Exhibit 10.42
Portions of this exhibit were omitted and filed separately with
the Secretary of the Commission pursuant to an application for
confidential treatment filed with the Commission pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934. Such
portions are marked by a series of asterisks.
Execution Copy
AMENDED AND RESTATED
RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT
AMONG
NEOSE TECHNOLOGIES, INC.
AND
NOVO NORDISK A/S
AND
NOVO NORDISK HEALTH CARE AG
DATED AS OF OCTOBER 31, 2006
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Table of Contents
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1.
DEFINITIONS
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2.
CONDUCT OF THE PROJECT AND COMMERCIALIZATION EFFORTS
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3.
FEES AND DEVELOPMENT PAYMENTS
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10 |
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4.
PRODUCT PAYMENTS AND ROYALTIES
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13 |
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5.
INTELLECTUAL PROPERTY GRANTS AND RIGHT OF NEGOTIATION
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15 |
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6.
OWNERSHIP OF INTELLECTUAL PROPERTY
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17 |
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7.
BLOCKING PATENTS
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27 |
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8.
SUPPLY AGREEMENT
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28 |
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9.
CONFIDENTIALITY
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28 |
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10.
REPRESENTATIONS AND WARRANTIES
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30 |
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11.
INDEMNIFICATIONS AND LIMITED LIABILITY
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31 |
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12.
TERM AND TERMINATION
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33 |
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13.
DISPUTE RESOLUTION
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35 |
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14.
GOVERNMENT APPROVAL
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35 |
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15.
NEGATIVE COVENANTS
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36 |
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16.
MUTUAL COOPERATION
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37 |
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17.
MISCELLANEOUS
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37 |
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AMENDED AND RESTATED
RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT
This AMENDED AND RESTATED RESEARCH,
DEVELOPMENT AND LICENSE AGREEMENT ( “
Agreement ” ), is dated as of
October 31, 2006 (the “ Restatement Date
”), among Neose Technologies, Inc., a Delaware
corporation ( “ Neose ” ),
and Novo Nordisk A/S , a Danish corporation, and Novo
Nordisk Health Care AG , a Swiss Corporation (collectively,
“ Novo ” ).
BACKGROUND
Neose and Novo are parties to two
Research, Development and License Agreements, dated
September 30, 2002 and October 28, 2002, respectively,
relating to the use of Neose’s technologies on Novo’s
recombinant human Factor VII and Factor VIIa. Additionally, Novo
and Neose entered into a Research, Development and License
Agreement dated November 17, 2003, as amended by letter
agreements dated December 18, 2003 and October 12, 2004
and by Amendment Number 3 dated December 15, 2005 (collectively,
the “ Amendments ”), respectively (as so
amended, the “ Original Agreement ”),
pursuant to which Novo and Neose are collaborating to develop a
long-acting Factor VII compound.
Novo and Neose desire to amend and
restate the Original Agreement to further amend the Original
Agreement and to incorporate all of the Amendments into one
document.
Contemporaneously with the execution
and delivery of the Original Agreement, Neose and Novo entered into
another Research, Development and License agreement regarding
coagulation Factors VIII and IX.
TERMS
NOW, THEREFORE, in
consideration of the premises and of the mutual agreements and
covenants contained in this Agreement, and intending to be legally
bound hereby, Novo and Neose agree as follows:
1. DEFINITIONS.
Capitalized terms not otherwise defined shall have the meaning set
forth in this Section 1 .
1.1 “ ****** ” means any New
Product that incorporates a ****** .
1.2
“ Affiliate ” means, with
respect to any Person, any other Person that directly or indirectly
controls, is controlled by, or is under common control with, such
Person. Without limiting the foregoing, a Person shall be regarded
as in control of another Person if it owns, or directly or
indirectly controls, more than fifty percent (50%) of the voting
stock or other ownership interest of the other Person.
1.3
“ Blocking Patent ” means any
Patent Rights claimed to be owned or Controlled by a Third Party
with respect to which Patent Rights an assertion is being made by
or on behalf of the Third Party that the use of the Neose
Technology under this Agreement infringes such Person’s
Patent Rights.
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1.4
“ Calendar Quarter ” means any
of the respective periods of three (3) consecutive calendar
months ending on March 31, June 30, September 30 or
December 31 during the Term.
1.5
“ Calendar Year ” shall mean
the respective periods of twelve (12) consecutive calendar
months ending on December 31 during the Term.
1.6 “ Carved Factor VII Claims ”
shall mean any Potential Carved Factor VII Claim with respect to
which the parties have filed, in accordance with
Section 6.4.2 , a separate patent application.
1.7
“ Commercially Reasonable Efforts
” shall mean efforts and resources normally used by a
Party in similar undertakings, taking into account the proprietary
position of the product or technology involved, the regulatory
structure involved, the profitability of such undertaking, the
competitiveness of the relevant marketplace, and other relevant
factors.
1.8
“ Commercial Sale ” means any
sale of a New Product by Novo, its Affiliates, or Sublicensees to a
Person other than their respective Affiliates or Neose.
1.9
“ Confidential Information ”
shall mean any of the Disclosing Party’s proprietary or
confidential information, technical data, trade secrets or
know-how, including, but not limited to, research, product plans,
products, the identity of the Novo Materials, information relating
to the Novo Materials, service plans, services, customer lists and
customers, markets, software, developments, inventions, processes,
formulas, technology, designs, drawings, engineering, marketing,
distribution and sales methods and systems, sales and profit
figures, finances and other business information disclosed to the
Recipient by or on behalf of the Disclosing Party, either directly
or indirectly, in writing, orally or by drawings or inspection of
documents or other tangible property.
1.10 “ Control ” or “
Controlled ” means possession of the ability of
one party to grant the licenses or sublicenses to the other party
as provided for herein without violating the terms of an agreement
or other arrangement with a Third Party existing before or after
the Effective Date.
1.11 “ Designated Representative
” means, in the case of Neose, its President and Chief
Executive Officer, or such other person designated by Neose in
writing from time to time to Novo, and, in the case of Novo, its
Executive Vice President and Chief Science Officer, or other such
other person designated by Novo in writing from time to time to
Neose.
