Exhibit 10.4
COLLABORATION
AGREEMENT
This Agreement is entered into as of June 14,
2005 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 PSMA DEVELOPMENT COMPANY
LLC , a Delaware limited liability corporation, having its
principal place of business at 777 Old Saw Mill River Road,
Tarrytown, New York 10591 (hereinafter referred to as “
Licensee ”).
WITNESSETH
WHEREAS, SGI Controls (as defined below) intellectual
property rights relating to certain technology useful for linking
certain proprietary [***] to other molecules, such as
antibodies, capable of directing such [***] to specific
tissues and/or cells;
WHEREAS, Licensee Controls intellectual property rights
relating to the Designated Antigen (as defined below), and is
currently conducting research and development relating to
Antibodies (as defined below) that bind to the Designated Antigen
pursuant to a Research Collaboration Agreement dated [***] ,
as amended (the “ Research Collaboration Agreement
”); and
WHEREAS, Licensee wishes to acquire from SGI, and SGI
wishes to grant to Licensee, an exclusive, worldwide license under
SGI patent rights and know-how related to SGI’s proprietary
[***] for use in conjunction with such Antibodies for the
development, commercialization, manufacture, marketing and sale of
Licensed Products (as defined below).
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
[***] 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 “ Adverse Drug Experience ”
shall mean any “adverse experience” as defined or
contemplated by 21 C.F.R. § 312.32 or 21 C.F.R. §
314.80.
1.1.5 “ 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. For purposes of clarification, each
of
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Progenics Pharmaceuticals, Inc.
(“ Progenics ”) and Cytogen Corporation (“
Cytogen ”) shall be deemed an Affiliate of Licensee so
long as their respective [***].
1.1.6 “ Agreement ” means this
agreement, all duly executed amendments and supplements to this
Agreement and all schedules to this Agreement, including the
following:
Schedule A
- Research Plan.
Schedule B
- SGI Patents.
Schedule C
- SGI In-Licenses.
1.1.7 “ Antibody ” or “
Antibodies ” means any molecule that binds
specifically to an Antigen, including, but not limited to,
[*** ].
1.1.8 “ Antigen ” means any
molecule that will induce an [*** ], including but not
limited to a [*** ].
1.1.9 “
[ ***]” means the SGI
Technology licensed to SGI under the BMS Agreement (as defined in
the definition of “ SGI In-Licenses
”).
1.1.10 “ Breaching Party ” has the
meaning set forth in Section 13.3.
1.1.11 “ Calendar Quarter ” means
any of the three-month periods beginning January 1, April 1, July 1
and October 1 in any year.
1.1.12 “ Combination Product ” means
any Licensed Product that contains, in [*** ], and (b)
[*** ].
1.1.13 “Commercially
Reasonable Efforts” means, with respect to a Party, the efforts and
resources typically used by biotechnology companies similar in size
and scope to such Party to perform the obligation at issue; in each
case with respect to a product or potential product of similar
nature at a similar stage in its development or product life and of
similar market potential, in view of conditions prevailing at the
time, and evaluated taking into account all relevant factors,
including without limitation, the mechanism of action, efficacy,
safety, the anticipated regulatory authority approved labeling, the
competitiveness of alternative products that are in the marketplace
or under development, the patent and other proprietary position of
the product, the likelihood of Regulatory Approval, the
profitability of the product and other technical, scientific,
legal, medical, marketing and competitive factors.
1.1.14 “ Confidential Information ”
has the meaning set forth in Section 8.1.
1.1.15
“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
without violating the terms of any agreement or other arrangement
with any Third Party. In the case of an Antigen, such Antigen will
be deemed to be Controlled by Licensee if Licensee Controls
[*** ].
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1.1.16 “Cost of
Goods” shall mean
with respect to Drug Conjugation Materials or ADCs supplied to
Licensee by SGI: (a) for manufacturing activities performed by
Third Parties, SGI’s reasonably documented out-of-pocket
costs actually incurred in such manufacture and supply of Drug
Conjugation Materials or ADCs, as well as SGI’s reasonable
internal costs incurred in supporting the Third Party manufacturing
relationship, including without limitation [*** ]; and (b)
for manufacturing activities performed by SGI or its Affiliates,
the consolidated fully burdened cost of manufacturing such Drug
Conjugation Materials or ADCs, which shall mean costs of the
following as such costs are actually incurred by SGI or its
Affiliates: [*** ], and as determined in accordance with
GAAP as consistently applied by SGI.
