EXHIBIT 10.26
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS
DENOTE SUCH OMISSIONS.
COLLABORATION AND LICENSE AGREEMENT
This COLLABORATION AND LICENSE AGREEMENT ("this Agreement"), effective
as of January 24, 2001 (the "Effective Date"), is between DYAX CORP., a Delaware
corporation, of One Kendall Square, Bldg. 600, Cambridge, Massachusetts 02139,
U.S.A. ("Dyax"), and DEBIOPHARM S.A., a Swiss corporation, of 17, rue des
Terreaux, 1000 Lausanne 9, Switzerland ("Debio"), the "Parties".
WHEREAS, Dyax and Debio are parties to a Research and Development
Agreement dated March 10, 1997 relating to EPI-HNE4, an inhibitor of human
neutrophil elastase; and
WHEREAS, the Parties wish to enter into this Agreement for the
commercialization of the results of the Research and Development Agreement, all
as herein defined and such commercialization rights shall be in accordance with
the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the mutual covenants set forth in
this Agreement, the Parties hereby agree as follows:
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS
ARTICLE 2. STATUS AND SCOPE
2.1 Status
2.2 Scope
ARTICLE 3. GRANTS AND RESERVATIONS OF RIGHTS
3.1 Grant of License and Sublicense by Dyax for CF Product
3.2 Grant of License and Sublicense by Dyax for Other Products
3.3 Grants of Licenses and Sublicenses by Debio
3.4 Other Therapeutic Indications Outside of the Field of Use
3.5 Additional Countries for the CF Product and Other Products
3.6 Limitation of Rights
ARTICLE 4. MANAGEMENT OF THE AGREEMENT
4.1 Steering Committee
4.2 Supply Committee
4.3 Post-Regulatory Approval Activities
4.4 General Disagreements
ARTICLE 5. RESEARCH PROGRAM
5.1 General
5.2 Responsibilities of Debio
5.3 Cooperation During the Research Program
ARTICLE 6. MANUFACTURE, SUPPLY AND COMMERCIALIZATION
6.1 General
6.2 API and Drug Product
6.3 Manufacture and Supply of Collaboration Products for Commercial Sale
6.4 Commercial Diligence
Article 7. PAYMENT AND ROYALTY OBLIGATIONS
7.1 Payments to Dyax
7.2 Payments to Debio
7.3 Use of Other Product Regulatory File by Dyax
7.4 Timing of Payments
7.5 Payments in U.S. Dollars
7.6 Records
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ARTICLE 8. USE OF MATERIALS AND INTELLECTUAL PROPERTY
8.1 Transfer and Handling of Materials
8.2 Ownership
8.3 Filing, Prosecution and Maintenance
8.4 Cooperation
8.5 Enforcement of Patent Rights; Defense of Infringement Actions
8.6 First Right to Respond
8.7 Second Right to Respond
8.8 Litigation and Settlement Expenses, and Awards
ARTICLE 9. CONFIDENTIALITY
ARTICLE 10. REPRESENTATIONS AND WARRANTIES
10.1 Authorization
10.2 Disclaimer of Representations and Warranties
10.3 Limitation of Liability
ARTICLE 11. INDEMNITY AND INSURANCE
11.1 Indemnity Obligations
11.2 Insurance
ARTICLE 12. PUBLICATIONS AND PUBLICITY
12.1 Publications
12.2 Publicity
ARTICLE 13. DISPUTE RESOLUTION
ARTICLE 14. TERM AND TERMINATION
14.1 Term
14.2 Termination
14.3 Effect of Termination
14.4 Notice of Termination
ARTICLE 15. MISCELLANEOUS
15.1 Force Majeure
15.2 Assignment
15.3 Law Governing
15.4 Severability
15.5 Notices
15.6 Entire Agreement
15.7 Headings
15.8 Independent Contractors
15.9 Waiver
15.10 Counterparts
EXHIBIT A: CF Patent Rights
EXHIBIT B: EPI-HNE Patent Rights
EXHIBIT C: Research Program
EXHIBIT D: Development Costs
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ARTICLE 1. DEFINITIONS
For purposes of this Agreement, the terms defined in this Article 1 shall have
the meanings specified below. Certain other capitalized terms are defined
elsewhere in this Agreement.
1.1 "AFFILIATES" shall mean any corporation or other business entity
controlled by, controlling, or under common control with or by either Party to
this Agreement. For this purpose, "control" means direct or indirect beneficial
ownership of more than fifty percent (50%) of the voting stock, or more than
fifty percent (50%) interest in the income, of a Party or of such corporation or
other business.
1.2 "CF KNOW-HOW" shall mean any and all [*****]
1.3 "CF PATENT RIGHTS" shall mean the patents and patent applications
of either Party that pertain to the Inventions (as defined in Section 8.2
hereof) arising out of the Research Program, in particular the patent
applications listed in EXHIBIT A attached hereto and hereby made a part hereof,
any and all continuations, divisions, renewals, reissues, reexaminations,
continuations-in-part and extensions corresponding thereto, and any patents
issuing therefrom.
1.4 "CF PRODUCT" shall mean the Product for cystic fibrosis which
includes the formulated active ingredient, related devices and the system of
delivery being developed pursuant to the Research Program described in this
Agreement.
1.5 "CONFIDENTIAL INFORMATION" shall mean each Party's confidential
information, know-how or data, and includes (i) test and development data,
processes, methods and technologies, and (ii) manufacturing, marketing,
personnel and other business information and plans, whether in oral, written,
graphic or electronic form, and which is identified as confidential.
Confidential information shall not be deemed confidential, and the receiving
Party shall have no obligation with respect to any (a) information which is
known by the receiving Party prior to disclosure by the furnishing Party, and
reduced to writing by the receiving Party, (b) information which is in the
public domain or subsequently enters the public domain through no fault of
either Party, (c) information that is received from an independent Third Party
with the lawful right to disclose, and (d) information that is independently
developed by the receiving Party without access to the Confidential Information
of the disclosing Party.
1.6 "DEBIO" shall mean Debiopharm S.A. and its Affiliates.
1.7 "DEVELOPMENT COSTS" shall mean the variable and fixed costs
incurred in connection with the conduct of the Research Program for the CF
Product by Debio and Dyax, as approved by the Steering Committee, 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 in the Territory and in
North America for such CF Product, (b)
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[*****]CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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amounts paid with respect to research and development for such CF Product,
including without limitation the efforts to develop and document process methods
and procedures for the manufacture, characterization and release of such CF
Product and the costs for batches of such CF Product manufactured and supplied
for use in preclinical and clinical trials, 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 CF Product, and (d) costs for preparing, submitting,
reviewing or developing data or information for the purpose of submission of
applications to obtain Regulatory Approvals in the Territory and in North
America for such CF Product. For purposes of this Section 1.7, "variable costs"
shall be deemed to be the cost of labor, raw materials, supplies and other
resources directly consumed in the conduct of the research, development and
manufacture of the CF Product for use in preclinical and clinical trials. For
purposes of this Section 1.7, "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 Research Program, development
and manufacture of the CF Product for use in preclinical and clinical trials,
allocated based upon the proportion of such costs directly attributable to
support the Research Program. Development Costs shall exclude any costs incurred
by either Party in connection with the conduct of the Research Program for which
such Party receives grants or subsidies, or reimbursement from the other Party
or from a Third Party outside of this Agreement. Development Costs shall not
include any costs associated with post-marketing surveillance or any other
post-approval activities even if required by any regulatory authority. All cost
determinations made hereunder shall be made in accordance with the accounting
standards and principles legally applicable to each Party, respectively.
