Exhibit 99.3
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND SUCH PORTIONS HAVE BEEN
FILED WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
COLLABORATION AND LICENSE AGREEMENT
This Agreement is entered into as of this 3rd day of November, 1999, by and
between American Home Products Corporation, and/or its affiliates, organized
under the laws of the state of Delaware, having its principal place of business
at Five Xxxxxxx Xxxxx, Xxxxxxx, Xxx Xxxxxx, 00000, X.X.X. acting through its
subsidiary company, Wyeth-Ayerst International Inc. division having an address
at X.X. Xxx 0000, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 (hereinafter "Wyeth-Ayerst")
and Neose Technologies, Inc., organized under the laws of the State of Delaware
having its principal place of business at 000 Xxxxxx Xxxx, Xxxxxxx,
Xxxxxxxxxxxx, 00000 (hereinafter "Neose").
WITNESSETH
WHEREAS, Neose has expertise in the production and isolation of
oligosaccharides, including [*];
WHEREAS, Wyeth-Ayerst has expertise in the formulation and manufacture of
milk-based compositions, including, but not limited to, Pediatric Nutritional
Compositions;
WHEREAS, Neose is interested in conducting research relating to the process for
producing and/or isolating [*] or mixtures thereof;
WHEREAS, Wyeth-Ayerst is interested in obtaining from Neose compositions
containing [*] or mixtures thereof; and
WHEREAS, Neose is interested in supplying to Wyeth-Ayerst the compositions
containing [*] or mixtures thereof.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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NOW, THEREFORE, in consideration of the foregoing premises and the mutual
premises, covenants and conditions contained in this Agreement, the Parties
agree as follows:
1. DEFINITIONS
1.1 "Affiliates" shall mean, in the case of either party, any corporation,
joint venture or other business entity which directly or indirectly
controls, is controlled by or is under common control with that party.
"Control" as used herein shall mean the ownership, directly or
indirectly, of fifty percent (50%) or more of the outstanding equity
securities of a corporation which is entitled to vote in the election
of directors, or a fifty percent (50%) or greater interest in the net
assets or profits of an entity which is not a corporation.
Notwithstanding the foregoing, for purposes of this Agreement, [*]
shall not be considered to be an Affiliate of Wyeth-Ayerst.
1.2 "Clinical Research Organization" shall mean Third Party organizations
contracted by Wyeth-Ayerst to manage the Clinical Studies hereunder.
1.3 "Clinical Studies" shall mean human clinical trials conducted with
Pediatric Nutritional Compositions
1.4 "Commercially Reasonable Efforts" shall mean efforts and resources
normally used by a party for a product owned by it or to which it has
rights, which is of similar market potential at a similar stage in its
product life, taking into account the competitiveness of the market
place, the proprietary position of the product, the regulatory
structure involved, the profitability of the products and other
relevant factors.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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1.5 "Covered Compound" shall mean pure [*] or a mixture of both or [*] in
accordance with the Specifications.
1.6 "Effective Date" shall mean the date upon which this Agreement is
executed by both parties.
1.7 "Field" shall mean the use of the Covered Compound in Pediatric
Nutritional Compositions, in both powder and liquid form.
1.8 "Final Product" shall mean the form of the Covered Compound that will
be used in toxicological or clinical testing as agreed to by the JDC.
1.9 "Final Report" shall mean the written, comprehensive final progress
report to be prepared by each party and detailing the results of the
activities it has conducted under the Research Program and which is
submitted to the other party within ninety (90) days after completion
of the Research Program. The Final Report shall set forth all data
relevant to the Research Program including, but not limited to, the
research results, supporting data and details of the achievement of
the objective of the Research Program.
1.10 "Good Manufacturing Practice" or "GMP" shall mean the current
standards for the manufacture of pharmaceuticals, as set forth in the
United States Federal Food, Drug and Cosmetics Act and applicable
regulations promulgated thereunder, as amended from time to time, and
such standards of good manufacturing practice as are required by the
European Union and other organizations and governmental agencies in
countries in which the Products are intended to be sold, to the extent
such standards are not inconsistent with United States GMP.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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1.11 "Guaranteed Minimum Supply" shall have the meaning set forth in
Section 7 hereof.
1.12 "Joint Development Committee" or "JDC" shall mean the committee
appointed by the parties as set forth in Section 2.
1.13 "Major Market" shall mean the following countries in the Territory:
[*]
1.14 "Manufacturing and Supply Agreement" shall have the meaning set forth
in Section 7 hereof.
1.15 "Master Regulatory Dossier" shall mean a dossier containing at least
the following documents: a free sale certificate; a GMP statement; a
statement of composition; finished product specifications; a
certificate of analysis; a stability report; medical/scientific
rationale; an authorization letter; labels; samples; lot code key;
license certification specifications; 100g/100ml statement; amino acid
composition statement; fat blend composition statement; methods of
analysis (raw and finished); Codex/EU compliance statement (if
necessary); expiration dating statement; packaging/container;
production flow and processing; "BSE-free" statement; pesticide
content; pricing certification; and country listing.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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1.16 "Neose Know-How" shall mean all proprietary technical information and
data relating to the process used by Neose for the production of
[*] in general and Covered Compound in particular, whether or not
covered by the Neose Patents and whether or not patentable, which is
owned or controlled by Neose and which is known as of the Effective
Date or which is developed or acquired by Neose in the conduct of the
Research Program or which is developed or acquired by Neose, subject
to the rights of Third Parties, whether now or hereafter existing,
outside of the Research Program during the term of this Agreement.
1.17 "Neose Patents" shall mean all patents or patent applications, in each
country of the Territory, and all divisionals, continuations,
continuations-in-part, reissues, reexaminations and foreign
counterparts thereof, owned by, licensed to or assigned to Neose or
jointly owned by (i) Neose and (ii) Wyeth-Ayerst or a Third Party,
existing as of the Effective Date or filed or issuing during the term
of this Agreement, at least one claim of which relates to Neose's
process for the manufacture of [*] and/or Covered Compound,
compositions containing [*] and/or methods of using [*]. Neose Patents
include, but are not limited to, the patents set forth in Exhibit A
and the patents set forth in Exhibit B originally assigned to Cytel
Corporation ("Cytel") and assigned to Neose pursuant to the terms of
the Asset Purchase Agreement between Neose and Cytel dated March 26,
1999.
1.18 "Neose Technology" shall mean all Neose Know-How and all Neose Patents
relating to Products, Covered Compound, [*], methods for the
manufacture of [*] and/or Covered Compound and methods of using [*].
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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1.19 "Net Sales" shall mean proceeds from sales of Products by
Wyeth-Ayerst, 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) and (v). 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-Ayerst would sell Product together with other products of
Wyeth-Ayerst 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-Ayerst to Third Parties during the reporting
period in which such sales relate.
1.20 "Pediatric Nutritional Compositions" shall mean infant and pediatric
(up to 10 years of age) formulas, including but not limited to low
birth weight and premature infant formulas, pediatric medical foods
and meal replacement beverages, whether in powder or liquid form,
which are useful as a food, a source of nutrition, the sole source of
nutrition or as a nutritional supplement.
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1.21 "Product(s)" shall mean any Pediatric Nutritional Composition(s)
containing Covered Compound.
1.22 "Research Program" shall mean a program for the evaluation and
development of data relating to the preparation of Pediatric
Nutritional Compositions containing Covered Compound as defined in
Section 2 of this Agreement. A description of the Research Program as
proposed is set forth as Exhibit C to this Agreement. The Research
Program will be written and adopted by the JDC.
1.23 "Regulatory Approval" shall mean all authorizations by the competent
authorities which are required for the regular marketing, promotion,
pricing and sale of Covered Compound, [*] or Product in a given
country or regulatory jurisdiction.
1.24 "Regulatory Authority(ies)" shall mean any national, supranational
(e.g., the European Commision, the Council of the European Union or
the European Agency for the Evaluation of Medicinal Products),
regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity involved in the
granting of Regulatory Approval for the Product.
1.25 "Specifications" shall mean specifications for or concerning the
manufacture, testing, quality assurance and packaging of Covered
Compound as may be agreed upon by the parties from time to time,
provided however that such Specifications shall comply with all
applicable Regulatory Approvals for the manufacture and sale of
Covered Compound or Product.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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1.26 [*] shall mean [*].
1.27 "Territory" shall mean worldwide (excluding Japan).
1.28 "Third Party(ies)" shall mean any person(s) or entity(ies) other than
Wyeth-Ayerst, Neose or their respective Affiliates.
