SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): December 19, 2001
NEOSE TECHNOLOGIES, INC.
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(Exact name of issuer as specified in charter)
DELAWARE 0-27718 13-3549286
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation or file Identification
Organization) number) Number)
102 Witmer Road,
Horsham, Pennsylvania 19044
(Address of principal executive offices)
(215) 441-5890
(Registrant's telephone number, including area code)
Item 5 - Other Events.
On December 19, 2001, Neose Technologies, Inc. ("Neose") announced that
it entered into a research, development and license agreement with Wyeth-Ayerst
Laboratories, the pharmaceutical division of American Home Products Corporation,
for the use of Neose's GlycoAdvance(TM) technology to develop an improved
production system for Wyeth's biopharmaceutical compound, rPSGL-Ig (P-selectin
glycoprotein ligand). This is Neose's first commercial partner for GlycoAdvance.
rPSGL-Ig is a P-selectin antagonist that is being developed to treat
inflammation and thrombosis associated with acute coronary syndrome and
reperfusion injury. It is currently being evaluated in Phase II clinical trials
in patients being treated for heart attack. Wyeth is evaluating the use of
GlycoAdvance in the production of rPSGL-Ig for Phase III clinical trials and
commercial launch.
Neose will develop processes for the commercial-scale manufacture of
proprietary enzymes and sugar nucleotides to be used in the production of
rPSGL-Ig, and will license GlycoAdvance to Wyeth for commercial production of
the drug. If Wyeth receives FDA approval of the drug, during commercial
production of Wyeth's current rPSGL-Ig, Neose will receive ongoing payments tied
to yield improvements achieved using GlycoAdvance in the production of rPSGL-Ig.
In addition, Wyeth has the option to use GlycoAdvance to develop a next
generation rPSGL-Ig, in which case Neose would receive royalties on product
sales.
Under the agreement, Neose will receive license, research, and
milestone payments that would total up to $17 million if all milestones are met.
In addition to ongoing product payments, following FDA approval of the drug,
Neose and Wyeth will also enter into a supply agreement for the long-term supply
of GlycoAdvance process reagents.
Item 7 - Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits
Exhibit No. Description
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10.1 * Research, Development and License Agreement, dated
December 19, 2001, between Neose Technologies, Inc. and
American Home Products Corporation.
* Portions of this Exhibit were omitted and filed separately
with the Secretary of the SEC pursuant to a request for
confidential treatment that has been filed with the SEC.
Signatures
Pursuant to the requirements of the Securities and Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, hereunto duly authorized.
NEOSE TECHNOLOGIES, INC.
Date: January 31, 2002 By: /s/ Stephen A. Roth
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Stephen A. Roth
Chairman and Chief Executive Officer
Index to Exhibits
Exhibit No. Description
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10.1* Research, Development and License Agreement, dated
December 19, 2001, between Neose Technologies, Inc. and
American Home Products Corporation.
* Portions of this Exhibit were omitted and filed separately
with the Secretary of the SEC pursuant to a request for
confidential treatment that has been filed with the SEC.
Portions of this exhibit were omitted and filed separately with the Securities
and Exchange 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 asterisks.
RESEARCH, DEVELOPMENT, AND LICENSE AGREEMENT
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This RESEARCH, DEVELOPMENT, AND LICENSE AGREEMENT (the "Agreement"), is
effective as of December 19, 2001 ("Effective Date"), between NEOSE
TECHNOLOGIES, INC., a Delaware corporation ("Neose"), and American Home Products
Corporation, a Delaware corporation acting through its Wyeth-Ayerst Laboratories
Division ("Wyeth").
BACKGROUND
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Neose has developed and continues to develop patented technology and
related know-how, known as GlycoAdvanceTM, for the glycosylation of recombinant
proteins and glycoprotein remodeling. Wyeth wishes to have Neose develop and
provide reagents needed for Wyeth to integrate the GlycoAdvance(TM) technology
into Wyeth's process for producing P-selectin Glycoprotein Ligand
Immunoconjugate (PSGL-Ig). Under the terms and conditions of this Agreement,
Neose is willing to develop and provide such reagents, and Neose is interested
in licensing to Wyeth and Wyeth wishes to obtain from Neose a license under
certain patents and know-how of Neose relating to the GlycoAdvance(TM)
technology.
TERMS
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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, Wyeth and Neose agree as follows:
1. DEFINITIONS. Capitalized terms not otherwise defined shall have the meaning
set forth in this Section 1.
1.1 "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, at least 50% of the voting stock or other ownership interest of the
other Person.
1.2 "Base Product" means a Product with a fucosylation pattern
functionally equivalent to PSGL-Ig.
1.3 "Blocking Patent" means any Patent Rights claimed to be owned or
controlled by a Person (other than a party to this Agreement or an Affiliate of
such party) with respect to which Patent Rights an assertion is being made by
such Person that the use of the Neose Technology under this Agreement infringes
such Person's Patent Rights.
1.4 "Calendar Quarter" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 or
December 31 for so long as this Agreement is in effect.
1.5 "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.
1.6 "Commercial Sale" means any sale of Products by Wyeth, its
Affiliates, or sublicensees to a Person other than their respective Affiliates
or Neose.
1.7 "Confidential Information" means any and all confidential or
proprietary information of a party to this Agreement, including, without
limitation, technical data, trade secrets or know-how, 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. Confidential
Information shall be disclosed in writing and labeled "Confidential." In the
event that Confidential Information is first disclosed orally or otherwise not
in writing, it shall be identified as confidential at the time of disclosure and
summarized in writing to the receiving party within 30 days after the initial
disclosure.
1.8 "Control" or "Controlled" means possession of the ability to grant
a license or sublicense 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.