1.8 "DYAX" shall mean Dyax Corp. and its Affiliates.
1.9 "DYAX NET SALES" shall mean [*****]
1.10 "EPI-HNE PATENT RIGHTS" shall mean the patents and patent
applications of Dyax listed in EXHIBIT B, attached hereto and hereby made a part
hereof, any and all continuations, divisions, renewals, reissues,
reexaminations, continuations-in-part and extensions corresponding thereto, and
any patents issuing therefrom.
1.11 "EPI-HNE TECHNOLOGY" shall mean molecules, including EPI-HNE4,
[*****] that produce EPI-HNE4 and methods of purifying EPI-HNE4 from [*****],
and other protein molecules with anti-neutrophil elastase activity as described
in the EPI-HNE Patent Rights.
1.12 "FDA" shall mean the United States Food and Drug Administration.
1.13 "FIELD OF USE" shall mean human therapeutic uses solely for the
treatment of (i) cystic fibrosis ("CF"), (ii) acute respiratory distress
syndrome ("ARDS"), and (iii) chronic obstructive pulmonary diseases ("COPD"),
such as emphysema and chronic bronchitis.
1.14 "FULLY ABSORBED COST OF GOODS" shall mean [*****]
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AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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1.15 "IND" shall mean an Investigational New Drug application or
similar application filed with the FDA.
1.16 "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 therapeutic product.
1.17 "NET REVENUES" shall mean [*****]
1.18 "NORTH AMERICA" shall mean the United States and Canada.
1.19 "OTHER PRODUCT" shall mean any Product that does not qualify as a
CF Product.
1.20 "OTHER RESEARCH PROGRAM" shall mean the comprehensive plan, time
schedule and budget for the development of EPI-HNE as an Other Product that the
Parties may subsequently agree upon and for which they then enter into an
amendment to this Agreement.
1.21 "PRODUCT" shall mean any pharmaceutical formulation containing
EPI-HNE for use in connection with any human therapeutic indication in the Field
of Use.
1.22 "REGULATORY APPROVALS" shall mean all approvals, designations or
grants (including orphan drug) from regulatory authorities in any country
required to lawfully manufacture and/or market a human therapeutic product in
any such country.
1.23 "RESEARCH AND DEVELOPMENT AGREEMENT" shall mean the Research and
Development Agreement between Debio and Dyax dated March 10, 1997.
1.24 "RESEARCH PROGRAM" shall mean the research conducted and developed
by Debio under the Research and Development Agreement and the comprehensive
plan, time schedule and budget for the preclinical and clinical development and
production of EPI-HNE4 as a CF Product, and the preparation and/or filing of
applications for Regulatory Approvals in the Territory and North America as more
fully described in Article 5 hereof and in EXHIBIT C, a preliminary version of
which is attached hereto and made a part hereof, which shall be finalized and
approved by the Steering Committee at its first meeting and thereafter may be
amended from time to time by the Steering Committee.
1.25 "SPECIFICATIONS" shall mean the written specifications for the CF
Product determined and approved by the Steering Committee as may be amended from
time to time by the Steering Committee; provided that such specifications shall
at all times comply with the relevant regulatory scheme in each country of sale
and in each country of use. Copies of such Specifications shall be maintained by
both Dyax and Debio and shall become a part of this Agreement as if incorporated
herein.
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[*****]CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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1.26 "STEERING COMMITTEE" shall mean the joint team composed of
representatives of Dyax and Debio responsible for overseeing the activities
conducted by the Parties pursuant to this Agreement.
1.27 "SUPPLY COMMITTEE" shall mean the joint team to be composed of
representatives of Dyax and Debio appointed by the Steering Committee to oversee
the activities pertaining to the manufacturing process and supply of the CF
Product.
1.28 "TERRITORY" shall mean the 15 countries of the European Union,
Norway, Iceland, Switzerland, the Czech and Slovak Republics, Poland, Hungary,
Romania, Bulgaria, Turkey, Israel, Albania, Liechtenstein, the Former Yugoslavia
and, with regard to any Other Product, any additional countries in which Dyax
may grant rights to Debio pursuant to Section 3.5.
1.29 "THIRD PARTY" shall mean any entity other than Dyax or Debio and
their respective Affiliates.
The above definitions are intended to encompass the defined terms in both the
singular and plural forms.
ARTICLE 2. STATUS AND SCOPE
2.1 STATUS. As of the Effective Date, Debio has completed through the
preclinical phase of the research contemplated by the Research and Development
Agreement and has completed Phase I Clinical Studies for EPI-HNE4 as a CF
Product. Debio has exercised its rights under the Research and Development
Agreement to obtain an exclusive license to commercialize Products in the
Territory. Debio has decided to make a CF Product the initial focus of its
efforts.
2.2 SCOPE. The Parties wish through this Agreement (1) to establish the
terms and conditions pursuant to which Debio shall continue and complete the
research and development of the CF Product under the Research Program, (2) to
provide for a plan by which the CF Product shall be manufactured and supplied
for use in the Phase II and Phase III Clinical Trials, and for
pre-commercialization and commercial purposes, (3) to grant the necessary
licenses to enable the Parties to accomplish the purposes of this Agreement, (4)
to provide for the overall management of this Agreement through a Steering
Committee which shall appoint a Supply Committee to oversee the manufacture and
supply of the CF Product, and (5) to otherwise set forth the rights and
obligations of each Party.
ARTICLE 3. GRANTS AND RESERVATIONS OF RIGHTS
3.1 GRANT OF LICENSE AND SUBLICENSE BY DYAX FOR CF PRODUCT. Subject to
the payment provisions of Section 7.1, Dyax hereby grants to Debio an exclusive
license with the right to sublicense during the term of this Agreement, under
the EPI-HNE Patent Rights, EPI-HNE Technology, the CF Know-How and CF Patent
Rights, to develop, use, offer for sale, sell, have sold, import and export CF
Product in the Territory and to make or have made or to purchase or have
purchased CF Product for such purposes.
3.2 GRANT OF LICENSE AND SUBLICENSE BY DYAX FOR OTHER PRODUCTS. Dyax
hereby grants to Debio, subject to the conditions, procedures and principles of
this Section 3.2, an exclusive license with the right to sublicense during the
term of this Agreement, under the EPI-HNE Patent Rights, EPI-HNE Technology, the
applicable CF Know-How and CF Patent Rights,
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to develop, use, offer for sale, sell, have sold, import and export any Other
Product in the Territory and to make or have made or to purchase or have
purchased such Other Products for such purposes. Should Debio wish to research,
develop and commercialize such an Other Product in the Territory while this
Agreement is in effect, Debio shall so notify the Steering Committee in writing,
including with such notice a proposal for an Other Research Program for such
Other Product. The Steering Committee shall meet and discuss Debio's research
proposal and the Parties shall then enter into an amendment to this Agreement
for the research, development and commercialization of such Other Product by
Debio pursuant to an Other Research Program, on applicable terms and conditions
comparable to the licensing of the CF Product hereunder. If, while this
Agreement is in effect, Dyax wishes to commercialize or have commercialized an
Other Product in the Territory that is not the subject of an Other Research
Program, Dyax shall notify the Steering Committee, including in such notice a
proposal for the commercialization of such Other Product. The Steering Committee
shall meet and discuss that proposal and shall endeavor to agree within a time
frame specified by the Steering Committee upon commercially reasonable terms by
which Debio shall commercialize such Other Product in the Territory that shall
then become incorporated into a mutually agreeable amendment to this Agreement.
