EXHIBIT 99.2
RESEARCH AGREEMENT
DATED NOVEMBER 1, 2001
BETWEEN
ARRAY BIOPHARMA INC.
AND
AMGEN INC.
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TABLE OF CONTENTS
SECTION TITLE PAGES
SECTION ONE - DEFINITIONS
1.1................................................................................. 1
SECTION TWO - RESEARCH PROGRAM
2.1 - 2.10.......................................................................... 1-5
SECTION THREE - LICENSES AND OPTION
3.1 - 3.5........................................................................... 5-6
SECTION FOUR - DEVELOPMENT AND COMMERCIALIZATION
4.1 - 4.2........................................................................... 6
SECTION FIVE - CONSIDERATION
5.1 - 5.7........................................................................... 7-9
SECTION SIX - INTELLECTUAL PROPERTY
6.1 - 6.4........................................................................... 9-11
SECTION SEVEN - CONFIDENTIALITY
7.1 - 7.4........................................................................... 11-14
SECTION EIGHT - TERMINATION
8.1 - 8.10.......................................................................... 14-18
SECTION NINE - REPRESENTATIONS, WARRANTIES AND
COVENANTS
9.1 - 9.3........................................................................... 18-20
SECTION TEN - INDEMNITY
10.1 - 10.4......................................................................... 20-21
SECTION ELEVEN - GENERAL PROVISIONS
11.1 - 11.14........................................................................ 21-24
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TABLE OF CONTENTS (CONT'D)
SECTION TITLE PAGES
EXHIBIT A - GLOSSARY......................................................... A-1 to A-6
EXHIBIT B - COLLABORATION TARGETS............................................ B-1
EXHIBIT C - RESEARCH PLAN ................................................... C-1 to C-3
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RESEARCH AGREEMENT
THIS
RESEARCH AGREEMENT (this "Agreement"), effective as of November 1,
2001 (the "Effective Date"), is made by and between
ARRAY BIOPHARMA INC., a
Delaware corporation having a place of business at 0000 Xxxxxx Xxxxxx, Xxxxxxx,
Xxxxxxxx 00000 ("Array"), and AMGEN INC., a Delaware corporation having a place
of business at Xxx Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000-0000
("Amgen").
RECITALS
WHEREAS, Amgen possesses scientific, clinical, regulatory and business
expertise in the worldwide development, manufacture and commercialization of
pharmaceutical products.
WHEREAS, Amgen possesses scientific, technical and proprietary
information and materials relating to one or more Collaboration Targets (as
defined below).
WHEREAS, Array possesses scientific, technical and proprietary
information and materials relating to the design and preparation of compounds.
WHEREAS, Amgen and Array desire to collaborate to identify, design,
generate, characterize and optimize compounds which modulate the activity of
Collaboration Targets.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants set forth below, the parties agree as follows:
1.0 DEFINITIONS
1.1 Defined Terms. Unless otherwise provided, each capitalized term used in this
Agreement shall have the meaning assigned to it in the Glossary attached hereto
as Exhibit A.
2.0 RESEARCH PROGRAM
2.1 Objectives. Array and Amgen shall undertake [***] Research Program(s) for
the purpose of designing, generating, characterizing and optimizing and testing
of compounds which possess Collaboration Target Activity.
2.2 Research Plan. The parties shall perform their respective obligations under
each Research Program in accordance with the corresponding Research Plan, as set
forth in Exhibit C. Any amendment to a Research Plan shall be effective when
executed in accordance with Section 2.3, below.
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2.3 Research Committee. A Research Committee will be created to manage each
Research Program.
(a) Within thirty (30) days after the Effective Date, each party will
designate two (2) representatives to act as voting members of the Research
Committee. The party designating a voting representative may at any time
designate a substitute for such representative by providing written notice to
the other party. Each party may also designate non-voting representatives to
attend meetings of the Research Committee to provide information relating to any
of the issues to be considered by the Research Committee. A chairman of the
Research Committee will be designated annually on an alternating basis by Array
and Amgen, with Array being responsible for designating the chairman for the
first year. A secretary of the Research Committee will be designated by a vote
of the Research Committee.
(b) The Research Committee shall meet quarterly during the term of the
Research Program, or at such other intervals as shall be determined by the
Research Committee, to set the priorities and review the progress of the
Research Program, to redesign and/or redirect the Research Plan and to amend the
Research Plan as appropriate (which amendment shall be effective when approved
in writing by the Research Committee). Such meetings are to occur at times and
locations as shall be determined by the Research Committee. The secretary of the
Research Committee will keep detailed minutes of all meetings of the Research
Committee.
(c) All decisions of the Research Committee shall be made by a majority
vote of the voting members of the Research Committee in the exercise of good
faith to further the Research Program, and any decision inconsistent with the
terms of this Agreement is void. It is intended that the Research Committee
proceed in a manner that fosters cooperation and communication between the
parties. In the event [***].
2.4 Array Researchers. The Research Committee shall approve the number and
qualifications of the Array Researchers, who shall have the education and
experience levels to meet the job description or requirements as set forth in
the Research Plan. Amgen and Array acknowledge the importance of having
personnel devoted full-time to work in the Research Program. Accordingly, in
order to maximize the effective conduct of the Research Program, Array will use
reasonable best efforts to maximize the continuity of Array Researchers
conducting the Research Program.
2.5 Employee Obligations. Prior to beginning work on the Research Program and/or
being given access to Array Technology, Amgen Technology or Licensed Technology,
each employee, consultant or contractor of Array and Amgen shall have signed or
shall be required to sign a non-disclosure and invention assignment agreement
pursuant to which each such person shall agree to comply with all of the
obligations of Array or Amgen, as appropriate, substantially including: (a)
promptly reporting any invention, discovery, process, software program or other
intellectual property right within Licensed Technology; (b) assigning to Array
or Amgen, as appropriate, all of his or her right, title and interest in and to
any such invention, discovery, process, software program or other intellectual
property right; (c) cooperating in the preparation, filing, prosecution,
maintenance and enforcement of any patent rights; (d) performing all acts and
signing, executing, acknowledging and delivering any and all papers, documents
and instruments required for effecting the obligations and purposes of this
Agreement and (e) abiding by the
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obligations of confidentiality and non-use set forth in this Agreement. It is
understood and agreed that any such non-disclosure and invention assignment
agreement need not be specific to this Agreement.
2.6 Materials and Equipment. Array shall be responsible for the procurement and
documentation of the quality of all materials, equipment and facilities used for
the preparation and analysis of Compound(s). Array covenants that the materials,
equipment and facilities to be used by Array under this Agreement shall be of
the same quality as Array in its experience and best scientific judgment uses in
its own research of similar nature. At its own expense, Array shall be
responsible for storing, handling, transporting and disposing of chemical
synthesis by-products generated by Array during the performance of the Research
Program.
2.7 Research Records. Array shall keep current written records, dated and
witnessed and otherwise suitable for patent and reporting purposes, of all work
performed and data developed for or on its behalf during the course of the
Research Program.
2.8 Transfer of Amgen Technology and Licensed Technology.
2.8.1 Upon request by Array, Amgen may, on a case-by-case basis and at
its sole discretion, supply Array with Amgen Technology for use by Array in
conducting the Research Program.
2.8.2 From time-to-time or upon the request of Amgen, but no less
frequently than on a quarterly basis during the term of the Research Program,
Array shall transfer to Amgen in writing (or in another mutually-agreed tangible
form), Licensed Technology developed by or received by Array in the course of
performing the Research Program, in a detail sufficient to enable Amgen to
practice its licenses under Article 3.0, below.
2.8.3 As part of each disclosure pursuant to Sections 2.8.2, Array
shall transfer or shall cause to be transferred to Amgen (or a Third Party
designated by Amgen), at Amgen's expense, all Collaboration Compounds
synthesized by Array, in quantities and a chemical purity as set forth in the
Research Plan or as otherwise agreed upon by the parties, for Amgen (or a Third
Party designated by Amgen) to conduct a preclinical evaluation thereof. Together
with each such Collaboration Compound, Array shall present to Amgen
corresponding data and associated information including, but not limited to,
end-of-compound preparation reports (e.g., detailed synthesis and analytical
procedures), synthesis completion dates and lot numbers, batch identifications
and a copy of all analytical data obtained. The parties shall confer, prior to
any such delivery of Collaboration Compound(s) to Amgen, regarding the container
and shipping details, the analytical results and other related data. Each of the
Collaboration Compound(s) delivered under this Agreement shall pass to Amgen
free and clear of any security interest, lien, or other encumbrance. Risk of
loss for each of the Collaboration Compound(s) shall remain with Array until
each such Collaboration Compound(s) has been delivered to the destination
specified by Amgen in writing.
