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EXHIBIT 10.20
CONFIDENTIAL MATERIAL OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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.
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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, *************** 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.
1.11 "Revenues" shall mean the *************** from the commercial use
or sale of Product, including all payments from sublicensees, less the
following items: (a) ***************,
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SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
(b) payments ***************, and (c) payments *************** (and
***************).
1.12 "Territory" means the countries of the European Union,
*************** 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 *************** 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
***************.
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.
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.
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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.
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 appurte- nant thereto, conceived and reduced to
practice pursuant
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
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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, *************** 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 ***************.
4.2 KNOW-HOW. Subject to Section 8 and unless otherwise agreed to by the
parties, ***************.
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
makesuch terms and conditions binding on their respective employees.
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.
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SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
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 ***************, the Research or
any other work performed under this Agreement, except as provided for
under 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 *************** 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
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
under this paragraph, shall be at *************** expense.
*************** shall, if requested by *************** and at
*************** 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 *************** 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
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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-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
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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.
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
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*************** in the Research Plan if such *************** has been started
(the "Option Period"). Debio shall not *************** 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: ***************, such as ***************
("Field of Use").
15.2.1 OTHER INDICATIONS. Debio shall have the *************** 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.
15.2.2 ADDITIONAL COUNTRIES. *************** and rights to
commercialize EPI-HNE in the Field of Use *************** outside the
Territory *************** Dyax shall grant Debio a *************** to
such other countries. Dyax will *************** to Debio of
*************** (***************). Debio shall *************** after
the *************** during which ***************. If Debio
***************, Dyax shall *************** and to ***************.
Before *************** with ***************, Dyax ***************.
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
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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
*************** from the exercise of the option, 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 *************** 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 ***************, 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 ex_aequo 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.
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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,
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.
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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.R. Mauvernay By: /s/ L. Xxxxxx Xxxxxx
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11/3/97 3/3/97
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EXHIBIT A - EPI-HNE Patent Rights
CONFIDENTIAL
DYAX NEUTROPHIL ELASTASE INHIBITOR PATENT RIGHTS
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COUNTRY APPLICATION NO. FILING DATE STATUS
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US *************** *************** Abandoned
(Xxxxxx 7C) in favor
of US
*********
******
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Canada *************** *************** Pending
(Xxxxxx 7C)
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EPO *************** *************** Pending
(Xxxxxx 7C)
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Japan *************** *************** Pending
(Xxxxxx 7C)
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PCT *************** ***************
(Xxxxxx 7C)
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US *************** *************** Allowed
(Ley 1)
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PCT *************** *************** Will go
(Ley 1A) national
6/16/97
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* Priority applciations: USSN *************** filed ***************
(Xxxxxx 7 which issued as US Patent 5,223,409) and USSN ************
filed *************** (Xxxxxx 9 abandoned in favor of **************)
