Exhibit 10.38
COLLABORATION
AGREEMENT
This Agreement is entered into as of
June 18, 2004 by and between:
SEATTLE GENETICS, INC.
, a Delaware corporation, having its
principal place of business at 21823 30th Drive S.E., Bothell,
Washington 98021
(hereinafter referred to as “
SGI ”)
and :
CURAGEN CORPORATION
, a Delaware corporation, having its
principal place of business at 555 Long Wharf Avenue, New Haven, CT
06511
(hereinafter referred to as “
Licensee ”).
WITNESSETH
WHEREAS, SGI owns or controls intellectual property
rights relating to certain technology useful for linking certain
proprietary cytotoxins to other molecules such as antibodies
capable of directing such cytotoxins to specific tissues and/or
cells;
WHEREAS, Licensee is currently conducting research and
development programs to discover antigens that may have activity in
certain disease-related pathways, and to develop antibodies that
bind to those antigens;
WHEREAS, the Parties have created ADCs (as such term is
defined below) to, and conducted initial characterization work
regarding, the First Exclusive Antigen (as such term is defined
below) pursuant to the terms and subject to the conditions of the
Initial Agreements (as such term is defined below);
WHEREAS, Licensee wishes to obtain an exclusive worldwide
license under certain of SGI’s patent rights and know-how
related to SGI’s proprietary cytotoxin and linker technology
to the First Exclusive Antigen for use in conjunction with
Licensee’s antibodies on the terms set forth below and
Licensee wishes to acquire from SGI an exclusive option to obtain
an exclusive worldwide license under SGI’s patent rights and
know-how related to SGI’s proprietary cytotoxin and linker
technology to a Second Exclusive Antigen for use in conjunction
with Licensee’s antibodies; and
WHEREAS, SGI wishes to grant to Licensee such license and
option and to allow Licensee to evaluate SGI’s cytotoxin and
linker technology for use with certain of Licensee’s antigens
and antibodies.
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
NOW, THEREFORE
, in consideration of the mutual
covenants and obligations set forth herein, the Parties hereto,
intending to be legally bound, agree as follows:
ARTICLE 1 - DEFINITIONS AND
INTERPRETATION
1.1 Definitions : For the purposes of
this Agreement the following words and phrases shall have the
following meanings:
1.1.1 “ AAA ” has the meaning set
forth in Section 19.3.4.
1.1.2 “ ADC ” or “
Antibody-Drug Conjugate ” means an Antibody that is
linked to a cytotoxin or cytostatic agent and that contains, uses
or is made using SGI Technology.
1.1.3 “ ADC Access Fee ” has the
meaning set forth in Section 6.1.1.
1.1.4 “ Affiliate ” of a Party
means any corporation or other business entity that, directly or
indirectly, through one or more intermediaries, controls, is
controlled by, or is under common control with a Party. As used
herein, the term “control” means the direct or indirect
ownership of [***] or more of the stock having the right to vote
for directors thereof or the ability to otherwise control the
management thereof.
1.1.5 “ Agreement ” means this
agreement, all amendments and supplements to this Agreement and all
schedules to this Agreement, including the following:
1.1.6 Schedule A - Research Plan.
1.1.7 Schedule B - SGI Patents.
1.1.8 Schedule C - SGI In-Licenses.
1.1.9 Schedule D - Designated Antigens and
Exclusive Antigens.
1.1.10 “ Antibody ” or “
Antibodies ” means any antibody, or [***], that binds
to an Antigen.
1.1.11 “ Antigen ” means any [***],
that is Controlled by Licensee.
1.1.12 “[***]” means [***] having a
GenBank accession number of [***].
1.1.13 “[***] ” means the SGI
Technology licensed to SGI under the BMS Agreement (as defined in
the definition of “SGI In-Licenses”).
1.1.14 “ Breaching Party ” has the
meaning set forth in Section 13.3.
1.1.15 “ Calendar Quarter ” means
any of the three-month periods beginning January 1,
April 1, July 1 and October 1 in any
year.
1.1.16 “ Change in Control ” has the
meaning set forth in Article 16.
1.1.17 “ Claims ” has the meaning
set forth in Section 14.1.1.
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Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
1.1.18 “ Combination Product ” means
any Licensed Product that contains, in addition to an ADC, one or
more other ingredients that (a) are not covered by SGI
Technology, and (b) [***].
1.1.19 “ Confidential Information ”
has the meaning set forth in Section 8.1.