2.8.4 During the term of each Research Program and thereafter until
termination of the Agreement, Array agrees that, as reasonably requested by
Amgen and at Amgen's expense, appropriate individuals shall be available to
assist and consult with Amgen in connection with
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the Licensed Technology. Such assistance and consultation by Array shall be by
means of personal visits, correspondence and telephone discussions.
2.8.5 Array shall use Licensed Technology specifically relating to
Active Compounds and Amgen Technology for the sole purpose of conducting the
Research Program at its company address listed above and not for any other use
or purpose without the prior express written consent of Amgen. Without the prior
written consent of Amgen, Array shall neither transfer nor provide access to
Licensed Technology specifically relating to Active Compounds and Amgen
Technology to any Third Party, and shall maintain Licensed Technology
specifically relating to Active Compounds and Amgen Technology only at its
company address set forth above. Any Amgen Technology transferred under this
Agreement shall be deemed the Confidential Information of Amgen and be subject
to the obligations of confidentiality and non-use set forth in this Agreement.
Other than for the conduct of the Research Programs as expressly set forth in
this Agreement, it is agreed that the provision of Amgen Technology to Array
under this Agreement shall not constitute any grant of, option or license to
Array under any Amgen intellectual property rights or any other rights.
2.8.7 Amgen shall use Array Technology for the sole purpose of
exercising its rights under this Agreement and not for any other use or purpose
without the prior written consent of Array. Without the prior written consent of
Array, Amgen shall neither transfer nor provide access to Array Technology to
any Third Party, other than as necessary to exercise its rights under this
Agreement and subject to such Third Party having agreed to be obligated to the
terms of confidentiality and non-use as set forth in this Agreement. Any Array
Technology transferred under this Agreement shall be deemed the Confidential
Information of Array and be subject to the obligations of confidentiality and
non-use set forth in this Agreement. Other than as expressly set forth in this
Agreement, it is agreed that the provision of Array Technology to Amgen under
this Agreement shall not constitute any grant of, option or license to Amgen
under any Array intellectual property rights or any other rights.
2.9 Reports. During the term of each Research Program, at its expense Array
shall promptly supply Amgen with oral reports upon request, and written interim
reports (with duplicate electronic copies in a format requested by Amgen) within
[***] after the end of each quarter, or at such other interval as Amgen and
Array shall agree as reasonable and appropriate. Each written report shall
include: (i) [***] conducting the Research Program, (ii) [***] to the Research
Program, (iii) a description in reasonable detail of the activities, including
the work conducted and data generated by Array Researchers in support of the
Research Program and (iv) a description in reasonable detail of all Licensed
Technology generated by Array, specifically including, but not limited to,
Collaboration Compound(s), all assay data generated with any such Collaboration
Compound(s), methods and processes for the preparation of any such Collaboration
Compound(s), synthetic intermediates thereof, and methods and processes for the
preparation of synthetic intermediates and raw materials useful in the
preparation of any such Collaboration Compound(s). Upon Amgen's written request
and within [***] after such request, Array shall make [***] at any reasonable
time during Array's regular working hours, and copies of all or any part [***]
upon request. [***].
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2.10 Term. The term of each Research Program shall be for the period of the
Research Program Initial Term, unless earlier terminated pursuant to Article
8.0, below, or extended in accordance with Sections 2.10.1 and 2.10.2, below.
2.10.1 The term of each Research Program may be extended for an
additional [***] period, upon Amgen providing Array with written notice thereof
at least [***] days prior to the expiration of the Research Program Initial
Term. Any extension of the term of the Research Program under this Section
2.10.1 shall be on the terms and conditions set forth in this Agreement.
2.10.2 Thereafter the Research Program(s) may be extended by the mutual
written agreement of the parties.
3.0 LICENSES AND OPTION
3.1 Exclusive License. Array hereby grants to Amgen a royalty-free, exclusive
license, with the right to sublicense, under Licensed Technology and Licensed
Patent Rights, to make, have made, use, sell, lease, offer to sell or lease,
import, export or otherwise transfer physical possession of or title in Active
Compound(s) in the Field of Use in the Territory.
3.2 Non-Exclusive License. Array hereby grants to Amgen a royalty-free,
non-exclusive license, with the right to sublicense, under Array Technology,
solely to make, have made, use, sell, lease, offer to sell or lease, import,
export or otherwise transfer physical possession of or title in Active
Compound(s) in the Field of Use in the Territory.
3.3 Research Use License. In addition to the provisions of Sections 3.1 and 3.2,
Array hereby grants to Amgen an irrevocable, perpetual, compensation-free,
non-exclusive license, without the right to sublicense, under Array Technology,
Licensed Patent Rights and Licensed Technology to make, have made and use Amgen
Compounds, and Collaboration Compounds for Amgen's own internal research
purposes (on its own or through a Third Party on behalf of or under the
authority of Amgen).
3.4 Option. Array also grants to Amgen a [***] option to obtain an exclusive
license to make, have made, use, sell, lease, offer to sell or lease, import,
export or otherwise transfer physical possession of or otherwise transfer title
in Non-Active Compounds in the Field of Use in the Territory ("Option"). The
Option shall become effective on the Effective Date and will continue until
termination of the Agreement. Within the term of the Option, the right to
exercise the Option shall expire, on a Non-Active Compound-By- Non-Active
Compound basis, prior to receiving Amgen's written notice of its intent to
exercise its option (as set forth hereinbelow), upon (i) Array granting a Third
Party the right to sell any such Non-Active Compound(s) for any purpose,
including human therapeutic, prophylactic and diagnostic uses, or (ii) Array's
election to develop such Non-Active Compound(s) itself. Amgen may exercise its
Option for a Non-Active Compound by providing written notice to Array. In the
event Amgen exercises the Option for a Non-Active Compound, Array shall provide
Amgen with a [***] from the date of
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such notice [***]. If the parties are [***], Array [***], provided however, that
if within [***] years after termination [***].
3.5 Non-Active, Non-Infringing Amgen Compounds. Notwithstanding anything to the
contrary in this Agreement, other than with respect to Amgen Compounds which are
Active Compounds, Amgen shall have the unrestricted, compensation-free right,
with the right to sublicense, under Array Technology and Licensed Technology to
make, have made, use, sell, lease, offer to sell or lease, import, export or
otherwise transfer physical possession of or title in, Amgen Compounds the
making, having made, using, selling, offering to sell, or importing of which
would not infringe one or more valid claims of an issued patent owned or
Controlled by Array.
4.0 DEVELOPMENT AND COMMERCIALIZATION
4.1 Product Development. Amgen shall have sole and full control, authority,
discretion and responsibility (e.g., on its own, through a sublicensee or
through a Third Party on behalf of or under the authority of Amgen or its
sublicensee) for conducting, funding and pursuing all aspects of clinical
development, regulatory, manufacturing and commercialization of Active Compounds
in the Field of Use in the Territory. Notwithstanding anything to the contrary
in this Agreement, Array shall have no rights and will have no involvement with
respect to any such clinical development, regulatory, manufacturing and
commercialization.
4.2 Regulatory Filings and Governmental Approvals. Amgen shall have sole and
full control, authority, discretion and responsibility (e.g., on its own,
through a sublicensee or by a Third Party on behalf of or under the authority of
Amgen or its sublicensee) to prepare, file and own all right, title and interest
in Regulatory Filings and Governmental Approvals relating to Active Compounds
developed by Amgen under this Section 4.2 in the Field of Use in the Territory.
Notwithstanding anything to the contrary in this Agreement, Array shall have no
rights with respect to the preparation, filing and ownership of any such
Regulatory Filings and Governmental Approvals, but will, upon Amgen's reasonable
request, assist Amgen in the preparation of such Regulatory Filings (at Amgen's
expense).
5.0 CONSIDERATION
5.1 Research Program Funding. Amgen shall fund and Array shall conduct the
Research Program(s) at the following effort levels ("Funding Commitment"):
5.1.1 Beginning on November 1, 2001, Amgen shall provide funding to
Array for [***] performing activities under the Research Programs or pursuant to
Section 5.7 below, through the [***] of the Research Program Initial Term.
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5.1.2 Each Array Researcher FTE allocated to the Research Program under
the Research Plan will be funded by Amgen during the Initial Term at a rate
[***] and, if the term of the Research Program is extended for an [***] pursuant
to Section 2.10.1, each Array Researcher FTE allocated to the Research Program
under a Research Plan, or performing activities pursuant to Section 5.7 below,
will be funded by Amgen at a mutually-agreed rate [***] (the "FTE Rate").
