Exhibit 10.85
Portions of this exhibit marked [*] are omitted and are requested to be treated
confidentially.
Execution Copy
DEVELOPMENT AND OPTION AGREEMENT
BETWEEN
ELAN PHARMA INTERNATIONAL LIMITED
AND
INCARA PHARMACEUTICALS CORPORATION
AND
AEOLUS PHARMACEUTICALS, INC.
Index
1 - DEFINITIONS
2 - RESEARCH AND DEVELOPMENT ACTIVITY
3 - STEERING COMMITTEE
4 - NON-COMPETITION
5 - PAYMENTS
6 - COMMERCIALISATION OPTION
7 - DEVELOPER LICENCE AGREEMENTS
8 - REPORTS
9 - WARRANTIES
10 - INDEMNIFICATION
11 - INTELLECTUAL PROPERTY
12 - TERM AND TERMINATION
13 - CONSEQUENCES OF TERMINATION
14 - CONFIDENTIAL INFORMATION/ANNOUNCEMENTS
15 - MISCELLANEOUS
SCHEDULE 1 - DEVELOPER PATENTS
SCHEDULE 2 - [*] HEADS OF AGREEMENT
SCHEDULE 3 - TECHNOLOGICAL COMPETITORS OF ELAN
SCHEDULE 4 - DUKE CONSENT
SCHEDULE 5 - NATIONAL JEWISH CONSENT
SCHEDULE 6 - PHASE I REPORT AND PHASE II REPORT
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
2
THIS AGREEMENT dated 15th May 2002
between:
(1) ELAN PHARMA INTERNATIONAL LIMITED, a public limited company
incorporated under the laws of Ireland, and having its registered
office at WIL House, Shannon Business Park, Shannon, County Clare,
Ireland ("EPIL");
(2) INCARA PHARMACEUTICALS CORPORATION, a Delaware corporation, having its
office at 79 T.W. Alexander Drive, 4401 Research Commons, Suite 200,
Research Triangle Park, North Carolina 27709; and
(3) AEOLUS PHARMACEUTICALS, INC., a Delaware corporation, having its office
at 79 T.W. Alexander Drive, 4401 Research Commons, Suite 200, Research
Triangle Park, North Carolina 27709
RECITALS:
A Incara and Aeolus are beneficially entitled to the use of various
patents, which have been granted or are pending under the International
Convention in relation to the development and production of drug
specific dosage forms for pharmaceutical products and processes.
B Incara, Aeolus and EPIL wish to cooperate in the research, development
and commercialisation of a series of catalytic antioxidant compounds
developed and licensed by Aeolus for a number of indications and routes
of administration.
C Incara and Aeolus have agreed to grant EPIL the option described in Clause 6.
NOW, IT IS HEREBY AGREED AS FOLLOWS in consideration of the mutual covenants
contained herein:
1 DEFINITIONS
For the purposes of this Agreement, the following terms shall have the
respective meanings set forth below:
"Aeolus" shall mean Aeolus Pharmaceuticals, Inc., a Delaware
corporation.
"Affiliate" shall mean a corporation or entity controlling, controlled
by, or under the common control with EPIL or Incara and Aeolus, as the
case may be, excluding, in the case of EPIL, an Elan JV. For the
purposes of this Agreement, "control" shall
3
mean the direct or indirect ownership of more than 50% of the issued
voting shares or other voting rights of the subject entity to elect
directors, or if not meeting the preceding criteria, any entity owned
or controlled by or owning or controlling at the maximum control or
ownership right permitted in the country where such entity exists.
"Albany" shall mean Albany Molecular Research, Inc.
"Albany Agreement" shall mean a research and manufacturing agreement
between Aeolus Pharmaceuticals, Inc. and Albany dated 4 August 1995.
"cGCP, cGMP, cGLP" shall mean respectively current Good Clinical
Practice, current Good Manufacturing Practice and current Good
Laboratory Practice as defined in the Federal Food, Drug and Cosmetic
Act and the regulations promulgated thereunder, as may be amended from
time to time, and/or equivalent laws and regulations in other countries
of the Territory, as applicable.
"Claims" shall mean all and any claims (whether successful or
otherwise), loss, liability, damages and expenses, including reasonable
attorneys' fees and expenses and legal costs.
"Commencement Date" shall have the meaning assigned thereto in Clause
2.2.
"Common Stock" shall have the same meaning as defined in the Securities
Purchase Agreement.
"Compounds" shall mean AEOL [*] and AEOL [*] and any additional
catalytic antioxidant compounds and/or related compounds that are
described by the Developer Patents.
"Confidential Information" shall mean know-how, trade secrets,
inventions (including patent applications covering such inventions),
data, information, and any improvements, modifications, derivations, or
compilations thereto that is owned, licensed by or controlled by the
disclosing party, provided however, that Confidential Information shall
not include any information which is:
(i) already known to the receiving party at the time of
disclosure, as evidenced by such party's written records,
provided such information was not obtained directly or
indirectly by the receiving party from the disclosing party
pursuant to a confidentiality agreement;
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
4
(ii) publicly known prior to or after disclosure, through no
default of the receiving party;
(iii) disclosed in good faith to the receiving party by a third
party, lawfully and contractually entitled to make such
disclosure; or
(iv) is independently discovered without the aid or application of
the Confidential Information as shall be evidenced by the
written records of the receiving party.
"Developer" shall mean Incara and Aeolus and any of their respective
Affiliates.
"Developer Intellectual Property" shall mean the Developer Patents,
Developer Know-How and Developer Improvements.
"Developer Improvements" shall mean any and all improvements to the
Developer Patents, Developer Know-How and/or Compounds that have been
conceived, created, developed and/or otherwise invented solely by, or
by a third party on behalf of, the Developer in the course of the
Development Plan.
In addition Developer Improvements shall include improvements to the
Developer Patents, the Developer Know-How and/or the Compounds
conceived, created, developed and/or otherwise invented by Developer
outside the Development Plan, except as limited by agreements with
third parties.
If the inclusion of any Developer Improvement in the EPIL Sub-Licence
is restricted or limited by a third party agreement, Developer shall
use reasonable commercial efforts to minimize any such restriction or
limitation.
"Developer Know-How" shall mean any and all rights owned, licensed or
controlled by the Developer to any scientific, pharmaceutical or
technical information, data, discovery, invention (whether patentable
or not), know-how, substances, techniques, processes, systems,
formulations, designs and expertise relating to the Compounds which is
not generally known to the public.
"Developer Patents" shall mean any and all rights under any and all
patent applications and/or patents, now existing, currently pending or
hereafter filed or obtained or licensed by Developer relating to the
Compounds examples of which are as set forth in Schedule 1, and any
foreign counterparts thereof and all divisionals, continuations,
continuations-in-part, any foreign counterparts thereof and all patents
issuing on any of the foregoing, and any foreign counterparts thereof,
together with all registrations, reissues, re-examinations,
supplemental protection certificates, or extensions thereof, and any
foreign counterparts thereof.
"Development Plan" shall have the meaning set out in Clause 2.1
5
"Developer Licence Agreements" shall mean the First Duke Agreement, the
Second Duke Agreement, the Third Duke Agreement, the National Jewish
Agreement and the Albany Agreement.