1.29 "Valid Claim" shall mean an unexpired claim of an issued patent
forming part of the Neose Patents, which claim has not been declared
invalid or unenforceable by a court or other tribunal of competent
jurisdiction.
1.30 "Wyeth-Ayerst Know-How" shall mean the proprietary technical and
clinical information, data and know-how relating to Pediatric
Nutritional Compositions owned or controlled by Wyeth-Ayerst, its
Affiliates, or licensed by a Third Party to Wyeth-Ayerst prior to or
during the term of this Agreement. Know-How shall include, without
limitation, all processes, formulas, discoveries and inventions
relating to biological, chemical, pharmacological, toxicological,
pharmaceutical, physical and analytical, manufacturing, regulatory,
safety, quality control and clinical data.
1.31 "Wyeth-Ayerst Major Competitors": [*]
1.32 "$" shall mean United States dollars.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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2. COLLABORATION
2.1 General. The parties have agreed on a Research Program, a copy of
which is attached hereto as Exhibit A. Under the Research Program,
Wyeth-Ayerst shall conduct research and development activities
relating to the use of Covered Compound in Pediatric Nutritional
Compositions and Neose shall conduct research and development
activities relating to improving the methods for the production and/or
isolation of Covered Compound and optimization of the Covered Compound
for use in Pediatric Nutritional Compositions. The Research Program
shall include, but shall not be limited to, preclinical and clinical
studies necessary to demonstrate the safety and efficacy of Product.
The Research Program will commence on the Effective Date and will
terminate three (3) years thereafter if not earlier terminated in
accordance with any of the provisions set forth herein unless extended
upon the mutual agreement of the parties as set forth in writing.
2.1.1 Supply of Covered Compound. In order to further the progress of
the Research Program, Neose shall supply Wyeth-Ayerst with
Covered Compound containing at least [*] which meets the
Specifications during the course of the Research Program at no
cost to Wyeth-Ayerst. The date(s) for delivery of Covered
Compound to Wyeth-Ayerst shall be established by the JDC. If
Wyeth-Ayerst requires additional Covered Compound during the
course of the Research Program, the parties shall negotiate in
good faith to reach agreement on an appropriate compensation and
delivery schedule related thereto.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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2.2 Joint Development Committee. The parties agree that the Collaboration,
including the Research Program shall be managed by a Joint Development
Committee (the "JDC").
2.2.1 Composition. No later than thirty (30) days after the Effective
Date, each of the parties shall appoint two (2) representatives
to the JDC. The chairperson of the JDC will be one of the
Wyeth-Ayerst representatives. A party may change any of its
representatives at any time by giving notice to the other party.
2.2.2 Responsibilities. The JDC will:
(a) monitor the progress of and compliance with the Research
Program and approve any change in the Research Program;
(b) develop research protocols; and
(c) review and evaluate the results of the Research Program.
2.2.3 Meetings of the JDC. The chairperson of the JDC shall call
meetings when deemed appropriate, at mutually convenient times
on reasonable notice, currently anticipated to be no less
frequently
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than once every three (3) months. If possible, the meetings
shall be held in person, or otherwise by video or telephone
conference. When held in person the location of the meeting
shall alternate between Wyeth-Ayerst's facilities and Neose's
facilities. The chairperson shall prepare an agenda for the
meeting, and shall include in the agenda items proposed by
Neose's representatives. Additional participants may be invited
by any member to attend meetings where appropriate (e.g.,
outside consultants). Such additional participants shall have no
vote. Minutes of each meeting of the JDC shall be exchanged for
review and comment by the members. Thereafter, they shall be
signed by the chairperson and distributed to each of the
parties. Each party shall be responsible for the expense
incurred by its representatives in attending such meetings.
2.2.4 Voting. The JDC shall make decisions by majority vote, with at
least one consenting vote of each party's JDC members. If the
required majority decision cannot be found and all the members
of each party take the same opposing positions in a matter which
either party deems to be of importance, the matter shall be
handled pursuant to Section 2.2.6 hereof. Voting by proxy is
permissible. Urgent matters may be decided by unanimous vote of
the chairperson and a representative of Neose.
2.2.5 Role of Chairperson. Except as explicitly set forth herein, in
no event shall the chairperson of the JDC have any additional
power or responsibilities beyond those delegated to such person
by such person's membership on the JDC. Without limiting the
foregoing, it is understood that, except as a voting member of
the JDC, the chairperson shall not have the power to control or
dictate decisions or to veto any decisions reached by the
committee under the decision making process set forth in Section
2.2.4 hereof.
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2.2.6 Dispute Resolution. If the JDC is unable to resolve, after
thirty (30) days, a dispute regarding any issue presented to it
or arising in it, such dispute shall be referred to the
President of Neose and the President of Wyeth-Ayerst
Laboratories or his designee for good faith resolution, for a
period of ninety (90) days. If such dispute is not resolved by
the end of this ninety (90) day period, the parties shall be
free to pursue any legal or equitable remedy available to them.
2.3 Technology and Information Transfer. Neose agrees to supply
Wyeth-Ayerst with all Neose Technology required by Wyeth-Ayerst to
carry out its activities under the Research Program and to
manufacture, package, and obtain Regulatory Approval for Products.
Wyeth-Ayerst agrees to supply Neose with all Wyeth-Ayerst Know-How
necessary for Neose to carry out its activities under the Research
Program. All information transferred, provided or exchanged under this
Section 2.2 shall be subject to the confidentiality provisions of
Section 12 hereof.
2.4 Record Keeping. Each party shall maintain records in sufficient detail
and in good scientific manner as appropriate for Regulatory Approval
and patent purposes.
2.5 Reporting. Each party shall supply the other with a written report
summarizing its activities under the Research Program within thirty
(30) days after the end of each calendar quarter. Each party will
supply the other with a Final Report on the results of the Research
Program within ninety (90) days after completion of the Research
Program
2.6 Funding of the Research Program.
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2.6.1 Funding. Wyeth-Ayerst shall pay Neose the sum of [*] per year,
payable quarterly, for a period not to exceed three (3) calendar
years, to begin on the Effective Date. The funds are to be used
by Neose to carry out its obligations under the Research Program
and for the development and optimization of a process for the
manufacture of Covered Compound, the isolation of Covered
Compound, the enhancement of Covered Compound for use by
Wyeth-Ayerst in Pediatric Nutritional Compositions and any other
expenses, except for capital expenditures, incurred by Neose in
carrying out the Research Program.
2.6.2 Reconciliation. Within thirty (30) days after the end of each
calendar year during the three (3) year period beginning January
1, 2000, Neose shall submit to Wyeth-Ayerst a report setting
forth under Generally Accepted Accounting Principles in the
United States, the total expenses incurred by Neose during the
previous calendar year in performing its obligations under the
Research Program and the payments made by Wyeth-Ayerst to Neose
pursuant to Section 2.6 hereof.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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2.7 Regulatory Approvals. Wyeth-Ayerst shall file all regulatory dossiers
for the Covered Compound and the Products under its or its Affiliates
names. Wyeth-Ayerst shall own all Regulatory Approvals for Covered
Compound or Product. Wyeth-Ayerst shall be responsible for all
communications with Regulatory Authorities with respect to Products.
2.8 Exclusivity. Unless and until Wyeth-Ayerst has converted the license
granted hereunder to a non-exclusive license pursuant to Section 5.2,
Neose will not conduct any research and development activities, either
independently or with Third Parties, with respect to Products in the
Field and will not provide [*] to any Third Party for the purpose of
conducting research and development activities with respect to
Products in the Field except to carry out the Research Program.
Notwithstanding the foregoing, Neose and Wyeth-Ayerst recognize that,
from time to time, it may be desirable or necessary to retain
consultants to assist in the Research Program. In such event, the
Parties shall enter into a consulting agreement with each such
consultant, which consulting agreement shall, in both form and
substance, be reasonably acceptable to both parties.
3. GRANT OF RIGHTS
3.1 License Grant. Subject to the provisions of Section 10.3 hereof, Neose
hereby grants to Wyeth-Ayerst an exclusive license (exclusive even as
to Neose) in the Territory under Neose Technology to use, sell, have
sold, offer for sale, import and export Products in the Field.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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3.2 Sublicense. Subject to the following conditions, as long as
Wyeth-Ayerst has not converted the license granted hereunder to a
non-exclusive license pursuant to Section 5.2 hereof, Wyeth-Ayerst
shall have the right to sublicense all or part of the rights granted
to it under Section 3.1 hereof to an Affiliate or a Third Party in any
country of the Territory. Wyeth-Ayerst shall not be required to obtain
Neose's approval of any sublicense.
