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
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
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
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 Xxxx-Xxxxx-Xxxxxx 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®,
GlycoPEGylation™ and GlycoConjugation™ 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, xxxxx 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 Xxxxxxx
Stennicke for Novo and Xxxxx Xxxxxxxx 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, Xxxxx Xxxxxxx and Xxxx Xxxxx Sidelman
representing Novo and Xxxxx X. Xxxx, M.D., Xxxxxxx X. Xxxxxxx and Xxxxxx Xxxxxxx, Xx. 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 Xxxxxx 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 Xxxxxxx Xxxxxx, Xxxxx Xxxxxxx, and Xxxx Xxxxx for Novo, and Xxxxxx Xxxxxxxxxx, 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
therefrom.
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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
| ****** | — Material has been omitted and filed separately with the Commission. |
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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.
| ****** | — Material has been omitted and filed separately with the Commission. |
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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.
000 Xxxxxx Xxxx
Xxxxxxx, XX 00000
Attention: General Counsel
Fax: 000-000-0000
000 Xxxxxx Xxxx
Xxxxxxx, XX 00000
Attention: General Counsel
Fax: 000-000-0000
If to Novo Nordisk A/S:
Novo Nordisk A/S
Xxxx Xxxx
0000 Xxxxxxxxx
Xxxxxxx
Attention: Vice President, Business Development
Xxxx Xxxx
0000 Xxxxxxxxx
Xxxxxxx
Attention: Vice President, Business Development
| ****** | — Material has been omitted and filed separately with the Commission. |
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Fax: 000-00-0000-0000
With a copy to the same address:
Attention: General Counsel
Fax: 000-00-0000-0000
Attention: General Counsel
Fax: 000-00-0000-0000
If to Novo Nordisk Health Care AG:
Novo Nordisk Health Care AG
Xxxxxxxxxxxxxx 00
XX - 0000 Xxxxxx Xxxxxxxx
Xxxxxxxxxxx
Attention: Head of Hematology Business Unit
Fax: 000-00-00-000-0000
Xxxxxxxxxxxxxx 00
XX - 0000 Xxxxxx Xxxxxxxx
Xxxxxxxxxxx
Attention: Head of Hematology Business Unit
Fax: 000-00-00-000-0000
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
| ****** | — Material has been omitted and filed separately with the Commission. |
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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/
Xxxxxx X. Xxxxxx |
|||
Name:
|
Xxxxxx X. Xxxxxx | |||
Title:
|
President & CEO | |||
| NOVO NORDISK A/S | ||||
By:
|
/s/ Mads Krosgaard Xxxxxxx |
|||
Name:
|
Mads Krosgaard Xxxxxxx | |||
Title:
|
Executive Vice President | |||
| ****** | — Material has been omitted and filed separately with the Commission. |
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| NOVO NORDISK HEALTH CARE AG | ||||
By:
|
/s/
Kåre Xxxxxxx |
|||
Name:
|
Kåre Xxxxxxx | |||
Title:
|
Chief Operating Officer | |||
| ****** | — Material has been omitted and filed separately with the Commission. |
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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
******
| ****** | — Material has been omitted and filed separately with the Commission. |
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Exhibit 3.5
******
| ****** | — Material has been omitted and filed separately with the Commission. |
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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, GlycoPEGylation™ and GlycoConjugation™ 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 xxxx 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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