5.1.3 Payment by Amgen to Array for the first quarter of the Research
Program shall be made within [***] days after the Effective Date. Thereafter
payments shall be made by Amgen to Array quarterly, in advance, within [***]
days after receipt of an invoice from Array which sets forth the actual Array
Researcher FTEs from the previous quarter and the estimated FTEs for the
upcoming quarter.
5.1.4 In the event that for any quarter of the Research Program the
number of Array Researcher FTEs funded by Amgen for such quarter shall exceed
the number of Array Researcher FTEs devoted to the conduct of the Research
Program in such quarter, Amgen shall be entitled to credit any such excess
against the Funding Commitment in the next quarter. In the event that upon
termination of the Research Program the aggregate number of Array Researcher
FTEs funded by Amgen over the term of the Research Program shall exceed the
aggregate number of Array Researcher FTEs devoted to the conduct of the Research
Program over the term of the Research Program, Array shall promptly reimburse
Amgen for such excess at the applicable FTE Rate.
5.1.5 The parties acknowledge that under a Research and License
Agreement, dated October 26, 2000, Amgen provided funding to Array for a
research collaboration. [***].
5.1.6 At any time during the term of the Research Program, either party
may propose in writing an increase or decrease of the number of FTEs, but the
other party is not obligated to accept such proposal, and any Funding Commitment
for the remaining term of the Research Program will be increased or decreased
only by mutual written agreement.
5.1.7 It is understood and agreed that Amgen shall reimburse Array for
the actual cost of fine chemicals and screening supplies and reagents, as set
forth in the Supplies Budget section of the Research Plan, or as otherwise
authorized in writing by the Research Committee. Other than as specifically set
forth in Section 5.1, Amgen shall have no obligation to reimburse Array for any
costs and expenses incurred by Array in the performance of the Research Program.
5.2 Milestones.
5.2.1 Research
Upon the achievement by the performance of Array of each of the
following research goals with respect to [***] which at the time of such
achievement [***] ("Research Milestone Event(s)"), Amgen shall pay to Array the
corresponding [***] research milestone payments set forth hereinbelow ("Research
Milestone Payment(s)"):
(a) [***]
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(b) [***]
5.2.2 Clinical
Within [***] days following the first achievement or occurrence by the
performance of Amgen or a sublicensee of Amgen of each of the following clinical
milestone events with a first Active Compound ("Clinical Milestone Event(s)"),
Amgen shall pay to Array the corresponding [***] clinical milestone payments set
forth hereinbelow ("Clinical Milestone Payment(s)"):
Event Payment
----- -------
[***] [***]
[***] [***]
[***] [***]
5.2.3 Amgen shall not be obligated to pay any Milestone Payment under
Section 5.2 more than [***], regardless of the number of Active Compound(s) that
achieve a particular Milestone Event in the same Research Program or other
Research Programs.
5.2.4 Amgen shall pay to Array a [***] of [***] within [***] days after
[***] of AN Active CompoundS by or on behalf of Amgen, its Affiliates or
sublicensees exceed [***]. Any subsequent [***] by any other Compound(s) from
the same Research Program or other Research Programs shall not trigger
additional [***] payment(s).
5.3 Signing Fee. On or before [***], Amgen shall pay to Array a one-time
non-refundable signing fee of [***],
5.4 No Further Consideration. Other than as set forth in this Article 5.0, Amgen
shall not be obligated to pay any additional fees or make any additional
payments.
5.5 Paid-Up License. Upon payment of the Research Funding pursuant to Section
5.1, and the Milestone Payments pursuant to Section 5.2, Amgen's licenses under
Sections 3.1 and 3.2 shall be fully paid up (without an obligation of further
consideration) and unrestricted as to any and all Active Compounds in all
Research Programs.
5.6 Payments. All payments by Amgen to Array under this Agreement shall be in
United States Dollars in immediately available funds and shall be made by wire
transfer from a United States bank located within the United States to such bank
account as designated by Array, or by an alternative mutually-agreed-upon
manner.
5.7 [***]
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6.0 INTELLECTUAL PROPERTY
6.1 Ownership of Licensed Technology.
6.1.1 All right, title and interest to all Collaboration Technology and
all patent rights and other intellectual property rights related thereto shall
belong to the party that is the employer of the inventor.
6.1.2 All right, title and interest to all Joint Technology and all
patent rights and other intellectual property rights related thereto shall
belong jointly to Amgen and Array.
6.1.3 All right, title and interest to all Amgen Technology and Amgen
Compounds and all patent rights and other intellectual property rights related
thereto shall belong to Amgen.
6.2 Prosecution of Licensed Patent Rights.
6.2.1 Amgen, at its own cost and expense, shall have the sole right to
prepare, file, prosecute, maintain and defend Licensed Patent Rights, using
mutually acceptable outside counsel. Amgen will keep Array reasonably informed
as to the status of patent matters relating to Licensed Patent Rights (including
providing Array copies of any documents that Amgen receives or sends to patent
offices) in reasonable time to allow Array, at Array's expense, to review and
provide comments concerning proposed responses, interferences and oppositions,
and Amgen will consider all reasonable comments received by Array.
6.2.2 Amgen shall be entitled to determine the countries in which
patent protection for Licensed Technology shall be sought and maintained under
this Agreement.
6.2.3. Amgen shall be free, at any time and at its sole option, not to
seek, to abandon or stop funding of patent prosecution or maintenance of any
Licensed Patent Rights in any country.
6.2.4 Array shall cooperate with Amgen and render all reasonable
assistance in preparing, filing, prosecuting, maintaining and defending Licensed
Patent Rights before any patent offices in the Territory. At Amgen's request and
expense, Array shall cooperate with Amgen (and use best efforts to cause the
cooperation of any of Array's employees, consultants or contractors as might
reasonably be requested) in any such matters and shall sign any necessary legal
papers and provide Amgen with data or other information in support thereof. Both
parties shall meet on a regular basis, but not less than annually, to discuss
the prosecution of and other proceedings such as interferences and oppositions
concerning Licensed Patent Rights.
6.2.5 Except as expressly provided in this Agreement, it is understood
that neither party shall have any obligation to account to the other for profits
or to obtain any approval of the other party to license or exploit any jointly
owned invention, by reason of joint ownership of any invention or other
intellectual property.
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6.3 Infringement Enforcement of Licensed Patent Rights.
6.3.1 If either party learns of a continuing infringement by a Third
Party of a claim of an issued patent within the Licensed Patent Rights, such
party shall promptly notify the other party and shall provide the other party
with available evidence of such infringement.
6.3.2 Amgen shall have the sole right but not the obligation, at its
own expense, to bring, defend and maintain any suit or action for infringement
by a Third Party of a claim of an issued patent within Licensed Patent Rights
concerning the making, having made, using, selling, leasing, offering to sell or
lease, importing, exporting or otherwise transferring physical possession of or
title in an Active Compound. In such case, Array shall actively assist, as
reasonably requested by Amgen, in the prosecution of any such action. If Amgen
finds it necessary or desirable for Array to join Amgen as a party, Array shall
execute all papers or perform such other acts as may reasonably be required by
Amgen. The costs and expenses of any such action (including any costs incurred
by Amgen's requested participation and assistance by Array) shall be borne by
Amgen. Any monetary award or settlement received by Amgen shall belong to Amgen.
In any suit under this Section 6.3.2 in which Array is joined or is named as a
party, Array shall not admit liability nor settle or otherwise consent to an
adverse judgment, without the prior written consent of Amgen.
6.4 Infringement Defense.
6.4.1 If Array receives any information or a notice of alleged
infringement of a Third Party's intellectual property rights concerning the
making, having made, using, selling, leasing, offering to sell or lease,
importing, exporting or otherwise transferring physical possession of or title
in an Active Compound, Array shall promptly notify Amgen and shall provide Amgen
with details concerning such information or notice.
6.4.2 Amgen shall have the right, but not the obligation, to defend any
suit against Amgen or its sublicensees alleging infringement of any patent claim
or other intellectual property right of a Third Party because of Amgen's (or its
sublicensees') practice of its licenses under this Agreement, including the
making, having made, using, selling, leasing, offering to sell or lease,
importing, exporting or otherwise transferring physical possession of or title
in an Active Compound by Amgen or its sublicensees. If Amgen finds it necessary
or desirable, Array agrees to cooperate with Amgen (as may reasonably be
requested by Amgen) and to use its best efforts to ensure that any Array
personnel (as may reasonably be requested for assistance by Amgen) will be
available to cooperate with Amgen, at Amgen's expense, during the defense of any
such suit. If Amgen finds it necessary or desirable for Array to join Amgen as a
party, Array shall execute all papers or perform such other acts as may
reasonably be required by Amgen. The costs and expenses of any action under this
Section 6.4.2, including attorney fees and all damages and settlements,
including any costs incurred by Array as a result of Amgen's requested
participation and assistance of Array shall be borne by Amgen. In any suit under
this Section 6.4.2 in which Array is joined or is named as a party, Array shall
neither admit liability nor settle or otherwise consent to an adverse judgment,
without the prior written consent of Amgen.
