Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Exhibit 10.26
RESEARCH AND DEVELOPMENT AGREEMENT
This RESEARCH AND DEVELOPMENT AGREEMENT ("Agreement") is made as of this
10th day of March, 1997 (hereinafter "Effective Date") by and between DEBIOPHARM
S.A., having its principal place of business at 00, xxx xxx Xxxxxxxx, XX-0000
Xxxxxxxx 0, Xxxxxxxxxxx ("Debio") and Dyax Corp., having its principal place of
business at One Xxxxxxx Square, Bldg. 600, 5th Floor, Cambridge, Massachusetts,
02139, USA ("Dyax") with respect to the following facts:
WITNESSETH:
WHEREAS, Dyax possesses certain know-how and proprietary rights, including
patents (granted and pending) concerning the identification, production and
purification of EPI-HNE4, an inhibitor of human neutrophil elastase, and of
other molecules with similar anti-neutrophil elastase activity;
WHEREAS, Debio possesses expertise in the development and registration of
therapeutic products and wishes to conduct certain "Research," as defined
herein, concerning EPI-HNE4 for the purpose of determining whether EPI-HNE4 has
therapeutic potential in humans; and
WHEREAS, both Dyax and Debio wish to enter into a Research and Development
Agreement, governing the "Research" to be conducted by Debio, which will then
provide Debio with the exclusive option to license certain exclusive rights to
develop and distribute EPI-HNE4 within certain geographic markets;
NOW, THEREFORE, Dyax and Debio agree as follows:
1. Definitions and Interpretations.
Terms, when used with initial capital letters, shall have the meanings set
forth below or at their first use when used in the Agreement.
1.1 "Affiliates" means 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 such
corporation or other business.
1
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
1.3 "Confidential Information," as used herein shall mean each party's
confidential information, know-how or data, and includes 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
information which is (a) 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 by the receiving party from an independent third party with the
lawful right to disclose. All test and development data, processes,
methods and other technology developed by Debio pursuant to the Agreement
shall also be "Confidential Information"
1.4 "Debio" shall mean Debiopharm S.A. and Affiliates.
1.5 Dyax" shall mean Dyax Corp. and Affiliates, and their successors and
assigns.
1.6 "EPI-HNE" 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 described in the Dyax patent application designated
LEY-1PCT in Exhibit A.
1.7 "EPI-HNE Patent Rights" shall mean the patent applications listed as
Exhibit A, attached hereto and hereby made a part hereof and any and all
continuations, divisions, renewals, reissues, reexaminations,
continuations-in-part and extensions corresponding thereto, and any
patents issuing therefrom.
1.8 "Know-How" shall mean any and all technical information, test and
development data, formulations, processes, ideas, protocols, regulatory
files and the like, which is non-patentable and discovered or developed
pursuant to the Research.
1.9 "Product" means any pharmaceutical formulation containing EPI-HNE for
use in the Field of Use (as defined in Section 15.2), pursuant to EPI-HNE
Patent Rights.
1.10 "Research" by Debio shall mean the procurement, investigation and
study of EPI-HNE4 for the purposes of determining whether EPI-HNE4 has
therapeutic potential in humans for the treatment of cystic fibrosis,
ARDS, or chronic obstructive pulmonary diseases, such as emphysema and
chronic bronchitis, all as set forth in the Research Plan in Exhibit B,
attached hereto and hereby made a part hereof.
2
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
1.11 "Revenues" shall mean the ************* from the commercial use or
sale of Product, including all payments from sublicensees, less the
following items: (a) *************, (b) payments *************, and (c)
payments ************* (and *************).
1.12 "Territory" means the countries of the European Union, Norway,
Iceland, Switzerland, Czech and Slovak Republics, Poland, Hungary,
Romania, Bulgaria, Turkey, Israel, Albania, Liechtenstein, Former
Yugoslavia and those Additional Countries in which Dyax may grant
rights to Debio pursuant to Article 15.2.2
2. The Development and Evaluation Work Phase.
2.1 Scope of Agreement.
2.1.1 Obligation of Dyax. To facilitate the Research, Dyax shall provide
a mutually acceptable contract manufacturer with EPI-HNE4 *********, at
no cost to Debio and all available information regarding the fermentation
of such strains and the purification of EPI-HNE4 ("EPI-HNE4 Materials")
for use solely in performance of the Research, under the conditions set
forth herein. Dyax shall also provide available information developed
by Dyax and third parties concerning the therapeutic potential of
EPI-HNE in humans.
