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EXHIBIT 10.36
RESEARCH AND LICENSE AGREEMENT
DATED OCTOBER 26, 2000
BETWEEN
ARRAY BIOPHARMA INC.
AND
AMGEN INC.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 - 7
SECTION FIVE - CONSIDERATION
5.1 - 5.7........................................................................... 7 - 10
SECTION SIX - INTELLECTUAL PROPERTY
6.1 - 6.4........................................................................... 10 - 12
SECTION SEVEN - CONFIDENTIALITY
7.1 - 7.4........................................................................... 12 - 14
SECTION EIGHT - TERMINATION
8.1 - 8.10.......................................................................... 15 - 18
SECTION NINE - REPRESENTATIONS, WARRANTIES AND
COVENANTS
9.1 - 9.3........................................................................... 19 - 21
SECTION TEN - INDEMNITY
10.1 - 10.4......................................................................... 21 - 22
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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TABLE OF CONTENTS (CONT'D)
SECTION TITLE PAGES
SECTION ELEVEN - GENERAL PROVISIONS
11.1 - 11.14.................................................................. 22 - 24
EXHIBIT A - GLOSSARY......................................................... A-1 to A-6
EXHIBIT B - LICENSED PATENT RIGHTS........................................... B-1
EXHIBIT C - RESEARCH PLAN.................................................... C-1 to ▇-▇▇
▇▇▇▇▇▇▇ ▇ - ▇▇▇-▇▇ ASSAY PROTOCOL............................................ D-1 to D-2
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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RESEARCH AND LICENSE AGREEMENT
THIS RESEARCH AND LICENSE AGREEMENT (this "Agreement"), effective as of
October 26, 2000 (the "Effective Date"), is made by and between ARRAY BIOPHARMA
INC., a Delaware corporation having a place of business at ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Array"), and AMGEN INC., a Delaware corporation having
a place of business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇-▇▇▇▇ ("Amgen").
RECITALS
WHEREAS, Array possesses scientific, technical and proprietary
information and materials relating to compounds which modulate the activity of
PTP-1B (as defined below).
WHEREAS, Amgen possesses scientific, clinical, regulatory and business
expertise in the worldwide development, manufacture and commercialization of
pharmaceutical products.
WHEREAS, Amgen and Array desire to collaborate to identify, design,
generate, characterize and optimize compounds which modulate the activity of
PTP-1B.
WHEREAS, Array wishes to grant and Amgen wishes to receive an exclusive
license to make, use and sell Active Compounds (as defined below) in the Field
of Use (as defined below) and other rights, on the terms and conditions set
forth in this Agreement.
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 the Research Program for
the purpose of designing, generating, characterizing and optimizing and testing
of compounds which possess PTP-1B Activity.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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2.2 Research Plan. The parties shall perform their respective obligations
under the Research Program in accordance with the Research Plan, as set forth in
Exhibit C. Any amendment to the Research Plan shall be effective when executed
in accordance with Section 2.3, below.
2.3 Research Committee. A Research Committee will be created to manage the
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. [ * ].
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
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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
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 Research Program.
2.8 Transfer of Amgen Technology, Array 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 Within thirty (30) days after the Effective Date, Array will
provide to Amgen in writing (or in another mutually-agreed tangible form) Array
Technology and Licensed Technology that exists as of the Effective Date, in a
detail sufficient to enable Amgen to practice its licenses under Section 3.0,
below.
2.8.3 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), additional Array Technology and Licensed Technology developed by or
received by Array during the term of the Research Program, in a detail
sufficient to enable Amgen to practice its licenses under Section 3.0, below.
From time-to-time as appropriate, thereafter, Array shall transfer to Amgen in
writing (or in another mutually-agreed tangible form) structure, synthesis and
characterization information
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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regarding Derivative Compounds developed by or received by Array after
termination of the Research Program until the termination of the Agreement.