1.1.20 “ Control ” means, with
respect to any information or intellectual property right,
possession by a Party of the ability to grant the right to access
or use, or to grant a license or a sublicense to, such information
or intellectual property right as provided for herein without
violating the terms of any agreement or other arrangement with any
Third Party. [***].
1.1.21 “ Cost of Goods ” shall mean
with respect to Drug Conjugate Materials supplied to Licensee
(a) for manufacturing activities performed by Third Parties,
[***], as well as [***], including without limitation [***]; and
(b) for manufacturing activities performed by SGI or its
Affiliates, the [***].
1.1.22 “ Designated Antigen ” means
the [***] Antigens targeted by the ADCs prepared by SGI and
designated as such in accordance with Section 2.5 of this
Agreement.
1.1.23 “ [***] ” means the [***]
that may be [***] pursuant to [***] of this Agreement.
1.1.24 “ Drug Conjugation Materials
” means the compound monomethyl Auristatin E and [***]
and [***] thereof, including [***], as well as compounds that are
useful in attaching such compounds to [***], in each case to the
extent included in or covered by the SGI Technology. Drug
Conjugation Materials shall also include Improvements to Drug
Conjugation Materials and any additional cytotoxic or cytostatic
compounds that are included in New Technologies and that the
Parties agree to include under this Agreement pursuant to
Section 3.7.2.
1.1.25 “ Drug Conjugation Technology
” means chemical compositions and methods that are useful to
attach cytotoxins or cytostatic compounds to Antibodies, including
the composition and methods of making and using cytotoxic or
cytostatic compounds, as well as compositions and methods useful
for attaching the foregoing cytotoxic or cytostatic compounds to
Antibodies.
1.1.26 “ Effective Date ” means the
date set forth in the first line of this Agreement.
1.1.27 “ Events of Force Majeure ”
has the meaning set forth in Article 15.
1.1.28 “ Exclusive Antigen ” means
collectively, the First Exclusive Antigen, the Second Exclusive
Antigen and any Replacement Antigen.
1.1.29 “ Exclusive License ” has the
meaning set forth in Section 3.2.
1.1.30 “ Exclusive License Maintenance Fee
” has the meaning set forth in Section 6.2.
-3-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
1.1.31 “ Existing Third Party Royalties
” has the meaning set forth in Section 6.5.1.
1.1.32 “ FD&C Act ” means the
federal Food, Drug & Cosmetic Act, as amended.
1.1.33 “ FDA ” means the United
States Food and Drug Administration, and any successor agency
thereto.
1.1.34 “ Field ” means the [***];
provided , that , with respect to use of the [***],
the Field shall be limited to [***].
1.1.35 “ First Commercial Sale ”
means, in each country of the Territory, the first commercial sale
of a Licensed Product by Licensee, its Affiliates or Sublicensees
to a Third Party following, if required by law, Regulatory Approval
and, when Regulatory Approval is not required by law, the first
commercial sale in that country, in each case for use or
consumption of such Licensed Product in such country by the general
public. Sales for test marketing, sampling and promotional uses,
clinical trial purposes or compassionate or similar use shall not
be considered to constitute a First Commercial Sale.
1.1.36 “ First Exclusive Antigen ”
means Antigen CG56972 having a [***].
1.1.37 “ FTE Fees ” has the meaning
set forth in Section 6.1.2.
1.1.38 “GAAP” means generally
accepted accounting principles in the United States.
1.1.39 “ Good Laboratory Practices ”
means the then-current standards for laboratory activities for
pharmaceuticals, as set forth in the FD&C Act and applicable
regulations and guidances promulgated thereunder, including without
limitation the Code of Federal Regulations, as amended from time to
time.
1.1.40 “ Improvements ” means all
patentable or non-patentable inventions, discoveries, or other
know-how developed and Controlled by either Party during the Term
that utilize, incorporate, are derived from, or are made using, the
SGI Technology; provided that Improvements shall not include
any [***] or any of the foregoing developed by SGI that, within a
reasonable time period after such inventions, discoveries or
know-how are made or identified, [***], which instead shall be
included in [***].
1.1.41 “ IND ” means (a) an
Investigational New Drug Application filed with the FDA or its
equivalent in any country outside the United States where a
regulatory filing is required or obtained to conduct a clinical
trial; or (b) with respect to any country where a regulatory
filing is not required or obtained to conduct a clinical trial, the
first enrollment of a patient in the first trial involving the
first use of a Licensed Product in humans.