The terms of such commercialization shall take into account the relative
contributions of each Party to the research and development of the Other Product
and the costs incurred in connection therewith by each such Party. Should Debio
not wish to commercialize such Other Product in the Territory, Dyax shall be
entitled to commercialize such Other Product in the Territory directly or
through a Third Party.
3.3 GRANTS OF LICENSES AND SUBLICENSES BY DEBIO. Debio hereby grants to
Dyax, under the CF Know-How and the CF Patent Rights:
(1) an exclusive license and sublicense, subject to the payment
provisions of Subsection 7.2 a., to develop, use, offer for
sale, sell, have sold, import and export CF Product in North
America and to make or have made or to purchase or have
purchased CF Product for such purposes;
(2) an exclusive license and sublicense, subject to the payment
provisions of Subsection 7.2 b., to develop, use, offer for
sale, sell, have sold, import and export CF Product outside of
the Territory and outside of North America and to make or have
made or to purchase or have purchased CF Product for such
purposes;
(3) an exclusive license and sublicense, free of royalties or
other payments to Debio, to develop, use, offer for sale,
sell, have sold, import and export Other Products outside of
the Territory and to make or have made or to purchase or have
purchased Other Products for such purposes;
(4) a worldwide exclusive license and sublicense, free of
royalties or other payments to Debio, to develop, use, offer
for sale, sell, have sold, import and export therapeutic
products outside of the Field of Use and to make or have made
or to purchase or have purchased therapeutic products outside
the Field of Use for such purposes;
(5) a worldwide exclusive license and sublicense, free of
royalties or other payments to Debio, to develop, use, offer
for sale, sell, have sold, import and export non-therapeutic
products and to make or have made or to purchase or have
purchased non-therapeutic products for such purposes.
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Nothing in subparagraphs (2) and (3) is intended to limit Debio's
rights under Section 3.5 and nothing in subparagraph (4) is intended to
limit Debio's rights under Section 3.4.
3.4 OTHER THERAPEUTIC INDICATIONS OUTSIDE OF THE FIELD OF USE. Debio
shall have the first right to negotiate a license in the Territory for the
rights to the EPI-HNE Patent Rights, EPI-HNE Technology, the CF Know-How and the
CF Patent Rights for any therapeutic indication outside the Field of Use,
provided that a Third Party does not already control the licensing of such
rights and that Dyax does not want to retain the rights to such therapeutic
indication for itself.
3.5 ADDITIONAL COUNTRIES FOR THE CF PRODUCT AND OTHER PRODUCTS. If at
any time that this Agreement is in effect Dyax wishes to outlicense to a Third
Party the rights to commercialize the CF Product or an Other Product in any
country or countries outside the Territory, Dyax shall give Debio a first right
of refusal to obtain a license to commercialize such CF Product or Other Product
for such additional country by providing notice to Debio through the Steering
Committee of its intention to outlicense and the proposed terms of the license
with a prospective Third Party (an "Offer Notice"), provided that Debio is not
in breach of any material term of this Agreement. Debio shall have sixty (60)
days after the receipt of an Offer Notice during which it may consider the terms
in the Offer Notice. If Debio has not delivered a written notice of its
acceptance of the terms in the Offer Notice to the Steering Committee within
such sixty (60) day period, Dyax shall be free to conclude an agreement with a
Third Party on materially the same terms or on terms more favorable to Dyax than
in the Offer Notice. Before concluding an agreement on terms less favorable to
Dyax than in the Offer Notice, Dyax must again offer such rights to Debio
following the same procedures, except that in the case of the same Third Party,
Debio shall only have thirty (30) days after receipt of the new terms to
consider the offer. The right of first refusal in this Section 3.5 shall apply
only to the outlicensing by Dyax to an independent unrelated Third Party of the
commercialization of the CF Product or Other Product. This right of first
refusal shall not apply to the commercialization by Dyax of the CF Product or an
Other Product in any country or countries outside of the Territory where Dyax
retains the rights to make or have made, sell or have sold the product.
3.6 LIMITATION OF RIGHTS. The licenses and options set forth in
Sections 3.1 through 3.5 shall at all times be subject to and conditioned upon
the satisfactory performance by the Parties of their obligations hereunder, in
particular the completion by Debio of the requirements of Section 5.2 and the
timely completion of all Debio tasks described in Exhibit C. Each Party agrees
that, except as expressly granted in this Agreement, no other rights or licenses
are granted to any patents, patent applications, inventions, trademarks, trade
secrets or other intellectual property, or to any materials, information, data
or know-how, of the other Party.
ARTICLE 4. MANAGEMENT OF THE AGREEMENT
4.1 STEERING COMMITTEE.
a. GENERAL. The Parties shall establish a Steering Committee to oversee
and manage the Research Program and commercialization activities contemplated by
this Agreement. The Steering Committee shall be composed of two (2)
representatives appointed by Dyax and two (2) representatives appointed by
Debio. Such representatives will be senior managers of their respective
companies. Within thirty (30) days following the signature of this Agreement,
each Party will notify to the other Party the identity of its first
representatives at the Steering Committee. The Steering Committee will meet for
the first time within three (3) months
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following the signature of this Agreement to finalize and approve the Research
Program and the Development Costs. Thereafter, the Steering Committee shall 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 either or both
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 that will be entitled to vote for the absent
member. 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 constitute the approval,
determination or other action of the Steering Committee, provided that at least
one representative of each Party is present on behalf of both representatives of
such Party. Representatives of either Dyax and Debio 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. At or before the commencement of
each meeting, the Steering Committee shall appoint one of its members to act as
secretary for such meeting or shall arrange for a person to be present in such
capacity. The Steering Committee shall keep accurate minutes of its
deliberations and shall record all proposed decisions and all actions
recommended or taken. The person acting as 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 Parties.
b. FUNCTIONS. The Steering Committee shall perform the following
functions: (1) determine the overall strategy for the Research Program in the
manner contemplated by this Agreement; (2) coordinate the activities of the
Parties hereunder, (3) review and approve the Research Program, Development
Costs and any amendments thereto, (4) review and approve the Specifications, (5)
appoint, oversee and settle disputes or disagreements that are unresolved by the
Supply Committee, (6) approve design of clinical trials and oversee clinical
trials, (7) approve any agreements with Third Party manufacturers for the supply
and manufacture of the CF Product, (8) review and consider any proposed Other
Research Program and any other notices provided pursuant to the rights set forth
in Sections 3.2, 3.4 and 3.5; (9) discuss all pertinent aspects of the
commercialization and other post-approval activities and, generally (10) perform
such other functions as appropriate to further the purposes of this Agreement as
determined by the Parties.