2.8.4 As part of each disclosure pursuant to Sections 2.8.2 and 2.8.3,
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 and
Derivative 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 and
Derivative 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) and/or Derivative Compound(s) to Amgen,
regarding the container and shipping details, the analytical results and other
related data. Each of the Collaboration Compound(s) and Derivative 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) and Derivative Compound(s) shall remain with Array
until each such Collaboration Compound(s) and Derivative Compound(s) has been
delivered to the destination specified by Amgen in writing.
2.8.5 During the term of the 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 the Licensed Technology. Such
assistance and consultation by Array shall be by means of personal visits,
correspondence and telephone discussions.
2.8.6 Array shall use Licensed Technology 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
relating to Active Compounds and Amgen Technology to any Third Party, and shall
maintain Licensed Technology 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 Program 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
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 the 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) the names of each Array Researcher conducting the Research Program,
(ii) an accounting in reasonable detail of Array Researcher FTEs devoted 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) and Derivative Compound(s), all assay data
generated with any such Collaboration Compound(s) and Derivative Compound(s),
methods and processes for the preparation of any such Collaboration Compound(s)
and Derivative 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) and Derivative
Compound(s). [ * ].
2.10 Term. The term of the Research Program shall be for the period of the
Research Program Initial Term, unless earlier terminated pursuant to Section
8.0, below, or extended in accordance with Sections 2.10.1 and 2.10.2, below.
2.10.1 The term of the Research Program may be extended for an
additional one (1) year period, upon Amgen providing Array with written notice
thereof at least ninety (90) 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 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
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 Patent
Rights, Array Technology, Licensed Patent Rights and Licensed Technology to
make, have made and use Amgen Compounds, Collaboration Compounds and Derivative
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 Collaboration Compounds which do not possess PTP-1B Activity and Derivative
Compounds which do not possess PTP-1B Activity (collectively, "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 [ * ] from the date of such notice
to exclusively negotiate in good faith reasonable terms and conditions under a
separate agreement to sublicense or to otherwise acquire Array's rights to such
Non-Active Compound. If the [ * ] Array shall be [ * ] provided however, that if
[ * ] Amgen Array [ * ] Non-Active Compound [ * ].
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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 Signing Fee. Amgen shall pay to Array a one-time non-refundable
signing fee of One Million Eight Hundred Forty Thousand Dollars ($1,840,000.00),
due and payable within thirty (30) days after the Effective Date.
5.2 Research Program Funding. Amgen shall fund and Array shall conduct the
Research Program at the following effort levels ("Funding Commitment"):
5.2.1 Array will devote (i) [ * ] Array Researcher FTEs during each
quarter of the first year of the Research Program Initial Term, provided
however, if Array has devoted [ * ] Array Researcher FTEs in any such quarter
then the Research Committee may approve an increase of [ * ] Array Researcher
FTEs in the remaining quarter(s) of the first year, so long as the average
number of Array Researcher FTEs for all four (4) quarters of the first year does
[ * ] Array Researcher FTEs per quarter; (ii) [ * ] Array Researcher FTEs during
each quarter of the second year of the Research Program Initial Term and (iii)
if the term of the Research Program is extended for an additional year pursuant
to Section 2.10.1, [ * ] Array Researcher FTEs during each quarter of such
additional year.
5.2.2 Each Array Researcher FTE for the Research Program will be funded
by Amgen during the Initial Term at a rate of [ * ] and, if the term of the
Research Program is extended for
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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an additional year pursuant to Section 2.10.1, at a mutually-agreed rate [ * ]
per year (the "FTE Rate").
5.2.3 Payment by Amgen to Array for the first quarter of the Research
Program shall be made within thirty (30) days after the Effective Date.
Thereafter payments shall be made by Amgen to Array quarterly, in advance,
within thirty (30) 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.
5.2.4 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.
5.2.5 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.
5.2.6 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 5.2, Amgen shall have no obligation to reimburse Array for any
costs and expenses incurred by Array in the performance of the Research Program.