3.2.1 All sublicenses shall include terms and conditions consistent
with the terms and conditions of this Agreement. Wyeth-Ayerst
shall provide to Neose documentation evidencing such sublicense
relationship within fourteen (14) business days of execution of
such sublicense. No sublicensee shall be permitted to further
any of its rights under any sublicense. Any sublicense not in
compliance with this Section 3.2 shall be void.
3.2.2 Notwithstanding the granting of a sublicense to a Third Party or
an Affiliate, Wyeth-Ayerst shall retain full responsibility and
liability to Neose for the performance of all obligations of
Wyeth-Ayerst, its Affiliates or any sublicensee. Any act or
omission by a sublicensee or an affiliate that would be a breach
of this Agreement if performed or not performed by Wyeth-Ayerst
will be considered a breach by Wyeth-Ayerst of this Agreement.
Nothing herein shall preclude Wyeth-Ayerst and its Affiliates
from utilizing a distributor to promote and/or distribute
Product in any country.
3.2.3 Notwithstanding the foregoing, prior to granting such
sublicense, Wyeth-Ayerst shall obtain the written agreement of
the sublicensee that it shall (i) protect the confidentiality of
Neose Technology and (ii) shall utilize Neose Technology only in
accordance with the terms of this Agreement.
3.2.4 Upon the expiration or early termination of this Agreement for
any reason in whole or in part, or with respect to any given
country or countries, each sublicense shall automatically
terminate on the same basis as this Agreement, unless otherwise
requested by Neose in which event such sublicense shall be
assigned to Neose.
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3.2.5 In the event Wyeth-Ayerst becomes subject to a bankruptcy event
as defined in Section 7.6(ii) hereof, all payments thereafter
due and owing to Wyeth-Ayerst from its sublicensees shall
thereupon, and without any notice from Neose to such sublicensee
become payable directly to Neose for the account of
Wyeth-Ayerst; provided that Neose shall remit to Wyeth-Ayerst
any amount by which such payments exceed the amounts owed by
Wyeth-Ayerst to Neose.
4. FUNDING
4.1 Development Fee. Wyeth-Ayerst agrees to pay Neose the sum of [*] upon
execution of this Agreement in consideration of Neose's agreement to
participate in the collaboration.
4.2 Development Payments. In addition to the Development Fee set forth in
Section 4.1 hereof, Wyeth-Ayerst shall pay Neose the additional sums
as set forth below:
(i) [*] upon delivery by Neose to Wyeth-Ayerst of Covered
Compound containing at least [*] for use by Wyeth-Ayerst
in clinical testing of Products;
(ii) [*] upon successful completion by Neose of a manufacturing
plant capable of producing Covered Compound in quantities
sufficient to deliver the Guaranteed Minimum Supply of
Covered Compound according to the Specifications as set
forth in the Manufacturing and Supply Agreement pursuant
to the provisions of Section 7.1 hereof; and
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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(iii) [*] upon first commercialization of Product in any country
in the Territory.
4.3 Effect of Early Termination. In the event this Agreement is terminated
by Wyeth-Ayerst under the provisions of Section 7.2 hereof,
Wyeth-Ayerst shall be under no obligation to make any payment to Neose
which shall become due subsequent to the date of such termination.
4.4 Method of Payment. All payments made under this Section 4 shall be
made by wire transfer to Neose within thirty (30) days from the date
corresponding to the event triggering such payment, provided, however,
that the payment due under Section 4.1 hereof shall be made by way of
wire transfer to Neose on the Effective Date.
5. ROYALITIES
5.1 Royalty Payments. In further consideration of the license granted to
Wyeth-Ayerst under Section 3 hereof, Wyeth-Ayerst shall pay to Neose a
royalty of [*] of annual Net Sales in the Territory of Products which
[*] on an annual basis.
5.2 Competitive Launch. In the event that one or more of Wyeth-Ayerst's
Major Competitors launches a Pediatric Nutritional Composition
enriched with [*], which Pediatric Nutritional Composition is the same
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-17-
or similar to Product ("Competing Product"), in any brand, in any
country in the Territory, upon twelve (12) months prior written notice
from Wyeth-Ayerst to Neose, Wyeth-Ayerst may choose, at its sole
discretion, to convert the license granted hereunder to a
non-exclusive license on a country by country basis. In the event that
Wyeth-Ayerst chooses to convert the license to a non-exclusive license
in more than one (1) country in a given Region, Wyeth-Ayerst can
choose to convert the license to a non-exclusive license in the entire
Region at its sole discretion. The "Region(s)" as used herein are
defined as follows:
North Asia: China, Hong Kong, Taiwan, and Korea;
Asian: Philippines, Singapore, Malaysia, Thailand, Vietnam, and
Indonesia;
Mid Asia: India, Pakistan, and Afghanistan;
Pacific: Australia and New Zealand;
Western Europe (Southern): Spain, Portugal, Italy, Greece and Turkey;
Western Europe (Northern): United Kingdom, Ireland, France, Germany,
Netherlands, Switzerland, Austria, and Belgium;
Scandinavia: Denmark, Sweden, Norway, Iceland, and Finland;
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Xxxxxxx Xxxxxx: Poland, Hungary, Romania, Russia, the Baltic countries
and all former Soviet Union countries;
Middle East: Saudi Arabia, U.A.E., Qatar, Israel, Syria, Jordan,
Kuwait, Iran, Iraq and Egypt;
Latin America: Mexico, the Caribbean;
Central America: all countries;
South America: all countries;
North America: United States and Canada.
In the event Wyeth-Ayerst chooses to so convert the license to a
non-exclusive license, the royalty payable by Wyeth-Ayerst to Neose
royalties hereunder and the and set forth in Section 5.1 hereof shall
be reduced by [*] effective immediately upon expiration of the twelve
(12) months notice period.
5.2.1 Third Party Licenses. Where the license granted to Wyeth-Ayerst
under this Agreement is converted by Wyeth-Ayerst into a
non-exclusive license under Section 5.2 hereof, Neose agrees
that in the event it enters into a commercial arrangement, with
a Third Party relating to the use of [*] in Pediatric
Nutritional Compositions, it shall immediately notify
Wyeth-Ayerst of the commercial terms of such arrangement and,
where the terms of such Third Party arrangement, with respect to
its royalty and manufacturing and supply provisions are, taken
as a whole, more favorable than the royalty provisions hereunder
and the Manufacturing and Supply Agreement between Neose and
Wyeth-Ayerst under the provisions of Section 7.1 hereof,
Wyeth-Ayerst shall have the right to revise the terms of its
Manufacturing and Supply Agreement and the royalties hereunder
with Neose to contain those terms.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-19-
5.3 Method of Payment of Royalties. Wyeth-Ayerst shall deliver to Neose
within sixty (60) days of the end of each calendar quarter, a report
certified by Wyeth-Ayerst as accurate to the best of its ability based
upon information then available for such calendar quarter, on a
country-by- country basis: (i) Net Sales of Product in each country;
(ii) the basis for any adjustments to the royalty payable to Neose for
the sale of Product in such country; and (iii) the total royalty due
for the sale of the Product in each such country. The total royalty
due to Neose during such calendar quarter shall be remitted at the
time such report is made in accordance with the following:
(i) the total royalty due for such calendar quarter shall accompany
the report for that quarter; (ii) the royalty shall be paid in
United States dollars; (iii) any currency translations that are
necessary to calculate the royalty shall be made at the exchange
rate applicable on the date of payment as used by Wyeth-Ayerst
for financial accounting purposes in accordance with generally
accepted accounting principals; and (iv) royalty checks are to
be made payable to Neose and mailed to the address specified in
Section 16.5.1 hereof.
-20-
5.4 If by reason of any restrictive exchange laws or regulations,
Wyeth-Ayerst shall be unable to convert to U.S. dollars amounts
equivalent to the total royalty due and payable by Wyeth-Ayerst
hereunder in respect to Products sold for funds other than U.S.
dollars, Wyeth-Ayerst shall notify Neose promptly with an explanation
of the circumstances. In such event all royalties due hereunder in
respect of the transaction so restricted (or the balance thereof due
hereunder) shall be deferred and paid in U.S. dollars as soon as
reasonably possible after, and to the extent that such restrictive
exchange laws or regulations are lifted so as to permit such
conversion to U.S. dollars, of which lifting Wyeth-Ayerst shall
promptly notify Neose. At its option, Neose shall have the right to
request payment, and upon such request Wyeth-Ayerst shall pay or cause
to be paid, all such amounts or portions thereof as specified by Neose
in funds other than U.S. dollars as designated by Neose under the
existing restrictive exchange laws or regulations.