2.1.2 Obligation of Debio. Debio agrees to perform the Research in
accordance with the Research Plan, as may be amended from time to time by
mutual agreement of the parties. The Research shall be conducted
at the sole expense of Debio.
2.1.3 Recordkeeping by Debio. Debio agrees to maintain records, in
accordance with generally accepted accounting practices in Switzerland, of
its research and development costs in performing the Research Plan. In the
event such costs are relevant to Revenue sharing in accordance with
Sections 4.4.1 or 15.3, Dyax shall have the right from time to time to
audit such records using an independent accountant.
2.2 Due Diligence and Workmanship. Debio shall use its best efforts to
conduct the Research in accordance with Good Clinical Practices and to
deliver to Dyax reports of the results. However, the parties agree that
the results of the Research cannot be accurately predicted, and that Debio
does not warrant or guarantee that the Research will yield any useful or
anticipated results. The sole obligation of Debio is to diligently pursue
the activities pursuant to the Research.
3
2.3 Development and Evaluation Phase Research Licenses.
2.3.1 License to Debio. For the term of this Agreement only and as
reasonably necessary to perform the Research (and with no commercial
rights), Dyax grants to Debio an exclusive royalty-free license under the
EPI-HNE Patent Rights, Dyax Know-How, EPI-HNE4 Materials and rights
arising under Section 4.1 herein in the Field of Use for the Territory.
2.3.2 To the best of Dyax's knowledge up to the Effective Date, the
EPI-HNE Patent Rights are valid and effective, as shown in Exhibit A, has
been properly filed, prosecuted and/or issued in the respective offices
and jurisdictions, and all applicable fees due and payable have been paid.
2.3.3 In the event that any of the EPI-HNE Patent Rights under Exhibit A
should not be granted or established by reasonable proof to Debio's
satisfaction, Debio may either terminate this Agreement under Section 8.1
or negotiate a license agreement with the relevant third party, in its
sole discretion, to conduct the Research.
3. Transfer and Handling of Materials.
3.1 Debio shall use the EPI-HNE4 Materials and Dyax Confidential
Information solely for the purposes specified in this Agreement and for no
other purpose, including without limitation, use in any research
activities other than those which relate directly to the purposes
specified herein, or for any commercial purpose. Such use shall be in
compliance with all applicable laws and regulations. Upon conclusion of
the Research, Debio shall return or destroy, as directed by Dyax, all
unused EPI-HNE4 Materials. Debio shall not sell, transfer, disclose or
otherwise provide access to the EPI-HNE4 Materials or Dyax Confidential
Information, any method or process relating thereto or any material that
could not have been made but for the foregoing, to any person or entity
without the prior express written consent of Dyax, except that Debio may
allow access to the EPI-HNE4 Materials to employees or agents for purposes
consistent with the Agreement. Debio will make diligent efforts to ensure
that such employees and agents will use the EPI-HNE4 Materials in a manner
that is consistent with the terms of the Agreement. Dyax shall use Debio
Know-How solely for the purposes specified in this Agreement and for no
other purpose.
3.2 Upon termination of the Agreement and except as provided under any
license agreement, Debio shall immediately cease all use, including,
without limitation, research and commercial use, of the EPI-HNE4 Materials
and Dyax Confidential Information and shall, according to Dyax's
instructions, destroy or return the EPI-HNE4 Materials and any copies or
replications thereof, under the control of Debio.
4
3.3 Debio acknowledges and agrees that the EPI-HNE4 Materials may have
biological and/or chemical properties that are unpredictable and unknown
at the time of transfer and that they are to be used with caution and
prudence.
3.4 Title to and ownership rights in the EPI-HNE4 Materials shall remain
with Dyax and Debio will acquire no title thereto as a result of this
Agreement.
4. Ownership of Results.
4.1 Patentable Inventions. Unless otherwise agreed to by the parties in
any license or other agreement, all patentable inventions, improvements
and any patent rights appurtenant thereto, conceived and reduced to
practice pursuant to the Research shall be owned jointly where created
jointly or solely by each party where so created. Licenses to any such
inventions, improvements and patent rights, however owned, shall be
governed by the terms of this Agreement and/or any future license
agreement pertaining to such rights.