1.12 “ Disclosing Party ”
is used as defined in Section 9.1 .
1.13 “ Effective Date ”
shall mean the date of execution of the Original Agreement by both
Parties.
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1.14 “ Factor VIII and IX Agreement
” means the Research, Development and License
Agreement between Neose and Novo with respect to coagulation Factor
VIII and IX, entered into contemporaneously with the execution of
the Original Agreement.
1.15 “ FDA ” means the
United States Food and Drug Administration and any successor
agency.
1.16 “ Field of Use ” means
the development and commercial manufacture of New Product for
****** .
1.17 “ GMPs ” shall mean
current good manufacturing practices for the methods to be used in,
and the facilities and controls to be used for, the manufacture,
processing, packing and holding of biological products, all as set
forth from time to time by the FDA, including all amendments and
supplements thereto throughout the term of this Agreement.
1.18 “ HSR Act ” shall mean
the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, and the rules and regulations promulgated
thereunder.
1.19 “ Improvements ” means
any and all developments, discoveries, inventions, additions,
amendments, modifications, ideas, processes, methods, compositions,
formulae, techniques, information and data, whether or not
patentable, conceived, developed or reduced to practice, that
improve or beneficially change, or enhance the economic and
technical attributes of, any Know-How or Patent Rights or any
process, device or composition.
1.20 “ IND ” means an
application for an Investigational Exemption for a New Drug filed
with the FDA, or any comparable filing made with a regulatory
authority outside the United States.
1.21 “ Joint Improvements ”
means any and all Improvements made, conceived or reduced to
practice jointly by Neose and Novo in the conduct of the Work Plan
under this Agreement, whether patentable or not, other than Neose
Improvements and Novo Improvements.
1.22 “ Know-How ” means any
and all formulae, procedures, processes, methods, designs,
know-how, show-how, trade secrets, discoveries, inventions (whether
or not patentable), patent applications, licenses, software and
source code, programs, prototypes, designs, discoveries,
techniques, methods, ideas, concepts, data, engineering and
manufacturing information, electronic control circuits,
specifications, diagrams, drawings, schematics, blueprints and
parts lists and other proprietary information, rights and works of
authorship, whether or not reduced to writing.
1.23 “ M1 Profile for the New Product
” means the parameters for candidate selection
required for PEG-F7a set forth on Exhibit 1.23 , as
amended from time to time in accordance with
Section 2.2 .
1.24 “ Mutual Nondisclosure Agreement
” means the Amended and Restated Mutual Nondisclosure
Agreement between the Parties dated November 25, 2002.
1.25 “ Neose Exclusive Compounds ”
shall mean any and all forms of ****** including, but
not limited to, with respect to either of the foregoing: full
length proteins, truncated proteins, fusion proteins, analogs,
mutants, splice variants, and conjugates with other molecular
entities such as proteins, peptides, organic or inorganic
substances.
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1.26 “ Neose Improvements ”
means any and all Improvements relating to the Neose Technology
made, conceived, or reduced to practice by (i) either Neose or
Novo or both in the conduct of the Work Plan under this Agreement,
(ii) either Neose or Novo or both under this Agreement,
(iii) Novo in the practice of any Neose Technology under the
licenses granted to Novo in Section 5.1 , or
(iv) Novo in the conduct of any activity using any Ownership
Rights assigned to Novo pursuant to Section 6.4.1 , in
each case of (i), (ii), (iii) or (iv), other than the Novo
Materials, the Novo Materials modified using the Neose Technology
and New Product. Specifically excluded from “Neose
Improvements” are (1) formulations, combinations and
methods of treatment to the extent relating to Novo Materials, the
Novo Materials modified using the Neose Technology and New Products
and (2) analytical techniques and purification methods
invented, developed or reduced to practice solely by Novo that did
not originate from or are not derived from Neose (collectively, the
“ Techniques ”)
1.27 “ Neose Improvement Claim ”
shall mean any Neose License Claim that relates to a Neose
Improvement.
1.28 “ Neose Intellectual Property
” means Neose Technology and the Neose Improvements.
1.29 “ Neose License Claim ” shall
mean a claim in or supportable by Patent Rights listed in
Section 16.2 (including any Patent Rights claiming priority to
such listed rights) and Controlled by Novo encompassing within its
scope: (i) any methods of ****** ; (ii) any
compositions-of-matter or methods of treatment specifically naming
Neose Exclusive Compounds derived from or used in the practice of
such methods described in clause (i) above; (iii) any
compositions-of-matter or methods of treatment related to any
compound other than the Neose Exclusive Compounds, any and all
forms of ******, or Novo Materials derived from or used in the
practice of such methods described in clause (i) above;
wherein any claim encompassed by clauses (i), (ii) or
(iii) must also be encompassed within the scope of a claim
supportable by any Patent Right listed in the listing of patents
and patent applications dated October 13, 2006 which has been
certified by Neose and delivered to Novo prior to the date hereof;
or (iv) any Neose Improvements made or reduced to practice by
Novo.
1.30 “ Neose Patents ”
means (a) all Patent Rights relating to methods and processes
for glycosylation design and remodeling of proteins, peptides and
antibodies that are Controlled by Neose, including, but not limited
to: (i) the Patent Rights listed in Exhibit 1.30 ,
(ii) the Patent Rights developed by Neose in the conduct of the
Work Plan during the Term of this Agreement, and (iii) any
later acquired Patent Rights Controlled by Neose and used to
develop any New Product, and (b) all Patent Rights Controlled
by Neose that would be infringed by the research, development
(including clinical development), manufacture, making, use,
marketing, promotion, sale, offer for sale, distribution, import
and export of New Products in the Territory.
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1.31 “ Neose Project-Related Costs
” means Neose’s costs of conducting the Work
Plan, which shall be determined in accordance with this Agreement
and calculated as follows: (i) with respect to personnel, at
the rate of ****** ; and (ii) with respect to
materials, at the ****** .