4.2 SUPPLY COMMITTEE.
a. GENERAL. The Steering Committee shall establish a Supply Committee
to oversee and to coordinate the manufacture and supply of the CF Product. The
Supply Committee shall be composed of not more than two (2) representatives
appointed by Dyax and two (2) representatives appointed by Debio. The Supply
Committee shall meet as needed, but not less than quarterly unless the Parties
mutually agree otherwise. Such meetings shall be at times and places or in such
form (e.g., telephone or video conference) as the members of the Supply
Committee shall agree. A Party may change one or more of its representatives to
the Supply Committee at any time. At or before the commencement of each meeting,
the Supply Committee shall appoint one of its members to act as secretary for
such meeting or shall arrange for a person to be present in such capacity. The
Supply Committee shall keep accurate minutes of its deliberations and shall
record all proposed decisions and all actions recommended or taken. The person
acting as the secretary shall be responsible for the preparation of draft
minutes. Draft minutes shall be sent to all members of the Supply Committee
within ten (10) working days after
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each meeting and shall be approved, if appropriate, at the next meeting. Copies
of all final minutes shall be provided to the Steering Committee, together with
any proposed actions requiring Steering Committee approval. All records of the
Supply Committee shall at all times be available to both parties.
b. FUNCTIONS. The Supply Committee shall be responsible for overseeing
the manufacture by Dyax of the active pharmaceutical ingredient ("API") and the
development by Debio of the final formulation, method and device for delivery
("Drug Product") of the CF Product. In connection with its responsibilities, the
Supply Committee shall perform the following functions: (1) assist and report to
the Steering Committee on an ongoing basis to facilitate the coordination,
control and timely development of the CF Product to obtain Regulatory Approvals,
(2) develop and prepare the Specifications for submission to the Steering
Committee for approval, (3) oversee relationships with Third Party Manufacturers
during the preclinical and clinical periods, (4) monitor and report on any
specific instructions with regard to the use and handling of the CF Product, (5)
oversee the response by either Party to requests for information from regulatory
agencies, (6) monitor compliance with laws and government regulations applicable
to the manufacture of CF Product in each country, (7) oversee scale up of the CF
Product to meet anticipated demand for preclinical, clinical trials and
commercial sale in accordance with the projections set forth in the Research
Program and (8) perform such other functions as directed by the Steering
Committee.
4.3 POST-REGULATORY APPROVAL ACTIVITIES. Before the CF Product has
received Regulatory Approvals in the Territory and in North America, each Party
will appoint one representative to work with the other Party to oversee the
manufacture of CF Product for commercialization purposes by a common supplier.
The representatives will perform the following functions: (1) monitor and
coordinate the relationships with Third Party manufacturers, (2) coordinate the
timely reporting between the Parties and with the regulatory agencies of the
occurrence of each material incident of CF Product performance required to be
reported to regulatory authorities, including without limitation adverse
reaction information, (3) coordinate and monitor the timely dissemination of any
required CF Product information and (4) such other functions as reasonably
required to carry out the intention of Section 6.3 of this Agreement. Each Party
will determine in its sole discretion the extent of its post-marketing
surveillance and/or post-regulatory approval activities, and will assume the
related cost.
4.4 GENERAL DISAGREEMENTS. All disagreements within the Supply
Committee and the Steering Committee shall be subject to the following:
(a) The representatives to the Steering Committee will negotiate in
good faith for a period of not less than thirty (30) days to attempt to resolve
the dispute. If the dispute involves the Supply Committee, the Steering
Committee will include the Supply Committee in its negotiations.
(b) In the event that the dispute is not resolved after the period
specified in clause (a) or if there is a dispute between the representatives
overseeing post regulatory approval activities, the applicable representatives
shall promptly present the disagreement to the Chief Executive Officers of Dyax
and Debio or a designee of such Chief Executive Officer reasonably acceptable to
the other Party.
(c) Such executives shall meet in person or discuss in a telephone or
video conference each of Dyax and Debio's views and explain the basis for such
dispute.
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(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 13 hereof.
ARTICLE 5. RESEARCH PROGRAM
5.1 GENERAL. The Research Program shall be supervised by the Steering
Committee. The Steering Committee will coordinate preclinical and clinical
testing of the CF Product and work with designated individuals at Dyax and Debio
in the preparation of filings for Regulatory Approvals for the CF Product in the
Territory and in North America. With the exception of the API activities for the
CF Product set forth in the Research Program and referenced in Section 6.2, the
Research Program will be conducted exclusively by Debio. Debio shall be
responsible for all expenses of the Research Program and costs incurred in
connection with the Research Program shall be Development Costs which must be
approved by the Steering Committee. The external Development Costs incurred to
date by Debio in connection with the Research Program and the projected external
Development Costs of Debio to complete the Research Program are set forth in
EXHIBIT D. The finalization and approval of the Research Program at the first
meeting of the Steering Committee, per Section 4.1, shall comprise the review
and completion of Exhibit D, in particular in order that (i) the internal
Development Costs of Debio (both incurred and projected) be added thereto, and
that (ii) the projected internal and external Development Costs of Dyax be shown
thereon. Each Party shall keep and maintain proper and complete records and
books of account documenting all Development Costs that it presents to the
Steering Committee for approval and shall permit independent accountants to have
access to its records and books for the sole purpose of determining the
appropriateness of all costs charged. The Steering Committee must agree to any
material change in the Research Program or in the projected Development Costs,
and the Research Program and projected Development Costs shall be amended to
reflect such agreed upon changes on an on-going basis. The updates shall address
any changes in schedule and budget, provide for regulatory plans and other
requirements necessary to conduct the activities set forth in the Research
Program, to obtain Regulatory Approvals in the Territory and in North America,
and to otherwise complete the research and development necessary to
commercialize a CF Product.
5.2 RESPONSIBILITIES OF DEBIO. Debio shall be responsible, at its
expense, for performing the tasks as described in the Research Program within
the required time frame. With the exception of the API activities that will be
performed by Dyax, the Research Program provides for the completion by Debio of
the preclinical and clinical activities for the CF Product necessary for
applying for and pursuing Regulatory Approvals in the Territory and in North
America as set forth in the Research Program including the designation of the CF
Product as an orphan drug in the Territory and in North America. While
performing the Research Program, Debio shall comply fully with current Good
Clinical Practice and regulatory requirements of the Territory and North America
and will diligently pursue the activities set forth therein. Debio shall
maintain and keep current the database of the clinical trial data accumulated
from all clinical trials of the CF Product conducted pursuant to the Research
Program and shall keep Dyax informed of the status of the clinical trials. Debio
shall provide regular reports to the Steering Committee regarding the status of
its work under the Research Program and will notify the Steering Committee as
soon as practicable of any delays in such work. In addition to seeking
Regulatory Approval for the Territory, during the course of the Research
Program, Debio shall be required to provide to Dyax the documentation and other
CF Know-How packaged in a format adequate for submission by Dyax of an IND and
NDA for Regulatory Approval of the CF Product in North America and that will be
compliant with the applicable regulatory requirements
-12-
of the FDA and its Canadian counterpart the HPB. The expectation of the Parties
is that upon completion of the Research Program and delivery by Debio of the CF
Know-How to Dyax, Dyax will not be required to perform any additional work or to
incur any additional costs associated with the development of the CF Product in
order to obtain Regulatory Approval in North America. After the submissions to
the FDA and HPB by Dyax, Debio shall continue to cooperate with and assist Dyax
upon Dyax's request, including the attendance at FDA and HPB meetings, in
connection with Dyax's Regulatory Approval in North America. If, subsequent to
the completion of the Research Program, further work that is not required to
obtain Regulatory Approval in the Territory is required by the FDA or HPB to
obtain Regulatory Approval in North America, Debio shall perform such further
work at its expense in a timely manner. In the event Debio fails to perform such
work in a timely manner to the satisfaction of the relevant regulatory
authority, Dyax may, after notice to Debio, perform it or to have it performed
by a Third Party and shall be able to recoup the full cost of such work before
making any payments to Debio pursuant to Section 7.2 a. Debio's performance
obligations pursuant to this Section 5.2 extends neither to post-marketing
surveillance nor to post-approval (Phase IV) studies.