4.1.1 If either party identifies or becomes aware of a patentable
invention, that party shall promptly submit a written description of the
subject matter of such invention to the other party. With regard to
inventions with application to the Research or future products within the
Field of Use, Debio shall have primary responsibility for determining
whether to file patent applications in the Territory, and shall be
responsible for determining the timing and scope of a patent
application and for selecting the countries for filing, and for the
filing, prosecution and maintenance of such patent application and all
patents issuing therefrom. Debio and Dyax shall provide to each other
all necessary cooperation relating to the filing, prosecution and
maintenance of such patent applications. All expenses for such matters
in the Territory shall be borne by Debio; provided however, that such
expenses shall be considered development costs for purposes of Section
15.3.
4.2 Know-How. Subject to Section 8 and unless otherwise agreed to by the
parties, any and all Know-How developed or discovered by Debio shall be
owned solely by Debio.
4.3 Cooperation. Both Debio and Dyax undertake to promptly notify the
other of any patentable invention, as described in Section 4.1, and to
cause their respective employees to sign and complete all such deeds,
documents, patent applications, assignments, and other instruments and to
do all such acts and things as are necessary to give full force and effect
to the terms and conditions contemplated by the Agreement and to make such
terms and conditions binding on their respective employees.
5
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
4.4 Rights of Dyax. Subject to Debio's rights to add additional countries
to its license pursuant to Section 15.2.2, as for all patentable
inventions and Know-How conceived as a result of the Research and owned
solely or jointly by Debio and subject to restrictions imposed by any
government source of grant monies received by Debio after the Effective
Date:
4.4.1 Outside of the Territory for all therapeutic uses, Dyax shall have
an exclusive license with the right to grant sublicenses; provided that
for any patentable invention and Know-How solely owned by Debio, Dyax
shall pay Debio *************; and
4.4.2 Throughout the world for all non-therapeutic uses, Dyax shall have a
royalty free exclusive license with the right to grant sublicenses.
5. Administration and Indemnification.
5.1 Representatives. Debio and Dyax will designate a person or persons of
their choice to act representatives during the term of this Agreement.
Dyax designates Xx. Xxxxxx Xxxxxx and Debio designates Xxxx X. Xxxxx to
act as representatives under this Agreement. Each party may change its
representative upon reasonable notice to the other party.
5.2 Reports and Access to Data. The parties agree to provide each other
with written detailed Research Status Reports no less frequently than
************* and to provide the other with access to all Know-How and any
information related to any pre-clinical or clinical investigations
developed from the Research.
5.3 Insurance and Indemnification.
5.3.1 Debio shall indemnify and hold harmless Dyax, its employees and
agents against all third party actions, proceedings, claims, demands,
losses, costs, damages or expenses whatsoever which may be brought against
or suffered by Dyax or which Dyax may sustain as a result of use of
Product for testing in or treatment of humans by Debio or under Debio's
supervision.
5.3.2 Both Dyax and Debio agree that each company will assume liability
for its own losses, costs, damages, and expenses of any nature which it
may suffer, sustain, par or incur by reason of any matter or thing
arising out of, or in any way attributable to, the Research or any
other work performed under this Agreement, except as provided for under
6
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Section 5.3.1 or where losses, costs, damages or expenses are the result
of the willful breach of any term hereof by the other party, or by the
other party's servants, agents, employees or subcontractors. Each party
shall indemnify and hold harmless the other party, its employees and
agents against all third party actions, proceedings, claims, demands,
losses, costs, damages or expenses whatsoever which may be brought against
or suffered by the other party or which such party may sustain, as a
result of willful breach of any term hereof by the indemnifying party.
Such indemnification will survive termination of the Agreement.
5.3.3 Each party undertakes to notify the other party if it has any reason
to believe that the use of EPI-HNE, EPI-HNE4 Materials, or Confidential
Information could result in a claim by any third party, and the parties
agree that in such case they shall consult in good faith to take such
remedial actions that are necessary to avoid such liability.
