1
Portions of this Exhibit 10.3 have been redacted and are the subject of
a confidential treatment request filed with the Secretary of the Securities and
Exchange Commission.
2
ONCOGENE SCIENCE, INC.
AND
SEPRACOR, INC.
MARCH 7, 1997
COLLABORATIVE RESEARCH, DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
3
TABLE OF CONTENTS
Page
----
ARTICLE 1
INTERPRETATION 2
1.1 Defined Terms ........................................................... 2
ARTICLE 2
RESEARCH PROGRAM 8
2.1 General ................................................................. 8
2.2 Scope ................................................................... 8
2.3 General Obligations of the Parties ...................................... 8
2.4 Joint Steering Committee ................................................ 9
2.4.1 Purpose .......................................................... 9
2.4.2 Expansion of Research Program .................................... 10
2.4.3 Composition ...................................................... 10
2.4.4 Voting ........................................................... 10
2.4.5 Chair ............................................................ 10
2.4.6 Meetings ......................................................... 10
2.4.7 Expenses ......................................................... 11
2.5 Joint Development Committee ............................................. 11
2.5.1 Purpose .......................................................... 11
2.5.2 Composition ...................................................... 11
2.5.3 Voting ........................................................... 11
2.5.4 Chair ............................................................ 11
2.5.5 Meetings ......................................................... 11
2.5.6 Reports .......................................................... 12
2.5.7 Expense .......................................................... 12
2.6 Reports ................................................................. 12
2.7 Laboratory Facilities ................................................... 12
2.8 Research Staff .......................................................... 12
2.9 Inspections ............................................................. 12
2.10 Patent and Confidential Information Agreements .......................... 13
2.11 Flexibility ............................................................. 13
2.12 Arrangements with Independent Third Parties ............................. 13
2.13 No Independent Research within the Scope of the Research Program ........ 13
2.14 Other Research Permitted ................................................ 13
2.15 Clinical Data ........................................................... 13
2.16 Lead Compounds .......................................................... 13
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ARTICLE 3
COSTS AND EXPENSES OF THE RESEARCH PROGRAM 14
3.1 Payment of Costs and Expenses ........................................... 14
ARTICLE 4
SECRET INFORMATION 14
4.1 General ................................................................. 14
4.2 Treatment of Secret Information ......................................... 14
4.3 Press Releases and Announcements ........................................ 15
4.4 Publications ............................................................ 15
ARTICLE 5
INTELLECTUAL PROPERTY RIGHTS 16
5.1 General ................................................................. 16
5.2 Research ................................................................ 16
5.3 Maintenance of Joint Patent Rights ...................................... 16
5.4 Infringement ............................................................ 17
5.5 Costs for Applying, Prosecuting and Maintaining ......................... 17
5.6 Disclosure of Inventions ................................................ 17
5.7 Ownership of Joint Intellectual Property ................................ 17
5.8 Copies of Patent Applications ........................................... 18
5.9 Other Patent Rights ..................................................... 18
5.10 Indemnification ......................................................... 19
ARTICLE 6
DEVELOPMENT AND COMMERCIALIZATION 19
6.1 Decision to Commercialize ............................................... 19
6.2 Commercialization Agreement ............................................. 19
6.3 Content of Commercialization Agreement .................................. 19
6.4 No Support .............................................................. 20
ARTICLE 7
OTHER RESEARCH VENTURES ETC. 21
7.1 Acquisition of Rights from Third Parties ................................ 21
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ARTICLE 8
TERM, EXTENSION, TERMINATION AND DISENGAGEMENT 21
8.1 Term .................................................................... 21
8.2 Events of Termination ................................................... 21
ARTICLE 9
CONSEQUENCES OF TERMINATION 22
9.1 Licenses upon Termination ............................................... 22
9.2 Termination upon the Occurrence of an Event of Termination .............. 23
9.3 Survival of Obligations; Return of Confidential Information ............. 24
ARTICLE 10
REPRESENTATIONS AND WARRANTIES 24
ARTICLE 11
COVENANTS 25
11.1 Affirmative Covenants Other than Reporting Requirements 25
ARTICLE 12
DISPUTE RESOLUTION 25
ARTICLE 13
NOTICES 26
ARTICLE 14
MISCELLANEOUS 26
14.1 Binding Effect .......................................................... 26
14.2 Headings ................................................................ 26
14.3 Entire Agreement ........................................................ 26
14.4 Severability ............................................................ 27
14.5 Counterparts ............................................................ 27
14.6 Amendment, Waiver, etc .................................................. 27
14.7 Force Majeure ........................................................... 27
14.8 Independent Contractor .................................................. 27
14.9 Assignment and Successors ............................................... 27
14.10 Governing Law ........................................................... 28
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6
COLLABORATIVE RESEARCH, DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
BETWEEN: SEPRACOR INC., a corporation incorporated
under the laws of Delaware and having its
principal place of business at 000 Xxxxx
Xxxxx, Xxxxxxxxxxx, Xxxxxxxxxxxxx
(hereinafter called "Sepracor").
AND: ONCOGENE SCIENCE, INC., a corporation
incorporated under the laws of Delaware and
having its principal place of business at
000 Xxxxxxx Xxxxxxxxx Xxxxxxxxx, Xxxxxxxxx,
Xxx Xxxx, 00000 (hereinafter called
"Oncogene").
AS OF: 7 March, 1997
WHEREAS Sepracor and its Affiliates possess technology in the area of synthesis
of libraries, including lead-seeking libraries and lead-optimizing libraries;
WHEREAS Oncogene and its Affiliates possess technology in the areas of assay
development, assay validation, high-throughput screening, in vitro assay
methodology, and chemical synthesis;
WHEREAS each of Sepracor and its Affiliates and Oncogene and its Affiliates is
currently conducting research in respect of anti-infective agents which target
certain illnesses and with respect to steroid chronic inflammatory targets
associated with certain illnesses;
WHEREAS Sepracor and its Affiliates, on the one hand, and Oncogene and its
Affiliates, on the other hand, have decided to collaborate and combine their
efforts in connection with the research, development and commercialization of
anti-infective agents which primarily target bacterial or fungal microbes, and
in connection with the research, development and commercialization of
anti-inflammatory agents that target steroid chronic inflammatory targets
represented by steroid receptors;
WHEREAS Sepracor and its Affiliates and Oncogene and its Affiliates are willing
to use their research facilities, scientists, research assistants, technicians
and other personnel to conduct their obligations under this Agreement.
7
NOW THEREFORE, THE PARTIES AGREE AS FOLLOWS:
ARTICLE 1
INTERPRETATION
1.1 DEFINED TERMS. In this Agreement, unless the context or subject matter
is inconsistent therewith, the following terms and expressions shall
have the following meanings:
(a) "ACQUISITION" shall have the meaning ascribed thereto at
Section 8.2(e) hereof.
(b) "AFFILIATE" shall mean, with respect to any Person (including
a Party), any other Person which directly or indirectly
controls or is controlled by, or is under direct or indirect
common control with, such first mentioned Person or any Person
which is directly or indirectly controlled by a Person which
controls the first mentioned Person; for the purpose of this
definition, "CONTROL" shall mean, with respect to any Person
(including any Party), the ownership of more than 50% of the
voting shares or other voting equity of that Person. This
definition notwithstanding, neither Versicor nor BioSepra
shall be considered to be affiliates of Sepracor for the
purposes of this Agreement.
(c) "AGREEMENT" shall mean this collaborative research,
development and commercialization agreement and all
instruments supplemental hereto or in amendment or in
confirmation HEREOF; "HEREIN", "HEREOF", "HERETO", "HEREUNDER"
and similar expressions mean and refer to this Agreement and
not to any particular article, section, subsection or other
subdivision; "ARTICLE", "SECTION", SUBSECTION" or other
subdivision of this Agreement shall mean and refers to the
specific article, section, subsection or other said
subdivision of this Agreement.