"Duke Consent" shall mean the consent of Duke University to the EPIL
Sub-Licence and certain other matters pursuant to the First Duke
Agreement and the Second Duke Agreement and the Third Duke Agreement by
letter of consent of Duke University dated 14 May 2002, and the
agreement by Duke University to certain amendments to the First Duke
Agreement and the Second Duke Agreement by way of amendment agreements
between Duke University and Aeolus each dated 14 May 2002 copies of
which are attached at Schedule 4.
"Effective Date" shall mean the date of this Agreement.
"Elan JV" shall mean an entity that Elan Corporation, plc and a third
party (i) establish or have established, (ii) take shareholdings in or
have a right to take shareholdings in, and (iii) grant certain licenses
in and to certain intellectual property rights for the purpose of
implementing a strategic alliance.
"EPIL Improvements" shall mean any and all rights to any scientific,
pharmaceutical or technical information, data, discovery, invention
(whether patentable or not), know-how, substances, techniques,
processes, systems, formulations, designs and expertise generated by,
or by a third party on behalf of, EPIL or jointly by EPIL and Developer
in the course of the Development Plan.
"EPIL Sub-Licence" shall have the meaning set out in Clause 6.1.
"EU" shall mean the Member States of the European Union, as same may
change from time to time in terms of Member States.
"Field" shall mean prevention and treatment of radiation-induced and
chemotherapy-induced tissue damage.
"First Duke Agreement" shall mean a licence agreement between Duke
University and Aeolus dated 21 July 1995 and any amendments thereto.
"First Phase I Milestone" shall mean the completion of dosing of
patients for a Phase I clinical trial for the Milestone Compound in the
Field. Completion of dosing shall mean that an agreed number of
patients have completed the dosing schedule as outlined in the
Development Plan and the Steering Committee has approved in writing the
completion of such dosing.
"First Phase II Milestone" shall mean the completion of the enrolment
of the Phase II clinical trial for the Milestone Compound in the Field.
Enrolment shall mean that an
6
agreed number of patients have been enrolled as outlined in the
Development Plan and the Steering Committee has approved in writing
such enrolment.
"IND" shall mean Investigational New Drug Application as set forth in
the CFR Section 312 and/or its equivalent in the other countries of the
Territory.
"IND Milestone" shall mean the occurrence and/or the achievement of all
of the following:
(i) US FDA acceptance of an IND filing with respect to the
Milestone Compound; and,
(ii) the approval by EPIL of the Phase I plan prepared by Developer
with respect to the Milestone Compound; and
(iii) an affirmative decision by the Steering Committee to proceed
with initiation of dosing in the first Phase I clinical trial
for the Milestone Compound in the Field in accordance with the
Development Plan.
"IND Milestone Purchase" shall mean the purchase by EPIL following the
occurrence of the IND Milestone of US$[*] of shares of Series B
Preferred Stock from Incara in accordance with and subject to the terms
of the Securities Purchase Agreement.
"In Market" shall mean the sale of the Compounds and/or Products in the
Territory by the Developer or an Affiliate of the Developer, to an
unaffiliated third party, such as a wholesaler, distributor, managed
care organisation, hospital or pharmacy which effects the final
commercial sale to the end-user consumer of the Compounds and/or
Products, and shall exclude the transfer pricing of such Compounds
and/or Products by one Developer Affiliate to another Developer
Affiliate.
"Milestone" shall mean any of the IND Milestone, First Phase I
Milestone, Second Phase I Milestone and Second Phase II Milestone.
"Milestone Compound" shall mean the first of the Compounds in respect
of which the US FDA accept an IND filing. The Steering Committee may
substitute another Compound as the Milestone Compound. Any required
amendments to the Development Plan to accommodate such substitute
Milestone Compound must be approved in writing in advance by the
Steering Committee.
"National Jewish Agreement" shall mean a licence agreement between
National Jewish Medical and Research Center and Aeolus dated 17
November 2000 and any amendment thereto.
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
7
"National Jewish Consent" shall mean the consent of National Jewish
Medical and Research Center to the EPIL Sub-Licence and certain other
matters pursuant to the National Jewish Agreement by letter of consent
of National Jewish Medical and Research Center dated 14 May 2002, and
the agreement by National Jewish Medical and Research Center to certain
amendments to the National Jewish Agreement by way of amendment
agreement between National Jewish Medical and Research Center and
Aeolus dated 14 May 2002, copies of which are attached at Schedule 5.
"Net Sales" shall mean in the case of Compounds and/or Products sold by
Developer, the aggregate gross In Market sales proceeds billed for
Compounds and/or Products by Developer in accordance with generally
accepted accounting principles, less the following:-
(i) customs and excise duties or other sales taxes (but (for the
avoidance of doubt) not income or corporation tax), directly
related to the sale of Compounds and/or Products in the
Territory which are actually paid by Developer;
(ii) such normal costs as are incurred by Developer in respect of
industry standard transport, shipping and insurance costs;
and industry standard or mandatory discounts or rebates
directly related to the sale of the Compounds and/or
Products in the Territory; and
(iii) amounts repaid or credited by Developer, or by a permitted
sub-licensee, as the case may be, consistent with its normal
business practices for similar compounds and/or products, by
reason of the rejection or return of goods.
"Net Revenues" shall mean all income received by the Developer in
respect of the commercialisation of the Compounds and/or Products,
including, but not limited to the following:
(i) any royalties, license grant fees, sub-licence fees,
milestone payments;
(ii) any R&D funding payments [*];
(iii) [*];
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
8
(iv) [*].
For the avoidance of doubt, "Net Revenues" shall exclude any funding
provided by EPIL by way of capital contribution, subscription for share
capital or otherwise.
"Phase I Report" shall mean a report detailing the results and
conclusions of the Phase I clinical trials for the Milestone Compound
in the Field and which report shall be referenced to the Development
Plan and shall include, but shall not be limited to, those matters set
out in Schedule 6.
"Phase II Report" shall mean a report detailing the results and
conclusions of the Phase II clinical trials for the Milestone Compound
in the Field and which report shall be referenced to the Development
Plan and shall include, but shall not be limited to, those matters set
out in Schedule 6.
"Preliminary Milestone" shall have the same meaning as that term is
defined in the Securities Purchase Agreement.
"Products" shall mean any products that include the Compounds, and any
formulations thereof.
"Second Duke Agreement" shall mean a licence agreement between Duke
University and Aeolus dated 25 June 1998.
"Second Phase I Milestone" shall mean the occurrence and/or the
achievement of all of the following:
(i) the approval by the Steering Committee of the Phase I
Report; and
(ii) the approval by EPIL of the Phase II plan prepared by
Developer with respect to the Milestone Compound; and
(iii) the affirmative decision of the Steering Committee to
proceed with a Phase II clinical trial for the Milestone
Compound in the Field in accordance with the Development
Plan.
"Second Phase I Milestone Purchase" shall mean the purchase by EPIL
following the occurrence of the Second Phase I Milestone of US$[*] of
shares of Series B Preferred Stock from Incara in accordance with and
subject to the terms of the Securities Purchase Agreement.