1.1.17 “Designated
Antigen” means the
PSMA Antigen having a GenBank Accession No. [***
].
1.1.18 “ Disclosing Party” has the
meaning set forth in Section 8.1.
1.1.19 “ Drug Conjugation Materials
” means the [***] and certain [*** ], as well
as other compounds that are useful in attaching such compounds to
[*** ]. Drug Conjugation Materials shall also include SGI
Inventions to the foregoing, and shall also include any additional
[***] compound or other compounds that are useful in
attaching compounds to Antibodies and that are included in New
Technologies that the Parties agree to include under this Agreement
pursuant to Section 3.3.
1.1.20 “ Effective Date ” means the
date set forth in the first line of this Agreement.
1.1.21 “ Events of Force Majeure ”
has the meaning set forth in Article 15.
1.1.22 “ Exclusive License ” has the
meaning set forth in Section 3.1.
1.1.23 “Exclusive License
Renewal Fee” has
the meaning set forth in Section 6.2.
1.1.24 “Existing Third
Party Royalties ”
has the meaning set forth in Section 6.4.3.
1.1.25 “ Extended Research Program Term
” has the meaning set forth in Section 2.2.
1.1.26 “FD&C
Act” means the
federal Food, Drug & Cosmetic Act, as amended.
1.1.27
“FDA” means
the United States Food and Drug Administration and its
subdivisions, and any successor agency thereto.
1.1.28 “ Field ” means the
[*** ].
1.1.29 “ 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
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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.
1.1.30 “ Former Designated Antigen ”
has the meaning set forth in Section 3.6.
1.1.31
“FTE” means a
full time equivalent person year, based upon a total of [***
].
1.1.32
“GAAP” means
generally accepted accounting principles in the United
States.
1.1.33 “Generic
Version” means,
with respect to a Licensed Product in a [***] and (ii) a
[*** ].
1.1.34 “Good Clinical
Practices” means
the standards, practices and procedures set forth in the guidelines
entitled “Guidance for Industry E6 Good Clinical Practice:
Consolidated Guidance,” including related regulatory
requirements imposed by the FDA, any successor agency and, as
applicable, the equivalent thereof in jurisdictions outside the
United States.
1.1.35 “Good Laboratory
Practices” means
the then-current good laboratory practice standards promulgated or
endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable
regulatory standards in jurisdictions outside the United
States.
1.1.36 “Good Manufacturing
Practices” means
the then-current good manufacturing practices required by the FDA
and set forth in the U.S. Federal Food, Drug, and Cosmetic Act, as
amended, and the regulations promulgated thereunder, for the
manufacturing and testing of pharmaceutical materials, and any
other laws or regulations applicable to the manufacturing and
testing of pharmaceutical materials in jurisdictions outside the
United States.
1.1.37
“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.
1.1.38 “ Indemnitee ” has the
meaning set forth in Section 14.3.1.
1.1.39 “ Indemnitor ” has the
meaning set forth in Section 14.3.1.
1.1.40 “ Initial Research Program Term
” has the meaning set forth in Section 2.2.
1.1.41 “ 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.
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1.1.42 “ Inventions ” means any
patentable or non-patentable inventions, discoveries or other
know-how discovered, created or developed and Controlled by either
Party that arise out of activities conducted under this Agreement
or the Research Collaboration Agreement; provided that
Inventions shall not include any [*** ].
1.1.43 “ Joint Inventions ” has the
meaning set forth in Section 9.1.2(c).
1.1.44 “ Joint Patents ” has the
meaning set forth in Section 9.2.2.
1.1.45 “ Licensed Product ” means
any and all products containing an ADC comprised of an Antibody
that binds to the Designated Antigen.
1.1.46
“Licensee” has the meaning set forth in the first paragraph
of this Agreement. Each reference to “Licensee” shall,
where appropriate, be deemed to include applicable
“Sublicensees”.