(d) "COMMERCIAL PRODUCT" shall mean any and all products in Final
Pharmaceutical Form comprising Lead Compounds and any and all
formulations, mixtures or compositions thereof emanating from
the Research Program pursued pursuant to this Agreement, the
making or use of which embodies any of Sepracor Technology,
Oncogene Technology or Joint Technology and in respect of
which Sepracor and Oncogene each has rights to commercialize
pursuant to this Agreement or any other agreement executed
between the Parties in furtherance to this Agreement.
(e) "COMMERCIALIZATION AGREEMENT" shall have the meaning ascribed
thereto at Section 6.2 hereof.
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8
(f) "COMMITMENT YEAR" shall mean each calendar year during the
term of this Agreement and, in respect of the First Commitment
Year, the period commencing on the Effective Date and
terminating on December 31, 1997.
(g) "COMPOUND" shall mean any compound being evaluated in
connection with the Field by the Parties pursuant to the
Research Program or developed by Sepracor and Oncogene and/or
their respective Affiliates pursuant to the provisions of this
Agreement.
(h) "CONFIDENTIAL INFORMATION" shall mean Sepracor Confidential
Information or Oncogene Confidential Information, as the case
may be.
(i) "DEFICIENCY AMOUNT" shall have the meaning ascribed thereto at
Section 2.4.1 hereof.
(j) "DEVELOPMENT CANDIDATE" shall mean a Lead Compound which has
been designated by the Joint Steering Committee as a potential
Commercial Product and which should be the subject of a
Development Program.
(k) "DEVELOPMENT PROGRAM" shall mean the written development plan
to be approved by the Joint Steering Committee describing the
development and other obligations of each Party in respect of
the development of any Compound for pre-clinical and clinical
development, which plan shall be approved by the Joint
Steering Committee no later than ninety (90) days following
the declaration by the Joint Steering Committee that a Lead
Compound has been designated as a Development Candidate,
failing which the matter shall be referred to the President of
Sepracor and the Chief Executive Officer of Oncogene for
discussion and resolution.
(l) "EFFECTIVE DATE" shall mean the date first appearing above.
(m) "ELECTING PARTY" shall have the meaning ascribed thereto at
Section 9.1 hereof.
(n) "ELECTION NOTICE" shall have the meaning ascribed thereto at
Section 9.1 hereof.
(o) "EVENT OF TERMINATION" shall have the meaning ascribed thereto
at Section 8.2 hereof.
(p) "FDA" shall mean the United States Food and Drug
Administration.
(q) "FIELD" shall mean, unless otherwise determined by the Joint
Steering Committee pursuant to Section 2.2, research,
development, marketing,
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9
distribution, and sale of ** including, without limitation, **
and such other bacterial and fungal targets, particularly
resistant strains of such, designated on a target by target
basis by the Joint Steering Committee, and, research,
development, marketing, distribution, and sale of ** also as
designated by the Joint Steering Committee on a target by
target basis.
(r) "FINAL PHARMACEUTICAL FORM" shall mean any presentation of a
Commercial Product in any final packaged and labeled dosage
form suitable for sale to and use by an end user.
(s) "FULL DEVELOPMENT" shall mean the first of the two events
described at Section 6.2 to occur.
(t) "INDEMNIFIED PARTY" shall have the meaning ascribed thereto at
Section 5.10 hereof.
(u) "INDEMNIFYING PARTY" shall have the meaning ascribed thereto
at Section 5.10 hereof.
(v) "INDEPENDENT THIRD PARTY" shall mean any Person other than
Sepracor, Oncogene and/or any of their respective Affiliates.
(w) "INITIAL TERM" shall have the meaning ascribed thereto at
Section 8.1 hereof.
(x) "JOINT DEVELOPMENT COMMITTEE" or "JDC" shall have the meaning
ascribed thereto at Section 2.5 hereof.
(y) "JOINT STEERING COMMITTEE" or "JSC" shall have the meaning
ascribed thereto at Section 2.4 hereof.
(z) "JOINT TECHNOLOGY" shall mean and include all technology and
information including all inventions, chemical structures and
methods for synthesis, structure-activity relationships, assay
methodology, methods, processes, formulae, plans,
specifications, characteristics, equipment and equipment
designs, know how, trade secrets, discoveries, formulations
and biological, toxicological and clinical data that are
conceived jointly by employees or agents of, or consultants
to, Sepracor and Oncogene, or licensed in the Field jointly by
the Parties or on behalf of the Parties during the term of
this Agreement, such that Sepracor and Oncogene each own an
undivided interest therein.
-----------------------
** This portion redacted pursuant to a request for confidential treatment.
4
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(aa) "LEAD COMPOUND" shall mean, subject to the provisions of
Section 2.16, any Compound designated as a Lead Compound by
the Joint Steering Committee and which has demonstrated such
properties of chemical structure, potency, mechanism of
action, selectivity and non-cytotoxicity as deemed necessary
by the JSC for such Compound to be a potential candidate for
chemical optimization studies.
(bb) "NET INVOICED SALES VALUE" shall mean the gross invoice price
charged for Commercial Products sold by Sepracor, Oncogene
and/or their respective Affiliates and sublicensees to
Independent Third Parties, less all allowances or credits
granted on such sales, including those in respect of rejected
or returned goods, recalls, transportation charge or
allowances, insurance charges, normal and customary quantity
and trade discounts (including managed care rebates), and
taxes or other governmental charges on, or measured by, the
sale, transportation, or use of Commercial Products, which
Sepracor, Oncogene and/or their respective Affiliates and
sublicensees have to pay or absorb on such sales.
(cc) "SALES" shall mean any Commercial Products sold in a
particular country by either Party and/or their respective
Affiliates and sublicensees to an Independent Third Party.
(dd) "NON-ELECTING PARTY" shall have the meaning ascribed thereto
at Section 9.1 hereof.
(ee) "NOTICE" shall have the meaning ascribed thereto at Section
9.1 hereof.
(ff) "NOTICE OF OPPORTUNITY" shall have the meaning ascribed
thereto at Section 9.1 hereof.
(gg) "NOTIFYING PARTY" shall have the meaning ascribed thereto at
Section 9.2 hereof.
(hh) "ONCOGENE CONFIDENTIAL INFORMATION" shall mean all
confidential information disclosed to Sepracor orally and
subsequently confirmed in writing as "CONFIDENTIAL" or
designated as "CONFIDENTIAL" by Oncogene or its Affiliates at
the time of disclosure to Sepracor, to the extent that such
information as of the date of disclosure to Sepracor is not
(i) demonstrably known to Sepracor other than by virtue of a
prior confidential disclosure to Sepracor by Oncogene or its
Affiliates, or (ii) disclosed in the published literature or
otherwise to the public through no fault of Sepracor, its
Affiliates, employees or consultants, or (iii) obtained from
an Independent Third Party having no obligation of
confidentiality to Oncogene or its Affiliates with respect to
such information.
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11
(ii) "ONCOGENE TECHNOLOGY" shall mean and include all technology
and technical information relating to a Compound, including
all inventions, chemical structures and methods for synthesis,
structure-activity relationships, assay methodology, methods,
processes, formulae, plans, specifications, characteristics,
equipment and equipment designs, know how, trade secrets,
discoveries, results, formulations and biological,
toxicological and clinical data and physical, chemical or
biological material that is conceived solely by employees or
agents of, or consultants to, Oncogene and/or its Affiliates,
prior to or during the term of this Agreement or acquired by
purchase, license, assignment or other means from third
parties prior to or during the term of this Agreement that is
not Joint Technology, but only to the extent that Oncogene or
its Affiliates is legally entitled to disclose such Technology
and technical information and use it in connection with the
performance by it of its obligations hereunder.
(jj) "PARTIES" shall mean Sepracor and Oncogene; and "PARTY" shall
mean any one of them.
(kk) "PATENT EXPENSES" shall mean all external fees and costs
incurred by a Party in financing the activities leading to a
Patent Right, including, without limitation, few and
reasonable attorneys' charges in connection with the
preparation filing, prosecution, maintenance and defense of
the Patent Rights and translation charges.