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
9
"Second Phase II Milestone" shall mean the occurrence and/or the
achievement of the following:
(i) completion of a Phase II clinical trial for the Milestone Compound
in the Field; and
(ii) the approval by the Steering Committee of the Phase II Report.
"Second Phase II Milestone Purchase" shall mean the purchase by EPIL
following the occurrence of the Second Phase II Milestone of US$[*] of
shares of Series B Preferred Stock from Incara in accordance with and
subject to the terms of the Securities Purchase Agreement.
"Securities Purchase Agreement" shall mean the Securities Purchase
Agreement dated the date of this Agreement between EPIL, Incara and
Aeolus.
"Series B Preferred Stock" shall have the same meaning as that term is
defined in the Securities Purchase Agreement.
"Technological Competitor of EPIL" shall mean any of those entities
listed on Schedule 3 attached hereto.
"Third Duke Agreement" shall mean a licence agreement between Duke
University and Aeolus dated 7 May 2002.
"Third Party Sub-Licensee" shall mean any sub-licensee appointed by the
Developer (other than EPIL) to import, make, use, offer for sale, and
sell the Compounds and/or Products in the Territory in the Field.
"Territory" shall mean all countries of the world.
"US FDA" shall mean the United States Food and Drug Administration or
any other successor agency whose approval is necessary to market the
Compounds and/or Product in the USA.
"US$" shall mean U.S. dollars.
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
10
2 RESEARCH AND DEVELOPMENT ACTIVITY
2.1 Within 60 days of the Effective Date, the Steering Committee (as
defined in Clause 3.1) shall approve a development plan that shall
contain, among other things, to the extent practicable, the research
and development objectives, compound specifications, plans for
preparation of IND filing, clinical indications, preliminary clinical
trial designs (Phase I and Phase II), development timelines and
budgeted costs with regard to the development of the Compounds in the
Field in the Territory (the "Development Plan") and the relative
responsibilities of Developer and EPIL as it relates to the
implementation of the Development Plan.
Each of Developer and EPIL shall use commercially reasonable efforts to
carry out their respective tasks under the Development Plan within the
timeframe contained therein.
Developer shall perform the Development Plan in accordance with cGMP
and cGLP.
2.2 The Steering Committee, shall agree in writing on a commencement date
for the Developer's activities under the Development Plan
("Commencement Date"), which date shall not be later than July 30,
2002.
2.3 Developer shall promptly notify the Steering Committee and EPIL of any
deviations from the Development Plan or delays in the performance of
the Development Plan.
2.4 Within 5 business days of the Effective Date, the Developer shall
designate one research employee as technical liaison to handle
technical matters and communications relating to the Development Plan.
Such research employee may be substituted by another research employee
at any time upon written agreement of the Steering Committee.
2.5 The Development Plan to be conducted by Developer shall be completed
when the Second Phase II Milestone has been achieved.
2.6 During the term of this Agreement:
2.6.1 each party shall co-operate with the other in good faith
particularly with respect to unforeseen events or
contingencies; and
2.6.2 save where the Developer has appointed a sub-contractor in
accordance with Clause 15.4, the Developer shall furnish,
maintain and preserve suitable and sufficient laboratory
facilities, equipment and personnel for the work to be done by
it; and
2.6.3 the Developer shall perform its obligations in good faith
hereunder in a commercially reasonable, diligent and
workmanlike manner.
11
2.7 Any amendments to the Development Plan shall require the prior written
approval of the Steering Committee.
2.8 The Steering Committee shall review the Development Plan following the
occurrence of each Milestone and make any amendments as the Steering
Committee deems necessary.
3 STEERING COMMITTEE AND PROJECT MANAGEMENT
3.1 Within 30 days of the Effective Date, the parties will establish a
steering committee ("Steering Committee"), which shall consist of
personnel from each party who are appropriately skilled and
knowledgeable in relation to the Development Plan and who are deemed
necessary to accomplish and oversee the work of the Development Plan.
The Steering Committee shall have an equal number of members from each
of the parties and the total size of the Steering Committee shall not
exceed 6 people .
3.2 Unless otherwise agreed by the parties:
3.2.1 the Steering Committee shall meet at least once every two
months, such meetings to continue throughout the Term (as
defined in Clause 12.1), at such location as the parties may
agree or by telephone conference;
3.2.2 at any such meeting, the presence of two EPIL members and two
Developer members shall be required to constitute a quorum
and, the unanimous vote of those members present at a meeting
at which such a quorum is present shall constitute an action
or approval of the Steering Committee;
3.2.3 meetings shall be chaired alternately by representatives of
the parties;
3.2.4 each party shall be responsible for its own costs in respect
of travel and accommodation expenses in attending meetings of
the Steering Committee;
3.2.5 at and between meetings of the Steering Committee, each party
shall keep the other fully and regularly informed as to its
progress with its respective tasks and obligations under the
Development Plan.
3.2.6 if the Steering Committee is unable to agree on a matter
connected with the Development Plan it shall be referred to
the CEO of the Developer and a senior executive of EPIL and
thereafter, in the event of continued deadlock, the dispute
shall be referred to an expert in pharmaceutical product
development and marketing (including clinical development and
regulatory affairs) jointly selected by the designated senior
officers of each of EPIL and the Developer, provided that the
decision of such expert will ultimately be non-binding on the
parties.
12
3.3 Developer must submit to all members of the Steering Committee the
Phase I Report and the Phase II Report as soon as each report becomes
available. Without prejudice to EPIL's entitlement through its
representatives on the Steering Committee to approve or not approve the
Phase I Report or the Phase II Report, an EPIL representative on the
Steering Committee shall use reasonable efforts to notify the Steering
Committee within [*] of receipt of such reports if EPIL believe
any issues or deficiencies arise in relation to such reports.
3.4 The Steering Committee shall, by unanimous agreement, be responsible
for determining Developer's strategy as regards the conduct of any
clinical trials with respect to the development of the Compounds and/or
Products in the Field. Any agreement between Developer and any
independent third party relating to the conduct of any clinical trial
in support of the development of the Compounds and/or Products in the
Field shall require the prior approval of the Steering Committee, which
approval shall not be unreasonably withheld or delayed.
3.5 Developer shall keep the Steering Committee promptly and fully advised
of Developer's regulatory activities, progress and procedures.
Developer shall inform Steering Committee of any dealings it shall have
with a regulatory authority, and shall furnish EPIL with copies of all
correspondence relating to the Compounds and/or Products.
Developer shall provide Steering Committee with reasonable prior notice
of all meetings between the Developer and any regulatory authority
relating to the Compounds and/or the Products in the Field and an EPIL
representative on the Steering Committee shall be entitled to attend
any such meeting. The Developer shall make available to the Steering
Committee the minutes of any such meetings.
3.6 The Steering Committee shall be responsible for ensuring that the
Developer's regulatory activities in relation to the Compounds and/or
Products in the Field comply in full with the Development Plan and the
Steering Committee will inform Developer of any proposals it may have
to ensure full compliance therewith. Developer shall use best efforts
to comply with and implement any such proposals from the Steering
Committee.
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
13
4 NON-COMPETITION
4.1 During the Option Period (as defined in Clause 6.1) Developer shall not
research, develop, market or otherwise commercialise the Compounds in
the Field in the Territory other than in accordance with this
Agreement.