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7.0 CONFIDENTIALITY
7.1 Obligations of Confidentiality. For a period of [***] after expiration or
termination of this Agreement, each party shall maintain in confidence the
Confidential Information of the other party which is disclosed pursuant to this
Agreement, and shall not disclose, use or grant use of the Confidential
Information of the other party except on a need-to-know basis to such party's
directors, officers, employees and consultants working on such party's premises,
to the extent such disclosure is reasonably necessary in connection with such
party's activities as expressly authorized by this Agreement. To the extent that
disclosure to any person is authorized by this Agreement, prior to disclosure, a
party making such disclosure shall have obtained written agreement of such
person to hold in confidence and not disclose, use or grant the use of the
Confidential Information of the other party except as expressly permitted under
this Agreement.
7.1.1 Notwithstanding the foregoing in Section 7.1, such obligations of
confidentiality and non-use shall not apply to that aspect of information which
the receiving party can establish by competent proof:
(a) was already known to the receiving party, other than under
an obligation of confidentiality, at the time of disclosure by the other party;
(b) was generally known to the public or otherwise part of the
public domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise part
of the public domain after its disclosure, through no fault of the receiving
party;
(d) was subsequently lawfully disclosed to the receiving party
by a Third Party who did not require the receiving party to hold it in
confidence or limit its use, provided it was not obtained by such Third Party
under an obligation of confidentiality directly or indirectly from the other
party; or
(e) was independently discovered or developed by the receiving
party without access to or the use of the other party's Confidential
Information, as can be documented by written records created at the time of such
independent discovery or development.
7.1.2 Subject to Section 7.1.3, below, all Confidential Information, if
disclosed in a writing or embodied in a tangible item or product, shall be
marked "confidential" or, if disclosed orally or in an intangible form, shall
within a reasonable period but in no event more than forty-five (45) days
following such disclosure be reduced to (or summarized in) writing, marked
"confidential" and delivered by the disclosing party to the receiving party.
7.1.3 Notwithstanding anything to the contrary in this Agreement
(including Section 7.1.2), for purposes of this Agreement: (i) Amgen Technology
and all oral or written communications regarding the Amgen Technology are, and
shall remain, Confidential Information of Amgen; and (ii) the Collaboration
Technology and Joint Technology exclusively licensed to Amgen and all oral or
written communications regarding the Collaboration Technology and Joint
Technology exclusively licensed to Amgen, the source data and information
therefor, and/or the reports (or any
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data or information contained therein) described in Article 2.0 are, and shall
be considered, the Confidential Information of Amgen.
7.2 Permitted Disclosure.
7.2.1 Notwithstanding the obligations of Section 7.1, each party may
disclose the other party's Confidential Information or joint Confidential
Information in establishing rights or enforcing obligations under this Agreement
or in complying with applicable laws and regulations; provided however, that in
each case described herein if a party shall be required to make any disclosure
of the other party's Confidential Information or joint Confidential Information
under this Section 7.2.1, (a) it will give reasonable advance notice to the
other party of such disclosure requirement, (b) it will provide a copy of the
proposed disclosure to the other party and (c) at the request of the other
party, it will use commercially reasonable efforts in assisting the other party
to secure confidential treatment of such Confidential Information required to be
disclosed, including cooperating with the other party to obtain a protective
order of the other party's Confidential Information or of joint Confidential
Information.
7.2.2 The parties agree that the material terms of this Agreement shall
be considered Confidential Information of both parties. Neither party shall
disclose any terms or conditions of this Agreement to any Third Party without
the prior consent of the other party; provided however, that (a) a party may
disclose the terms or conditions of this Agreement on a need-to-know basis to
its legal and financial advisors to the extent such disclosure is reasonably
necessary in connection with such party's activities as expressly permitted by
this Agreement and in confidence under terms and conditions at least as
restrictive as set forth in this Agreement, provided however, in no event will
Array disclose Exhibits C or D; (b) Amgen may disclose the terms or conditions
of this Agreement or any aspect of the research conducted pursuant to this
Agreement in confidence under terms and conditions at least as restrictive as
set forth in this Agreement, to prospective sublicensee(s) and shall use
reasonable efforts to secure confidential treatment of such Confidential
Information) and (c) the parties will consult with one another concerning the
terms of this Agreement to be redacted in SEC filings.
7.2.3 Amgen may disclose Array Technology to the extent such disclosure
is reasonably necessary in the following instances: (a) Regulatory Filings; (b)
complying with applicable governmental regulations; (c) conducting pre-clinical
or clinical trials of Licensed Products; and (d) medical education, marketing
and sales of Licensed Products.
7.3 Public Announcements. Except as may otherwise be required by law or
regulation in accordance hereinbelow, neither party shall make any public
announcement, directly or indirectly, concerning this Agreement or the subject
matter hereof without first submitting a copy of the proposed announcement to
the other party for review and obtaining the prior written approval of the other
party. If either party is required by law to make a public announcement
concerning this Agreement or the subject matter hereof (including, without
limitation, in a filing with the United States Securities and Exchange
Commission), such party shall give reasonable prior advance notice of the
proposed text of such announcement to the other party for its prior review and
approval, which approval shall not be unreasonably withheld. The other party
shall provide its comments, if any, on such announcement as soon as practicable,
and in no event later
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than four (4) business days or such other time as mutually agreed upon to
consent to the publication of such announcement, such consent not to be
unreasonably withheld. The parties will work together in good faith to agree on
the format, content and other elements of such announcement.
7.4 Publication. Amgen may publish scientific results of its work within the
scope of the licenses granted under this Agreement; provided however, that Amgen
complies with the following procedure:
(a) At least [***] days prior to submission for publication, Amgen
shall provide Array with a copy of any such planned publication by Amgen that
would disclose the Confidential Information of Array, for Array's written
consent prior to the disclosure of such Confidential Information. Array shall
notify Amgen in writing within [***] days after receipt of the planned
publication as to whether (i) Array consents to the disclosure of such
Confidential Information of Array, (ii) Array requires Amgen to remove all or
part of any Confidential Information of Array prior to publication or (iii)
Array reasonably believes that any invention in Licensed Technology would be
disclosed by such planned publication. In the event of notice by Array under
Section 7.4(a)(ii), Amgen agrees to remove such Confidential Information of
Array requested in the notice by Array. In the event of notice by Array under
Section 7.4(a)(iii), Amgen agrees to delay publication for a reasonable time
period (not to exceed [***] days) sufficient for a patent application thereon to
be filed pursuant to Section 6.2. It is understood and agreed that failure of
Amgen to receive notification from Array within [***] days of receipt of a
planned publication under this Section 7.4(a) shall be deemed consent by Array
to such publication.
(b) Any such publication will include recognition of the contributions
of Array according to standard practice for assigning scientific credit, either
through authorship or acknowledgment, as may be appropriate.
(c) Array shall have no right to publish scientific results of its work
within the scope of the licenses granted under this Agreement.
8.0 TERMINATION
8.1 Term. Unless terminated earlier pursuant to the terms of this Article 8.0,
this Agreement will continue in full force and effect until Array receives
notification from Amgen pursuant to Section 8.4(b), below.
8.2 Termination of the Research Program. Upon [***] days prior written notice,
Amgen shall have the right at any time to terminate the Research Program prior
to the expiration of the Research Program Initial Term, and the effects of such
termination shall be as set forth in Section 8.3. Array shall neither increase
the number of Array Researcher FTEs nor make any additional purchases for the
Research Program (e.g., materials, equipment, fine chemicals, screening supplies
and reagents) after receiving such notice from Amgen.
8.3 Effects of Termination of Research Program. Upon termination of the Research
Program, the parties shall have the following rights and obligations:
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8.3.1 Unless terminated under Sections 8.6 or 8.7, below, if the
Research Program is terminated prior to [***] of the commencement date of the
Research Program Initial Term, this Agreement shall be terminated.
8.3.2 If the Research Program is terminated on or after [***] of the
commencement date of the Research Program Initial Term or is earlier terminated
under Sections 8.6 or 8.7, below, all rights and obligations set forth under
this Agreement (specifically including Amgen's license rights under Article 3.0
and obligations under Sections 5.2.2, 5.2.4, 5.4 and 5.6) shall remain in full
force and effect; provided however, that Amgen's obligation to fund and Array's
obligation to conduct the Research Program will terminate and Amgen's
obligations under Section 5.3.1 shall terminate.
