infringement or misappropriation of the relevant Neose License
Claims is occurring with regard to a Neose Exclusive Compound then, upon Neose’s written request,
the Parties shall seek the opinion of patent counsel acceptable to both Parties as to whether there
has been or continues to be a misappropriation or infringement of the Neose License Claims that
affects a Neose Exclusive Compound by such Third Party. If such patent counsel concurs with Neose’s
opinion, Neose shall have the right, but not the obligation, to bring suit against such Third Party
under the Neose License Claims and to join Novo as a party plaintiff. Novo will cooperate with
Neose in any such suit brought against a Third Party and shall have the right to consult with Neose
and to participate in and be represented by counsel in such suit at its own expense. In the event
that Neose recovers any sums in such suit by way of damages or in settlement thereof, such sums
shall be used first to reimburse each of Neose and Novo for their documented, out-of-pocket legal
expenses, with Neose retaining any remaining amounts.

     6.7 Novo Trademarks. Subject to its assignment obligations under Section 6.3.2, Novo
shall select and own the trademarks for marketing the New Products in
the Territory. All expenses for (i) registration of such trademarks, and (ii) bringing, maintaining and prosecuting any action
to protect or defend such trademarks, shall be borne by Novo, and Novo shall retain all recoveries
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     7. BLOCKING PATENTS

          7.1 Mutual Information. Each Party shall immediately notify the other if a claim or other
proceedings are brought against either Party alleging that the use of the Neose Technology in
making, using or selling the New Product infringes upon the Patent Rights of a Third Party.

          7.2 Defense of Third Party Action. If claims or proceedings are brought against Novo by a
Third Party alleging that the use of the Neose Technology to produce a New Product infringes upon
the Patent Rights of a Third Party, the Designated Representatives shall consult on an expedited
basis, and Neose shall give due consideration to any reasonable request of Novo relating to the
proposed defense or settlement of such claims or proceedings. Subject to Section 7.4, the
final decision whether or not and, as the case may be, how to defend or settle such claims or
proceedings shall be with Neose. Neose shall immediately notify Novo of such decision sufficiently
in advance of any deadlines by which formal responses are due in any such proceedings to enable
Novo to undertake its own defense and Novo shall have the right to join any such proceedings as a
party thereto at its own expense by counsel of its own choice. Each Party shall provide the other
with such assistance as is reasonably necessary and shall cooperate in the defense of any such
action or proceeding. Neose shall not enter into any settlement, consent judgment, or other
voluntary final disposition of such suit that would adversely affect Novo’s rights under this
Agreement or which would result in Novo being liable for damages, without Novo’s prior written
consent, which consent shall not be unreasonably withheld.

          7.3 Declaratory Judgment Action. Neose shall have the right, but not the obligation, to file
any declaratory judgment action in any court of competent jurisdiction as to questions of validity
or infringement of any Third Party patent relating to the use of the Neose Technology.

               7.3.1 Cooperation. The Parties shall closely cooperate in any such declaratory judgment
action. In conducting such action, the Parties shall render each other all reasonable assistance,
free of charge. The final strategy in such action shall be determined by Neose and Neose’s legal
counsel in coordination with Novo and any additional legal counsel of Novo.

               7.3.2 Costs. Subject to Article 11 hereof, each Party shall bear its own costs and
expenses
incurred in connection with actions pursuant to Sections 7.2 and 7.3.

 
 

			
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          7.4 Third-Party Licenses

               7.4.1 Novo Third-Party Licenses. In the event that Novo is of the opinion, at any time during
the Term, that a license under any Blocking Patent is necessary or advisable for purposes of
enabling Novo to exercise its license rights under Section 5.1.1, it shall notify Neose.
The Parties shall then seek an opinion of patent counsel acceptable to both Parties. If such patent
counsel concurs with Novo’s opinion, Novo and Neose shall co-operate to obtain such a license for
the benefit of Novo and, as the case may be, also for Neose, in accordance with the following
provisions:

                    7.4.1.1 Neose shall be primarily responsible for obtaining any
such Third Party license at its
own expense. The matter shall be deemed resolved if Neose is granted a license, ******, under the
relevant Blocking Patent that would make the continued exercise of the rights granted to Novo by
Neose hereunder non-infringing with respect to ******. ****** shall be solely responsible for
****** under such license.

                    7.4.1.2 However, in the event that Neose is unable to resolve
the matter in accordance with
Section 7.4.1.1 within one hundred twenty (120) days from receipt of notice from Novo upon
terms that are commercially reasonable to Neose at Neose’s discretion, then Novo shall be entitled
to negotiate a license in favor of Novo under such Blocking Patents; provided that to the extent
that Novo must ****** under such license, Novo may ****** payments owed under Sections 4.1 or
4.2, provided that no payment owed under Section 4.1 or 4.2 shall be ****** more than
****** as a result of the operation of this Section 7.4.1.2.

                    7.4.1.3 In relation to the negotiation and contracting of any
such Blocking Patent license,
the provisions of this Section 7.4 shall prevail over the provisions of Sections 7.2
and 7.3.

     8. SUPPLY AGREEMENT

     No later than ****** after Novo accepts the ****** , the Parties will execute and deliver the
Supply Agreement under which Neose will be a supplier to Novo of the Reagents needed to produce New
Products in the Field of Use. Pricing for Reagents will be based on Neose’s ******. The Parties
acknowledge and agree that Novo plans to have two production sites for the supply of Reagents and
that the costs of technology transfer to Novo or any approved Sublicensee will be borne by Novo.

     9. CONFIDENTIALITY

          9.1 Confidential Information. With respect to any and all Confidential Information received
by one Party under this Agreement and/or during the course of the Project, (the “Recipient”) from
the other Party (the “Disclosing Party”) at any time and from time to time prior to
the Effective Date or during the Term, the Recipient for a period of five (5) years from the
expiration or earlier termination of this Agreement: (a) shall maintain the secrecy of, and hold in
strict

 
 

			
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confidence, the Confidential Information received hereunder; (b) shall not use such
Confidential Information for any other purpose other than in furtherance of this Agreement; and (c)
shall not, without express written authorization from the Disclosing Party, use, disclose or grant
the use of such Confidential Information to any other Persons except to those of the Recipient’s
directors, officers, employees, and advisors to whom such disclosure is reasonably necessary in
furtherance of this Agreement and each of whom is otherwise bound to Recipient by contract or legal
or fiduciary obligation at the time of such disclosure to maintain the secrecy of, and hold in
confidence, such Confidential Information. The Recipient shall notify the Disclosing Party
promptly upon discovery of any unauthorized use or disclosure of the Disclosing Party’s
Confidential Information.