4.2 Nothing in this Agreement shall prevent the Developer, either alone or
in association with a co-development partner or sub-licensee, from
licensing, developing or commercialising any of the Compounds or
derivatives thereof or Products outside the Field.
However, in the event of such development or commercialisation,
Developer shall to the extent that the Developer is not legally
prohibited from doing so inform EPIL of any information discovered and
of the progress of such development or commercialisation programmes
which may have an impact on, or be capable of assisting in, the
development of the Compounds in the Field.
Prior to providing any such information to EPIL, Developer shall notify
EPIL so that it may consult with its patent attorneys prior to any such
receipt of information to consider any issues that may arise.
5 PAYMENTS
5.1 EPIL shall make purchases of shares of Series B Preferred Stock from
Incara in accordance with and subject to the terms set out in the
Securities Purchase Agreement.
5.2 Any income or other taxes on any monies payable to Developer which EPIL
is required by law to pay or withhold on behalf of Developer, shall be
deducted by EPIL from such monies due. EPIL shall furnish Developer
with proof of such payments. Any such tax required to be paid or
withheld shall be an expense of and borne solely by Developer. EPIL
shall promptly provide Developer with a certificate or other
documentary evidence to enable Developer to support a claim for a
refund or a foreign tax credit with respect to any such tax so withheld
or deducted by EPIL. At Developer's request, EPIL reasonably cooperate
to support any claim by Developer for such a refund or credit.
14
6. COMMERCIALIZATION OPTION
6.1 From the Effective Date until [*] after the occurrence of the Second
Phase II Milestone Purchase (the "Option Period"), Developer shall
grant EPIL an exclusive option (the "Licence Option") to conclude an
exclusive, sub-licensable sub-licence and supply agreement whereby
Developer would grant EPIL a sub-licence to the Developer Patents, the
Developer Know-How and the Developer Improvements to import, make, use,
offer for sale, and sell the Compounds and/or Products in the Territory
in the Field on terms to be agreed in good faith on the basis of the
[*] heads of agreement set out in Schedule 2 (the "EPIL Sub-Licence").
6.2 If EPIL does not exercise the Licence Option, EPIL shall be entitled to
elect to negotiate in good faith exclusively with the Developer during
the Option Period an alternate form of collaboration or
commercialisation agreement such as, but not limited to, a co-promotion
or co-marketing arrangement for the further development of the
Compounds in the Field in the Territory.
6.3 For the avoidance of doubt, during the Option Period, Developer will
not negotiate in any form, directly or indirectly, with any other
corporation, entity or person in relation to the subject matter of
Clause 6.1 and Clause 6.2, nor provide any information relating thereto
to third parties, save with the prior consent in writing of EPIL.
6.4 If, despite good faith negotiations, EPIL and Developer do not reach
agreement within the Option Period, then Developer shall be free, for a
period of [*], thereafter to enter into negotiations with a third party
(other than a Technological Competitor of EPIL) to agree terms upon
which the third party would commercialise the Compounds in the Field in
the Territory, provided that such terms when taken as a whole, are not
more favourable to the third party than the principal terms of the last
written proposal offered by Developer to EPIL or by EPIL to Developer,
as the case may be.
Prior to entering into any such agreement with the third party,
Developer shall promptly notify EPIL in writing of the principal terms
of such proposed agreement and shall certify that the third party with
whom Developer intends to contract is not a Technological Competitor of
EPIL.
6.5 If Developer has not entered into an agreement with a third party for
the Compounds within the Field within the [*] period described
above the Licence Option shall be deemed to have re-commenced upon the
same terms as set forth herein, after which, if EPIL and Developer have
not reached an agreement within such recommenced Option Period, the
Developer shall again have the rights set forth in Clause 6.4.
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
15
7. REPORTS
7.1 Developer shall issue the following full and complete reports to the
satisfaction of EPIL:
7.1.1 the Phase I plan;
7.1.2 report on the completion of dosing of patients for a Phase I
clinical trial of the Milestone Compound in the Field;
7.1.3 the Phase I Report;
7.1.4 the Phase II plan;
7.1.5 report on the completion of enrolment of a Phase II clinical
trial of the Milestone Compound in the Field;
7.1.6 report on the completion of dosing of a Phase II clinical
trial of the Milestone Compound in the Field;
7.1.7 the Phase II Report;
7.1.8 An annual report detailing progress related to all the
Compounds in the Field
8 DEVELOPER LICENCE AGREEMENTS
8.1 Developer shall be responsible for payments related to the financial
provisions and obligations of the Developer Licence Agreements and of
any third party agreement with respect to the Developer Intellectual
Property to which it is a party on the Effective Date (including
amendments thereto) (the "Developer Effective Date Agreements"),
including without limitation, any royalty or other compensation
obligations triggered thereunder on the Effective Date, or triggered
thereunder after the Effective Date.
For the avoidance of doubt, royalties, milestones or other payments
which arise from the process of the commercialisation or exploitation
of Compounds or products that include the Compounds under the Developer
Effective Date Agreements (for example, a milestone payment payable
upon successful completion of Phase I or II clinical trials shall be
payments for which Developer will be responsible under this Clause 8.1.
8.2 If, after the Effective Date, Developer:
8.2.1 licenses or otherwise acquires from a third party know-how or
patent rights relating to the Developer Intellectual Property
in the Field in the Territory; or
16
8.2.2 acquires or merges with a third party entity that has know-how
or patent rights relating to the Developer Intellectual
Property in the Field in the Territory;
("After Acquired Technology")
then Developer shall offer to license the After Acquired Technology to
EPIL (subject to existing contractual obligations) solely to import,
make, use, offer for sale and sell the Compounds and/or Products in the
Field in the Territory.
EPIL shall notify Developer in writing as to whether EPIL wishes to
license the After Acquired Technology within [*] after the date upon
which an offer is made by Developer to EPIL hereunder.
If notice in writing has not been received by Developer from EPIL
within such [*] period, EPIL shall be deemed to have rejected
Developer's offer hereunder.
If EPIL notifies Developer hereunder that it wishes to license the
After Acquired Technology, the parties shall negotiate the terms of the
license agreement in good faith on commercially reasonable terms.
If EPIL does not accept Developer's offer hereunder, Developer agrees
that it shall not use the After Acquired Technology to research,
develop, market or otherwise commercialise the Compounds and/or the
Products in the Field in the Territory.
8.3 During the Term, Developer shall not in any way amend, modify, or waive
any of its rights under the Developer Licence Agreements, without the
prior written approval of the Steering Committee.
For the avoidance of doubt, Developer shall not terminate any of its
rights under the Developer Licence Agreements without the prior written
approval of the Steering Committee.
8.4 Developer shall indemnify and hold harmless EPIL against all costs,
claims and liabilities in respect of any claims or proceedings which
may be taken by Duke University or National Jewish Medical and Research
Center or Albany and/or by a third party beneficiary under the
Developer Licence Agreements against EPIL which arise from the
performance or non-performance by Developer of any of its obligations
under the Developer Licence Agreements.