5.5 Any and all taxes levied on account of royalties paid from a country
in which a provision is made in the law or by regulation for
withholding shall be deducted from such royalty paid to Neose
hereunder and proof of payment of such taxes shall be received and
reported in the reports described in Section 5.3 hereof.
6. ACCOUNTS AND RECORDS
6.1 Record Keeping by Wyeth-Ayerst. After commercial launch of Product in
any country in the Territory, Wyeth-Ayerst shall and shall cause its
Affiliates and/or sublicensees, if any, to keep accurate books and
accounts of record in connection with the sale by or for it of the
Products in sufficient detail to permit accurate determination of all
figures necessary for verification of payments required to be paid
hereunder. Wyeth-Ayerst shall and shall cause its Affiliates and/or
sublicenses to maintain such records for a period of three (3) years
after the end of the year in which they were generated.
-21-
6.2 Audit by Neose. Neose, through an independent certified public
accountant reasonably acceptable to Wyeth-Ayerst, shall have the
right, at its own expense, to access the books and records of
Wyeth-Ayerst its Affiliates or sublicensees as the case may be, for
the sole purpose of determining whether a payment under Section 5 has
become due and the accuracy thereof. Such access shall be conducted
after reasonable prior written notice to Wyeth-Ayerst and during
ordinary business hours and shall not be more frequent than once per
calendar year. Wyeth-Ayerst may require such independent certified
public accountant to sign a customary confidential disclosure
agreement prior to permitting such independent certified public
accountant to have access to its books, records or facilities. The
parties agree that such independent certified public accountant shall
disclose to Neose only, for the period covered by such audit, the Net
Sales of Product in each country, the basis for any adjustments to the
royalty payable to Neose for the sale of Product in such countrty, and
the total royalty due for the sale of Product in each such country.
Neose agrees to keep in strict confidence all information learned in
the course of such audit, except when it is necessary to reveal such
information in order to enforce its rights under this Agreement.
Neose's right to have such records examined shall survive termination
or expiration of this Agreement. In the event such audit reveals an
underpayment, Wyeth-Ayerst shall promptly pay to Neose the amount of
such underpayment. In the event that such audit reveals an
underpayment of five percent (5%) or more of the amount actually due,
Wyeth-Ayerst shall also promptly reimburse Neose for the reasonable
out-of-pocket expenses incurred by Neose in conducting such audit.
6.3 Record Keeping by Neose. Neose shall keep accurate books and accounts
of record in connection with the activities conducted by it in
carrying out
-22-
the Research Program in sufficient detail to verify that the amounts
received by Neose pursuant to Section 2.6 hereof have been expended in
accordance with the Research Program. Neose shall maintain such
records for a period of three (3) years after the end of the last year
in which funds were received by Neose in accordance with Section 2.6
hereof.
6.4 Audit by Wyeth-Ayerst. Wyeth-Ayerst, through an independent certified
public accountant reasonably acceptable to Neose, shall have the
right, at its own expense, to access the books and records of Neose
for the sole purpose of verifying that the amounts received by Neose
pursuant to Section 2.6 hereof have been expended in accordance with
the Research Program. Such access shall be conducted after reasonable
prior written notice to Neose and during ordinary business hours and
shall not be more frequent than once per calendar year. Neose may
require such independent certified public accountant to sign a
customary confidential disclosure agreement prior to permitting such
independent certified public accountant to have access to its books,
facilities or records. The parties agree that such independent
certified public accountant shall disclose to Wyeth-Ayerst only
whether such amounts were expended in accordance with the Research
Program. Wyeth-Ayerst agrees to keep in strict confidence all
information learned in the course of such audit, except when it is
necessary to reveal such information in order to enforce its rights
under this Agreement. Wyeth-Ayerst's right to have such records
examined shall survive termination or expiration of this Agreement.
7. TERM AND TERMINATION OF LICENSE
7.1 Term. This Agreement shall be effective as of the Effective Date and,
unless earlier terminated as set forth below, shall continue in full
force and effect, on a country by country basis, until the later of
(i) the expiration of the last to expire Neose Patent incorporating at
least one Valid Claim in such country or (ii) ten (10) years after the
date of first commercial sale of
-23-
Products by Wyeth-Ayerst hereunder. Upon the expiration of the
Agreement, Wyeth-Ayerst's license shall become a fully paid-up,
perpetual, exclusive license in each such country subject only to any
sublicenses granted by Wyeth-Ayerst, provided that to the extent
Wyeth-Ayerst has converted the license granted hereunder to
non-exclusive license pursuant to Section 5.2, such license will be
non-exclusive.
7.2 Unilateral Termination by Wyeth-Ayerst. Wyeth-Ayerst shall have the
right to unilaterally terminate this Agreement, on a country by
country basis, upon thirty (30) days prior written notice to Neose. In
the event of such termination, all of Wyeth-Ayerst's rights in and to
the Neose Technology in such country shall revert to Neose.
7.3 Unilateral Termination by Neose--Pre-Clinical Studies. Neose shall
have the right to unilaterally terminate this Agreement, upon thirty
(30) days prior written notice to Wyeth-Ayerst as follows:
7.3.1 If Wyeth-Ayerst does not:
(i) complete toxicology studies of the Final Product within
twenty four (24) months after its receipt of sufficient
material from Neose to begin such studies.
(ii) complete Clinical Studies of Final Product within thirty
six (36) months after its receipt of sufficient material
from Neose to begin such studies, which material has
satisfied the requirements of the toxicology studies
conducted in accordance with Section 7.3.1(i) above.
7.4 Unilateral Termination by Neose - Post Clinical Studies. Neose shall
have the right to unilaterally terminate this Agreement, on a
country-by-country
-24-
basis, upon thirty (30) days prior written notice to Wyeth-Ayerst as
follows:
(i) If Wyeth-Ayerst fails to file for Regulatory Approval in
any Major Market within twelve (12) months after
completion of Clinical Studies. For purposes of this
section, "completion of Clinical Studies" shall mean (a)
receipt of a positive outcome from said Clinical Studies
based upon standards of infant safety growth and tolerance
as established in the protocol for such Clinical Study and
(b) the receipt of a final audited report from all
Clinical Research Organization in a form reasonably
acceptable to Wyeth-Ayerst. The twelve (12) month period
referred to herein shall not commence until a Master
Regulatory Dossier is completed. It is understood and
agreed that the Master Regulatory Dossier shall take up to
nine (9) months to complete. Neose agrees to provide its
full cooperation in the completion of the Master
Regulatory Dossier.
(1) In the event Wyeth-Ayerst does not receive a positive
outcome from the Clinical Studies as set forth in
Section 7.4 (i)(a) hereof, the JDC shall establish
appropriate timelines for conducting a follow-up
Clinical Study. In the event Wyeth-Ayerst decides
that it shall not conduct a follow-up Clinical Study,
or, if after commencing a follow-up Clinical Study,
Wyeth-Ayerst fails to complete such study within the
timeline established by JDC, Neose may terminate the
Agreement on thirty (30) days prior written notice to
Wyeth-Ayerst.
(ii) If Wyeth-Ayerst does not launch Licensed Product in any
Major Market within twelve (12) months after receiving
Regulatory Approval in that Major Market.
-25-
(iii) If Wyeth-Ayerst does not launch Licensed Product in any
single Major Market within eight (8) years from the
Effective Date.
7.5 The parties agree that the JDC shall determine appropriate timelines
for the completion of the Research Program and the supply of Covered
Compound by Neose to Wyeth-Ayerst. In the event Neose fails to perform
under the timelines established by the JDC for the completion of the
Research Program and the supply of Covered Compounds, all time periods
set forth in Sections 7.3 and 7.4 hereof shall be extended for a
period equivalent to Neose's delay in performing under such timelines.
7.6 Termination for Cause. This Agreement may be terminated upon prior
written notice by either party at any time during the term of this
Agreement:
(i) for material breach by the other party, which breach
remains uncured for sixty (60) days after written notice
of said breach is given to the breaching party or, if such
breach is not susceptible to cure within such sixty (60)
day period, and the breaching party utilizes diligent good
faith efforts to cure such breach, the period shall be
extended to one hundred twenty (120) days from the date on
which the written notice is provided to the breaching
party; or
(ii) 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 (60) days after the filing thereof.