1.1.47 “Licensee ADC
Know-How” means all
technical information, processes, formulae, data, inventions,
methods, chemical compounds, biological or physical materials,
know-how and trade secrets Controlled by Licensee, in each case
that are not in the public domain, that are developed by Licensee
using SGI Technology, and that relate to or are useful in
identifying, developing, making, using or selling [***
].
1.1.48 “Licensee ADC
Patents” means all
patent applications and patents that are Controlled by Licensee
that claim inventions made using SGI Technology, which inventions
are for identifying, developing, making, using or selling
[*** ].
1.1.49 “Licensee
Know-How” means all
technical information, processes, formulae, data, inventions,
methods, chemical compounds, biological or physical materials,
know-how and trade secrets Controlled by Licensee, in each case
that are not in the public domain, that relate to or are useful in
(a) [***] or (b) [*** ].
1.1.50 “Licensee
Indemnified Parties” has the meaning set forth in Section
14.2.
1.1.51 “Licensee Invention
Patents” has the
meaning set forth in Section 9.3.3.
1.1.52 “Licensee
Inventions ” has
the meaning set forth in Section 9.1.2(a).
1.1.53 “Licensee
Patents” means all
patent applications and patents that are Controlled by Licensee
that claim (a) [*** ], or (b) [*** ].
1.1.54 “ Losses ” has the meaning
set forth in Section 14.1.
1.1.55 “ 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,
[***] with respect to sales of Licensed Products:
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All of the foregoing [***]
shall be determined in accordance with GAAP. In the event that
Licensee, its Affiliates or Sublicensees make any adjustments to
such [***] 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 [***] during the applicable royalty
reporting period, by the [***] in each case during the
applicable royalty reporting period or, if sales of the Licensed
Product [***] did not occur in such period or country, then
in the most recent royalty reporting period in which [***]
Licensed Product occurred in such country or if no such sales have
occurred in such country, the [***] during the applicable
royalty period. In the event that such [*** ].
1.1.56 “ New Technologies ” means
any [***] (i) that are [***] Controlled by SGI, or
(ii) that are first developed by SGI after the Effective Date and
that are [*** ], including but not limited to the chemical
compositions and the methods useful for [***] .
1.1.57 “ Notice of Dispute ” has the
meaning set forth in Section 19.3.1.
1.1.58 “ Parties ” means Licensee
and SGI, and “Party” means either of them.
1.1.59 “ Person ” means a natural
person, a partnership, a corporation, an association, a joint stock
company, a limited liability company, a trust, a joint venture or
an unincorporated organization.
1.1.60 “ Personnel Fees ” has the
meaning set forth in Section 6.1.2.
1.1.61 “ Phase I Clinical Trial ”
means a human clinical trial, the principal purpose of which is a
preliminary determination of safety in healthy individuals or
patients.
1.1.62 “ 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.
1.1.63 “ 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.
1.1.64 “ Publication ” has the
meaning set forth in Section 8.5.
1.1.65 “ Receiving Party ” has the
meaning set forth in Section 8.1.
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1.1.66 “ 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.
1.1.67 “[ ***] ” has the meaning set
forth in Section 3.6.
1.1.68 “ Replacement Antigen Fee ”
has the meaning set forth in Section 3.6.
1.1.69 “ Reports ” has the meaning
set forth in Section 7.1.1.
1.1.70 “ Research Fees ” has the
meaning set forth in Section 6.1.2.
1.1.71 “ Research Fees Report ” has
the meaning set forth in Section 6.1.2.
1.1.72 “ Research Plan ” means the
plan for the Research Program agreed upon by the Parties and
attached hereto as Schedule A .
1.1.73 “ Research Program ” means
the research program conducted pursuant to Article 2.
1.1.74 “ Research Program Term ”
means the term of the Research Program set forth in Section
2.2.
1.1.75 “ Royalty Term ” means, on a
Licensed Product-by-Licensed Product and country-by-country basis,
the later to occur of: (a) the 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.
1.1.76 “ Serious Adverse Drug Experience
” shall mean any Adverse Drug Experience that is fatal or
life-threatening, is permanently disabling, requires in-patient
hospitalization or prolongation of existing hospitalization,
results in a persistent or significant disability or incapacity, or
is a congenital anomaly, or overdose, or other event which would
constitute a “serious” adverse experience pursuant to
the terms of 21 C.F.R. § 312.32 or 21 C.F.R.