8.5 Developer hereby confirms to EPIL as follows:
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
17
8.5.1 EPIL will not require the consent of Developer, Duke
University or National Jewish Medical and Research Center or
Albany or any other third party in order to assign the EPIL
Sub-Licence or to grant a sub-license to any third party under
the EPIL Sub-Licence. EPIL will inform the relevant parties 30
days in advance of any such proposed assignment, licence or
sub-licence.
8.5.2 In the event of the termination of the Developer Licence
Agreements after the exercise by EPIL of the Licence Option,
the EPIL Sub-License, and any assignment, license or
sub-license granted by EPIL to any third party as described in
Clause 8.5.1 shall continue in accordance with the provisions
of the Developer Licence Agreements.
8.5.3 In the event of termination of the Developer Licence
Agreements following the grant by Developer of an exclusive,
fully paid up (except as provided in Clause 13.1.1)
sub-licensable sub-licence to EPIL pursuant to Clause 13.1.1,
such sub-licence shall continue in accordance with the terms
of the Developer Licence Agreements.
8.6 Without prejudice to the generality of Clause 9, Developer hereby
further confirms to EPIL as follows:
8.6.1 Developer has obtained the consent of Duke University to the
replacement throughout the First Duke Agreement and the Second
Duke Agreement of the term "best efforts" with the term
"commercially reasonable efforts" as set out in the Duke
Consent.
8.6.2 Developer has obtained the consent of National Jewish Medical
and Research Center to the replacement throughout the National
Jewish Agreement of the term "best efforts" with the term
"commercially reasonable efforts" as set out in the National
Jewish Consent.
8.6.3 Developer has obtained the consent of Duke University and
National Jewish Medical and Research Center to amend Article
6.01 of each of the First Duke Agreement, Second Duke
Agreement, Third Duke Agreement and National Jewish Agreement
and Article 6.02 of each of the First Duke Agreement, Second
Duke Agreement and National Jewish Agreement, as set out in
the Duke Consent and the National Jewish Consent.
9 WARRANTIES
9.1 Developer (jointly and severally) represents and warrants to EPIL as of
the Effective Date, as follows:
9.1.1 Developer has the right to enter into this Agreement;
18
9.1.2 Developer has the right to grant the EPIL Sub-Licence and has
obtained the Duke Consent and any other consents required
including the consent of National Jewish Medical Center and
Albany to the extent necessary to enter into this Development
and Option Agreement and perform all its obligations set forth
herein;
9.1.3 there are no agreements between Developer and any third party
that conflict with this Agreement or with the Developer's
right to grant the EPIL Sub-Licence, or that conflict with any
rights granted by Developer to EPIL hereunder or any
obligations undertaken by Developer to EPIL hereunder;
9.1.4 for the avoidance of doubt, the National Jewish Agreement does
not contain any provisions that conflict with the Developer's
right to grant the EPIL Sub-Licence;
9.1.5 there are no proceedings threatened or pending against
Developer in connection with the Developer Intellectual
Property in relation to the Field and that to the best of
Developer's knowledge, Developer Patents are valid and
enforceable or are likely to issue and be valid and
enforceable or are likely to issue with regard to claims
necessary for performance under this Agreement and such claims
are likely to be valid and enforceable and be of sufficient
scope to warrant investment in the development of the
Compounds and/or Products in the Field as prescription
pharmaceuticals;
9.1.6 to the best of Developer's knowledge, there is no patent or
patent application of others which contains claims that
dominate the Developer Patents.
9.2 Developer further agrees and represents and warrants to EPIL as
follows:
9.2.1 as of the Effective Date, the Developer Licence Agreements are
valid and in full force and effect;
9.2.2 as of the Effective Date, there are no existing or claimed
defaults by Developer, and to Developer's best knowledge by
Duke University or the National Jewish Medical and Research
Center or Albany, under the Developer Licence Agreements and
no event, act or omission has occurred which (with or without
notice, lapse of time or the happening or occurrence of any
other event) would result in a default under the Developer
Licence Agreements by Developer, or to Developer's best
knowledge by Duke University or the National Jewish Medical
and Research Center or Albany;
9.2.3 during the Term, Developer will fully comply with all of the
terms and conditions of the Developer Licence Agreements.
Developer, will enforce its rights under the Developer Licence
Agreements and Developer will not assign its rights under the
Developer Licence Agreements; and
19
9.2.4 during the Term, Developer will keep EPIL fully informed with
respect to Developer's transactions, arrangements and business
under the Developer Licence Agreements that relate to EPIL
and/or the transactions contemplated hereunder, and Developer
shall provide EPIL with any written notices delivered by
Developer and/or Duke University or National Jewish Medical
and Research Center or Albany thereunder that relate to EPIL
and/or the transactions contemplated hereunder, or that may
affect EPIL, including any proposals by Duke University or
National Jewish Medical and Research Center to make any
publications under the Developer Licence Agreements.
10 INDEMNIFICATION
10.1 In addition to any other indemnities provided for in this Agreement,
Developer shall indemnify and hold harmless EPIL and its Affiliates and
their respective employees, agents, officers and directors from and
against any Claims incurred or sustained by EPIL arising out of or in
connection with any:
10.1.1 breach of any representation, covenant, warranty or obligation
by Developer hereunder; or
10.1.2 negligent or wilful act or omission or failure to comply with
applicable laws and regulations on the part of Developer or
any of its respective employees, agents, officers and
directors in the performance of this Agreement.
10.2 Developer shall further indemnify and hold harmless EPIL and its
Affiliates and their respective employees, agents, officers and
directors against all Claims made or brought against such a person to
which the other party may become liable:
10.2.1 seeking damages for personal injury (including death) and/or
for costs of medical treatment, caused or attributed to the
Compounds;
10.2.2 based upon an allegation that the manufacture, importation,
use, offer for sale, sale or other commercialisation of the
Compounds or Products infringe or misappropriate any third
party's intellectual property rights; or
10.2.3 caused by the use of the Compounds in humans in clinical
trials or otherwise.
10.3 In addition to any other indemnities provided for herein, EPIL shall
indemnify and hold harmless Developer and its Affiliates and their
respective employees, agents, officers and directors from and against
any Claims incurred or sustained by Developer arising out of or in
connection with any:
10.3.1 breach of any representation, covenant, warranty or obligation
by EPIL hereunder; or
20
10.3.2 negligent or wilful act or omission on the part of EPIL or any of
its agents or employees in the performance of this Agreement;
in each case save to the relative extent that such Claim is attributable to
Developer's negligence or wilful misconduct.
10.4 The party seeking an indemnity shall:
10.4.1 fully and promptly notify the other party of any claim or
proceedings, or threatened claim or proceedings;
10.4.2 permit the indemnifying party to take full control of such claim or
proceedings, with counsel of the indemnifying party's choice,
provided that the indemnifying party shall reasonably and regularly
consult with the indemnified party in relation to the progress and
status of such claim or proceedings;
10.4.3 co-operate in the investigation and defence of such claim or
proceedings; and
10.4.4 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceedings.
Save as aforesaid, neither the indemnifying party nor the party to be
indemnified shall acknowledge the validity of, compromise or otherwise
settle any Claim without the prior written consent of the other, which
shall not be unreasonably withheld.
