Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Exhibit 10.25
COLLABORATION AGREEMENT
between
GENZYME CORPORATION
and
DYAX CORP.
dated as of October 1, 1998
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT dated as of October 1, 1998 (the "Agreement")
is made between Genzyme Corporation, a Massachusetts corporation having its
principal place of business at Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000 ("Genzyme") and Dyax Corp., a Delaware corporation having its principal
place of business at Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000
("Dyax"). Genzyme and Dyax are sometimes referred to herein individually as a
"Party" and collectively as the "Parties."
R E C I T A L S
A. Dyax is developing EPI-KAL-2 ("EPI-KAL-2"), *************. Dyax is
currently developing EPI-KAL-2 for the treatment of HAE and other inflammatory
diseases.
B. Genzyme has expertise in the areas of development, manufacturing and
marketing of bio-pharmaceutical products.
C. Dyax and Genzyme desire to collaborate in developing EPI-KAL-2 for the
treatment of HAE and other inflammatory diseases.
NOW THEREFORE, in consideration of the premises and of the covenants
herein contained, the Parties mutually agree as follows:
ARTICLE 1 DEFINITIONS
For purposes of this Agreement, the terms defined in this Article shall
have the meanings specified below. Certain other capitalized terms are defined
elsewhere in this Agreement.
1.1 "Affiliate" shall mean any corporation or other entity which controls,
is controlled by, or is under common control with a Party. A corporation or
other entity shall be regarded as in control of another corporation or entity if
it owns or directly or indirectly controls more than fifty percent (50%) of the
voting stock or other ownership interest of the other corporation or entity, or
if it possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or other entity or
the power to elect or appoint more than fifty percent (50%) of the members of
the governing body of the corporation or other entity.
i
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
1.2 "Collaboration Product" shall mean EPI-KAL-2 and ************* any
combination products, delivery systems and dosage forms related thereto,
together with any process developed for use in the Field by a Party utilizing,
based upon or arising out of the Genzyme Patent Rights, the Dyax Patent Rights,
the Joint Patent Rights, the Genzyme Technology, the Dyax Technology, the Joint
Technology or the Manufacturing Know-How owned or controlled by either Party.
*************.
1.3 "Commercialization Costs" with respect to a Collaboration Product
shall mean the variable costs and fixed costs incurred by the Parties or by
Kallikrein LLC with respect to work performed by the Parties and their
Affiliates and subcontractors in connection with the performance of the
Commercialization Plan for such Collaboration Product, including without
limitation, sales and marketing costs related to performing market research,
post-marketing studies, advertising, producing promotional literature,
sponsoring seminars and symposia, sales training meetings and seminars,
originating sales, providing reimbursement and other patient support services
and such other expenses described in Section 6.4 hereof. For purposes of this
Section 1.3, "variable costs" shall be deemed to be the cost of labor, raw
materials, supplies and other resources directly consumed in the conduct of the
Commercialization Plan and manufacture of Collaboration Product for use in
commercialization activities, as well as royalties payable to Third Parties. For
purposes of Section 1.3, "fixed costs" shall be deemed to be the cost of
facilities, utilities, insurance, equipment depreciation and other fixed costs
directly related to the conduct of the Commercialization Plan and the
manufacture of Collaboration Product for use in commercialization activities,
allocated based upon the proportion of such costs directly attributable to the
support or performance of the Commercialization Plan and the manufacture of
Collaboration Product for use in commercialization activities or by such other
method of cost allocation as may be approved by the Steering Committee.
Commercialization Costs shall exclude all costs otherwise reimbursed pursuant to
this Agreement. All cost determinations made hereunder shall be made in
accordance with GAAP.
1.4 "Commercialization Plan" shall mean, with respect to a particular
Collaboration Product, the comprehensive plan for the commercialization of such
Collaboration Product, as more specifically described in Section 6.1 hereof.
1.5 "Commercially reasonable and diligent efforts" shall have the meaning
ascribed to it in Section 5.1.1.
1.6 "Development Costs" with respect to a Collaboration Product shall mean
the variable costs and fixed costs incurred by the Parties or by Kallikrein LLC
with respect to work performed by the Parties and their Affiliates and
subcontractors in connection with the conduct of the Development Plan for such
Collaboration Product, including without limitation (a) direct, out-of-pocket
external costs, including clinical grants, clinical laboratory fees, positive
controls and the cost of studies conducted and services provided by contract
research organizations and individuals, consultants, toxicology contractors, and
manufacturers necessary or useful for the purpose of obtaining Regulatory
Approvals for such Collaboration Product, (b) amounts paid to Genzyme by Dyax
prior to satisfaction by Dyax of the Initial Funding Commitment (as defined
herein), or to Genzyme and Dyax by Kallikrein LLC after satisfaction by Dyax of
the Initial Funding Commitment, with respect to research and development and
pre-commercialization sales and marketing efforts as set forth in the
Development Plan for such Collaboration Product, including without limitation
the efforts of the Parties to develop and document process methods
2
and procedures for the manufacture, characterization and release of such
Collaboration Product and the Fully Absorbed Cost of Goods for batches of such
Collaboration Product manufactured and supplied for use in preclinical and
clinical trials and pre-commercialization activities, including quality control
and quality assurance, (c) costs related to data management, statistical designs
and studies, document preparation and other expenses associated with the
clinical testing program for such Collaboration Product, (d) costs for
preparing, submitting, reviewing or developing data or information for the
purpose of submission of applications to obtain Regulatory Approvals for such
Collaboration Product and (e) the pro rata share of license fees and other
amounts payable to Third Party licensors and costs relating to the prosecution
and maintenance of Patent Rights, allocated based on the proportion of such
costs directly attributable to such Collaboration Product. For purposes of this
Section 1.6, "variable costs" shall be deemed to be the cost of labor, raw
materials, supplies and other resources directly consumed in the conduct of the
Development Program and the manufacture of the Collaboration Product for use in
preclinical and clinical trials and pre-commercialization activities. For
purposes of this Section 1.6, "fixed costs" shall be deemed to be the cost of
facilities, utilities, insurance, facility and equipment depreciation and other
fixed costs directly related to the conduct of the Development Program and the
manufacture of the Collaboration Product for use in preclinical and clinical
trials and pre-commercialization activities, allocated based upon the proportion
of such costs directly attributable to support of the Development Program and
the manufacture of the Collaboration Product for use in preclinical and clinical
trials and pre-commercialization activities or by such other method of cost
allocation as may be approved by the Steering Committee. Development Costs shall
exclude all costs otherwise reimbursed pursuant to this Agreement. All cost
determinations made hereunder shall be made in accordance with GAAP.
1.7 "Development Plan" shall mean, with respect to a particular
Collaboration Product, the comprehensive plan and budget for the development of
such Collaboration Product under the Development Program, as more specifically
described in Section 5.1 hereof.
1.8 "Development Program" shall mean, with respect to a particular
Collaboration Product, the preclinical and clinical development of such
Collaboration Product including the preparation and filing of all applications
for Regulatory Approvals for such Collaboration Product.
1.9 "Dyax Companies" shall mean Dyax and a wholly-owned subsidiary of Dyax
("Subsidiary") to be formed prior to the LLC Formation Date for the purpose of
holding a one percent (1%) interest in Kallikrein LLC.
1.10 "Dyax Patent Rights" shall mean all Patent Rights owned or controlled
by, or licensed (to the extent licensed and if there is the right to sublicense)
to, Dyax, to the extent that such Patent Rights claim Collaboration Products or
are necessary for the research, development, manufacture or commercialization of
Collaboration Products in the Field. The Dyax Patent Rights in existence on the
Effective Date are set forth on Schedule 1.10. This schedule will be updated by
Dyax on the LLC Formation Date to include all Dyax Patent Rights owned or
controlled by Dyax as of such date.
1.11 "Dyax Technology" shall mean all Technology owned or controlled by,
or licensed (to the extent licensed and if there is the right to sublicense) to,
Dyax that is necessary
3
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
for, or specifically relates or is specifically useful to, the research,
development, manufacture or commercialization of Collaboration Products for use
in the Field.
1.12 "Effective Date" shall mean the date first above written.
1.13 "FDA" shall mean the United States Food and Drug Administration, any
successor agency, or the regulatory authority of any country other than the
United States with responsibilities comparable to those of the United States
Food and Drug Administration.
1.14 "Field" shall mean ************* uses of a Collaboration Product.
1.15 "Fully Absorbed Cost of Goods" with respect to a Collaboration
Product shall mean (a) the variable costs and fixed costs incurred by a Party
associated with the manufacture (inclusive of finishing processes) of batches of
such Collaboration Product or (b) if such Collaboration Product is not
manufactured by the Parties, the transfer price for batches of such
Collaboration Product purchased from Third Party manufacturers. For purposes of
this Section 1.15, "variable costs" shall be deemed to be the cost of labor, raw
materials, supplies and other resources directly consumed in the manufacture of
batches of such Collaboration Product, including quality control and quality
assurance. For purposes of this Section 1.15, "fixed costs" shall be deemed to
be the cost of facilities, utilities, insurance, facility and equipment
depreciation and other fixed costs directly related to the manufacture of
batches of such Collaboration Product, as well as royalties payable to Third
Parties in connection with the manufacture, use or sale of a Collaboration
Product. Fixed costs shall be allocated to such Collaboration Product based upon
the proportion of such costs directly attributable to support of the
manufacturing process for such Collaboration Product. If a facility is used to
manufacture Collaboration Products and products for other programs of either
Genzyme or Dyax, fixed costs shall be allocated in proportion to the use of such
facility for the manufacture of Collaboration Products and products for such
other programs. Fully Absorbed Cost of Goods shall exclude all costs otherwise
reimbursed pursuant to this Agreement. In the event that either Dyax or Genzyme
subcontracts with the other Party to perform any work on its behalf in
connection with the manufacturing responsibilities assigned to Dyax or Genzyme,
respectively, pursuant to Section 7.2.1 hereof, Dyax and Genzyme (i) shall each
directly charge Kallikrein LLC their respective Fully Absorbed Cost of Goods and
(ii) shall not include any part of the other Party's Fully Absorbed Cost of
Goods in the amount so charged to Kallikrein LLC. Except as otherwise provided
in this Agreement, all cost determinations made hereunder shall be made in
accordance with GAAP.
1.16 "GAAP" shall mean United States generally accepted accounting
principles, consistently applied, except when different accounting principles
are required under the terms of the Operating Agreement, in which case the
accounting principles mandated under the Operating Agreement shall control.
1.17 "Genzyme Patent Rights" shall mean all Patent Rights owned or
controlled by, or licensed (to the extent licensed and if there is the right to
sublicense) to, Genzyme, to the extent that such Patent Rights claim
Collaboration Products or are necessary for the research, development,
manufacture or commercialization of Collaboration Products in the Field. The
Genzyme Patent Rights in existence on the Effective Date are set forth on
Schedule 1.17. This
4
schedule will be updated by Genzyme on the LLC Formation Date to include all
Genzyme Patent Rights owned or controlled by Genzyme as of such date.
1.18 "Genzyme Technology" shall mean all Technology owned or controlled
by, or licensed (to the extent licensed and if there is the right to sublicense)
to, Genzyme that is necessary for or specifically relates or is specifically
useful to, the research, development, manufacture or commercialization of
Collaboration Products for use in the Field.
1.19 "Joint Patent Rights" shall mean the Patent Rights that claim Joint
Inventions (as such term is defined in Section 9.1.1 hereof) that are jointly
discovered, made or conceived during and in connection with the Program to the
extent that such Patent Rights relate to or are useful for the research,
development, manufacture or commercialization of Collaboration Products for use
in the Field.
1.20 "Joint Technology" shall mean all Technology discovered, made or
conceived during and in connection with the Program, and future Technology owned
or controlled by, or licensed (with the right to sublicense where possible) to,
either Genzyme or Dyax relating to or useful for the research, development,
manufacture or commercialization of Collaboration Products for use in the Field.
1.21 "Kallikrein LLC" shall mean the Delaware limited liability company to
be organized by Dyax in accordance with Section 2.1 hereof for the purpose of
developing and commercializing Collaboration Products in the Territory and in
the Field.
1.22 "LLC Formation Date" shall mean the date the Certificate of Formation
of Kallikrein LLC is filed with the Secretary of State of Delaware.
1.23 "Manufacturing Know-How" shall mean all information, techniques,
inventions, discoveries, improvements, practices, methods, knowledge, skill,
experience and other technology, whether or not patentable or copyrightable, and
any copyrights based thereon, relating to or necessary or useful for the
production, purification, packaging, storage and transportation of Collaboration
Products, including without limitation specifications, acceptance criteria,
manufacturing batch records, standard operating procedures, engineering plans,
installation, operation and process qualification protocols for equipment,
validation records, master files submitted to the FDA, process validation
reports, environmental monitoring processes, test data including
pharmacological, toxicological and clinical test data, cost data and employee
training materials.
1.24 "Manufacturing Party" shall have the meaning set forth in Section
7.3.
1.25 "Member" shall have the meaning set forth in the Operating Agreement.
1.26 "NDA" shall mean a New Drug Application, Biologics License
Application, or similar application filed with the FDA after completion of human
clinical trials to obtain marketing approval for a Collaboration Product.
1.27 "Net Profit" of Kallikrein LLC for any period shall be equal to (a)
the sum during such period of all revenues recognized and recorded by Kallikrein
LLC during such period, including without limitation (i) revenues from sales of
all Collaboration Products sold by
5
Kallikrein LLC and (ii) all revenues received by Kallikrein LLC from Third
Parties as consideration for sublicensing the manufacture, use, distribution or
sale of Collaboration Products, less (b) all expenses incurred by Kallikrein LLC
during such period, including without limitation expenses incurred in respect of
Development Costs and Commercialization Costs and facility and equipment
depreciation costs not otherwise accounted for. All determinations made
hereunder shall be made in accordance with GAAP.
1.28 "Operating Agreement" shall mean the Operating Agreement of
Kallikrein LLC in substantially the form attached hereto as Schedule 1.28 to be
entered into by Dyax, Subsidiary and Genzyme on the LLC Formation Date.
1.29 "Patent Rights" shall mean any patents, patent applications,
certificates of invention, or applications for certificates of invention,
together with any extensions, registrations, confirmations, reissues, divisions,
continuations or continuations-in-part, re-examinations or renewals thereof,
that may be sought throughout the world.
1.30 "Percentage Interest" shall have the meaning set forth in the
Operating Agreement; provided, however, prior to the execution of the Operating
Agreement, the Percentage Interest of both Genzyme and Dyax shall be fifty
percent (50%).
1.31 "Program" shall mean the collaboration described in this Agreement.
1.32 "Program Costs" shall mean all Program-related costs, including
without limitation Development Costs and Commercialization Costs, in each case
as such costs are incurred or accrued by the Parties or by Kallikrein LLC on or
after the Effective Date.
1.33 "Program Management Team" shall mean the joint team composed of
representatives of Genzyme and Dyax described in Section 8.1.1 hereof.
1.34 "Purchase Agreement" shall mean the Purchase Agreement in
substantially the form attached hereto as Schedule 1.34 to be entered into by
Dyax and Genzyme on the LLC Formation Date.
1.35 "Regulatory Approvals" shall mean all approvals from regulatory
authorities in any country required lawfully to manufacture and market
Collaboration Products in any such country, including without limitation any
NDA, any establishment license application filed with the FDA to obtain approval
of the facilities and equipment to be used to manufacture a Collaboration
Product, and any product pricing approvals where applicable. Regulatory
Approvals shall also include "orphan drug" designations granted by the FDA for a
Collaboration Product.
1.36 "Regulatory Scheme" shall mean the United States Public Health
Service Act, the United States Food, Drug and Cosmetics Act, and the
regulations, interpretations and guidelines promulgated thereunder by the FDA or
the regulatory scheme applicable to the Collaboration Products in any country
other than the United States, as such statutes, regulations, interpretations and
guidelines or regulatory schemes may be amended from time to time.
1.37 "Specifications" with respect to a Collaboration Product shall mean
the written specifications for such Collaboration Product determined by the
Program Management Team and
6
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
approved by the Steering Committee; provided that such specifications shall at
all times comply with the relevant Regulatory Scheme in the country of sale and
in the country of use. The Specifications may be amended from time to time by
the Program Management Team provided that such amendments are approved by the
Steering Committee or the written agreement of the Parties, as the case may be.
Copies of such Specifications shall be maintained by both Dyax and Genzyme and
shall become a part of this Agreement as if incorporated herein.
1.38 "Steering Committee" shall mean the joint team composed of
representatives of Dyax and Genzyme appointed as described in Section 8.2.1
hereof. The Steering Committee shall also be the governing body of Kallikrein
LLC following the LLC Formation Date.
1.39 "Technology" shall mean inventions, trade secrets, copyrights,
know-how, data and other intellectual property of any kind (including without
limitation any proprietary biological or other materials, compounds or reagents,
but not including Patent Rights).
1.40 "Territory" shall mean all of the countries in the world.
1.41 "Third Party" shall mean any entity other than Kallikrein LLC, Dyax
or Genzyme and their respective Affiliates.
ARTICLE 2 SCOPE AND STRUCTURE OF THE COLLABORATION
2.1 General. Genzyme and Dyax desire to collaborate in developing
Collaboration Products in the Field and in the Territory, with the initial focus
of the Program to be on the development of a Collaboration Product for the
treatment of HAE. Dyax shall initially be responsible for undertaking the
Development Program as described in the Development Plan. ************* at a
time to be mutually agreed upon by the Parties, but in no event later than the
satisfaction by Dyax of the Initial Funding Commitment (as defined in Section
4.1), Dyax will form Kallikrein LLC as the vehicle for a joint venture between
Dyax and Genzyme to further develop and commercialize Collaboration Products in
the Field and in the Territory. Dyax will be the sole initial member of
Kallikrein LLC. Immediately following the formation of Kallikrein LLC,
Kallikrein LLC will execute and become a Party to this Agreement. Immediately
following the execution and delivery of this Agreement by Kallikrein LLC, Dyax
will transfer and assign one percent (1%) of its interest to Subsidiary, and
Subsidiary will be admitted as a member of Kallikrein LLC. Immediately
thereafter, Dyax will sell and assign to Genzyme a fifty percent (50%) interest
in Kallikrein LLC (subject to adjustment pursuant to Section 4.2.1 hereof and
pursuant to the Operating Agreement) pursuant to the Purchase Agreement and
Article 4 hereof and, upon execution and delivery of the Operating Agreement,
Genzyme will be admitted as a member of Kallikrein LLC. Kallikrein LLC will then
undertake the Development Program for each Collaboration Product, with each of
the Parties assuming responsibility for those portions of the Development
Program allocated to it under this Agreement. Upon completion of the Development
Program, the Manufacturing Party or Parties will manufacture the Collaboration
Products on behalf of Kallikrein LLC and Genzyme will market and sell the
Collaboration Products in the Field and in the Territory as exclusive agent for
Kallikrein LLC all on the terms and conditions set forth in this Agreement or
such other terms and conditions as the Parties may agree upon.