1.9 "Designated Representative" means, in the case of Neose, its Vice
President, Business and Commercial Development, or such other person designated
by Neose in writing from time to time to Wyeth, and, in the case of Wyeth, its
Senior Vice President of Global Business Development, or other such other person
designated by Wyeth in writing from time to time to Neose.
1.10 "Effective Date" shall mean the later of (i) the date of execution
of the Agreement by both parties or (ii) if notification is required to be made
under the HSR Act, the expiration or earlier termination of any notice and
waiting period under the HSR Act.
1.11 "FDA" means the United States Food and Drug Administration and any
successor agency.
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1.12 "Field" means the process development and commercial manufacture,
for use as a human therapeutic, of PSGL1-Ig and other proteins with amino acid
sequences that are greater than ***% identical, or greater than ***% similar, to
the *** of Wyeth's PSGL-IG, and contain an ***, and contain ***.
1.13 "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.
1.14 "HSR Act" shall mean the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended, and the rules and regulations promulgated thereunder.
1.15 "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.
1.16 "Joint Working Group" means the joint working group described in
Section 2.4.1.
1.17 "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.
1.18 "Neose Patents" means all Patent Rights relating to methods and
processes for glycosylation of recombinant proteins or glycoprotein remodeling
and (i) currently Controlled by Neose and listed in Exhibit 1.18, as may be
amended from time to time to include Patent Rights under clauses (ii) or (iii)
hereof; (ii) developed by Neose in the conduct of the Project Plan, or (iii)
subject to the rights of Third Parties, developed or acquired by Neose outside
the Project Plan during the term of this Agreement.
1.19 "Neose Project-Related Costs" means Neose's costs of conducting
the Project, which costs shall be calculated at the rate of $*** per FTE.
1.20 "Neose Technology" means the Neose Patents and any Know-How
Controlled by Neose and relating to methods and processes for the glycosylation
of recombinant proteins or glycoprotein remodeling.
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1.21 "New Product" means any Product that is not the Base Product.
1.22 "Net Sales" means proceeds from Commercial Sales of Products by
Wyeth, its Affiliates or sublicensees, as appropriate, to Third Parties, less
the sum of (a) and (b) where (a) is a provision, determined under Generally
Accepted Accounting Principles in the United States, for (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, (iv) charges actually
incurred for freight and insurance directly related to the distribution of
Products (excluding amounts reimbursed by Third party customers), (v) bad debt
actually written off by Wyeth in accordance with Wyeth accounting policies, and
(vi) credits or allowances actually given or made for wastage replacement, and
(b) is a periodic adjustment of the provision determined in (a) to reflect
amounts actually incurred for (i), (ii), (iii), (iv), (v) and (vi). A "sale" of
a Product is deemed to occur upon the invoicing, or if no invoice is issued,
upon the earlier of shipment or transfer of title in the Product to a Third
Party. In the event that 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 would be determined
above by a fraction, the numerator of which is the fair market value of the
Product in such Combination Product, and the denominator of which is the fair
market value of the Combination Product. In the event that Wyeth would sell
Product together with other products of Wyeth to Third Parties, and the price
attributable to the Product is less than the average price of "arms length"
sales to Third Parties for the reporting period in which sales occur (such sales
to be excluded from the calculation of the average price of "arms length"
sales), Net Sales for any such sales would be average price of "arms length"
sales by Wyeth to Third Parties during the reporting period in which such sales
relate.
1.23 "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.
1.24 "Patent Rights" means any patents or patent applications,
including all corresponding foreign patents and patent applications, all
divisions, continuations, continuations-in-part, reissues, renewals, extensions
or additions to any such patents and patent applications.
1.25 "Payment Components" shall have the meaning set forth in Exhibit
4.1.
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1.26 "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 Products.
1.27 "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.
1.28 "Product" means PSGL-Ig produced using the Neose Technology, or
other proteins with amino acid sequences that are greater than ***% identical,
or greater than ***% similar, to the *** of PSGL-Ig, and ***, and contain ***
produced using the Neose Technology.
1.29 "Project" means the project to be conducted hereunder by the
parties in accordance with the Project Plan.
1.30 "Project Manager" means the project managers described in Section
2.4.2.
1.31 "Project Plan" means the plan of work to be created and updated by
the parties pursuant to Section 2.2, and to be carried out by the parties under
this Agreement.
1.32 "PSGL-Ig" shall mean the glycoprotein identified in, and with the
sequence and fucosylation pattern set forth in, Exhibit 1.32.
1.33 "Reagents" means the enzymes and sugar nucleotides required to use
the Neose Technology in the manufacture of Products.
1.34 "Regulated Market" means any jurisdiction worldwide that requires
a Permit for clinical trials, Commercial Sales or other use of the Products.
1.35 "Regulatory Approval" shall mean all Permits by the competent
authorities required for the regular marketing, promotion, pricing and sale of a
Product in a Regulated Market.
1.36 "Supply Agreement" means the supply agreement to be entered into
between Neose and Wyeth in accordance with Section 8.
1.37 "Territory" means the world.
1.38 "Term" means the term of this Agreement, as described in Section
12.1.
1.39 "Third Party" means any Person other than Wyeth, Neose, or their
respective Affiliates.
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1.40 "Valid Patent Claim" means a claim of an issued and unexpired
patent forming part of the Neose Patents that has not been held revoked,
unenforceable or invalid by a decision of a court or other government agency of
competent jurisdiction, 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.
1.41 "Wyeth Technology" means the Patent Rights and Know-How Controlled
by Wyeth relating to PSGL-Ig.
2. PROJECT.
2.1 Conduct. Neose and Wyeth will use Commercially Reasonable Efforts
to carry out their respective obligations under the Project Plan.