10.5 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND
DEVELOPER SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION
OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER
THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR
INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR
FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER
OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR
AGENTS OR OTHERWISE.
10.6 Developer shall maintain product liability insurance in relation to the
Compounds, Products and this Agreement of at least US$[*] for the
duration of this Agreement and for a period of [*] thereafter. Prior to
commencing any clinical trials in relation to the Compounds and/or Products
in the Field, Developer shall
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
21
increase its product liability insurance (and any other insurances
necessary in relation to clinical trials) in relation to the Compounds,
Products and this Agreement and any clinical trials conducted by the
Developer pursuant to this Agreement to US$[*] for the remaining term of
this Agreement and for a period of [*] thereafter.
Developer shall provide EPIL with a certificate from the insurance company
verifying the above and shall notify the other party in writing at least 30
days prior to the expiration or termination of such coverage.
11 INTELLECTUAL PROPERTY
11.1 Developer shall remain the owner of the Developer Patents, the Developer
Know-How and the Developer Improvements.
11.2 EPIL shall be the owner of any EPIL Improvements.
11.3 Each of the parties shall promptly notify the other party in writing of any
claim or proceedings made against either of them alleging infringement or
other unauthorised use of the proprietary rights of a third party arising
from the manufacture, importation, use, offer for sale, sale or other
commercialisation of the Compounds in the Territory.
11.4 The parties acknowledge the provisions of Clause 10.4.2.
11.5 Developer shall:
11.5.1 secure the grant of any patent applications within the Developer
Patents in major markets as agreed to by the Steering Committee but
which shall not be less than the US, EU, Canada, Mexico, and Japan;
11.5.2 file and prosecute patent applications on patentable inventions and
discoveries relating to the same in such countries;
11.5.3 defend all such applications against third party oppositions in such
countries; and
11.5.4 maintain in force any issued letters patent that relate to the same
in such countries.
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
22
11.6 Developer shall discuss the filing, defending, and prosecuting strategy for
any proposed patents and patent application(s) with EPIL and shall
co-ordinate the filing, defending, and prosecuting of such patent
application(s) between the two parties in order to protect the intellectual
property rights of both parties.
11.7 After the exercise of the Licence Option, in the event that Developer
declines to file, prosecute or maintain an application or patent, EPIL
shall upon thirty days written notice to the Developer have the right to
file, prosecute, or maintain such application or patent at its own expense
at which time such application or patent shall be assigned to EPIL.
Provided that the ownership rights of any party other than the Developer in
respect of the subject matter of any such patent application shall not be
assigned to EPIL but shall remain with the owner on record as of the
Effective Date where contractual or other legally binding restrictions
prohibit Developer from assigning such ownership rights to EPIL.
12 TERM AND TERMINATION
12.1 This Agreement shall come into force on the Effective Date and, subject to
Clause 15.10, shall remain in effect until the expiry of the Option Period
(the "Term"), unless EPIL has earlier terminated the agreement in
accordance with Clause 12.2 below.
12.2 EPIL shall be entitled to terminate this Agreement at any time by serving
[*] written notice on the Developer.
12.3 In addition to the rights of termination provided for elsewhere in this
Agreement, either party shall be entitled forthwith to terminate this
Agreement by written notice to the other party if:
12.3.1 that other party commits any material breach of any of the
provisions of this Agreement or of the Securities Purchase
Agreement, and in the case of a breach capable of remedy, fails to
cure the same within 60 days after receipt of a written notice
giving full particulars of the breach and requiring it to be cured;
or
12.3.2 that other party goes into liquidation (except for the purposes of
amalgamation or reconstruction and in such manner that the company
resulting therefrom effectively agrees to be bound by or assume the
obligations imposed on that other party under this Agreement); or
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
23
12.3.3 an encumbrancer takes possession or a receiver is appointed over any
of the property or assets of that other party ; or
12.3.4 any proceedings are filed or commenced by that other party under
bankruptcy, insolvency or debtor relief laws or anything analogous
to any of the foregoing under the laws of any jurisdiction occurs in
relation to that other party.
For the purposes of Clause 12.3.1, a breach will be considered capable of
being cured if the party in breach can comply with the provision in
question in all respects other than as to the time of performance (provided
that time of performance is not of the essence).
13 CONSEQUENCES OF TERMINATION
13.1 If EPIL terminates this Agreement pursuant to Clause 12.3 the following
shall occur:
13.1.1 upon EPIL's election, the Developer shall grant to EPIL an
exclusive, fully paid up (except as provided below), sub-licensable
sub-licence to the Developer Patents, the Developer Know-How and the
Developer Improvements to import, make, use, offer for sale, and
sell the Compounds and/or Products in the Territory in the Field;
[*] shall be liable to Duke University and National Jewish Medical
and Research Center and Albany for any and all royalty and milestone
obligations under the Developer Licence Agreements which may become
due to such parties [*], the Developer shall be liable for all
accrued obligations under the Developer Licence Agreements [*] shall
remit any such royalties to Duke University and National Jewish
Medical and Research Center and Albany as the case may be;
13.1.2 in addition to the grant of the sub-licence under clause 13.1.1, if
the Developer has appointed a Third Party Sub-Licensee outside the
Field the following shall occur:
13.1.2.1 if EPIL terminates prior to making the IND Milestone
Purchase, Developer shall be obliged to pay to EPIL [*]%
of Net Revenues outside the Field;
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
24
13.1.2.2 if EPIL terminates after making the IND Milestone Purchase
but prior to making the Second Phase I Milestone Purchase,
Developer shall be obliged to pay to EPIL [*]% of Net
Revenues outside the Field;
13.1.2.3 if EPIL terminates after making the Second Phase I
Milestone Purchase but prior to making the Second Phase II
Milestone Purchase, Developer shall be obliged to pay to
EPIL [*]% of Net Revenues outside the Field.
13.1.3 in addition to the grant of the sub-licence under clause 13.1.1, if
the Developer has not appointed a Third Party Sub-Licensee outside
the Field the following shall occur:
13.1.3.1 if EPIL terminates prior to making the IND Milestone
Purchase, Developer shall be obliged to pay to EPIL [*]%
of Net Sales outside the Field;
13.1.3.2 if EPIL terminates after making the IND Milestone Purchase
but prior to making the Second Phase I Milestone Purchase,
Developer shall be obliged to pay to EPIL [*]% of Net
Sales outside the Field;
13.1.3.3 if EPIL terminates after making the Second Phase I
Milestone Purchase but prior to making the Second Phase II
Milestone Purchase, Developer shall be obliged to pay to
EPIL [*]% of Net Sales outside the Field.
13.2 If EPIL terminates this Agreement pursuant to Clause 12.2 and the Developer
has appointed a Third Party Sub-Licensee, the following shall occur:
13.2.1 if EPIL terminates prior to making the IND Milestone Purchase,
Developer shall be obliged to pay to EPIL [*]% of Net Revenues
inside the Field;
13.2.2 if EPIL terminates after making the IND Milestone Purchase but prior
to making the Second Phase I Milestone Purchase, Developer shall be
obliged to pay to EPIL [*]% of Net Revenues inside the Field;
13.2.3 if EPIL terminates after making the Second Phase I Milestone
Purchase but prior to making the Second Phase II Milestone Purchase,
Developer shall be obliged to pay to EPIL [*]% of Net Revenues
inside the Field.