7
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
2.2 Exclusive Relationship. Subject to Section 3.2, neither Kallikrein
LLC, Genzyme, Dyax nor any of their respective Affiliates shall independently,
or with a Third Party, conduct research or development activities regarding, or
engage in the manufacture, marketing, sale or distribution of, EPI-KAL-2
************* during the term of this Agreement other than as part of the
Program. *************; provided, however, that in the event that this Agreement
is terminated pursuant to Section 13.2.2 hereof and the non-terminating Party
does not exercise its option under Section 13.3.2(a) hereof, then the
restrictions set forth in this sentence shall not apply. *************.
ARTICLE 3 GRANTS AND RESERVATIONS OF RIGHTS
3.1 Licenses of Rights to Kallikrein LLC.
3.1.1 Grants from Dyax. Except as otherwise expressly provided
herein, Dyax will grant to Kallikrein LLC on the LLC Formation Date a worldwide,
exclusive, royalty-free right and sublicense during the term of this Agreement,
************* under Dyax Patent Rights, Dyax Technology, the Joint Patent Rights
and the Joint Technology and any Manufacturing Know-How owned or held by Dyax to
develop, make, have made, use, offer for sale, sell, have sold, import and
export Collaboration Products in the Field.
3.1.2 Grants from Genzyme. Except as otherwise expressly provided
herein, Genzyme will grant to Kallikrein LLC on the LLC Formation Date a
worldwide, exclusive, royalty-free right and sublicense during the term of this
Agreement, ************* under the Genzyme Patent Rights, Genzyme Technology,
Joint Patent Rights and the Joint Technology and any Manufacturing Know-How
owned or held by Genzyme to develop, make, have made, use, offer for sale, sell,
have sold, import and export Collaboration Products in the Field.
3.1.3 Kallikrein LLC Undertakings; Sublicenses. In consideration of
the licenses to be granted under this Section 3.1, Kallikrein LLC will undertake
to pay all royalties, sublicense fees and other costs or expenses payable to
Third Parties associated with the acquisition or use of such licenses by
Kallikrein LLC for use in connection with the Program. Except as provided in
Section 3.2 below, all sublicenses granted by Kallikrein LLC shall be subject to
prior approval by the Steering Committee.
3.1.4 Rights of Kallikrein LLC to Patent Rights or Technology
Developed Outside the Program. *************.
3.2 Proposals For Additional Indications. Genzyme and Dyax acknowledge and
agree that the initial focus of the Program shall be the use of a Collaboration
Product for the treatment of HAE. At any time during the term of this Agreement,
either Genzyme or Dyax (the "Proposing Party") may make a proposal to the
Steering Committee to develop a Collaboration Product for an additional disease
indication. *************.
3.3 Sublicenses of Rights from Kallikrein LLC to Dyax and Genzyme.
Kallikrein LLC will grant to each of Dyax and Genzyme a worldwide,
non-exclusive, royalty-free right and sublicense during the term of this
Agreement under the Patent Rights, Technology and Manufacturing Know-How
licenses granted to it pursuant to Section 3.1 solely to the extent required to
permit such Party to perform its duties under this Agreement. *************.
8
Kallikrein LLC will further grant to Genzyme a worldwide, non-exclusive,
royalty-free right and license during the term of this Agreement to use any and
all trademarks owned or licensed (with the right to sublicense) by Kallikrein
LLC in connection with the commercialization of Collaboration Products in the
Field and in the Territory to the extent required to permit Genzyme to perform
its duties under this Agreement.
3.4 Reservation of Rights.
3.4.1 Reservation by Dyax. Notwithstanding the license grants set
forth in Section 3.1, Dyax will at all times reserve the rights under the Dyax
Patent Rights, the Dyax Technology, the Joint Patent Rights, the Joint
Technology and the Manufacturing Know-How owned or controlled by Dyax (a) to
make, have made and use Collaboration Products for research and development
purposes only, (b) to develop, make, have made, use, offer for sale, sell, have
sold, import and export products outside the Field and (c) to grant licenses to
Third Parties for the foregoing purposes.
3.4.2 Reservation by Genzyme. Notwithstanding the license grants set
forth in Section 3.1, Genzyme will at all times reserve the rights under the
Genzyme Patent Rights, the Genzyme Technology, the Joint Patent Rights, the
Joint Technology and Manufacturing Know-How owned or controlled by Genzyme (a)
to make, have made and use Collaboration Products for research and development
purposes only, (b) to develop, make, have made, use, offer for sale, sell, have
sold, import and export products outside the Field and (c) to grant licenses to
Third Parties for the foregoing purposes.
3.5 Assignment of Orphan Drug Designation. Except to the extent prohibited
by the Regulatory Scheme, the Parties agree to assign to Kallikrein LLC on the
LLC Formation Date any "Orphan Drug" designations for any Collaboration Product
which Dyax or Genzyme may receive during the term of this Agreement.
ARTICLE 4 PROGRAM FUNDING; LLC INTEREST
4.1 Initial Funding Commitment. Dyax hereby undertakes to fund the first
six million dollars ($6,000,000) in Program Costs (the "Initial Funding
Commitment"). At a time mutually agreed upon by the Parties, but in no event
later than the satisfaction by Dyax of the Initial Funding Commitment, Dyax will
form Kallikrein LLC in accordance with the provisions of Section 2.1.
4.2 Program Funding Capital Contributions.
4.2.1 General. Following satisfaction of the Initial Funding
Commitment, Genzyme and Dyax each undertakes to make capital contributions to
Kallikrein LLC in an amount equal to fifty percent (50%) of all Program Costs.
In the event that either Dyax, on behalf of the Dyax Companies, or Genzyme fails
to make a capital contribution to Kallikrein LLC as required by this Section
4.2.1, and the other Party does not elect to terminate this Agreement pursuant
to Section 13.2.1 hereof, then the Percentage Interests in Kallikrein LLC and
the future funding responsibility of the Members shall be adjusted as provided
in Section 4.1(b) of the Operating Agreement.
9
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
4.2.2 Initial Capital Contributions. Within five (5) working days
after the LLC Formation Date, Dyax and Genzyme shall each make a capital
contribution to Kallikrein LLC in an amount equal to one-half of the Program
Costs budgeted to be incurred by Kallikrein LLC from the LLC Formation Date
through and including the end of the next calendar month after the LLC Formation
Date, less any amounts required to be funded solely by Dyax pursuant to the
Initial Funding Commitment.
4.2.3 Monthly Capital Contributions. With respect to each calendar
month thereafter, Genzyme and Dyax, on behalf of the Dyax Companies, shall each
make capital contributions to Kallikrein LLC, monthly in advance, not later than
the fifteenth (15th) day of the prior calendar month, in an aggregate amount
equal to one-third of the Program Costs budgeted to be incurred by Kallikrein
LLC in any then-current Development Plan or Commercialization Plan for the
calendar quarter in which such calendar month occurs, allocated between such
Parties in accordance with the funding responsibility assumed by Genzyme and
Dyax, on behalf of the Dyax Companies, pursuant to Sections 4.1 and 4.2.1 above.
Upon receipt of each such capital contribution from Genzyme or Dyax, as the case
may be, Kallikrein LLC shall promptly pay each of the Parties an amount equal to
that portion of the budgeted Program Costs to which they are respectively
entitled.
4.2.4 Quarterly Statements; Quarterly Reconciliation. Within thirty
(30) days after the end of each of the first three (3) calendar quarters of each
year and within sixty (60) days after the end of each calendar year, each of
Dyax and Genzyme shall provide Kallikrein LLC with a detailed itemization of its
Program Costs actually incurred during the previous quarter. Each of Dyax and
Genzyme shall provide the other Party with estimates of such costs upon the
reasonable request of the other Party prior to the dates such statements are
due. Within thirty (30) days following receipt of the quarterly statement of
actual Program Costs provided by each of Dyax and Genzyme, Dyax, on behalf of
the Dyax Companies, and Genzyme shall each make an additional capital
contribution to Kallikrein LLC in the amount of any actual Program Costs shown
thereon and not yet paid for which such Party has assumed funding responsibility
pursuant to Section 4.2 above but only to the extent that such amount, together
with all prior capital contributions to date during such year, does not exceed
************* of the total Program Costs budgeted year-to-date through the end
of the quarter to which such statement relates (except to the extent such excess
is approved by the Steering Committee pursuant to Section 5.1.3 hereof). If the
aggregate amount stated to be due from Kallikrein LLC in such quarterly
statements for actual Program Costs is less than the amount already contributed
by the Parties to the capital of Kallikrein LLC with respect to budgeted Program
Costs for such calendar quarter, such excess shall be credited pro rata against
the next successive monthly capital contribution due from Genzyme or Dyax
hereunder.
4.3 Distributions. Distributions shall be made quarterly to each Member in
amounts determined in accordance with the Operating Agreement. Amounts available
for distribution shall be calculated for each calendar quarter after the date of
the first sale of a Collaboration Product following Regulatory Approval of such
Collaboration Product and shall be reported to each of Dyax and Genzyme within
ninety (90) days following the end of each such quarter. All distributions to
the Parties will be accompanied by a report setting forth the basis for such
distribution. Such reports shall be subject to audit rights as set forth in
Section 4.5 below, mutatis mutandis.
10
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
4.4 Sale and Purchase of LLC Interest. Immediately after the assignment by
Dyax of one percent (1%) of its interest in Kallikrein LLC to Subsidiary, in
accordance with the terms and conditions of the Purchase Agreement, Dyax shall
sell, assign and transfer to Genzyme, and Genzyme shall purchase from Dyax, a
fifty percent (50%) interest in Kallikrein LLC (subject to adjustment pursuant
to Section 4.2.1 hereof and pursuant to the Operating Agreement) for an
aggregate amount of *************:
(a) *************;
(b) *************;
(c) *************.
************* payments shall be made in United States dollars by certified or
bank check or by wire transfer *************.
4.5 Books of Account; Audit. Genzyme shall keep and maintain proper and
complete books of account, and shall maintain a bank account, on behalf of
Kallikrein LLC. Dyax shall have reasonable access to such books of account and
bank records upon reasonable prior notice to Genzyme. In the event that either
Dyax or Genzyme reasonably deems the Program to be material to Dyax or Genzyme,
as the case may be, for financial accounting purposes, then, upon such Party's
request, audited financial statements of Kallikrein LLC shall be prepared by an
independent accounting firm to be selected by the Steering Committee. Each of
Dyax and Genzyme shall keep and maintain proper and complete records and books
of account documenting all Program Costs incurred by it. Each of Kallikrein LLC,
Dyax and Genzyme shall permit independent accountants retained by the other
Parties to have access to its records and books for the sole purpose of
determining the appropriateness of Program Costs charged by the non-auditing
Party hereunder. Such examination shall be conducted during regular business
hours and upon reasonable notice, at the auditing Party's own expense and no
more than once in each calendar year during the term of this Agreement and once
during the three (3) calendar years following the termination hereof. If such
examination reveals that such Program Costs have been misstated, any adjustment
shall be promptly refunded or paid, as appropriate. The auditing Party shall pay
the fees and expenses of the accountant engaged to perform the audit, unless
such audit reveals an overcharge of ************* or more for the period
examined, in which case the Party who received such overpayment shall pay all
reasonable costs and expenses incurred by the auditing Party in the course of
making such determination, including the fees and expenses of the accountant.
4.6 Enforceability of Sections 4.1 and 4.2. The agreements regarding
funding commitments and capital contributions set forth in Sections 4.1 and 4.2
hereof are by and between, and for the benefit of, Genzyme and Dyax only, and
are not enforceable by Kallikrein LLC or any Third Party.
11
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
ARTICLE 5 THE DEVELOPMENT PROGRAM
5.1 Conduct of the Development Program.
5.1.1 General. The Parties each agree to collaborate diligently in
the development of Collaboration Products in the Field and to use commercially
reasonable and diligent efforts to develop, obtain Regulatory Approvals for and
bring to market Collaboration Products in the Field and in the Territory as soon
as practicable, all in accordance with the Development Plan and the
Commercialization Plan for such Collaboration Products. The Parties agree to
execute and substantially perform and to cooperate with each other in carrying
out the Development Plan and the Commercialization Plan for each Collaboration
Product. Neither Dyax nor Genzyme shall be required to undertake activities in
furtherance of the Development Plan or Commercialization Plan in the absence of
funding pursuant to the provisions of this Agreement. As used in this Agreement,
the term "commercially reasonable and diligent efforts" will mean that level of
effort which, consistent with the exercise of prudent scientific and business
judgment, is applied by the Party in question to its other therapeutic products
at a similar stage of development and with similar commercial potential.
5.1.2 Development Plan. Prior to the LLC Formation Date, the
Development Program shall be conducted by Dyax under a Development Plan which
shall describe the proposed overall program of development for each
Collaboration Product, including preclinical studies, toxicology, formulation,
clinical trials and regulatory plans and other key elements necessary to obtain
Regulatory Approvals for such Collaboration Product. Following the LLC Formation
Date, the Development Program shall be conducted by Genzyme and Dyax on behalf
of Kallikrein LLC under the Development Plan in effect as of such date. Pursuant
to the applicable Development Plan, development work may be subcontracted by
Dyax to Genzyme, or by Kallikrein LLC to Genzyme and Dyax, as applicable, at
fully absorbed costs determined by GAAP. The respective charges to Dyax or
Kallikrein LLC, as the case may be, shall be invoiced following completion of
the work, and shall be payable by Dyax or Kallikrein LLC, as applicable, within
a commercially reasonable time thereafter *************. The Development Plan
shall include a summary of estimated Development Costs expected during the
development process through obtaining such Regulatory Approvals and a detailed
description of and budget for all development activities proposed for each
calendar year for each Collaboration Product.
5.1.3 Initial and Updated Development Plan. The Parties have agreed
to a preliminary Development Plan and initial budget for the Program for the
period beginning on the Effective Date and ending on December 31, 1998. The
Program Management Team shall submit an updated Development Plan and budget for
the period beginning on the Effective Date and ending on December 31, 1999 to
the Steering Committee for approval no later than December 1, 1998. The
Development Plan shall be updated annually by the Program Management Team and
submitted to the Steering Committee for review and approval not later than sixty
(60) days prior to January 1 of each year during the Development Program. Each
such updated Development Plan shall include (a) an overall development plan for
each Collaboration Product which sets forth all major development tasks
remaining to be accomplished prior to submission of filings for Regulatory
Approvals and (b) a detailed description and budget for the development and
pre-commercialization activities proposed for the forthcoming calendar year. The
Project Management Team shall be primarily responsible for preparing the annual
updates to the Development Plan and, in connection with the preparation of such
updates, shall consult with
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Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Genzyme and Dyax regarding the identification, timing and execution of and
budget for the major tasks and detailed activities required to perform the
updated Development Plan. Each such updated Development Plan approved by the
Steering Committee shall be signed by an authorized representative of each of
Dyax and Genzyme. The members of the Program Management Team shall actively
consult with one another throughout the term of the Development Plan so as to
adjust the specific work performed under the Development Plan to conform to
evolving developments in technology and the results of the development work
performed. While minor adjustments to the Development Plan may be made from time
to time upon approval of the Program Management Team, significant changes in the
scope or direction of the work and any changes in funding exceeding
************* of the total amount budgeted in any calendar year for the
Development Program must be approved by the Steering Committee, in the absence
of which approval the most recently approved Development Plan shall remain in
effect.
5.1.4 Execution and Performance. The Development Program shall
allocate among the Parties responsibility for each of the activities described
therein. The Parties shall use commercially reasonable and diligent efforts to
conduct the activities described in the Development Plan. The Development Plan
shall be supervised by the Program Management Team. The Program Management Team
will coordinate preclinical and clinical testing of the Collaboration Products
and work with designated individuals at Dyax and Genzyme in the preparation of
Regulatory Approval filings for the Collaboration Products.
5.1.5 Attendance at Regulatory Meetings. Each Party shall provide
the others with prior notice of all meetings and teleconferences between
representatives of the notifying Party and regulatory authorities regarding any
Collaboration Product. Except as otherwise provided herein, the Party receiving
such notice shall have the right to have representatives participate in all such
meetings and teleconferences. Each Party shall keep a reasonably detailed record
of each contact between such Party and all regulatory authorities regarding any
Collaboration Product and deliver a copy of such record to the other Party
within three (3) business days of such contact.
5.2 Development Information.
5.2.1 Ownership of Pre-Clinical and Clinical Data. The Parties shall
jointly own all pre-clinical and clinical trial data generated as part of the
Program or otherwise funded or partially funded by the Parties. Upon the
formation of Kallikrein LLC, the Parties shall assign their respective interests
in such data to Kallikrein LLC and Kallikrein LLC shall thereafter own such
data.
5.2.2 Reports and Information Exchange. Each of Dyax and Genzyme
shall use commercially reasonable and diligent efforts to disclose to the other
Party and, if applicable, Kallikrein LLC, all material information relating to
any Collaboration Product promptly after it is learned or its materiality is
appreciated. The Party performing or supervising clinical trials of
Collaboration Products in accordance with the Development Plan shall, on behalf
and in the name of the owner of the clinical trial data accumulated from all
clinical trials of Collaboration Products, maintain the database of such data
and of adverse reaction information for all such Collaboration Products. Each
Party shall also keep the Program Management Team informed as to its progress in
the Development Plan. Within sixty (60) days following the end of each calendar
quarter during the Development Program, each of Dyax and Genzyme shall provide
the
13
other Parties with a reasonably detailed written report describing the progress
to date of all activities for which such Party was allocated responsibility
during such quarter under the Development Plan.