          9.2 Permitted Disclosures. The obligations set forth in Section 9.1 shall not apply
to the extent that the Recipient: (a) is required to disclose information by law, order or
regulation of a governmental agency or a court of competent jurisdiction, provided that the
Recipient shall provide written notice thereof and sufficient opportunity to the Disclosing Party
to object to any such disclosure or to request confidential treatment thereof; or (b) can
demonstrate that: (i) the information was public knowledge or generally known by publication in
scientific or other journals or other public media at the time of such disclosure to the Recipient
or thereafter became public knowledge or generally known other than as a result of acts directly or
indirectly attributable to the Recipient in violation hereof; (ii) the information was rightfully
known by the Recipient (as shown by its written records) prior to the date of disclosure to the
Recipient by the Disclosing Party under this Agreement; (iii) the information was disclosed to the
Recipient on an unrestricted basis by a Third Party not under a duty of confidentiality to the
Disclosing Party, or (iv) the information was independently developed by Recipient (as shown by its
written records) without any use of or access to information of the Disclosing Party. In addition,
provided that Neose maintains the confidentiality of Novo’s name, with the prior approval of Novo,
which approval will not be unreasonably withheld, Neose will have the right to use data about Novo
Materials and New Product (i) to support a patent application by Neose, and (ii) for promotional
purposes, subject to compliance with any publication plan for the development of the New Product
that shall have been approved by the Steering Committee.

          9.3 Enforcement. 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 Disclosing Party agrees that if the Recipient breaches any of such covenants, the
Disclosing Party will have available, in addition to any other right or remedy available, the right
to obtain an injunction from a court of competent jurisdiction restraining such breach or
threatened breach and to specific performance of any such provision of this Agreement. Both
Parties further agrees that no bond or other security shall be required in obtaining such equitable
relief and each Party hereby consents to the issuance of such injunction and to the ordering of
specific performance.

          9.4 Publicity. Except as required by law, all publicity, press releases and other
announcements relating to this Agreement or the transactions contemplated hereby, shall be reviewed
in advance by, and shall be subject to the reasonable approval of, both Parties.

 
 

			
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     10. REPRESENTATIONS AND WARRANTIES

          10.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the
other that:

                 10.1.1 The execution, delivery and performance of this Agreement by it have been
duly
authorized by all requisite corporate action, and this Agreement has been duly executed and
delivered by and on behalf of such Party.

                 10.1.2 The execution, delivery and performance by such Party of this Agreement
does not (i)
conflict with or violate any applicable statute, law, rule or regulation, (ii) conflict with or
violate its charter, bylaws or other organizational document, or (iii) conflict with or constitute
a default under any contract or agreement of such Party.

          10.2 Representations and Warranties of Neose. Neose warrants to Novo, as of the Effective and
Restatement Date, that:

                10.2.1 It is a corporation duly incorporated, validly existing and in good standing
under the
laws of the State of Delaware, with the power and authority to sign, deliver and perform all of its
obligations under this Agreement.

                10.2.2 It is the sole and exclusive owner of the Neose Patents, or otherwise Controls
the
Neose Patents, and has the full corporate power and authority to grant the licenses granted
hereunder.

                 10.2.3 To Neose’s knowledge, the use of the Neose Technology pursuant to the
terms of this
Agreement does not infringe upon the rights of any Third Party.

                 10.2.4 To Neose’s knowledge, there is no Blocking Patent that, if asserted
by Third Parties,
would prevent Novo from using the Neose Technology to make New Products hereunder.

                 10.2.5 To Neose’s knowledge, no claims or proceedings have been brought by
Third Parties
alleging the invalidity in whole or in part of any of the Neose Patents.

          10.3 Representations and Warranties of Novo. Novo warrants to Neose, as of the Effective and
Restatement Date, that:

                 10.3.1 Novo Nordisk A/S is a corporation duly incorporated, validly existing and
in good
standing under the laws of the Kingdom of Denmark, with the power and authority to sign, deliver
and perform all of its obligations under this Agreement.

                 10.3.2 Novo Nordisk Health Care AG is a corporation duly incorporated, validly
existing and in
good standing under the laws of Switzerland, with the power and authority to sign, deliver and
perform all of its obligations under this Agreement.

                 10.3.3 It is the sole and exclusive owner of the Novo Technology, and has the
full corporate
power and authority to grant the licenses granted hereunder.

                 10.3.4 To Novo’s knowledge, the use of the Novo Technology pursuant to the
terms of this
Agreement does not infringe upon the rights of any Third Party.

 
 

			
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               10.3.5 To Novo’s knowledge, there is no Blocking Patent that, if asserted by Third
Parties,
would prevent Neose from using the Novo Technology to perform its activities under the Work Plan.

               10.3.6 To Novo’s knowledge, no claims or proceedings have been brought by Third Parties
alleging the invalidity in whole or in part of any of the Novo Technology.

               10.3.7 To Novo’s knowledge, Novo has disclosed to Neose, and Section 16.2
lists, all
Patent Rights of Novo supporting any claims relating to any of (i) any methods of ******; and (ii)
any ****** derived from or used in the practice of such methods described in clause (i) above, as
well as all patent claims arising out of, enabled by, infringing or otherwise covering the Neose
Technology or Neose Improvements filed by Novo.

          10.4 Disclaimer of Warranties. EXCEPT FOR THE WARRANTIES SET FORTH IN SECTION 11.3,
EACH PARTY HEREBY DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
TITLE OR NON-INFRINGEMENT.

          10.5 Acknowledgment by Novo. Novo acknowledges and hereby agrees that Neose makes no
representations or warranties as to the outcome of the Project, including without limitation
whether the application of the Neose Technology will improve any of the Novo Materials.