[*] Confidential treatment requested; certain
information omitted and filed separately with the SEC.
25
13.3 If EPIL terminates this Agreement pursuant to Clause 12.2 and the Developer
has not appointed a Third Party Sub-Licensee, the following shall occur:
13.3.1 if EPIL terminates prior to making the IND Milestone Purchase,
Developer shall be obliged to pay to EPIL [*]% of Net Sales
inside the Field;
13.3.2 if EPIL terminates after making the IND Milestone Purchase but
prior to making the Second Phase I Milestone Purchase,
Developer shall be obliged to pay to EPIL [*]% of Net Sales
inside the Field;
13.3.3 if EPIL terminates after making the Second Phase I Milestone
Purchase but prior to making the Second Phase II Milestone
Purchase, Developer shall be obliged to pay to EPIL [*]% of
Net Sales inside the Field.
13.4 If Developer terminates this Agreement pursuant to Clause 12.3, the Licence
Option shall terminate.
14 CONFIDENTIAL INFORMATION/ANNOUNCEMENTS
14.1 Upon execution of this Agreement, and thereafter during the term hereof, at
such times as the parties shall mutually agree, each party may disclose to
the others, in confidence Confidential Information necessary or useful to
the activities contemplated by this Agreement.
Except as specifically authorised or permitted by this Agreement, each
party shall, for the term of this Agreement and for [*] after its
expiration or termination keep confidential and not disclose to others
(except its Affiliates), and use only as permitted hereunder, all of the
Confidential Information owned by the other parties.
14.2 Save as otherwise specifically provided herein, each party shall disclose
Confidential Information of the other parties only to those employees,
representatives and agents requiring knowledge thereof in connection with
fulfilling the party's obligations under this Agreement. Each party further
agrees to (i) inform all such employees, representatives and agents of the
terms and provisions of this Agreement relating to Confidential Information
and their duties hereunder, and (ii) obtain their agreement hereto as a
condition of receiving Confidential Information, provided that such
agreement shall be deemed given in respect of such employees,
representatives and agents that, at the time of disclosure, are under
existing obligations of confidentiality no less onerous than those
contained herein covering such disclosure. Each party shall exercise the
same standard of care as it would itself exercise in relation to its own
confidential information (but in no event less than a reasonable standard
of care) to protect and preserve the proprietary and confidential nature of
the Confidential Information disclosed to it by the other parties.
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
26
14.3 Notwithstanding the provisions of this Clause 14, Confidential Information
may be:
14.3.1 published if and to the extent such publication has been approved in
writing by each of the parties; or
14.3.2 disclosed to the extent required by applicable laws or regulations
or as ordered by a court or other regulatory body having competent
jurisdiction, provided that if a party becomes legally required to
disclose any Confidential Information of the other party hereunder,
the receiving party shall give the disclosing party prompt notice of
such requirement to enable the disclosing party to seek a protective
order or other appropriate remedy concerning any such disclosure.
The receiving party shall fully co-operate with the disclosing party
in connection with the disclosing party's efforts to obtain any such
order or other remedy. If any such order or other remedy does not
fully preclude disclosure, the receiving party shall make such
disclosure only to the extent that such disclosure is legally
required.
14.4 The parties agree that the obligations of this Clause 14 are necessary and
reasonable in order to protect the parties' respective businesses, and each
party agrees that monetary damages would be inadequate to compensate a
party for any breach by the other party of its covenants and agreements set
forth herein.
The parties agree that any such violation or threatened violation shall
cause irreparable injury to a party and that, in addition to any other
remedies that may be available, in law and equity or otherwise, each party
shall be entitled to seek injunctive relief against the threatened breach
of the provisions of this Clause 14, or a continuation of any such breach
by the other party, specific performance and other equitable relief to
redress such breach together with damages and reasonable counsel fees and
expenses to enforce its rights hereunder.
14.5 Subject to Clause 14.2 and Clause 14.3.2, neither party shall have the
right to disclose to third parties the existence of this Agreement or any
of the terms and conditions hereof without the prior written consent of the
other party. In the event that either party wishes to make an announcement
concerning the Agreement, that party will seek the consent of the other
party, which consent shall not be unreasonably withheld or delayed. The
terms of any such announcement shall be agreed in good faith.
15 MISCELLANEOUS
15.1 This Agreement shall be governed by and construed in accordance with the
laws of the State of New York and the parties submit to the non-exclusive
jurisdiction of the Federal and State courts located in New York.
27
15.2 No waiver of any right under this Agreement shall be deemed effective
unless contained in a written document signed by the party charged with
such waiver, and no waiver of any breach or failure to perform shall be
deemed to be a waiver of any future breach or failure to perform or of any
other right arising under this Agreement.
15.3 Neither party to this Agreement shall be liable for delay or failure in the
performance of any of its obligations hereunder to the extent such delay or
failure results from causes beyond its reasonable control, including,
without limitation, acts of God, fires, strikes, acts of war, or
intervention of a government authority, non-availability of raw materials,
but any such delay or failure shall be remedied by such party as soon as
practicable.
15.4 This Agreement and, except as otherwise provided for in this Agreement, the
rights and obligations hereunder, shall not be assigned by any party
without the prior written consent of the other parties save that:
15.4.1 any party may assign this Agreement in whole or in part and delegate
its duties hereunder to its Affiliate or Affiliates without such
consent provided that such assignment or delegation has no material
adverse tax implications for the other parties; and
15.4.2 in the event of a proposed assignment of this Agreement by any party
to a third party, such consent shall not be unreasonably withheld or
delayed provided that, without prejudice to the generality of the
foregoing, the parties acknowledge that it will not be unreasonable
for EPIL to withhold consent hereunder in the event of a proposed
assignment of this Agreement by Developer to a Technological
Competitor of EPIL.
Any permitted assignee shall assume all obligations of its assignor
under this Agreement.
[*]
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
28
15.5 Nothing contained in this Agreement is intended or is to be construed to
constitute Developer and EPIL as partners or members of a joint venture or
any party as an employee of the other. None of the parties hereto shall
have any express or implied right or authority to assume or create any
obligations on behalf of or in the name of the other parties or to bind the
other parties to any contract, agreement or undertaking with any third
party.
15.6 No amendment, modification or addition hereto shall be effective or binding
on any party unless set forth in writing and executed by a duly authorised
representative of each of the parties.
15.7 Any notice to be given under this Agreement shall be sent in writing in
English by overnight courier, registered airmail or telecopied to:
EPIL at:
Elan Pharma International Limited
C/o Elan International Services Ltd.
102 St James Court
Flatts
Smiths FL04
Bermuda
Attention: Secretary
Telefax : +1 441 292 2224
Incara at:
Incara Pharmaceuticals Corporation,
P.O. Box 14287
79 T.W. Alexander Drive
4401 Research Commons, Suite 200
Research Triangle Park, North Carolina 27709
Attention: Chief Executive Officer
Telephone: (919) 558 8688
Telefax: (919) 544 1245
Aoelus at:
Aeolus Pharmaceuticals Inc
P.O. Box 14287
79 T.W. Alexander Drive,
29
4401 Research Commons, Suite 200
Research Triangle Park, North Carolina 27709
Attention: Chief Executive Officer
Telephone: (919) 588-8688
Telefax: (919) 544 1245
or to such other address(es) and telecopier numbers as may from time to
time be notified by any of the parties to the others hereunder.