5.3 Milestones.
5.3.1 Research
Upon the achievement by the performance of Array of each of the
following research goals with respect to at least one (1) Active Compound which
is owned or Controlled by Array and which at the time of such achievement is not
in the public domain and/or claimed by a Third Party patent or published patent
application (not Controlled by Array) ("Research Milestone Event(s)"), Amgen
shall pay to Array the corresponding one-time research milestone payments set
forth hereinbelow ("Research Milestone Payment(s)"):
(a) Within thirty (30) days following receipt of notice and
invoice by Amgen of achievement by the performance of
Array (during the term of the
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Research Program) of all the specified Stage I Research
Goals of the Research Program, as defined in the Research
Plan and as reasonably determined by Amgen, Amgen shall
pay to Array a one-time Research Milestone Payment [ * ]
provided however, that if the achievement has occurred
more then thirty (30) days prior to the first anniversary
of the commencement date of the Research Program Initial
Term, then the Research Milestone Payment will be paid on
or before such first anniversary.
(b) Within thirty (30) days following receipt of notice and
invoice by Amgen of achievement by the performance of
Array (during the term of the Research Program) of all
the specified Stage II Research Goals of the Research
Program, as defined in the Research Plan and as
reasonably determined by Amgen, Amgen shall pay to Array
a one-time Research Milestone Payment of [ * ].
5.3.2 Clinical
Within thirty (30) 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 one-time clinical
milestone payments set forth hereinbelow ("Clinical Milestone Payment(s)"):
Clinical Milestone
Clinical Milestone Event Payment
------------------------ ------------------
(a) Upon administration of an Active Compound
to the first patient [ * ]
(b) Upon administration of an Active Compound
to the first patient in the first Pivotal Trial [ * ]
(c) Upon the first filing of an NDA/PLA or an equivalent
application seeking authorization to market an Active
Compound in (i) the United States; (ii) Japan; or
(iii) the European Union (EU) [ * ]
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Clinical Milestone
Clinical Milestone Event Payment
------------------------ ------------------
(d) Upon the first approval of an NDA/PLA or an equivalent
authorization to market an
Active Compound in the United States [ * ]
(e) Upon the first approval to market an Active
Compound in the European Union (EU) [ * ]
(f) Upon the first approval to market an Active
Compound in Japan [ * ]
Total $33,000,000.00
--------------
5.3.3 Amgen shall not be obligated to pay any Milestone Payment under
Section 5.3 more than once, regardless of the number of Active Compound(s) that
achieve a particular Milestone Event.
5.4 License Maintenance Fees. In order to retain its licenses under
Sections 3.1 and 3.2 following the respective dates set forth below, Amgen shall
pay to Array [ * ] license maintenance fees totaling [ * ] payable as follows:
(a) On or before [ * ], Amgen shall pay Array a one-time non-refundable
fee of [ * ] provided the Research Program was not terminated prior to [ * ];
and
(b) On or before [ * ], Amgen shall pay Array a one-time non-refundable
fee of [ * ] provided the Research Program was not terminated prior to [ * ].
5.5 No Further Consideration. Other than as set forth in this Section 5.0,
Amgen shall not be obligated to pay any additional fees or make any additional
payments.
5.6 Paid-Up License. Upon payment of the Signing Fee pursuant to
Section 5.1, Research Funding pursuant to Section 5.2, Milestone Payments
pursuant to Section 5.3 and the License Maintenance Fee pursuant to Section 5.4,
Amgen shall have a fully paid-up (without an obligation of further
consideration), perpetual, unrestricted, exclusive license, with a right to
sublicense, under Array Technology, Licensed Technology, Array Patent Rights 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 Compounds in the Field of Use in the Territory.
5.7 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 Array.
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. Except as expressly provided in this
Agreement, it is understood that Amgen shall have no obligation to account to
Array for profits or to obtain any approval of Array to license or exploit any
jointly owned invention, by reason of joint ownership of any invention or other
intellectual property.
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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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6.3 Infringement Enforcement of Licensed Patent Rights.
6.3.1 If Array learns of a continuing infringement by a Third Party of
a claim of an issued patent within the Licensed Patent Rights, Array shall
promptly notify Amgen and shall provide Amgen 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.