1.32 “ Neose Technology ”
means the Neose Patents and any Know-How Controlled by Neose
relating to methods and processes for the ****** ,
including, without limitation, its GlycoAdvance®,
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:
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Combination Product] |
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[B + A] |
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The
distribution costs associated with any Combination Product will be
allocated in the same proportion among the licensed active
ingredient components and all other active ingredient
components.
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If the active
ingredient components of a Combination Product are not sole
separately in identical strengths to those contained in the
Combination Product, then the parties agree to negotiate in good
faith the calculation of Net Sales with regard to such Combination
Product.
1.34 “ New Product ” shall
mean the following: (a) any of the Novo Materials modified
using either (i) the Neose Technology, (ii) any Neose
Improvements, or (iii) any combination of all or some of
(i) and (ii) above, and (b) any Novo Materials
covered by any Carved Factor VII Claims (except to the extent such
claims constitute Novo Improvements) .
1.35 “ Novo Improvements ”
means any and all Improvements that are related to the Novo
Materials and/or any of the New Products made, conceived or reduced
to practice by Novo or Neose or both, other than Neose
Improvements.
1.36 “ Novo Materials ”
means any and all forms of Factor VII and Factor VIIa, including,
but not limited to, full length rFVII, truncated rFVII,
****** such as ****** substances.
1.37 “ Novo Technology ”
means the Patent Rights and Know-How Controlled by Novo relating to
the Novo Materials .
1.38 “ Ownership Rights ”
means any and all right, title and interest under patent,
copyright, trade secret and trademark law, or any other
intellectual property or other law, in and to any Know-How, Patent
Rights, or Improvements.
1.39 “ Parties ” means
Neose and Novo, collectively.
1.40 “ Party ” means Neose
or Novo, as the context requires, or each of Neose and Novo,
individually.
1.41 “ Patent Rights ”
shall mean individually and collectively any and all patents and/or
patent applications and provisional applications, all inventions
disclosed therein, and any and all continuations,
continuations-in-part, continued prosecution applications,
divisions, renewals, patents of addition, reissues, confirmations,
registrations, revalidations, revisions and re-examinations
thereof, utility models, petty patents, design registrations and
any and all patents issuing therefrom and any and all foreign
counterparts thereof and extensions of any of the foregoing
including without limitation extensions under the U.S. Patent Term
Restoration Act, extensions under the Japanese Patent Law, and
Supplementary Protection Certificates (SPCs) according to Counsel
Regulation (EEC) No. 1768/92 and similar extensions for
other patents under any applicable law in any country of the
world.
1.42 “ Permit ” means any
governmental or regulatory filing, submission, approval, permit or
license that is required by applicable law in any jurisdiction
worldwide for clinical trials, Commercial Sales or other use of any
of the New Products.
1.43 “ Person ” means an
individual, corporation, partnership, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, government,
governmental agency, authority or instrumentality, or any other
form of entity not specifically listed in this Agreement.
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1.44 “ Potential Carved Factor VII
Claims” shall mean ****** .
1.45 “ Product-Candidate ”
means any new ****** product-candidate Controlled by
Neose during the Term.
1.46 “ Project ” means the
project to be conducted hereunder by the Parties in accordance with
the Work Plan.
1.47 “ Project Manager ”
means the project managers described in Section 2.4.1
.
1.48 “ Reagents ” means the
enzymes and sugar nucleotides required to use the Neose Technology
in the manufacture of New Products.
1.49 “ Recipient ” is used
as defined in Section 9.1 .
1.50 “ Regulated Market ”
means any jurisdiction worldwide that requires a Permit for
clinical trials, Commercial Sales or any other use of a New
Product.
1.51 “ Regulatory Approval
” means any marketing authorization (including
authorizations approving a Biologics License Application) required
for a New Product, exclusive of any pricing or third-party
reimbursement approval.
1.52 “ Required Agreement ”
means any agreement with a Sublicensee required under Section
5.1.3 .
1.53 “ ****** ”
****** .
1.54 “ Steering Committee ”
means the steering committee established pursuant to Section
2.4.2 , or any successor group appointed by the Parties.
1.55 “ Sublicensee ” means
a sublicensee of Novo’s rights under
Section 5.
1.56 “ Supply Agreement ”
means the supply agreement to be entered into between Neose and
Novo in accordance with Section 8 .
1.57 “ Territory ” means
the world .
1.58 “ Term ” means the
term of this Agreement, which shall commence on the Restatement
Date and shall expire or terminate as described in
Section 12 .
1.59 “ Third Party ” means
any Person other than Novo, Neose, or their respective
Affiliates.
1.60 “ Valid Patent Claim ”
means a claim of an issued and unexpired patent forming part of the
Neose Patents or the Carved Factor VII Claims that has not been
held revoked, unenforceable or invalid by a decision of a court or
other government agency of competent jurisdiction, or unappealable
or unappealed within the time allowed for appeal, or which has not
been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise. For the purposes of determining royalties
due and payment obligations under this Agreement, any claim being
prosecuted in a pending patent application included in the Neose
Patents or the Carved Factor VII Claims shall be deemed a Valid
Patent Claim, provided that such claim is not pending, other
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than
because of any action taken by Novo or Affiliate of Novo,
****** in which the subject matter of the claim is
disclosed, after which period it shall cease to be considered a
Valid Patent Claim until the patent issues.
1.61 “ Work Plan ” means
the Work Plan attached hereto as Exhibit 2.2, and, unless
otherwise specified, as amended from time to time in accordance
with Section 2.2 .
2. CONDUCT OF THE PROJECT
AND COMMERCIALIZATION EFFORTS
2.1
Conduct. Commencing promptly after the Restatement Date, Neose
and Novo will continue to use Commercially Reasonable Efforts to
carry out their respective obligations under the Work Plan.