     11. INDEMNIFICATIONS AND LIMITED LIABILITY

          11.1 Indemnification by Neose. Neose shall indemnify, defend and hold harmless Novo and its
Affiliates, and each of their respective employees, officers, directors and agents (each, a “Novo
Indemnified Party”) from and against any and all claims, suits, losses, obligations, damages,
deficiencies, costs, penalties, liabilities (including strict liabilities), assessments, judgments,
amounts paid in settlement, fines, and expenses (including court costs and reasonable fees of
attorneys and other professionals) (individually and collectively, “Losses”) resulting from or
arising in connection with (i) the breach by Neose of any of its representations or warranties
contained in Section 10, (ii) any claim by a Third Party alleging that the use of the Neose
Technology infringes upon the Patent Rights of such Third Party, and (iii) any activities of Neose
under this Agreement. Notwithstanding the foregoing, Neose shall have no obligation to indemnify,
defend or hold harmless a Novo Indemnified Party for any Losses to the extent that such Losses were
caused by (x) the negligence or willful misconduct of any of the Novo Indemnified Parties, or (y) a
breach by Novo of any of its representations and warranties set forth in Section 10.

          11.2 Indemnification by Novo. Novo shall indemnify, defend and hold harmless Neose and its
Affiliates, and each of their respective employees, officers, directors and agents (each, a
“Neose Indemnified Party”) from and against any and all Losses resulting from or arising in
connection with (i) the breach by Novo of any of its representations and warranties set forth in
Section 10, (ii) the failure of any Affiliate to comply with any obligation of Novo
applicable to the

 
 

			
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Affiliate under this Agreement, (iii) the failure of any Sublicensee to comply
with any obligation under a sublicense granted by Novo hereunder, (iv) the promotion, distribution,
use, testing, marketing, sale, or other disposition of any New Product, (v) any claim by a Third
Party alleging that the use of the Novo Technology or the manufacture, sale or use of New Products
infringes upon the Patent Rights of such Third Party, except to the extent such claims arise solely
as a result of the use of Neose Technology, and (vi) any activities of Novo under this Agreement.
Notwithstanding the foregoing, Novo shall have no obligation to indemnify, defend or hold harmless
a Neose Indemnified Party for any Losses to the extent that such Losses were caused by (x) the
negligence or willful misconduct of Neose, its Affiliates, sublicensees, or any of their respective
employees, officers, directors, or agents, or (y) a breach by Neose of any of its representations
and warranties set forth in Section 10.

               11.3 Indemnification Procedure. Each Party shall provide prompt written notice to the other
of any actual or threatened Loss or claim therefor of which the other becomes aware; provided that
the failure to provide prompt written notice shall only be a bar to recovering Losses to the extent
that a Party was prejudiced by such failure. In the event of any such actual or threatened Loss or
claim therefor, each Party shall provide the other information and assistance as the other shall
reasonably request for purposes of defense and each Party shall receive from the other all
necessary and reasonable cooperation in such defense including, but not limited to, the services of
employees of the other Party who are familiar with the transactions or occurrences out of which any
such Loss may have arisen. Each Party shall have the right to participate in and with respect to
the defense of any Loss or Losses with counsel of its choosing whose fees shall be borne by the
Party with liability for indemnification under Sections 11.1 or 11.2, as the case may be,
and no Party shall have the right to settle any claim or agree to the entry of any judgment or
other relief without the prior consent of the other Party, which consent shall not be withheld
unreasonably.

               11.4 Consequential Damages. NEITHER PARTY SHALL HAVE ANY LIABILITY TO THE OTHER PARTY FOR ANY
SPECIAL, INDIRECT, CONSEQUENTIAL, EXEMPLARY, PUNITIVE OR INCIDENTAL DAMAGES SUFFERED BY SUCH OTHER
PARTY AND ARISING OUT OF OR RELATED TO THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY (INCLUDING NEGLIGENCE), INCLUDING, WITHOUT LIMITATION, LOST PROFITS, AND WHETHER OR NOT
SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

               11.5 Insurance. During the term of the Supply Agreement, Neose agrees to obtain and maintain
commercial general liability insurance with reputable and financially secure insurance carriers to
cover the use of the Neose Technology in New Products, with limits of not less than ****** per
occurrence and ****** in the aggregate. Novo agrees to maintain during the Term commercial general
liability insurance with limits of not less than ****** per occurrence and ****** in the aggregate
to cover its indemnification obligations under Section 11.2. In addition, Novo agrees to
maintain during the Term clinical trials insurance and product liability insurance with limits
reasonable to cover its indemnification obligations under Section 11.2. All insurance
shall be procured with reputable and financially secure insurance carriers.

 
 

			
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     12. TERM AND TERMINATION

          12.1 Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and,
unless sooner terminated in accordance with Section 12.2, shall terminate on the expiration
of the last to expire patent included in the Neose Technology incorporating a Valid Patent Claim
that would be infringed by making, using, selling, offering to sell, importing or exporting New
Product, after which Novo shall have a perpetual, fully paid up, royalty free, exclusive (even as
to Neose) license to commercialize New Product.

          12.2 Termination

               12.2.1 Termination of Project Plan. If the Project is terminated by mutual agreement, this
Agreement will automatically terminate.

               12.2.2 No Commercial Sale. If after achievement of the milestone described in Section
3.2.2, Novo ceases to exert Commercially Reasonable Efforts toward the development or
commercialization of New Product or wishes to terminate the development of New Product before
Regulatory Approval of New Product for reasons other than toxicology findings, lack of clinical
efficacy, side effects, lack of stability of formulation of the New Product, or regulatory
restrictions relating, in each case, to New Product, Novo shall provide notice thereof to Neose,
specifying the reasons therefor, together with a termination fee of ******, and this Agreement will
terminate upon receipt by Neose of such notice and payment from
Novo.

               12.2.3 Termination for Cause.

                    12.2.3.1 Breach. A Party shall have the right to terminate this
Agreement at any time for a
material breach of this Agreement by the other Party upon written notice by the non-breaching Party
to the other Party describing such breach in reasonable detail and stating the non-breaching
Party’s intention to terminate this Agreement, provided that the other Party shall have a period of
****** from the date of such notice to cure the breach, or, if such breach is not susceptible of
being cured within such ****** period, and the breaching Party utilizes diligent good faith efforts
to cure such breach, then such period shall be extended to ******. If such breach is cured within
the applicable period, the termination notice shall become ineffective. Otherwise, the termination
shall become effective upon the expiration without cure of the applicable period.