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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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7.0 CONFIDENTIALITY
7.1 Obligations of Confidentiality. For a period of [ * ] years 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 and all oral or written communications regarding
the Collaboration Technology and Joint Technology, the source data and
information and/or the reports (or any data or information contained therein)
described in Section 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
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 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 [ * ] 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 [ * ] 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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8.0 TERMINATION
8.1 Term. Unless terminated earlier pursuant to the terms of this
Section 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 one hundred eighty (180) 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:
8.3.1 Unless terminated under Sections 8.6 or 8.7, below, if the
Research Program is terminated prior to the second anniversary 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 the second
anniversary 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 Section 3.0 and obligations under Sections 5.3.2, 5.3.4, 5.4 and 5.7)
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 [ * ] for
non-payment. If the Defaulting Party
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 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 Section 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 Section 5.0,
Array may only seek remedies which may be available at law, but may not seek to
terminate this Agreement; provided however, that all of Amgen's rights and
obligations under this Agreement shall remain in full force and effect.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 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 Section 8.0, the following rights and obligations shall
apply:
8.8.1 Amgen shall have no further payment obligations under Section 5.0
(Consideration), subject to Section 8.9, below.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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, 5.5, 5.6, 6.2 and 6.3, provided however, in the event of termination
of this Agreement in accordance with Sections 8.2 prior to the second
anniversary of the commencement date of the Research Program Initial Term or
8.5.3, Amgen shall cease development of Active Compounds pursuant to Section 4.1
and all rights granted by Array to Amgen under Sections 3.1, 3.2, 3.4, 5.6, 6.2
and 6.3 shall revert to Array. In the event of a termination described in the
preceding sentence, for a period of one (1) year after the date of termination
of this Agreement, Array shall have the exclusive option to negotiate reasonable
terms and conditions under a separate agreement to sublicense or otherwise
acquire the rights in or to Amgen's rights in Active Compounds within Joint
Technology and in Licensed Patent Rights claiming Active Compounds within Joint
Technology; provided however, that if the parties are unable to agree on terms
within such exclusive period, then Amgen shall be free to use, sublicense or
otherwise dispose of such rights;
(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) Sections 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 Section 8.0 shall be without
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 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) Exhibit B contains a list of all patents and/or patent
applications within Licensed Patent Rights in the Territory as of the Effective
Date;
(b) Array owns or Controls all Array Patent Rights and Licensed
Patent Rights set forth in Exhibit B and has all rights necessary to grant the
rights and licenses with respect to Array Patent Rights, Licensed Patent Rights,
Array Technology and Licensed Technology existing as of the Effective Date;
(c) Array has no knowledge that any patents or patent
applications within the Licensed Patent Rights are totally invalid or
unenforceable in their entirety;
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(d) 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
(e) 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.
(d) Array covenants not to utilize any process, intermediate
or reagent in the preparation of any Collaboration Compound or to prepare any
Collaboration Compound 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 [ * ] years 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
Compounds, Collaboration Compounds and/or Derivative 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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10.2 Array Indemnity. For a period of [ * ] years 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.
10.3 Procedure. A party that intends to claim indemnification under this
Section 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
Section 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 Section
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 Section 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 Section 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.
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
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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:
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ AMGEN INC.
ARRAY BIOPHARMA INC. ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
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
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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such dispute, the matter shall be referred to the President or another
designated representative of 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) 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
Material Transfer Agreement, dated [ * ], and as supplemented on [ * ] (Amgen
Reference Nos. 20002671 and 20003694) and Non-Disclosure Agreement, dated [ * ]
(Amgen Reference No. 20005093) are hereby superseded, provided that all
Compounds and Confidential Information disclosed under the Material Transfer
Agreement and 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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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IN WITNESS THEREOF, the parties have caused this Agreement to be duly
executed and delivered as of the Effective Date.
ARRAY BIOPHARMA INC.
By:
--------------------------------
(Signature)
▇▇▇▇▇ ▇▇▇▇▇▇▇
-----------------------------------
(Printed Name)
Chief Operating Officer
-----------------------------------
(Title)
AMGEN INC.