2.2 Creation and Modification of Project Plan. Attached hereto as
Exhibit 2.2 is the Project Plan, setting forth an ***-month work plan summary
and timetable. Within 60 days after the execution hereof, the parties will
cooperate to amend the Project Plan to set forth additional detail regarding the
work plan and the responsibilities of the parties. Neose shall be responsible
for the development of validated, GMP processes for the production of Reagents
for use in the manufacture of Products and protocols for the use of the Reagents
in the manufacture of Products by Wyeth. The Project Plan may be amended or
modified from time to time, but only in a writing signed by each party's
Designated Representative.
2.3 Funding. Wyeth will pay *** of the Neose Project-Related Costs
quarterly in advance. No earlier than 30 days before the beginning of each
Calendar Quarter, Neose will invoice Wyeth for such amount based on a budgeted
estimate of Neose Project-Related Costs for such Calendar Quarter. Within 30
days after the end of each Calendar Quarter, Neose shall submit to Wyeth a
written report setting forth the actual Neose Project-Related Costs for such
Calendar Quarter, and shall, as applicable, pay to Wyeth any amounts paid by
Wyeth for such Calendar Quarter in excess of *** of the actual Neose
Project-Related Costs shown in such report, or invoice Wyeth for any additional
amounts owed hereunder. Wyeth will pay all invoices delivered under this Section
within sixty days after receipt.
2.4 Management of Project.
2.4.1 Joint Working Group. The Project will be managed by the Joint
Working Group.
2.4.1.1 Composition. The Joint Working Group will consist of
the Project Managers and two other representatives of each party.
The initial Joint Working Group is listed in Exhibit 2.4.1. Wyeth's
Project Manager will serve as the chair of the Joint Working Group.
A party may change any of its representatives at any time by notice
to the other.
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2.4.1.2 Meetings. The Joint Working Group shall meet (in
person or otherwise) at least once during each Calendar Quarter at
such place and time as is agreed upon by the parties, to review the
Project Plan and the progress of the Project. Neose and Wyeth shall
bear their respective costs of attending such meetings. The Joint
Working Group shall keep minutes of all such meetings. Prior to
each such meeting, the Project Managers shall mutually select the
party to keep the minutes for such meeting. Promptly following each
meeting, the party assigned to keeping the minutes shall submit
draft minutes to the other party for review and approval (not to be
unreasonably withheld or delayed), which minutes shall be
considered final only when both parties have approved them.
2.4.1.3 Dispute Resolution. If the Joint Working Group is
unable to resolve, after thirty days, a dispute regarding any issue
presented to it or arising in it, such dispute shall be referred to
the Designated Representative of each party for good faith
resolution for a period of thirty days. If such dispute is not
resolved by the end of such thirty-day period, the parties shall be
free to pursue any legal or equitable remedy available to them.
2.4.2 Project Managers. Within thirty days after the Effective
Date, each of the parties shall appoint a Project Manager, who will be each
party's first point of contact with respect to the Project. Each Project
Managers shall keep the other reasonably informed of their respective progress
under the Project Plan. The Project Managers shall have appropriate authority
and decision-making power to carry out their respective responsibilities
hereunder. The Project Managers shall be responsible for overseeing and
directing the research under and in accordance with the Project Plan.
2.5 Cooperation. Throughout the Term, each party shall cooperate with
the other in the conduct of the Project 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 any clinical trials, Commercial Sales or other
use of any Product in a Regulated Market, Wyeth shall obtain at its expense all
Permits. Wyeth shall submit all applications for Permits for the Products in the
name of Wyeth or its Affiliates. Wyeth shall hold all such Permits, if and when
granted, in its name alone. Neose, at Wyeth's expense, shall provide reasonable
assistance and technical support to Wyeth in obtaining the Permits for the
Products. Wyeth shall pay all expenses with respect to obtaining the Permits for
the Products including, without limitation, the cost of clinical trials and
preparation and prosecution of permit applications. Wyeth shall be solely
responsible for renewing any Permits at its expense. Neose shall supply Wyeth,
at Wyeth's expense, with Reagents for producing Products to be used in
connection with prosecuting Permit applications such as clinical trials.
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2.7 Additional Development Activities. Except as set forth in Section
2.3 or in the Project Plan, neither party shall have any obligation to
collaborate in, or fund, any further research, development, technical support,
improvements, modifications, or other activities.
3. FEES AND DEVELOPMENT PAYMENTS.
3.1 License Fee. In consideration of the licenses granted by Neose
hereunder, Wyeth shall pay Neose a nonrefundable license fee of $*** within 10
business days after the Effective Date.
3.2 Annual Maintenance Fee. In consideration of the development efforts
of Neose under the Project Plan, Wyeth shall pay to Neose an annual maintenance
fee of $***, commencing on the first business day of the Calendar Quarter
following the last invoice to Wyeth for Neose Project-Related Costs pursuant to
Section 2.3, and thereafter on the anniversary of such date until the first
Commercial Sale of a Product. In any year in which a development payment
pursuant to Section 3.3 in excess of $*** is earned, the annual maintenance fee
paid in such year pursuant to this Section 3.2 shall be credited against payment
of such development payment.
3.3 Development Payments. In consideration of the development efforts
of Neose under the Project Plan, Wyeth shall pay Neose the amounts set forth in
Exhibit 3.3 upon the occurrence of the corresponding events set forth therein.
4. PRODUCT PAYMENTS AND ROYALTIES.
4.1 Product Payments. With respect to the Base Product, from and after
the first Commercial Sale, Wyeth will make quarterly payments in accordance with
Exhibit 4.1 within 10 days after the end of each Calendar Quarter.