5.2.3 Adverse Reaction Reporting. Each of Dyax and Genzyme shall
notify the other Parties of any adverse reaction information relating to any
Collaboration Product within twenty-four (24) hours of the receipt of such
information and as necessary for compliance with regulatory requirements.
"Adverse reaction information" includes without limitation information relating
to any experience that (a) suggests a significant hazard, contraindication, side
effect or precaution, (b) is fatal or life threatening, (c) is permanently
disabling, (d) requires or prolongs inpatient hospitalization, (e) involves a
congenital anomaly, cancer or overdose or (f) is one not identified in nature,
specificity, severity or frequency in the current investigator brochure or the
United States labeling for the Collaboration Product.
5.2.4 Clinical and Regulatory Audits. Each of Dyax and Genzyme shall
permit Kallikrein LLC and the other Party, or the representatives of Kallikrein
LLC or the other Party, to have access during regular business hours and upon
reasonable advance notice, at the auditing Party's own expense and no more than
once in each calendar year during the term of this Agreement, to the
non-auditing Party's records and facilities relating to the Development Program
for the purpose of monitoring compliance with Good Clinical Practice and other
applicable requirements of the Regulatory Scheme.
5.3 Regulatory Approval Filings. Regulatory Approval filings in the
Territory for the Collaboration Products and for the facilities used to
manufacture such Collaboration Products shall be filed in the name of an entity
determined by the Steering Committee. The entity in whose name such Regulatory
Approval filings are filed shall give each of the Parties a right of reference
in such filings if such right is not prohibited under the applicable Regulatory
Scheme. Prior to submission to the FDA, the Parties, through the Program
Management Team, shall consult, cooperate in preparing and mutually agree on the
content and scope of the Regulatory Approval filings. In the event that
Regulatory Approvals are required to be filed in the name of an entity other
than Dyax, Genzyme or Kallikrein LLC, the Steering Committee shall ensure that a
duly authorized officer of such entity agrees in writing that (a) such entity
shall hold the licenses issued in respect of such Regulatory Approval filings,
maintain control over the manufacturing facilities, equipment and personnel, and
engage in pharmacovigilence to the extent required by the Regulatory Scheme, (b)
such entity shall maintain compliance with applicable Regulatory Schemes, (c)
such entity shall provide manufacturing and supply services at the Fully
Absorbed Cost of Goods of Collaboration Products so manufactured and supplied,
(d) the Parties shall have an irrevocable right of access and reference to such
Regulatory Approval filings, licenses and facilities and (e) such entity agrees
to comply with the provisions of Article 13 hereof with respect to the ownership
and/or disposition of such Regulatory Approvals in the event this Agreement is
terminated and to provide the level of cooperation described in Section 14.1
hereof in connection therewith.
5.4 Facilities Visits. Representatives of Dyax and Genzyme may visit all
manufacturing sites and the sites of any clinical trials or other experiments
being conducted by the other Party, Kallikrein LLC or a Third Party in
connection with the Development Program. If requested by the other Party, Dyax
and Genzyme shall cause appropriate individuals working on the Development
Program to be available for meetings at the location of the facilities where
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Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
such individuals are employed at times reasonably convenient to the Party
responding to such request.
ARTICLE 6 SALES, MARKETING AND ADMINISTRATIVE SERVICES
6.1 Commercialization Plans.
6.1.1 General. The commercialization of each Collaboration Product
shall be governed by a Commercialization Plan which shall describe the overall
plan for commercializing such Collaboration Product, including without
limitation (a) a comprehensive marketing, sales, pricing, manufacturing,
distribution and licensing strategy for such Collaboration Product in all
applicable countries, including the identification of any Third Parties engaged
or to be engaged in connection with such activities and the arrangements with
them that have been or are proposed to be agreed upon (including policies and
procedures for adjustments, rebates, bundling and the like), (b) estimated
launch date, market and sales forecasts, in numbers of patients and local
currency, and competitive analysis for such Collaboration Product, (c) a
detailed budget for the Commercialization Costs to be incurred in connection
with performing such Commercialization Plan, (d) reasonable due diligence
obligations to be met by Genzyme with respect to commercialization objectives to
be achieved during the calendar year to which the Commercialization Plan relates
(such as minimum annual sales objectives) and (e) a detailed manufacturing plan.
6.1.2 Initial and Updated Commercialization Plans. No later than
immediately prior to the completion of the submission of all Regulatory Approval
filings for a Collaboration Product in any given country, Genzyme shall develop
and submit to the Steering Committee for review and approval an initial
Commercialization Plan in accordance with its customary standard for a product
of comparable market potential, taking into consideration factors such as market
conditions, regulatory factors, competition and the costs and profits of such
Collaboration Product. Genzyme shall be primarily responsible for developing
each Commercialization Plan and, in connection therewith, shall consult with
Dyax regarding the identification, timing and execution of and budget for the
major commercialization tasks required to perform the Commercialization Plan.
Each Commercialization Plan shall be updated annually by Genzyme, in
consultation with Dyax below as herein provided, and shall be submitted to the
Steering Committee for approval not later than sixty (60) days prior to January
1 of each year. Each Commercialization Plan approved by the Steering Committee
shall be signed by an authorized representative of each of Dyax and Genzyme.
While minor adjustments to the Commercialization Plan may be made from time to
time without Steering Committee approval, significant changes in the scope or
direction of the work and any changes in funding exceeding ************* of the
total amount budgeted in any calendar year for the Commercialization Plan must
be approved by the Steering Committee, and in the absence of such approval, the
provisions of the most recently approved Commercialization Plan shall remain in
effect. Within sixty (60) days following the end of each calendar quarter after
the filing of the first application for a Regulatory Approval (other than an
application for "orphan drug" designation of a Collaboration Product), each of
Dyax and Genzyme shall provide the other Parties with a reasonably detailed
written report describing the progress to date of all activities for which such
Party was allocated responsibility during such quarter under the
Commercialization Plan, including, if reasonably available, sales information
for each Collaboration Product on a country-by-country basis.
15
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
6.2 Exclusive Engagement. Kallikrein LLC will engage Genzyme on an
exclusive basis to market and sell Collaboration Products within the Territory
for use within the Field. Genzyme will (by itself or through its Affiliates) use
commercially reasonable and diligent efforts to establish each Collaboration
Product in the markets, fulfill market demand and meet the marketing and
distribution goals set forth in the Commercialization Plan for such
Collaboration Product.
6.3 Orders. Genzyme shall provide written notice to Kallikrein LLC of its
requirements for the Collaboration Products, setting forth the quantity of
Collaboration Products required, any specifications therefor and the date
required. Kallikrein LLC, on the date set forth in the applicable requirements
notice, shall deliver the Collaboration Products to Genzyme for sale within the
Territory. All freight, insurance, duties and all other charges associated with
shipment of the Collaboration Products shall be considered Commercialization
Costs for such Collaboration Products only to the extent such costs are not
charged to Genzyme's customers.
6.4 Marketing and Distribution Expenses. Genzyme's ordinary expenses
incurred in the course of performing its marketing and distribution obligations
hereunder shall constitute Commercialization Costs budgeted as part of the
then-effective Commercialization Plan and, as such, shall be reimbursed by Dyax
prior to the satisfaction by Dyax of the Initial Funding Commitment and by
Kallikrein LLC after the satisfaction by Dyax of the Initial Funding Commitment,
but only to the extent that such amounts, together with all other
Commercialization Costs to date during such calendar year, do not exceed
************* of the Commercialization Costs budgeted in the Commercialization
Plan then in effect for such calendar year (except to the extent such excess is
approved by the Steering Committee pursuant to Section 6.1.2 above). Ordinary
marketing and distribution expenses include, but are not limited to, recruitment
costs and salaries and associated expenses for sales and marketing personnel and
support staff, advertising and promotion costs, transportation expenses
including insurance (but only to the extent not charged to customers and only
such proportion of all such costs directly attributable to support of the
Commercialization Plan), duties and taxes, bad debt expense, and costs
associated with cash and other trade discounts and allowances and other
marketing concessions to customers actually allowed and taken.
6.5 Responsibilities of Genzyme. Genzyme shall be solely responsible for
all aspects of the marketing of the Collaboration Products in accordance with
the strategy, policies and procedures established in the Commercialization Plan,
including without limitation the responsibilities described in this Section 6.5.
(a) Genzyme shall be primarily responsible for the
implementation of each Commercialization Plan, including without limitation
setting all terms of sale, including establishing pricing policies, credit terms
and cash discounts and allowances, formulating marketing plans, negotiating
agreements with Third Party distributors (if any), providing patient
information, providing customer support services, providing reimbursement
counseling services and sales force training.
(b) Genzyme shall employ sufficiently trained and experienced
individuals in numbers adequate to carry out its responsibilities under this
Article 6. Sales and support personnel shall be familiar with the Collaboration
Products and with competitive products and shall respond promptly to customer
requests for support.
16
(c) Genzyme shall provide instructions and appropriate
training to customers in the proper use and handling of the Collaboration
Products and shall monitor performance of the Collaboration Products.
(d) Genzyme shall have sole responsibility for responding to
all requests for medical information regarding Collaboration Products.
(e) Genzyme shall comply with all laws and government
regulations applicable to the sale of Collaboration Products within the
Territory.
(f) The Collaboration Products shall be sold under trademarks
selected by the Steering Committee and owned by or licensed to Kallikrein LLC in
accordance with Section 9.1.2 hereof.
(g) Genzyme shall maintain complete and accurate records of
all movements and transactions involving Collaboration Products by an
appropriate identifier and by customer so that all such movements and
transactions can be traced quickly and effectively. Upon written request,
Genzyme will provide copies of such records to the other Parties, with access to
facilities used by Genzyme in performing its duties under this Article 6 during
normal business hours and upon reasonable advance notice for the purpose of
inspecting such facilities for compliance with the terms of this Agreement. The
records maintained by Genzyme pursuant to this clause (g) shall be subject to
the other Parties' audit rights under Section 4.5 hereof.
(h) Genzyme shall report to the Steering Committee in writing
the occurrence of each material incident of Collaboration Product performance
required to be reported to regulatory authorities, including without limitation
adverse reaction information in accordance with Section 5.2.3 hereof, within
three (3) business days of the happening of such occurrence.
6.6 Responsibilities of Kallikrein LLC and Dyax. Kallikrein LLC shall
supply Collaboration Products to Genzyme in accordance with notices of
requirements pursuant to Section 6.3 above. Neither Kallikrein LLC nor Dyax
shall actively solicit for its own account sales of Collaboration Products in
the Territory. Any solicitations or requests to purchase Collaboration Products
received by Kallikrein LLC or Dyax from any customer or prospective customer
with its principal address or place of business located in the Territory or who
Kallikrein LLC or Dyax, as the case may be, knows intends to use the
Collaboration Products in the Territory or ship such Collaboration Products into
the Territory shall be immediately referred to Genzyme.
6.7 General and Administrative Services. General and administrative
services required by Kallikrein LLC shall be provided at cost by either or both
of Dyax and Genzyme as determined by the Steering Committee. All such costs, in
addition to general and administrative costs payable to Third Parties (such as
accountants) and general and administrative costs incurred by Dyax and Genzyme
in satisfying their respective obligations under this Agreement, shall be
considered to be Program Costs.
17
ARTICLE 7 MANUFACTURE AND SUPPLY
Subject to the terms and conditions of this Agreement, Collaboration
Products shall be manufactured and supplied for preclinical and clinical testing
and for commercial sale upon the following terms and conditions:
7.1 Process Development. The Parties will use commercially reasonable and
diligent efforts to develop a process for the manufacture of each Collaboration
Product and to scale up that process to a scale sufficient to manufacture and
supply (a) the anticipated demand for preclinical studies and clinical trials of
such Collaboration Product in accordance with the projections set forth in the
Development Plan and (b) the anticipated market demand for such Collaboration
Product at the time Regulatory Approval is obtained for such Collaboration
Product in accordance with the projections set forth in the Commercialization
Plan for such Collaboration Product. The development of the process for the
manufacture of Collaboration Products as well as the scale up of such process
and all material issues incident to the development of the ability to produce
Collaboration Products for commercial purposes in sufficient quantity and in a
timely manner will be within the purview of the Program Management Team. The
Parties will use commercially reasonable and diligent efforts, and will cause
any approved Third Party supplier, to make filings necessary to obtain approval
of any license application for a manufacturing facility which may be required as
part of any Regulatory Approval for the first Collaboration Product.
7.2 Manufacture and Supply of Collaboration Products for Clinical Trials.
Dyax will use commercially reasonable and diligent efforts to manufacture and
supply, or to have manufactured and supplied, Collaboration Products for
preclinical studies and clinical trials in quantities and within a time period
sufficient to conduct the activities set forth in the Development Plan. The
Fully Absorbed Cost of Goods for such Collaboration Products shall be deemed
Development Costs and reimbursed in accordance with the terms of this Agreement.
7.3 Manufacture and Supply of Collaboration Products for Commercial Sale.
Kallikrein LLC shall, as determined by the Steering Committee, designate one of
the Parties (the "Manufacturing Party") to manufacture and supply Collaboration
Products (or cause Collaboration Products to be manufactured or supplied) for
commercial sale pursuant to a supply agreement entered into by Kallikrein LLC
and the Manufacturing Party (a "Supply Agreement"). The terms of each Supply
Agreement shall include, without limitation, the terms and conditions set forth
below.
7.3.1 General. Kallikrein LLC shall use commercially reasonable and
diligent efforts to manufacture and supply Collaboration Products to meet market
demand for Collaboration Products ordered in accordance with the terms hereof.
The Manufacturing Party shall be entitled to charge Kallikrein LLC an amount
equal to its Fully Absorbed Cost of Goods for such Collaboration Products. The
costs of any failed or discarded lots shall be borne by the Manufacturing Party
and shall not be considered Program Costs. The Manufacturing Party may
subcontract with Genzyme, Dyax or Third Parties for the manufacture or packaging
of Collaboration Products, as determined by the Steering Committee.
Notwithstanding the foregoing provisions of this Section 7.3.1, to the extent
required by the Regulatory Scheme, any entity selected by the Steering Committee
pursuant to Section 5.3 above may be engaged by Kallikrein LLC to manufacture
Collaboration Products. The respective charges to Kallikrein
18
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
LLC shall be invoiced following completion of the work, and shall be payable by
Kallikrein LLC within a commercially reasonable time thereafter *************.
7.3.2 Forecasts. The Program Management Team shall establish a
procedure for providing forecasts of customer orders for Collaboration Products
pursuant to Section 6.3 above, updating such forecasts and ordering
Collaboration Product, in each case within time periods sufficient to enable
Kallikrein LLC to manufacture such Collaboration Products to meet such forecasts
in a commercially reasonable and diligent manner.
7.4 Certificates of Analysis. The Manufacturing Party selected pursuant to
Section 7.3 above shall perform, or cause its contract manufacturer(s) to
perform, quality assurance and control tests on each lot of Collaboration
Products before delivery and shall prepare, or cause its contract
manufacturer(s) to prepare and deliver, a written report of the results of such
tests (for purposes of Sections 7.4, 7.5 and 7.6, such contract manufacturer(s)
shall be included in the definition of the term "Manufacturing Party"). Each
test report shall set forth for each lot delivered the items tested,
specifications and results in a certificate of analysis containing the types of
information which shall have been approved by the Program Management Team or
required by the FDA or other applicable regulatory authority. The Manufacturing
Party shall maintain such certificates for a period of not less than five (5)
years from the date of manufacture and for so long as required under applicable
requirements of the FDA or other applicable regulatory authority.
7.5 Certificates of Manufacturing Compliance. The Manufacturing Party
shall prepare, or cause its contract manufacturer(s) to prepare and deliver, and
maintain for a period of not less than five (5) years and for so long as
required under applicable requirements of the FDA or other applicable regulatory
authority for each lot of Collaboration Products manufactured a certificate of
manufacturing compliance containing the types of information which shall have
been approved by the Program Management Team or required by the FDA or other
applicable regulatory authority, which certificate will certify that the lot of
Collaboration Products was manufactured in accordance with the Specifications
and the Good Manufacturing Practices of the FDA or other applicable regulatory
authority as the same may be amended from time to time. The Manufacturing Party
shall advise the other Parties immediately if an authorized agent of the FDA or
other regulatory authority visits any of the Manufacturing Party's manufacturing
facilities, or the facilities where the Collaboration Products are being
manufactured, for an inspection with respect to the Collaboration Products. The
Manufacturing Party shall furnish to the other Parties the report by such agency
of such visit, to the extent that such report relates to Collaboration Products,
within ten (10) business days of the Manufacturing Party's receipt of such
report, and the other Parties shall have the right to comment on any response by
the Manufacturing Party to such inspecting agency.
7.6 Access to Facilities. Each Party shall have the right to inspect those
portions of the manufacturing, finish processing or storage facilities and
testing labs of the Manufacturing Party where Collaboration Products are being
manufactured, finished, stored or tested, or any subcontractor who is
manufacturing, finishing, storing or testing Collaboration Products for the
Manufacturing Party, at any time during regular business hours and upon
reasonable advance notice to ascertain compliance with the Good Manufacturing
Practices of the FDA or other applicable regulatory authority, as the same may
be amended from time to time. Any confidential information disclosed to or
otherwise gathered by the Party conducting such
19
inspection during any such inspection shall be deemed "Information" as defined
in Section 10.1 below.