                    12.2.3.2 Bankruptcy. A Party shall have the right to terminate
this Agreement at any time
upon the filing or institution of bankruptcy, reorganization, liquidation or receivership
proceedings, or upon an assignment of a substantial portion of the assets of the benefit of
creditors by the other Party, or in the event a receiver or custodian is appointed for such Party’s
business, or if a substantial portion of such Party’s business is subject to attachment or similar
process; provided, however, that in the case of any involuntary bankruptcy proceeding, such right
to terminate shall only become effective if the proceeding is not dismissed within ****** after
the filing thereof.

                    12.2.3.3 Termination by Novo. Novo may terminate this Agreement
at any time without cause
upon ****** prior written notice to Neose of such termination, provided that Novo shall pay to
Neose one hundred percent (100%) of all documented Neose Project-Related Costs and any other costs
incurred or accrued by Neose prior to the effective date of such termination for the conduct of the
Work Plan through the date of termination.

 
 

			
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          12.3 Effect of Termination or Expiration

               12.3.1 Prior Obligations. Termination or expiration of this Agreement shall not relieve the
Parties of any obligation arising prior to the effective date of such termination or expiration and
shall not constitute a waiver of any right of the Parties under this Agreement as a result of
breach or default.

               12.3.2 Confidential Information. Upon the termination or expiration of this Agreement, each
Recipient shall, as the Disclosing Party may direct, destroy or return to the Disclosing Party
promptly all tangible materials provided to Recipient by the Disclosing Party that embody the
Disclosing Party’s Confidential Information and shall erase or delete all of the Disclosing Party’s
Confidential Information embodied in any magnetic, optical or intangible medium or stored or
maintained on any information storage and/or retrieval device, and deliver to the Disclosing Party
a certification of such destruction, return, erasure or deletion signed by an officer of the
Disclosing Party.

               12.3.3 Survival. No termination under this Agreement shall constitute a waiver of any rights
or causes of action that either Party may have for any acts or omissions or breach under this
Agreement by the other Party prior to the termination date. The following Sections of this
Agreement shall survive the expiration or any termination of this Agreement in accordance with
their respective meanings: Sections 4.8, 5.1.2, 5.1.6, 5.2.2, 5.3, 5.5, 6, 9, 11, 12, 13, 15.1,
15.2, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 17.10, 17.11, 17.13, 17.14 and any
other provision required to interpret this Agreement or any of the surviving provisions.

               12.3.4 Effect on Sublicensees. Any sublicenses granted by Novo hereunder shall automatically
terminate or expire at the same time this Agreement terminates or expires.

          12.4 Alternate or Similar Products.

               12.4.1 In the event this Agreement is terminated by Novo prior to the commercialization of
any
New Product, other than (i) by reason of a Preclinical or Clinical Failure, or (ii) due to material
breach by Neose, and Novo, alone or in conjunction with a third party, develops a product based on
the Novo Materials and using any methods of ****** any New Product developed and tested in animals
or humans under this Agreement (a “Similar Product”), Novo shall pay Neose within ****** after the
first filing in any Nation or Region for Regulatory Approval for the Similar Product the amount of
******.

               12.4.2 In the event this Agreement is terminated by Novo prior to the commercialization of
any
New Product, other than (i) by reason of a Preclinical or Clinical Failure, or (ii) due to material
breach by Neose, and Novo, alone or in conjunction with a third party, develops a product based on
the Novo Materials and using any methods of ****** any New Product developed and tested in animals
or humans under this Agreement (an “Alternate Product”), Novo shall pay Neose within ****** after
the first filing in any Nation or Region for Regulatory Approval for the Alternate Product the
amount of ******.

 
 

			
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               12.4.3 For the purpose of this Section 12.4, “Preclinical or Clinical Failure”
means that due
to safety or toxicity reasons or due to a lack of efficacy, it is clear that all New Products have
reached their furthest clinical trial and cannot be approved.

     13. DISPUTE
RESOLUTION

          13.1 By Senior Officers. Except as otherwise provided in Section
9.3, all disputes arising under this Agreement will first be submitted in writing for dispute
resolution to the Designated Representative of each Party. If the dispute is not resolved within
forty-five (45) days, the dispute shall be referred to arbitration in accordance with Section
13.2.

          13.2 Arbitration

               13.2.1 Rules and Location. Except with respect to disputes arising under
Section 9.3,
all disputes arising between the Parties under this Agreement that have not been resolved in
accordance with Section 13.1 shall be settled by arbitration conducted in accordance with
the procedures of the International Chamber of Commerce (“ICC”). The version of the arbitration
rules which are in force when the dispute occurs shall be decisive. The arbitration tribunal shall
have one arbitrator, who shall be selected from the panels of the ICC by agreement of the Parties,
provided, however that if the parties cannot agree on the arbitrator, the arbitration tribunal
shall consist of three arbitrators, one selected by Neose, one selected by Novo, and the third
selected by the other two arbitrators. The arbitration tribunal may also decide on the validity of
the arbitration agreement. The place of the arbitration tribunal shall be Philadelphia,
Pennsylvania. The arbitration proceedings, orders and writs shall be in the English language.

               13.2.2 Judgments. Any award rendered by the arbitrators shall be binding upon the Parties
hereto and shall be final. Judgment upon the award may be entered in any court of record of
competent jurisdiction.

               13.2.3 Expenses. Each Party shall pay its own expenses of arbitration and the expenses of the
arbitrators shall be equally shared unless otherwise ordered by the arbitrators.

     14. GOVERNMENT APPROVAL

          14.1 HSR Filing. Novo, in consultation with Neose, shall make the determination as to whether
filing under the HSR Act is required. If any HSR filing is required, to the extent necessary, each
Party shall file, as soon as practicable after the date this Agreement is executed, with the
Federal Trade Commission (the “FTC”) and the Antitrust Division of the United States Department of
Justice (the “Antitrust Division”) the notification and report form (the “Report”) required under
the HSR Act with respect to the transactions as contemplated hereby and shall reasonably cooperate
with the other Party to the extent necessary to assist the other Party in the preparation of its
Report and to proceed to obtain necessary approvals under the HSR Act, including but not limited to
the expiration or earlier termination of any and all applicable
waiting periods required by the HSR
Act. Each Party shall bear its own expenses, including, without limitation, legal fees, incurred
in connection with preparing such filings.