1.1.42 “ Indemnitee ” has the
meaning set forth in Section 14.2.
1.1.43 “ Indemnitor ” has the
meaning set forth in Section 14.2.
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Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
1.1.44 “ Initial Agreements ” means
(a) the [***] by and between the Parties and (b) the
[***] by and between the Parties.
1.1.45 “ Initiation ” means, with
respect to a human clinical trial, the dosing of the first patient
with a Licensed Product pursuant to the clinical protocol for the
specified clinical trial.
1.1.46 “ Joint Patents ” has the
meaning set forth in Section 9.2.2.
1.1.47 “ Liabilities ” has the
meaning set forth in Section 14.1.1.
1.1.48 “ Licensed Product ” means
any and all products containing an ADC comprised of an Antibody
that binds specifically to an Exclusive Antigen and that is
attached to a cytotoxin or cytostatic agent included in the Drug
Conjugation Materials: (a) the manufacture, use, sale, offer
for sale or import of which [***]; or (b) [***].
1.1.49 “ Licensee ADC Know-How ”
means all Program Inventions developed by Licensee using SGI
Technology, and that are necessary or useful for identifying,
developing, making, using or selling ADCs that bind to any
Exclusive Antigen or Designated Antigen.
1.1.50 “ Licensee ADC Patents ”
means all patent applications and patents that are Controlled by
Licensee that claim Licensee ADC Know-How.
1.1.51 “ Licensee Know-How ” means
all technical information, processes, formulae, data, inventions,
methods, chemical compounds, biological or physical materials,
know-how and trade secrets, in each case that are not in the public
domain, used by Licensee in the Research Program and that are
Controlled by Licensee, including technical information, processes,
formulae, data, inventions, methods, chemical compounds, biological
or physical materials, know-how and trade secrets that relate to
(a) the composition, method of using or method of making an
Exclusive Antigen or Designated Antigen, or (b) the
composition, method of using or method of making an Antibody that
binds specifically to an Exclusive Antigen or Designated Antigen.
[***].
1.1.52 “ Licensee Materials ” means
any tangible chemical, biological or physical research materials
that are furnished by or on behalf of Licensee to SGI in connection
with this Agreement.
1.1.53 “ Licensee Patents ” means
all patent applications and patents that claim Licensee
Know-How.
1.1.54 “ Net Sales ” means, as to
each calendar quarter, the gross invoiced sales prices charged for
all Licensed Products sold by or for Licensee, its Affiliates and
Sublicensees to independent Third Parties during such quarter,
[***]:
(a) [***];
(b) [***];
-5-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
(c) [***]; and
(d) [***].
All of the [***] from the gross
invoiced sales prices of Licensed Products shall be determined in
accordance with GAAP. In the event that Licensee, its Affiliates or
Sublicensees make any adjustments [***] after the associated Net
Sales have been reported pursuant to this Agreement, the
adjustments shall be reported and reconciled in the next report and
payment of any royalties due.
In the event a Licensed Product is
sold as part of a Combination Product, the Net Sales from the
Combination Product, for the purposes of determining royalty
payments, shall be determined by multiplying the Net Sales of the
Combination Product (as defined in the standard Net Sales
definition above), during the applicable royalty reporting period,
by [***]. In the event that such average sale price cannot be
determined for the Licensed Product, on the one hand, and all other
product(s) included in the Combination Product, on the other, Net
Sales for the purposes of determining royalty payments shall be
[***].
1.1.55 “[***]” means any [***], or other
[***] that either: (a) are developed by SGI after the
Effective Date and that, within a reasonable time period after such
[***] are made or identified, SGI determines are [***] or
(b) are in-licensed by SGI after the Effective Date, and that
in each case either (x) [***], or (y) [***]. [***] shall
include without limitation cytotoxic or cytostatic compounds other
than those included in the Drug Conjugation Materials as of the
Effective Date that SGI Controls during the Term.
1.1.56 “ Notice of Dispute ” has the
meaning set forth in Section 19.3.1.
1.1.57 “ Option ” has the meaning
set forth in Section 3.3.
1.1.58 “ Option Period ” means, with
respect to each Designated Antigen, the period commencing on the
date such [***] and continuing until [***] (a) [***] or
(b) [***]; provided that all Option Periods shall
terminate when [***] pursuant to the terms hereof; and provided
further that, if applicable, the Option Period for [***] shall
be for a period of [***] after SGI notifies Licensee that
[***].