§314.80.
1.1.77 “ SGI Indemnified Parties”
has the meaning set forth in Section 14.1.
1.1.78 “SGI
In-Licenses ” means
the following agreements between SGI and the indicated Third
Parties: (a) [*** ].
1.1.79 “SGI
Inventions” has the
meaning set forth in Section 9.1.2(b).
1.1.80 “ SGI Know-How ” means all
technical information, processes, formulae, data, inventions,
methods, chemical compounds, biological or physical materials,
know-how and
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trade secrets Controlled by SGI, in
each case that are not in the public domain, that relate to or are
useful in the discovery, research, development, manufacture or use
of Drug Conjugation Materials or ADCs for purposes of the offer and
sale of Licensed Products in the Field, including but not limited
to the chemical compositions and the methods useful for attaching
the Drug Conjugation Materials to Antibodies. SGI Know-How shall
exclude any [*** ].
1.1.81 “SGI
Patents” means:
(a) any patents and patent
applications listed in Schedule B to this Agreement (each,
an “ Existing SGI Patent ”), which shall be
amended from time to time to add any other patents and patent
applications which shall be included as SGI Patents;
(b) any patents and patent
applications covering SGI Know-How or SGI Inventions and, solely to
the extent the parties so agree pursuant to [*** ], and
Schedule B to this Agreement shall be amended from time to
time to add patents or patent applications that arise from any of
the foregoing;
(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), divisional or provisional of any of the
foregoing patent applications or any patent applications from which
the foregoing patents issued; and
(d) any reissues, reexaminations,
confirmations, renewals, registrations, substitutions, extensions,
or counterparts of any of the foregoing.
1.1.82 “ SGI Technology ” means the
SGI Patents, the Drug Conjugation Materials, the SGI Know-How,
SGI’s rights in the Joint Inventions and the SGI Inventions.
For purposes of clarification, SGI Technology shall include,
without limitation, the technology comprising [***] in each
case as set forth on Schedule B , or as may otherwise be
identified as an SGI In-License pursuant to Section
1.1.78.
1.1.83 “ 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.
1.1.84 “Supply
Fees” has the
meaning set forth in Section 5.3.
1.1.85 “ Term ” has the meaning set
forth in Article 13.
1.1.86 “ Territory ” means all
countries in the world.
1.1.87 “ Third Party ” means any
person or entity other than Licensee, SGI and their respective
Affiliates.
1.1.88 “Third Party
Claim” has the
meaning set forth in Section 14.1.
1.1.89 “Valid Patent
Claim” means a
claim (a) of any issued and unexpired SGI Patent (as applicable)
which has not been revoked or held unenforceable or invalid by a
decision
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of a court or governmental agency of
competent jurisdiction from which no appeal can be taken, or with
respect to which an appeal is not taken within the time allowed for
appeal, and which has not been disclaimed, denied or admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise,
or (b) of any patent application contained in the SGI Patents (as
applicable) which shall not have been pending on or after the
[***] of the date of issuance of a first patent office
communication during examination of the first application related
thereto (in the relevant country), and shall not have been earlier
cancelled, withdrawn or abandoned, and, on a country-by-country
basis, which is enforceable on the operative date of inquiry by
virtue of applicable law in such country.
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. 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. SGI’s research activities
hereunder which are designated by Licensee to be used in support of
regulatory filings will be performed in a good scientific manner,
consistent with Good
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Laboratory Practices. SGI shall deliver to
Licensee a report summarizing the results of such research
activities within [***] of the end of any calendar quarter
in which such research activities were conducted.
2.2 Term of the Research
Program . The initial
term of the Research Program shall be for a period of [***]
after the Effective Date (the “ Initial Research Program
Term ”), [***] ; provided, however, that, upon
notice and payment to SGI of [*** ], Licensee may renew
(prior to the end of Initial Research Program Term) the Research
Program for an [ ***] (the “ Extended Research
Program Term ”, and together with the Initial Research
Program Term, the “ Research Program Term
”).