 
 

			
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          14.2 Obligations. Each Party shall use its good faith efforts to eliminate any concern on the
part of any court or government authority regarding the legality of the proposed transaction,
including, if required by federal or state antitrust authorities, promptly taking all steps to
secure government antitrust clearance, including, without limitation, cooperating in good faith
with any government investigation including the prompt production of documents and information
demanded by a second request for documents and of witnesses if requested.

          14.3 Additional Approvals. Each Party will cooperate and use respectively all reasonable
efforts to make all other registrations, filings and applications, to give all notices and to
obtain as soon as practicable all governmental or other consents, transfers, approvals, orders,
qualifications authorizations, permits and waivers, if any, and to do all other things necessary or
desirable for the consummation of the transactions as contemplated hereby. Neither Party shall be
required, however, to divest or out-license products or assets or materially change its business if
doing so is a condition of obtaining approval under the HSR Act or other governmental approvals of
the transactions contemplated by this Agreement.

          14.4 Termination. If a Report is required to be filed under the HSR Act, either Party hereto
may terminate this Agreement by written notice to the other Party, if, within one hundred twenty
(120) days after this Agreement is signed by the Parties, approval of the transactions contemplated
by this Agreement under the HSR Act has not been obtained or the notice and waiting period, as may
be extended by the FTC, under the HSR Act has not expired without adverse action regarding this
Agreement or the transactions contemplated hereby. If this Agreement is terminated pursuant to
this Section 14.4, then, notwithstanding any provision in this Agreement to the contrary,
neither Party hereto shall have any further obligation to the other Party with respect to the
subject matter of this Agreement.

     15. COVENANTS. From and after the Restatement Date, each party covenants as follows:

          15.1 Novo Covenants. Novo agrees to not take any affirmative action, by itself or via a Third
Party, to contest, limit or in any manner diminish the scope of Neose’s issued patents in
any Nation or Region, or any of Neose’s current or future pending patent applications, each to
the extent claiming Neose Intellectual Property, in any National or Regional Patent Office, and
particularly agrees without limitation:

               15.1.1 Not to provoke an interference, or participate in an interference initiated by the
United States Patent and Trademark Office (the “USPTO”) or file any application, or claim in any
application under prosecution before the USPTO ,any claim that could reasonably be used to provoke
an interference, against any Neose patent application or patent to the extent that such patent or
patent application includes claims relating to Neose Intellectual Property, and further agrees to
withdraw from prosecution any claim in a patent application owned or controlled by Novo

 
 

			
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upon which an examiner in the USPTO proposes to base such an interference. Novo shall ensure that this
covenant is binding on any assignee, purchaser, or transferee of a Novo Patent Right that could be
used to provoke an interference with any of Neose’s current or future pending patent applications,
each to the extent claiming Neose Intellectual Property.

               15.1.2 Not to initiate or participate in any ex parte or inter partes
reexamination proceeding
before the USPTO for any Neose patent including claims relating to Neose Intellectual Property.

               15.1.3 Not to initiate or participate in any opposition before any National or Regional
Patent
Office against any Neose patent including claims relating to Neose Intellectual Property.

               15.1.4 Not to file any third party observation or participate in any filing of a third party
observation in any National or Regional Patent Office against any Neose patent application to the
extent that such patent application includes claims relating to Neose Intellectual Property.

          15.2 Neose Covenants. Neose covenants that, to the extent that any Carved Factor VII Claims
are subject to terminal disclaimers over any Neose Patent Rights, Neose shall not assign, sell, or
otherwise transfer such Carved Factor VII Claims and such Neose Patent Rights in a manner resulting
in separation of ownership between such Carved Factor VII Claims and such Neose Patent Rights.
Neose shall ensure that this covenant is binding on any assignee, purchaser, or transferee of a
Neose Patent Right, to the extent such assigned, purchased or transferred Patent Right contains any
Carved Factor VII Claims.

     16. MUTUAL COOPERATION

          16.1 Novo shall use reasonable commercial efforts to notify Neose of, and to provide to Neose
for review and comment, at least ten (10) days prior to filing, all patent claims
arising out of, enabled by, to Novo’s knowledge infringing or otherwise covering the Neose
Technology or Neose Improvements to be filed by Novo.

          16.2 ******:

          ******

          16.3 Novo shall use reasonable commercial efforts to fully disclose to Neose all pending
patent applications of which it has knowledge that are based on the Novo Materials and would
support any Neose License Claims.

 
 

			
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     17. MISCELLANEOUS

          17.1 Release. ******

          17.2 Force Majeure. Any delays in or failures of performance by either Party under this
Agreement (other than failure to pay amounts due) shall not be considered a breach of this
Agreement if and to the extent caused by occurrences beyond the reasonable control of the Party
affected, including but not limited to: acts of God, earthquake, new regulations or laws of any
government, strikes or other concerted acts of workers; fire, floods, explosions; riots; wars;
rebellion; and, sabotage, and any time for performances under this Agreement shall be extended by
the time of delay reasonably occasioned by such occurrence. Each Party agrees to notify the other
promptly of any factor, occurrence or event coming to its attention that may affect its ability to
meet its obligations under this Agreement.

          17.3 Notices. Any notice, consent or report (each, a “Notice”) required or permitted to be
given by either Party under this Agreement shall be in writing and shall be either personally
delivered or sent by facsimile (confirmed by internationally-recognized express courier), or by
internationally-recognized express courier (such as Federal Express or DHL), to the other Party at
its address set forth below, or such new address as may from time to time be supplied under this
Agreement by a Party. Except as otherwise set forth in this Agreement, any Notice shall be
effective upon receipt by the addressee. Provided that all postage or delivery charges are prepaid
in full by the sender and the Notice has been addressed as set forth in this Agreement:

               17.3.1 if such Notice is sent by facsimile (confirmed by internationally recognized express
courier which includes a copy of the report showing the date and time of transmission), then the
Notice shall be deemed to be received upon transmission (if received on a business day) or the next
business day following transmission; and

               17.3.2 if such Notice is sent by internationally-recognized express courier, then the Notice
shall be deemed to be received two (2) business days after deposit with the courier service.

     If to Neose:

Neose Technologies, Inc.