1.1.59 “ Parties ” means Licensee
and SGI, and “Party” means either of them.
1.1.60 “ Phase II Clinical Trial ”
means a controlled dose clinical trial prospectively designed to
evaluate the efficacy and safety of a candidate drug in the
targeted patient population and to define the optimal dosing
regimen.
1.1.61 “ Phase III Clinical Trial ”
means a controlled, and usually multi-center, clinical trial,
involving patients with the disease or condition of interest to
obtain sufficient efficacy and safety data to support Regulatory
Approval of a candidate drug.
1.1.62 “ Program Invention ” means
any process, formula, method, chemical compound, biological or
physical material, invention, technology, know-how, trade secret or
data conceived or reduced to practice by either Party or jointly by
both Parties in the conduct of the
-6-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
activities under this Agreement
and/or under the Initial Agreements; provided , that any
Program Inventions made pursuant to the Initial Agreements that are
not related to a Designated Antigen or an Exclusive Antigen shall
remain governed by the terms of the Initial Agreements.
1.1.63 “ Program Licensee Patents ”
has the meaning set forth in Section 9.3.3.
1.1.64 “ Publication ” has the
meaning set forth in Section 8.5.
1.1.65 “ Regulatory Approval ” means
final regulatory approval (including, where applicable, pricing
approval in the event that actual sales do not take place before
such approval) required to market a Licensed Product for a disease
or condition in accordance with the applicable laws and regulations
of a given country. In the United States, its territories and
possessions, Regulatory Approval means approval of a New Drug
Application (“ NDA ”), Biologics License
Application (“ BLA ”) or an equivalent by the
FDA.
1.1.66 “ [***] ” means the
Designated Antigen, if any, designated by Licensee to replace the
[***] in accordance with [***] of this Agreement.
1.1.67 “ Reports ” has the meaning
set forth in Section 7.1.1.
1.1.68 “ Research Fees ” has the
meaning set forth in Section 6.1.2.
1.1.69 “ Research Fees Report ” has
the meaning set forth in Section 6.1.2.
1.1.70 “Research License” has the
meaning set forth in Section 3.1.
1.1.71 “ Research Plan ” means the
plan for the Research Program agreed upon by the Parties and
attached hereto as Schedule A .
1.1.72 “ Research Program ” means
the research program conducted pursuant to
Article 2.
1.1.73 “ Research Program Term ”
means the term of the Research Program set forth in
Section 2.2.
1.1.74 “ Royalty Term ” means, on a
Licensed Product-by-Licensed Product and country-by-country basis,
until the later to occur of: (a) the (10
th
) tenth anniversary
of the date of First Commercial Sale of the Licensed Product in
such country; or (b) the expiration of the last to expire
Valid Patent Claim that would be infringed by the sale of the
Licensed Product in such country, if not for the licenses granted
hereunder.
1.1.75 “ Second Exclusive Antigen ”
means a Designated Antigen, other than the First Exclusive Antigen,
for which Licensee exercises the Option for an Exclusive License
under Section 3 of this Agreement.
1.1.76 “ SGI In-Licenses ” means the
following agreements between SGI and the indicated Third Parties:
(a) the [***]); (b) [***]; and (c) any other license
agreement between SGI and a Third Party covering [***] under which
Licensee is [***].
-7-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
1.1.77 “ SGI Know-How ” means any
and all technical information, processes, formulae, data,
inventions, methods, chemical compounds, biological or physical
materials, know-how and trade secrets, in each case that are not in
the public domain, that relate to or are useful to practice the
Drug Conjugation Technology and that have been, or hereafter are
during the Term, Controlled by SGI. SGI Know-How shall include
Improvements Controlled by SGI but shall exclude [***] unless
[***].
1.1.78 “ SGI Patents ”
means:
(a) any existing patents and patent
applications listed in Schedule B to this Agreement,
which shall be amended from time to time to reflect any other
patents and patent applications;
(b) any patents and patent
applications covering Improvements and, solely to the extent the
Parties so agree [***], [***], in each case that are Controlled by
SGI;
(c) any future patents issued from
any patent applications referred to above and any future patents
issued from any continuation, continuation-in part (to the extent
Controlled by SGI), or divisional of any of the foregoing patent
applications or any patent applications from which the foregoing
patents issued, in each case to the extent Controlled by SGI;
and
(d) any reissues, reexaminations,
confirmations, renewals, registrations, substitutions, extensions,
or counterparts of any of the foregoing, in each case to the extent
Controlled by SGI.