-26-
7.7 Termination for Cause - Effect. Termination of this Agreement for
cause under Section 7.6 hereof shall have the following effect:
(i) In the event Wyeth-Ayerst terminates this Agreement under
Section 7.6(i) hereof, the license granted to Wyeth-Ayerst
pursuant to Section 3.1 shall become a fully paid-up,
perpetual license in each country of the Territory.
(ii) In the event that Neose terminates this Agreement under
Section 7.6(i) hereof, then the rights and licenses
granted to Wyeth-Ayerst hereunder shall terminate and all
rights to the Neose Technology shall revert to Neose.
(iii) In the event that Wyeth-Ayerst terminates this Agreement
under Section 7.6(ii) or this Agreement is otherwise
terminated under Section 7.6(ii), the parties agree that
Wyeth-Ayerst shall retain all rights and licenses granted
to it hereunder and the license granted to Wyeth-Ayerst
under Section 3.1 hereof shall become a perpetual license
under which Wyeth-Ayerst shall remain obligated to pay
royalties to Neose as set forth in Section 5 hereof.
7.8 Insolvency.
7.8.1 Effect on Licenses. All rights and licenses granted under or
pursuant to this Agreement by Neose to Wyeth-Ayerst are, for all
purposes of Section 365(n) of Title 11 of the United States Code
("Title 11") licenses of rights to "intellectual property" as
defined in Title 11. Neose agrees that Wyeth-Ayerst, as licensee
of such rights under this Agreement shall retain and may fully
exercise all
-27-
of its rights and elections under Title 11. Neose agrees during
the term of this Agreement to create and maintain current copies
or, if not amenable to copying, detailed descriptions or other
appropriate embodiments, to the extent feasible, of all such
intellectual property. If a case is commenced by or against
Neose under Title 11, Neose (in any capacity, including
debtor-in-possession) and its successors and assigns (including
without limitation, a Title 11 Trustee) shall:
(i) as Wyeth-Ayerst may elect in a written request,
immediately upon such request:
(a) perform all of the obligations provided in this
Agreement to be performed by Neose including, where
applicable and without limitation, providing to
Wyeth-Ayerst portions of such intellectual property
(including embodiments thereof) held by Neose and
such successors and assigns or otherwise available to
them; or
(b) provide to Wyeth-Ayerst all such intellectual
property (including all embodiments thereof) held by
Neose and such successors and assigns or otherwise
available to them; and
(ii) not interfere with the rights of Wyeth-Ayerst under this
Agreement, or any agreement supplemental hereto, to such
intellectual property, including any right to obtain such
intellectual property from another entity.
7.8.2 Rights to Intellectual Property. If a Title 11 case is commenced
by or against Neose and this Agreement is rejected as provided
in Title 11, and Wyeth-Ayerst elects to retain its rights
hereunder as provided in
-28-
Title 11, then Neose (in any capacity, including
debtor-in-possession) and its successors and assigns (including,
without limitation, Title 11 Trustee) shall provide to
Wyeth-Ayerst all such intellectual property (including all
embodiments thereof) held by Neose and such successors and -
assigns, or otherwise available to them, immediately upon
Wyeth-Ayerst's written request. Whenever Neose or any of its
successors or assigns provides to Wyeth-Ayerst any of the
intellectual property licensed hereunder (or any embodiment
thereof) pursuant to this Section 7.8, Wyeth-Ayerst shall have
the right to perform the obligations of Neose hereunder with
respect to such intellectual property, but neither such
provision nor such performance by Wyeth-Ayerst shall release
Neose from any such obligation or liability for failing to
perform it.
7.8.3 Wyeth-Ayerst's Rights. All rights, powers and remedies of
Wyeth-Ayerst provided herein are in addition to and not in
substitution for any and all other rights, powers and remedies
now or hereafter existing at law or in equity (including,
without limitation, Title 11) in the event of the commencement
of a Title 11 case by or against Neose. Wyeth-Ayerst, in
addition to the rights, powers and remedies expressly provided
herein, shall be entitled to exercise all other such rights and
powers and resort to all other such remedies as may now or
hereafter exist at law or in equity (including, without
limitation, Title 11) in such event. The parties agree that they
intend the foregoing Wyeth-Ayerst rights to extend to the
maximum extent permitted by law, including, without limitation,
for purposes of Title 11:
(i) the right of access to any intellectual property of Neose
or any Third Party with whom Neose contracts to perform an
-29-
obligation of Neose under this Agreement, and, in this
case of a Third Party, which is necessary for the
development, registration, manufacturing and marketing of
Covered Compound and/or Products; and
(ii) the right to contract directly with any Third Party
described in (i) above to complete the contracted work.
7.9 Prior Obligations. Termination or expiration of this Agreement shall
not operate to deprive either party of any rights or remedies either
at law or in equity or to relieve either party of any of its
obligations incurred prior to the date of such termination or
expiration.
7.10 Survival. Except as otherwise noted, the provisions of Sections 2.6.2,
2.7, 6, 11, 12, 13.1, 14, 16.5, 16.6 and 16.10 shall survive
expiration or earlier termination of this Agreement.
8. MANUFACTURE OF PRODUCT
8.1 Product Manufacture. Wyeth-Ayerst shall be responsible for the
manufacture of all quantities of Products according to GMP standards.
9. MANUFACTURE AND SUPPLY
9.1 Covered Compound Manufacture and Supply. Neose shall manufacture or
have manufactured and supply to Wyeth-Ayerst, and Wyeth-Ayerst shall
purchase from Neose, all of Wyeth-Ayerst's requirements of Covered
Compound for use in Products. The manufacture of Covered Compound
shall be in accordance with Specifications and all quality assurance
standards and ingredient testing as may be required by Wyeth-Ayerst
and attached to the Manufacturing and Supply Agreement as a
mutually-agreed upon schedule.
-30-
9.1.1 Manufacturing and Supply Agreement. The parties agree to meet no
later than [*] after the Effective Date, to negotiate and
conclude a Manufacturing and Supply Agreement. The parties agree
to negotiate in good faith to conclude the Manufacturing and
Supply Agreement within [*] of the Effective Date. In the event
that the Manufacturing and Supply Agreement is not executed by
both parties within [*] after the Effective Date, this
Collaboration and License Agreement shall immediately terminate.
This period may be extended for sixty (60) days upon the mutual
written consent of the parties.
9.1.2 Terms of the Manufacturing and Supply Agreement. The parties
agree that the Manufacturing and Supply Agreement shall contain
at least the following terms:
(i) The Manufacturing and Supply Agreement shall include a
Guaranteed Minimum Supply;
(ii) Under the Manufacturing and Supply Agreement, Neose shall
be responsible for the production of Covered Compound in
accordance with the Specifications.
(iii) It shall be Neose's responsibility to develop, construct
and operate a manufacturing facility capable of producing
Covered Compound in quantities sufficient to deliver
Wyeth-Ayerst's requirements of Covered Compound.
(iv) Neose shall consult with Wyeth-Ayerst regarding the
location of the manufacturing facility referred to in
Section 7.1.2(iii) hereof. The final location of the
manufacturing facility shall be mutually agreed upon by
the parties.
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-31-
(v) Neose shall provide Covered Compound to Wyeth-Ayerst on
the following basis and at the following costs:
(a) Neose shall use its commercially reasonable efforts
to provide the Covered Compound required by
Wyeth-Ayerst at the lowest price possible, not to
exceed [*] per kilogram of the [*] component of the
Covered Compound (hereinafter "the Target Price")
plus [*] paid by Wyeth-Ayerst over the previous six
(6) month period, FOB Neose plant.
(b) In the event the Target Price is less than [*], Neose
will, subject to subsection (c) below sell the
Covered Compound to Wyeth-Ayerst at a price per
kilogram equal to [*].
----------
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-32-
(c) In the event that the price to Wyeth-Ayerst of the
[*] component of the Covered Compound exceeds [*] of
Wyeth-Ayerst's net selling price of Products, the
parties agree to re-negotiate in good faith the
provisions of the Manufacturing and Supply Agreement
relevant to the price of the [*] to arrive at such
terms as are fair and equitable to both parties.
(d) In the event that the cost to Wyeth-Ayerst of a
kilogram of the [*] component of the Covered Compound
calculated on a [*] basis as set forth in Section
9.1.2(v)(b) hereof is lower than the Target Price,
the actual price of the [*] component of the Covered
Compound to be charged to Wyeth-Ayerst shall be equal
to [*].
