Exhibit 10.2
Confidential treatment has been
requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request.
Omissions are designated as [***]. A complete version of this
exhibit has been filed separately with the Securities and Exchange
Commission.
COLLABORATION
AGREEMENT
This Agreement is entered into as of
July 2, 2008 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
DAIICHI SANKYO CO.,
LTD. , a corporation
organized under the laws of Japan, having its place of business at
1-2-58, Hiromachi, Shinagawa-ku,
Tokyo, Japan, 140-8710
(hereinafter referred to as “
Licensee ”).
WITNESSETH
WHEREAS, SGI owns or Controls (as defined below)
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 owns or Controls (as defined below)
intellectual property rights relating to antibodies to the
Designated Antigen (as defined below), and is currently conducting
research and development programs to incorporate such antibodies
into pharmaceutical compounds that may have activity in certain
disease-related pathways, and to develop antibodies that bind to
the Designated Antigen;
WHEREAS, Licensee wishes to acquire from SGI an exclusive
worldwide license under SGI patent rights and know-how related to
SGI’s proprietary cytotoxin and linker technology for use in
conjunction with Licensee’s development, commercialization,
manufacture, marketing and sale of Licensee’s antibodies that
bind to the Designated Antigen; and
WHEREAS, SGI wishes to grant to Licensee an exclusive
worldwide license to SGI’s cytotoxin and linker technology
for use in conjunction with Licensee’s 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 that
is linked to a cytotoxin or cytostatic compound and that contains,
uses or is made using Drug Conjugation Technology.
1.1.3 “ ADC Access Fee ” has the
meaning set forth in Section 6.1.1.
1.1.4 “ADC
Data” has the
meaning set forth in Section 2.6.
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.
1.1.6 “ Agreement ” means this
agreement, all 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 antibody, or fragment thereof,
that has a unique amino acid sequence and that selectively binds to
the Designated Antigen.
1.1.8 “ Breaching Party ” has the
meaning set forth in Section 13.3.
1.1.9 “Calendar
Quarter” means any
of the three-month periods beginning on January 1,
April 1, July 1 or October 1 of any year.
1.1.10 “Change in Control” has the
meaning set forth in Article 16.
1.1.11
“Claims” has
the meaning set forth in Section 14.1.1.
1.1.12 “Confidential
Information” has
the meaning set forth in Section 8.1.
1.1.13
“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.
1.1.14 “Cost of
Goods” shall mean
with respect to Drug Conjugation Materials supplied to Licensee
(a) [***]; and (b) [***].
1.1.15 “Designated
Antigen” means the
human DR5 antigen, encoded by the gene designated Gene ID: [***],
[***] of the [***], and naturally occurring post-translational
modifications thereof.
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-2-
1.1.16 “ Drug Conjugation Materials
” means (a) the compounds [***] and [***] and [***]
thereof, (b) compounds that are useful in attaching such
compounds to [***] and (c) any related raw materials and
reagents SGI provides to Licensee pursuant to the Research Program,
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 [***]
compounds that are included in New Technologies and that the
Parties agree to include under this Agreement pursuant to
Section 3.3.2.
1.1.17 “ Drug Conjugation Technology
” means (a) [***] compounds such as [***] and [***] and
certain [***] and [***] thereof, and methods of making and using
such [***] compounds (b) compositions and methods useful for
attaching the foregoing [***] compounds to [***] and (c) any
related assays and methods SGI provides to Licensee pursuant to the
Research Program.
1.1.18 “ Effective Date ” means the
date set forth in the first line of this Agreement.
1.1.19 “ Events of Force Majeure ”
has the meaning set forth in Article 15.
1.1.20 “ Exclusive License ” has the
meaning set forth in Section 3.1.
1.1.21 “Exclusive License Renewal
Fee” has the meaning set forth in
Section 6.2.
1.1.22 “ Existing Third Party Royalties
” has the meaning set forth in Section 6.4.1.
1.1.23 “FD&C
Act” means the
federal Food, Drug & Cosmetic Act, as amended.
1.1.24
“FDA” means
the United States Food and Drug Administration, and any successor
agency thereto.
1.1.25 “ Field ” means monoclonal
antibody targeting applications for the treatment and diagnosis of
conditions and diseases in humans and animals.
1.1.26 “ 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.
1.1.27
“Fiscal Year” means any twelve-month period
beginning on April 1st and ending on March 31
st
of succeeding
year.
1.1.28 “ FTE Fees ” has the meaning
set forth in Section 6.1.2.
1.1.29
“GAAP” means
generally accepted accounting principles in the United
States.
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-3-
1.1.30 “Generic
Product” means, on
a country-by-country basis, an ADC using or incorporating SGI
Technology that binds selectively to the Designated Antigen:
(i) the manufacture, use or sale of which [***] in such
country (provided that an enforcement action is not currently
proceeding pursuant to Section 9.3 based on such ADC); and
(ii) [***].
1.1.31 “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.