2.3 SGI Preparation of
ADCs . SGI will
prepare, in accordance with the procedures set forth in the
Research Plan, such research quantities of ADCs as may be
reasonably requested by Licensee using Antibodies supplied by
Licensee to SGI and Drug Conjugation Materials manufactured by SGI,
or by or on behalf of Licensee, and shall deliver the resulting
ADCs to Licensee in accordance with the reasonable timelines
requested by Licensee (or as otherwise set forth in the Research
Plan). SGI will also provide Licensee, in accordance with Article 4
and the Research Plan, with [*** ]. All such Drug
Conjugation Materials provided by SGI to Licensee hereunder will be
deemed Confidential Information of SGI pursuant to Article
8.
2.4 Payment .
Licensee shall pay SGI the amounts
set forth in Section 6.1.2 for any research efforts or other
assistance provided by SGI pursuant to Section 2.3.
2.5 Disclaimer
. EXCEPT AS MAY BE
OTHERWISE PROVIDED IN ARTICLE 12, NEITHER PARTY MAKES ANY
REPRESENTATION OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER
IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, REGARDING
THE DRUG CONJUGATION MATERIALS, ANTIBODIES, ANTIGENS, ADCs OR
LICENSED PRODUCTS, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR USE
OR PURPOSE.
ARTICLE 3
EXCLUSIVE LICENSE
3.1 Exclusive License
Grant . 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 be automatically
deemed to grant to Licensee a worldwide, exclusive (even as to
SGI), royalty-bearing license under the SGI Technology, with the
right to sublicense as permitted in Section 3.2, to discover,
research, develop, make, have made, import, have imported and use,
Licensed Products in the Field and Drug Conjugation Materials for
the offer and sale of Licensed Products in the Field in the
Territory (the “ Exclusive License ”). The
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 Renewal
Fees set forth in Section 6.2.
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3.2 Rights to Sublicense
.
3.2.1 Licensee shall have the right to grant
sublicenses of the rights granted to Licensee pursuant to this
Agreement to any Affiliate or any Third Party, subject to the
restrictions contained in this Section 3.2 and the requirements of
Section 3.4. Licensee shall not have the right to sublicense the
SGI Technology outside the scope of the license granted in Section
3.1, including to develop further Drug Conjugation Materials on a
stand alone basis or to create ADCs that include or are based upon
any Antibodies that do not bind to the Designated Antigen or
Replacement Antigen, if any.
3.2.2 Licensee agrees that it shall have
responsibility to make payments to SGI for the achievement of any
milestones set forth in Section 6.5 by its Sublicensee(s), and to
pay royalties on Net Sales of any Licensed Products by any such
Sublicensee(s) pursuant to Section 6.3 (subject to reduction in
accordance with Section 6.4). In addition, Licensee shall be
responsible for the compliance by its Sublicensee(s) with all terms
of this Agreement applicable to Licensee (including all terms of
this Agreement identified as applicable to such Sublicensee(s)).
Licensee shall also require any such Sublicensee(s) to agree in
writing to keep books and records and permit SGI to review the
information concerning such books and records in accordance with
Section 7.2.
3.2.3 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.
3.3 [ *** ] . The
Exclusive License shall extend to [***] as follows: SGI
shall promptly notify Licensee of any [*** ] to which it
obtains rights (with the right to grant sublicenses thereunder)
during the Term by providing to Licensee a [ *** ],
including all [***] under which Licensee 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 [ ***] ; provided, however, that in no event
shall the costs to Licensee associated with Licensee’s use of
such [***] exceed the amount of any [***
].
3.4 Compliance with the SGI
In-Licenses .
3.4.1 Licensee, its Affiliates and Sublicensees shall
comply with all obligations, covenants and conditions of the SGI
In-Licenses listed in Schedule C (unless such obligations,
conditions or covenants have been redacted by SGI in the version of
SGI In-License delivered to Licensee), and any amendments thereto
following written disclosure thereof to Licensee, to the extent (i)
expressly applicable to sublicensees under such SGI In-Licenses,
and (ii) technology included within such SGI In-License is being
utilized in the Research Program or is incorporated into a Licensed
Product. Licensee shall be entitled to all rights expressly
provided sublicensees under the terms of the SGI In-Licenses,
including but not limited to the rights provided under [***
]. The Parties agree that BMS is a Third Party beneficiary to this
Agreement to the extent SGI Technology includes BMS Technology. SGI
shall use best efforts to include in each SGI In-License executed
after the Effective Date a provision requiring the licensor of such
rights to treat Licensee as a direct licensee under the terms of
such SGI In-License in the event that such SGI In-License is
terminated; provided that Licensee is then in compliance with the
terms of such SGI In-License.