ARTICLE 8 MANAGEMENT
8.1 Program Management Team.
8.1.1 General. The Parties have established a Program Management
Team to oversee and control development of Collaboration Products and to prepare
for and oversee the launch of Collaboration Products. The Program Management
Team shall be composed of not more than three (3) representatives appointed by
Dyax and three (3) representatives appointed by Genzyme. Such representatives
will include individuals with expertise and responsibilities in such areas as
preclinical development, clinical development, manufacturing, regulatory
affairs, marketing, sales management and reimbursement. The Program Management
Team shall meet as needed, but not less than monthly unless the Parties mutually
agree otherwise. The Program Management Team shall appoint one of its members to
act as Secretary. Such meetings shall be at times and places or in such form
(e.g., telephone or video conference) as the members of the Program Management
Team shall agree. A Party may change one or more of its representatives to the
Program Management Team at any time. Members of the Program Management Team may
be represented at any meeting by another member of the Program Management Team
or by a deputy. Any approval, determination or other action agreed to by a
majority of the members of the Program Management Team appointed by each of Dyax
and Genzyme or their deputies present at the relevant Team meeting shall be the
approval, determination or other action of the Program Management Team, provided
at least two (2) representatives of each of Dyax and Genzyme are present at such
meeting. Representatives of either Dyax and Genzyme who are not members of the
Program Management Team may attend meetings of the Program Management Team as
agreed to by the representative members of the other Party. The Program
Management Team may designate project leaders to the extent it deems it
necessary or advisable.
8.1.2 Development Program Functions. During the term of the
Development Program, the Program Management Team shall coordinate, expedite and
control the development of Collaboration Products to obtain Regulatory
Approvals. The Program Management Team will (a) develop and recommend to the
Steering Committee Development Plans (including annual development budgets), (b)
facilitate the flow of information with respect to development work being
conducted for each Collaboration Product throughout the Territory and (c)
discuss and cooperate regarding the conduct of such development work.
8.1.3 Commercialization Functions. Following submission of filings
for Regulatory Approvals for the first Collaboration Product, the functions of
the Program Management Team shall be expanded to include: (a) monitoring the
commercialization of Collaboration Products pursuant to the Commercialization
Plan, including oversight of planning, annual budgeting, manufacturing,
marketing, sales and distribution, and licensing of Collaboration Products; (b)
monitoring actual expenses incurred in the manufacture, marketing, sale and
distribution of Collaboration Products; (c) overseeing any post-marketing
studies of a Collaboration Product and (d) facilitating cooperation regarding
the commercialization and marketing activities of the Parties. In addition,
following the formation of Kallikrein LLC, the Program Management Team shall
function as the operational staff of Kallikrein LLC.
20
8.1.4 Minutes. The Program Management Team shall keep accurate
minutes of its deliberations which shall record all proposed decisions and all
actions recommended or taken. The Secretary shall be responsible for the
preparation of draft minutes. Draft minutes shall be sent to all members of the
Program Management Team within five (5) working days after each meeting and
shall be approved, if appropriate, at the next meeting. All records of the
Program Management Team shall at all times be available to all of the Parties.
8.2 Steering Committee.
8.2.1 General. The Parties have established a Steering Committee to
oversee and manage the collaboration contemplated by this Agreement. The
Steering Committee is and shall continue to be composed of three (3)
representatives appointed by Dyax and three (3) representatives appointed by
Genzyme. Such representatives will be senior officers and/or managers of their
respective companies. Genzyme and Dyax shall each designate one (1) of their
respective representatives on the Steering Committee to act as Co-Chairman. The
Steering Committee shall appoint one (1) of its members to act as Secretary. The
Steering Committee will meet as needed but not less than once each calendar
quarter. Such meetings shall be at times and places or in such form (e.g.,
telephone or video conference) as the members of the Steering Committee shall
agree. A Party may change one or more of its representatives to the Steering
Committee at any time. Members of the Steering Committee may be represented at
any meeting by another member of the Steering Committee or by a deputy. Any
approval, determination or other action agreed to by unanimous consent of the
members of the Steering Committee or their deputies present at the relevant
Steering Committee meeting shall be the approval, determination or other action
of the Steering Committee, provided at least two (2) representatives of each of
Dyax and Genzyme are present at such meeting. Representatives of either Dyax and
Genzyme who are not members of the Steering Committee may attend meetings of the
Steering Committee as agreed to by the representative members of the other
Party.
8.2.2 Functions. The Steering Committee shall perform the following
functions: (a) determine the overall strategy for the Program in the manner
contemplated by this Agreement; (b) coordinate the activities of the Parties
hereunder; (c) settle disputes or disagreements that are unresolved by the
Program Management Team; (d) approve any agreements with Third Parties regarding
a Collaboration Product or which involve the grant of any rights related to the
development, manufacture or marketing of a Collaboration Product; (e) review and
approve each Development Plan, including each significant change and annual
update thereto, submitted to it pursuant to Section 5.1.3 hereof; (f) review and
approve each Commercialization Plan, including each significant change and
annual update thereto, submitted to it for approval pursuant to Section 6.1.2
hereof; (g) following the formation of Kallikrein LLC, serve as the governing
body of Kallikrein LLC; and (h) perform such other functions as appropriate to
further the purposes of this Agreement as determined by the Parties.
8.2.3 Minutes. The Steering Committee shall keep accurate minutes of
its deliberations which shall record all proposed decisions and all actions
recommended or taken. The Secretary shall be responsible for the preparation of
draft minutes. Draft minutes shall be sent to all members of the Steering
Committee within ten (10) working days after each meeting and shall be approved,
if appropriate, at the next meeting. All records of the Steering Committee shall
at all times be available to both Dyax and Genzyme.
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Exchange Commission. Asterisks denote such omissions.
8.3 General Disagreements. All disagreements within the Program Management
Team and the Steering Committee shall be subject to the following:
(a) The representatives to the Program Management Team or
Steering Committee will negotiate in good faith for a period of not less than
thirty (30) days to attempt to resolve the dispute. In the case of the Program
Management Team, any unresolved dispute shall be referred to the Steering
Committee for good faith negotiations for an additional period of not less than
thirty (30) days to attempt to resolve the dispute.
(b) In the event that the dispute is not resolved after the
period specified in clause (a), the representatives shall promptly present the
disagreement to the Chief Executive Officers of Dyax and Genzyme or a designee
of such Chief Executive Officer reasonably acceptable to the other Party.
(c) Such executives shall meet or discuss in a telephone or
video conference each of Dyax and Genzyme's views and explain the basis for such
dispute.
(d) If such executives cannot resolve such disagreement within
sixty (60) days after such issue has been referred to them, then such dispute
shall be referred to arbitration as described in Section 14.10 hereof.
ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS
9.1 Ownership. The Parties acknowledge that the ownership rights set forth
herein (a) shall not be affected by the participation in the discovery or
development of an Invention (as defined below) by the Program Management Team or
the Steering Committee in the course of discharging their duties hereunder and
(b) are subject to the license grants set forth in Article 3 above.
9.1.1 Ownership and Assignment of Discoveries and Improvements. All
right, title and interest in all writings, inventions, discoveries, improvements
and other technology, whether or not patentable or copyrightable, and any patent
applications, patents or copyrights based thereon (collectively, the
"Inventions") that are discovered, made or conceived during and in connection
with the Program solely by employees of Dyax or others acting on behalf of Dyax
("Dyax Inventions") shall be owned by Dyax. All right, title and interest in all
Inventions that are discovered, made or conceived during and in connection with
the Program solely by employees of Genzyme or others acting on behalf of Genzyme
("Genzyme Inventions") shall be owned by Genzyme. All right, title and interest
in all Inventions that are discovered, made or conceived during and in
connection with the Program jointly by employees of Dyax and Genzyme ("Joint
Inventions") *************. Each of Dyax and Genzyme shall promptly disclose to
Kallikrein LLC and the other Party the making, conception or reduction to
practice of Inventions by employees or others acting on behalf of such Party.
All Dyax Inventions, Genzyme Inventions and Joint Inventions shall be
automatically licensed to Kallikrein LLC in accordance with the provisions of
Section 3.1 hereof.
9.1.2 Ownership of Trademarks. The Steering Committee shall select
and Kallikrein LLC shall own all trademarks for the sale and use of
Collaboration Products in the Territory, and all expenses thereof shall be
considered Program Costs. All such trademarks shall
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Exchange Commission. Asterisks denote such omissions.
be registered in the name of Kallikrein LLC if and when registered. In the event
that the applicable laws and regulations of any country in which the Steering
Committee elects to register any such trademark require that such trademark be
registered in the name of an entity other than Kallikrein LLC, or if the
Steering Committee determines that it is in the best interests of the parties,
then the Steering Committee shall select such entity and ensure that a duly
authorized officer of such entity agrees in writing that such entity shall (a)
grant Kallikrein LLC a worldwide, exclusive, fully-paid, royalty-free,
irrevocable (during the term of this Agreement) right and license (with the
right to grant sublicenses) to use such trademark and (b) comply with the
provisions of Article 13 hereof with respect to the ownership and/or disposition
of such trademark in the event this Agreement is terminated and provide the
level of cooperation described in Section 14.1 hereof in connection therewith.
9.1.3 Cooperation of Employees. Each of Dyax and Genzyme represents
and agrees that all employees or others acting on its behalf in performing its
obligations under this Agreement shall be obligated under a binding written
agreement to assign to such Party, or as such Party shall direct, all Inventions
made or conceived by such employee or other person. In the case of non-employees
working for other companies or institutions on behalf of Dyax or Genzyme, Dyax
or Genzyme, as applicable, shall have the right to obtain licenses for all
Inventions made by such non-employees on behalf of Dyax or Genzyme, as
applicable, in accordance with the policies of said company or institution. Dyax
and Genzyme agree to undertake to enforce such agreements (including, where
appropriate, by legal action) considering, among other things, the commercial
value of such Inventions.
9.2 Filing, Prosecution and Maintenance of Patent Rights.
9.2.1 Filing, Prosecution and Maintenance. Each of Dyax and Genzyme
shall be responsible for the filing, prosecution and maintenance of all patent
applications and patents which make up its Patent Rights. *************. For so
long as any of the license grants set forth in Article 3 hereof remain in effect
and upon request of the other Party, each of Dyax and Genzyme agrees to file and
prosecute patent applications and maintain the patents covering the Patent
Rights for which it is responsible in all countries in the Territory selected by
the Steering Committee. Each of Dyax and Genzyme shall consult with and keep the
other fully informed of important issues relating to the preparation and filing
(if time permits), prosecution and maintenance of such patent applications and
patents, and shall furnish to the other Party copies of documents relevant to
such preparation, filing, prosecution or maintenance in sufficient time prior to
filing such document or making any payment due thereunder to allow for review
and comment by the other Party and, to the extent possible in the reasonable
exercise of its discretion, the filing Party shall incorporate all such
comments.
9.2.2 Patent Filing Costs. All costs associated with filing,
prosecuting and maintaining patent applications and patents covering each of
Dyax and Genzyme's Patent Rights and the Joint Patent Rights specific to the
Field in the Territory (including costs relating to patent oppositions,
interferences, reexaminations and reissues) shall be deemed Development Costs;
provided, however, that if the subject matter of any such Patent Rights would
include claims outside the Field, one-half (1/2) of such costs shall be deemed
Development Costs.
9.3 Cooperation. Each of Dyax and Genzyme shall make available to the
other Party (or to the other Party's authorized attorneys, agents or
representatives) its employees, agents or
23
consultants to the extent necessary or appropriate to enable the appropriate
Party to file, prosecute and maintain patent applications and resulting patents
with respect to inventions owned by a Party and for periods of time sufficient
for such Party to obtain the assistance it needs from such personnel. Where
appropriate, each of Dyax and Genzyme shall sign or cause to have signed all
documents relating to said patent applications or patents at no charge to the
other Party.
9.4 Notification of Patent Term Restoration. Each of Dyax and Genzyme
shall notify the other Party of (a) the issuance of each United States patent
included within the Patent Rights for which the notifying Party is responsible,
giving the date of issue and patent number for each such patent, and (b) each
notice pertaining to any patent included within the Patent Rights for which the
notifying Party is responsible which it receives as patent owner pursuant to the
Drug Price Competition and Patent Term Restoration Act of 1984, including
notices pursuant to ss.ss.101 and 103 of such Act from persons who have filed an
abbreviated NDA. Such notices shall be given promptly, but in any event within
ten (10) business days after receipt of each such notice pursuant to such Act.
Each of Dyax and Genzyme shall notify the other Party of each filing for patent
term restoration under such Act, any allegations of failure to show due
diligence and all awards of patent term restoration (extensions) with respect to
the Patent Rights for which the notifying Party is responsible.
9.5 No Other Technology Rights. Except as otherwise expressly provided in
this Agreement, under no circumstances shall a Party hereto, as a result of this
Agreement, obtain any ownership interest in or other right to the Patent Rights,
Technology or Manufacturing Know-How of the other Party, including items owned,
controlled or developed by the other Party, or transferred by the other Party to
said Party at any time pursuant to this Agreement. It is understood and agreed
that this Agreement does not grant either Party any license or other right in
the Patent Rights of the other Party for uses other than as specified in Article
3 hereof and this Article 9.
9.6 Enforcement of Patent Rights; Defense of Infringement Actions. Dyax
and Genzyme shall each promptly notify the other in writing of any alleged or
threatened infringement of any patents or patent applications for which it is
responsible pursuant to Section 9.2 above or if either Party, or any of their
respective Affiliates, shall be individually named as a defendant in a legal
proceeding by a Third Party for infringement of a patent because of the
manufacture, use or sale of a Collaboration Product or because of attempts to
invalidate Patent Rights.
9.6.1 First Right to Respond. Each of Dyax and Genzyme shall have
the first right to respond to or defend (in consultation with the Steering
Committee) against such challenge or infringement of the Patent Rights for which
it is responsible pursuant to Section 9.2 above or charge of infringement. Such
right shall be exercised in a diligent and timely manner in order to protect the
rights of the Parties in the Patent Rights. In the event such Party elects to so
respond or defend, the other Party will cooperate with the responding Party's
legal counsel, join in such suits as may be brought by the responding Party to
enforce its Patent Rights, and be available at the responding Party's reasonable
request to be an expert witness or otherwise to assist in such proceedings.
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Exchange Commission. Asterisks denote such omissions.
9.6.2 Sharing of Litigation and Settlement Expenses. The costs
incurred (a) in responding to or defending against a challenge to or
infringement of a Party's Patent Rights specific to the Field or a charge that
the manufacture, use or sale of Collaboration Products infringe upon the Patent
Rights of Third Parties, (b) in settling any such actions, which may not be done
without the prior written consent of the Steering Committee, which consent shall
not be unreasonably withheld or delayed, and (c) as damages paid as a result of
such actions shall be deemed Program Costs.
9.6.3 Second Right to Respond. If a Party does not exercise its
right to respond to or defend against challenges or infringements of its Patent
Rights as provided in Section 9.6.1 above within thirty (30) days of becoming
aware of or being notified of such challenges or infringements, then the other
Party shall have the option to do so at its sole cost; provided that in such
case all amounts so recovered from such Third Party shall be retained by the
Party undertaking such response or defense and the Party so responding shall
have no further obligations to the other Party with respect to the response or
defense thereof.
ARTICLE 10 CONFIDENTIALITY
10.1 Nondisclosure Obligations. Except as otherwise provided in this
Article 10, during the term of this Agreement and for a period of *************
thereafter, the Parties shall, and Dyax shall cause Subsidiary to, maintain in
confidence and use only for purposes specifically authorized under this
Agreement (a) confidential information and data resulting from or related to the
development, commercialization or marketing of Collaboration Products and (b)
all information and data not described in clause (a) but supplied by one Party
to the other under this Agreement or in the course of the Parties' due diligence
investigations prior to the execution of this Agreement and marked or identified
as "Confidential."
For purposes of this Article 10, information and data described in clause
(a) or (b) of the preceding paragraph shall be referred to as "Information." To
the extent it is reasonably necessary or appropriate to fulfill its obligations
or exercise its rights under this Agreement, a Party may disclose Information it
is otherwise obligated under this Section not to disclose to its Affiliates,
sublicensees, employees, consultants, outside contractors and clinical
investigators, on a need-to-know basis and on the condition that such entities
or persons agree to keep the Information confidential for the same time periods
and to substantially the same extent as such Party is required to keep the
Information confidential; and a Party or its sublicensees may disclose such
Information to government or other regulatory authorities to the extent that
such disclosure is reasonably necessary to obtain patents or authorizations to
conduct clinical trials with and to market commercially Collaboration Products.
The obligation not to disclose Information shall not apply to any part of such
Information that: (i) is or becomes patented, published or otherwise becomes
publicly known other than by acts of the Party obligated not to disclose such
Information or its Affiliates or sublicensees in contravention of this
Agreement; (ii) can be shown by written documents to have been disclosed to the
receiving Party or its Affiliates or sublicensees by a Third Party, provided
that such Information was not obtained by such Third Party directly or
indirectly from the other Party under this Agreement; (iii) prior to disclosure
under this Agreement, was already in the possession of the receiving Party or
its Affiliates or sublicensees, provided that such Information was not obtained
directly or indirectly from the other Party under this Agreement; (iv) can be
shown by written documents to have been independently developed by the receiving
Party or its Affiliates without use of the other Party's
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Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Information or breach of any of the provisions of this Agreement; or (v) is
disclosed by the receiving Party pursuant to a subpoena lawfully issued by a
court or governmental agency, provided that the receiving Party notifies the
other Party immediately upon receipt of any such subpoena.
10.2 Terms of this Agreement; Press Releases. The Parties agree to seek
confidential treatment for any filing of this Agreement with the Securities and
Exchange Commission and shall agree upon the content of the request for
confidential treatment made by each Party in respect of such filing. Except as
permitted by the foregoing provisions or as otherwise required by law, Dyax and
Genzyme each agree not to disclose any terms or conditions of this Agreement to
any Third Party without the prior consent of the other Party. The Parties agree
that all press releases related to the Program shall be issued jointly by Dyax
and Genzyme and that the Party preparing any such press release shall provide
the other Party with a draft thereof reasonably in advance of disclosure so as
to permit the other Party to review and comment on such press release.
10.3 Publications. Each Party recognizes the mutual interest in obtaining
valid patent protection. Consequently, any Party, its employees or consultants
wishing to make a publication (including any oral disclosure made without
obligation of confidentiality) relating to work performed by such Party as part
of the Program (the "Publishing Party") shall transmit to a representative of
the other Party (the "Reviewing Party") on the Program Management Team a copy of
the proposed written publication at least thirty (30) days prior to submission
for publication, or an abstract of such oral disclosure at least ten (10) days
prior to submission of the abstract or the oral disclosure, whichever is
earlier. The Reviewing Party shall have the right to (a) request a delay in
publication or presentation in order to protect patentable information, (b)
propose modifications to the publication for patent reasons or (c) request that
the information be maintained as a trade secret.