4.2 Royalties. With respect to a New Product, Wyeth will pay royalties
to Neose in accordance with Exhibit 4.2 within 45 days after the end of each
Calendar Quarter. Royalty payments shall commence, with respect to each New
Product in each country, on the date of first Commercial Sale in such country.
4.3 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.
4.4 Payment Reports.
4.4.1 Within 30 days after the close of each Calendar Quarter
during the Term, Wyeth shall furnish to Neose a written report showing in
reasonably specific detail, on a country-by-country basis for the Base Product:
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4.4.1.1 Payment Components for such quarter.
4.4.1.2 Payments due under Section 4.1, including the
calculation of such amounts.
4.4.2 Within 45 days after the close of each Calendar Quarter
during the Term, Wyeth shall furnish to Neose a written report showing in
reasonably specific detail, on a country-by-country and Product-by-Product
basis:
4.4.2.1 All Net Sales of New Products during such quarter
expressed in United States Dollars.
4.4.2.2 The exchange rate used in determining Net Sales in
United States Dollars in accordance with Section 4.3.
4.4.2.3 Royalties payable in United States Dollars based upon
such Net Sales during such quarter.
4.5 Payment Method. Wyeth shall make all payments under this Agreement
in United States Dollars by bank wire transfer in immediately available funds to
Hudson United Bank, ABA # 031901482, Acct Name: Neose Technologies, Inc., Acct #
0004187962, or to such other account as Neose shall designate to Wyeth in
writing before such payment is due.
4.6 Records; Audits. Wyeth 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 Products in
sufficient detail to permit accurate determination of all figures necessary for
verification of payments required to be made by Wyeth under this Agreement,
including without limitation Payment Components, and Net Sales. Wyeth shall, and
shall cause its Affiliates and sublicensees, if any, to, maintain such records
for at least 4 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 accountant reasonably acceptable to Wyeth, to examine the records
required to be maintained by Wyeth, its Affiliates and sublicensees under this
Section upon reasonable notice and during regular business hours prior to the
termination or expiration of this Agreement and for three years thereafter for
the purpose of verifying the reports delivered pursuant to Section 4.4, provided
that such examination shall not take place more often than once a year. Wyeth
may require such certified public accountant to sign a confidential disclosure
agreement prior to permitting such certified public accountant to have access to
its books, records or facilities. Such accountant shall report to Neose only,
for the period covered by the examination, whether or not the reports submitted
by Wyeth are accurate and details concerning any discrepancies. In the event
such audit uncovers an underpayment, Wyeth shall promptly pay to Neose the
amount of such underpayment. If such underpayment exceeds 5% of the amount due,
Wyeth shall pay the entire expense of such audit within 20 days after invoice.
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4.7 Taxes. Wyeth may deduct the amount of any taxes imposed on Neose
which are required to be withheld or collected by Wyeth or its sublicensees
under the laws of any country from amounts owing to Neose hereunder to the
extent Wyeth, its Affiliates or sublicensees pay such withholding taxes to the
appropriate governmental authority on behalf of Neose. If available, Wyeth shall
promptly deliver to Neose a receipt or other proof of payment of such taxes as
soon as practicable.
5. INTELLECTUAL PROPERTY GRANTS.
5.1 Neose Technology. Subject to the terms and conditions of this
Agreement, Neose hereby grants to Wyeth the following rights and licenses:
5.1.1 Exclusive License. Subject to the terms and conditions of
this Agreement, including without limitation Sections 5.1.3 , 5.1.4 and 5.1.5,
Neose hereby grants Wyeth an exclusive, royalty-bearing license, with the right
to sublicense, under the Neose Technology in the Field, (i) to develop, make,
have made, use, sell, import and export Product in the Territory, and (ii) to
make and use the Reagents in the Territory. Such license does not permit Wyeth
to practice or use the Neose Technology outside the Field.
5.1.2 Direct License to Affiliates. If reasonably necessary for
commercialization of the Products, Wyeth may at anytime request from Neose and
Neose agrees to grant directly to Wyeth's Affiliates in any country or
countries, equivalent rights as granted to Wyeth under Section 5.1.1. Upon
receipt of Wyeth's request, Neose shall enter into and sign a separate direct
license agreement with the companies designated by Wyeth in the request. All
direct license agreements entering into force under this Section 5.1 shall be
prepared by Wyeth and Wyeth shall pay all costs directly associated with the
preparation of such agreements; further, such agreements shall contain terms and
conditions which are identical with those of this Agreement. In those countries
in which the validity for such a direct license agreement requires prior
government approval or registration, such direct license agreement shall not be
binding or have any force or effect until the required governmental approval or
registration has been granted.
5.1.3 Sublicense and Exercise of Have-Made Rights. Wyeth may
exercise its have-made rights or sublicense its rights granted under Section
5.1.1 as follows:
5.1.3.1 Manufacture of Products. Subject to compliance with
Section 5.1.4, Wyeth may exercise its have-made rights or
sublicense the right to manufacture Products utilizing the Neose
Technology granted under Section 5.1.1 to Affiliates or a Third
Party.
5.1.3.2 Manufacture of Reagents. Subject to compliance with
Section 5.1.4, Wyeth may exercise its have-made rights for Reagents
or sublicense the right to manufacture the Reagents to an Affiliate
or a Third Party manufacturer only if Neose is unable to meet its
supply obligations under the Supply Agreement.
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5.1.3.3 Sublicense of All Rights. Subject to compliance with
Section 5.1.5, with the prior approval of Neose, which approval
shall not be unreasonably withheld, Wyeth may exclusively
sublicense all of its rights to the Neose Technology in the Field
(i) to a purchaser of all Wyeth's rights to the Products, or (ii)
in conjunction with the license by it of all of its rights to the
Products.