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3.4.2 SGI shall perform all obligations required to be
performed by it under each SGI In-License in accordance with the
terms and conditions of each such SGI In-License, and SGI will use
its Commercially Reasonable Efforts to maintain each SGI In-License
in full force and effect. SGI will not [*** ]. In the event
that SGI receives notice of a material breach of any SGI
In-License, SGI shall immediately inform Licensee of receipt of
such notice.
3.4.3 SGI will not [***] any [***] to an
[***] that [*** ].
3.5 Limited 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,
non-sublicenseable (except to the extent that the Research Plan
provides for the use of a Third Party subcontractor by SGI) license
under the Licensee Patents and Licensee Know-How in the Territory,
for the sole purpose of enabling SGI to perform its obligations
under Article 2 and the Research Plan.
3.6 [*** ]. At any time during the [*** ],
Licensee shall have the right to [***] subject to and in
accordance with the procedures described below and upon payment of
[***]. Once the Designated Antigen [***], such Designated Antigen
shall be considered the “ Former Designated Antigen
” and (a) [***] and (b) [***] provided,
however, that the terms of this Section 3.6 shall not be deemed to
grant to SGI any rights in the Licensee Patents, Licensee Know-How,
Licensee Inventions, Licensee Invention Patents, or Joint
Inventions, beyond the [***]. For the avoidance of doubt,
the grant of this license is not [*** ]. Thereafter, the
[***] shall be considered the Designated Antigen for purposes of
this Agreement (except, for the limited purpose of the license
provided in [*** ]) to the extent the Designated Antigen is
considered the Former Designated Antigen and this Agreement shall
be appropriately amended or modified to establish the [***] as the
Designated Antigen. The [***], will have no effect on the
intellectual property ownership rights of the parties relating to
such Designated Antigen as such rights existed on the date of the
replacement. In addition, upon designation of the [***].
3.7 Availability
of [
***] . To
determine if an Antigen is available to become the [ *** ],
Licensee shall provide SGI with a [*** ], including to the
extent available, the [*** ], which Licensee desires to [
***] for purposes of this Agreement. Within [*** ],
SGI shall notify Licensee in writing whether the Exclusive License
is available with respect to such Antigen. If the Exclusive License
is available for such Antigen, such Antigen shall [*** ].
The Parties hereby acknowledge and agree that an Antigen
[***] (a) [***] or (b) [*** ].
ARTICLE 4
TECHNOLOGY
DISCLOSURE
As soon as reasonably practicable following the
Effective Date, and from time to time during the Term upon the
reasonable request of Licensee, SGI shall deliver to Licensee, in
such form as may reasonably be requested by Licensee from time to
time, the SGI Know-How as is necessary or reasonably useful to
enable Licensee to manufacture or have manufactured and use the
Drug Conjugation Materials and the ADCs as provided in this
Agreement, including, without limitation, available written or
electronic information relating to the [*** ]. During the
Term, upon Licensee’s reasonable request, SGI will provide
Licensee, or such Affiliate of Licensee as
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may be designated by Licensee, with assistance
and training regarding the manufacture and/or use of Drug
Conjugation Materials and ADCs; provided that if in-person
assistance is required, such assistance shall take place upon at
least [***] prior written notice to SGI at SGI’s
facilities, unless otherwise mutually agreed upon. Licensee shall
pay to SGI for such assistance an amount equal to the Personnel
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. Notwithstanding the foregoing, Licensee shall have
[*** ].
5.2 Funding and Progress
Reports . Except as
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. Beginning on [***] ,
and annually thereafter within [ ***] following the
[*** ], Licensee shall provide SGI with a written report
summarizing Licensee’s significant activities related to
research and development of Licensed Products and status of
clinical trials and applications for Regulatory Approval necessary
for marketing Licensed Products. Such reports shall be deemed
Licensee’s Confidential Information for the purposes of
Article 8.
5.3 Manufacturing
.