If the Reviewing Party requests a delay as described in clause (a) above,
the Publishing Party shall delay submission or presentation of the publication
for a period ************* to enable patent applications protecting each Party's
rights in such information to be filed. Upon the expiration of thirty (30) days,
in the case of proposed written disclosures, or ten (10) days, in the case of an
abstract of proposed oral disclosures, from transmission of such proposed
disclosures to the Reviewing Party, the Publishing Party shall be free to
proceed with the written publication or the oral presentation, respectively,
unless the Reviewing Party has requested the delay described above.
To the extent possible in the reasonable exercise of its discretion, the
Publishing Party shall incorporate all modifications proposed under clause (b)
above. If a trade secret that is the subject of a request made under clause (c)
above cannot be otherwise protected without unreasonable expense to the
Reviewing Party, such information shall be omitted from the publication.
ARTICLE 11 REPRESENTATIONS AND WARRANTIES
11.1 Authorization. Each Party warrants and represents to the other
Parties that (a) it has the legal right and power to enter into this Agreement,
to extend the rights and licenses granted to the other in this Agreement, and to
perform fully its obligations hereunder, (b) this
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Exchange Commission. Asterisks denote such omissions.
Agreement has been duly executed and delivered and is a valid and binding
agreement of such Party, enforceable in accordance with its terms, (c) such
Party has obtained all necessary approvals to the transactions contemplated
hereby and (d) such Party has not made and will not make any commitments to
others in conflict with or in derogation of such rights or this Agreement.
11.2 Intellectual Property Rights. On the LLC Formation Date, and prior to
granting the licenses set forth in Article 3 hereof, the Parties will represent
and warrant to each other as follows:
11.2.1 Dyax will represent and warrant that, as of the LLC Formation
Date, ************* it has the right to (i) enter into the obligations set forth
in this Agreement and (ii) grant the rights and licenses set forth in Article 3
hereof.
11.2.2 Genzyme will represent and warrant that, as of the LLC
Formation Date, (a) the Genzyme Patent Rights and the Genzyme Technology are
free and clear of any lien or other encumbrance and (b) it has the right to (i)
enter into the obligations set forth in this Agreement and (ii) grant the rights
and licenses set forth in Article 3 hereof.
11.3 Warranties.
11.3.1 Genzyme Warranties. Genzyme warrants that (i) any
Collaboration Products delivered by Genzyme pursuant to Section 7.3 hereof, if
any, will conform in all material respects to the Specifications, the conditions
of any applicable Regulatory Approvals regarding the manufacturing process and
any applicable requirements of the Regulatory Scheme regarding the manufacturing
process and (ii) the Collaboration Products sold pursuant to Section 6.2 hereof
will be marketed and sold in all material respects in accordance with the
conditions of all applicable laws and regulations, including any applicable
Regulatory Approvals and any applicable labeling claims.
11.3.2 Dyax Warranties. Dyax warrants that any Collaboration
Products delivered by Dyax pursuant to Sections 7.2 or 7.3 hereof will conform
in all material respects to the Specifications, the conditions of any applicable
Regulatory Approvals regarding the manufacturing process and any applicable
requirements of the Regulatory Scheme regarding the manufacturing process.
11.4 Disclaimer of Representations and Warranties. EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT, NONE OF DYAX, GENZYME OR KALLIKREIN LLC
MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, AND THE NON-INFRINGEMENT OF ANY THIRD-PARTY PATENTS OR
PROPRIETARY RIGHTS. ALL UNIFORM COMMERCIAL CODE WARRANTIES ARE EXPRESSLY
DISCLAIMED BY THE PARTIES.
11.5 Limitation of Liability. It is agreed by the Parties that no Party
shall have a right to or shall claim special, indirect or consequential damages,
including lost profits, for breach of this Agreement. Remedies shall be limited
to claims for amounts due hereunder or as otherwise
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Exchange Commission. Asterisks denote such omissions.
provided in this Agreement, including claims for indemnification as provided in
Section 12.1 hereof.
ARTICLE 12 INDEMNITY
12.1 Indemnity Obligations Prior to the LLC Formation Date. Each Party
(the "Indemnifying Party") shall defend, indemnify and hold harmless the other
Party (the "Indemnified Party") and its directors, officers, employees and
agents from and against any and all claims, liabilities, losses and expenses,
including attorney's fees, incurred by or asserted against the Indemnified Party
or any of the foregoing prior to the LLC Formation Date arising out of the
development, testing, manufacture, handling or storage by the Indemnifying Party
of any Collaboration Product in accordance with the Development Plan or
Commercialization Plan, as the case may be, except to the extent such claims,
liabilities, losses and expenses result from the negligent, reckless or
intentional acts or omissions of the Indemnified Party, in which case the
Indemnified Party shall indemnify and hold harmless the Indemnifying Party and
its directors, officers, employees and agents.
12.2 Kallikrein LLC Indemnity Obligations. The Operating Agreement shall
provide that Kallikrein LLC shall indemnify each of the Members and its
Affiliates, employees and agents (each an "Indemnified Person") for any act
performed by such Indemnified Person within the scope of the authority conferred
upon such Indemnified Person under this Agreement; provided that it shall be a
condition to such indemnity that (a) the Indemnified Person seeking
indemnification acted in good faith and in a manner reasonably believed to be
in, or not opposed to, the best interests of Kallikrein LLC, (b) the act for
which indemnification is sought did not constitute gross negligence or willful
misconduct by such Indemnified Person and (c) payment and indemnification of any
matter disposed of by a compromise payment by such Indemnified Person, pursuant
to consent decree or otherwise, shall have been approved by the Members, which
approval shall not be unreasonably withheld or delayed, or by a court of
competent jurisdiction.
12.3 Insurance.
12.3.1 Kallikrein LLC shall obtain and maintain product liability
insurance with respect to the design, development, manufacture, modification,
distribution and sale of Collaboration Products and comprehensive general
liability insurance, each in amounts reasonably believed by Genzyme and Dyax to
be adequate and customary for the development, manufacture and sale of novel
therapeutic products and for the property of Kallikrein LLC. Each such insurance
policy shall be for an amount determined by the Steering Committee. The
insurance will contain a deductible to be determined by the Steering Committee.
*************. The aforementioned product liability and comprehensive general
liability insurance shall be obtained as soon as practicable after the LLC
Formation Date, but in no event later than ninety (90) days thereafter, from an
insurance carrier approved by the Steering Committee. The costs of all such
insurance shall be included in the Program Costs.
12.3.2 Genzyme and Dyax shall each maintain at their own cost
similar product liability and comprehensive general liability insurance coverage
in amounts reasonably
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Exchange Commission. Asterisks denote such omissions.
determined by the Steering Committee from time to time. Genzyme and Dyax shall
each also provide coverage for Kallikrein LLC after the LLC Formation Date in
excess of any valid and collectible insurance available from Kallikrein LLC by
including their respective Percentage Interests under their respective product
liability insurance policies to the extent their respective interests appear and
to the extent such Parties are legally obligated to pay. Genzyme shall also
provide coverage for Kallikrein LLC under its property and transit insurance
policies, with the costs of the associated insurance premiums to be included in
the Program Costs subject to reimbursement by Kallikrein LLC within thirty (30)
days after receipt of an invoice therefor.
12.3.3 Each Party will furnish the other Parties a certificate(s)
from an insurance carrier (having a minimum AM Best rating of B) showing all
insurance set forth above.
12.3.4 The insurance certificate(s) showing Kallikrein LLC's
insurance will include the following statement: "The insurance certified
hereunder is applicable to all contracts between Genzyme Corporation, Dyax Corp.
and the Insured. This insurance may be canceled or altered only after ten (10)
days' written notice to Genzyme Corporation and Dyax Corp." The insurance, and
the certificate(s), will (a) name each of Genzyme and Dyax (including their
respective officers, directors, employees, Affiliates, agents, successors and
assigns) as additional insureds with respect to matters arising from this
Agreement, (b) provide that such insurance is primary to any liability insurance
carried by Genzyme and Dyax and (c) provide that underwriters and insurance
companies of Kallikrein LLC may not have any right of subrogation against
Genzyme or Dyax (including their respective officers, directors, employees,
servants, Affiliates, agents, successors and assigns) except in the event a
claim results from Genzyme's or Dyax's respective gross negligence or willful
misconduct. Such certificate(s) shall be made available to each Party upon
reasonable advance request.
12.3.5 The Steering Committee shall review the adequacy of the
insurance described above on a quarterly basis and the Steering Committee shall
have the power to reasonably direct the modification of such insurance.
ARTICLE 13 TERM AND TERMINATION
13.1 Term. The term of this Agreement shall be perpetual unless terminated
pursuant to Section 13.2 below.
13.2 Termination. This Agreement may be terminated in the following
circumstances:
13.2.1 For Certain Material Breaches. If either Dyax or Genzyme (a)
fails to use commercially reasonable and diligent efforts to perform any
material duty imposed upon such Party under this Agreement or a Development Plan
or Commercialization Plan or (b) following the formation of Kallikrein LLC,
fails to make ************* or more capital contributions in accordance with
Article 4 hereof, and such failure to perform is not cured within
*************of written notice thereof from the non-breaching Party, the
non-breaching Party may elect, in its sole discretion, to (i) in the case of
clause (b) above, waive the terms of Article 4 hereof with respect to any one or
more required capital contributions and cause the respective Percentage
Interests and future funding responsibilities of the Parties to be adjusted in
accordance with Section 4.2.1 hereof or (ii) terminate this Agreement with the
consequences set forth in Section 13.3.1 below. *************.
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13.2.2 For Convenience. Either Dyax or Genzyme may elect to
terminate this Agreement for any reason at any time after the satisfaction by
Dyax of the Initial Funding Commitment upon ************* prior written notice
to the other Party (during which ************* period the obligations of the
Parties, including without limitation obligations with respect to the funding of
Program Costs, shall continue in full force and effect) with the consequences
set forth in Section 13.3.2 below.
13.2.3 Upon Change of Control. Either Dyax or Genzyme may terminate
this Agreement with the consequences set forth in Section 13.3.3 in the event
that the other Party is a party to a transaction involving (a) a merger or
consolidation in which such party is not the surviving entity or (b) the sale of
all or substantially all of the assets of such Party to a Third Party.
Termination of this Agreement pursuant to this Section 13.2.3 shall be effective
as of the effective date of such transaction.
13.2.4 Upon Bankruptcy. Either Dyax or Genzyme may terminate this
Agreement with the consequences set forth in Section 13.3.4 below upon the
bankruptcy, insolvency, dissolution or winding-up of the other Party, except in
the case of a petition in bankruptcy filed involuntarily against a Party, if
such petition is dismissed within sixty (60) days of the date of its filing.
13.3 Effects of Termination.
13.3.1 For Certain Material Breaches. In addition to the rights and
duties set forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have
the following rights and duties upon termination of this Agreement pursuant to
Section 13.2.1(ii) above:
(a) the non-breaching Party shall obtain from the breaching
Party the irrevocable right and license, with the right to grant sublicenses,
under the breaching Party's Patent Rights, Technology and Manufacturing Know-How
to develop, make, have made, use, offer for sale, sell, have sold, import and
export Collaboration Products in the Field and in the Territory, and the
breaching Party shall execute such documents and take all action as may be
necessary or desirable to effect the foregoing; provided that such license shall
be for the same level of exclusivity as the rights that had been or would be
granted with respect thereto under Section 3.1 hereof; and provided, further,
that any license granted hereunder shall be subject to the obligation of the
non-breaching Party to use commercially reasonable and diligent efforts to
develop and market Collaboration Products pursuant to such license;
(b) if applicable, the breaching Party shall assign and
transfer all of its interest in Kallikrein LLC to the non-breaching Party, and
the non-breaching Party may dissolve Kallikrein LLC in its sole discretion;
provided that in the event that Dyax is the breaching party, it shall also cause
Subsidiary to assign and transfer all of its interest in Kallikrein LLC to
Genzyme.
(c) (i) any licenses granted pursuant to Article 3 shall be
revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any
applicable Regulatory Approvals (other than any Regulatory Approvals filed in
the name of an entity other than Kallikrein LLC or the non-breaching Party
pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or
licensed by Kallikrein LLC or the breaching Party and any trademarks owned or
licensed by
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Kallikrein LLC (other than any trademarks registered in the name of an entity
other than Kallikrein LLC or the non-breaching Party pursuant to Section 9.1.2
hereof) shall be assigned or licensed to the non-breaching Party and (iii) any
Regulatory Approvals filed and any trademarks registered in the name of an
entity other than Kallikrein LLC or the non-breaching Party shall be (A)
exclusively licensed to Kallikrein LLC, the non-breaching Party or any Third
Party or Affiliate designated by such Party until such time as Kallikrein LLC,
the non-breaching Party or its designee is qualified to hold such Regulatory
Approvals or trademarks under the applicable provisions of the Regulatory Scheme
and (B) transferred or assigned to Kallikrein LLC, the non-breaching Party or
its designee, as appropriate, as soon as practicable thereafter; and
(d) the non-breaching Party shall become obligated to pay the
breaching Party an amount equal to ************* (the "Breach Buyout Amount"),
payable as follows:
(1) if the non-breaching Party elects to sell or
otherwise dispose of all or any portion of its or its Affiliates' right, title
and interest in the Collaboration Products, then the non-breaching Party shall,
upon any such sale or other disposition, pay the breaching Party an amount equal
to *************;
(2) for as long as the non-breaching Party (together, in
the case of Dyax with Subsidiary) has not sold or otherwise disposed of all or a
portion of its (together in the case of Dyax, with Subsidiaries) right, title
and interest in the Collaboration Products which is equal to or greater than the
breaching Party's (together in the case of Dyax, with Subsidiaries) Percentage
Interest as of the date of termination, the non-breaching Party shall pay the
breaching Party (and, in the event that Dyax is the breaching Party, Subsidiary)
*************
(3) on the ************* the date of termination, the
non-breaching Party shall pay the breaching Party (and, in the event that Dyax
is the breaching Party, Subsidiary) *************;
provided, that the aggregate amount of all payments made under clauses (1), (2)
and (3) shall not exceed the Breach Buyout Amount.
13.3.2 For Convenience. In addition to the rights and duties set
forth in Sections 13.4 and 13.5 below, Subsidiary shall have the following
rights and Dyax and Genzyme shall have the following rights and duties upon
termination of this Agreement pursuant to Section 13.2.2 above:
(a) the non-terminating Party shall have an option exercisable
upon written notice to the terminating Party within the ************* period
provided in Section 13.2.2 hereof to obtain from the terminating Party the
irrevocable right and license, with the right to grant sublicenses, under the
terminating Party's Patent Rights, Technology and Manufacturing Know-How to
develop, make, have made, use, offer for sale, sell, have sold, import and
export Collaboration Products in the Field and in the Territory, and the
terminating Party shall execute such documents and take all action as may be
necessary or desirable to affect the foregoing; provided that such license shall
be for the same level of exclusivity as the rights that had been or would be
granted with respect thereto under Section 3.1; and provided, further, that any
license
31
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
granted hereunder shall be subject to the obligation of the non-terminating
Party to use commercially reasonable and diligent efforts to develop and market
Collaboration Products pursuant to such license;
(b) if applicable, upon exercise of its license option
provided in paragraph (a) of this Section 13.3.2, the terminating Party shall
assign and transfer all of its interest in Kallikrein LLC to the non-terminating
Party, and the non-terminating Party may dissolve Kallikrein LLC in its sole
discretion;
(c) upon exercise of its license option provided in paragraph
(a) of this Section 13.3.2, (i) any licenses granted pursuant to Article 3 shall
be revoked, (ii) if Kallikrein LLC does not yet exist or is dissolved, any
applicable Regulatory Approvals (other than any Regulatory Approvals filed in
the name of an entity other than Kallikrein LLC or the non-terminating Party
pursuant to Section 5.3 hereof), pre-clinical and clinical data owned or
licensed by Kallikrein LLC or the terminating Party and any trademarks owned or
licensed by Kallikrein LLC (other than any trademarks registered in the name of
an entity other than Kallikrein LLC or the non-terminating Party pursuant to
Section 9.1.2 hereof) shall be assigned to the non-terminating Party and (iii)
any Regulatory Approvals filed and any trademarks registered in the name of an
entity other than Kallikrein LLC or the non-terminating Party shall be (A)
exclusively licensed to Kallikrein LLC, the non-terminating Party or any Third
Party or Affiliate designated by such Party until such time as Kallikrein LLC,
the non- terminating Party or its designee is qualified to hold such Regulatory
Approvals or trademarks under the applicable provisions of the Regulatory Scheme
and (B) transferred or assigned to Kallikrein LLC, the non-terminating Party or
its designee, as appropriate, as soon as practicable thereafter;
(d) upon the exercise of its license option provided in
paragraph (a) of this Section 13.3.2, the non-terminating Party shall become
obligated to pay to the terminating Party an amount equal to ************* (the
"Convenience Buyout Amount"), payable on the terms and conditions and in
accordance with the schedule of payments set forth in Section 13.3.1(d), mutatis
mutandis; ************* and
(e) if the license option provided in paragraph (a) of this
Section 13.3.2 is not exercised, then all right, title and interest in the
Collaboration Products shall be sold to the highest bidder within eighteen (18)
months from the date of termination and the proceeds shall be allocated between
the Members in proportion to their Percentage Interests as of the date of
termination and if applicable, Kallikrein LLC shall be dissolved.