5.1.4 Conditions to Exercise of Have-Made Rights and Sublicense of
Manufacturing Rights. Wyeth shall not exercise its have-made rights or
sublicense any of its rights to manufacture using the Neose Technology except in
compliance with the following:
5.1.4.1 Affiliate. If an Affiliate of Wyeth is to manufacture
a Product, or Reagents pursuant to Section 5.1.3.2, Wyeth must only
notify Neose of the identity of such Affiliate and the specific
Product or Reagents to be produced by such Affiliate.
5.1.4.2 Notice to Neose. If a Person other than an Affiliate
of Wyeth is to manufacture a Product or Reagents utilizing the
Neose Technology, Wyeth must first notify Neose of the identity of
such Person (the "Supplier"), the specific Product or Reagents to
be produced by the Supplier, and the location where the Product or
Reagents will be produced by the Supplier.
5.1.4.3 Unacceptable Suppliers. If the Supplier is one of the
Suppliers listed in Exhibit 5.1.4.3, Wyeth shall not utilize such
Supplier. Neose may amend Exhibit 5.1.4.3 from time to time by
giving Wyeth written notice of such amendment, but only to add a
Person who Neose can reasonably demonstrate has breached an
agreement comparable to the one described in Section 5.1.4.4 or
Section 5.1.5.3 relating to Wyeth or another customer of Neose.
Wyeth may utilize a Supplier listed in Exhibit 5.1.4.3 to
manufacture Reagents in accordance with Section 5.1.3.2 if (i)
Wyeth can reasonably demonstrate that such Supplier is the only
source other than Neose for such Reagents, and (ii) Neose consents
to such Supplier, which consent shall not be unreasonably withheld.
5.1.4.4 Required Agreement. Before Wyeth discloses the Neose
Technology to a Supplier, supplies any Reagents to a Supplier,
allows a Supplier to manufacture Products using the Neose
Technology, or sublicenses the right to manufacture using the Neose
Technology, Wyeth shall require that the Supplier execute and
deliver to Neose a non-disclosure and non-use agreement
substantially in the form attached as Exhibit 5.1.4.4.
5.1.5 Conditions to Sublicense of All Rights. Wyeth shall not
sublicense all its rights under the Neose Technology except in compliance with
the following:
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5.1.5.1 Notice to and Approval of Neose. Prior to any
sublicense of all its rights under the Neose Technology, Wyeth must
notify Neose of the proposed sublicensee. Neose will have 30 days
after such notice to notify Wyeth of (i) its approval of such
sublicense, or (ii) the reasons why it withholds its approval,
which approval shall not be unreasonably withheld.
5.1.5.2 Unacceptable Sublicensees. If the Sublicensee is one
of the Sublicensees listed in Exhibit 5.1.5.2, Wyeth shall not
utilize such Sublicensee. Neose may amend Exhibit 5.1.5.2 from time
to time by giving Wyeth written notice of such amendment, but only
to add a Person who Neose can reasonably demonstrate (i) has
breached an agreement comparable to the one described in Section
5.1.4.4 or Section 5.1.5.3 relating to Wyeth or another customer of
Neose, or (ii) is a competitor of Neose.
5.1.5.3 Required Agreement. Upon approval by Neose, but prior
to any sublicense, Wyeth shall obtain the approved sublicensee's
execution and delivery to Neose of a non-disclosure and non-use
agreement substantially in the form attached hereto as Exhibit
5.1.5.3.
5.1.6 Liability. Wyeth shall remain primarily liable to Neose for
the performance by Affiliate, Supplier or Sublicensee in accordance with the
terms and conditions of this Agreement, and any sublicense or supply agreement
with a Supplier or Sublicensee shall terminate upon the breach by the Supplier
or Sublicensee of the Required Agreement, which breach has been demonstrated by
Neose.
5.1.7 Reservation of Rights. Neose hereby reserves to itself all
right, title and interest in and to the Neose Technology 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 Technology with
glycoproteins outside of the Field, including without limitation with
glycoproteins that may be considered competitive with PSGL-Ig; (b) developing,
making, using or selling glycoproteins, whether in conjunction with the Neose
Technology or otherwise, outside of the Field, even if such glycoproteins can be
considered competitive with PSGL-Ig; 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.
5.2 Wyeth 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 Project Plan, Wyeth hereby grants to Neose, for the term
of the Project Plan, a non-exclusive, royalty-free, license under the Wyeth
Technology to use such Wyeth Technology for the sole purpose of carrying out its
obligations under the Project Plan. Wyeth shall retain at all times all of its
rights, title and interest to the Wyeth Technology.
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5.3 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 the Neose Technology
and the Reagents shall remain at all times with Neose. All Ownership Rights in
PSGL-Ig, any Product, and the Wyeth Technology shall remain at all times with
Wyeth.
6.2 Improvements.
6.2.1 Neose Improvements. Any and all Improvements relating to the
Neose Technology or any methods or processes of carbohydrate synthesis made,
conceived, or reduced to practice, by either Neose or Wyeth or both in the
conduct of the Project Plan under this Agreement ("Neose Improvements") shall be
owned by Neose and shall be deemed to be part of the Neose Technology for all
purposes, including the license granted in Section 5.1. Except as set forth in
Section 6.2.2, any and all Improvements made, conceived, or reduced to practice
solely by Neose shall be owned by Neose.
6.2.2 Wyeth Improvements. Any and all Improvements to the
composition of PSGL-Ig or Products made, conceived, or reduced to practice by
either Wyeth or Neose or both in the conduct of the Project Plan under this
Agreement ("Wyeth Improvements") shall be owned by Wyeth for all purposes.