(ll) "PATENT RIGHTS" shall mean all patents and patent
applications, including any divisional, continuation,
continuation-in-part, reissue, renewal or extension thereof,
or substitute therefor, any registration or confirmation
thereof, relating to any Technology, Compounds or Commercial
Products, their methods of manufacture or uses of
intermediates therefor, or formulations thereof. "ONCOGENE
PATENT RIGHTS" shall mean Patent Rights claiming inventions
that are conceived solely by employees or consultants of
Oncogene or its Affiliates. "JOINT PATENT RIGHTS" shall mean
Patent Rights claiming inventions that are conceived solely by
employees, agents, or consultants of Oncogene and employees or
consultants of Sepracor and of their respective Affiliates.
"SEPRACOR PATENT RIGHTS" shall mean Patent Rights claiming
inventions that are conceived jointly by employees, agents, or
consultants of Sepracor or its Affiliates.
(mm) "PERSON" shall mean any individual, corporation, company,
cooperative, partnership, trust, unincorporated association or
any other entity which possesses a juridical personality,
including any governmental authorities or body of competent
jurisdiction; and pronouns when referring to a Person, shall
have a similar extended meaning.
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(nn) "PROGRAM REPRESENTATIVE" shall mean an employee of a Party
designated by such Party as its representative for
consultation and communication with the other Party. Any Party
may change its Program Representative at any time by written
notice given to the other Party or designate more than one
Program Representative provided that each of its
representatives shall be assigned different responsibilities.
(oo) "RENEWAL PERIOD" shall have the meaning ascribed thereto at
Section 8.1 hereof.
(pp) "RESEARCH PROGRAM" shall mean the written research plan
annexed hereto as Schedule A, as subsequently revised or
replaced by the Joint Steering Committee, which plan describes
the research and other obligations to be carried out during
each Commitment Year by each of Sepracor and Oncogene and
their Affiliates.
(qq) "SECRET INFORMATION" shall have the meaning ascribed thereto
at Section 4.1 hereof.
(rr) "SEPRACOR CONFIDENTIAL INFORMATION" shall mean all
confidential information disclosed to Oncogene orally and
subsequently confirmed in writing as "CONFIDENTIAL" or
designated as "CONFIDENTIAL" by Sepracor or its Affiliates at
the time of disclosure to Oncogene, to the extent that such
information as of the date of disclosure to Oncogene is not
(i) demonstrably known to Oncogene other than by virtue of a
prior confidential disclosure to Oncogene by Sepracor or its
Affiliates, or (ii) disclosed in the published literature or
otherwise to the public through no fault of Oncogene, its
Affiliates, employees or consultants, or (iii) obtained from
an Independent Third Party having no obligation of
confidentiality to Sepracor or its Affiliates with respect to
such information.
(ss) "SEPRACOR TECHNOLOGY" shall mean and include all technology
and technical information relating to a Compound, including
all inventions, chemical structures and methods for synthesis,
structure activity relationships, assay methodology, methods,
processes, formulae, plans, specifications, characteristics,
equipment and equipment designs, know how, trade secrets,
discoveries, results, formulations and biological,
toxicological and clinical data and physical, chemical or
biological material that is conceived solely by employees or
agents of, or consultants to, Sepracor and/or its Affiliates,
prior to or during the term of this Agreement or acquired by
purchase, license, assignment or other means from third
parties prior to or during the term of this Agreement that is
not Joint Technology, but only to the extent that Sepracor or
its Affiliates is legally entitled to disclose such Technology
and technical information and use it in connection with the
performance by it of its obligations hereunder.
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(tt) "SUBMITTED LICENSE" shall have the meaning ascribed thereto at
Section 9.1 hereof.
(uu) "TARGET" shall have the meaning ascribed thereto at Section
8.2 hereof.
(vv) "TECHNOLOGY" shall mean, collectively, Sepracor Technology,
Oncogene Technology and Joint Technology.
ARTICLE 2
RESEARCH PROGRAM
2.1 GENERAL. Subject to the terms and conditions of this Agreement, each of
Sepracor and Oncogene agrees, as of the Effective Date, to undertake
and to cause its Affiliates to undertake, the Research Program and, in
the Field, to collaborate in respect thereof.
2.2 SCOPE. The Research Program shall involve the identification, research
and development of Lead Compounds derived from Sepracor Technology,
Oncogene Technology and Joint Technology or which may be contained in
any compound library prepared by or on behalf of any Party or to which
the Parties and their Affiliates hereto have access to and the right to
use in connection with this Agreement in respect of the Field with the
goal of identifying Development Candidates among such Lead Compounds.
2.3 GENERAL OBLIGATIONS OF THE PARTIES. During the term of this Agreement,
the Parties hereto hereby agree to diligently pursue the following, and
to cause their respective Affiliates to diligently pursue the
following, to the extent that it is reasonably necessary to the purpose
of this Agreement and in accordance with the Research Program:
(a) Each of Sepracor and Oncogene and/or their respective
Affiliates has synthesized and isolated and/or shall continue
to synthesize and/or isolate Compounds for use within the
Field.
(b) Each of Sepracor and Oncogene and/or their respective
Affiliates shall provide the other Party with information
concerning, and, if required by the JDC, with samples of,
Compounds for use within the Field, including those which pass
primary screening in order that the other Party may
collaborate in the evaluation of potential activity as
antibacterial or anti-fungal agents.
(c) Each of Sepracor and Oncogene shall aid, and shall cause their
respective Affiliates to aid, the other Party in the
fulfillment of its obligations hereunder, provide structural
chemistry analysis and access to combinatorial chemistry
technology, and scale up potential Compounds for in vitro and
in vivo studies,
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and provide through in vitro and in vivo evaluations, toxicity
and mechanisms of action studies in order to select, as
promptly as possible, Lead Compounds for development.
(d) Each of Sepracor and Oncogene shall provide to the other Party
access, limited for use or access by such other Party in the
Field, to compound libraries made by it or on its behalf or to
which it has access and the right to use in connection with
the conduct of the Research Program.
(e) Each of Sepracor and Oncogene shall, and each shall cause its
Affiliates to, conduct research and development activities in
respect of targets identified by the JSC.
(f) Sepracor and Oncogene agree, on their behalf and on behalf of
their respective Affiliates, (i) to fulfill their respective
obligations under, and pursue the goals of, the Research
Program and (ii) to perform their responsibilities as outlined
in the Research Program or allocated to it by the Joint
Steering Committee.
(g) Each of Sepracor and Oncogene agrees to utilize laboratory
facilities and equipment and research staff in accordance with
the provisions hereof to fulfill its obligations hereunder and
to give effect to the intention of the Parties to collaborate
in the Field.
2.4 JOINT STEERING COMMITTEE.
2.4.1 PURPOSE. A steering committee (the "Joint Steering
Committee" or "JSC") is hereby established by
Sepracor and Oncogene, and will begin functioning
within fifteen (15) days of the date of this
Agreement, to manage all business and commercial
aspects between the Parties pursuant to this
Agreement (including financial planning, resource
allocation, prioritization, addition of new targets
within the Field), agree upon and assign
responsibilities (other than specific scientific
tasks) within the Research Program to each Party,
approve the annual budgets to be spent by each Party
during any Commitment Year and review and monitor
work conducted by the Joint Development Committee and
to process and approve technical and scientific
recommendations of the JDC. In particular, the JSC
will be responsible, throughout the term of this
Agreement, for (a) selecting targets and reviewing
the Research Program and revising it as necessary,
(b) for preparing, monitoring and revising on an
annual basis the budgets necessary for the
performance by the Parties of their obligations
pursuant to the Research Program and this Agreement,
(c) monitoring the fulfillment by each Party of its
obligations pursuant to this Agreement, (d)
designating any Compounds as Lead Compounds, (e)
determining the allocation between the Parties of
their resources in connection with the conduct of the
Research Program, (f) designating Development
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Candidates, (g) negotiating and soliciting, if
appropriate, third parties to collaborate for
purposes of conducting the Research Program, (h)
determining on an annual basis the amount, if any,
(the "Deficiency Amount") owed by one party to the
other in order that contributions of both Parties
during any Commitment Year referred to in Section 2.8
be approximately the same, and (i) determining the
GAAP rules and principles applicable for purposes of
the accounting and maintenance of books and records
by both Parties. Either Party may in committee
propose that the Parties commence development of a
promising Lead Compound.