8.4 Termination of Licenses or Agreement. In addition to Amgen's ability to
terminate the Research Program under Section 8.2, Amgen shall have the right (a)
at any time to terminate any of its license rights, in whole or part (on a
territory-by-territory basis or otherwise), and its corresponding obligations
(subject to Section 8.9) under this Agreement, provided all other rights and
obligations under this Agreement remain in full force and effect and/or (b) to
terminate this Agreement by providing notice under Section 9.2.2(c), below.
8.5 Default.
8.5.1 In the event any material representation or warranty made under
this Agreement by either party shall have been untrue in any material respect
("Representation Default") or upon any material breach or material default of a
material obligation of this Agreement by a party ("Performance Default"), the
party not in default ("Non-Defaulting Party") must first give the other party
("Defaulting Party") written notice thereof ("Notice of Default"), which notice
must state the nature of the Representation Default or Performance Default in
reasonable detail and request the Defaulting Party cure such default [***]. If
the Defaulting Party shall dispute the existence, extent or nature of any
default set forth in a Notice of Default, the parties shall use good faith
efforts to resolve the dispute.
8.5.2 In the event of (a) a Representation Default by Array wherein the
underlying facts shall not have been brought into conformity with the
representation and warranty within the period set forth in Section 8.5.1 after
receipt of a Notice of Default (or, if the underlying facts of such
Representation Default cannot be brought into conformity within such period and
Array shall have failed to commence substantial remedial actions to bring such
facts into conformity within such period and to diligently pursue the same) or
(b) a Performance Default by Array that shall not have been cured within the
period set forth in Section 8.5.1 after receipt of a Notice of Default (or, if
such Performance Default cannot be cured within such period and Array shall have
failed to commence substantial remedial actions to cure such Representation
Default or Performance Default within such period and to diligently pursue the
same); then upon such failure of Array to cure such Representation Default or
Performance Default, Amgen (in addition to any other remedies which may be
available to Amgen at law or equity), at its option, may (i) in the event such
Representation Default or Performance Default is curable, maintain this
Agreement and place the amount, when due, of any then- or subsequently-due
Milestone
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Payment in an interest-bearing escrow account until such default is cured or
(ii) terminate this Agreement. Promptly following the cure of such Default,
Amgen shall cause all amounts paid into such escrow account, together with all
accrued interest thereon, to be delivered to Array. Array shall pay all fees for
establishing and maintaining such escrow account.
8.5.3 In the event of (a) a Representation Default by Amgen, wherein
the underlying facts shall not have been brought into conformity with the
representation and warranty within the period set forth in Section 8.5.1 after
receipt of a Notice of Default (or, if the underlying facts of such
Representation Default cannot be brought into conformity within such period and
Amgen shall have failed to commence substantial remedial actions to bring such
facts into conformity within such period and to diligently pursue the same)
Array, at its option, may terminate this Agreement (in addition to any other
remedies which may be available to Array at law or equity); (b) a Performance
Default by Amgen that shall not have been cured within the period set forth in
Section 8.5.1 after receipt of a Notice of Default (or, if such Performance
Default cannot be cured within such period and Amgen shall have failed to
commence substantial remedial actions to cure such Performance Default within
such period and to diligently pursue the same) and such Performance Default
arises from a material breach or material default of Article 5.0, Array (in
addition to any other remedies which may be available to Array at law or
equity), at its option, may terminate this Agreement; or (c) a Performance
Default by Amgen that shall not have been cured within the period set forth in
Section 8.5.1 after receipt of a Notice of Default (or, if such Performance
Default cannot be cured within such period and Amgen shall have failed to
commence substantial remedial actions to cure such Performance Default within
such period and to diligently pursue the same) and such Performance Default
arises from a material breach or material default of other than Article 5.0,
Array may only seek remedies which may be available at law, but may not seek to
terminate this Agreement; provided however, that in the case of this clause (c),
all of Amgen's rights and obligations under this Agreement shall remain in full
force and effect.
8.6 Bankruptcy.
8.6.1 Amgen may terminate the Agreement if, during the term of the
Research Program, Array shall file in any court or agency pursuant to any
statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the appointment of
a receiver or trustee of Array or of its assets, or if Array proposes a written
agreement of composition or extension of its debts, or if Array shall be served
with an involuntary petition in bankruptcy or seeking reorganization,
liquidation, dissolution, winding-up arrangement, composition or readjustment of
its debts or any other relief under any bankruptcy, insolvency, reorganization
or other similar act or law of any jurisdiction now or hereafter in effect, or
there shall have been issued a warrant of attachment, execution, distraint or
similar process against it, filed in any insolvency proceeding, and such
petition shall not be dismissed within ninety (90) days after the filing
thereof, or if Array shall propose or be a party to any dissolution or
liquidation, or if Array shall make an assignment for the benefit of creditors.
8.6.2 All rights and licenses granted under or pursuant to this
Agreement by Amgen or Array are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to
"intellectual property" as defined under Section 101 of the
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U.S. Bankruptcy Code. The parties agree that Amgen shall retain and may fully
exercise all of its rights and elections under the U.S. Bankruptcy Code. The
parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against Array under the U.S. Bankruptcy Code, Amgen shall be
entitled to a complete duplicate of (or complete access to, as appropriate) any
such intellectual property and all embodiments of such intellectual property,
and same, if not already in their possession, shall be promptly delivered to
them (i) upon any such commencement of a bankruptcy proceeding upon their
written request therefor, unless Array (or a trustee on behalf of Array) elects
to continue to perform all of their obligations under this Agreement or (ii) if
not delivered under (i) above, upon the rejection of this Agreement by or on
behalf of Array upon written request therefor by Amgen.
8.7 Acquisition. In the event that during the term of the Research Program, a
Third Party (the "Acquiring Party") shall acquire, directly or indirectly, [***]
or more of the shares of Array stock entitled to vote for the election of
directors of Array, Amgen shall have the right, within one hundred twenty (120)
days of such acquisition, to terminate such Research Program upon ninety (90)
days notice to the Acquiring Party, and Amgen's obligations to fund and Array's
obligation to conduct the Research Program shall terminate.
8.8 Consequences of Termination of this Agreement. Upon termination of this
Agreement under this Article 8.0, the following rights and obligations shall
apply:
8.8.1 Amgen shall have no further payment obligations under Article 5.0
(Consideration), subject to Section 8.9, below.
8.8.2 Subject to Section 8.9, below, the parties shall have no further
obligations (a) under Section 9.1, below and (b) under Section 9.2, below, in
the event this Agreement is terminated in accordance with Section 8.5.3.
8.8.3 Any rights or obligations set forth under this Agreement which of
their nature are intended to extend beyond the term of the Agreement shall
survive, specifically including the following:
(a) The parties shall retain all of their respective ownership
rights as set forth in Section 6.1;
(b) Amgen shall retain all of its rights under Sections 3.3,
3.5, 4.2 and 6.4;
(c) Amgen shall retain all of its rights under Sections 3.1,
3.2, 3.4, 4.1, 5.4, 5.5, 6.2 and 6.3, provided however, in the event of
termination of this Agreement in accordance with Sections 8.2 prior to the [***]
of the commencement date of the Research Program Initial Term or 8.5.3, Amgen
shall cease development of Collaboration Compounds pursuant to Section 4.1 and
all rights granted by Array to Amgen under Sections 3.1, 3.2, 3.4, 5.5, 6.2 and
6.3 shall revert to Array. In the event of a termination described in the
preceding sentence, for a period of [***] after the date of termination of this
Agreement, Array shall have the [***]; provided however, that if the parties
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(d) The parties shall retain all rights and obligations under
Section 9.2, below, (except as otherwise set forth in Section 8.8.2(b)) and
Section 9.3, provided however, in the event this Agreement is terminated in
accordance with Section 8.5.2, Array shall have no further obligations under
Sections 9.2.1(a) and (d); and
(e) Articles 7.0 (Confidentiality); 8.0 (Termination); 10.0
(Indemnity), below, and 11.0 (General Provisions), below, shall remain in full
force and effect.
8.8.4 Within thirty (30) days thereafter, Array shall at Amgen's
request destroy or return all Amgen Technology (other than with respect to
maintaining one (1) archival copy of Confidential Information related thereto
for its legal files, for the sole purpose of determining its obligations under
this Agreement) and shall provide Amgen with certification by an officer of
Array that all such materials have been destroyed or returned to Amgen, as
appropriate.
8.9 Accrued Rights. Termination, relinquishment or expiration of any licenses
under this Agreement or of this Agreement for any reason in accordance with
Article 8.0 shall be without prejudice to any rights which shall have accrued to
the benefit of either party prior to such termination, relinquishment or
expiration.