1.1.79 “ SGI Technology ” means the
SGI Patents and the SGI Know-How.
1.1.80 “ Sublicensees ” means any
person or entity that is granted a sublicense under the SGI
Technology by Licensee or its Affiliates in accordance with the
terms of this Agreement.
1.1.81 “ Supply Fees ” has the
meaning set forth in Section 6.1.2.
1.1.82 “ Term ” has the meaning set
forth in Article 13.
1.1.83 “ Territory ” means all
countries in the world.
1.1.84 “ Third Party ” means any
person or entity other than Licensee, SGI and their respective
Affiliates.
1.1.85 “ Valid Patent Claim ” means
(a) an unexpired claim of an issued patent which has not been
found to be unpatentable, invalid or unenforceable by an unreversed
and unappealable decision of a court or other authority in the
subject country; or (b) a claim of an application for a patent
that has been pending for less than [***].
-8-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
1.2 Certain Rules of Interpretation in this
Agreement and the Schedules.
1.2.1 Unless otherwise specified, all references to
monetary amounts are to United States of America currency (U.S.
Dollars);
1.2.2 The preamble to this Agreement and the
descriptive headings of Articles and Sections are inserted solely
for convenience of reference and are not intended as complete or
accurate descriptions of the content of this Agreement or of such
Articles or Sections;
1.2.3 The use of words in the singular or plural, or
with a particular gender, shall not limit the scope or exclude the
application of any provision of this Agreement to such person or
persons or circumstances as the context otherwise
permits;
1.2.4 The words “include” and
“including” have the inclusive meaning frequently
identified with the phrases “without limitation” and
“but not limited to”;
1.2.5 Unless otherwise specified, time periods within
or following which any payment is to be made or act is to be done
shall be calculated by excluding the day on which the period
commences and including the day on which the period ends and by
extending the period to the next business day following if the last
day of the period is not a business day in the jurisdiction of the
Party to make such payment or do such act; and
1.2.6 Whenever any payment is to be made or action to
be taken under this Agreement is required to be made or taken on a
day other than a business day, such payment shall be made or action
taken on the next business day following such day to make such
payment or do such act.
ARTICLE 2 - RESEARCH
PROGRAM
2.1 Objective and Conduct of the Research
Program . Licensee intends to conduct a Research Program,
with SGI’s support, to evaluate ADCs for commercial
development under this Agreement with the goal of using SGI
Technology to identify [***] for further development by Licensee as
Licensed Products, as more fully described in the Research Plan.
Licensee acknowledges that, in addition to the licenses to the SGI
Patents granted hereunder, the SGI Know-How transferred to Licensee
under this Agreement contains valuable information that is critical
to Licensee’s development of ADCs hereunder. All research
work performed by Licensee and SGI hereunder shall be performed in
a good scientific manner and in compliance with all applicable
laws.
2.2 Term of the Research Program . The
term of the Research Program shall initially be for a period of
[***] after the Effective Date (the “ Research Program
Term ”), unless terminated earlier in accordance with
Article 13.
2.3 Delivery of Drug Conjugation Materials
. In support of the Research Program, SGI will deliver Drug
Conjugation Materials to Licensee at mutually agreed upon times and
in mutually agreed upon quantities to enable Licensee to attach
such materials to Licensee’s Antibodies to create ADCs. At
Licensee’s request, SGI will also provide Licensee with the
[***] provided to Licensee to [***]. All such Drug Conjugation
Materials and other information provided by SGI to Licensee
hereunder will be deemed Confidential Information of SGI pursuant
to Article 8.
-9-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
2.4 SGI Preparation of ADCs . [***].
In order to identify the Second Exclusive Antigen during the
Research Program Term, SGI will prepare mutually agreed upon
research quantities of ADCs using the Drug Conjugation Materials
for up to [***] targeted to up to [***] supplied by Licensee to
SGI.