2.2
Creation and Modification of Work Plan. Attached hereto as
Exhibit 2.2 is the Work Plan, setting forth a project summary
and timetable for the research and development, scale-up and
technology transfer activities to be conducted under this
Agreement. Neose shall be responsible for the development of
validated, GMP processes for the production of Reagents for use in
the manufacture of New Products and protocols for the use of the
Reagents in the manufacture of New Products by Novo, all as set
forth in Exhibit 2.2 . The Work Plan may be amended or
modified from time to time, but only in a writing signed by each
Party’s Designated Representative and specifying the
Parties’ estimate of any additional Neose Project-Related
Costs that will be paid by Novo as a result of such
amendment.
2.3
Funding.
2.3.1 Estimate. The Neose Project-Related Costs are
estimated to be ****** , plus the cost of materials.
This estimate is based upon the Work Plan set forth in
Exhibit 2.2. If the Parties amend the Work Plan in a manner
that requires any new product or service to be provided by Neose
(e.g., a new Reagent, expression system, scale up activity) which
is not currently incorporated in the Work Plan, the Parties shall
agree in writing on any increase in the Neose Project-Related Costs
that are authorized in connection with such amendment.
2.3.2 Payment. Novo will pay for the Neose Project-Related
Costs ****** . No earlier than thirty (30) days
before the beginning of each Calendar Quarter following the
Restatement Date, Neose will invoice Novo for such amount based on
a budgeted estimate of Neose Project-Related Costs for such
Calendar Quarter. Within thirty (30) days after the end of
each Calendar Quarter, Neose shall submit to Novo a written report
setting forth the actual Neose Project-Related Costs for such
Calendar Quarter, and shall, as applicable, pay to Novo any amounts
paid by Novo for such Calendar Quarter in excess of the actual
Neose Project-Related Costs shown in such report, or invoice Novo
for any additional amounts owed hereunder. Novo will pay all
invoices delivered under this Section 2.3 within
****** days after receipt.
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2.4
Management of Project
2.4.1 Project Managers. The Project Managers existing as of
the Restatement Date are Henning Stennicke for Novo and Megan
Townsend for Neose and each shall remain the Project Managers
immediately following the Restatement Date. The Project Managers
shall keep each other reasonably informed of the progress under the
Work Plan and shall be responsible for maintaining appropriate
records of the deliberations and decisions of the Project Managers
and the Steering Committee. The Project Managers shall be
responsible for overseeing and directing the day-to-day activities
conducted at their respective sites in accordance with the Work
Plan and suggesting changes for consideration by the Steering
Committee. A Party may change its Project Manager at any time, and
from time to time, effective upon notice to the other Party of such
change.
2.4.2 Establishment and Responsibilities of Steering
Committee. As of the Restatement Date the Steering Committee
will consist of Søren Bjørn, Peter Nielsen and Ulla
Grove Sidelman representing Novo and David A. Zopf, M.D., Kathryn
J. Gregory and Elliot Morales, Jr. representing Neose. The
responsibilities of the Steering Committee are to monitor the
progress of the Work Plan, to evaluate and recommend to the Parties
any proposed amendments or modifications to the Work Plan and the
costs thereof, to approve and monitor compliance with any
publication policy provided to it by Novo, and to carry out all
other obligations assigned to it under this Agreement or by the
Parties. Each Party may designate a co-chairperson and secretary of
the Steering Committee.
2.4.3 Action by Steering Committee and Dispute Resolution.
The Steering Committee shall consist of such number of members and
alternate members as the Parties may determine from time to time.
Each Party shall appoint fifty percent (50%) of the permanent and
alternate members of the Steering Committee. The members of the
Steering Committee shall include members of senior management of
each Party. The members of the Steering Committee representing a
Party and present at a meeting shall have one vote, collectively.
If the Steering Committee cannot reach agreement on any matter,
****** shall be entitled to ****** ;
provided, however, that if the Steering Committee cannot reach
agreement on any matter involving a change in the scope of work to
be conducted by ****** under the Work Plan, the
schedule of the work to be conducted by ****** under
the Work Plan, or the ****** , such dispute shall
resolved in accordance with Section 13 .
2.4.4 Changes to Steering Committee. Each Party may remove
and replace its representatives on the Steering Committee at any
time, without cause, upon written notice to the other Party. An
alternate member designated by a Party shall be entitled to
participate in the absence of a permanent member designated by such
Party. All references to “ members ” in
this Agreement refer to the then permanent members of the Steering
Committee and any alternate member acting in the place of a
permanent member.
2.4.5 Meetings. Regular meetings of the Steering Committee
shall be scheduled by the Project Managers or the secretary of the
Steering Committee designated by either Party. Special meetings of
the Steering Committee may be called by the Project Managers or
by
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any two
or more members, at least one of whom represents each Party.
Meetings may be in person or by teleconference or videoconference,
and notice of meetings may be by email. Each Party will bear its
own costs in connection with the management of the Project and the
Steering Committee.
2.4.6 No Waiver. No action, nor any failure to act, by the
Steering Committee shall alter, amend, waive or otherwise affect
the obligations of the Parties under this Agreement. The Parties
may amend this Agreement only in accordance with
Section 15.6 , and a Party may waive any of its rights
under this Agreement only in accordance with
Section 15.9 .
2.5
Cooperation. Throughout the Project, each Party shall cooperate
with the other in the conduct of the Work Plan, and will provide
such information in its possession or under its Control to the
other Party as is reasonably necessary for the other Party to
comply with and satisfy the requirements of any and all
international, national, state, local or other laws, treaties,
rules, procedures or regulations for purposes of this Agreement, or
to carry out its obligations under this Agreement.
2.6
Permits. Prior to the commencement of any clinical trials,
Commercial Sales or other use of any New Product in a Regulated
Market, Novo shall obtain at its expense all Permits required for
such activity in the applicable jurisdictions. Novo shall submit
all applications for Permits for the New Products in the name of
Novo or its Affiliates. Novo shall hold all such Permits, if and
when granted, in its name alone. Neose, at Novo’s expense,
shall provide reasonable assistance and technical support to Novo
in obtaining the Permits for the New Products. Novo shall pay all
expenses with respect to obtaining the Permits for the New Products
including, without limitation, the cost of clinical trials and
preparation and prosecution of permit applications. Novo shall be
solely responsible for renewing any Permits at its expense. Neose
shall supply Novo, at Novo’s expense, with Reagents for
producing New Products under the terms and conditions of the Supply
Agreement.