2.4.2 EXPANSION OF RESEARCH PROGRAM. Save for the first
Commitment Year, in which case the Research Program
is defined as set out in Schedule A of this Agreement
and a general outline in respect of the other
Commitment Years, the JSC shall define the Research
Program in each Commitment Year and amend, if it
deems appropriate, the Field.
2.4.3 COMPOSITION. Sepracor and Oncogene each shall
appoint, in their sole discretion, three (3) members
to the JSC. Alternates or replacements of any Party
may be appointed by such Party at any time by notice
to the other Party.
Initially the members shall be:
for Sepracor:
for Oncogene:
2.4.4 VOTING. Each member of the JSC shall have one vote,
and decisions shall be made by unanimity. Where a
vote does not produce a unanimous decision, the
matters at issue shall be submitted to the President
of Sepracor and the Chief Executive Officer of
Oncogene for discussion and resolution.
2.4.5 CHAIR. A Chairperson shall be nominated alternatively
by Sepracor and Oncogene for one year terms, the
first term being served by a nominee appointed by
Oncogene.
2.4.6 MEETINGS. Meetings shall be convened four times each
year at times determined by the JSC . The JSC,
however, may unanimously agree to meet more or less
frequently. Representatives of Oncogene, Sepracor, or
both, in addition to members of the JSC, may attend
meetings but shall have no voting rights. Meetings
shall be held alternatively at each Party's
facilities. Minutes of each meeting shall be prepared
by a representative of the host party and distributed
to all members of the JSC within thirty (30) days
following any meeting.
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2.4.7 EXPENSES. The Parties will each bear their own
expenses and those expenses related to the
participation of their appointees to the JSC.
2.5 JOINT DEVELOPMENT COMMITTEE
2.5.1 PURPOSE. A "JOINT DEVELOPMENT COMMITTEE" (or "JDC")
shall be established by the JSC to (a) manage, agree
upon and assign specific responsibilities within the
Research Program and the Development Program to each
Party; (b) prepare and review the Research Program
and the Development Program, revising it as
necessary; (c) recommend to the JSC any Compound as
Lead Compounds; (d) recommend to the JSC any Lead
Compounds as Development Candidates; (e) participate
in all aspects of the planning and development work
carried out on any Development Candidate; (f)
determine the responsibilities of each Party in
seeking regulatory approvals; (g) manage and deal
with such other responsibilities which may, from time
to time, be delegated to it by the Joint Steering
Committee; and (h) review and discuss scientific
questions which may arise in connection with the
execution of the Research Program and scientific
inventions, breakthroughs or developments in the
Field made pursuant to the Research Program.
2.5.2 COMPOSITION. Sepracor and Oncogene each shall
appoint, in their sole discretion, three (3) members
to the JDC. Replacements of any Party may be
appointed by such Party at any time by notice to the
other Party.
2.5.3 VOTING. Each member of the Joint Development
Committee shall have one vote, and decisions shall be
made by unanimity, subject to approval by the Joint
Steering Committee. Where a vote does not produce a
unanimous decision, the matters at issue shall be
submitted to the JSC for discussion and resolution.
2.5.4 CHAIR. A Chairperson shall be nominated alternatively
by Sepracor and On-cogene for one year terms, the
first term being served by a nominee appointed by
Sepracor.
2.5.5 MEETINGS. Meetings of the JDC shall be held four
times each year at times determined unanimously by
the JDC. The JDC, however, may unanimously agree to
meet more or less frequently. Representatives of
Oncogene, Sepracor, or both, in addition to members
of the Joint Development Committee, may attend
meetings but shall have no voting rights. Meetings
shall be held alternatively at each Party's
facilities. Minutes of each meeting shall be prepared
by a representative of the host party and distributed
to all members of the JDC within fifteen (15) days
after each meeting.
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2.5.6 REPORTS. During the term of this Agreement, each
Party shall cause its contingent to the JDC to
prepare and submit to the Joint Steering Committee a
summary report within thirty (30) days following the
end of each calendar quarter, describing the work
accomplished and progress under the Research Program
during the preceding calendar quarter, discussing and
evaluating the results of such work, and recommending
any qualified Compounds to be designated as Lead
Compounds.
2.5.7 EXPENSE. The Parties will each bear their own
expenses and those expenses related to the
participation of their appointees on the Joint
Development Committee.
2.6 REPORTS. During the term of this Agreement, Sepracor and Oncogene each
shall provide to the JSC and to the other Party access to primary data
derived or used in connection with the performance by it of its
obligations hereunder and on a quarterly basis and no later than thirty
(30) days following the end of each Commitment Year, a statement of all
costs and expenses incurred by such Party and its Affiliates pursuant
to Section 3.1.
2.7 LABORATORY FACILITIES. Sepracor and Oncogene each agree to utilize, or
cause their respective Affiliates to utilize, suitable laboratory
facilities and equipment for carrying out its obligations under the
Research Program and this Agreement.
2.8 RESEARCH STAFF. Each of Sepracor and Oncogene shall, no later than
fifteen (15) days following commencement of JSC function under this
Agreement, appoint research teams comprised of such number of suitably
qualified scientists and other personnel as may be determined by the
JSC to be reasonably necessary in order to achieve the goals of the
Research Program and Development Program, it being understood that,
unless otherwise agreed in writing by the Parties, over the term of
this Agreement, (a) each Party shall have contributed, in terms of
out-of-pocket expenses incurred during the term of this Agreement by
the Parties and their Affiliates (including salaries and such other
costs and expenses referred to in Section 3.1 hereof), approximately
equally in connection with the performance of their obligations under
the Research Program and this Agreement, and (b) such contribution are
estimated to total up to approximately $12 million (or approximately up
to $6 million by each Party) for the initial three year period.
2.9 INSPECTIONS. Sepracor and Oncogene shall each have the right to arrange
for its employees, external consultants, and such other persons as it
may reasonably delegate, to visit the other Party at its offices and
laboratories and to discuss work under the Research Program and its
results in detail with the other Party's Program Representative, the
staff, and consultants of the other Party; provided that such visits
are during normal business hours, have been arranged on not less than
ten (10) business days notice and shall not unreasonably interrupt the
operations of the other Party.
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2.10 PATENT AND CONFIDENTIAL INFORMATION AGREEMENTS. Each of Sepracor and
Oncogene shall require all of its employees, all employees of its
Affiliates and all Independent Third Parties involved in, or associated
with the Research Program to have executed an agreement for the
assignment of inventions and for the protection of Secret Information
in such reasonable form as may from time to time be used by Sepracor
and Oncogene for such purpose.
2.11 FLEXIBILITY. In conducting its research and other obligations under
this Agreement, each of Sepracor and Oncogene shall have and maintain
sufficient flexibility to allow a shift in effort and emphasis within
the Research Program that will, in the opinion of the JSC, achieve the
best results in the attainment of the objectives of the Research and
Development Programs.
2.12 ARRANGEMENTS WITH INDEPENDENT THIRD PARTIES. Each of Sepracor and
Oncogene shall have the right to contract with its Affiliates and
Independent Third Parties for work, consulting services, or the
financing of the costs of its work or of its share of the costs of work
in connection with the Research Program General form agreements that
shall be used by each of the Parties for Independent Third Parties that
function as investigators or consultants are appended hereto and have
been approved for general use. Material deviations from these forms
will be subject to prior approval by the other party, which approval
shall not unreasonably be withheld and shall be decided within thirty
(30) days of receipt of a request for approval.
2.13 NO INDEPENDENT RESEARCH WITHIN THE SCOPE OF THE RESEARCH PROGRAM.
During the term of this Agreement, the Parties to this Agreement shall
not undertake independent research, either directly or indirectly
through any Affiliate or any other Person, in any area falling within
the Field or which competes with any Compound being developed pursuant
to this Agreement without the consent of the Joint Steering Committee.