2.5 Availability of Antigens .
Licensee shall provide SGI with a confidential written description
of each Antigen, including to the extent available, the GenBank
accession number and the cDNA and/or amino acid sequence for each
Antigen, which Licensee desires to designate as a Designated
Antigen for purposes of this Agreement. Within [***] following
SGI’s receipt of such written notice with respect to a
particular Antigen, SGI shall notify Licensee in writing whether
the Exclusive License described in Article 3 of this Agreement is
available with respect to such Antigen. In addition, SGI shall
promptly notify Licensee in writing if at any time during the
Research Program Term [***]. To the extent such Exclusive License
to [***] is and/or becomes available as described in this
Section 2.5, then [***] shall be deemed to be a Designated
Antigen under this Agreement and Licensee shall have an Option
Period of [***] thereafter to determine whether to exercise an
Exclusive License to [***] as the Second Exclusive Antigen.
Schedule D to this Agreement will be amended from time to
time to list the Designated Antigens and the Second Exclusive
Antigen (including a description thereof) under this Agreement. The
Parties hereby acknowledge and agree that an Antigen shall be
available for designation by Licensee as a Designated Antigen
unless (a) [***] or (b) [***]. Licensee may not designate
Antigens as Designated Antigens following expiration of the
Research Program Term. If, after designation of an Antigen as a
Designated Antigen, a [***], SGI shall inform Licensee in writing,
and Licensee shall have a period of [***] to inform SGI in writing
that Licensee [***]. If Licensee does not exercise an Exclusive
License for such Designated Antigen [***], then (a) [***]
(b) below and (b) [***].
2.6 Additional Activities under Research
Program . Upon mutual agreement of the Parties, the
Research Program may also include the development by SGI of a
technology transfer program for the conjugation of toxins to
Antibodies, including the associated purification and
analytics.
2.7 Payment . Licensee shall pay SGI
the amounts set forth in Section 6.1.2 for any research
efforts or other assistance provided by SGI.
2.8 Supply of Licensee Materials .
From time to time during the Term, Licensee may supply SGI with
Licensee Materials for use in the Research Program. In connection
therewith, SGI hereby agrees that (a) it shall not use
Licensee Materials for any purpose other than exercising any rights
granted to it hereunder; (b) it shall use the Licensee
Materials only in compliance with all applicable federal, state,
and local laws and regulations; (c) it shall not transfer any
Licensee Materials to any Third Party without the prior written
consent of Licensee; (d) Licensee shall retain full ownership
of all such Licensee Materials; and (e) upon the expiration or
termination of this Agreement, SGI shall at the instruction of
Licensee either destroy or return any unused Licensee
Materials.
2.9 Disclaimers . EXCEPT AS MAY BE
OTHERWISE PROVIDED IN ARTICLE 12, SGI MAKES NO REPRESENTATIONS AND
GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY
OPERATION OF LAW, BY STATUTE OR
-10-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
OTHERWISE, REGARDING THE DRUG CONJUGATION
MATERIALS OR ANY ADCs PREPARED BY SGI, INCLUDING ANY WARRANTY OF
QUALITY, MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A
PARTICULAR USE OR PURPOSE. EXCEPT AS MAY BE OTHERWISE PROVIDED IN
ARTICLE 12, LICENSEE MAKES NO REPRESENTATIONS AND GRANTS NO
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF
LAW, BY STATUTE OR OTHERWISE, REGARDING THE LICENSEE MATERIALS,
INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY,
NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR USE OR
PURPOSE.
ARTICLE 3 - LICENSES; OPTION;
DROPPED ANTIGENS
3.1 Research License Grants . Upon
payment of the ADC Access Fee set forth in Section 6.1.1,
subject to the terms and conditions of this Agreement, SGI shall
automatically be deemed to have granted to Licensee a
non-exclusive, worldwide, royalty-free license under the SGI
Technology solely to conduct the Research Program in accordance
with Article 2 of this Agreement (the “ Research
License ”). The Research License shall include the right
to evaluate and conduct research on ADCs that bind to any
Designated Antigen solely for the purpose of determining
Licensee’s interest in exercising the Option for such
Designated Antigen, but shall not include (a) the right to
grant sublicenses thereto to any Third Party, (b) the right to
initiate any human clinical trial utilizing such ADCs in any
country or (c) the right to make, have made, use or sell a
Licensed Product or any SGI Technology. Notwithstanding the
foregoing, [***], a form of which has been provided by Licensee to
SGI. The Research License shall continue for the Research Program
Term, unless earlier terminated pursuant to Article 13;
provided that the Research License shall terminate when
Licensee no longer has the right to designate any Designated
Antigen(s) as either a Replacement Antigen or a Second Exclusive
Antigen pursuant to the terms hereof.