Except as set forth in Section 6.2.1, any and all Improvements made, conceived,
or reduced to practice, solely by Wyeth shall be owned by Wyeth.
6.2.3 Joint Improvements. Except as otherwise provided in this
Section 6.2, each of Neose and Wyeth shall own a *** interest in any
Improvements made, conceived, or reduced to practice jointly by Neose and Wyeth
in the conduct of the Project Plan under this Agreement, whether patentable or
not ("Joint Improvements").
6.3 Assignment by Wyeth. To the extent that Wyeth may retain any
Ownership Rights in any Neose Improvements, Wyeth 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 Wyeth may
assign and transfer to Neose under this Section 6.3, at the request of Neose,
and at Neose's expense, either before or after termination of this Agreement,
Wyeth 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. Wyeth'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, Wyeth
agrees that any and all employees and contractors employed or engaged by Wyeth
and providing any service in connection with the Project, prior to providing
such service, shall have agreed in writing to covenants consistent with Wyeth's
covenants set forth in this Section.
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6.4 Assignment by Neose. To the extent that Neose may retain any
Ownership Rights in any Wyeth Improvements, Neose hereby irrevocably assigns and
transfers to Wyeth any and all such Ownership Rights, in perpetuity or for the
longest period otherwise permitted by law, without the necessity of further
consideration, and Wyeth shall be entitled to receive and hold in its own name
all such Ownership Rights. With respect to any Ownership Rights that Neose may
assign and transfer to Wyeth under this Section 6.4, at the request of Wyeth,
and at Wyeth's expense, either before or after termination of this Agreement,
Neose shall assist Wyeth in acquiring and maintaining patent, copyright, trade
secret and trademark protection upon, and confirming Wyeth'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 Wyeth. For the purpose of facilitating the above assignment, 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.
6.5 Prosecution and Maintenance of Patent Rights. Each party shall, in
its sole discretion, prepare, file, prosecute and maintain all patent
applications and patents covering Improvements that the party owns pursuant to
Section 6. 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. Wyeth shall file, prosecute, and maintain, at its
expense, such patent applications. Wyeth may at any time, in its sole
discretion, discontinue the preparation, prosecution or maintenance of such
patent applications, in which case Wyeth 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. Wyeth shall promptly report in
writing to Neose during the Term any infringement or misappropriation or
suspected infringement or misappropriation of any Neose Technology of which
Wyeth becomes aware and shall provide Neose with its full cooperation in the
protection and enforcement of the Neose Technology and all available evidence
supporting said infringement, misappropriation, suspected infringement or
unauthorized use or misappropriation. Neose shall reimburse Wyeth for its
reasonable, documented costs of such cooperation, unless such infringement or
misappropriation is by a Supplier or Sublicensee of Wyeth.
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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. Neose shall not enter into any settlement, consent judgment or
other voluntary final disposition of such suit that would adversely affect
Wyeth's rights under this Agreement without Wyeth's prior written consent, which
consent shall not be unreasonably withheld.
6.6.3 Continued Infringement. If Neose fails to either bring suit
against or enter into negotiations for settlement with such Third Party within
six months after receipt of notice of such infringement and Wyeth is of the
opinion that the alleged infringement or misappropriation of Neose Technology is
occurring in the Field then, upon Wyeth'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 by such Third Party. If such patent counsel
concurs with Wyeth's opinion, Wyeth shall have the right, but not the
obligation, to bring suit against such Third Party under the Neose Technology
and join Neose as a party plaintiff. Neose will cooperate with Wyeth in any suit
brought against a Third Party and shall have the right to consult with Wyeth and
participate in and be represented by counsel in such suit at its own expense. In
the event Wyeth recovers any sums in such suit by way of damages or in
settlement thereof, such sums shall be used first to reimburse each of Wyeth and
Neose for their documented, out-of-pocket legal expenses, with Wyeth retaining
any remaining amounts.
6.7 Wyeth Trademarks. Wyeth shall select and own the trademarks for
marketing PSGL-Ig and the 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 Wyeth and
Wyeth shall retain all recoveries therefrom.
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 Product
infringes upon the Patent Rights of a Third Party.
7.2 Defense of Third Party Action. If claims or proceedings are brought
against Wyeth by a Third Party alleging that the use of the Neose Technology to
produce a Product infringes upon the Patent Rights of a Third Party, the parties
shall immediately consult on how to further proceed. Subject to Section 7.4, The
final decision whether or not and, as the case may be, how to defend or settle
such claim or proceedings shall be with Neose; provided that Neose shall
immediately notify Wyeth of such decision sufficiently in advance of any
deadlines by which formal responses are due in any such proceedings to enable
Wyeth to undertake its own defense. Wyeth 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 Wyeth's rights under
this Agreement or which would result in Wyeth being liable for damages, without
Wyeth's prior written consent, which consent shall not be unreasonably withheld.
In the event that Neose obtains a license under the Third Party Patent Rights
that are allegedly infringed by the use of the Neose Technology, Neose shall be
solely responsible for all payments required thereunder.
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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 Wyeth and any additional legal counsel of Wyeth.
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.
7.4 Third-Party Licenses.
7.4.1 Wyeth Third-Party Licenses. In the event that Wyeth 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 Wyeth 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 Wyeth's opinion, Wyeth and Neose shall co-operate to obtain such a
license for the benefit of Wyeth 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, whether
royalty-free or royalty-bearing, under the relevant Blocking Patent
that would make the continued exercise of the rights granted to
Wyeth by Neose hereunder non-infringing with respect to such
Blocking Patent. Neose shall be solely responsible for all payments
required 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 120 days from
receipt of notice from Wyeth upon terms that are commercially
reasonable to Neose at Neose's discretion, then Wyeth shall be
entitled to negotiate a license in favor of Wyeth under such
Blocking Patents; provided that to the extent that Wyeth must pay a
royalty under such license, Wyeth may decrease the amount of
payments owed under Sections 4.1 and 4.2 up to a maximum of ***% in
the aggregate for all such royalties.