13.3.3 Upon a Change of Control. In addition to the rights and
duties set forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have
the following rights and duties upon termination of this Agreement pursuant to
Section 13.2.3:
(a) the terminating Party shall have the exclusive,
irrevocable and, except as provided in Section 13.3.3(d), royalty-free right and
license, with the right to grant sublicenses, under the non-terminating Party's
Patent Rights, Technology and Manufacturing Know-How to develop, make, have
made, use, offer for sale, sell, have sold, import and export Collaboration
Products in the Territory and in the Field, and the non-terminating Party shall
execute such documents and take all action as may be necessary or desirable to
effect the foregoing; provided that such license shall be for the same level of
exclusivity as the rights that
32
had been or would be granted with respect thereto under Section 3.1; and
provided, further, that any license granted hereunder shall be subject to the
obligation of the terminating Party to use commercially reasonable and diligent
efforts to develop and market Collaboration Products pursuant to such license;
(b) if applicable, the non-terminating Party shall assign and
transfer all of its interest in Kallikrein LLC to the terminating Party, and the
terminating Party may dissolve Kallikrein LLC in its sole discretion; provided
that in the event that Dyax is the non-terminating party, it shall also cause
Subsidiary to assign and transfer all of its interest in Kallikrein LLC to
Genzyme;
(c) (i) any licenses granted to Article 3 shall be revoked,
(ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable
Regulatory Approvals (other than any Regulatory Approvals filed in the name of
an entity other than Kallikrein LLC or the terminating Party pursuant to Section
5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC
or the non-terminating Party and any trademarks owned or licensed by Kallikrein
LLC (other than any trademarks registered in the name of an entity other than
Kallikrein LLC or the terminating Party pursuant to Section 9.1.2 hereof) shall
be assigned or licensed to the terminating Party and (iii) any Regulatory
Approvals filed and any trademarks registered in the name of an entity other
than Kallikrein LLC or the terminating Party shall be (A) exclusively licensed
to Kallikrein LLC, the terminating Party or any Third Party or Affiliate
designated by such Party until such time as Kallikrein LLC, the terminating
Party or its designee is qualified to hold such Regulatory Approvals or
trademarks under the applicable provisions of the Regulatory Scheme and (B)
transferred or assigned to Kallikrein LLC, the terminating Party or its
designee, as appropriate, as soon as practicable thereafter; and
(d) the terminating Party (the "Offeror") shall, pursuant to
the conditions set forth in this Section 13.3(d), give the other Party (Genzyme
in the case Dyax is terminating or the Dyax Companies in the case Genzyme is
terminating, in either case the "Offeree") at the time of termination written
notice of the Offeror's intention to purchase Offeree's entire interest in and
to (i) the Collaboration Products as of the date of termination and (ii) if
applicable, the Percentage Interest of the net asset value of Kallikrein LLC as
of the date of termination (the "Notice of Offer"). The Notice of Offer shall
state therein the specific price, terms and conditions under which the Offeror
agrees to purchase Offeree's entire interest in and to (i) the Collaboration
Products as of the date of termination and (ii) if applicable, the Percentage
Interest of the net asset value of Kallikrein LLC as of the date of termination;
provided, however, that the purchase price shall be paid in cash,
publicly-traded and registered securities or as the Parties otherwise agree. The
Offeree shall then have ninety (90) days (the "Acceptance Period") from the
receipt of the Notice of Offer to give notice (the "Notice of Acceptance") of
the Offeree's intention to accept the offer of the Offeror and shall sell
Offeree's entire interest in and to (i) the Collaboration Products as of the
date of termination and (ii) if applicable, the Percentage Interest of the net
asset value of Kallikrein LLC as of the date of termination to Offeror for the
price and upon such terms and conditions as set forth in the Notice of Offer. In
the event the Offeree gives such Notice of Acceptance, a closing shall be held
within ninety (90) days of the receipt of the Notice of Acceptance by the
Offeror. In the event the Offeree elects not to accept the Offeror's offer to
purchase, by giving the Offeror written notice thereof, or by failing to give
the appropriate Notice of Acceptance within the Acceptance Period, the Offeree
shall thereby automatically be bound to purchase Offeror's entire interest in
33
and to (i) the Collaboration Products as of the date of termination and (ii) if
applicable, the Percentage Interest of the net asset value of Kallikrein LLC as
of the date of termination for the same price (as adjusted for Percentage
Interest, if necessary) and upon such terms and conditions as specified in the
Notice of Offer. In such event, a closing shall be held within ninety (90) days
of the earlier to occur of the expiration of the Acceptance Period and the date
of receipt of the written rejection, whichever is the first to occur. In
addition to any other remedies provided by this Agreement, in the event the
Offeree rejects the offer contained in the Notice of Offer, but thereafter fails
for any reason to timely close as provided herein above, the Offeree shall, by
such failure to close, be deemed to have accepted the original offer contained
in the Notice of Offer, and shall thereafter sell Offeree's entire interest in
and to (i) the Collaboration Products as of the date of termination and (ii) if
applicable, the Percentage Interest of the net asset value of Kallikrein LLC as
of the date of termination to the Offeror pursuant to the terms of the Notice of
Offer. For purposes of Sections 13.3.3 (a)-(c) above, the Party purchasing the
other Party's interest in (i) the Collaboration Products and (ii) if applicable,
the Percentage Interest of the net asset value of Kallikrein LLC shall be deemed
to be the terminating Party and the other Party shall be deemed to be the
non-terminating Party.
13.3.4 Upon Bankruptcy. In addition to the rights and duties set
forth in Sections 13.4 and 13.5 below, Dyax and Genzyme shall have the following
rights and duties upon termination of this Agreement pursuant to Section 13.2.4
above:
(a) the terminating Party shall obtain from the
non-terminating Party the irrevocable right and license, with the right to grant
sublicenses, under the non-terminating Party's Patent Rights, Technology and
Manufacturing Know-How to develop, make, have made, use, offer for sale, sell,
have sold, import and export Collaboration Products in the Field and in the
Territory, and the non-terminating Party shall execute such documents and take
all action as may be necessary or desirable to affect the foregoing; provided
that such license shall be for the same level of exclusivity as the rights that
had been or would be granted with respect thereto under Section 3.1 hereof; and
provided, further, that any license granted hereunder shall be subject to the
obligation of the terminating Party to use commercially reasonable and diligent
efforts to develop and market Collaboration Products pursuant to such license;
(b) if applicable, the non-terminating Party shall assign and
transfer all of its interest in Kallikrein LLC to the terminating Party, and the
terminating Party may dissolve Kallikrein LLC in its sole discretion;, provided
that in the event that Dyax is the non-terminating Party, it shall also cause
Subsidiary to assign and transfer all of its interest in Kallikrein LLC to
Genzyme.
(c) (i) any licenses granted to Article 3 shall be revoked,
(ii) if Kallikrein LLC does not yet exist or is dissolved, any applicable
Regulatory Approvals (other than any Regulatory Approvals filed in the name of
an entity other than Kallikrein LLC or the terminating Party pursuant to Section
5.3 hereof), pre-clinical and clinical data owned or licensed by Kallikrein LLC
or the non-terminating Party and any trademarks owned or licensed by Kallikrein
LLC (other than any trademarks registered in the name of an entity other than
Kallikrein LLC or the terminating Party pursuant to Section 9.1.2 hereof) shall
be assigned or licensed to the terminating Party and (iii) any Regulatory
Approvals filed and any trademarks registered in the name of an entity other
than Kallikrein LLC or the terminating Party shall be (A) exclusively licensed
to Kallikrein LLC, the terminating Party or any Third Party or Affiliate
34
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
designated by such Party until such time as Kallikrein LLC, the terminating
Party or its designee is qualified to hold such Regulatory Approvals or
trademarks under the applicable provisions of the Regulatory Scheme and (B)
transferred or assigned to Kallikrein LLC, the terminating Party or its
designee, as appropriate, as soon as practicable thereafter; and
(d) the terminating Party shall become obligated to pay to the
non-terminating Party an amount equal to ************* (the "Bankruptcy Buyout
Amount"), payable on the terms and conditions and in accordance with the
schedule of payments set forth in Section 13.3.1(d), mutatis mutandis.
13.3.5 Fair Value. For purposes of this Section 13.3, the "Fair
Value" of a Party's interest in the Collaboration Products shall be the amount
an informed and willing buyer under no compulsion to buy would be willing to pay
and an informed and willing seller under no compulsion to sell would be willing
to accept for all right, title and interest in such Party's interest in the
Collaboration Products, determined as of the date of termination, which
determination shall be made by the mutual agreement of Dyax and Genzyme. In the
event that Dyax and Genzyme are unable to agree upon the Fair Value within one
hundred and twenty (120) days of the date of termination, the Fair Value shall
be determined by an investment banking firm selected by mutual agreement of Dyax
and Genzyme, and the costs and expenses incurred in connection with the
engagement of such investment banking firm shall be shared equally by Dyax and
Genzyme.
13.4 Inventory. Upon the termination of this Agreement, if Genzyme does
not obtain a license pursuant to Section 13.3 hereof, Dyax shall have the option
to repurchase Genzyme's inventory of Collaboration Products acquired by Genzyme
pursuant to Article 6 hereof. Within ten (10) days after such termination, Dyax
shall elect in writing to either (a) permit Genzyme to sell off its remaining
inventory of Collaboration Products, provided that Genzyme shall comply with all
of the terms and conditions of this Agreement restricting such selling
activities as in effect immediately prior to such termination, or (b) repurchase
Genzyme's inventory of Collaboration Products. If Dyax fails to make such an
election, Genzyme shall be permitted to sell-off its remaining inventory of
Collaboration Products in accordance with clause (a) of this Section 13.4. Any
repurchase of Genzyme's inventory of Collaboration Products shall be at the
price as stated in Genzyme's then-current price list, less a handling charge to
be reasonably determined by the Parties in good faith.
13.5 Survival of Rights and Duties. No termination of this Agreement shall
eliminate any rights or duties of the Parties accrued prior to such termination.
The provisions of Article 1, Sections 2.2, 3.4, 4.3, 4.5, 9.1.1, 9.1.3, 9.3,
9.5, Article 10, Article 12, Sections 13.2, 13.3, 13.4, 14.1, 14.3, 14.4, 14.8,
14.9, 14.10 and 14.11 hereof shall survive any termination of this Agreement.
ARTICLE 14 MISCELLANEOUS
14.1 Cooperation. If either Dyax or Genzyme (the "Assuming Party") shall
assume the Program rights from the other Party (the "Responsible Party") in
accordance with the provisions of Article 13 hereof, the Responsible Party shall
promptly provide to the Assuming Party (or any Third Party or Affiliate
designated by the Assuming Party) all Technology, Manufacturing Know-How and
access to regulatory filings sufficient to allow the Assuming Party to perform
35
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
the duties assumed. The Responsible Party shall further use its best efforts to
provide all assistance required by the Assuming Party with respect to such
transfer so as to permit the Assuming Party to begin to perform such duties as
soon as possible to minimize any disruption in the continuity of supply or
marketing of Collaboration Products. If the Responsible Party is the
Manufacturing Party for a Collaboration Product, the Responsible Party shall, at
the option of the Assuming Party, supply such Collaboration Product to the
Assuming Party, at a mutually agreeable price not to exceed the Fully Allocated
Cost of Goods for such Collaboration Product, until the earlier of: (i)
************* from the effective date of termination and (ii) *************
after the Assuming Party delivers notice to the Responsible Party that the
Assuming Party is able to manufacture such Collaboration Product. In addition,
if upon the date this Agreement is terminated Collaboration Products are being
manufactured in facilities owned or leased by the Responsible Party (including
facilities subleased by Kallikrein LLC from the Responsible Party), the
Responsible Party agrees to lease such facilities to the Assuming Party on
commercially reasonable terms *************.
14.2 Exchange Controls. All payments due hereunder shall be paid in United
States dollars. If at any time legal restrictions prevent the prompt remittance
of part or all payments with respect to any country in which Collaboration
Products are sold, payment shall be made through such lawful means or methods as
the Parties may determine in good faith.
14.3 Withholding Taxes. If applicable laws or regulations require that
taxes be withheld from payments made hereunder, the Party paying such taxes will
(a) deduct such taxes, (b) timely pay such taxes to the proper authority and (c)
send written evidence of payment to the Party from whom such taxes were withheld
within sixty (60) days after payment. Each Party will assist the other Party or
Parties in claiming tax refunds, deductions or credits at such other Party's
request and will cooperate to minimize the withholding tax, if available, under
various treaties applicable to any payment made hereunder.
14.4 Interest on Late Payments. Any payments to be made hereunder that are
not paid on or before the date such payments are due under this Agreement shall
bear interest, to the extent permitted by applicable law, at the Base Rate of
interest declared from time to time by BankBoston, N.A. in Boston,
Massachusetts, calculated on the number of days payment is delinquent.
14.5 Force Majeure. Neither Party shall be held liable or responsible to
the other Party nor be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party, including without limitation fire, floods,
embargoes, war, acts of war (whether war is declared or not), insurrections,
riots, civil commotions, strikes, lockouts or other labor disturbances, acts of
God or acts, omissions or delays in acting by any governmental authority or the
other Party; provided, however, that the Party so affected shall use
commercially reasonable and diligent efforts to avoid or remove such causes of
non-performance, and shall continue performance hereunder with reasonable
dispatch wherever such causes are removed. Each Party shall provide the other
Parties with prompt written notice of any delay or failure to perform that
occurs by reason of force majeure. The Parties shall mutually seek a resolution
of the delay or the failure to perform in good faith.
36
14.6 Assignment. This Agreement may not be assigned or otherwise
transferred by any Party without the consent of the other Parties; provided,
however, that either Dyax or Genzyme may, without such consent, assign its
rights and obligations under this Agreement (a) in connection with a corporate
reorganization, to any member of an affiliated group, all or substantially all
of the equity interest of which is owned and controlled by such Party or its
direct or indirect parent corporation or (b) in connection with a merger,
consolidation or sale of substantially all of such Party's assets to an
unrelated Third Party; provided, however, that such Party's rights and
obligations under this Agreement shall be assumed by its successor in interest
in any such transaction and shall not be transferred separate from all or
substantially all of its other business assets, including without limitation
those business assets that are the subject of this Agreement. Any permitted
assignee shall assume all obligations of its assignor under this Agreement. Any
purported assignment in violation of this Section 14.6 shall be void.
14.7 Severability. Each Party hereby agrees that it does not intend to
violate any public policy, statutory or common laws, rules, regulations, treaty
or decision of any government agency or executive body thereof of any country or
community or association of countries. Should one or more provisions of this
Agreement be or become invalid, the Parties hereto shall substitute, by mutual
consent, valid provisions for such invalid provisions which valid provisions in
their economic effect are sufficiently similar to the invalid provisions that it
can be reasonably assumed that the Parties would have entered into this
Agreement with such valid provisions. In case such valid provisions cannot be
agreed upon, the invalidity of one or several provisions of this Agreement shall
not affect the validity of this Agreement as a whole, unless the invalid
provisions are of such essential importance to this Agreement that it is to be
reasonably assumed that the Parties would not have entered into this Agreement
without the invalid provisions.
14.8 Notices. Any consent, notice or report required or permitted to be
given or made under this Agreement by one of the Parties hereto to the other
shall be in writing, delivered personally or by facsimile (and promptly
confirmed by personal delivery or courier), by a next business day delivery
service of a nationally recognized overnight courier service or by courier,
postage prepaid (where applicable), addressed to such other Party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor in accordance with this Section 14.8 and
shall be effective upon receipt by the addressee.
If to Dyax: Dyax Corp.
or Subsidiary Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: President
Facsimile: (000) 000-0000
with a copy to: Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxxxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
If to Genzyme: Genzyme Corporation
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
37
Attention: President
Facsimile: (000) 000-0000
with a copy to: Genzyme Corporation
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Legal Officer
Facsimile: (000) 000-0000
If to Kallikrein Kallikrein LLC
LLC (if such c/o Genzyme Corporation
notice is sent One Xxxxxxx Square
by Dyax): Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: President
Facsimile: (000) 000-0000
with a copy to: Genzyme Corporation
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Legal Officer
Facsimile: (000) 000-0000
If to Kallikrein Kallikrein LLC
LLC (if such c/o Dyax Corp.
notice is sent One Xxxxxxx Square
by Genzyme): Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: President
Facsimile: (000) 000-0000
with a copy to: Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxxxxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
14.9 Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of the Commonwealth of Massachusetts without regard to
any choice of law principle that would dictate the application of the laws of
another jurisdiction.
14.10 Arbitration. Any disputes arising between the Parties relating to,
arising out of or in any way connected with this Agreement or any term or
condition hereof, or the performance by either Party of its obligations
hereunder, whether before or after termination of this Agreement (a "Dispute"),
which has not resolved in accordance with the provisions of Section 8.3 hereof,
shall be finally resolved by binding arbitration as herein provided.
14.10.1 General. Except as otherwise provided in this Section 14.10,
any arbitration hereunder shall be conducted under the commercial rules of the
American Arbitration Association. Each such arbitration shall be conducted in
the English language by a panel of
38
three (3) arbitrators (the "Arbitration Panel"). Each of Dyax and Genzyme shall
appoint one (1) arbitrator to the Arbitration Panel and the third arbitrator
shall be appointed by the two (2) arbitrators appointed by Dyax and Genzyme. The
Arbitration Panel shall be convened upon delivery of the Notice of Arbitration
(as herein defined). Any such arbitration shall be held in Boston,
Massachusetts. The Arbitration Panel shall have the authority to grant specific
performance, and to allocate between the Parties the costs of arbitration in
such equitable manner as it shall determine. Judgment upon the award so rendered
may be entered in any court having jurisdiction or application may be made to
such court for judicial acceptance of any award and an order of enforcement, as
the case may be.
14.10.2 Procedure.
(a) Whenever a Party (the "Claimant") shall decide to
institute arbitration proceedings, it shall give written notice to that effect
(the "Notice of Arbitration") to the other Party (the "Respondent"). The Notice
of Arbitration shall set forth in detail the nature of the Dispute, the facts
upon which the Claimant relies and the issues to be arbitrated (collectively,
the "Arbitration Issues"). Within fifteen (15) days of its receipt of the Notice
of Arbitration, the Respondent shall send the Claimant and the Arbitration Panel
a written Response (the "Response"). The Response shall set forth in detail the
facts upon which the Respondent relies. In addition, the Response shall contain
all counterclaims which the Respondent may have against the Claimant which are
within the Arbitration Issues, whether or not such claims have previously been
identified. If the Response sets forth a counterclaim, the Claimant may, within
fifteen (15) days of the receipt of the Response, deliver to the Respondent and
the Arbitration Panel a rejoinder answering such counterclaim.