1.1.32 “ Improvements ” means all
patentable or non-patentable inventions, discoveries or other
know-how developed and Controlled by either Party after the
Effective Date that utilize, incorporate, derive directly from,
directly relate to, are made using or are based directly on the SGI
Technology; provided that Improvements shall not include any
of the foregoing developed by SGI that, within a reasonable time
period after such inventions, discoveries or know-how are made or
identified, [***].
1.1.33 “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.
1.1.34 “ Indemnitee ” has the
meaning set forth in Section 14.2.
1.1.35 “ Indemnitor ” has the
meaning set forth in Section 14.2.
1.1.36 “ 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.
1.1.37 “ Joint Patents ” has the
meaning set forth in Section 9.2.2.
1.1.38 “ Liabilities ” has the
meaning set forth in Section 14.1.1.
1.1.39 “ Licensed Product ” means
any and all products utilizing or incorporating an ADC:
(a) the manufacture, use, sale, offer for sale, export or
import of which [***]; or (b) [***].
1.1.40 “Licensee ADC
Know-How” means all
technical information, processes, formulae, data, inventions,
methods, chemical compounds, biological or physical materials,
know-how and trade secrets, other than Improvements, that are
Controlled by Licensee, in each case that are not in the public
domain and are developed by Licensee using SGI Technology that are
necessary for identifying, developing, making, using or selling
ADCs.
1.1.41 “Licensee ADC
Patents” means all
patent applications and patents that are Controlled by Licensee
claiming inventions (other than Improvements) that are necessary
for identifying, developing, making, using or selling ADCs made
using SGI Technology.
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-4-
1.1.42 “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, that relate to (a) [***], or (b) [***].
1.1.43 “Licensee
Patents” means all
patent applications and patents Controlled by Licensee that claim
(a) [***], or (b) [***].
1.1.44 “ 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) [***];
(c) [***]; and
(d) [***].
All of the foregoing deductions 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 to [***] 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.
1.1.45 “[***]” means any [***] that either:
(a) [***] or (b) [***] (x) [***] existing as of the
Effective Date, or (y) [***]. [***] shall include without
limitation [***] compounds, other than those included in the Drug
Conjugation Materials as of the Effective Date, that SGI Controls
during the Research Program Term.
1.1.46 “ Notice of Dispute ” has the
meaning set forth in Section 19.3.1.
1.1.47 “ Parties ” means SGI and
Licensee, and “Party” means either of them.
1.1.48 “ 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.
1.1.49 “ 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.
1.1.50 “ 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.
1.1.51 “ Program Inventions ” has
the meaning set forth in Section 9.1.1.
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-5-
1.1.52 “Program Licensee
Patents” has the
meaning set forth in Section 9.3.3.
1.1.53 “ Publication ” has the
meaning set forth in Section 8.5.
1.1.54 “ 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.
1.1.55 “ Reports ” has the meaning
set forth in Section 7.1.1.
1.1.56 “ Research Fees ” has the
meaning set forth in Section 6.1.2.
1.1.57 “ Research Fees Report ” has
the meaning set forth in Section 6.1.2.
1.1.58 “ Research Plan ” means the
plan for the Research Program agreed upon by the Parties and
attached hereto as Schedule A .
1.1.59 “ Research Program ” means
the research program conducted pursuant to Article 2 and the
Research Plan.
1.1.60 “ Research Program Term ”
means the term of the Research Program set forth in
Section 2.2.
1.1.61 “ Royalty Term ” means, on a
Licensed Product-by-Licensed Product and country-by-country basis,
until the later to occur of: (a) [***]; or
(b) [***].
1.1.62 “ SGI In-Licenses ” means the
following agreements between SGI and the indicated Third Parties:
(a) the License Agreement between [***] (“[***]”)
and SGI dated [***], as amended (the “[***]”);
(b) the License Agreement between [***] (“[***]”)
and SGI dated [***], as amended (the “[***]”); and
(c) any other license agreement between SGI and a Third Party
covering [***] under which Licensee is granted a sublicense under
this Agreement as provided in Section 3.3.2.
1.1.63 “ 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 Research Program Term, Controlled by SGI. SGI Know-How
shall include Improvements Controlled by SGI but shall exclude New
Technologies unless included pursuant to
Section 3.3.2.
1.1.64 “SGI Patents”
means:
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-6-
(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
pursuant to Section 3.3.2, New Technologies, 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.
For clarification, SGI’s
interest in any Joint Patents shall not be considered SGI
Patents.
1.1.65 “ SGI Technology ” means the
SGI Patents and the SGI Know-How.
1.1.66 “ Sublicensee ” 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.
1.1.67 “Supply
Fees” has the
meaning set forth in Section 6.1.2.
1.1.68 “ Term ” has the meaning set
forth in Article 13.
1.1.69 “ Territory ” means all
countries in the world.
1.1.70 “ Third Party ” means any
person or entity other than Licensee, SGI and their respective
Affiliates.
1.1.71 “ Valid Patent Claim ” means
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.