102 Witmer Road

Horsham, PA 19044

Attention: General Counsel

Fax: 215-315-9100

     If to Novo Nordisk A/S:

Novo Nordisk A/S

Novo Allé

2880 Bagsvaerd

Denmark

Attention: Vice President, Business Development

 
 

			
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Fax: 011-45-4442-1830

With a copy to the same address:

Attention: General Counsel

Fax: 011-45-4498-0670

     If to Novo Nordisk Health Care AG:

Novo Nordisk Health Care AG

Andreasstrasse 15

CH - 8050 Zurich Oerlikon

Switzerland

Attention: Head of Hematology Business Unit

Fax: 011-41-43-222-4404

          17.4 Governing Law. This Agreement and any controversy, claim or dispute arising under this
Agreement shall be governed by, and construed in accordance with, the laws of the Commonwealth of
Pennsylvania, United States of America, without regard to the conflicts of law principles of any
jurisdiction.

          17.5 U.S. Export Laws and Regulations. The Parties hereby acknowledge that their rights and
obligations under this Agreement may be subject to the laws and regulations of the United States of
America relating to the export of products and technical information. Without limitation, each
Party shall comply, and assist the other Party in complying, with all such laws and regulations.

          17.6 Assignment.

               17.6.1 Consent of Other Party. Neither Party may assign any of its rights or obligations
under the Agreement, in whole or in part, by operation of law or otherwise, without the prior
written consent of the other Party, which consent shall not be unreasonably withheld, provided that
either Party may assign (i) any of its rights or obligations under this Agreement in any country to
any of its Affiliates, for so long as they remain Affiliates, and (ii) all of its rights or
obligations under this Agreement in connection with the merger or similar reorganization or sale of
all or substantially all of its assets or a sale of that part of its business relating to the
subject matter of the Agreement. A Party shall notify the other Party in writing upon making such
assignment.

               17.6.2 Certain Assignments by Neose. In the event that Neose assigns all of its rights or
obligations under this Agreement in connection with the merger or similar reorganization or sale of
all or substantially all of its assets or a sale of that part of its business relating to the
subject matter of this Agreement, Novo may, within the thirty (30)-day period following receipt of
notice from Neose of such assignment, elect to proceed under this Section 15.5.2 with
respect to the provision of any reports required under this Agreement and/or other disclosure of
Confidential Information by Novo hereunder. Novo shall make such election by notice in writing
addressed to Neose and its successor at the address of Neose set forth in Section

 
 

			
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15.2.3(as amended). From and after an election by Novo under this Section 15.5.2, Novo shall
be entitled to provide reports required under this Agreement, and/or to provide any other
Confidential Information hereunder, to an independent certified public auditing firm selected by
Neose’s successor and reasonably acceptable to Novo, in lieu of providing such reports and/or
Confidential Information to Neose’s successor. Such auditing firm shall report to Neose’s
successor only (i) whether or not the reports submitted by Novo are accurate and conform to any
related payments made to Neose’s successor and (ii) whether or not, in respect of other matters
relating to such reports and/or Confidential Information, Novo has complied with its obligations
under this Agreement. Novo shall be responsible for and promptly shall pay all fees and expenses
of the auditing firm in connection with its services rendered in accordance with this Section
15.5.2.

               17.6.3 Binding Effect. Any purported assignment in violation of this Section 15.5
shall be null and void. This Agreement shall bind and inure to the benefit of each Party and its
respective permitted successors and assigns.

          17.7 Amendments. No change, modification, extension, termination or waiver of the Agreement,
or any of the provisions in this Agreement contained, shall be valid unless made in writing and
signed by duly authorized representatives of the Parties to this Agreement.

          17.8 Independent Contractors. The Parties to this Agreement are acting as independent
contractors and shall not be considered partners, joint venturers or agents of the other. Neither
Party shall have the right to act on behalf of, or to bind, the other.

          17.9 Severability. The provisions of this Agreement are intended to be severable. If any one
or more of the provisions of this Agreement is or becomes invalid, is ruled illegal by a court of
competent jurisdiction or is deemed unenforceable under the current applicable law from time to
time in effect during the Term, it is the intention of the Parties that the remainder of the
Agreement shall not be affected thereby and shall continue to be construed to the maximum extent
permitted by
law at such time. It is further the intention of the Parties that in lieu of each such
provision which is invalid, illegal, or unenforceable, there shall be substituted or added as part
of this Agreement by such court of competent jurisdiction or any arbitrator(s) appointed pursuant
to Section 13.2, a provision which shall be as similar as possible, in economic and
business objectives as intended by the Parties to such invalid, illegal or unenforceable provision,
but shall be valid, legal and enforceable.

          17.10 Waiver. The waiver by either Party to this Agreement of any right under this Agreement
or the failure to perform or of a breach by the other Party shall not be deemed a waiver of any
other right under this Agreement or of any other breach or failure by said other Party whether of a
similar nature or otherwise.

          17.11 No Third Party Beneficiaries. Each of Neose and Novo intend that only Neose and Novo
will benefit from, and are entitled to enforce the provisions of, this Agreement and that no Third
Party beneficiary is intended under this Agreement.

          17.12 Descriptive Headings; Section and Exhibit References. The headings of the several
sections of this Agreement are intended for convenience of reference only and are not intended to
be a part of or to affect the meaning or interpretation of this Agreement. All references in this Agreement to a Section or Exhibit shall be interpreted as references to the respective Section or
Exhibit of this Agreement unless the context requires otherwise.

 
 

			
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          17.13 Counterparts. This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument.

          17.14 Entire Agreement. This Agreement, including all exhibits to this Agreement (the
“Attachments”), and the Research and Development Collaboration Agreement between the Parties dated
October 28, 2002 embody the entire understanding between the Parties and supersede any prior
understanding and/or other agreements between and among them respecting the development of the New
Product. Both this Agreement and the Research and Development Collaboration Agreement between the
Parties dated October 28, 2002 shall remain in effect in accordance with their respective terms
from and after the date on which this Agreement is executed and delivered by the Parties. There
are no representations, agreements, arrangements or understandings, oral or written, between the
Parties to this Agreement relating to the subject matter of this Agreement, which are not fully
expressed in this Agreement. If any provisions of any such Attachment conflict with any provisions
set forth in this Agreement, the provisions of this Agreement shall take precedence. The Parties
acknowledge and agree that the Mutual Nondisclosure Agreement remains in full force and effect with
respect to any and all subject matter other than the subject matter of this Agreement or the Factor
VIII and IX Agreement.

                    IN WITNESS WHEREOF, the undersigned Parties, acting through their duly
authorized
representatives, have executed this Agreement in multiple counterparts.