(b) Within fifteen (15) days after the later of (i) the
expiration of the period provided in Section 14.10.2(a) above for the Claimant
to deliver a rejoinder or (ii) the completion of any discovery proceedings
authorized by the Arbitration Panel: (A) the Claimant shall send to the
Arbitration Panel a proposed resolution of the Arbitration Issues and a proposed
resolution of any counterclaims set forth in the Response, including without
limitation the amount of monetary damages, if any, or other relief sought (the
"Claimant's Proposal"); and (B) the Respondent shall send to the Arbitration
Panel a proposed resolution of the Arbitration Issues, a proposed resolution of
any counterclaims set forth in the Response and a proposed resolution of any
rejoinder submitted by the Claimant, including without limitation the amount of
monetary damages, if any, or other relief sought (the "Respondent's Proposal").
Once both the Claimant's Proposal and the Respondent's Proposal have been
submitted, the Arbitration Panel shall deliver to each Party a copy of the other
Party's proposal.
(c) The Arbitration Panel shall issue an opinion with respect
to any Dispute, which opinion shall explicitly accept either the Claimant's
Proposal or the Respondent's Proposal in its entirety (the "Final Decision").
The Arbitration Panel shall not have the authority to reach a Final Decision
that provides remedies or requires payments other than those set forth in the
Claimant's Proposal or the Respondent's Proposal. The concurrence of two (2)
arbitrators shall be sufficient for the entry of a Final Decision. The
arbitrators shall issue a Final Decision within one (1) month from the later of
(i) the last day for submission of proposals under Section 14.10.2(b) above or
(ii) the date of the final hearing on any Dispute held by the Arbitration Panel.
A Final Decision shall be binding on both Parties.
39
14.11 Injunctive Relief. The Parties hereby acknowledge that a breach of
their respective obligations under Article 10 hereof may cause irreparable harm
and that the remedy or remedies at law for any such breach may be inadequate.
The Parties hereby agree that, in the event of any such breach, in addition to
all other available remedies hereunder, the non- breaching Party or Parties
shall have the right to obtain equitable relief to enforce Article 10 hereof.
14.12 Entire Agreement. This Agreement and the Operating Agreement contain
the entire understanding of the Parties with respect to the subject matter
hereof. All express or implied agreements and understandings, either oral or
written, heretofore made are expressly merged in and made a part of this
Agreement, including, but not limited to the Confidential Disclosure Agreement
and modifications thereof dated October 1, 1997. This Agreement may be amended,
or any term hereof modified, only by a written instrument duly executed by both
Parties hereto. Each of the Parties hereby acknowledges that this Agreement is,
and the Operating Agreement will be, the result of mutual negotiation and
therefore any ambiguity in their respective terms shall not be construed against
the drafting Party.
14.13 Headings. The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.
14.14 Independent Contractors. It is expressly agreed that Dyax and
Genzyme shall be independent contractors and that, except as Members of
Kallikrein LLC, the relationship between the two Parties shall not constitute a
partnership, joint venture or agency. Neither Dyax nor Genzyme shall have the
authority to make any statements, representations or commitments of any kind, or
to take any action, which shall be binding on the other, without the prior
consent of the other Party to do so.
14.15 Waiver. Except as expressly provided herein, the waiver by either
Party hereto of any right hereunder or of any failure to perform or any breach
by the other Party shall not be deemed a waiver of any other right hereunder or
of any other failure to perform or breach by said other Party, whether of a
similar nature or otherwise, nor shall any singular or partial exercise of such
right preclude any further exercise thereof or the exercise of any other such
right.
14.16 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
40
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
GENZYME CORPORATION
By: /s/ Xxxxx Xxxxx
------------------------------------
Title:
---------------------------------
DYAX CORP.
By: /s/ Xxxxx X. Xxxxxxx
-----------------------------------
Title:
---------------------------------
41
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
SCHEDULE 1.10
DYAX PATENT RIGHTS
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COUNTRY APPLICATION NUMBER FILING DATE STATUS
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Abandoned in favor of
U.S. (Xxxxxxxx 1) ************* 1/11/94 US *************
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U.S. CIP (Xxxxxxxx 1A) ************* 3/10/94 Pending
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U.S. Patent 5,795,865
U.S. CIP (Xxxxxxxx 0X) ************* 9/25/96 issued 8/18/98
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U.S. Div. (Xxxxxxxx 1B
Div) ************* 8/17/98 Pending
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Canada (Xxxxxxxx 0X) ************* 1/11/95 Pending
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EPO (Xxxxxxxx 0X) ************* 1/11/95 Pending
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Japan (Xxxxxxxx 1B) ************* 1/11/95 Pending
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PCT (Xxxxxxxx 1B) ************* 1/11/95
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42
SCHEDULE 1.17
GENZYME PATENT RIGHTS
None
43
Schedule 1.28
OPERATING AGREEMENT
of
KALLIKREIN LLC
dated as of _________________
44
TABLE OF CONTENTS
ARTICLE 1. FORMATION AND MEMBERSHIP..........................................1
1.1 Formation.........................................................1
1.2 Members...........................................................1
1.3 Management........................................................1
ARTICLE 2. OFFICES, NAME, ETC................................................2
2.1 Principal Office..................................................2
2.2 Registered Office; Resident Agent.................................2
2.3 Name..............................................................2
2.4 Term..............................................................2
2.5 Business Ventures.................................................2
ARTICLE 3. PURPOSES AND POWERS...............................................2
3.1 Purpose...........................................................2
3.2 Powers............................................................2
ARTICLE 4. MEMBERS AND THEIR CONTRIBUTIONS AND LOANS.........................2
4.1 Contributions.....................................................2
4.2 Capital Accounts..................................................3
4.3 Loans.............................................................4
4.4 Additional Members................................................4
4.5 Liability of Members..............................................4
4.6 Withdrawal of Members.............................................4
ARTICLE 5. ALLOCATIONS.......................................................4
5.1 Certain Definitions...............................................4
5.2 Allocations of Profit and Loss....................................6
5.3 Special Allocations...............................................6
ARTICLE 6. DISTRIBUTIONS.....................................................8
6.1 Distribution of Company Funds.....................................8
ARTICLE 7. INDEMNIFICATION...................................................9
7.1 Indemnification of Members........................................9
ARTICLE 8. ASSIGNABILITY OF MEMBERSHIP INTERESTS............................10
8.1 Assignment.......................................................10
8.2 Substitute Members...............................................10
8.3 Rights of Assignees..............................................11
8.4 Other Restrictions...............................................11
45
ARTICLE 9. FISCAL YEAR, ACCOUNTING, INSPECTION OF BOOKS.....................11
9.1 Fiscal Year and Accounting.......................................11
9.2 Inspection of Books..............................................11
ARTICLE 10. DISSOLUTION.....................................................11
10.1 Events of Dissolution...........................................11
10.2 Consent to Continue Company.....................................12
10.3 Distribution Upon Dissolution...................................12
ARTICLE 11. GENERAL PROVISIONS..............................................12
11.1 Complete Agreement; Modification................................12
11.2 Governing Law; Severability.....................................13
11.3 Notice..........................................................13
11.4 Pronouns........................................................13
11.5 Titles..........................................................13
11.6 Successors and Assigns..........................................13
11.7 Counterparts....................................................13
46
OPERATING AGREEMENT
OF
KALLIKREIN LLC
THIS OPERATING AGREEMENT (the "Agreement") is made and adopted as of
______ __, by and among Genzyme Corporation, a Massachusetts corporation having
its principal place of business at Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000 ("Genzyme"), Dyax Corp., a Delaware corporation having its principal place
of business at Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 ("Dyax"), [Subsidiary], a
Delaware corporation and a wholly-owned subsidiary of Dyax having its principal
place of business at Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 (""Subsidiary") and
such other persons who may become members of Kallikrein LLC (the "Company") in
accordance with law or the terms hereof (hereinafter collectively referred to as
the "Members" and individually as a "Member"). Dyax and Subsidiary are
hereinafter collectively referred to as the "Dyax Companies." Capitalized terms
used but not defined herein shall be given the same meaning as provided in the
Collaboration Agreement dated as of September ___, 1998 between Dyax and Genzyme
(the "Collaboration Agreement").
ARTICLE 1. FORMATION AND MEMBERSHIP
1.1 Formation. The Company has been organized as a limited liability
company pursuant to the Delaware Limited Liability Company Act (the "Act"). The
Act shall govern the rights and liabilities of the parties hereto except as
otherwise expressly stated herein.
1.2 Members. The sole initial Member of the Company was Dyax. Following
the execution and delivery of the Collaboration Agreement, Dyax assigned one
percent (1%) of its interest in the Company to Subsidiary, and Subsidiary was
admitted as a Member of the Company. The Company elected under Section 754 of
the Internal Revenue Code of 1986, as amended ("IRC"), to apply the provisions
of Sections 734(b) and 743(b) of the IRC. Thereafter, effective upon execution
and delivery of the Purchase Agreement of even date herewith by and between Dyax
and Genzyme (the ""Purchase Agreement"), Dyax has sold and assigned to Genzyme a
fifty percent (50%) interest in the Company (subject to adjustment as provided
herein and in Section [4.2.1] of the Collaboration Agreement). Upon execution
and delivery of this Agreement, Dyax and Subsidiary each hereby consent to the
admission of Genzyme as a Member of the Company and Genzyme is hereby admitted
as a Member of the Company. Hence, the Members of the Company are those persons
listed on Schedule A attached hereto, as amended from time to time.
1.3 Management. The Company shall be managed by the Steering Committee
provided for in Section [8.2] of the Collaboration Agreement
1
ARTICLE 2. OFFICES, NAME, ETC.
2.1 Principal Office. The principal office of the Company shall be located
at Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 or such place within the
Commonwealth of Massachusetts as may be determined by the Members from time to
time. The Company shall maintain its records at such address.
2.2 Registered Office; Resident Agent. The name and address of the
Company's registered agent for service of process in the State of Delaware shall
be Corporation Service Company, 0000 Xxxxxx Xxxx, Xxxxxxxxxx, Xxxxxxxx
00000-0000. The name and address of the Company's registered agent for service
of process in the Commonwealth of Massachusetts shall be Genzyme Corporation,
Xxx Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000.
2.3 Name. The business of the Company shall be conducted under the name of
"Kallikrein LLC".
2.4 Term. The term of the Company shall commence upon the filing of the
Certificate of Formation (the "Effective Date") and shall be perpetual until it
is terminated as hereinafter provided.
2.5 Business Ventures. Any Member may engage independently or with others
in other business ventures of every nature and description, and neither the
Company nor any Member shall have any rights in and to such independent ventures
or the income or profits derived therefrom; provided, however, that a Member's
participation in such venture is subject to and consistent with the provisions
of Section [2.2] of the Collaboration Agreement.
ARTICLE 3. PURPOSES AND POWERS
3.1 Purpose. The purpose of the Company is to: (i) develop and
commercialize the Collaboration Products; (ii) act as a partner in limited
partnerships, general partnerships and limited liability partnerships, and as a
member of limited liability companies; and (iii) engage in any other business
permitted under the Act that the Members shall deem desirable or expedient.
3.2 Powers. The Company shall have all the powers necessary or convenient
to the conduct, promotion or attainment of the business, trade, purposes or
activities of the Company, including, without limitation, all the powers of an
individual, partnership, corporation or other entity.
ARTICLE 4. MEMBERS AND THEIR CONTRIBUTIONS AND LOANS
4.1 Contributions.
2
(a) Each Member has agreed to contribute the amounts and/or property set
forth in Sections [3.1, 3.2, 3.5, 4.1 and 4.2] of the Collaboration Agreement.
The amount so contributed is hereinafter referred to as each Member's "Capital
Contribution". The cash and agreed value of any property contributed by each
Member as of the date hereof is set forth in Schedule A attached hereto.
(b) Pursuant to the terms of the Collaboration Agreement, Dyax, on behalf
of the Dyax Companies, and Genzyme have undertaken to make monthly Capital
Contributions to the Company in the amount equal to fifty percent (50%) of all
Program Costs following satisfaction of the Initial Funding Commitment.
If either Genzyme or Dyax (on behalf of the Dyax Companies) fails to
make all or any portion of a monthly Capital Contribution, the other Member may
elect to make such Contribution (or a portion thereof). If either Genzyme or
Dyax (on behalf of the Dyax Companies) fails to make all or any portion of a
monthly Capital Contribution, the Percentage Interests (as defined below) shall
be adjusted to correspond to the percentage of cumulative Capital Contributions
made by or on behalf of each Member and subsequent monthly Capital Contributions
shall be made by the Members in proportion to their adjusted Percentage
Interests;
(c) No interest shall accrue on any Capital Contributions, and no Member
shall have the right to withdraw or to be repaid any capital it has contributed,
except as otherwise specifically provided in this Agreement.
(d) Each Member's percentage interest ("Percentage Interest") is as set
forth in Schedule A hereto, subject to adjustment as provided in Section 4.1(b)
of this Agreement.
4.2 Capital Accounts. A separate account (a "Capital Account") shall be
maintained for each Member and adjusted in accordance with Treasury Regulation
Section 1.704-1(b) as follows:
(a) There shall be credited to each Member's Capital Account the amount of
such Member's Capital Contribution as of the date, and to the extent, that such
Capital Contribution has been paid, and such Member's allocable share of Net
Profits (and any items in the nature of income or gain separately allocated to
such Member); and there shall be charged against each Member's Capital Account
the amount of all distributions to such Member and such Member's allocable share
of Net Losses (and any items in the nature of losses or deductions separately
allocated to such Member). Capital Contributions made by or on behalf of the
Dyax Companies shall be credited to their Capital Accounts in proportion to
their relative Percentage Interests.
(b) If the Company at any time distributes any of its assets in kind to
any Member, the Capital Account of each Member shall be adjusted to account for
that Member's allocable share (as determined under Section 5.1 below) of the Net
Profits or Net Losses that would have been realized by the Company had it sold
the assets that were distributed at their respective fair market values
immediately prior to their distribution.
3
(c) In the event any Member's interest is transferred in accordance with
the terms of this Agreement, the transferee shall succeed to the Capital Account
of the transferor to the extent it relates to the transferred interest.
4.3 Loans. The Members shall not make loans to the Company unless the
Members unanimously agree in writing to make such loans.
4.4 Additional Members. Except as otherwise provided in Section 8.2 below
with respect to Substitute Members, additional Members may only be admitted with
the prior written unanimous approval of the Members. Such additional Members
shall execute and acknowledge a counterpart to this Agreement or shall otherwise
evidence in writing their agreement to be bound by the terms hereof in such
manner as the Members shall determine.
4.5 Liability of Members.
(a) No Member shall be liable for the obligations of the Company solely by
reason of being a Member.
(b) No Member shall be required to make any contributions to the capital
of the Company other than as provided in this Article 4.
(c) No Member shall be personally liable to the Company or its other
Members for monetary damages for breach of fiduciary duty as a Member to the
extent permitted by applicable law; provided, however, that this provision shall
not eliminate the liability of a Member (i) for any breach of the Member's duty
of loyalty to the Company or its other Members, (ii) for acts or omissions not
in good faith or which involve intentional misconduct or a knowing violation of
law or (iii) for any transaction from which the Member derived an improper
personal benefit. No amendment to or repeal of this Section 4.5(c) shall apply
to or have any effect on the liability or alleged liability of any Member for or
with respect to any acts or omissions of such Member occurring prior to such
amendment or repeal.
4.6 Withdrawal of Members. No Member shall have the right to withdraw from
the Company or to demand a return of its capital interest at any time except
upon termination and dissolution of the Company, unless agreed to by the
unanimous written consent of the other Members.
ARTICLE 5. ALLOCATIONS
5.1 Certain Definitions. For purposes of this Agreement, the following
terms shall have the meanings given them in this Article 5:
(a) "Adjusted Capital Account" for a Member means such Member's
Capital Account (i) reduced by the net adjustments,
allocations and distributions described in Treasury Regulation
Sections 1.704-1(b)(2)(ii)(d)(4), (5) and
4
(6) which, as of the end of the Company's taxable year are
reasonably expected to be made to such Member, and (ii)
increased by the sum of (A) the amounts a Member is obligated
to restore to its Capital Account or is deemed obligated to
restore pursuant to the penultimate sentences of Treasury
Regulation Sections 1.704-2(g)(1) and 2(i)(5), (B) the excess,
if any, of such Member's Capital Contribution over such
Member's actual paid-in capital contribution and (C) that
portion of any indebtedness of the Company (other than
"partner nonrecourse debt" as defined in Treasury Regulation
Section 1.704-2(b)(4)) with respect to which the Member bears
the economic risk of loss that such indebtedness would not be
repaid out of the assets of the Company if all of the assets
of the Company were sold at their respective book values as of
the end of the fiscal period and the proceeds from the sales
together with any amounts described in clauses (A) and (B)
above, were used to pay the liabilities of the Company.
(b) "Net Profits" and "Net Losses" mean the taxable income or
loss, as the case may be, for a period (or from a transaction)
as determined in accordance with Section 703(a) of the IRC
(for this purpose, all items of income, gain, loss or
deduction required to be separately stated pursuant to IRC
Section 703(a)(1) shall be included in taxable income or loss)
computed with the following adjustments:
(i) To the extent required by (and in the manner
described in) Treasury Regulation 1.704-1(b)(2),
items of gain, loss and deduction shall be
computed based upon the book values of the
Company's assets rather than upon such assets'
adjusted bases for federal income tax purposes (if
different);
(ii) Any tax-exempt income received by the Company
shall be included as an item of gross income;
(iii) The amount of any adjustments to the adjusted
bases (or book values if clause (i) above applies)
of any assets of the Company pursuant to IRC
Section 743 shall not be taken into account; and
(iv) Any expenditure of the Company described or
treated as being described in IRC Section
705(a)(2)(B) shall be treated as a deductible
expense.
(c) "Member Loan Nonrecourse Deductions" means any Company
deductions that would be Nonrecourse Deductions if they were
not attributable to a liability owed to or guaranteed by a
Member within the meaning and intent of Treasury Regulation
Section 1.704-2(i).