9.3 Exclusive Purchase. Wyeth-Ayerst agrees to purchase all of its
requirements of Covered Compound exclusively from Neose, subject to
Neose's ability to supply all of Wyeth-Ayerst's requirements of
Covered Compound in a given period, consistent with reasonable
forecasts by Wyeth-Ayerst of its requirements. In the event Neose is
unable to supply all of Wyeth-Ayerst's requirements of Covered
Compound, Wyeth-Ayerst shall have the right, at its sole discretion,
to manufacture its required quantities of Covered Compound or to
designate a Third Party manufacturer to supply its required quantities
of Covered Compound. Wyeth-Ayerst shall continue to have such right
until such time Neose is able to demonstrate to Wyeth-Ayerst's
reasonable satisfaction that it is able to supply Wyeth-Ayerst's
requirements of Covered Compound. Neose agrees to provide Wyeth-Ayerst
and/or its designated Third Party manufacturer with all of the Neose
Technology necessary to manufacture Covered Compound according to
Specifications.
----------
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-33-
10. REPRESENTATIONS AND WARRANTIES
10.1 Representations and Warranties of Each Party. Each of Neose and
Wyeth-Ayerst hereby represents, warrants and covenants to the other
party hereto as follows:
(a) it is a corporation or entity duly organized and validly
existing under the laws of the state or other jurisdiction
of incorporation or formation;
(b) the execution, delivery and performance of this Agreement
by each party has been duly authorized by all requisite
corporate action and do not require any shareholder action
or approval;
(c) it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;
(d) the execution, delivery and performance by such party of
this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with or
result in a breach of any of the terms and provisions of
or constitute a default under (i) a loan agreement,
guaranty, financing agreement, agreement affecting a
product or other agreement or instrument binding or
affecting it or its property; (ii) the provisions of its
charter or operative documents or bylaws; or (iii) any
order, writ, injunction or decree of any court or
governmental authority entered against it or by which any
of its property is bound; and
(e) it shall comply with all applicable material laws and
regulations relating to its activities under this
Agreement.
-34-
10.2 Representations and Warranties of Neose. In addition to the
Representations and Warranties made by Neose under Section 10.1
hereof, Neose hereby further represents and warrants to Wyeth-Ayerst
that, to the best of its knowledge:
(a) as of the Effective Date, the Neose Patents and Neose
Know-How are existing and are not invalid or
unenforceable, in whole and in part;
(b) as of the Effective Date, it has the full right, power and
authority to grant the licenses granted by it hereunder
and it has not previously granted, and during the term of
the Agreement will not grant, any rights which conflict
with the licenses granted hereunder;
(c) subject to the provisions of Section 10.3 hereof, it is
the sole and exclusive owner or licensee in the Field of
the Neose Patents, Neose Technology and Neose Know-How
existing as of the Effective Date, all of which are free
and clear of any liens, charges and encumbrances, and no
other person, corporate or other private entity, or
governmental entity or subdivision thereof, has or shall
have any claim of ownership with respect to the Neose
Patents Neose Technology or Neose Know-How existing as of
the Effective Date, whatsoever;
(d) the Neose Patents, Neose Technology and Neose Know-How,
and the development, manufacture, use, distribution,
marketing, promotion and sale of [*] and Products do not,
as of the Effective Date, interfere with or infringe on
any intellectual property rights owned or possessed by any
Third Party;
----------
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-35-
(e) the manufacture of [*] is covered by one or more Valid
Claims of the Neose Patents;
(f) none of the Neose Patents is the subject of any reissue,
reexamination, interference, opposition or other similar
proceeding;
(g) as of the Effective Date, there are no claims, judgments
or settlements against or owed by Neose or, pending or
threatened claims or litigation relating to the Neose
Patents, Neose Technology or related Neose Know-How;
(h) during the Term of this Agreement it will use diligent
efforts not to diminish the rights under the Neose
Patents, Neose Technology and Neose Know-How in the Field
licensed to Wyeth-Ayerst hereunder, unless previously
considered and agreed to by the JDC, including without
limitation, by not committing or permitting any actions or
omissions which would cause (i) the Neose Patents to lapse
or to otherwise become abandoned or (ii) the breach of any
agreements between itself and Third Parties which provide
for intellectual property rights applicable to the
development, manufacture, use or sale of Products, that it
will provide Wyeth-Ayerst promptly with notice of any such
alleged breach, and that as of the Effective Date, it is
in compliance in all material respects with any agreements
with Third Parties relating to the Neose Patents, Neose
Technology and related Know-How, and/or the Products; and
----------
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-36-
(i) pursuant to the Research and License Agreement dated
December 30, 1992 between Neose and Xxxxxx Laboratories
("Abbott"), as amended, Neose has the right to convert the
licenses granted therein to Xxxxxx ("Xxxxxx License") to a
non-exclusive license, and, as of the Effective Date,
Neose will have taken all actions required to convert the
Abbott License to a non-exclusive license. [*].
Except as expressly set forth herein, Wyeth-Ayerst and Neose
make no representations or warranties regarding the subject
matter of this Agreement.
10.3 Research and License Agreement - Neose and Xxxxxx Laboratories. The
parties acknowledge that Neose is party to a Research and License
Agreement with Xxxxxx Laboratories ("Abbott") and a subsequent
Amendment Agreement (collectively the "Abbott Agreements"). Neose
warrants that it has the right to convert the license granted under
the Abbott Agreements to a non-exclusive license. [*].
10.3.1 [*]
10.4 Rights of Abbott. Notwithstanding anything contained herein to the
contrary, Wyeth-Ayerst acknowledges that the license granted to
Wyeth-Ayerst pursuant to Section 3.1 hereof is not exclusive as to
Abbott with respect to any Neose Patents, Neose Know-How, or Neose
Technology existing as of the Effective Date.
10.5 Inconsistent Activities. Neither party has in effect and after the
Effective Date neither party shall enter into any oral or written
agreement or arrangement that would be inconsistent with its
obligations under this Agreement.
----------
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-37-
10.6 Legal Representation. Each party hereto represents that it has been
represented by legal counsel in connection with this Agreement and
acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this Agreement,
the parties agree that no presumption shall exist or be implied
against the party which drafted such terms and provisions.
11. TRADEMARKS
11.1 Wyeth-Ayerst. Wyeth-Ayerst shall select and own the trademarks for
marketing Products in all countries in the Territory. All expenses for
(i) registration of such trademarks and (ii) bringing, maintaining,
and prosecuting any action to defend such trademarks shall be borne by
Wyeth-Ayerst and Wyeth-Ayerst shall retain all recoveries therefrom.
11.2 Neose. Neose shall have the right to select and own trademarks for the
Covered Compound. All expenses for (i) the registration of such
trademarks and (ii) bringing, maintaining, and prosecuting any action
to defend such trademarks shall be borne by Neose and Neose shall
retain all recoveries therefrom. Wyeth-Ayerst shall have the right to
use such trademarks in the Field in connection with the sale of
Products containing Covered Compound.
-38-
12. CONFIDENTIAL INFORMATION
12.1 Non-Disclosure Obligation. Each of Wyeth-Ayerst and Neose shall use
only in accordance with the terms of this Agreement and shall not
disclose to any Third Party, any information received by it from the
other party in connection with this Agreement, including but not
limited to Wyeth-Ayerst Know-How and Neose Know-How, without the prior
written consent of the other party. These obligations shall survive
the expiration or termination of this Agreement for a period of five
(5) years. Notwithstanding the foregoing, the parties agree that
Wyeth-Ayerst may disclose information received under this Agreement,
including information relating to the Neose Patents and Neose
Technology, to its sublicensees, so long as such sublicensees agree to
be bound by obligations of Confidentiality no less strict than those
set forth herein. These obligations shall not apply to information
that:
(i) is known by the receiving party, as evidenced by its
records, at the time of its receipt and not through a
prior disclosure by the disclosing party;
(ii) is at the time of disclosure or thereafter becomes
published or otherwise part of the public domain through
no fault of the receiving party;
-39-
(iii) is subsequently disclosed to the receiving party as
evidenced by its records, by a Third Party having the
right to make such a disclosure;
(iv) is developed by the receiving party as evidenced by its
records independently of information received by it from
the disclosing party hereunder;
(v) is disclosed to any Regulatory Authority in order to
obtain approval to market the Product, but such disclosure
may be made only to the extent necessary to obtain such
approval; or
(vi) is required by law, regulation, rule, act or order of any
governmental authority or agency to be disclosed by a
party, provided that notice is promptly given to the other
party in order to provide an opportunity to seek a
protective order or the like with respect to such
information and the disclosing party discloses only the
minimum information required to be disclosed in order to
comply with the request.