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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 Section 7.2 to Section 7.3.
8. SUPPLY AGREEMENT. No later than 90 days after Wyeth accepts the first batch
of Reagents, the parties will execute and deliver the Supply Agreement under
which Neose will be the exclusive supplier to Wyeth of the Reagents needed to
produce Products in the Field. Pricing for Reagents will be based on Neose's
actual manufacturing costs plus and an agreed-upon markup, but will not exceed
$*** per kilogram of sugar nucleotides or $*** per kilogram of Product for
enzymes unless a higher price is mutually agreed to. If Neose is unwilling or
unable to meet its supply obligations for Reagents contained in the Supply
Agreement, Neose will become a nonexclusive supplier and Wyeth may either
manufacture the Reagents, or, consistent with Section 5.1.3, contract with a
Supplier.
9. CONFIDENTIALITY.
9.1 Confidential Information. With respect to any and all Confidential
Information disclosed by one party to this Agreement (the "Disclosing Party") to
the other party (the "Recipient") at any time and from time to time prior to the
Effective Date or during the Term, the Recipient for a period of five years from
the expiration or earlier termination of this Agreement: (a) shall maintain the
secrecy of, and hold in strict confidence, such Confidential Information; (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 other Persons except to the Recipient's directors,
officers, employees, and advisors to the extent that such disclosure is
reasonably necessary in furtherance of this Agreement; provided that such
Persons are 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 in information of the Disclosing Party.
In addition, provided that Neose maintains the confidentiality of Wyeth's name
and the identity of PSGL-Ig, with the prior approval of Wyeth, Neose will have
the right to use data about PSGL-Ig generated in the conduct of the Project Plan
(i) to support a patent application by Neose, or (ii) for marketing purposes.
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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. Attached hereto as Exhibit 9.4 is an
approved form of a press release to be issued by Neose upon the execution and
delivery of this Agreement.
10. REPRESENTATIONS AND WARRANTIES.
10.1 Mutual Representations and Warranties. Each party hereby
represents and warrants to the other that:
10.1.1 It is a corporation duly organized, 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.
10.1.2 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
10.1.3 The execution, delivery and performance by such party of
this Agreement does not (i) in any material respect, conflict with or violate
any applicable statute, law, rule or regulation, (ii) conflict with or violate
its charter or bylaws, or (iii) conflict with or constitute a default under any
contract or agreement of such party.
10.2 Warranties of Neose. Except as set forth in Exhibit 10.2, Neose
warrants to Wyeth, as of the Effective Date, that:
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10.2.1 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.
10.2.2 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.
10.2.3 To Neose's knowledge, there are no Blocking Patents that may
be asserted by Third Parties to prevent Wyeth from using the Neose Technology to
make Products hereunder.
10.2.4 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 Disclaimer of Warranties. EXCEPT FOR THE WARRANTIES SET FORTH IN
THIS SECTION 10, 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.
10.4 Acknowledgment by Wyeth. Wyeth 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 PSGL-Ig.
11. INDEMNIFICATIONS AND LIMITED LIABILITY.
11.1 Indemnification by Neose. Neose shall indemnify, defend and hold
harmless Wyeth and its Affiliates, and each of their respective employees,
officers, directors and agents (each, a "Wyeth 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 representation or warranty contained in Section 10, and
(ii) any claim by a Third Party alleging that the use of the Neose Technology
infringes upon the Patent Rights of such Third Party. Notwithstanding the
foregoing, Neose shall have no obligation to indemnify, defend or hold harmless
a Wyeth Indemnified Party for any Losses to the extent that such Losses were
caused by (i) the negligence or willful misconduct of Wyeth, its Affiliates,
sublicensees, or any of their respective employees, officers, directors, or
agents, or (ii) a breach by Wyeth of its representations and warranties set
forth in Section 10.
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11.2 Indemnification by Wyeth. Wyeth 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 Wyeth of its representations and warranties set forth in Section 10,
(ii) the breach by an Affiliate or Supplier of any provision of this Agreement,
(iii) the promotion, distribution, use, testing, marketing, sale, or other
disposition of any Product, and (iv) any claim by a Third Party alleging that
the use of the Wyeth Technology or the manufacture, sale or use of Products
infringes upon the Patent Rights of such Third Party, except to the extent such
claims relate to the use of Neose Technology. Notwithstanding the foregoing,
Wyeth 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
(i) the negligence or willful misconduct of Neose, its Affiliates, sublicensees,
or any of their respective employees, officers, directors, or agents, or (ii) a
breach by Neose 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 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 Products, with limits of not less than $*** per occurrence and $*** in the
aggregate. Wyeth agrees to maintain during the term of this Agreement 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. Insurance shall be procured with carriers having an AM Best Rating of
A-VII or better.
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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.
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 there is no Commercial Sale of a
Product within *** years after expiration of the Project Plan, either party may
terminate this Agreement upon 30 days written notice to the other.
12.2.3 Termination for Cause.
12.2.2.1 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 60
days from the date of such notice to cure the breach, or, if such
breach is not susceptible of being cured within such 60 day period,
and the breaching party utilizes diligent good faith efforts to
cure such breach, then such period shall be extended to 120 days.
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.
12.2.2.2 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 sixty days after the filing thereof.