5.3.4 Dyax shall take reasonable action to institute and prosecute
legal proceedings against third parties who infringe patents from the
EPI-HNE Patent Rights, or to otherwise defend any issued patent rights
for EPI-HNE4, in the Fields of Use in the Territory. Any such action,
taken under this paragraph, shall be at Dyax's expense. Debio shall, if
requested by Dyax and at Dyax's expense, assist in the prosecution of
such action.
5.4 Steering Committee.
5.4.1 The parties agree to form a Steering Committee to oversee the
Research and to undertake a development program to exploit all indications
for EPI-HNE *************. The Steering Committee shall be composed of two
representatives of Debio and two representatives of Dyax. Such Committee
shall meet at least every six months (more frequently, if deemed necessary
by at least two members of the Committee) to discuss the progress of the
Research and to consider options for development of new indications.
Representatives may be accompanied at such meetings by consultants and
experts bound by appropriate confidentiality agreements who may
participate, but may not vote at said meetings. Decisions of the Steering
Committee shall be made by a vote of three or more representatives of the
parties. Each party shall bear their own respective travel and
accommodation expenses, as well as all fees and costs incurred by their
consultants associated with attending such meetings.
6. Confidentiality.
6.1 The parties agree that Confidential Information exchanged during the
course of the Agreement will be accorded confidential treatment and shall not be
used for any other purpose than the performance of this Agreement for a period
of
7
Seven (7) years from the expiration or termination of the Agreement. Debio
and Dyax may disclose confidential information to candidate sublicensees
solely for the purpose of entering into a business relationship subject to
these candidate sublicensees entering into confidentiality and non-use
agreements no less restrictive than the terms and conditions of Section 6.1.
7. General Provisions.
7.1 Notices. Notices required or permitted to be made or given to either
party hereto pursuant to this Agreement shall be sufficiently made or
given on the date of mailing if sent to such party by certified or
registered mail, postage prepaid, addressed to it at its address set forth
or to such other address as it shall designate by written notice to the
other party as follows:
In the case of Dyax:
Dyax Corp.
One Xxxxxxx Square, Bldg. 600, 5th Floor
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxxx Xxxxxx
In the case of Debio:
Debiopharm S.A.
00, xxx xxx Xxxxxxxx
Xxxx Xxxxxxx 000
XX-0000 Xxxxxxxx 0
Xxxxxxxxxxx
Attn: Legal Department
Copies to:
Kostopulos & Associates
000 X. Xxxxxxx Xx., Xxxxx 000
Xxxxxxxxxx, XX 00000
Attn: N. Xxxxx Xxxxxxxxxx
Telecopier: (000) 000-0000
8. Termination.The Agreement can be terminated at anytime depending upon the
following circumstances:
8.1 The Agreement can be terminated by Debio alone, at any time upon three
(3) months written notice to Dyax.
8.2 In the event that the Agreement is terminated by Debio under Section
8.1 or by Dyax under Section 8.3, all rights granted to Debio under
Section 2.3.1 shall revert to Dyax. The parties shall meet immediately to
negotiate an assignment to Dyax to all Know-
8
How under Sections 4.1 and 4.2, information under Section 5.2, and all
regulatory filings. With respect to the assignment of any patentable
inventions and/or patent filings which are solely owned by Debio, the
amounts and details will be negotiated in good faith by Debio and Dyax.
8.3 In the event of any breach of any material term or condition of this
Agreement by either party, the non-breaching party shall give sixty (60)
days written notice to the breaching party to correct such breach, along
with a written explanation supporting its reasons for termination. In the
event the breach is not cured with the sixty-day period, the non-breaching
party shall have the following rights:
8.3.1 immediately terminate and/or modify this Agreement; provided,
however the non-breaching party shall continue to have all rights under
this Agreement, including the right to conduct Research under 2.3.1 and
the right to use all patentable inventions under Section 4.1, all know-how
under Section 4.2, information under Section 5.2, and all regulatory
filings, as well as the license options under Section 15; all of which,
under terms and conditions no less favorable than provided for under this
Agreement;
8.3.2 receive losses and damages sustained as a result of the breach(s) by
the breaching party, unless otherwise excluded or limited by a provision
of the Agreement.
9. Term of Agreement. Unless terminated earlier pursuant to Section 8 or other
mutual agreement, this Agreement shall commence upon the Effective Date and
shall terminate upon the expiration of the option set forth in Section 15.