2.7
Additional Development and Commercialization Activities. Except
as set forth in the Work Plan or the Supply Agreement, Neose shall
not have any obligation to perform any further research,
development, technology transfer, technical support, improvements,
modifications, or other activities. Novo shall use Commercially
Reasonable Efforts to obtain Regulatory Approvals for, and
Commercial Sales of, each New Product.
3. FEES AND DEVELOPMENT
PAYMENTS
3.1
License Fee. In consideration of the licenses granted by Neose
under this Agreement and the Factor VIII and IX Agreement, Novo
paid Neose a one-time, nonrefundable upfront fee of
****** within ten (10) days after the Effective
Date.
3.2
Milestone Payments Relating to Development of the New Product.
In consideration of the development efforts of Neose under the Work
Plan, Novo shall pay Neose the amount of each milestone payment set
forth in this Section 3.2 with respect to the
development of the New Product. With respect to the milestone
payment described in Section 3.2.1 the Parties agree
that Neose shall have earned the right to receive a milestone
payment solely as a result of the achievement of the milestone
event. With respect to the milestone payments described in
Sections 3.2.2 through 3.2.8 , the Parties agree that
Neose shall have earned the right to receive a milestone
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payment,
and Novo shall be obligated to pay the milestone payment and shall
have met its diligence obligations with respect to the milestone,
in each case, as a result of either (i) the achievement of the
milestone event prior to the occurrence of the corresponding
anniversary date or (ii) the occurrence, alone, of the
corresponding anniversary date.
3.2.1 ****** for the achievement of In Vivo
Biological Success, defined as improved pharmacokinetics of New
Product (modified) in dogs when compared to Novo Materials
(unmodified) as follows: ****** , using the
assay attached hereto as Exhibit 3.2.1 . The New
Product and Novo Materials will be administered in equi-molar
concentrations.
3.2.2 ****** upon the earlier to occur of:
(i) the first date on which there shall be a candidate which
has been shown to meet the ****** for the New
Product, and Neose shall have delivered to Novo
****** for the production of such candidate; and
(ii) the ****** anniversary of the Effective
Date.
3.2.3 ****** upon the earlier to occur of
****** of an ****** with respect to the
New Product or the ****** anniversary of the
achievement of the milestone (or occurrence of the date) described
in Section 3.2.2 above.
3.2.4 ****** upon the earlier of ******
of the ****** of the New Product ******
or the ****** anniversary of the achievement of the
milestone (or occurrence of the date) described in
Section 3.2.3 above.
3.2.5 ****** upon the earlier to occur of
****** of the ****** of the New Product
or the ****** anniversary of the achievement of the
milestone (or occurrence of the date) described in
Section 3.2.4 above.
3.2.6 ****** upon the earlier to occur of the first
****** for the New Product or the
****** anniversary of the achievement of the
milestone (or occurrence of the date) described in
Section 3.2.5 above.
3.2.7 ****** upon the ****** of the New
Product in ****** .
3.2.8 ****** upon the ****** of the New
Product in ****** .
3.3
Restriction on Multiple Milestone Payments. The Parties
acknowledge and agree that at anytime prior to the
****** for the New Product, the Steering Committee
may decide to continue the development of the New Product solely
with a back-up candidate if a candidate initially taken into
development should fail for ****** reasons,
including, but not limited to, ****** , or the
occurrence of ****** . In the event that the Steering
Committee makes such a decision, this Agreement shall be amended to
reflect, among other things, the resulting changes to the Work Plan
and the Neose Project-Related Costs mutually agreed upon by the
Parties. In such event, Novo ****** be required to
****** each of the milestone payments set forth in
Sections 3.2.2 through 3.2.5 .
3.4
Coordination with Factor VIII and IX Agreement. The Parties
agree that it may be appropriate to adjust one or more of the
anniversary dates set forth in Sections 3.2.2 through
3.2.5 as a result of ****** limitations (e.g.,
****** ) that may be encountered by Novo if the
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New
Product and either or both of the products being developed under
the Factor VIII and IX Agreement are scheduled to pass through the
same ****** at the same time. Novo may request such
an adjustment at any time, and from time to time, by providing
notice of the proposed adjustment to Neose. Promptly after receipt
of such a notice, the Steering Committee shall meet to evaluate the
request. Within thirty (30) days after Novo provides such
notice, the Steering Committee shall provide a written
recommendation to both Parties with respect to such request. Within
fifteen (15) days after receipt of any such recommendation, the
Steering Committee shall meet to discuss the recommendation and, if
mutually agreeable, to negotiate and propose to the Parties the
terms of amendment(s) to the Work Plan and this Agreement which
would permit Novo to continue developing the New Product and the
****** Factor VIII and IX ****** in a
practical and efficient manner, with the goal of minimizing the
aggregate time to market for the New Product and the
****** Factor VIII and IX ******
.
3.5
Milestone Payments Relating to Development of the
****** . In consideration of the development
efforts of Neose under the Work Plan related to the
****** , Novo shall pay Neose the amount of each
milestone payment set forth in this Section 3.5 . The
Parties agree that Neose shall have earned the right to receive
each respective milestone payment set forth in this
Section 3.5 , and Novo shall be obligated to pay such
milestone payment, in each case, as a result of either (i) the
achievement of the milestone set forth for such payment, or
(ii) the failure by Novo to inform Neose within 30 days
after the receipt of the material, results or data provided by
Neose that the applicable milestone set forth in
Sections 3.5.1 or 3.5.2 was not achieved. For each
milestone set forth in Sections 3.5.1 and 3.5.2 , upon
the occurrence of (i) or (ii) above, Neose shall issue an
invoice to Novo and payment of the respective milestone payment
shall be due upon the later of (a) 30 days following the
receipt of such invoice by Novo and (b) January 1,
2006.