By:
--------------------------------
(Signature)
▇▇▇▇▇ ▇. ▇▇▇▇▇▇
-----------------------------------
(Printed Name)
President & Chief Executive Officer
-----------------------------------
(Title)
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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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 PATENTS" shall mean the following intellectual property rights which
claim Array 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.7 "ARRAY RESEARCHER(s)" shall mean consultants, researchers and scientists
employed or contracted by Array.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
33
A.8 "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.9 "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
in the Research Field prior to the commencement date of the
Research Program Initial Term; or
(b) 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
(c) discovered, developed, owned, licensed or acquired by Array
Researcher(s) funded by Amgen in accordance with Section 6;
or
(d) in the Research Field and discovered, developed, owned,
licensed or acquired by Array from the commencement date of
the Research Program Initial Term until termination of the
Agreement.
For the avoidance of doubt, it is intended that Collaboration Technology shall
exclude Amgen Technology, Array Technology and Joint Technology.
A.10 "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.11 "COMPOUND(s)" shall mean any one or more chemical entity or entities,
whether of natural or of partially or wholly synthetic origin.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
34
(a) "ACTIVE COMPOUND(s)" shall mean any one or more Amgen
Compounds possessing PTP-1B Activity, Collaboration
Compounds possessing PTP-1B Activity or Derivative Compounds
possessing PTP-1B 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
or a Derivative Compound; (ii) are based on
structure-activity data relating to Collaboration Compounds
or Derivative 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 (i) any one or more
Compound(s) which are synthesized by Array in the course of
its program in the Research Field prior to the commencement
date of the Research Program Initial Term or (ii) any one or
more Compound(s) synthesized by Array during the course of
the Research Program.
(d) "DERIVATIVE COMPOUND(s)" shall mean any one or more
Compound(s) made by or on behalf of Array, other than in the
course of the Research Program, 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 under Section 6.2 or by Array, which patent
application or patent discloses any compound in subsection
(i) or (ii) above.
A.12 "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.13 "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.14 "FDA" shall mean the Federal Food and Drug Administration of the United
States Department of Health and Human Services or its successor agencies.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
35
A.15 "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.16 "FTE" shall mean one (1) full-time equivalent staff member.
A.17 "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.18 "IND" shall mean an Investigational New Drug application filed with the FDA
pursuant to Section 21 C.F.R. 312.20.
A.19 "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.20 "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.21 "LICENSED TECHNOLOGY" shall mean, collectively, Collaboration Technology
and Joint Technology.
A.22 "MILESTONE EVENT(s)" shall mean, collectively or individually, Research
Milestone Events as defined in Section 5.3.1 and Clinical Milestone Events as
defined in Section 5.3.2.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
36
A.23 "MILESTONE PAYMENT(s)" shall mean, collectively or individually, Research
Milestone Payment(s) as defined in Section 5.3.1 and Clinical Milestone Payments
as defined in Section 5.3.2.
A.24 "NDA" shall mean a New Drug Application filed with the United States FDA,
to obtain marketing approval of a human drug therapeutic product.
A.25 "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.26 "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.27 "PTP-1B" shall mean protein tyrosine phosphatase-1B.
A.28 "PTP-1B ACTIVITY" shall mean [ * ].
A.29 "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.30 "RESEARCH FIELD" shall mean the field of research to identify, design,
generate, characterize and optimize Compound(s) which modulate the activity of
PTP-1B, as well as processes for making and methods of using such Compound(s).
A.31 "RESEARCH GOALS" shall mean the Stage I and Stage II goals set forth in the
Research Plan.
A.32 "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.33 "RESEARCH PROGRAM" shall mean the collaborative research program which
shall be conducted by Array and Amgen pursuant to Section 2.0.
A.34 "RESEARCH PROGRAM INITIAL TERM" The initial term of the Research Program
shall commence on November 1, 2000 and, shall continue in effect for a period of
twenty-four (24) months thereafter.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
37
A.35 "TERRITORY" shall mean the world.
A.36 "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.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EXHIBIT B -- LICENSED PATENT RIGHTS
[ * ]
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EXHIBIT C - RESEARCH PLAN
[ * ]
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EXHIBIT D - PTP-1B ASSAY PROTOCOL
[ * ]
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.