5.3.1 Except as otherwise set forth in this Agreement,
Licensee shall be responsible for all manufacturing and supply of
Licensed Products. Licensee shall pay SGI for all Drug Conjugation
Materials and/or ADCs supplied by SGI to Licensee under Section 2.3
at the [***] (the “ Supply Fees
”).
5.3.2 SGI shall, upon request by Licensee (i)
[***] , and (ii) provide Licensee, or Third Parties
manufacturing Drug Conjugation Materials on behalf of Licensee,
such assistance related to the manufacture of Drug Conjugation
Materials as may reasonably be requested by Licensee pursuant to
the terms of Article 4 and the Research Plan. Notwithstanding the
foregoing, SGI shall [*** ].
5.3.3 SGI shall, upon reasonable request by Licensee,
[*** ].
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ARTICLE 6
FEES, ROYALTIES AND
PAYMENTS
6.1 Research Fees
. Licensee shall pay to
SGI the following amounts in consideration of the Research
Program:
6.1.1 Within ten (10) days of the Effective Date,
Licensee shall pay to SGI the sum of Two Million U.S. Dollars
($2,000,000) by wire transfer of immediately available funds (the
“ ADC Access Fee ”).
6.1.2 Licensee shall pay SGI at a rate of [***]
per FTE for the performance by such FTEs as requested by Licensee
pursuant to Sections 2.4, 5.3.2 and 5.3.3 and Articles 2, 4 and 11
of this Agreement (the “ Personnel Fees ”).
Commencing upon the [***] of the Effective Date and upon
every [***] thereafter, the Personnel Fees will increase by
[***] per FTE per year. The Personnel Fees and the Supply
Fees are collectively referred to herein as the “ Research
Fees ”. For purposes of clarification, costs for labor
that are appropriately includable within the calculation of
Personnel Fees shall not be included in the calculation of Supply
Fees. Within [ ***] days after the end of each [***
], SGI shall submit a report to Licensee supporting the calculation
of the Research Fees due for such [***] (a “
Research Fees Report ”). Licensee shall pay all
Research Fees to SGI within [***] of receipt of each
Research Fees Report.
6.1.3 SGI shall be obligated to maintain all books and
records relating to Research Fees billed to Licensee during the
Term. Licensee shall have the right to engage an independent
certified public accounting firm of internationally recognized
standing, selected by Licensee and reasonably acceptable to SGI, to
audit the books and records of SGI related to the Research Fees to
verify the accuracy of the Research Fees Reports upon at least
[***] prior notice and [*** ]. Such accountants may
audit the books and records relating to the Research Fees Reports
for any year [ ***] of such request. The accounting firm
shall disclose to Licensee only whether such Research Fees Reports
were correct or not, and the specific details concerning any
discrepancies. No other information obtained by such accountants
shall be shared with Licensee. If such accounting firm concludes
that there was an overpayment of the Research Fees during any time
period that is subject to the audit, SGI shall refund such
overpayment within [***] of the date Licensee delivers to
SGI such accounting firm’s written report so correctly
concluding. The fees charged by such accounting firm shall be paid
by [***] ; provided , however , if the audit
discloses that the Research Fees charged for the audited period are
more than [***] of the Research Fees actually due for such
period, then [***] shall pay the reasonable fees and
expenses charged by such accounting firm. If such accounting firm
concludes that the Research Fees paid were less than what was owed
during such period, Licensee shall pay the amount of any
underpayment within [***] of the date Licensee receives such
accounting firm’s written report so concluding.
6.2 License Maintenance
Fees . Licensee shall
be [***] to SGI in the sum of [***] by wire transfer
of immediately available funds (the “ Exclusive License
Renewal Fee ”) on [*** ]. Notwithstanding the
foregoing, the Exclusive License Renewal Fee [***
].
6.3 Royalties Payable by
Licensee . In
consideration for the Exclusive License granted to Licensee herein,
during the Royalty Term, and subject to Section 6.4, Licensee shall
pay to SGI royalties on Net Sales of Licensed Products. Such
royalties shall be paid at the following rates, determined on a
Licensed Product-by-Licensed Product basis as set forth
below:
6.3.1 [***]
of the first [***] in
aggregate [***] of the [***] in [***
];
6.3.2 [***]
of the portion of aggregate
[***] of the [***] between [*** ];
and
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6.3.3 [**