Sections 4.1, 4.4 5.2, 5.3, 6 and 7.1 shall survive expiration or termination of
the Agreement
10. Independent Contractor. The relationship of Debio and Dyax under this
Agreement is intended to be that of an independent contractor. Nothing contained
in this Agreement is intended or is to be construed so as to constitute the
undersigned parties as partners or either party hereto as an agent or employee
of the other. Neither party has any express or implied right or authority under
this Agreement to assume or create any obligations on behalf of or in the name
of the other, or to bind the other party hereto to any contract, agreement or
undertaking with any third party.
11. Complete Agreement. The parties hereto acknowledge that this document sets
forth the entire agreement and understanding of the parties, except for
pre-existing confidentiality obligations between the parties, and supersedes all
prior written or oral agreements or understandings with respect to the subject
matter hereof. No modification of this Agreement shall be deemed to be valid
unless in writing and signed by both parties.
12. Assignment. This Agreement shall be binding upon and inure to the benefit of
the successors or permitted assignees of each of the parties, and may not be
assigned or transferred by either party without the prior written consent of the
other.
9
13. Law Governing and Dispute Resolution.
13.1 This Agreement shall be governed by and construed under the laws of
the Commonwealth of Massachusetts.
13.2 In the event the parties are unable to resolve a dispute, the parties
shall engage a single mediator acceptable to both parties. Said mediator
will immediately meet with Senior Vice Presidents of both parties to
discuss the basis for the dispute and to attempt to resolve the dispute.
13.3 Any dispute, controversy or claim arising under, out of or relating
to this Agreement and any subsequent amendments of this Agreement,
including, without limitation, its formation, validity, binding effect,
interpretation, performance, breach or termination, as well as non
contractual claims, shall be referred to and finally determined by
arbitration in accordance with the WIPO Arbitration Rules. The arbitral
tribunal shall consist of three arbitrators. The place of arbitration
shall be Geneva, Switzerland. The language to be used in the arbitral
proceedings shall be English.
14. Execution. This Agreement shall be executed in two (2) counterparts, each of
which shall be deemed an original, but both of which together shall constitute
one and the same instrument.
15. Option to Obtain License. Dyax hereby grants to Debio an option to enter
into an exclusive license to manufacture, have manufactured, use and sell
EPI-HNE products in the Territory (the "License Agreement"), for a period of
three (3) years after the Effective Date subject to extension until
completion of the first Phase II clinical trial in the Research Plan if such
trial has been started (the "Option Period"). Debio shall not pay any licnese
fee (cash or milestones) to Dyax for entering into the License Agreement.
Such a license with Debio shall include, among other things, the following
terms:
15.1 Definitions. The license agreement shall incorporate definitions from
the Research and Development Agreement, plus additional definitions deemed
appropriate by the parties.
15.2 Grant of Rights Dyax shall grant exclusive rights, including the
right to sublicense, to make, have made, use and sell Product, under the
EPI-HNE Patent Rights, Dyax Know-How, inventions and know-how developed
under Sections 4.1 and 4.2 in this Agreement, for the following
therapeutic uses: treatment of cystic fibrosis, ARDS or chronic
obstructive pulmonary diseases, such as emphysema and chronic
bronchitis ("Field of Use").
15.2.1 Other Indications. Debio shall have the first right to negotiate a
license in the Territory for the rights to any other therapeutic
indication outside of the Field of Use, provided that a third party does
not already control the licensing of such rights.
10
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
15.2.2 Additional Countries. If at the time of the license in the
Territory set forth in this Section 15 is granted to Debio and rights to
commercialize EPI-HNE in the Field of Use remain available outside the
Territory (including for North America), Dyax shall grant Debio a right
of first refusal to such other countries. Dyax will deliver written
notice to Debio of its intention to grant such rights to a third party,
of the country or countries concerned and of the proposed terms of such
a grant (an "Offer Notice"). 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 written ntoice of its
acceptance of the terms in the Offer Notice within such sixty (60) day
period, Dyax shall be free to negotiate with third parties and to
conclude an agreement with a third party on the same terms or on terms
even more favorable to Dyax than in the Offer Notice. Before concluding
an agreement with a third party on terms less favorable to Dyax, Dyax
must again offer such rights to Debio following the same procedure.