3.5.1 Novo will pay Neose ****** upon delivery
of approximately ****** of ****** (
****** ) meeting the ****** criteria
set forth in Exhibit 3.5 or as provided in clause
(i) of Section 3.5 . The Parties acknowledge that
the amount set forth in this Section 3.5.1 has been paid
prior to the Restatement Date.
3.5.2 Novo will pay Neose ****** upon the delivery of
approximately ****** of ****** meeting the
****** criteria set forth in Exhibit 3.5 or as
provided in clause (ii) of Section 3.5 .
3.5.3 In the event that, notwithstanding good faith efforts
on the part of Neose to meet the milestones set forth in
Section 3.5.1 and 3.5.2 , neither milestone has been
met by Neose, Novo will pay the milestone payments provided for in
Sections 3.5.1 and 3.5.2 upon delivery by Neose to Novo
of ****** for use in the production by Novo of ******
.
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4. PRODUCT PAYMENTS AND
ROYALTIES
4.1
Royalties on Net Sales . Novo will pay to Neose royalties as a
percentage of annual Net Sales of each New Product during the Term
at the applicable rates set forth in this Section 4.1 and in
accordance with this Section 4 :
4.1.1 ****** of annual Net Sales of the New Product
up to ****** .
4.1.2 ****** of annual Net Sales of the New Product
over ****** .
4.2
Minimum Royalties. Commencing with the first
****** of the ****** full Calendar Year
following the First Commercial Sale of New Product, Novo will pay
minimum royalties in respect of the New Product for such Calendar
Year and ****** during the Term, in the amounts set
forth in this Section 4.2 and in accordance with this
Section 4 :
4.2.1 For the ****** Calendar Year following
the First Commercial Sale of the New Product: ******
.
4.2.2 For the ****** Calendar Year following
the First Commercial Sale of the New Product:
******.
4.2.3 For the ****** Calendar Year following
the First Commercial Sale of the New Product and
****** thereafter: ****** .
All
minimum royalty payments made in accordance with this
Section 4.2 shall be ****** against royalties
payable under Section 4.1 in respect of the New Product
in the same or any subsequent Calendar Quarter during the same
Calendar Year.
4.3
Competitive Product(s). If a Competitive Product (as defined
below in this Section 4.3 ) reaches a ******
equal to or greater than ****** percent (
****** %) of the market for a New Product marketed by
Novo, then the royalties otherwise payable in accordance with
Section 4.1 , and the minimum royalties otherwise payable in
accordance with Section 4.2 , with respect to the New
Product shall be ****** by the applicable percentage
set forth below:
Market Share of Competitive
Product ****** Royalty Rate Otherwise
Payable
More
than ******
More
than ******
More
than ******
More
than ******
For
purposes of this Section 4.3 , “
Competitive Product ” means any product
marketed by a Third Party that is not a Sublicensee of Novo, which
product is a ****** Factor VIIa with a ******
substantially equivalent to or better than the ****** of the
New Product marketed by Novo.
4.4
Royalty Payments. Novo shall make royalty payments to Neose on
a quarterly basis, within forty-five (45) days after the end
of each Calendar Quarter. Royalty payments due under
Section 4.1 shall commence, with respect to each New
Product in each country, on the date of first Commercial Sale in
such country.
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4.5
Currency Conversion. If any currency conversion from a foreign
currency into United States Dollars shall be required in connection
with the calculation of Net Sales, such conversion shall be made
using the average exchange rate for the applicable Calendar
Quarter, as reported by the Wall Street Journal .
4.6
Payment Reports. Within forty-five (45) days after the
close of each Calendar Quarter, Novo shall furnish to Neose a
written report showing in reasonably specific detail, on a
country-by-country basis for each New Product:
4.6.1 All Net Sales of the New Product during such quarter
expressed in United States Dollars.
4.6.2 The exchange rates used in determining Net Sales of
the New Product in United States Dollars in accordance with
Section 4.5 .
4.6.3 Royalties payable in United States Dollars based upon
such Net Sales of the New Product during such quarter.
4.7
Payment Method . Novo shall make all payments under this
Agreement in United States Dollars by bank wire transfer in
immediately available funds to Hudson United Bank, ABA #
****** , Acct Name: Neose Technologies, Inc., Acct #
****** , or to such other account as Neose shall
designate to Novo in writing before such payment is due.
4.8
Records; Audits. Novo shall, and shall cause its Affiliates and
Sublicensees, if any, to keep complete, true, and accurate books of
account and records in connection with the production and
Commercial Sales of New Products in sufficient detail to permit
accurate determination of all figures necessary for verification of
payments required to be made by Novo under this Agreement. Novo
shall, and shall cause its Affiliates and Sublicensees, if any, to,
maintain such records for at least ****** years
following the end of the quarter to which such books and records
pertain. Neose shall have the right, at its expense, through a
certified public accounting firm reasonably acceptable to Novo, to
examine the records required to be maintained by Novo, its
Affiliates and Sublicensees under this Section 4.8 upon
reasonable notice and during regular business hours prior to the
termination or expiration of this Agreement and for
****** years thereafter for the purpose of verifying
the reports delivered pursuant to Section 4.6 provided
that such examination shall not take place more often than once a
year. Novo may require such certified public accounting firm to
sign a confidential disclosure agreement prior to permitting such
certified public accounting firm to have access to its books,
records or facilities. Such accounting firm shall report to Neose
only whether or not the reports submitted by Novo are accurate for
the period covered and the details concerning any identified
discrepancies. If any such audit uncovers an underpayment, Novo
shall promptly pay to Neose the amount of such underpayment. If any
such underpayment exceeds ****** of the amount due,
Novo shall pay the entire expense of such audit within
****** after invoice.
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4.9
Taxes. Novo may deduct the amount of any taxes imposed on Neose
which are required to be withheld or collected by Novo or its
Sublicensees under the laws of any country from amounts owing to
Neose hereunder to the extent Novo, its Affiliates or Sublicensees
pay such withholding taxes to the appropriate governmental
authority on behalf of Neose and promptly deliver to Neose a
receipt or other proof of payment of such taxes.