	 	 	 	 	 
	NEOSE TECHNOLOGIES, INC.	 	 
	 
	 	 	 	 
	By:

	 	/s/
George J. Vergis
	 	 
	Name:

	 	George J. Vergis	 	 
	Title:

	 	President & CEO	 	 
	 
	 	 	 	 
	NOVO NORDISK A/S	 	 
	 
	 	 	 	 
	By:

	 	/s/ Mads Krosgaard Thomsen
	 	 
	Name:

	 	Mads Krosgaard Thomsen	 	 
	Title:

	 	Executive Vice President	 	 

 
 

			
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	NOVO NORDISK HEALTH CARE AG	 	 
	 
	 	 	 	 
	By:

	 	/s/
Kåre Schultz
	 	 
	Name:

	 	Kåre Schultz	 	 
	Title:

	 	Chief Operating Officer	 	 

 
 

			
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Exhibit 1.23

******

 
 

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

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Exhibit 1.30

******

 
 

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

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Exhibit 2.2

******

 
 

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

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Exhibit 3.2.1

******

 
 

			
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Exhibit 3.5

******

 
 

			
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Exhibit 5.1.3

NEOSE TECHNOLOGIES, INC.

FORM OF REQUIRED AGREEMENT FOR PROPOSED SUBLICENSEES

     This
CONFIDENTIALITY AGREEMENT (this “Agreement”) is made as of this ___ day of                     ,
200_, by and between Neose Technologies, Inc., a Delaware corporation (“Neose”), and
                                        
 , a                      corporation (“Recipient”).

BACKGROUND

     Neose has developed and continues to develop proprietary technologies and related know-how for
the glycosylation, design and remodeling of proteins, peptides and antibodies, including, but not
limited to its GlycoAdvanceTM, GlycoPEGylationTM and GlycoConjugationTM technologies
(collectively, the “Technology”). Pursuant to a Research, Development and License Agreement dated
___, 2003 (the “License Agreement”), Neose has granted Novo Nordisk A/S, a Danish corporation,
and Novo Nordisk Health Care AG, a Swiss corporation (collectively,“Novo”), certain exclusive
worldwide rights under the Technology throughout the world, including certain rights to sublicense.
Novo desires to sublicense to Recipient certain rights granted to Novo under the License
Agreement. Novo, therefore, desires to disclose to Recipient confidential and proprietary
information, which is a part of the Technology and is considered valuable by Neose. As a condition
to Novo disclosing such confidential and valuable proprietary information to Recipient, Recipient
is entering into this Agreement for Neose’s benefit.

     NOW, THEREFORE, in consideration of the foregoing premises and in consideration of Novo
disclosing Neose’s confidential and proprietary information to Recipient, and intending to be
legally bound hereby, Recipient agrees as follows:

Definitions

     “Confidential Information” means any and all proprietary or confidential information of Neose
disclosed to Recipient, including, without limitation, all technical data, trade secrets or
know-how, including, but not limited to, research, product plans, products, service plans,
services, customer lists and customers, markets, software, developments, inventions, processes,
formulas, technology, designs, drawings, engineering, marketing, distribution and sales methods and
systems, sales and
profit figures, finances and other business information disclosed to Recipient related to
Neose, either directly or indirectly, in writing, orally or by drawings or

 
 

			
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inspection of documents
or other tangible property. The fact that a given piece of information is marked or identified as
confidential or proprietary shall conclusively indicate that such information is considered
Confidential Information, but the failure to so mark information shall not conclusively determine
that such information was or was not considered Confidential Information.

     “Neose Know-How” means any and all formulae, procedures, processes, methods, designs,
know-how, show-how, trade secrets, discoveries, inventions (whether or not patentable), patent
applications, licenses, software and source code, programs, prototypes, designs, discoveries,
techniques, methods, ideas, concepts, data, engineering and manufacturing information, electronic
control circuits, specifications, diagrams, drawings, schematics, blueprints and parts lists and
other proprietary information, rights and works of authorship, whether or not reduced to writing,
controlled by Neose and relating to the Technology

     “Neose Patents” means all patents and patent applications (including all corresponding foreign
patents and patent applications, all divisions, continuations, continuations-in-part, reissues,
renewals, extensions and additions to any such patents or patent applications) relating to the
Technology licensed by Neose to Novo under the License Agreement.

     “Neose Technology” means the Neose Know-How and Neose Patents.

     “Person” means an individual, corporation, partnership, trust, business trust, association,
joint stock company, joint venture, syndicate, sole proprietorship, unincorporated organization,
government, governmental agency, authority or instrumentality, or any other form of entity not
specifically listed in this Agreement.

     “Product” means any of the “Novo Materials” (as defined in the License Agreement modified by
using the Neose Technology.

     “Sublicense Agreement” means the agreement under which Novo sublicenses to Recipient certain
rights granted by Neose to Novo under the License Agreement.

     “Third Party” means any Person other than Recipient, Neose or Novo.

Non-Disclosure; Non-Use; Reasonable Care

     Non-Disclosure. Without the prior written consent of an authorized officer of Neose,
Recipient shall not, directly or indirectly, disclose to any Third Party any Confidential
Information or Neose Know-How.

     Non-Use. Without the prior written consent of an authorized officer of Neose, Recipient shall
not, directly or indirectly, use any of the Confidential Information or Neose Technology for its
own benefit or for the benefit of any Third Party.

 
 

			
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     Reasonable Care. Recipient shall take all reasonable measures to protect the secrecy of, and
avoid the unauthorized disclosure or use of, the Confidential Information and Neose Technology,
including, without limitation, the following: (i) Recipient shall exercise the highest degree of
care that Recipient uses to protect Recipient’s own confidential and proprietary information of a
similar nature; (ii) Recipient shall disclose Confidential Information and/or Neose Know-How only
to its employees and contractors who have a need to know; and (iii) Recipient shall require anyone
who has access to any of the Confidential Information and/or Neose Know-How to sign or be a party
to an effective agreement with Recipient, applicable to the Confidential Information and Neose
Know-How, containing provisions that are substantially similar to the terms of this Agreement.
Recipient shall notify Neose in writing of any disclosure, misuse or misappropriation of any
Confidential Information or Neose Technology that may come to Recipient’s attention.