8.10 Damages. Notwithstanding anything to the contrary in this Agreement,
neither party shall be liable for consequential or incidental damages of any
nature arising from such party's activities under this Agreement, including,
without limitation, lost profits or opportunities or injury to a person or
property resulting from the termination (in whole or part) of the licenses to
Licensed Technology or this Agreement.
9.0 REPRESENTATIONS, WARRANTIES AND COVENANTS
9.1 Representations and Warranties.
9.1.1 Each party represents and warrants to the other party on the
Effective Date that:
(a) it is duly organized and validly existing and in good
standing under the laws of the State of Delaware, and it has the corporate power
and authority and the legal right to enter into this Agreement and to perform
its obligations under this Agreement;
(b) the execution and delivery of this Agreement and the
performance of the transactions contemplated hereby have been duly authorized by
all necessary corporate action of such party, and the person executing this
Agreement on behalf of each party has been duly authorized to do so by all
requisite corporate actions;
(c) the execution and delivery of this Agreement and the
performance by such party of any of its obligations under this Agreement do not
and will not (i) conflict with or constitute a breach or violation of any other
contractual obligation to which it is a party, any
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judgment of any court or governmental body applicable to such party or its
properties or, to such party's knowledge, any statute, decree, order, rule or
regulation of any court or governmental agency or body applicable to such party
or its properties, and (ii) with respect to the execution and delivery of this
Agreement, require any consent or approval of any governmental authority or
other person;
(d) it is aware of no action, suit, inquiry or investigation
contemplated or instituted by any governmental agency which questions or
threatens the validity of this Agreement; and
(e) this Agreement is legally binding and enforceable in
accordance with its terms.
9.1.2 Array further represents and warrants to Amgen that on the
Effective Date:
(a) Array has no knowledge of any intellectual property rights
of Third Parties that would materially impair the license rights that are
granted under this Agreement to Amgen; and
(b) Array is aware of no action, suit or inquiry or
investigation contemplated or instituted by any U.S. federal or state
governmental agency which questions or threatens the validity of this Agreement.
9.2 Covenants.
9.2.1 Covenants of Array:
(a) Array covenants (i) to use commercially reasonable
efforts, and to commit the personnel, facilities and other resources reasonably
necessary to conduct its obligations under the Research Program, and (ii) to
conduct its obligations under the Research Plan to accomplish the goals and
objectives set forth in this Agreement using no less than commonly accepted
professional standards of workmanship.
(b) Array covenants that during the term of the Research
Program and thereafter until termination of the Agreement it shall work
exclusively with Amgen regarding the Research Field, including specifically that
it (i) shall not grant any right, license, consent or privilege to any Third
Party that would conflict with the rights granted to Amgen under this Agreement;
(ii) shall not file or prosecute any patent application for which Amgen has a
right to file or prosecute under Section 6.2; and (iii) shall not either itself,
or with or through any Third Party (other than Amgen pursuant to this
Agreement), directly or indirectly undertake to make, have made, use, sell,
lease, offer to sell or lease, import, export or otherwise transfer physical
possession of or title in (including to develop and seek registration for) any
Active Compound for any use in the Territory or otherwise engage in any
activities in the Research Field.
(c) Array covenants that it shall not (without Amgen's written
consent) conduct any activity, either itself or through a Third Party, that
conflicts with the rights granted to Amgen under this Agreement.
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(d) Array covenants not to utilize any process, intermediate
or reagent in the preparation of any Collaboration Compound or to prepare any
Collaboration Compound, in each case in the course of performing the Research
Program, which to Array's knowledge would infringe the claim of any issued
patent or fall within the scope of other intellectual property rights, including
but not limited to the claims of published patent applications, of a Third Party
without Amgen's prior written consent.
(e) Array covenants that it shall comply with all applicable
laws, regulations and guidelines in connection with the performance of its
obligations and rights pursuant to this Agreement.
9.2.2 Covenants of Amgen:
(a) Amgen covenants that it shall use Commercially Reasonable
Efforts in conducting clinical trials of Active Compound(s). It shall be in
Amgen's sole discretion as to which and how many Active Compound(s) shall be
developed under this Agreement; by way of example and not by way of minimum
requirement, if Amgen pursues development of one (1) Active Compound it will be
deemed to have used Commercially Reasonable Efforts under this Agreement.
(b) Amgen covenants that it shall comply with all applicable
laws, regulations and guidelines in connection with the performance of its
obligations and rights pursuant to this Agreement.
(c) Amgen covenants that, after expiration of the Research
Program Initial Term, it shall promptly notify Array in writing upon Amgen's
decision to abandon all research, development and/or commercialization
activities and plans related to all Active Compounds.
9.3 Disclaimers. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE TECHNOLOGY
PROVIDED UNDER THIS AGREEMENT ARE BEING PROVIDED "AS IS" AND WITHOUT ANY
REPRESENTATIONS OR WARRANTIES. NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, OF ANY TYPE WHATSOEVER REGARDING THE MATERIALS,
INFORMATION, AMGEN TECHNOLOGY, ARRAY TECHNOLOGY AND THE LICENSED TECHNOLOGY,
INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS TO
THIRD PARTIES.
10.0 INDEMNITY
10.1 Amgen Indemnity. For a period of [***] after expiration or termination of
this Agreement, Amgen will indemnify Array and hold Array harmless from all
liability, loss, damage and cost arising out of any claims, demands, actions or
other proceedings by Third Parties of any nature (other than claims by Third
Parties relating to patent infringement) to the extent the same arises out of
(i) the research, development, marketing and/or sale of Amgen
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Compounds, Collaboration Compounds (specifically including Active Compounds) by,
on behalf of or under authority of Amgen or its sublicensees pursuant to the
licenses granted under this Agreement and/or (ii) any Amgen representation or
warranty set forth in this Agreement having been untrue in any material respect
when made, except to the extent in either (i) or (ii) above that such claim
arises from Array's willful misconduct or negligence or otherwise covered by
Section 10.2.
10.2 Array Indemnity. For a period of [***] after expiration or termination of
this Agreement, Array will indemnify Amgen and hold Amgen harmless from all
liability, loss, damage and cost arising out of any claims, demands, actions or
other proceedings by Third Parties of any nature (other than claims by Third
Parties relating to patent infringement) to the extent the same arises out of
(i) the conduct by Array of its obligations under this Agreement and/or (ii) any
Array representation or warranty set forth in this Agreement having been untrue
in any material respect when made, except to the extent in either (i) or (ii)
above that such claim arises from Amgen's willful misconduct or negligence or
otherwise covered by Section 10.1.
10.3 Procedure. A party that intends to claim indemnification under this Article
10.0 (the "Indemnitee") shall promptly notify the other party (the "Indemnitor")
of any loss, liability, damage, expense, claim, demand, action or other
proceeding in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall have the right to participate in, and
to the extent the Indemnitor so desires to assume (jointly with any other
indemnitor similarly noticed) the defense thereof with counsel selected by the
Indemnitor and reasonably satisfactory to the Indemnitee; provided however, that
the Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitee, if representation of such Indemnitee by
the counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between such Indemnitee and any other party
represented by such counsel in such proceedings. The indemnity agreement in this
Article 10.0 shall not apply to amounts paid in settlement of any loss,
liability, damage, expense, claim, demand, action or other proceeding if such
settlement shall be effected without the consent of the Indemnitor, which
consent shall not be unreasonably withheld. The failure by the Indemnitee to
deliver notice to the Indemnitor within a reasonable time after commencement of
any such action, if prejudicial to its ability to defend such action, shall
relieve such Indemnitor of any liability to the Indemnitee under this Article
10.0, but the omission to deliver notice to the Indemnitor will not relieve the
Indemnitor of any liability that it may have to the Indemnitee other than under
this Article 10.0. The Indemnitor may not settle the action or otherwise consent
to an adverse judgment in such action or other proceeding that materially
diminishes the rights or interests of the Indemnitee without the express written
consent of the Indemnitee. The Indemnitee under this Article 10.0 and its
employees and agents shall cooperate reasonably with the Indemnitor and its
legal representatives in the investigation of any action, claim or liability
covered by this indemnification.
10.4 Insurance. Each party will maintain, through self-insurance or commercially
placed insurance, adequate coverage for the indemnification obligations set
forth in this Agreement.
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11.0 GENERAL PROVISIONS
11.1 Independent Contractors. The relationship of the parties hereto shall be
that of independent contractors. The parties hereto shall not be deemed to be
agents, employer-employee, partners or joint venturers of the other for any
purpose as a result of this Agreement or of the transactions contemplated
thereby. No party shall incur any debts or make any commitments for the other
party except to the extent, if at all, specifically provided in this Agreement.