2.14 OTHER RESEARCH PERMITTED. The Parties and their Affiliates have the
right to conduct research on Compounds and use its own Technology and
Joint Technology outside the Field alone or in collaboration with third
parties, notwithstanding their potential utility of such Compounds in
the Field.
2.15 CLINICAL DATA. All clinical data obtained from studies conducted
pursuant to the Research Program and the Development Program shall be
jointly owned by Sepracor and Oncogene and may be used by either Party
and its Affiliates outside the Field, it being understood that any such
Party shall not, in the course of such use or conduct, take or omit to
take any action which would cause prejudice to the other Party or to
the Research or Development Programs.
2.16 LEAD COMPOUNDS. Notwithstanding any provision of this Agreement, if a
Compound is not designated as a Development Candidate within two (2)
years following its designation by the JSC as a Lead Compound, such
Lead Compound shall cease to be
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considered a Compound within the meaning of this Agreement and neither
party shall have any continuing obligation to the other in respect of
development or commercialization thereof.
ARTICLE 3
COSTS AND EXPENSES OF THE RESEARCH PROGRAM
3.1 PAYMENT OF COSTS AND EXPENSES. Each Party shall be responsible for all
expenses and costs incurred by it and its employees, its Affiliates and
its consultants in the performance of such Party's obligations
hereunder, including, without limitation, in respect of Patent Expenses
relating to Joint Patent Rights for which it is responsible, salaries
of its employees, fees of its consultants, materials, equipment and
administrative expenses and travel costs of its employees, employees of
its Affiliates and consultants. Each party shall document such costs
and expenses in accordance with the methods to be established by the
JSC. In order that each party bears an equal share of such costs and
expenses, a Party shall reimburse the other Party the Deficiency Amount
within ninety (90) days from the end of any year.
ARTICLE 4
SECRET INFORMATION
4.1 GENERAL. Each of Sepracor and Oncogene recognizes that the other
Party's Confidential Information, Sepracor Technology, Oncogene
Technology, Joint Technology (collectively, the "Secret Information")
all constitute highly valuable proprietary
confidential information.
4.2 TREATMENT OF SECRET INFORMATION.
(a) Subject to the disclosure obligations set forth in this
Article 4, each of Sepracor and Oncogene agree that, during
the term of this Agreement, each Party will maintain, and
shall cause its Affiliates to maintain, the Secret Information
of the other in confidence and shall not disclose, divulge or
otherwise communicate such Secret Information to Independent
Third Parties (except those bound to secrecy pursuant to
Section 2.10 above), or use it for any purpose except pursuant
to, and in order to carry out the terms and objectives of this
Agreement. Notwithstanding any provision of this Agreement,
Sepracor and Oncogene hereby agree that they shall, together
with their Affiliates, be entitled to use, outside of the
Field, its own Confidential Information, its own Technology,
and its share of Joint Technology obtained during the term of
this Agreement.
(b) Each Party further agrees to exercise, and shall cause its
Affiliates to exercise, reasonable precautions to prevent and
restrain the unauthorized disclosure of
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such Secret Information by any of its directors, officers,
employees, consultants, subcontractors, sublicensees or agents
or those of its Affiliates.
(c) Each Party shall maintain, and shall cause its Affiliates to
maintain, the other Party's Confidential Information in
confidence. During the term of this Agreement and for a period
of ten (10) years thereafter each Party shall not disclose,
divulge or otherwise communicate the other Party's
Confidential Information to Independent Third Parties except
those bound by secrecy pursuant to Section 2.10 above or in
the event of an assignment by such Party of its rights
hereunder in accordance with the provisions hereof.
4.3 PRESS RELEASES AND ANNOUNCEMENTS.
(a) Neither Oncogene or Sepracor shall, and Oncogene and Sepracor
shall cause their Affiliates not to, issue any press release
or other public announcement relating to or disclosing any
Secret Information (other than its own Confidential
Information or its own Technology) without the prior written
consent of the other Party, except where such announcements or
press releases are required by law for the purposes of
securing the registration of, and or governmental approval to
market, in accordance with this Agreement, any Commercial
Products, or for the procurement of patent protection of a
Joint Patent Right. Notwithstanding the foregoing, each Party
shall have the right to disclose the existence of this
Agreement in any prospectus, offering memorandum or other
document or filing required by applicable securities laws or
other applicable law or regulation.
(b) Where a press release or public announcement is required by
law, the Party required to disclose Secret Information shall
inform the other Party and provide it with a copy of any such
press release or public announcement prior to release.
(c) Each of Sepracor and Oncogene shall inform the other Party of
any Secret Information which it is required to disclose.
4.4 PUBLICATIONS. Notwithstanding the provisions of Sections 4.1, 4.2 and
4.3, a Party or its Affiliates may submit the results obtained in the
course of the Research Program for publication subject to approval of
the JSC. The Parties further recognize, however, that the JSC's right
to approve or prohibit publication may be subject to the publication
rights of third party investigators as contemplated in Section 2.12
above.
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ARTICLE 5
INTELLECTUAL PROPERTY RIGHTS
5.1 GENERAL. The following provisions relate to inventions and know-how
conceived, directly or indirectly through Affiliates, by Sepracor or
Oncogene or Sepracor and Oncogene, jointly, during the course of
carrying out the Research Program.
5.2 RESEARCH. All Technology, information, data, discoveries and inventions
arising from programs of research carried out by Oncogene and its
Affiliates, on the one hand, or by Sepracor and its Affiliates, on the
other hand, and all intellectual property rights relating thereto shall
be the exclusive property of Oncogene or Sepracor and their Affiliates,
as the case may be.
5.3 MAINTENANCE OF JOINT PATENT RIGHTS. The JSC shall appoint either
Sepracor or Oncogene on a case by case basis as the party responsible
for taking all necessary actions to obtain, sustain and enforce patent
protection for Joint Patent Rights including, without derogation from
the foregoing:
(a) Filing applications for patents on any patentable inventions
included within Joint Patent Rights; provided that any Party
wishing to file such application shall inform the other Party
and the Joint Steering Committee regarding countries in which
such applications should be filed; the JSC shall determine
which countries where such applications shall be made;
(b) Prosecuting all pending and new patent applications included
within Joint Patent Rights and responding to opposition or any
other form of action for invalidity or revocation of Patent
Rights filed by Independent Third Parties against the grant of
patents for such applications;
(c) Maintaining in force any patents included within Joint Patent
Rights by duly filing all necessary papers and paying any fees
required by the patent laws of the particular country in which
such patents were granted.
Each Party shall undertake to provide all necessary assistance to the
JSC and the other Party to achieve the objectives of this Section 5.3.
The responsible Party shall continue to prosecute and maintain all
relevant patent rights relating to Joint Technology within the Field in
full consultation with the JSC. Each Party shall keep the other Party
informed as to all developments with respect to Joint Patent Rights by
copying all documents and correspondence related to such protection and
maintenance.
If the JSC decides to abandon a patent application or an issued patent
included within Joint Patent Rights, any Party whose appointees on the
JSC shall have voted against such abandonment shall have the option, at
its expense, of continuing to prosecute any such patent application or
of keeping the issued patent in force. If a Party elects to
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file, at its own expense, patent applications in respect of Joint
Patent Rights in countries in which the JSC has elected not to file,
such Party shall have the unrestricted right to negotiate licenses with
Independent Third Parties in such nonelected countries or exploit it
directly.
5.4 INFRINGEMENT. Each Party shall promptly inform the other Party of any
suspected infringement of any Joint Patent Rights. During the term of
this Agreement, both Parties shall have the right to institute an
action for infringement of the Joint Patent Rights against such
Independent Third Party in accordance with the following:
(a) Both Parties shall institute suit jointly, the suit shall be
brought in both their names and the out-of-pocket costs
thereof shall be borne equally. Once accounting is made for
such equal bearing of costs any recovery or settlement
received by a Party in excess of the total, equally shared out
of pocket costs shall be shared equally. The JSC shall decide
upon the manner in which any Party shall exercise control over
such action. Any Party may, if it so desires, also be
represented by separate counsel of its own selection, the fees
for which counsel shall be paid by it.