Any notice sent by overnight courier, registered mail or telecopier shall
be deemed to have been delivered upon receipt by the addressee.
15.8 If any provision in this Agreement is agreed by the parties to be, or is
deemed to be, or becomes invalid, illegal, void or unenforceable under any
law that is applicable hereto:-
15.8.1 such provision will be deemed amended to conform to applicable laws
so as to be valid and enforceable or, if it cannot be so amended
without materially altering the intention of the parties, it will
be deleted, with effect from the date of such agreement or such
earlier date as the parties may agree; and
15.8.2 the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired or affected in
any way.
15.9 This Agreement sets forth all of the agreements and understandings between
the parties with respect to the subject matter hereof, and supersedes and
terminates all prior agreements and understandings between the parties
with respect to the subject matter hereof. There are no agreements or
understandings with respect to the subject matter hereof, either oral or
written, between the parties other than as set forth in this Agreement.
15.10 The provisions of Clauses 1, 8.1, 8.3, 9, 10, 11, 13, 14, and 15 shall
survive the termination for any reason of this Agreement.
15.11 At the request of any of the party, the other parties shall (and shall use
reasonable efforts to procure that any other necessary third parties
shall) execute and do all such documents, acts and things as may
reasonably be required subsequent to the signing of this Agreement for
assuring to or vesting in the requesting party the full benefit of the
terms hereof.
30
IN WITNESS WHEREOF, the parties hereto have executed this Agreement.
SIGNED
for and on behalf of
Elan Pharma International Limited
Date
SIGNED
For and on behalf of
Incara Pharmaceuticals Corporation
Date
SIGNED
For and on behalf of
Aeolus Pharmaceuticals, Inc.
Date
31
Schedule 1
Developer Patents
1) [*]
Serial Nos.: U.S. application [*]
PCT application [*]
Docket Numbers: U.S. #[*]
PCT #[*]
From Nixon & Vanderhye P.C.
Arlington, VA
INVENTORS:
[*]
[*]
[*]
[*]
2) [*]
Serial Nos.: U.S. Application #: [*]
International application #: [*]
Foreign equivalents in [*]
Docket Numbers: U.S. #:[*]
International #s: [*]
From Nixon & Vanderhye P.C.
Arlington, VA
INVENTORS:
[*]
[*]
[*]
[*]
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
32
[*]
[*]
[*]
3) [*]
Serial Nos.: U.S. application [*]
PCT application [*]
Docket Numbers: U.S. #[*]
PCT #[*]
From Nixon & Vanderhye P.C.
Arlington, VA
INVENTORS:
[*]
[*]
[*]
[*]
[*]
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
33
Schedule 2
[*] Heads of Agreement for the EPIL Sub-Licence
1. Right granted [*]
2. Territory [*]
3. Development Work [*]
4. Licence Fees [*]
5. Royalties [*]
[*]
6. Intellectual Property [*]
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
34
[*]
7. Term and termination [*]
(i) [*]
(ii) [*]
[*]
[*]
[*]
8. Consequences of Termination [*]
9. Applicable law The Agreement will be subject to [*]
law.
[*] Confidential treatment requested;
certain information omitted and filed separately with the SEC.
35
10. Warranties [*]
11. Marketing and Promotion [*]
12. Regulatory Matters [*]
[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.
36
Schedule 3
Technological Competitors of EPIL
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*]
[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.
37
Schedule 4
Duke Consent
38
May __, 2002
Robert Taber
Office of Science & Technology
Duke University
PO Box 90083
2020 West Main Street, Suite 10
Durham, NC 27705
Dear Mr. Taber:
As you know, we are in the final stages of negotiating a Development and Option
Agreement among Elan Corporation, plc (including its affiliates) ("Elan"),
Incara Pharmaceuticals Corporation and Aeolus Pharmaceuticals, Inc. ("Aeolus")
(the "Elan Agreement") to develop and eventually commercialize in the Field (as
defined in the Elan Agreement) the catalytic antioxidant technology licensed by
Aeolus from Duke University ("Duke").
Under the Agreement, Elan has an option to obtain a sublicensable sublicense
(the "Option Sublicense") of certain of Aeolus' rights under the License
Agreements dated July 21, 1995, June 25, 1998 and May __, 2002 between Duke and
Aeolus (the "License Agreements"), and may be granted such a sublicense under
certain other circumstances described in the Elan Agreement (the "Default
Sublicense" together with the Option Sublicense are collectively the "Elan
Sublicense").
We hereby request: (i) [*] Your timely consent and agreement by designation
below is greatly appreciated.
Sincerely,
Clayton I. Duncan
President and CEO
Aeolus Pharmaceuticals, Inc.
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
39
Acknowledged and Agreed:
Duke University
By:_________________________
Name:_______________________
Title:______________________
Date:_______________________
40
Schedule 5
National Jewish Consent
41
May __, 2002
Mr. Verne Singleton
Chief Operating Officer
National Jewish Medical and Research Center
1400 Jackson Street
Denver, CO 80206
Dear Mr. Singleton:
As you know, we are in the final stages of negotiating a Development and Option
Agreement among Elan Corporation, plc (including its affiliates) ("Elan"),
Incara Pharmaceuticals Corporation and Aeolus Pharmaceuticals, Inc. ("Aeolus")
(the "Elan Agreement") to develop and eventually commercialize in the Field (as
defined in the Elan Agreement) the catalytic antioxidant technology licensed
from National Jewish Medical and Research Center ("National Jewish").
Under the Agreement, Elan has an option to obtain a sublicense (the "Option
Sublicense") of certain of Aeolus' rights under the License Agreement dated
November 17, 2000 between National Jewish and Aeolus (the "License Agreement"),
and may be granted such a sublicense under certain other circumstances described
in the Elan Agreement (the "Default Sublicense" together with the Option
Sublicense, the "Elan Sublicense").
Specifically, but without prejudice to the generality of the rights to be
granted by Aeolus to Elan under the Elan Agreement, we hereby request [*] Your
timely consent and agreement by designation below is greatly appreciated.
Sincerely,
Clayton I. Duncan
President and CEO
Aeolus Pharmaceuticals, Inc.
[*] Confidential treatment requested;
certain information omitted and filed
separately with the SEC.
42
Acknowledged and Agreed:
National Jewish Medical and Research Center
By:____________________________
Name:__________________________
Title:_________________________
Date:__________________________
43
Schedule 6
Phase I Report and Phase II Report
The information to be included in each of the Phase I Report and the Phase II
Report will be set out in the Development Plan.
Phase I Report
At a minimum, the Phase I Report should contain the following information
relating to the Phase I clinical trial:
1) [*]
2) [*]
3) [*]
4) [*]
5) [*]
Phase II Report
At a minimum the Phase II Report should contain the following information
relating to the Phase II clinical trial:
1) [*]
[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.
44
2) [*]
3) [*]
4) [*]
5) [*]
[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.
45