Array shall use its own discretion and shall have complete and authoritative
control over its employees and the details of performing its obligations under
this Agreement.
11.2 Assignments. Neither party shall assign any of its rights nor assign or
delegate any of its obligations under this Agreement except: (i) as incident to
a merger, consolidation, reorganization or acquisition of stock or assets or
similar transaction affecting all or substantially all of the assets or voting
control of the assigning party; (ii) to any directly or indirectly wholly-owned
subsidiary if the assigning party remains liable and responsible for the
performance and observance of all of the subsidiary's duties and obligations
under this Agreement; or (iii) upon the written consent of the other party, such
consent not to be unreasonably withheld. This Agreement shall be binding upon
the successors and permitted assigns of the parties, and the name of a party
appearing in this Agreement shall be deemed to include the names of such party's
successors and permitted assigns to the extent necessary to carry out the intent
of this Agreement. Any assignment not in accordance with this Section 11.2 shall
be void.
11.3 Further Actions. Each party agrees to execute, acknowledge and deliver such
further instruments and to do all such other acts as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
11.4 No Trademark Rights. Except as otherwise provided in this Agreement or
agreed to in advance in writing, no right, express or implied, is granted by
this Agreement to use in any manner the names "Array" or "Amgen", or any other
trade name or trademark of Array or Amgen or the names of any employees thereof,
for any purpose.
11.5 Export Requirements. Each party agrees to comply with all applicable laws
and regulations. In particular, it is understood and acknowledged that the
transfer of certain commodities and technical data is subject to United States
laws and regulations controlling the export of such commodities and technical
data, including all Export Administration Regulations of the United States
Department of Commerce. Each party hereby agrees and by entering into this
Agreement gives written assurance that it will comply with all United States
laws and regulations controlling the export of commodities and technical data
within Licensed Technology, that it will be solely responsible for any violation
of any such laws and regulations by itself or its sublicensees, and that it will
indemnify, defend and hold the other party harmless from any liability in the
event of any legal action of any nature occasioned by such violation.
11.6 Severability. In the event any one or more of the provisions of this
Agreement should for any reason be held by any court or authority having
jurisdiction over this Agreement or either of the parties to be invalid, illegal
or unenforceable, such provision or provisions shall be validly reformed to as
nearly as possible approximate the intent of the parties and, if unreformable,
shall
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be divisible and deleted in such jurisdiction; elsewhere this Agreement shall
not be affected so long as the parties are still able to realize the principal
benefits bargained for in this Agreement.
11.7 Captions. The captions to this Agreement are for convenience only, and are
to be of no force or effect in construing or interpreting any of the provisions
of this Agreement.
11.8 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the substantive laws of the State of California, without
reference to the conflicts of law principles thereof. The parties hereby
acknowledge their diversity (Array having its principal place of business in
Colorado and Amgen having its principal place of business in California) and, if
Array brings suit under this Agreement such suit shall be brought in Federal
District Court in Los Angeles, California or the California state courts of
general jurisdiction in Los Angeles, California (and the parties will submit to
the jurisdiction thereof) and, if Amgen brings suit under this Agreement such
suit shall be brought in the Federal District Court in Denver,
Colorado or the
Colorado state courts of general jurisdiction in Denver,
Colorado (and the
parties will submit to the jurisdiction thereof).
11.9 Notices and Deliveries. Any notice, requests, delivery, approval or consent
required or permitted to be given under this Agreement shall be in writing and
shall be deemed to have been sufficiently given if delivered in person,
transmitted by commercial overnight courier, or transmitted by telex, telegram
or telecopy (receipt verified) to the party to whom it is directed at its
address shown below or such other address as such party shall have last given by
notice to the other party. All notices shall be effective upon receipt.
If to Array, addressed to: If to Amgen addressed to:
0000 Xxxxxx Xxxxxx AMGEN INC.
ARRAY BIOPHARMA INC. Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxx, XX 00000 Xxxxxxxx Xxxx, XX 00000-0000
Attn: President Attn: Executive Vice President, Research
cc: Chief Operating Officer cc: Secretary and General Counsel
11.10 Force Majeure. If the performance of any part of this Agreement by either
party or of any obligation under this Agreement (other than for the payment of
money) shall be prevented, restricted, interfered with or delayed by reason of
any cause beyond the reasonable control of the party liable to perform (unless
conclusive evidence to the contrary shall be provided), the party so affected
shall, upon giving written notice to the other party, be excused from such
performance to the extent of such prevention, restriction, interference or
delay, provided that the affected party shall use commercially reasonable
efforts to avoid or remove such causes of non-performance and shall continue
performance with the utmost dispatch whenever such causes are removed. When such
circumstances arise, the parties shall discuss what, if any, modification of the
terms of this Agreement may be required in order to arrive at an equitable
solution.
11.11 Dispute Resolution. Array and Amgen shall deal with each other in good
faith. The parties agree that in the event of a dispute between them arising
from, concerning or in any way relating to this Agreement, the parties shall
undertake good faith efforts to amicably resolve such dispute between
themselves. In the event the Research Committee shall be unable to resolve any
such dispute, the matter shall be referred to the President or another
designated representative of
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Array and to the Executive Vice President, Research or another designated
representative of Amgen for further review and resolution.
11.12 Exhibits. All Exhibits referenced in and attached hereto are incorporated
in this Agreement by reference. In case of any discrepancies between language
incorporated from the Exhibits and the terms of the Sections of this Agreement,
the terms of the Sections shall prevail.
11.13 Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
11.14 Entire Agreement of the Parties; Amendments. This Agreement (and its
Exhibits), together with the Amendment and Termination Agreement dated [***],
constitutes and contains the entire understanding and agreement of the parties
and cancels and supersedes any and all prior negotiations, correspondence,
representations, understandings and agreements, whether verbal or written,
between the parties respecting the subject matter hereof. The Non-Disclosure
Agreement, dated [***] (Amgen Reference No. 20013879) is hereby superseded,
provided that all Confidential Information disclosed under the Non-Disclosure
Agreement shall be treated as if disclosed under, and be subject to the terms
of, this Agreement. No waiver, modification or amendment of any provision of
this Agreement (and its Exhibits) shall be valid or effective unless made in
writing and signed by a duly authorized representative of each of the parties.
The failure or delay of either party in enforcing any of its rights under this
Agreement shall not be deemed a continuing waiver or a modification by such
party of any such right.
IN WITNESS THEREOF, the parties have caused this Agreement to be duly
executed and delivered as of the Effective Date.
ARRAY BIOPHARMA INC.
By: /s/ Xxxxx Xxxxxxx
----------------------------------------------
(Signature)
Xxxxx Xxxxxxx
-------------------------------------------------
(Printed Name)
Chief Operating Officer
-------------------------------------------------
(Title)
AMGEN INC.
By: /s/ Xxxxx Xxxxxxxxxx
----------------------------------------------
(Signature)
Xxxxx Xxxxxxxxxx
-------------------------------------------------
(Printed Name)
Executive Vice President Research & Development
-------------------------------------------------
(Title)
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EXHIBIT A - GLOSSARY
For purposes of this Agreement, the capitalized terms defined in this Exhibit A
shall have the respective meanings set forth below:
A.1 "AFFILIATE" shall mean any corporation or other entity which is directly or
indirectly controlling, controlled by or under common control with a party. For
the purpose of this section, "control" shall mean the direct or indirect
ownership of fifty percent (50%) or more of the outstanding shares or other
voting rights to elect directors of the subject entity, or if not meeting the
preceding, any entity owned or controlled by or owning or controlling such
entity at the maximum control or ownership right permitted in the country where
such entity exists.
A.2 "AGREEMENT" shall mean this Agreement, including all Exhibits hereto.
A.3 "AMGEN" shall mean Amgen Inc. and every Affiliate of Amgen.
A.4 "AMGEN TECHNOLOGY" shall mean all technology including, but not limited to,
trade secrets, know-how, inventions and information (including test data,
protocols and screening methodology), and materials (including Compounds),
whether patentable or not, directed to products, processes, formulations and/or
methods that Amgen discovers, develops, identifies, licenses or acquires
independently of Array (i.e., without the use of the Confidential Information of
Array). For the avoidance of doubt, it is intended that Amgen Technology shall
exclude Array Technology, Collaboration Technology and Joint Technology.
A.5 "ARRAY" shall mean
Array BioPharma Inc. and every Affiliate of Array.
A.6 "ARRAY RESEARCHER(s)" shall mean consultants, researchers and scientists
employed or contracted by Array.