5. INTELLECTUAL PROPERTY
GRANTS AND RIGHT OF NEGOTIATION
5.1
Neose Technology. Subject to the terms and conditions of this
Agreement, Neose hereby grants, and agrees to grant, to Novo, as of
the Effective Date, the following rights and licenses:
5.1.1 Exclusive License. As of the Effective Date, Neose
hereby grants, and agrees to grant, to Novo an exclusive (even as
to Neose), royalty-bearing license under the Neose Intellectual
Property in the Field of Use during the Term, (i) to conduct
research, sample, develop (including clinical development),
manufacture, make, use, market, promote, sell, offer for sale, have
sold, distribute, import and export New Products in the Territory,
and (ii) to use the Reagents in the Territory solely for the
purpose of making New Products. Such license does not permit Novo
(x) to practice or use the Neose Intellectual Property outside
the Field of Use or (y) to sublicense any of its rights
without the prior written approval of Neose, except as provided in
Section 5.1.2 .
5.1.2 Limited Sublicense Rights. Novo shall be entitled to
grant full sublicenses to its Affiliates and limited sublicenses to
its distribution, marketing and/or sales partners, in each case, in
compliance with the provisions of this Section 5.1.2
and Section 5.1.3 . In any sublicense granted under
this Section 5.1. 2 to a Third Party that is not an
Affiliate of Novo, Novo may grant the Sublicensee only the
following rights: to market, promote, sell, offer for sale, have
sold, distribute, import and export New Products for Novo. Novo
shall not be entitled to disclose any Confidential Information of
Neose to a non-Affiliate Sublicensee under a sublicense permitted
to be granted under this Section 5.1.2 . Novo shall
include in each sublicense granted under this
Section 5.1.2 all of the terms and conditions necessary
to ensure Novo’s compliance with this Agreement, and the
provisions of Section 5.1.4 shall apply to each
sublicense granted under this Section 5.1.2 .
5.1.3 Required Agreement for Certain Proposed Sublicensees.
Prior to entering into discussions with any proposed sublicensee,
Novo shall identify the proposed sublicensee to Neose. If the
proposed sublicensee is not an Affiliate of Novo, Novo shall obtain
the approval of Neose prior to entering into such discussions and
shall obtain the proposed sublicensee’s execution and
delivery to Neose of a non-disclosure and non-use agreement
substantially in the form attached hereto as
Exhibit 5.1.3 . If the proposed sublicensee is an
Affiliate of Novo, Novo may enter into the proposed sublicense
without obtaining the approval of Neose if: (i) the sublicense
between Novo and the Sublicensee/Affiliate provides that Neose is a
third-party beneficiary of the Sublicense, and (ii) Neose
receives an original fully executed copy of the sublicense between
Novo and the Sublicensee/Affiliate within five (5) business
days after its execution.
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5.1.4 Liability. Novo shall remain primarily liable to Neose
for the performance by each Affiliate and Sublicensee in accordance
with the terms and conditions of this Agreement, and each
sublicense shall terminate upon the termination of this Agreement
or any breach by the Sublicensee of the Required Agreement between
Neose and the Sublicensee, if any.
5.1.5 Reservation of Rights. Neose hereby reserves to itself
all right, title and interest in and to the Neose Intellectual
Property not expressly granted in Section 5.1 . Without
limiting the foregoing, in no event shall this Agreement be
construed to prohibit Neose from engaging in any of the following
activities: (a) practicing the processes, methods and Know-How
of the Neose Intellectual Property outside of the Field of Use,
including, without limitation, with proteins that may be considered
competitive with any of the New Products, subject, however, to
Novo’s rights with respect to Product-Candidates under
Section 5.3 ; (b) developing, making, using or
selling proteins or Reagents, whether in conjunction with the Neose
Intellectual Property or otherwise, outside of the Field of Use; or
(c) entering into and performing agreements with Third Parties
regarding any of the foregoing including, without limitation,
research agreements, development agreements and licensing
agreements.
5.1.6 Carved Factor VII Claim Licenses. Neose hereby grants,
and agrees to grant, to Novo a worldwide, exclusive (even as to
Neose), perpetual, irrevocable, and royalty-bearing (subject only
to the payment of royalties in accordance with Section 4)
license, with the right to sublicense, to any Carved Factor VII
Claims that do not constitute Novo Improvements for any and all
purposes. The royalties due with regard to the foregoing license
shall be determined in accordance with Section 4 of this
Agreement. In addition to the foregoing, Neose hereby grants, and
agrees to grant, to Novo a worldwide, exclusive (even as to Neose),
perpetual, irrevocable, and royalty-free license, with the right to
sublicense, to any Carved Factor VII Claims that constitute Novo
Improvements for any and all purposes.
5.2
Novo Technology. Subject to the terms and conditions of this
Agreement, and solely to the extent necessary to enable Neose to
carry out its obligations under the Work Plan, Novo hereby grants
to Neose, for the term of the Work Plan, a non-exclusive, royalty
free, license under the Novo Technology to use such Novo Technology
for the sole purpose of carrying out its obligations under the Work
Plan. Novo shall retain at all times all of its rights, title and
interest to the Novo Technology.
5.3
Licenses to Neose. Novo hereby grants, and agrees to grant, to
Neose, a worldwide, exclusive (even as to Novo) as to Neose
Exclusive Compounds and non-exclusive as to all other compounds,
perpetual, irrevocable and royalty free license, with the right to
sublicense, to Neose License Claims as defined in clauses (i)-(iii)
of Section 1.29, for any and all purposes, except in
connection with any and all forms of insulin or Novo Materials.
Novo hereby grants, and agrees to grant, to Neose, a worldwide,
exclusive (even as to Novo), perpetual, irrevocable and royalty
free license, with the right to sublicense, to Neose License Claims
as defined in clause (iv) of Section 1.29, for any and all
purposes.