5.3 COOPERATION DURING THE RESEARCH PROGRAM. The applying Party shall
keep the other Party informed of the status of the applying Party's applications
for Regulatory Approval contemplated by the Research Program, shall permit the
other Party to review and comment on documents prior to filing by the applying
Party, and where applicable, shall do the following:
a. ATTENDANCE AT REGULATORY MEETINGS. The applying Party shall provide
the other Party with prior notice of all meetings and teleconferences between
the applying Party's representatives and regulatory authorities regarding the CF
Product. The other Party shall have the right to have representatives
participate in all such meetings and teleconferences with the applying Party.
The applying Party shall keep a reasonably detailed record of each contact
between it and all regulatory authorities and deliver a copy of such record to
the other Party upon such Party's request.
b. ADVERSE EVENT REPORTING. Debio shall notify Dyax of any event
reported to any regulatory authority and of any serious adverse event
information, irrespective of its reason, promptly after Debio's receipt of such
information and as necessary for compliance with the applicable regulatory
requirements in the Territory and in North America. "Serious adverse event
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 or (e) involves a congenital
anomaly, cancer or overdose.
c. CLINICAL AND REGULATORY AUDITS. Debio shall permit Dyax to have
access during regular business hours and upon reasonable advance notice, to
Debio's records and facilities relating to the Research Program for the purpose
of monitoring compliance with current Good Clinical Practice and other
applicable regulatory requirements. Each Party shall have an irrevocable right
of access and reference to the Regulatory Approval filings, licenses and
facilities of the applying Party. Debio shall give Dyax a reasonable opportunity
to review and comment on the clinical protocols.
d. FACILITIES VISITS. Representatives of Dyax may visit the sites of
any clinical trials or other experiments being conducted by Debio under the
Research Program. If requested by Dyax, Debio shall cause appropriate
individuals working on the Research Program to be
-13-
available for meetings at the location of the facilities where such individuals
are employed at times reasonably convenient to Debio.
ARTICLE 6. MANUFACTURE, SUPPLY AND COMMERCIALIZATION
6.1 GENERAL.
a. Debio shall [*****] CF Product pursuant to the license set forth in
Section 3.1, or Other Product pursuant to the license set forth in Section 3.2,
and Debio shall be responsible for [*****] Dyax, which [*****] and shall, if so
requested by Debio, reasonably[*****], at no cost to Dyax except minor internal
costs.
b. The CF Product shall be manufactured and supplied in accordance with
its Specifications, with current Good Manufacturing Practice and in conformity
with all applicable regulatory requirements. To facilitate this requirement, the
Steering Committee shall appoint the Supply Committee that will oversee the
manufacture of the API and Drug Product for the CF Product for preclinical and
clinical testing as described in this Article 6. The post regulatory approval
activities pertaining to the manufacture and supply of CF Product for commercial
sale will be overseen jointly by a representative of each Party.
6.2 API AND DRUG PRODUCT. [*****]
6.3 MANUFACTURE AND SUPPLY OF CF PRODUCT FOR COMMERCIAL SALE. To
[*****] Each Party shall enter into an agreement for the manufacture and supply
of CF Product for commercial sale from such Third Parties (a "Supply
Agreement"). The designated representative of each Party for post regulatory
approval activities shall be responsible for coordinating the purchase by the
Parties of finished Drug Product from said Third Parties and shall also monitor
and oversee any ongoing post regulatory approval requirements with regard to the
CF Product. It shall be the responsibility of each Party to pay for all of the
CF Product for commercial sale that it orders from the Third Party
manufacturer(s) under its Supply Agreement.
6.4 COMMERCIAL DILIGENCE. After Regulatory Approvals have been
obtained, Debio in the case of the Territory and Dyax in the case of North
America, shall use commercially reasonable and diligent efforts to market,
distribute and sell or cause to be marketed, distributed and sold CF Product.
ARTICLE 7. PAYMENT AND ROYALTY OBLIGATIONS
7.1 PAYMENTS TO DYAX. In consideration for the license granted to Debio
by Dyax for the CF Product under Section 3.1 of this Agreement, Debio shall pay
Dyax [*****] of Debio's Net Revenues. In connection with the calculation of the
amount of Net Revenues due to Dyax, Debio [*****] approved by the Steering
Committee for the CF Product. The obligations of Debio to make payment to Dyax
hereunder shall continue on a country-by-country basis [*****]
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7.2 PAYMENTS TO DEBIO.
a. FOR NORTH AMERICA: In consideration for the full performance of
Debio's obligations pursuant to Section 5.2 and the license granted to Dyax by
Debio pursuant to Section 3.3(1), Dyax shall pay Debio a royalty of [*****] of
Dyax Net Sales for CF Product sold by Dyax for use in North America. The
obligations of Dyax to make royalty payments to Debio hereunder shall continue
until [*****] from the first commercial sale of CF Product in North America,
whichever is longer. If Dyax outlicenses to a Third Party the sales and
marketing of the CF Product in North America, Dyax shall pay to Debio, in lieu
of a [*****] royalty on Dyax Net Sales, [*****] of Dyax's Net Revenues received
by Dyax from such Third Party in connection with the outlicense.
b. OUTSIDE OF NORTH AMERICA: To the extent that Dyax uses the
documentation and CF Know-How delivered to Dyax by Debio pursuant to Section 5.2
for Regulatory Approval in North America to obtain Regulatory Approval for the
CF Product in any country outside of the Territory and North America, and in
consideration of the license granted to Dyax by Debio pursuant to Section
3.3(2), Dyax shall pay Debio a royalty of [*****] of Dyax Net Sales for CF
Product sold by Dyax for use in any such country. The obligations of Dyax to
make royalty payments to Debio hereunder shall continue until [*****], or for a
period of [*****] from the first commercial sale of CF Product in each relevant
country, whichever is longer. Subject to Debio's rights under Section 3.5,
should Dyax outlicense to a Third Party the sales and marketing of the CF
Product in any such country, Dyax shall pay to Debio, in lieu of a [*****]
royalty on Dyax Net Sales, [*****] of Dyax's Net Revenues received by Dyax from
such Third Party in connection with the outlicense. The provision of Section 5.2
allowing Dyax to recoup its full cost before making any payment to Debio
pursuant to Section 7.2 a. shall apply by analogy to Dyax's costs associated
with obtaining Regulatory Approvals in any such country.