(b) In the absence of agreement to institute a suit jointly, any
Party may institute suit, and, at its option, name the other
Party as a plaintiff. The Party instituting shall bear the
entire costs of such litigation, including defending any
counterclaims brought against the other Party and paying any
judgments rendered against the other Party, and shall be
entitled to retain the entire amount of any recovery or
settlement.
(c) Should either Party commence a suit under the provisions of
this Section 5.4 and thereafter elect to abandon such suit,
the abandoning Party shall give timely notice to the other
Party who may, if it so desires, continue prosecution of such
suit, provided that the sharing of expenses and any recovery
in such suit shall be as agreed upon between both Parties.
5.5 COSTS FOR APPLYING, PROSECUTING AND MAINTAINING. The costs of applying
for, prosecuting and maintaining patent applications and patents as
specified in Section 5.3 shall be borne equally by Sepracor and
Oncogene.
5.6 DISCLOSURE OF INVENTIONS. Each of Sepracor and Oncogene shall promptly
inform the other Party of all inventions and Joint Technology that are
conceived in the course of carrying out the Research Program by its
respective employees, agents, Affiliates or consultants, whether
invented solely or jointly with employees of or consultants to the
other Party.
5.7 OWNERSHIP OF JOINT INTELLECTUAL PROPERTY. Sepracor and Oncogene shall
jointly own the entire right, title and interest in all Technology,
patents, know how and other
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rights in any idea, design, invention, discovery, improvement or other
creation, including any Compound, method or apparatus conceived jointly
by employees, agents, or consultants Sepracor and employees, agents, or
consultants of Oncogene, in the course of the Research Program. The
commercial exploitation by Sepracor and Oncogene as joint owners of
their rights is subject to the provisions of Article 6 of this
Agreement.
5.8 COPIES OF PATENT APPLICATIONS. Each Party shall provide to the other
Party, as to those applications which it is filing, copies of all
patent applications for Joint Patent Rights prior to filing, for the
purpose of obtaining comments and advice from the other Party's patent
advisors and the other Party's approval to so file which approval shall
be provided within a reasonable time. Upon the other Party's approval,
such Party shall be free to file said patent applications. Such Party
shall also consult with the other Party on the prosecution of said
applications and provide to such Party copies of all substantive
documents relating to the prosecution of said applications. Such Party
shall provide to the other Party every six (6) months a report
detailing the status of all patent applications that are part of Joint
Patent Rights.
5.9 OTHER PATENT RIGHTS. Each Party shall be responsible at its sole
expense and discretion for taking all necessary actions to obtain,
sustain and enforce patent protection for its sole Patent Rights,
including the following:
(a) Filing applications for patents on any patentable inventions;
(b) Prosecuting all pending and new patent applications and
responding to opposition or any other form of action for
invalidity or revocation of Patent Rights filed by Independent
Third Parties against the grant of patents for such
application;
(c) Maintaining in force any patents by duly filing all necessary
papers and paying any fees required by the patent legislation
of the particular country in which such patents were granted.
In the event that a Party institutes suit to protect its own Patent
Rights against suspected infringement involving manufacture, use, or
sale of a Development Candidate or Commercial Product aside from a
Development Candidate or Commercial Product that targets ** or ** it
shall notify the other Party who shall have the option, to be exercised
in writing no later than thirty (30) days from receipt of the notice,
to elect to assume 50% of all expenses relating to such suit, including
attorneys' fees, in which case any recovery or settlement received by
the Party having instituted suit shall be shared equally by both
Parties. In the event that a Party
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institutes suit to protect its own Patent Rights against suspected
infringement involving anufacture, use, or sale of a Development
Candidate or Commercial Product that targets ** or ** it shall notify
the other Party who shall have the option, to be exercised in writing
no later than thirty (30) days from receipt of the notice, to elect to
assume 25% of all expenses relating to such suit in the case of
Oncogene's election, or 75% of all expenses relating to such suit in
the case of Sepracor's election, including attorneys' fees, in which
case any recovery or settlement received by the Party having instituted
suit shall be shared by the Parties in proportion to their share of
expenses.
The Party having instituted suit shall have the authority to make all
decisions concerning such suit, including without limitation, the right
to compromise the claim.
5.10 INDEMNIFICATION. Each Party (the "INDEMNIFYING PARTY") shall indemnify
the other Party, its directors, officers, employees and consultants
(the "INDEMNIFIED PARTY") from and against any and all claims, demands,
losses, liabilities, expenses or damages which the Indemnified Party
may suffer, pay or incur as a result of claims, demands or suits
against the Indemnified Party arising or alleged to arise by reason of
or in connection with any and all personal injury and property damage
caused or contributed to, in whole or in part, by the Indemnifying
Party's actions or infringement.
ARTICLE 6
DEVELOPMENT AND COMMERCIALIZATION
6.1 DECISION TO COMMERCIALIZE. The Joint Steering Committee has the
authority, following recommendation from the JDC, to determine that a
Lead Compound is suitable for development and therefore qualifies as a
Development Candidate. This authority of the JSC is governed by Section
2.4.
6.2 COMMERCIALIZATION AGREEMENT. Where a Compound has been designated as a
Development Candidate, the Parties shall enter into a commercialization
agreement (the "COMMERCIALIZATION AGREEMENT") for the development and
commercialization of that Compound as soon as possible after the first
to occur of the following events: (a) the decision to enter into a full
clinical development program as approved by the JSC, or (b) the
beginning of Phase III clinical studies, conducted to support the
application for marketing approval of the Development Candidate for an
indication.
6.3 CONTENT OF COMMERCIALIZATION AGREEMENT. The Commercialization Agreement
shall provide that the Parties shall both have commercialization rights
worldwide, and the parties intend to jointly exploit any Commercial
Products in the Field and share in the
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** This portion redacted pursuant to a request for confidential treatment.
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profits from such exploitation in the same proportion as they share in
the expenses incurred under this Agreement in developing such
Commercial Products. The mechanism for commercialization will be
negotiated between the Parties through good faith negotiations; it
shall take into account the respective contributions of the Parties
pursuant to Section 2.8, and profits should, unless otherwise agreed to
by the Parties, be essentially equally shared between the Parties,
except in the cases of Commercial Products within either of the two
classes of (a) ** and (b) ** where Sepracor will receive ** and
Oncogene ** of profits. The Parties agree that they shall both have
commercialization rights world wide. The Commercialization Agreement
shall provide that rights hereunder may be sublicensed to a third party
by mutual agreement of the Parties, and to any affiliate of a Party.
6.4 NO SUPPORT. If any Party's representatives on the JSC or JDC declines
to support the advancement of a Compound to a Lead Compound stage or a
Lead Compound to a development stage for reasons which may include, but
are not limited to, the proposed market being outside the scope of its
interest or being too small, and the other Party's representatives on
the JSC or JDC support the advancement of said Compound to a Lead
Compound stage or of a Lead Compound to a development stage with an
objective of commercialization of said Compound, then the JSC or JDC,
as the case may be, shall record a notice ("NOTICE OF OPPORTUNITY") in
the minutes of the meeting where the representatives express such
positions. For a period of sixty (60) days after the date of such
Notice of Opportunity the Parties shall negotiate in good faith to
resolve the issue in a mutually agreeable manner. If the Parties are
unable to resolve the issue, then, for a period of one hundred and
twenty (120) days thereafter, the Party having supported the
advancement of the Compound or the Lead Compound (the "NOTIFYING
PARTNER") shall have a first right to undertake worldwide development
and commercialization of such Compound or Lead Compound. Upon the
Notifying Party exercising such right, such Party shall be granted a
worldwide exclusive license from the other Party under all relevant
intellectual property which shall contain usual terms and conditions
for agreements of that type and provide for the payment by the
Notifying Party to the other Party of royalties of ** of Net Invoiced
Sales Value to be paid within thirty (30) days following the end of any
calendar quarter. If, at any time, a Party which has commenced
development on a Compound or a Lead Compound, halts such development,
then the other Party shall have the right to undertake development of
said Compound or Lead Compound, under the same mechanism and subject to
the same conditions as described in this Section 6.4.