Acknowledgements. Recipient acknowledges and agrees that: (i) this Agreement is necessary
for the protection of the legitimate business interests of Neose; (ii) the execution of this
Agreement by an authorized representative of Recipient and delivery of this Agreement to Neose is a
mandatory condition precedent to Novo disclosing any Confidential Information and any information
concerning the Neose Technology to Recipient, without which Neose would not permit Novo to disclose
such information; (iii) neither Neose nor Novo has granted to Recipient any rights under the Neose
Technology in any manner; and (iv) because of the unique nature of the Confidential Information and
Neose Technology and its broad applicability to the manufacture and remodeling of glycoproteins,
Neose will not have an adequate remedy at law if Recipient breaches any term of this Agreement.

Return of Materials. Upon the earlier of termination of Novo’s license to the Neose
Technology under the License Agreement or termination of the Sublicense Agreement, Recipient shall:
(i) discontinue all use of the Confidential Information and Neose Technology; (ii) destroy any and
all items in its possession containing any Confidential Information or Neose Technology; and (iii)
certify in writing to Neose, within ten (10) days after Neose’s request therefor, that Recipient
has taken all actions described in this Section 4.

Intellectual Property

     Ownership Rights. All right, title and interest under patent, copyright, trade secret and
trademark law and any other intellectual property or other law (collectively, “Ownership Rights”),
in and to the Confidential Information and Neose Technology shall remain at all times with Neose.
Any and all Ownership Rights to developments, discoveries, inventions, additions, amendments,
modifications, ideas, processes, methods, compositions, formulae, techniques, information and data,
whether or not patentable, relating to the Neose Technology, which is made, conceived or reduced to
practice by Neose, Novo or Recipient or any combination of them (“Neose Improvements”) shall be
owned by Neose and shall be deemed to part of the Neose Technology for all purposes.

 
 

			
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     Assignment. To the extent that Recipient may retain any Ownership Rights in any Neose
Improvements, Recipient hereby irrevocably assigns and transfers to Neose any and all such
Ownership Rights, in perpetuity or for the longest period otherwise permitted by law, without the
necessity of further consideration, and Neose shall be entitled to receive and hold in its own name
all such Ownership Rights. With respect to any Ownership Rights that Recipient may assign and
transfer to Neose under this Section 5.2, at the request of Neose, and at Neose’s expense, either
before or after termination of this Agreement, Recipient shall assist Neose in acquiring and
maintaining patent, copyright, trade secret and trademark protection upon, and confirming Neose’s
title in and to, any such Ownership Rights. Recipient’s assistance shall include, but shall not be
limited to, signing all applications, and any other documents and instruments for patent, copyright
and any other proprietary rights, cooperating in legal proceedings, and taking any other actions
considered necessary or desirable by Neose. For the purpose of facilitating the above assignment,
Recipient agrees that any and all employees and contractors employed or engaged by Recipient and
providing any service in connection with the use of the Neose Technology, prior to providing such
service, shall have agreed in writing to covenants consistent with Recipient’s covenants set forth
in this Section 5.2

Exceptions. The non-disclosure obligations with respect to Confidential Information and Neose Know-How
set forth in Section 2.1 shall not apply to any information that: (i) at the time of disclosure by
or on behalf of Novo or Neose to Recipient is in, or after disclosure by or on behalf of Novo or
Neose becomes part of, the public domain through no improper act on the part of Recipient or on the
part of any of Recipient’s employees, independent contractors, advisors or consultants; (ii) is
disclosed, published or disseminated by Neose without any confidentiality constraints; (iii) was in
Recipient’s possession free of any obligation of non-disclosure or non-use at the time of
disclosure to Recipient, as shown by written evidence; (iv) Recipient receives from a Third Party
free of any obligation of non-disclosure or non-use, but only if such Third Party had no direct or
indirect obligation to Neose not to disclose such information; (v) was developed by Recipient
independent of information received hereunder, as shown by its written records; or (vi) subject to
Section 7, is required to be disclosed by law or pursuant to legal, judicial or administrative
process.

Notice of Required Disclosure. If Recipient is required by judicial or administrative process
to disclose any Confidential Information or Neose Know-How, then Recipient shall promptly notify
Neose and, before disclosing such Confidential Information or Neose Know-How, allow Neose a
reasonable time to oppose such process.

Successors; Assignment. This Agreement shall be binding upon Recipient and Recipient’s
successors and assigns and inure to the benefit of Neose and its successors and assigns. Recipient
may not assign its rights or delegate its obligations under this Agreement, in whole or in part,
except with the prior written consent of Neose, which consent shall not be unreasonably withheld.
Neose may assign this Agreement without seeking or obtaining Recipient’s consent.

 
 

			
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Governing Law. This Agreement and any controversy, claim or dispute arising under this
Agreement shall be governed by, and construed in accordance with the laws of the Commonwealth of
Pennsylvania, United States of America, without regard to the conflicts of law principles of any
jurisdiction.

Remedies. In addition to any other remedies that may be available, at law, in equity or
otherwise, Neose shall be entitled to obtain injunctive relief to enforce the provisions of this
Agreement without necessity of posting bond.

Entire Agreement. This Agreement contains the entire agreement and understanding relating to the subject
matter hereof and merges and supersedes all prior discussions, agreements and understandings. This
Agreement may not be changed or modified, except in a writing signed by both Neose and Recipient.
The failure or delay of Neose to exercise any right under this Agreement shall not be deemed a
waiver of any rights under this Agreement.

     IN WITNESS WHEREOF, each party has caused its authorized representative to execute this
Agreement as of the date first written above.

	 	 	 	 	 	 	 	 	 	 	 
	NEOSE TECHNOLOGIES, INC.	 	 	 	[INSERT NAME OF RECIPIENT]	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	 	 	 	 	By:	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	Name:

	 	 	 	 	 	Name:	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	Title:

	 	 	 	 	 	Title:	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 

 
 

			
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Exhibit 17.1

******

 
 

			
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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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-21-

 

	 	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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-22-

 

          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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-23-

 

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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Appendix 2-1

 

	 	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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Appendix 2-2

 

	 	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:	 	 
	 

	 	 	 		 	 

 

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

Appendix 2-15

 

Appendix 3

Program Price and Payment Schedule

******

 

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

Appendix 3-1

 

Appendix 4

Confidentiality Agreement

 

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

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	 	 

 

			
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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

 

			
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Appendix 4-2

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