5.4
Option and Right of First Negotiation
5.4.1 Option. Neose hereby grants to Novo an option to
negotiate a worldwide license under the Neose Technology to conduct
research,
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sample,
develop (including clinical development), manufacture, make, use,
market, promote, sell, offer for sale, have sold, distribute,
import and export each and every Product-Candidate. The option
granted under this Section 5.4.1 shall be exercisable
by Novo, from time to time during the Term with respect to each
Product-Candidate, within fifteen (15) days after Novo
receives notice of the Product-Candidate from Neose.
5.4.2 Negotiations. If Novo duly exercises its option under
Section 5.4.1 with respect to a Product-Candidate, the
Parties shall enter into negotiations to consummate an agreement,
which would grant to Novo the license described in
Section 5.4.1 with respect to such Product-Candidate,
upon commercially reasonable terms, to be negotiated promptly,
diligently and in good faith by the Parties. If the Parties shall
not have entered into such a license within ******
after Novo’s exercise of its option with respect to such
Product-Candidate, Neose shall be free to proceed with the
development and/or commercialization of the Product-Candidate,
whether alone or with a Third Party or Third Parties, without any
further obligation to Novo with respect to such Product-Candidate,
except as provided in Section 5.4.3 .
5.4.3 Right of First Negotiation. During the Term, Neose
shall not enter into an agreement with a Third Party relating to
the use of the Neose Technology for the further development and
commercialization of a Product-Candidate without first allowing
Novo to enter into an agreement with respect to such
Product-Candidate upon substantially the same terms. If Neose shall
not have already offered (and Novo shall not have already refused)
substantially the same terms to Novo under
Section 5.4.2 , Neose shall provide notice to Novo of
the proposed terms and conditions of any such agreement, and Novo
may exercise its right of first refusal under this
Section 5.4.3 by notice to Neose within
****** after receiving the proposed terms and
conditions from Neose. If Novo does not exercise its right of first
refusal with respect to the terms proposed by Neose, or exercises
its right of first refusal but does not enter into an agreement
with Neose upon substantially the proposed terms within
****** after receipt thereof, Neose shall be free to
proceed with the further development and/or commercialization of
such Product-Candidate with a Third Party or Third Parties, upon
terms no more favorable to the Third Party or Third Parties than
those offered to Novo, without any further obligation to Novo with
respect to such Product-Candidate.
5.5
No Other Right or Licenses. Except for the rights and licenses
expressly granted in this Agreement, nothing in this Agreement
shall be deemed to grant to any Party any other rights or licenses,
including, without limitation, any implied licenses.
6. OWNERSHIP OF INTELLECTUAL
PROPERTY
6.1
No Transfer of Title. All Ownership Rights in and to the Neose
Intellectual Property and the Reagents shall remain at all times
with Neose. All Ownership Rights in the Novo Materials, any New
Product, and the Novo Technology shall remain at all times with
Novo, subject to Novo’s obligation to assign certain
Ownership Rights to Neose under Section 6.3 .
6.2
Improvements
6.2.1 Neose Improvements. Subject to Section 6.3.1, any
and all Neose Improvements shall be owned by Neose and shall be
deemed to be part of the Neose Intellectual Property for all
purposes, including, without limitation, the license granted in
Section 5.1 . Except as provided in Section 6.4
, any and all Improvements made, conceived, or reduced to practice
solely by Neose shall be owned solely by Neose.
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6.2.2 Novo Improvements. Subject to Section 6.4.1,
except as otherwise provided in Section 6.3 , any and
all Novo Improvements shall be owned by Novo for all purposes.
Except as set forth in Section 6.3 , any and all
Improvements made, conceived, or reduced to practice, solely by
Novo shall be owned solely by Novo.
6.2.3 Joint Improvements. Each of Neose and Novo shall own a
one-half undivided interest in any and all Joint Improvements.
Neither Party shall be permitted to license or sublicense its
one-half undivided interest in any Joint Improvement(s) to a Third
Party that is not an Affiliate of Novo for use in connection with
any blood factor products VII, VIII or IX, except with the prior
written approval of the other Party.
6.2.4 Other Improvements. If any Improvements, other than
Neose Improvements, Novo Improvements and Joint Improvements, are
made, conceived or reduced to practice jointly by Neose and Novo
under this Agreement, each Party shall own a one-half undivided
interest in and to any and all such Improvements and the Parties
shall not have any restriction with respect to the use thereof or
any requirement to report or account to the other Party with
respect to any such use, unless and except to the extent that the
Parties may agree otherwise in writing.
6.3
Assignment by Novo.
6.3.1 Neose Improvements. To the extent that Novo may retain
any Ownership Rights in any Neose Improvements during the Term,
Novo hereby irrevocably assigns and transfers, and agrees to assign
and transfer, to Neose, at the request of Neose, any and all such
Ownership Rights that have not been licensed to Neose under
Section 5.3, in perpetuity or for the longest period otherwise
permitted by law, without the necessity of further consideration,
and Neose shall be entitled to receive and hold in its own name all
such Ownership Rights, subject to Neose’s obligations to
assign certain rights to Novo under Section 6.4 .
6.3.2 Joint Improvements. If and when Novo terminates the
development of New Product during the Term, Novo hereby irrevocably
assigns and transfers, and agrees to assign and transfer to Neose,
in perpetuity or for the longest period otherwise permitted by law,
without the necessity of further consideration, and Neose shall be
entitled to receive and hold in its own name all Ownership Rights
in and to the Joint Improvements. With respect to any Ownership
Rights and licenses that Novo is required to assign and transfer to
Neose under this Section 6.3.2 , at the request of
Neose, and at Neose’s expense, either before or after
termination of the Term, Novo shall assist Neose in acquiring and
maintaining patent, copyright, trade secret and trademark
protection upon, and confirming Neose’s title in and to, any
such respective Ownership Rights, and Novo shall provide Neose
appropriate documentation evidencing the licenses to which Neose is
entitled. Novo’s assistance shall include, but shall not be
limited to, signing all applications, and any other documents and
instruments for patent, copyright and any other proprietary rights,
providing executed license documents, cooperating in legal
proceedings, and taking any other actions considered necessary or
desirable by Neose. For the purpose of facilitating the above
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