12.2.4 Termination by Wyeth. Wyeth may terminate this Agreement at
any time without cause upon *** days prior written notice to Neose of such
termination, provided that Wyeth shall pay to Neose 100% of all documented Neose
Project-Related Costs through the date of termination, less $*** and after
deduction for any Neose Project-Related Costs paid by Wyeth pursuant to Section
2.3.
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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 4.6, 4.7, 5.1.6, 5.1.7, 6.1, 6.2, 6.3, 6.4,
6.5, 6.7,9, 11, 12.2.4, 12.3.1, 12.3.2, 15.2, 15.3, 15.6, 15.7, and 15.8.
12.3.4 Effect on Sublicensees. Any permitted sublicenses granted by
Wyeth hereunder shall automatically terminate or expire at the same time this
Agreement terminates or expires.
13. DISPUTE RESOLUTION. 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 30 days, the parties shall be
free to take all legal action necessary or appropriate to enforce their
respective rights.
14. GOVERNMENT APPROVAL.
14.1 HSR Filing. Wyeth, 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, except that the HSR filing fees shall be shared equally by the
parties.
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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, before the Effective Date, 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 Paragraph 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. MISCELLANEOUS.
15.1 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.
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15.2 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 overnight express mail), or by
internationally-recognized overnight express mail (such as Federal Express), 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 the parties. Except as
otherwise set forth in the 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:
(a) if such Notice is sent by facsimile (confirmed by
internationally recognized overnight express mail 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
(b) if such Notice is sent by internationally-recognized
overnight express mail, then the Notice shall be deemed to be received two (2)
business days after deposit with the express mail service.
If to Neose:
Neose Technologies, Inc.
102 Witmer Road
Horsham, PA 19044
Attention: President
Fax: 215-441-5896
with a courtesy copy to (and provided that
notification of Neose only shall suffice to
constitute effective notice):
Pepper Hamilton LLP
1235 Westlakes Drive, Suite 400
Berwyn, PA 19312-2401
Attention: Jeffrey P. Libson, Esquire
Fax: 610-640-7835
If to Wyeth:
Wyeth-Ayerst Laboratories
150 Radnor-Chester Road
St. Davids, Pa 19087
Attn: Senior Vice President Global Business Development
Fax: 610-688-9498
With a copy to:
American Home Products Corporation
5 Giralda Farms
Madison, New Jersey 07940
Attention: Senior Vice President and General Counsel
Fax: 973-660-7050
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15.3 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.
15.4 U.S. Export Laws and Regulations. Each party hereby acknowledges
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.
15.5 Assignment.
15.5.1 By Wyeth. Except as expressly permitted by Section 5.1,
Wyeth shall not assign its rights or obligations under the Agreement, in whole
or in part, by operation of law or otherwise, without the prior written consent
of Neose, which consent shall not be unreasonably withheld, provided that Wyeth
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 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. Wyeth shall notify Neose in writing upon making such assignment.
Any purported assignment in violation of this Section shall be null and void.
This Agreement shall bind and inure to the benefit of each party and its
respective permitted successors and assigns.
15.5.2 By Neose. Prior to the completion of the Project Plan, Neose
shall not assign its rights or obligations under the Agreement, in whole or in
part, by operation of law or otherwise, without the prior written consent of
Wyeth, which consent shall not be unreasonably withheld, provided that Neose 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
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. Neose shall notify Wyeth in writing upon making such assignment. Any
purported assignment in violation of this Section shall be null and void. This
Agreement shall bind and inure to the benefit of each party and its respective
permitted successors and assigns.
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15.6 Waivers and 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.
15.7 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.
15.8 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 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.
15.9 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.
15.10 No Third Party Beneficiaries. Each of Neose and Wyeth intend that
only Neose and Wyeth will benefit from, and are entitled to enforce the
provisions of, this Agreement and that no Third Party beneficiary is intended
under this Agreement.
15.11 Descriptive Headings. 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.
15.12 Counterparts. The 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.
15.13 Entire Agreement. The Agreement, including all exhibits to this
Agreement (the "Attachments"), embodies the entire understanding between the
parties and supersedes any prior understanding and agreements between and among
them respecting the subject matter of this Agreement. There are no
representations, agreements, arrangements or understandings, oral or written,
between the parties to this Agreement relating to the subject matter of the
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.
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[THIS PAGE IS FOLLOWED BY THE SIGNATURE PAGE]
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IN WITNESS WHEREOF, the undersigned parties, acting through their duly
authorized representatives, have executed this Agreement in multiple
counterparts.
NEOSE TECHNOLOGIES, INC.
By: /s/ P. Sherrill Neff
--------------------------------------------
P. Sherrill Neff
President and Chief Operating Officer
AMERICAN HOME PRODUCTS CORPORATION
By: /s/ Jeffrey S. Sherman
--------------------------------------------
Name: Jeffrey S. Sherman
--------------------------------------------
Title: Vice President and Associate General Counsel
--------------------------------------------
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Exhibits Index
Exhibit 1.18 - Neose Patents
Exhibit 1.31 - Project Plan
Exhibit 1.32 - PSGL-Ig
Exhibit 2.2 - Project Plan
Exhibit 2.4.1 - Joint Working Group
Exhibit 3.3 - Development Payments
Exhibit 4.1 - Product Payments
Exhibit 4.2 - Royalties
Exhibit 5.1.4.3 - Unacceptable Suppliers
Exhibit 5.1.4.4 - Required Agreement (Suppliers)
Exhibit 5.1.5.2 - Unacceptable Sublicensees
Exhibit 5.1.5.3 - Required Agreement (Sublicensees)
Exhibit 9.4 - Approved Press Release
Exhibit 10.2 - Exceptions to Warranties of Neose
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