12.2 Permitted Disclosure. Information provided under this Agreement may be
disclosed to employees, agents, consultants, sublicensees, or
suppliers of the receiving party, but only to the extent required to
accomplish the purposes of this Agreement and only after the receiving
party obtains the prior agreement of its employees, agents,
consultants, sublicensees or suppliers to whom disclosure is to be
made to hold in confidence and not make use of such information for
any purpose other than that permitted by this Agreement.
12.3 Publicity. Except as required by law, all publicity, press releases
and other announcements relating to this Agreement or the transactions
-40-
contemplated hereby shall be reviewed in advance by, and shall be
subject to the approval of, both parties.
12.4 Publication. The parties shall cooperate in the appropriate
publication of the results of research and development work performed
pursuant to this Agreement, but subject to their predominating
interest in obtaining patent protection for any patentable subject
matter. The determination of authorship for any paper shall be in
accordance with accepted scientific practice. Notwithstanding anything
in this Section 12.4, all publications and presentations of the
results of research and development work performed under this
Agreement must be approved in advance by both parties.
13. INTELLECTUAL PROPERTY RIGHTS
13.1 Ownership of Inventions. Wyeth-Ayerst shall own all inventions and
discoveries whether or not patentable (i) made solely by its employees
and agents during the term of this Agreement and (ii) relating solely
to the use of Covered Compound in the Field, made jointly by the
employees or agents of Neose and Wyeth-Ayerst. Neose shall own all
inventions and discoveries whether or not patentable (i) made solely
by its employees and agents during the term of this Agreement and (ii)
relating to the manufacture of Covered Compound and [*], made jointly
by the employees or agents of Neose and Wyeth-Ayerst. All other
inventions and discoveries made jointly by employees and agents of
Wyeth-Ayerst and Neose shall be owned jointly by the parties. All the
determinations of inventorship shall be made in accordance with United
States law.
----------
[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
-41-
13.1.1 Patent Procurement. Neose and Wyeth-Ayerst shall each disclose
to the other and discuss any inventions and discoveries arising
during the term of this Agreement and the desirability of
filing one or more patent applications covering such inventions
or discoveries. The party owning the invention or discovery
shall make the final decision with respect to any such filings
and shall have the right to select patent counsel and to take
other actions as appropriate to prepare, file, prosecute, and
maintain patent protection with respect to its inventions and
discoveries arising under this Section 13.1. With respect to
jointly owned inventions, the parties shall meet to determine
in which countries, if any, the patent applications claiming
such joint inventions and discoveries should be filed. In the
event that either party does not wish to share in the expenses
of both filing and prosecuting patent applications claiming
such joint inventions and discoveries in any country of the
Territory, such party shall promptly assign or cause to be
assigned to the other party all of its right, title, and
interest in and to such joint inventions and discoveries and
thereafter, such joint inventions and discoveries shall be
treated as an invention or discovery solely owned by the other
party for all purposes of this Agreement. In the event the
parties decide to share in the expenses for applying for,
obtaining and maintaining patents claiming such a joint
invention or discovery in one or more countries of the
Territory, Wyeth-Ayerst shall file and prosecute any such
patent applications in such countries and the out-of-pocket
expenses incurred by Wyeth-Ayerst in preparing, filing and
prosecuting joint patent applications and maintaining patents
issuing therefrom shall be shared equally by the parties.
-42-
13.2 Prosecution and Maintenance of Patent Rights. Each party shall be
responsible for prosecuting and maintaining its own patent rights
throughout the Territory.
13.3 Cooperation. Each of the parties shall execute or have executed by its
employees, representatives, agents and contractors such documents as
may be reasonably necessary to obtain, perfect or maintain any patent
rights which would be filed pursuant to this Agreement, and to
cooperate with the other party as far as reasonably necessary with
respect to furnishing all information and data in its possession to
obtain patent rights.
13.4 Patent Infringement. Wyeth-Ayerst shall give immediate notice in
writing to Neose of any known or presumed infringement in the Field in
the Territory of any of the Neose Patents and will provide Neose its
full cooperation in the protection and enforcement of the Neose
Patents. Any award or recovery from an infringement suit against or a
settlement with such infringer shall be first applied to the
reimbursement of legal fees, costs and expenses incurred by the
parties and the remainder, if any, shall be divided eighty percent
(80%) to Neose and twenty percent (20%) to Wyeth-Ayerst between the
parties. In any and all settlements between such alleged infringer of
Neose Patents and Neose, the prior written consent thereto by
Wyeth-Ayerst shall be obtained by Neose, such consent not to be
unreasonably withheld. If Neose fails to either bring suit against or
to enter into negotiations for a settlement with such alleged
infringer of a Neose Patent within a reasonable time after written
notice of the alleged infringement shall have been given to Neose by
Wyeth-Ayerst, then, to the extent such an infringement occurs in a
country in the Territory, Wyeth-Ayerst may seek to prevent such
infringement in such country at its cost in either or both of the
names of the parties hereto. If Wyeth-Ayerst commences an infringement
action, Neose shall cooperate fully with Wyeth-Ayerst and any recovery
obtained by Wyeth-Ayerst as the result of its proceedings by court
action, settlement or otherwise, shall be the
-43-
property of Wyeth-Ayerst after reimbursement of twenty-five percent
(25%) of the legal fees incurred by Neose in cooperating with
Wyeth-Ayerst in such infringement action. In any and all settlements
between such an alleged infringer of Neose Patents and Wyeth-Ayerst,
the prior written consent thereto by Neose shall be obtained by
Wyeth-Ayerst, such consent not to be unreasonably withheld.
13.5 Infringement of Third Party Patent Rights. In the event Wyeth-Ayerst
should be of the opinion that it can not make, import, use, market
and/or sell Products in any country of the Territory under Neose
Patents and Neose Technology under this Agreement without infringing a
Third Party patent, 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-Ayerst's opinion, they shall, at
Wyeth-Ayerst's sole option, endeavors to secure a license from the
Third Party on terms reasonably acceptable to the parties.
13.5.1 Opinion of Counsel. If, in the opinion of patent counsel
selected under Section 13.5, the Third Party patent, if
litigated, would be found invalid or not infringed by the
manufacture, use or sale of Product, or if the parties
otherwise mutually agree to obtain a license to such Third
Party patent, the parties shall proceed in accordance with the
terms of this Agreement, unless an action for infringement is
brought against one or both parties.
13.5.2 Defense against Claim of Infringement. If either party is sued
for infringement of any Third Party patent arising out of the
manufacture, use, sale, importation or exportation of a Product
in any country of the Territory, the parties shall promptly
meet to discuss the course of action to be taken to resolve or
defend any such infringement litigation. Each party shall
provide the other with such assistance as is reasonably
necessary and shall
-44-
cooperation in the defense of any such action. The cost/expense
of defending such an action and any damages imposed shall be
shared equally by the parties. Payments due Neose pursuant to
this Agreement shall be reduced if Wyeth-Ayerst is required to
obtain a royalty-bearing license from such Third Party under
any patent of said Third Party which would be infringed by the
sale of Product by Wyeth-Ayerst and the infringement of such
patent cannot be reasonably avoided.
14. INDEMNIFICATION AND INSURANCE
14.1 Indemnification by Wyeth-Ayerst. Wyeth-Ayerst shall indemnify, defend
and hold harmless Neose and its Affiliates, and each of its and their
respective employees, officers, directors and agents (each an "Neose
indemnified party") from and against all liability, loss, damage, cost
and expense (including reasonable attorneys fees) which the Neose
indemnified party may incur, suffer or be required to pay resulting
from or arising in connection with (i) the breach by Wyeth-Ayerst of
any representation or warranty contained in this Agreement; or (ii)
the promotion, distribution, use, testing, marketing, sale or other
disposition of the Product by Wyeth-Ayerst, its Affiliates or
sublicenses. Notwithstanding the foregoing, Wyeth-Ayerst shall have no
obligation to indemnify, defend or hold harmless any Neose indemnified
party with respect to claims, demands, costs or judgments which result
from the willful misconduct or negligent acts or omissions of Neose,
its Affiliates or any of their respective employees, officers,
directors or agents.