A.7 "ARRAY TECHNOLOGY" shall mean, other than Licensed Technology, all
technology including, but not limited to, trade secrets, know-how, inventions
and information (including test data, protocols and screening methodology), and
materials, whether patentable or not, directed to products, processes,
intermediates and reagents which are owned or Controlled by Array and which are
necessary or useful in the preparation of Active Compounds.
For the avoidance of doubt, it is intended that Array Technology shall exclude
Amgen Technology, Collaboration Technology and Joint Technology.
A.8 "COLLABORATION TARGET" shall mean a target as identified in Exhibit B.
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A.9 "COLLABORATION TARGET ACTIVITY" shall mean a modulation of the activity of
each Collaboration Target, which is no greater then [***] micromolar, as
measured in an appropriate in vitro Collaboration Target biochemical assay
and/or functional cellular assay. The appropriate biochemical assay and/or
functional cellular assay (Collaboration Target Assay Protocol) will be agreed
to by the Research Committee for each Collaboration Target. In the event of a
disagreement between the parties regarding the Collaboration Target Assay
Protocol used to determine such activity, the determining assay to resolve such
conflict shall be conducted by or under the direction of Amgen to its
satisfaction.
A.10 "COLLABORATION TECHNOLOGY" shall mean, other than Joint Technology, all
technology including, but not limited to, trade secrets, know-how, inventions,
information (including structure-activity data) and materials (including
Compounds), whether patentable or not, directed to products, processes,
formulations and/or methods:
(a) discovered, developed, owned, licensed or acquired by Array
(whether or not with funding support by Amgen) arising out of
or in connection with the conduct of the Research Program; or
(b) discovered, developed, owned, licensed or acquired by Array
Researcher(s) funded by Amgen in accordance with Article 5 in
the course of performing activities under the Research
Program.
For the avoidance of doubt, it is intended that Collaboration Technology shall
exclude Amgen Technology, Array Technology and Joint Technology.
A.11 "COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and resources commonly
used in the research-based pharmaceutical industry for a product of similar
market potential at a similar stage in its product life, taking into account
efficacy, the competitiveness of alternative products in the marketplace, the
patent and other proprietary position of the product, the likelihood of
regulatory approval given the regulatory structure involved, the profitability
of the product and alternative products, and other relevant factors.
Commercially Reasonable Efforts shall be determined on a market-by-market basis
for an Active Compound, and it is anticipated that Amgen's level of effort will
change over time, reflecting changes in the status of the Active Compound and
the market involved.
A.12 "COMPOUND(s)" shall mean any one or more chemical entity or entities,
whether of natural or of partially or wholly synthetic origin.
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(a) "ACTIVE COMPOUND(s)" shall mean any one or more Amgen
Compounds possessing Collaboration Target Activity, or
Collaboration Compounds possessing Collaboration Target
Activity.
(b) "AMGEN COMPOUND(s)" shall mean any one or more Compound(s)
made by or on behalf of Amgen or its sublicensees from the
commencement date of the Research Program Initial Term until
termination of the Agreement which (i) result from a chemical
synthesis program based on a Collaboration Compound; (ii) are
based on structure-activity data relating to Collaboration
Compounds which are active or inactive in the Research Field;
or (iii) are claimed in any patent application or patent filed
by Amgen, which patent application or patent discloses any
compound in subsection (i) or (ii) above.
(c) "COLLABORATION COMPOUND(s)" shall mean any one or more
Compound(s) synthesized by Array during the course of the
Research Program.
(d) "[***] COMPOUND(s)" shall mean any one or more Compound(s)
[***].
(e) "NON-ACTIVE COMPOUND(s)" shall mean any one or more
Collaboration Compounds that do not possess Collaboration
Target Activity.
A.13 "CONFIDENTIAL INFORMATION" shall mean, with respect to a party, all
information of any kind whatsoever (and all tangible and intangible embodiments
thereof of any kind whatsoever) which relate to the Research Field and which are
owned or Controlled by such party.
A.14 "CONTROL" OR "CONTROLLED" shall mean the possession of the ability to grant
a license or sublicense as provided for in this Agreement without violating the
terms of any agreement or other arrangement with a Third Party.
A.15 "FDA" shall mean the Federal Food and Drug Administration of the United
States Department of Health and Human Services or its successor agencies.
A.16 "FIELD OF USE" shall mean all uses of Compound(s) including, but not
limited to, all human therapeutic, prophylactic and diagnostic uses of
Compound(s).
A.17 "FTE" shall mean one (1) full-time equivalent staff member.
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A.18 "GOVERNMENTAL APPROVALS" shall mean any approvals, licenses, registrations
or authorizations, howsoever called, of any foreign or United States federal,
state or local regulatory agency, department, bureau or other government entity,
including the FDA, necessary for the distribution, importation, manufacture,
production, use, storage, transport or sale of Compound(s).
A.19 "IND" shall mean an Investigational New Drug application filed with the FDA
pursuant to Section 21 C.F.R. 312.20.
A.20 "JOINT TECHNOLOGY" shall mean all technology including, but not limited to,
trade secrets, know-how, inventions, information (including structure-activity
data) and materials (including Compounds), whether patentable or not, directed
to products, processes, formulations and/or methods that are developed by Array
using Amgen Technology or are discovered, developed, licensed or acquired
jointly by Array and Amgen during the Research Program or thereafter until
termination of the Agreement. For the avoidance of doubt, it is intended that
Joint Technology shall exclude Amgen Technology, Array Technology and
Collaboration Technology.
A.21 "LICENSED PATENT RIGHTS" shall mean the following intellectual property
rights which describe or claim Licensed Technology and which are owned or
Controlled by Array (in whole or in part): (a) any and all patent applications
(including all divisionals, continuations or continuations-in-part) filed or
having legal force in any country within the Territory, (b) any and all patents
that have issued or in the future issue from the foregoing patent applications,
including utility, model and design patents and certificates of invention, and
(c) any and all extensions or restorations by existing or future extension or
restoration mechanisms, including without limitation Supplementary Protection
Certificates or the equivalent thereof, substitutions, confirmations,
reregistrations, reexaminations, revalidations, reissues, renewals, extensions
or additions to any such foregoing patent applications and patents.
A.22 "LICENSED TECHNOLOGY" shall mean, collectively, Collaboration Technology
and Joint Technology.
A.23 "MILESTONE EVENT(s)" shall mean, collectively or individually, Research
Milestone Events as defined in Section 5.2.1 and Clinical Milestone Events as
defined in Section 5.2.2.
A.24 "MILESTONE PAYMENT(s)" shall mean, collectively or individually, Research
Milestone Payment(s) as defined in Section 5.2.1 and Clinical Milestone Payments
as defined in Section 5.2.2.
A.25 "NDA" shall mean a New Drug Application filed with the United States FDA,
to obtain marketing approval of a human drug therapeutic product.
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A.26 "PIVOTAL TRIAL" shall mean a clinical trial which, if the defined
end-points are met, is intended by Amgen as of the start of such trial to be a
pivotal clinical trial of safety and efficacy that would constitute sufficient
basis for receipt of marketing approval in the United States or an equivalent
foreign approval.
A.27 "PLA" shall mean a Product License Application filed with the FDA or an
equivalent foreign filing to obtain marketing approval of a pharmaceutical
product.
A.289 "REGULATORY FILINGS" shall mean, collectively, INDs, PLAs, establishment
license applications (ELAs) and drug master files (DMFs) or any other similar
filings (including any foreign equivalents and further including any related
correspondence and discussions) as may be required by the FDA or equivalent
foreign regulatory agencies for the clinical testing, manufacture or sale of
Compound(s).
A.29 "RESEARCH FIELD" shall mean the field of research to identify, design,
generate, characterize and optimize Compound(s) which modulate the activity of
any Collaboration Target, as well as processes for making and methods of using
such Compound(s).
A.30 "RESEARCH GOALS" shall mean the Stage I and Stage II goals set forth in the
Research Plan.
A.31 "RESEARCH PLAN" shall mean the written plan describing the work within the
Research Field, which plan is to be carried out by Array and Amgen solely in
furtherance of the Research Program. The Research Plan is attached to and made
part of this Agreement as Exhibit C.
A.32 "RESEARCH PROGRAM" shall mean the collaborative research program which
shall be conducted by Array and Amgen pursuant to Article 2.0.
A.33 "RESEARCH PROGRAM INITIAL TERM" The initial term of the Research Program
shall commence on November 1, 2001 and, shall continue in effect for a period of
[***] thereafter.
A.345 "TERRITORY" shall mean the world.
A.35 "THIRD PARTY" shall mean any individual, partnership, joint venture,
corporation, trust, estate, unincorporated organization, government or any
department or agency thereof, or any entity other than Amgen or Array.
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EXHIBIT B - COLLABORATION TARGETS
[***]
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