15.3 Royalties.
15.3.1 Payments to Dyax. As to rights granted by Dyax to Debio, Debio
shall pay Dyax ************* of all Revenues received by Debio in the
Field of Use in the Territory. Prior to sharing such Revenues with Dyax,
Debio shall be entitled to ************* equal to *************. In the
event that *************, the parties agree *************.
15.3.2 Duration of Payments. Payments under 15.3.1 shall continue on a
country-by-country basis until the expiration or finally determined
invalidity of all patents, granted or to be granted, covering the products
for which Revenues are being received in each country, or for
ten (10) years from the first Commercial Sale of Product in each country,
whichever is longer, provided that revenues are being received on the
Product.
15.4 Territory. The territory will be the same geographic areas as defined
in the Agreement.
15.5 Exercise of the option. At any time during the Option Period, Debio
may notify Dyax that Debio exercises the option. Debio and Dyax shall then
meet at their mutual convenience to negotiate in good faith the remaining
terms of the License Agreement.
15.5.1 If Debio and Dyax have not signed the License Agreement within
90 days from the exercise of the option,
11
Confidential material omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
either party may refer the matter to mediation followed, in the absence of
an agreement, by arbitration.
15.5.2 The License Agreement will be effective no later than *************
after the commencement of the mediation, even if the final agreement is
reached later or the final decision is rendered later.
15.5.3 Mediation. Any disagreement as to the terms of the License
Agreement shall be submitted to mediation in accordance with the WIPO
Mediation Rules. The place of mediation shall be Geneva. The language to
be used in the mediation shall be English.
15.5.4 Arbitration. If, and to the extent that, any such disagreement as
to the terms of the License Agreement has not been settled pursuant to the
mediation within 90 days of the commencement of the mediation, it
shall, upon the filing of a Request for Arbitration by either party, be
referred to and finally determined by arbitration in accordance with
the WIPO Expedited Arbitration Rules. Alternatively, if, before the
expiration of the said period of 90 days, either party fails to
participate or to continue to participate in the mediation, the
disagreement as to the terms of the License Agreement shall, upon the
filing of a Request for Arbitration by the other party, be referred to
and finally determined by arbitration in accordance with the WIPO
Expedited Arbitration Rules. The place of arbitration shall be Geneva.
The language to be used in the arbitral proceedings shall be English.
15.5.4.1 Within a short period to be fixed by the Arbitral Tribunal, each
party shall submit to the Arbitral Tribunal a full proposal for the
License Agreement, which will not be communicated to the other party. The
Arbitral Tribunal shall then decide which of the two proposals is closer
to the common intent of the parties as evidenced by documentary record
between the two parties, including, but not limited to the research and
development program and correspondence between the parties. The Arbitral
Tribunal is authorised to decide ex8aequo et xxxx. The Arbitral Tribunal
may not take some terms in one proposal and some other terms in the other
proposal, but shall choose one proposal and decide that it shall
constitute the License Agreement deemed entered into by the parties.
16. Force Majeure.
16.1 Neither party shall be liable for a failure to comply with a
provision herein, if it is prevented from performing the said provision
because of force majeure, this notion being defined as an event beyond the
control of the parties hereto and independent from their will including,
but not limited to, strikes or other labor trouble, war,
12
insurrection, fire, flood, explosion, discontinuity in supply of power,
court order or governmental interference.
16.2 Despite the event of force majeure, either party hereto shall
undertake reasonable efforts to comply to the extent possible with its
obligations vis-a-vis the other party, pursuant to this Agreement.
16.3 The party invoking an event of force majeure must notify it forthwith
to the other party, and must specify which one or ones of its obligations
it is being prevented from complying with, and the nature of force
majeure, and must give an estimate of the period during which it is likely
that it shall be prevented from complying with the said obligation or
obligations.
17. Miscellaneous.
17.1 In the event that, during the duration of this Agreement, the
regulations in force at the time of its execution are drastically
modified, or in the event that the data on which the parties hereto relied
to enter into this Agreement change in such a manner that one party shall
suffer severe hardship, which could not reasonably be foreseen as of the
date on which this Agreement was executed, the parties hereto shall then
meet and adapt the conditions of this Agreement to the new situation, in a
manner equitable to both parties.