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ARTICLE 7
OTHER RESEARCH VENTURES ETC.
7.1 ACQUISITION OF RIGHTS FROM THIRD PARTIES. During the term of this
Agreement, Sepracor and Oncogene shall promptly notify the other in
writing of any and all opportunities to acquire from Independent Third
Parties, whether by license, assignment or otherwise, technology or
patents which may be useful in, or may relate to, the purposes of the
Research Program.
Sepracor and Oncogene shall work together in a manner mutually
agreeable and beneficial to secure third party technology or patents
which they have determined would be useful in or relate to the purpose
of the Research Program. Each Party shall (a) inform the other Party of
all third party technology or patents that may be useful or relate to
the Research Program, (b) solicit the other Party's participation and
approval in the formulation and implementation of a strategy for
securing such technology or patents and, (c) provide status reports on
the progress of such strategy.
ARTICLE 8
TERM, EXTENSION, TERMINATION AND DISENGAGEMENT
8.1 TERM. The initial term (the "INITIAL TERM") of this Agreement shall be
three (3) years, commencing on the Effective Date. Following the
expiration of the Initial Term, this Agreement shall be automatically
renewed for additional successive one-year periods (each, a "RENEWAL
PERIOD") unless either Party gives the other notice of its intent not
to renew one hundred and twenty (120) days prior to the expiration of
the Initial Term or any Renewal Period, as the case may be.
8.2 EVENTS OF TERMINATION. The following events shall constitute events of
termination (each an "EVENT OF TERMINATION"):
(a) Any representation or warranty by Sepracor or Oncogene in this
Agreement proves incorrect, or inaccurate, in any material
respect when made or deemed made as determined by an
independent arbitrator and the defaulting Party does not
remedy or cure such incorrect or inaccurate representation or
warranty within sixty (60) days following written notice from
the other Party of such breach.
(b) Sepracor or Oncogene fails to perform or observe any term of
this Agreement or Schedules thereto and such failure remains
unremedied for a period of sixty (60) days following written
notice thereof from the nondefaulting Party or such longer
period if the defaulting Party is diligently taking action to
remedy such failure.
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(c) Sepracor or Oncogene makes an assignment for the benefit of
its creditors, becomes insolvent, files a petition in
bankruptcy, petitions or applies to any tribunal for the
appointment of a custodian, receiver or any trustee for it or
a substantial part of its assets, or commences any proceeding
under any bankruptcy, reorganization, arrangement,
readjustment of debt, dissolution or liquidation law or
statute of any jurisdiction, whether now or hereafter in
effect; or if there has been filed any such petition or
application against Sepracor or Oncogene, or any such
proceeding has been commenced against it, in which an order
for relief is entered or which remains undismissed for a
period of sixty (60) days or more; or Sepracor or Oncogene by
any act or omission indicates its consent to, approval of or
acquiescence in, any such petition, application or proceeding
or order for relief or the appointment of a custodian,
receiver or any trustee for it or any substantial part of any
of its properties, or is the subject of any such
custodianship, receivership or trusteeship that continues
undischarged for a period of sixty (60) days or more.
(d) Sepracor or Oncogene generally fails to pay its debts as such
debts become due.
(e) In respect of any Party, if a Person acquires (the
"Acquisition") shares of such Party (the "Target"), directly
or indirectly, which carry the right to cast, in the
aggregate, more than 50% of the votes for the election of
directors.
ARTICLE 9
CONSEQUENCES OF TERMINATION
9.1 LICENSES UPON TERMINATION. Before the expiration of a period of one
hundred and twenty (120) days following delivery of a notice pursuant
to Section 8.1, either Party (the "ELECTING PARTY") may, by written
notice (the "NOTICE") accompanied by a Submitted License (as defined
hereinafter) at its option offer to the other Party: (a) to have an
exclusive worldwide license for any or all of the Joint Patent Rights
or Joint Technology in accordance with the terms and conditions of an
agreement to be submitted by the Electing Party to the other Party (the
"SUBMITTED LICENSE"); or (b) to grant to the other Party (the
"NON-ELECTING PARTY") an exclusive worldwide license for such Joint
Patent Rights or Joint Technology in accordance with the Submitted
License.
The Non-Electing Party shall have the option to either (i) grant to the
Electing Party a worldwide exclusive license for such Joint Patent
Rights or Joint Technology in accordance with the terms and conditions
of the Submitted License, or (ii) to have an exclusive worldwide
license for such Joint Patent Rights or Joint Technology in accordance
with the terms of the Submitted License.
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Such election may be made by the Non-Electing Party in writing,
addressed to the Electing Party (the "ELECTION NOTICE") within ninety
(90) days following receipt of the Notice, failing which he shall be
deemed to have elected to grant the Electing Party a license upon the
terms of the Submitted License. The Parties shall execute a license
based on the Submitted License within six (6) months following receipt
by the Electing Party of the Election Notice.
9.2 TERMINATION UPON THE OCCURRENCE OF AN EVENT OF TERMINATION. Upon the
occurrence of any Event of Termination set forth in Section 8.2 (a) -
(d), for a period of sixty (60) days from the date of the occurrence of
any Event of Termination, the Parties shall negotiate in good faith to
resolve the issue in a mutually agreeable manner, and if the Parties
are unable to resolve the issue, then the Party not responsible for
such Event of Termination may, by notice to the other Party, terminate
this Agreement. In the event of any termination by a Party (the
"NOTIFYING PARTY") pursuant to Section 8.2 (a) - (d), all Joint
Technology and Joint Patent Rights shall become the sole exclusive
property of the Notifying Party, and the other Party shall execute and
perform all transfers and assignments to the Notifying Party which are
required by law. Upon the occurrence of an Event of Termination set
forth in Section 8.2(e), the Party, the shares of which are not being
acquired (the "OTHER PARTY"), shall, within sixty (60) days of its
knowledge of such Event of Termination, choose one of the following
options:
(a) Continue the Agreement in full force and effect, in which
event the Target shall not be considered to be in default
hereunder;
(b) Terminate the Agreement and be granted an exclusive license by
the Target to all Joint Technology and Joint Patent Rights
pursuant to which the Other Party shall pay to the Target
royalties on Net Sales made by the Other Party and its
Affiliates in the amount of ** of Net Invoiced Sales Value for
Commercial Products which were not, at the time of
termination, in Full Development or ** of Net Invoiced Sales
Value for Commercial Products which were, at the time of
termination, in Full Development but for which a
Commercialization Agreement is not yet in effect; or
(c) Terminate the Agreement and grant an exclusive license to the
Target to all Joint Technology and Joint Patent Rights
pursuant to which the Target shall pay to the Other Party
royalties on Net Sales made by the Target and its Affiliates
in the amount of ** of Net Invoiced Sales Value for Commercial
Products which were not, at the time of termination, in Full
Development or ** of Net Invoiced Sales Value for Commercial
Products which were, at the time of termination, in Full
Development but for which a Commercialization Agreement is not
yet in effect.
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9.3 SURVIVAL OF OBLIGATIONS; RETURN OF CONFIDENTIAL INFORMATION.
Notwithstanding any termination of this Agreement, the obligations of
the Parties with respect to the protection and nondisclosure of
Confidential Information, including those set forth in Article 4, shall
survive and continue to be enforceable. Upon any termination of this
Agreement, each Party shall promptly return to the other Party all of
that other Party's Confidential Information, and all copies thereof.
Sepracor and Oncogene acknowledge that after termination of this
Agreement each Party will be free to use its own Confidential
Information and Technology without restriction.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
Each of Sepracor and Oncogene represents and warrants as follows:
(a) GOOD STANDING. It is a corporation duly organized, validly
existing and is in good standing under the laws of its
jurisdiction of incorporation and has all requisite power and
authority, corporate or otherwise, to conduct its business as
now being conducted, to own, lease and operate its properties
and to execute, deliver and perform this Agreement.