3.2 Exclusive License Grants . Upon
payment of the ADC Access Fee set forth in Section 6.1.1 with
respect to the First Exclusive Antigen, and the Option Exercise Fee
set forth in Section 6.3 of this Agreement with respect to the
Second Exclusive Antigen, subject to the terms and conditions of
this Agreement, and commencing as of the date SGI has received the
ADC Access Fee or Option Exercise Fee, as the case may be, from
Licensee, SGI shall automatically be deemed to have granted to
Licensee an exclusive (even as to SGI), royalty-bearing license
under the SGI Technology, with the right to sublicense as permitted
in Section 3.6, to discover, develop, have developed, make,
have made, import, use, offer for sale, and sell Licensed Products
that bind specifically to the Exclusive Antigen within the Field in
the Territory (each, an “ Exclusive License ”
and collectively, the “ Exclusive Licenses ”).
Each Exclusive License shall continue for the Royalty Term, unless
earlier terminated pursuant to Article 13, subject to payment of
applicable milestones, royalties and the Exclusive License
Maintenance Fees set forth in Section 6.2 of this Agreement
applicable to such Exclusive License.
3.3 Grant of Option . Subject to the
provisions of this Agreement, SGI hereby grants Licensee an option
to obtain the Exclusive License described in Section 3.2 of
this Agreement to the Second Exclusive Antigen (the “
Option ”) during the Option Period.
-11-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
3.4 Procedure to Exercise Option . At
any time during the Option Period, Licensee shall have the right to
notify SGI in writing that it desires to obtain the Exclusive
License to the Second Exclusive Antigen by providing written notice
to SGI. Licensee shall pay SGI the Option Exercise Fee described in
Section 6.3 of this Agreement (the date of payment by Licensee
of the Option Exercise Fee being referred to herein as the “
Option Exercise Date ”) whereupon (a) such
Designated Antigen shall be deemed to be the Second Exclusive
Antigen for purposes of this Agreement and (b) Licensee shall
be deemed to have been granted an Exclusive License with respect to
such Second Exclusive Antigen in accordance with Section 3.2
of this Agreement, without any further action of the Parties.
[***].
3.5 [***] .
If at any time during the period
commencing on the Effective Date and continuing for a period of
[***] thereafter, Licensee reasonably determines [***] for purposes
of this Agreement by providing SGI with written notice of same.
Licensee shall have the right to designate [***] as a [***] in
accordance with the procedure described in Sections 2.5 and 3.4 of
this Agreement. Once the [***] becomes a [***] (a) [***],
(b) [***] and (c) [***].
3.6 Rights to Sublicense
.
3.6.1 Licensee shall have the right to grant
sublicenses of each Exclusive License to any Affiliate or Third
Party with respect to any Licensed Product for which Licensee has
either retained marketing rights or upon which Licensee has
expended material research and/or development effort, it being
understood that any Licensed Product that contains a Designated
Antigen and/or an Antibody to a Designated Antigen developed by
Licensee shall be deemed to have satisfied the foregoing condition
and that Licensee shall have the right to grant sublicenses under
the Exclusive License with respect to such Licensed Product,
subject to the remainder of this Section 3.6.1. Licensee
agrees to contractually obligate any Sublicensee to make all
payments due to SGI pursuant to this Agreement by reason of
achievement of any milestones set forth in Section 6.6 or owed
on Net Sales of any Licensed Products by any such Sublicensee
pursuant to Sections 6.4 and 6.5, as well as to comply with all
terms of this Agreement and the SGI In-Licenses applicable to
Licensee (including all terms of this Agreement identified as
applicable to Sublicensee). Licensee shall also require any such
Sublicensee to agree in writing to keep books and records and
permit SGI to review the information concerning such books and
records in accordance with the terms of this Agreement.
3.6.2 Licensee shall notify SGI of each sublicense
granted to Affiliates or Third Parties and shall provide SGI with
the name and address of each Sublicensee and a description of the
rights granted and the territory covered by each
Sublicensee.
-12-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
3.7 Improvements and New
Technologies .
3.7.1 Improvements
. In the event that,
during the Research Program Term, either Party conceives, develops
or reduces to practice an Improvement, such Party shall promptly
notify the other Party of the discovery of such Improvement. SGI
shall own all Improvements and, to the extent that any Improvements
shall have been conceived, developed or reduced to practice by
Licensee, Licensee hereby assigns all of its right, title and
interest therein to SGI. SGI’s interest in any such
Improvements shall be included in the SGI Technology and made
available to Licensee via the Research License and Exclusive
License provided in Article 3.