17.2 If any provision of this Agreement should be or become fully or
partly invalid or unenforceable for any reason whatsoever or should
violate any applicable law, this Agreement is to be considered divisible
as to such provision and such provision is to be deemed deleted from this
Agreement, and the remainder of this Agreement shall be valid and binding
as if such provision were not included therein. There shall be substituted
for any such provision deemed to be deleted a suitable provision which, as
far as is legally possible, comes nearest to the sense and purpose of the
stricken provision.
17.3 Failure by any party to enforce any term or provision of this
Agreement in any specific instance or instances hereunder shall not
constitute a waiver by such party of any such term or provision, and such
party may enforce such term or provision in any subsequent instance
without any limitation or penalty whatsoever.
17.4 The headings set forth in this Agreement are for convenience only and
do not qualify or affect the terms or conditions of this Agreement.
13
IN WITNESS WHEREOF, the Parties have executed this Agreement on the day and year
first above written.
DEBIOPHARM S.A. DYAX CORP.
By: /s/ R.Y. Mauvernay By: /s/ L. Xxxxxx Xxxxxx
------------------------ ----------------------
11/3/97 3/3/97
14
EXHIBIT A - EPI-HNE Patent Rights
Confidential
DYAX NEUTROPHIL ELASTASE INHIBITOR PATENT RIGHTS
===============================================================================
COUNTRY APPLICATION NO. FILING DATE STATUS
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US 08/133,031 2/28/92 Abandoned in
(Xxxxxx 7C) favor of US
08/358,160
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Canada 2,105,304 2/28/92 Pending
(Xxxxxx 7C)
-------------------------------------------------------------------------------
EPO 92/9088481.2 2/28/92 Pending
(Xxxxxx 7C)
-------------------------------------------------------------------------------
Japan 92/508204 2/28/92 Pending
(Xxxxxx 7C) 4-507558 pub 9/1/93
-------------------------------------------------------------------------------
PCT US92/01501 2/28/92
(Xxxxxx 7C) WO92/15605
-------------------------------------------------------------------------------
US 08/358,160 12/16/94 Allowed
(Ley 1)
-------------------------------------------------------------------------------
PCT US95/16349 12/15/95 Will go
(Ley 1A) WO national
6/16/97
===============================================================================
* Priority applciations: USSN 664,989 filed 3/1/91 (Xxxxxx 7 which issued as
US Patent 5,223,409) and USSN 715,834 filed 6/1/91 (Xxxxxx 9 abandoned in
favor of 08/133,031)
15
AMENDMENT No. 1
TO THE
RESEARCH AND DEVELOPMENT AGREEMENT
BETWEEN DEBIOPHARM S.A. AND DYAX CORP.
This Amendment (the "Amendment"), effective as of May 10, 2000, is made
by and between DEBIOPHARM S.A. ("Debio") and DYAX CORP. ("Dyax") to the
Research and Development Agreement effective as of March 10, 1997 (the
"Agreement").
WHEREAS, Debio has, by letter dated February 29, 2000, exercised its
option pursuant to Article 15 of the Agreement to obtain a license, and the
parties have been and are continuing to negotiate the terms of such license;
WHEREAS, Section 15.5.1 of the Agreement provides that, if Debio and
Dyax have not signed the license agreement within 90 days from the exercise
of the option, either party may refer the matter to mediation followed, in
the absence of an agreement, by arbitration;
WHEREAS, notwithstanding the ongoing negotiations, the parties do not
anticipate to have signed a license agreement by May 28, 2000; and
WHEREAS, the parties wish to extend the 90-day period set forth in
Section 15.5.1 of the Agreement.
NOW, THEREFORE, the parties hereto agree as follows:
1. The parties hereby agree to extend the 90-day negotiation period set
forth in Section 15.5.1 of the Agreement until up through and including
September 15, 2000.
2. Except as modified herein, all other terms and conditions of the
Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, the parties hereto have signed this Amendment as of the
date set forth above.
DEBIOPHARM S.A. DYAX CORP.
By: /s/ Xxxxxxx-Xxxx Mauvernay By: /s/ Xxxxx X. Xxxxx
-------------------------- ----------------------------
Name: Xxxxxxx-Xxxx Mauvernay Name: Xxxxx X. Xxxxx
Title: President Title: CEO and Chairman