(b) PROPER AUTHORIZATION. The execution, delivery and performance
of this Agreement have been duly authorized by all necessary
corporate action and do not and will not (i) require any
consent or approval of its stockholders, (ii) violate any
provision of any law, rule, regulation, order, writ, judgment,
in- junction, decree, determination or award presently in
effect having applicability to it or any provision of its
charter or by-laws, or (iii) result in a breach of or
constitute a default under any material agreement, mortgage,
lease, license, permit or other instrument or obligation to
which it is a party or by which it or its properties may be
bound or affected.
(c) BINDING AGREEMENT. This Agreement is a legal, valid and
binding obligation of it, enforceable against it in accordance
with its terms and conditions, except as such enforceability
may be limited by applicable bankruptcy, insolvency,
moratorium, reorganization or similar laws, from time to time
in effect, affecting creditors' rights generally.
(d) ABSENCE OF CONFLICT. It is not under any obligation to any
Person, contractual or otherwise, that is conflicting or
inconsistent in any respect with the terms of this Agreement
or that would impede the diligent and complete fulfillment of
its obligations hereunder.
(e) TITLE. Each of Sepracor and Oncogene for itself represents it
has good and marketable title to or valid leases or licenses
for, all of its properties, rights and assets, excluding
patent property, to be used in the fulfillment of its
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responsibilities under the Research Program, subject to no
claim of any third party other than the relevant lessors or
licensors.
ARTICLE 11
COVENANTS
11.1 AFFIRMATIVE COVENANTS OTHER THAN REPORTING REQUIREMENTS. Throughout the
term of this Agreement, each of Sepracor and Oncogene shall:
(a) Comply in all material respects with the requirements of all
applicable laws, rules, regulations and orders of any
government authority to the extent necessary to conduct the
Research Program;
(b) Maintain and preserve all of its properties, rights and assets
to be used in the proper conduct of the Research Program in
good working order and condition in accordance with the
general practice of other companies of similar size and
character;
(c) Conduct all experiments related to the Research Program and
maintain all facilities used in connection therewith in
accordance with applicable research guidelines, and with all
applicable federal, state, and local environmental
requirements;
(d) Pay to the other Party, if any, any Deficiency Amount
determined by the JSC.
ARTICLE 12
DISPUTE RESOLUTION
Any and all disputes arising between the parties under this Agreement shall be
resolved using proceedings in the following order: (i) good faith negotiations
between executives of the parties having full authority to negotiate and resolve
the dispute; (ii) if such negotiations fail to bring about a resolution within
sixty days of notice of the dispute, non-binding mediation at a mutually
acceptable location in accordance with the rules of the Center for Public
Resources, with costs shared equally; (iii) the procedures of this Article 12
are exclusive; however, nothing in this Article 12 shall preclude either party
from taking any action necessary to preclude imminent and irreparable harm. If
such mediation fails, the matter of differences shall be determined by
arbitration. Arbitration shall be conducted under the Commercial Arbitration
Rules of the American Arbitration Association by one (1) person appointed by the
Parties or, if the Parties cannot agree within thirty (30) days following
notification by one Party that it wishes to refer a matter to arbitration, by
such person empowered by the American Arbitration Association to so appoint an
arbitrator. Arbitration shall take place in a location agreed to by the Parties,
or absent such agreement, chosen by the arbitrator. The decision of the
arbitrator shall be final and binding on both Parties. The fees and expenses of
the arbitrator shall be borne equally by the Parties.
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ARTICLE 13
NOTICES
Any notice, statement, payment or other document required to be given hereunder
shall be in writing and shall be given either personally, by mailing the same,
postage prepaid, by certified or registered mail (return receipt requested), in
the absence of an actual or apprehended disruption of mail service or delivered
by telecopier addressed as follows, or to such other Addresses as may be
designated from time to time by notice given, in the manner provided in this
Article 13.
If to Sepracor: Sepracor Inc.
000 Xxxxx Xxxxx
Xxxxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Executive Officer
Telecopier: (000) 000-0000
If to Oncogene: Oncogene Science, Inc.
000 Xxxxxxx Xxxxxxxxx Xxxx.
Xxxxxxxxx, Xxx Xxxx 00000-0000
Attention: Chief Executive Officer
Telecopier: (000) 000-0000
Notices given personally shall be deemed given as of the date delivered. Notices
given by telecopier shall be deemed given on the first business day following
the date of transmission. Mailed notices shall be deemed given on the fifth
business day following the date of such mailing.
ARTICLE 14
MISCELLANEOUS
14.1 BINDING EFFECT. This Agreement shall be binding upon and inure to the
benefit of the Parties hereto and their respective legal
representatives, successors and permitted as- signs.
14.2 HEADINGS. The headings contained in this Agreement are for convenience
of reference only and do not form a part of this Agreement, and no
construction or inference shall be derived therefrom.
14.3 ENTIRE AGREEMENT. This Agreement and the documents and other agreements
referred to herein or signed concurrently herewith set forth the entire
agreement and understanding of the Parties.
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14.4 SEVERABILITY. In the event that any provision of this Agreement is held
by a court of competent jurisdiction to be unenforceable because it is
invalid or in conflict with any law of any relevant jurisdiction, the
validity of the remaining provisions shall be construed and enforced as
if the Agreement did not contain the particular provisions held to be
unenforceable.
14.5 COUNTERPARTS. This Agreement may be executed simultaneously in two or
more counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument.
14.6 AMENDMENT, WAIVER, ETC. This Agreement may be amended, modified,
superseded or canceled, and any of the terms hereof may be waived, only
by a written instrument executed by each Party hereto or, in the case
of waiver, by the Party or Parties waiving compliance. The delay or
failure of any Party at any time or times to require performance of any
provision hereof shall in no manner affect the rights at a later time
to enforce the same. No waiver by any Party of any condition or of the
breach of any term contained in this Agreement, whether by conduct or
otherwise, in any one or more instance, shall be deemed to be, or
construed as, a further or continuing waiver of any such condition or
of the breach of such term or any other term of this Agreement.
14.7 FORCE MAJEURE. In the event that either Party is prevented from or is
unable to perform any of its obligations under this Agreement due to
any act of God, fire, casualty, flood, war, strike, lockout, failure of
public utilities, injunction of any act, exercise, assertion or
requirement of governmental authority, including any governmental law,
order, or regulation permanently or temporarily prohibiting or reducing
the level of research and development work hereunder, epidemic,
destruction of production facilities, riots, insurrection, inability to
procure or use materials, labor, equipment, transportation or energy
sufficient to meet experimentation needs, or any other cause beyond the
reasonable control of the Party invoking this Article 14 if such Party
shall have used its best efforts to avoid such occurrence, such Party
shall give notice to the other Party in writing promptly, and thereupon
the affected Party's performance shall be excused and the time for
performance shall be extended for the period of delay or inability to
perform due to such occurrence.
14.8 INDEPENDENT CONTRACTOR. Nothing in this Agreement shall be construed as
constituting both Parties as partners or joint venturers with respect
to this Agreement. Both Parties are independent contractors under this
Agreement.
14.9 ASSIGNMENT AND SUCCESSORS. This Agreement and the rights and interests
hereunder may not be assigned by either Party in whole or in part
except to an Affiliate, a purchaser of all or substantially all of the
assets of a Party or to any successor corporation resulting from any
merger or consolidation of either Party with or into such corporation.
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14.10 GOVERNING LAW. This Agreement shall be construed and interpreted in
accordance with the laws of the State of New York.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
as a sealed instrument in their names by their properly and duly authorized
representatives as of the date first written above.
SEPRACOR INC.
By: /s/
----------------------------------------
Date: 3-4-97
--------------------------------------
ONCOGENE SCIENCE, INC.
By: /s/ Xxxx X. Xxxxxxxx
----------------------------------------
Date: 3-7-97
----------------------------------------
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