7.3 USE OF OTHER PRODUCT REGULATORY FILE BY DYAX. Should the Parties
subsequently amend this Agreement to provide for an Other Research Program and
Dyax uses any of the Other Product know-how (which excludes any and all CF
Know-How for which Dyax shall have a paid up license pursuant to Section 3.3(3))
generated by Debio pursuant to any such Other Research Program or any patentable
inventions owned solely or jointly by Debio that arise out of such Other
Research Program (which exclude the CF Patent Rights for which Dyax shall have a
paid up license pursuant to Section 3.3(3)) in connection with obtaining
Regulatory Approval for an Other Product outside of the Territory, the amendment
shall provide that Dyax shall pay Debio, in connection with the
commercialization of each such Other Product, [*****] Dyax Net Revenues [*****]
Dyax shall have a [*****] exclusive worldwide license and sublicense to use all
Other Product know-how and Other Product patentable inventions for any
non-therapeutic uses.
7.4 TIMING OF PAYMENTS. Within 30 days after the conclusion of the
calendar quarter during which the first commercial sale of a CF Product occurs
in each country for which payments will be due by one Party to the other Party
under this Article 7, and within 30 days
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-15-
after the conclusion of each calendar quarter thereafter, the Party with the
payment obligation, shall deliver to the other Party, a report containing the
following information, on a country-by-country basis: Gross receipts from a CF
Product; calculation of Net Revenues or Dyax Net Sales, as the case may be,
together with the exchange rates used for conversion; and calculation of the
amount payable to the other Party for the applicable calendar quarter. Payment
shall be made contemporaneously with each report. If no royalties or other
payments are due for any reporting period, the report shall so state. The method
of payment shall be by check or wire transfer as directed from time to time by
the receiving Party. All amounts payable to either Party under this Agreement
will first be calculated in the currency of sale and then converted into U.S.
dollars in accordance with Section 7.5 and such amounts shall be paid, [*****]
7.5 PAYMENTS IN U.S. DOLLARS. All payments due under this Agreement
shall be payable in United States dollars. Conversion of foreign currency to
U.S. dollars shall be made at the conversion rate reported in the WALL STREET
JOURNAL as prevailing on the last working day of the applicable calendar
quarter. Any payments that are not paid on or before the date such payments are
due under this Agreement shall bear interest, to the extent permitted by law, at
two percentage points above the base prime rate of interest most recently
reported by THE WALL STREET JOURNAL, calculated based on the number of days that
payment is delinquent.
7.6 RECORDS. Each Party shall maintain, and shall obligate each
licensee and sublicensee to maintain, complete and accurate records containing
sufficient information to permit the other Party to confirm the accuracy of any
reports delivered to such Party in accordance with Section 7.4. The reporting
Party shall retain such records for at least [*****] after payment to the
receiving Party, during which time the other Party shall have the right, at its
expense, to cause an independent certified public accountant to inspect such
records during normal business hours for the sole purpose of verifying any
reports and payments delivered under this Agreement. Such accountant shall not
disclose to the auditing Party any information other than information relating
to the accuracy of reports and payments delivered under this Agreement and shall
provide the audited Party with a copy of any report given to the auditing Party.
The Parties shall reconcile any underpayment or overpayment within thirty (30)
days after the accountant delivers the results of the audit. In the event that
any audit performed under this Section 7.6 reveals an underpayment in excess of
[*****] for any period, the audited Party shall bear the full cost of such
audit.
ARTICLE 8. USE OF MATERIALS AND INTELLECTUAL PROPERTY
8.1 TRANSFER AND HANDLING OF MATERIALS. Debio shall use the EPI-HNE4
and any other materials provided to it by Dyax during the Research Program, the
Confidential Information of Dyax, the results of the Research Program and all
other CF Know-How solely for the purposes specified in this Agreement and
subject to the confidentiality provisions as set forth in Article 9.
8.2 OWNERSHIP. All right, title and interest in the EPI-HNE Patent
Rights and the EPI-HNE Technology shall be owned by Dyax. With regard to the CF
Know-How and the CF
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-16-
Patent Rights and subject to the rights granted by one Party to the other under
this Agreement: (1) all patentable inventions, improvements and any patent
rights appurtenant thereto (collectively, the "Inventions") that are discovered,
made or conceived solely by employees of Dyax or others acting on behalf of Dyax
("Dyax Inventions") shall be owned by Dyax, (2) all right, title and interest in
all Inventions that are discovered, made or conceived solely by employees of
Debio or others acting on behalf of Debio ("Debio Inventions") shall be owned by
Debio and (3) all right, title and interest in all Inventions that are
discovered, made or conceived jointly by employees of Dyax and Debio ("Joint
Inventions") shall be jointly owned by Debio and Dyax. Each Party shall promptly
disclose to the Steering Committee the making, conception or reduction to
practice of Inventions by employees or others acting on behalf of such Party and
shall make such Inventions available to the other for use as contemplated by the
rights granted under this Agreement.
8.3 FILING, PROSECUTION AND MAINTENANCE. Dyax shall, at its sole
expense, be responsible for the filing, prosecution and maintenance of the
EPI-HNE Patent Rights. With regard to the CF Patent Rights, each of Dyax and
Debio shall be responsible for the filing, prosecution and maintenance of all
patent applications and patents which make up its Inventions which expense shall
be covered by the owner of the Invention, unless the Steering Committee agrees
otherwise. The Steering Committee shall designate either Dyax or Debio as the
Party responsible for the filing, prosecution and maintenance of all patent
applications and patents, which make up any Joint Inventions and shall determine
the allocation of expenses associated therewith. Each of Dyax and Debio shall
consult with and keep the other informed regarding the preparation and filing,
prosecution and maintenance of its patent applications and patents.
8.4 COOPERATION. Each of Dyax and Debio shall make available to the
other Party (or to the other Party's authorized attorneys, agents or
representatives) its employees, agents or consultants assistance to the extent
necessary to enable the appropriate Party to file, prosecute and maintain patent
applications and resulting patents relating to Inventions allowing for a period
of time sufficient for such Party to obtain the assistance it needs from such
personnel. Where appropriate, each of Dyax and Debio shall sign or cause to have
signed all documents relating to said patent applications or patents at no
charge to the other Party.
8.5 ENFORCEMENT OF PATENT RIGHTS; DEFENSE OF INFRINGEMENT ACTIONS. Dyax
and Debio 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 this Article 8 or if either Party 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 CF Product or because of
attempts to invalidate any patents or patent applications for which it is
responsible pursuant to this Article 8.
8.6 FIRST RIGHT TO RESPOND. Dyax shall have the first right to respond
to or defend against any challenge or infringement of any right derived from the
EPI-HNE Patent Rights or to any charge of infringement upon the patent rights of
a Third Party, and each of Dyax and Debio shall have the first right to respond
to or defend against any challenge or infringement of the CF Patent Rights for
the Inventions for which it is responsible pursuant to this Article 8 or against
any charge of infringement. The Steering Committee shall determine the course of
action to respond or defend against any challenge or infringement for Inventions
owned jointly pursuant to this Article 8 or any charge of infringement. The
rights hereunder shall be exercised in a diligent and timely manner in order to
protect the rights of the Parties. In the event that a Party elects to respond
or defend, the other Party will cooperate with the responding Party's legal
-17-
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.