3.7.2 [***] .
Subject to the [***], Licensee shall
have the right to practice any [***] pursuant to the Exclusive
Licenses granted under Article 3 as follows: SGI shall [***] of any
[***] by providing to Licensee a written [***] of the [***],
including all [***] under which [***] would be able to access such
[***]. If Licensee is interested in practicing such [***], the
Parties shall discuss in good faith modifications to this Agreement
to reflect the terms governing Licensee’s access to any [***]
pursuant to this Agreement, which shall include without limitation
Licensee’s agreement to [***] attributable to
Licensee’s use of such [***] and; provided that the
[***] shall be deemed to include [***] (as applicable) relating to
or covering such [***] only after the Parties execute an amendment
to this Agreement specifying such modified terms. Except as set
forth in the foregoing sentence and any modifications to this
Agreement including any such modification relating to [***] for
[***], SGI shall be responsible for [***] of all consideration
(including all [***]) [***] under any agreements covering
[***].
3.7.3 [***] . [***] shall
be amended from time to time to [***] Controlled by SGI [***] in
accordance with this Section 3.7.
3.8 Compliance with the SGI
In-Licenses .
3.8.1 Licensee, its Affiliates and Sublicensees shall
comply with all obligations, covenants and conditions of the SGI
In-Licenses listed in Schedule C applicable to Licensee and
its Affiliates and Sublicensees, and any amendments thereto
following written disclosure thereof to Licensee, that apply under
each of the SGI In-Licenses. The Parties agree that BMS is a Third
Party beneficiary of this Agreement solely to the extent SGI
Technology licensed to Licensee hereunder includes technology
sublicensed by SGI under the BMS Agreement.
3.8.2 SGI will not [***] any [***] to an [***] that
[***] or [***] of the [***] hereunder [***].
3.9 License to SGI . Subject to the
provisions of this Agreement, Licensee hereby grants to SGI during
the Research Program Term a non-exclusive, royalty-free,
sublicenseable license under the Licensee Patents and Licensee
Know-How, to enable SGI to perform or have performed its
responsibilities under the Research Program.
ARTICLE 4 - TECHNOLOGY
DISCLOSURE
4.1 Disclosure of Drug Conjugation
Technology . During the Term, SGI shall (a) disclose
to Licensee such SGI Know-How as is reasonably useful to enable
Licensee to use the
-13-
Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
Drug Conjugation Materials and Drug Conjugation
Technology as provided in the Research Plan or to practice the
Research License and Exclusive Licenses, and subject to the
conditions, of this Agreement and (b) upon Licensee’s
reasonable request and with adequate notice to SGI, make available
to Licensee at SGI’s facilities, SGI’s personnel to
provide a reasonable amount of technical assistance and training to
Licensee’s personnel. Licensee shall pay to SGI for such
assistance an amount equal to the FTE Fees in accordance with
Section 6.1.2 for SGI employees providing such
assistance.
ARTICLE 5 - DEVELOPMENT AND
COMMERCIALIZATION; MANUFACTURING
5.1 Diligence . Licensee shall use
commercially reasonable efforts to develop, commercialize and
market Licensed Products, such efforts to be consistent with the
exercise of prudent scientific and business judgment and comparable
to the efforts Licensee applies to its other projects of similar
potential and market size. Without limiting the foregoing, Licensee
shall, as commercially prudent, (a) conduct such preclinical
and clinical trials as are necessary to obtain Regulatory Approvals
for Licensed Products in major markets therefor,
(b) diligently obtain any necessary approvals to market such
Licensed Products in major markets therefor (including, as
relevant, pricing and reimbursement approval), and (c) market
such Licensed Products in each country in which Licensee has
received Regulatory Approval therefor. Licensee shall comply with
all applicable laws, rules and regulations (including Good
Laboratory Practices, and good clinical and manufacturing
practices, to the extent applicable) in the development and
commercialization of such Licensed Products, and shall cause its
Affiliates and Sublicensees to do the same.
5.2 Funding and Progress Reports .
Except as expressly set forth herein, as between SGI and Licensee,
Licensee shall be solely responsible for funding all costs of the
development and commercialization of Licensed Products. Licensee
shall keep SGI informed in a timely manner as to the
progres