5
(d) "Member Loan Minimum Gain" has the meaning set forth in
Treasury Regulation Section 1.704-2(i)(3).
(e) "Minimum Gain" has the meaning set forth in Treasury
Regulation Section 1.704-2(d). Minimum Gain shall be computed
separately for each Member in a manner consistent with the
Treasury Regulations under IRC Section 704(b).
(f) "Nonrecourse Deductions" has the meaning set forth in Treasury
Regulation Section 1.704-2(b)(1). The amount of Nonrecourse
Deductions for a taxable year of the Company shall be
determined according to the provisions of Treasury Regulation
Section 1.704-2(c).
(g) "Nonrecourse Liability" means any liability of the Company
with respect to which no Member has personal liability, as
determined in accordance with IRC Section 752 and the Treasury
Regulations promulgated thereunder.
5.2 Allocations of Profit and Loss. As of the end of each fiscal year of
the Company, or at the time any allocation is determined to be necessary by the
Members, Net Profits or Net Losses shall be allocated as follows:
(a) Except as provided in Sections 5.2(b) and 5.3 below, any allocation
required by this Section 5.2 to be made to the Members shall be allocated among
the Members in proportion to their respective Percentage Interests.
(b) With respect to the allocation of Net Losses or Net Profits pursuant
to this Section 5.2 among the Members for any fiscal year in which an additional
or substitute Member is admitted to the Company or there is an adjustment to the
Percentage Interests during such fiscal year, all Net Losses or Net Profits so
allocable shall be allocated in a manner which takes into account the varying
Percentage Interests during such fiscal year based on an accounting convention
chosen by the Members. In no event shall a retroactive allocation of Net Losses
be made pursuant to this Section 5.2.
5.3 Special Allocations. Notwithstanding the provisions of Section 5.2
above, the following allocations of Net Profits and Net Losses and items thereof
shall be made:
(a) If, during any year a Member unexpectedly receives any adjustment,
allocation or distribution described in Treasury Regulation Section
1.704-1(b)(2)(ii)(d)(4), (5) or (6) and, as a result of such adjustment,
allocation or distribution, such Member's Adjusted Capital Account has a
negative balance (computed with the adjustments set forth in clauses (i) and
(ii) of Section 5.1(a)), then items of gross income for such year (and, if
necessary, subsequent years) shall first be allocated to such Member in the
amount necessary to eliminate such negative balance as quickly as possible. This
Section 5.3(a) is intended to constitute a "qualified income offset" provision
within the meaning of the above Treasury Regulations, and shall be so
interpreted.
6
(b) Nonrecourse Deductions for a taxable year or other period shall be
specially allocated among the Members in proportion to their Percentage
Interests.
(c) Any Member Loan Nonrecourse Deduction for any taxable year or other
period shall be specially allocated to the Member or Members who bear the risk
with respect to the loan to which the Member Loan Nonrecourse Deduction is
attributable in accordance with Treasury Regulation Section 1.704-2(b).
(d) In no event shall Net Losses of the Company be allocated to a Member
if such allocation would cause or increase a negative balance in such Member's
Adjusted Capital Account.
(e) Except as set forth in Treasury Regulation Section 1.704-2(f)(2), (3)
and (4), if, during any taxable year, there is a net decrease in Minimum Gain,
each Member, prior to any other allocation pursuant to this Article 5, shall be
specially allocated items of gross income and gain for such taxable year (and,
if necessary, subsequent taxable years) in an amount equal to that Member's
share of the net decrease in Minimum Gain, computed in accordance with Treasury
Regulation Section 1.704-2(g). Allocation of gross income and gain pursuant to
this Section 5.3(e) shall be made first from gain recognized from the
disposition of Company assets subject to non-recourse liabilities (within the
meaning of the Treasury Regulations promulgated under IRC Section 752), to the
extent of the Minimum Gain attributable to those assets, and thereafter, from a
pro rata portion of the Company's other items of income and gain for the taxable
year. It is the intent of the parties hereto that any allocation pursuant to
this Section 5.3(e) shall constitute a "minimum gain chargeback" under Treasury
Regulation Section 1.704-2(f). With respect to a net decrease in Member Loan
Minimum Gain, items of gross income shall be specially allocated consistent with
the preceding sentence, and Treasury Regulation Section 1.704-2(i)(4).
(f) In the event that Net Profits, Net Losses or items thereof are
allocated to one or more Members pursuant to paragraphs (a) or (d) above,
subsequent Net Profits and Net Losses will first be allocated (subject to the
provisions of paragraphs (a) through (d)) to the Members in a manner designed to
result in each Member having a Capital Account balance equal to what it would
have been had the original allocation of Net Profits, Net Losses or items
thereof pursuant to paragraphs (a) or (d) not occurred.
(g) The respective Percentage Interests in the Net Profits and Net Losses
or items thereof shall remain as set forth above (subject to adjustment as
provided in Section 4.1(b) and Article 5) unless changed by amendment to this
Agreement or by an assignment of an interest in the Company authorized by the
terms of this Agreement. Except as otherwise provided herein, for tax purposes,
all items of income, gain, loss, deduction or credit shall be allocated to the
Members in the same manner as are Net Profits and Net Losses; provided, however,
that if, as a result of clause (i) of Section 5.1(b), the book value of any
property of the Company was used in computing Net Profits or Net Losses, then
items of income, gain, deduction or credit related to such property for tax
purposes shall be allocated among the Members so as to take account of the
7
variation between the adjusted basis of the property for tax purposes and its
book value in the manner provided for under IRC Section 704(c).
(h) If a Member's Percentage Interest is reduced (provided the reduction
does not result in a complete termination of the Member's interest in the
Company), the Member's share of the Company's "unrealized receivables" and
"substantially appreciated inventory" (within the meaning of IRC Section 751)
shall not be reduced, so that, notwithstanding any other provisions of this
Agreement to the contrary, that portion of the Net Profit otherwise allocable
upon a liquidation or dissolution of the Company pursuant to Article 5 hereof
which is taxable as ordinary income (recaptured) for federal income tax purposes
shall, to the extent possible without increasing the total gain to the Company
or to any Member, be specially allocated among the Members in proportion to the
deductions (or basis reductions treated as deductions) giving rise to such
recapture.
(i) In each taxable year of the Company, items of deduction and credit
attributable to Program Costs shall be allocated to the Members in proportion to
the Capital Contributions which funded the applicable expenditure.
ARTICLE 6. DISTRIBUTIONS
6.1 Distribution of Company Funds. The timing of distributions by the
Company (other than distributions in dissolution to which Section 10.3 applies)
shall be determined in accordance with the provisions of Section [4.3] of the
Collaboration Agreement. Such distributions shall be made to the Members first
in proportion to the excess of the positive balances in their Capital Accounts
over the amounts of their Capital Contributions, and then in proportion to their
remaining positive Capital Account balances; provided, however, that the amount
distributable to the Members pursuant to this Section 6.1 shall be reduced by
the amount required to fund the budgeted capital, working capital and reserve
requirements of the Company during the one hundred and eighty (180) day period
following the proposed distribution date and by such other amounts as the
Steering Committee reasonably determines to be necessary or appropriate for the
operation of the Company.
8
ARTICLE 7. INDEMNIFICATION
7.1 Indemnification of Members.
(a) The Company shall, to the fullest extent permitted by the Act, as
amended from time to time, indemnify each Member, each Member's Affiliates, and
the respective directors, officers, employees and agents of each Member and its
Affiliates (collectively, "Indemnified Persons") from and against all expenses
and liabilities (including counsel fees, judgments, fines, excise taxes,
penalties and amounts paid in settlements) reasonably incurred by or imposed
upon an Indemnified Person in connection with any threatened, pending or
completed action, suit or other proceeding, whether civil, criminal,
administrative or investigative, in which such Indemnified Person may become
involved by reason of (i) any act performed by such Indemnified Person in
connection with the performance of and within the scope of the authority
conferred by the Collaboration Agreement or (ii) such Indemnified Person's
service as a director, officer, manager or member of the Company or any of its
subsidiaries or, if such service was undertaken at the request of the Company,
such Indemnified Person's service as a director, officer or trustee of, or in a
similar capacity with, another organization.
(b) Indemnification may include payment by the Company of expenses in
defending an action or proceeding in advance of the final disposition of such
action or proceeding upon receipt of an undertaking by the Indemnified Person to
repay such payment if it is ultimately determined that such Indemnified Person
is not entitled to indemnification under this Article 7, which undertaking may
be accepted without reference to the financial ability of the Indemnified Person
to make such repayments.
(c) The Company shall not indemnify any Indemnified Person in connection
with a proceeding (or part thereof) initiated by such person unless such
Indemnified Person is successful on the merits, the proceeding was authorized by
the Members or the proceeding seeks a declaratory judgment regarding such
Indemnified Person's own conduct.
(d) The indemnification rights provided in this Article 7 (i) shall not be
deemed exclusive of any other rights to which Indemnified Persons may be
entitled under any law, agreement or vote of disinterested Members or otherwise
and (ii) shall inure to the benefit of the heirs, executors and administrators
of Indemnified Persons. The Company may, to the extent authorized from time to
time by its Members, grant indemnification rights to employees or agents of the
Company or persons other than Indemnified Persons serving the Company and such
rights may be equivalent to, or greater or less than, those set forth in this
Article 7.
(e) No indemnification shall be provided for any Indemnified Person with
respect to (i) any matter as to which such Indemnified Person shall have been
finally adjudicated in any proceeding not to have acted in good faith in the
reasonable belief that such Indemnified Person's action was in the best
interests of the Company, (ii) any act which constitutes gross negligence or
wilful misconduct or (iii) any matter disposed of by a compromise payment by
such Indemnified Person, pursuant to a consent decree or otherwise, unless the
payment and
9
indemnification thereof have been approved by the Members, which approval shall
not unreasonably be withheld, or by a court of competent jurisdiction.
(f) Any amendment or repeal of the provisions of this Article 7 shall not
adversely affect any right or protection of an Indemnified Person with respect
to any act or omission of such Indemnified Person occurring prior to such
amendment or repeal.
ARTICLE 8. ASSIGNABILITY OF MEMBERSHIP INTERESTS
8.1 Assignment.
(a) Except in accordance with Article [13] of the Collaboration Agreement,
a Member may not assign his or her interest in whole or in part to any assignee
which is not already a Member without the prior written consent of all of the
other Members who may or may not consent in their absolute discretion.
(b) An assignment of a Member's interest does not of itself dissolve the
Company or permit the assignee to participate in the business and affairs of the
Company or to become a Member or exercise any rights or powers of a Member.
8.2 Substitute Members. No assignee of a Member's interest (other than an
assignee which is already a Member) shall have the right to be admitted as a
substitute member in place of the assignor (a "Substitute Member") unless:
(a) the assignor shall designate in writing satisfactory to the
other Members the intention that the assignee is to become a Substitute
Member;
(b) the assignee shall agree in writing to be bound by all of the
terms of this Agreement;
(c) all of the other Members consent in writing to the admission of
the assignee as a Substitute Member, which consent may be withheld in
their absolute discretion;
(d) the assignee shall execute and/or deliver such instruments,
including without limitation, an opinion of counsel satisfactory to the
Members, to the effect that such proposed assignment and substitution does
not violate the registration requirements of state or federal securities
laws, and such instrument as the Members deem necessary or desirable to
effect such assignee's admission as a Substitute Member and to evidence
the assignee's acceptance of the terms of this Agreement; and
(e) the assignee shall pay all reasonable expenses in connection
with the assignee's admission as a Substitute Member.
10
8.3 Rights of Assignees. An assignee who does not become a Substitute
Member shall succeed only to the rights of the assignor to receive allocations
and distributions from the Company as provided in Articles 5, 6 and 10 hereof,
and shall not have the right to become a Member or exercise any rights or powers
of a Member.
8.4 Other Restrictions. A Member may not pledge, encumber or hypothecate
any of its interest without the consent of the other Members.
ARTICLE 9. FISCAL YEAR, ACCOUNTING, INSPECTION OF BOOKS
9.1 Fiscal Year and Accounting. Except as otherwise approved by the
Members, or required by law, the fiscal year of the Company shall be the
calendar year and the books of the Company shall be kept on the accrual method.
9.2 Inspection of Books. The books of the Company shall at all times be
available for inspection and audit by any Member at the Company's principal
place of business during business hours. The Company shall furnish each Member
with all necessary tax reporting information as to its interest in the Company,
with an annual balance sheet and profit and loss statement and with a cash flow
statement showing any distributions made to the Members, within sixty (60) days
after the close of each fiscal year.
ARTICLE 10. DISSOLUTION
10.1 Events of Dissolution. The term of the Company shall commence on the
Effective Date and shall be in full force and effect until the earliest of the
following:
(a) the sale or disposition of all or substantially all of the
Company property;
(b) the dissolution of the Company by the unanimous written consent
of the Members;
(c) the bankruptcy or dissolution of a Member other than Subsidiary;
provided, however, that if there are at least two (2) remaining Members, the
Members may consent to the continuation of the business of the Company after the
occurrence of such an event, pursuant to Section 18-802 of the Act and Section
10.2 of this Agreement;
(d) the entry of a decree of judicial dissolution under Section
18-802 of the Act;
(e) the occurrence of any event, other than those referred to in
paragraph (d), which causes dissolution of a limited liability company under the
Act; or
(f) upon the occurrence of an event and at the time specified in
Article [13] of the Collaboration Agreement.
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Notwithstanding the dissolution of the Company, the business of the
Company shall continue to be governed by this Agreement until the winding up of
the Company occurs.
10.2 Consent to Continue Company. The Members may vote to continue the
business of the Company within ninety (90) days after the occurrence of an event
of dissolution set forth in Section 10.1(d) of this Agreement, pursuant to and
in accordance with Section 18-801(4) of the Act. The agreement of the remaining
Members holding a majority of the remaining Percentage Interests shall
constitute the consent of the Members to the continuation of the Company.
10.3 Distribution Upon Dissolution.
(a) After payment of liabilities owing to creditors, the Members or
liquidator shall set up such reserves as they deem reasonably necessary for any
contingent or unforeseen liabilities or obligations of the Company, including
the expenses of liquidation. Such reserves may be paid over by the Members or
liquidator to a bank, to be held in escrow for the purpose of paying any such
contingent or unforeseen liabilities or obligations and, at the expiration of
such period as the Members or liquidator may deem advisable, such reserves shall
be distributed to all of the Members or their assigns in the manner set forth in
Section 10.3(b) below. In the event that any part of such net assets consists of
securities or other non-cash assets, the Members or liquidator may (but shall
not be required to) take whatever steps they deem appropriate to convert such
assets into cash or into any other form that would facilitate the distribution
thereof.
(b) After payment has been made pursuant to Section 10.3(a) above, the
Members or the liquidator shall cause the remaining net assets of the Company to
be distributed to and among the Members in proportion to and to the extent of
their positive Capital Account balances (after such balances have been adjusted
to reflect all allocations of Net Profits and Net Losses and distributions
pursuant to Article 6). Cash and non-cash assets shall be distributed to each
Member on a pro rata basis, or in such other manner as the Members may agree,
with all noncash assets being distributed on the basis of their fair market
value.
(c) The Company shall terminate when all property has been distributed
among the Members. Upon such termination, the Members shall execute and cause to
be filed a certificate of cancellation of the Company, as provided for in
Section 18-203 of the Act, and any and all other documents necessary in
connection with the termination of the Company.
ARTICLE 11. GENERAL PROVISIONS
11.1 Complete Agreement; Modification. This Agreement and the
Collaboration Agreement together contain a complete statement of all the
agreements among the parties with respect to the Company. There are no
representations, agreements, arrangements or undertakings, oral or written,
between or among the parties to this Agreement relating to the subject matter of
this Agreement which are not fully expressed in this Agreement. This Agreement
may be amended or modified only with the unanimous consent of the Members.
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11.2 Governing Law; Severability. All questions with respect to the
construction of this Agreement and the rights and liabilities of the parties
shall be determined in accordance with the applicable provisions of the laws of
the State of Delaware, and this Agreement is intended to be performed in
accordance with, and only to the extent permitted by, all applicable laws,
ordinances, rules and regulations of such state. If any provision of this
Agreement, or the application thereof to any person or circumstances, shall, for
any reason and to any extent, be invalid or unenforceable, the remainder of this
Agreement and the application of that provision to other persons or
circumstances shall not be affected but rather be enforced to the extent
permitted by law.
11.3 Notice. All notices, requests, consents and statements hereunder
shall be deemed to have been properly given if mailed from within the United
States by prepaid certified mail, return receipt requested, or if sent by
prepaid telegram, or overnight delivery service, or if hand delivered, addressed
in each case if to the Company at its principal place of business and, if to any
Member, to the address set forth herein, or to such other address or addresses
as any such Member shall have theretofore designated in writing to the Company
in accordance with this Section 11.3.
11.4 Pronouns. Feminine or masculine pronouns shall be substituted for the
neuter pronouns, neuter pronouns for masculine or feminine pronouns, plural for
the singular and the singular for the plural, in any place in this Agreement
where the context may require such substitution.
11.5 Titles. The titles of Articles and Sections are included only for
convenience and shall not be construed as a part of this Agreement or in any
respect affecting or modifying its provisions.
11.6 Successors and Assigns. This Agreement shall be binding upon and
inure to the benefit of all parties hereto and their heirs, successors, assigns
and legal representatives.
11.7 Counterparts. This Agreement may be signed in one or more
counterparts and all counterparts so executed shall constitute one agreement
binding on all parties hereto, notwithstanding that all parties have not signed
the original or the same counterpart.
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IN WITNESS WHEREOF, we have affixed our signatures as of the day first
above written.
MEMBERS:
GENZYME CORPORATION
By:__________________________________
Title:_______________________________
Date:________________________________
DYAX CORP.
By:__________________________________
Title:_______________________________
Date:________________________________
SUBSIDIARY
By:__________________________________
Title:_______________________________
Date:________________________________
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Schedule A
Members Capital Contribution Percentage Interest
------- -------------------- -------------------
Genzyme Corporation 50.00%
Dyax Corp. 49.00%
Subsidiary 1.00%
-----
TOTAL: 100.00%
15
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
SCHEDULE 3.2
EXTERNAL PRODUCTS
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