8.7 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 8.6 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, after confirming that the Party actually received notice, 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.
8.8 LITIGATION AND SETTLEMENT EXPENSES, AND AWARDS. The Steering
Committee shall determine whether the costs incurred (a) in responding to or
defending against a challenge to or infringement of a Party's patent rights, (b)
in settling any such actions, and (c) any damages paid as a result of such
actions may be deducted from Dyax Net Sales or Net Revenues, as the case may be.
With regard to any award or settlement granted to either Party in connection
with an action brought by such Party to enforce its patent rights, such Party
shall be entitled to recover all of its expenses, costs and fees incurred in
connection with such action and after the deduction thereof, any balance of such
award or settlement shall be shared in an equitable manner by the Parties as
determined by the Steering Committee.
ARTICLE 9. CONFIDENTIALITY
During the term of this Agreement, and for a period of five (5) years
thereafter, each Party shall maintain in confidence and use only for purposes
specifically authorized under this Agreement, Confidential Information of the
other Party. To the extent it is reasonably necessary or appropriate to fulfill
its obligations or exercise its rights under this Agreement, a Party may
disclose Confidential Information it is otherwise obligated under this Article 9
not to disclose, to its licensees, sublicensees, employees, consultants, outside
contractors, clinical investigators, potential partners and collaborators on a
need-to-know basis, on the condition that such entities or persons agree in
writing 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 licensees, 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 commercialize the Products. The
confidentiality provisions of this Article 9 shall not apply to the extent that
a Party is required to disclose information by applicable law, regulation or
order of a governmental agency or a court of competent jurisdiction; PROVIDED,
HOWEVER, that to the extent practicable, such Party (a) shall provide advance
written notice thereof to the other Party and consult with the other Party prior
to such disclosure with respect thereto, and (b) shall provide the other Party
with reasonable assistance, as requested by the other Party, to object to any
such disclosure or to request confidential treatment thereof, and (c) shall take
reasonable action to avoid and/or minimize the extent of such disclosure.
ARTICLE 10. REPRESENTATIONS AND WARRANTIES
10.1 AUTHORIZATION. Each Party warrants and represents to the other
Party that (a) it has the legal right and power to enter into this Agreement, to
extend the rights and licenses
-18-
granted to the other in this Agreement, and to perform fully its obligations
hereunder, (b) this 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 corporate 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
and licenses or this Agreement.
10.2 DISCLAIMER OF REPRESENTATIONS AND WARRANTIES. EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN SECTION 10.1, NEITHER DYAX NOR DEBIO MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND WITH REGARD TO SUCH
PARTY'S PATENT RIGHTS, INVENTIONS, RESEARCH OR KNOW-HOW, 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.
10.3 LIMITATION OF LIABILITY. Neither Party shall have a right to or
shall claim special, indirect or consequential damages, including lost profits,
for breach of this Agreement against the other Party. Remedies shall be limited
to claims for amounts due hereunder or as otherwise provided in this Agreement,
including claims for indemnification as provided in Article 11 hereof.
ARTICLE 11. INDEMNITY AND INSURANCE
11.1 INDEMNITY OBLIGATIONS. Each Party (the "Indemnifying Party") shall
defend, indemnify and hold harmless the other Party and its directors, officers,
employees and agents (the "Indemnified Party") from and against any and all
claims, liabilities, losses and expenses, including attorney's fees, incurred by
or asserted against the Indemnified Party arising out of the development,
testing, manufacture, handling or storage, or the sale or distribution by the
Indemnifying Party of any CF Product, 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.
11.2 INSURANCE. Debio shall obtain and maintain product liability
insurance with respect to the clinical trials and pre-commercialization
activities that it conducts pursuant to the Research Program in amounts
customary in the industry for the testing of novel therapeutic products. Debio
and Dyax shall each obtain product liability insurance for the sale of CF
Product in the Territory and in North America, respectively, in amounts
customary in the industry for the sale of novel therapeutic products. Each Party
shall obtain and maintain comprehensive general liability insurance, and for its
property in amounts customary in the industry. Debio shall obtain the
aforementioned product liability insurance on or before the commencement of the
clinical trials and Dyax shall obtain such product liability insurance prior to
the sale of CF Product in North America. Each Party shall provide the other
Party with evidence of the foregoing insurance upon the other Party's request.
ARTICLE 12. PUBLICATIONS AND PUBLICITY
12.1 PUBLICATIONS. It is the intention of the Parties that the results
of the Research Program be published. Before either Party wishes to publish, in
oral or written form, any results of the Research Program, it will promptly
notify the other Party and provide the other Party with a written copy of the
proposed publication at least two weeks prior to its submission for
-19-
publication or of an abstract of the proposed oral disclosure at least two weeks
prior to publication. At the receiving Party's request, the Party who wishes to
publish shall delay publication for a period sufficient for the appropriate
Party to file patent applications in accordance with the provisions of Article
8. No publication will disclose any Confidential Information without the prior
written permission of both Parties.
12.2 PUBLICITY. No public announcement concerning the terms of this
Agreement shall be made, either directly or indirectly, by any Party to this
Agreement without prior written notice and, except as may be legally required,
or as may be required for a public offering of securities, or as may be required
for recording purposes with any regulatory authority, without first obtaining
the approval of the other Party and agreement upon the nature and text of such
announcement, such agreement and/or approval not to be unreasonably withheld.
The Party desiring to make any such public announcement not permitted by the
preceding sentence shall inform the other Party of the proposed announcement or
disclosure at least five (5) business days prior to public release, and shall
provide the other Party with a written copy thereof, in order to allow such
other Party to comment upon such announcement or disclosure. This Section 12.2
shall not apply to any information in a public announcement that is information
essentially identical to that contained in a previous public announcement agreed
to pursuant to this paragraph.
ARTICLE 13. DISPUTE RESOLUTION
All disputes between the Parties arising out of the circumstances and
relationships contemplated by this Agreement including disputes relating to the
validity, construction or interpretation of this Agreement shall be in the first
instance referred to the respective Chief Executive Officers of the Parties. If
they fail to agree within 30 days after reference to them then any dispute shall
be resolved as follows:
13.1. With regard to disputes arising out of the actions by either
Party concerning any provision of this Agreement as it pertains to North
America, the Parties shall submit to mediation in accordance with the mediation
rules of the American Arbitration Association. If, and to the extent that, any
such dispute has not been settled within ninety (90) days of the commencement of
mediation, upon the filing of a Request for Arbitration by either Party, the
dispute shall be referred to and finally determined by arbitration under the
guidelines of the American Arbitration Association ("AAA") in Boston,
Massachusetts under the commercial rules then in effect for the AAA.
Alternatively, if, before the expiration of the said period of ninety (90) days,
either Party fails to participate or to continue to participate in the
mediation, the dispute shall, upon the filing of a Request for Arbitration by
the other Party, be referred to and finally determined by arbitration in
accordance with this Section 13.1.