14.2 Indemnification by Neose. Neose shall indemnify, defend and hold
harmless Wyeth-Ayerst and its Affiliates, and each of its and their
respective employees, officers, directors and agents (each a
"Wyeth-Ayerst indemnified party") from and against any and all
liability, loss, damage, cost and expense (including reasonable
attorneys fees) which the Wyeth-Ayerst
-45-
indemnified party may incur, suffer, or be required to pay resulting
from or arising in connection with the breach by Neose of any
representation or warranty contained in this Agreement.
Notwithstanding the foregoing, Neose shall have no obligation under
this Agreement to indemnify, defend and hold harmless any Wyeth-Ayerst
indemnified party with respect to claims, demands, costs or judgements
which result from the willful misconduct or negligent acts or
omissions of Wyeth-Ayerst, its Affiliates or any of their respective
employees, officers, directors or agents.
14.3 Conditions to Indemnification. The obligations of the indemnifying
party under Sections 14.1 and 14.2 are conditioned upon the delivery
of written notice to the indemnifying party of any potential liability
promptly after the indemnified party becomes aware of such liability.
The indemnifying party shall have the right to assume the defense of
any part or claim related to the potential liability if it has assumed
responsibility for the suit or claim in writing. The indemnified party
shall cooperate with the indemnifying party in the defense of any such
suit or claim.
14.4 Settlements. Neither party may settle a suit or claim related to a
potential liability without the consent of the other party if such
settlement would impose any monetary obligations on the other party or
require the other party to submit to an injunction or otherwise limit
the other party's rights under this Agreement.
14.5 Insurance. Each party agrees to use its Commercially Reasonable
Efforts to obtain and maintain, during the term of this Agreement,
Commercial General Liability Insurance, including Products Liability
Insurance, with reputable and financially secure insurance carriers to
cover its indemnification obligations under this Section 14, or in the
case of Wyeth-Ayerst, self-insurance, with a limit of not less than
one million dollars ($1,000,000) per occurance and five million
dollars ($5,000,000) in the aggregate. Each party shall furnish the
other with a certificate of insurance evidencing liability overage
upon request.
-46-
15. ASSIGNMENT
15.1 Assignment by Neose. Neose may assign any of its rights or obligations
under this Agreement in any country to any of its Affiliates. Neose
may also assign its rights and obligations hereunder in connection
with a merger or a similar reorganization or sale of all or
substantially all of its assets. Neose may not otherwise assign any of
its rights or obligations under this Agreement without the prior
written consent of Wyeth-Ayerst. Any assignment by Neose under this
Section 15.1, shall not relieve Neose of its responsibilities for the
performance of its obligations under this Agreement.
15.2 Assignment by Wyeth-Ayerst. Wyeth-Ayerst may assign any of its rights
or obligations under this Agreement in any country to any of its
Affiliates. Wyeth-Ayerst shall notify Neose, in writing, upon making
any such assignment. Wyeth-Ayerst may also assign its rights or
obligations under this Agreement in connection with a merger or
similar reorganization or the sale of all or substantially all of its
assets or a sale of that part of its business relating to the subject
matter of this Agreement. Any assignment by Wyeth-Ayerst under this
Section 15.2, shall not relieve Wyeth-Ayerst of its responsibilities
for the performance of its obligations under this Agreement.
15.3 Binding Nature. This Agreement shall be binding upon and inure to the
benefit of the successors and permitted assigns of the parties. Any
assignment not in accordance with this Section 15 shall be void.
-47-
16. MISCELLANEOUS
16.1 Force Majeure. Neither party shall be liable to the other for delay or
failure in the performance of the obligations on its part contained in
this Agreement if and to the extent that such failure or delay is due
to circumstances beyond its control which it could not have avoided by
the exercise of reasonable diligence. It shall notify the other party
promptly should such circumstances arise, giving an indication of the
likely extent and duration thereof, and shall use all commercially
reasonable efforts to resume performance of its obligations as soon as
practicable.
16.2 No Waiver. The failure of either party to require performance by the
other party of any of that other party's obligations hereunder shall
in no manner affect the right of such party to enforce the same at a
later time. No waiver by any party hereto of any condition, or of the
breach of any provision, term, representation or warranty contained in
this Agreement, whether by conduct or otherwise, in any one or more
instances, shall be deemed to be or construed as a further or
continuing waiver of any such condition or breach, or of any other
condition or of the breach of any other provision, term,
representation or warranty hereof.
16.3 Severability. If a court or other tribunal of competent jurisdiction
should hold any term or provision of this Agreement to be excessive,
or invalid, void or unenforceable, the offending term or provision
shall be deleted, and, if possible, replaced by a term or provision
which, so far as practicable, achieves the legitimate aims of the
parties.
16.4 Relationship Between the Parties. Both parties are independent
contractors under this Agreement. Nothing herein contained shall be
deemed to create an employment, agency, joint venture or partnership
relationship between the parties hereto or any of their agents or
employees, or any other legal arrangement that would impose liability
upon one party for the act or failure to act of the other party.
Neither party shall have any express or implied power to enter into
any contracts or commitments or to incur any liabilities in the name
of, or on behalf of, the other party, or to bind the other party in
any respect whatsoever.
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16.5 Correspondence and Notices. Correspondence, reports, documentation,
and any other communication in writing between the parties in the
course of implementation of this Agreement shall be in writing and
sent by prepaid air mail, or by facsimile confirmed by prepaid
registered or certified air mail letter, and shall be deemed to have
been properly served to the addressee upon receipt of such written
communication.
16.5.1 Address for Notices. In the case of Neose, the proper address
for communications and for all payments shall be:
Neose Technologies, Inc.
000 Xxxxxx Xxxx
Xxxxxxx, Xxxxxxxxxxxx 00000
Attn: President
cc: Xxxxxx, Xxxxx and Bockius LLP
0000 Xxxxxx Xxxxxx
Xxxxxxxxxxxx XX 00000-0000
Attn: Xxxxx X. Xxxx, Esq.
and it the case of Wyeth-Ayerst, the proper address for
communications and for all payments shall be:
Wyeth-Ayerst International Inc.
X.X. Xxx 0000
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000
Attn: Senior Vice President, Global Business Development
With a copy to:
American Home Products Corporation
0 Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attn: Senior Vice President and General Counsel
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16.6 Choice of Law. This Agreement is subject to and governed by the
laws of the Commonwealth of Pennsylvania, U.S.A. (without
regard to conflict of law principles).
16.7 Entire Agreement; Amendment. This Agreement, including the
Exhibits and Schedules hereto and thereto and all the
covenants, promises, agreements, warranties, representations,
conditions and understandings contained herein and therein sets
forth the complete, final and exclusive agreement between the
parties and supersedes and terminates all prior and
contemporaneous agreements and understandings between the
parties, whether oral or in writing. There are no covenants,
promises, agreements, warranties, representations, conditions
or understandings, either oral or written, between the parties
other than as are set forth in this Agreement. No subsequent
alteration, amendment, change, waiver or addition to this
Agreement shall be binding upon the parties unless reduced to
writing and signed by an authorized officer of each party. No
understanding, agreement, representation or promise, not
explicitly set forth herein, has been relied on by either party
in deciding to execute this Agreement.
16.8 Headings. The headings and captions used in this Agreement are
solely for the convenience of reference and shall not affect
its interpretation.
16.9 Counterparts. This Agreement may be executed in one or more
counterparts each of which shall be an original and all of
which shall constitute together the same document.
16.10 Further Actions. Each party agrees to execute, acknowledge and
deliver such further instruments, and to do all other acts, as
may be necessary or appropriate in order to carry out the
purposes and intent of this Agreement including, without
limitation, any filings with any antitrust agency which may be
required.
-50-
IN WITNESS WHEREOF, the parties have caused the Agreement to be
executed by their duly authorized representatives.
American Home Products Corporation Neose Technologies, Inc.
By: _________________________ By: _________________________
Name: ______________________ Name: _______________________
Title: ______________________ Title: ______________________
Date: ______________________ Date: _______________________
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EXHIBIT A
Neose Technologies Patents/Patent Applications
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Title Inventor Country Serial No. Filing Date Patent/Pub No. Issue Date
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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EXHIBIT B
Former Cytel Corporation Patents/Patent Applications
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Title Inventor Country Serial No. Filing Date Patent/Pub No. Issue Date
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[*] We are seeking confidential treatment of the terms that have been omitted.
The confidential portions have been filed separately with the Securities and
Exchange Commission.
-55-
EXHIBIT C
o [*]
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[*] We are seeking confidential treatment of these terms, which have been
omitted. The confidential portions have been filed separately with the
Securities and Exchange Commission.
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