13.2. With regard to disputes arising out of the actions by either
Party concerning any provision of this Agreement as it pertains to outside of
North America, the Parties shall submit to mediation in accordance with WIPO
Mediation Rules. If, and to the extent that, any such dispute has not been
settled within ninety (90) days of the commencement of mediation, upon the
filing of a Request for Arbitration by either Party, the dispute shall be
referred to and finally determined by arbitration in
-20-
accordance with the WIPO Expedited Arbitration Rules. Alternatively, if, before
the expiration of the said period of ninety (90) days, either Party fails to
participate or to continue to participate in the mediation, the dispute shall,
upon the filing of a Request for Arbitration by the other Party, be referred to
and finally determined by arbitration in accordance with this Section 13.2. The
place of mediation and arbitration shall be Geneva, Switzerland. The language to
be used in mediation and arbitration shall be English.
13.3 The decision of the arbitrator will be binding upon the Parties
without the right of appeal, and judgment upon the decision may be entered in
any court having jurisdiction thereof.
13.4 Nothing in this Article 13 is intended to limit the rights of
either Party to seek an injunction or other equitable relief from the other in a
court of competent jurisdiction in connection with the conduct of the other for
which no adequate remedy at law exists.
ARTICLE 14. TERM AND TERMINATION
14.1 TERM. Unless earlier terminated in accordance with this Article
14, this Agreement shall remain in effect until the CF Product is no longer
being supplied and manufactured for commercial sale. The obligations to pay
royalties on Dyax Net Sales or to share Net Revenues, as the case may be, shall
extend until the later of 10 years from the first commercial sale of the CF
Product in each relevant country or the last to expire of the applicable patent
right or orphan drug designation in each such country covering such CF Product
for which the payment obligation exists.
14.2 TERMINATION. This Agreement may be terminated, in its entirety or
with respect to certain countries, in the following circumstances:
14.2.1 TERMINATION BY DEBIO. Debio may terminate this
Agreement at any time and in its sole discretion upon six (6) month written
notice to Dyax, and Debio shall with such notice provide to Dyax all CF
Know-How.
14.2.2 TERMINATION BY DYAX WITH REGARD TO NORTH AMERICA. In
the event of [*****], Dyax may terminate this Agreement if [*****] Dyax shall
exercise its right to terminate under this Section 14.2.2 by giving Debio at
least [*****] days prior written notice. If the conditions [*****]
14.2.3 TERMINATION FOR NONPAYMENT. In the event that either
Party fails to make timely payment of any amounts due to the other Party under
this Agreement, the non-breaching Party shall have the option to either
terminate this Agreement upon thirty (30) days written notice to the breaching
Party, unless the breaching Party pays all past-due amounts prior to the
expiration of such thirty (30)-day notice period, or to offset its own payments
towards undisputed amounts past due by the breaching Party.
14.2.4 TERMINATION FOR OTHER MATERIAL BREACH. In the event
that either Party commits a material breach of any of its obligations under this
Agreement, other than that stated in Section 14.2.3, and such Party fails to
remedy that breach within ninety (90) days after receiving written notice
thereof from the other Party, that other Party may immediately terminate this
Agreement upon written notice to the breaching Party. For purposes of this
Section 14.2.4,
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and for the avoidance of doubt, a material breach of this Agreement shall
include the failure of Debio to comply fully and in a timely manner with each of
its obligations under Section 5.2 and as set forth in the Research Program. A
termination of this Agreement will be limited to the rights of Debio pertaining
to North America in the event Debio's material breach relates solely to its
obligation to supply Dyax with an IND and NDA acceptable for submission by Dyax
to the FDA and HPB and Debio has already satisfied the requirements for
Regulatory Approval in at least the countries in the Territory that are
participating in the centralized procedure for Regulatory Approvals set by the
European Agency for the Evaluation of Medicinal Products.
14.3 EFFECT OF TERMINATION. Upon the expiration or termination of this
Agreement by Debio pursuant to Section 14.2.1 or by Dyax pursuant to Sections
14.2.3 or 14.2.4, (i) Debio's rights under the licenses and rights granted
pursuant to Sections 3.1, 3.2, 3.4 and 3.5 shall terminate immediately, (ii)
Debio shall provide all of the CF Know-How to Dyax that has not yet been
delivered, (iii) Dyax shall be entitled to use all of the CF Know-How and CF
Patent Rights for any purposes, and (iv) Dyax's obligations to make payments to
Debio pursuant to Sections 7.2 and 7.3 shall terminate. Dyax's rights under the
licenses granted pursuant to Section 3.3 shall survive the expiration or
termination of this Agreement, other than for a termination of this Agreement by
Dyax pursuant to Section 14.2.2 or by Debio for a breach by Dyax pursuant to
Sections 14.2.3 and 14.2.4. Notwithstanding the expiration or termination,
subject to the payment and reporting provisions of Article 7, the terminated
Party may continue to sell any CF Product on hand as of the effective date of
termination. The following provisions shall also survive the expiration or
termination of this Agreement: Article 1 "Definitions", Section 3.6 "Limitation
of Rights", Article 8 "Use of Materials and Intellectual Property", Article 9
"Confidentiality", Article 10 "Representations and Warranties", Article 11
"Indemnity and Insurance", Article 12 "Publications and Publicity", Article 13
"Dispute Resolution" and Section 15.3 "Law Governing".
14.4 NOTICE OF TERMINATION. In the event that this Agreement is
terminated, Debio shall so notify each sublicensee with whom it has entered into
a sublicense agreement and each sublicense agreement shall so terminate.
ARTICLE 15. MISCELLANEOUS
15.1 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 or a Third 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 Party 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.
15.2 ASSIGNMENT. This Agreement may not be assigned or otherwise
transferred by any Party without the prior written consent of the other Party;
PROVIDED, HOWEVER, that either Party may, without such consent, assign its
rights and obligations under this Agreement (a) in
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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 15.2 shall be void. Nothing
herein is intended to prevent either Party from sublicensing any of its rights
in accordance with the terms of this Agreement.
15.3 LAW GOVERNING. 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.
15.4 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.
15.5 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 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 15.5 and shall be
effective upon receipt by the addressee.
IF TO DYAX: IF TO DEBIO:
Dyax Corp. Debiopharm S.A.
One Kendall Square, Bldg 600 17, rue des Terreaux
Cambridge, Massachusetts 02139, USA P.O. Box 211
Attention: Chief Executive Officer 1000 Lausanne 9, Switzerland
Facsimile: (+1617) 225-2501 Attention: Legal Director
Facsimile: (+4121) 321-0178
15.6 ENTIRE AGREEMENT. This Agreement contains 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. 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
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acknowledges that this Agreement is the result of mutual negotiation and
therefore any ambiguity in their respective terms shall not be construed against
the drafting Party.
15.7 HEADINGS. The Table of Contents and 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.
15.8 INDEPENDENT CONTRACTORS. It is expressly agreed that Dyax and
Debio shall be independent contractors and that the relationship between the two
Parties shall not constitute a partnership, joint venture or agency. Neither
Dyax nor Debio 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.
15.9 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.
15.10 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.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
DYAX CORP. DEBIOPHARM S. A.
By: /s/ Henry E. Blair By: /s/ Jean-Pierre Petchot-Bacque
------------------------------
Title: President Title: Medical Director
---------------------------
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EXHIBIT A
CF PATENT RIGHTS
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EXHIBIT B
EPI-HNE PATENT RIGHTS
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EXHIBIT C
DYAX/DEBIOPHARM COLLABORATION AND LICENSE AGREEMENT
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EXHIBIT D
DEVELOPMENT COSTS
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