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;
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-7-
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 research,
development and commercialization under this Agreement. Licensee
acknowledges that, in addition to the licenses to the SGI Patents
granted hereunder, the SGI Know-How transferred to Licensee during
the Research Program 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 two
(2) years after the Effective Date (the “ Research
Program Term ”), unless terminated earlier in accordance
with Article 13. Licensee shall have a one-time right to extend the
Research Program Term for an additional year by providing written
notice to SGI not less than [***] prior to the expiration of the
initial Research Program Term. SGI shall submit, within [***] from
the expiration of the Research Program Term (in the case that the
Research Program Term is extended by Licensee as set forth above,
within [***] from the expiration of such extended term), a written
report to Licensee which describes the research activities
conducted by SGI during such Research Program Term.
2.3 Delivery of Drug
Conjugation Materials . In support of the Research Program, during the
Research Program Term, SGI will (a) deliver Drug Conjugation
Materials to Licensee in accordance with the Research Plan; and
(b) at Licensee’s request, provide Licensee with the
[***] provided to the Licensee to enable [***]. All Drug
Conjugation Materials and other information provided by SGI to
Licensee hereunder will be deemed Confidential Information of SGI
pursuant to Article 8.
2.4 SGI Preparation of ADCs . SGI will
use reasonable commercial efforts to prepare ADCs using Antibodies
supplied by Licensee to SGI which shall meet and satisfy
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-8-
specifications mutually agreed upon by SGI and
Licensee, and shall deliver the resulting ADCs to Licensee in
accordance with the Research Plan.
2.5 Payment .
Licensee shall pay SGI the amounts
set forth in Section 6.1.2 for any research efforts or other
assistance provided by SGI.
2.6 Ownership of Data. Licensee shall
own all right, title and interest in and to the data, research and
results related specifically to ADCs arising out of activities
conducted pursuant to the Research Program (“ ADC Data
”). SGI shall disclose to Licensee any ADC Data that are
developed, conceived, or otherwise made, solely or jointly, by or
on behalf of SGI in the course of, as a result of, or in connection
with the Research Program, promptly after the same is developed,
conceived or otherwise made. SGI hereby assigns to Licensee any and
all right, title, and interest SGI may have in, to and under ADC
Data; provided, that SGI may retain copies of, and use, all ADC
Data for any purpose related to this Agreement, including but not
limited to, patent prosecution and defense pursuant to
[***].
2.7 Disclaimer
. EXCEPT AS MAY BE
OTHERWISE EXPRESSLY PROVIDED IN ARTICLE 12 OR THE RESEARCH PLAN,
SGI MAKES NO REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
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.
ARTICLE 3 - EXCLUSIVE
LICENSE
3.1 Exclusive License Grant
.
3.1.1 Upon execution of this Agreement, subject to the
terms and conditions of this Agreement, including payment of the
ADC Access Fee set forth in Section 6.1.1, 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, export, use,
offer for sale, and sell Licensed Products that bind selectively to
the Designated Antigen within 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 Licensee’s compliance with
the terms and conditions of this Agreement, including payment of
all applicable fees, milestones and royalties hereunder.
3.1.2 During the Term, SGI shall not carry out, by
itself or in collaboration with any third parties, to discover,
research, develop, make, have made, import, export, use, offer for
sale, and sell any antibody-drug conjugate products that bind
selectively to the Designated Antigen within the Field in the
Territory.
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 terms
and
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-9-
conditions of the SGI In-Licenses
listed on Schedule C . 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 Technology on a stand-alone basis or to create
antibody-drug conjugates that include or are based upon any
antibodies that bind selectively to an antigen other than the
Designated Antigen.
3.2.2 Licensee agrees to contractually obligate any
Sublicensee to make all payments due to SGI pursuant to this
Agreement by reason of achievement of any fees, milestones and
royalties set forth herein, as well as to comply with all terms of
this Agreement 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.
3.2.3 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 Improvements and New
Technologies .
3.3.1 Improvements . In the event that,
during the Term, Licensee conceives, develops or reduces to
practice an Improvement that relates to the Drug Conjugation
Technology, Licensee shall promptly notify SGI of the discovery of
such Improvement. SGI shall own all such Improvements that relate
to the Drug Conjugation Technology and, to the extent that such
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 that it Controls shall be included in the SGI
Technology and made available to Licensee via the Exclusive License
provided in Article 3. Licensee may use such Improvement
assigned to SGI by Licensee for any purpose within the scope of the
Exclusive License granted herein solely during the Term of this
Agreement.
3.3.2 [***] . Subject to the bona fide rights of Third Parties
that may exist, Licensee shall have the right to practice any New
Technologies in the Research Program pursuant to the Exclusive
License granted under Article 3 as follows: SGI shall [***] of any
[***] to which it obtains rights (with the right to grant
sublicenses thereunder) during the Research Program Term by
providing to Licensee a [***] of the [***], 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 that the [***]
shall be deemed to include [***] and [***] (as applicable) relating
to or covering such [***] only after the Parties execute an
amendment to this Agreement specifying such modified
terms.
3.3.3 Amendment of Schedule
B . Schedule B
shall be amended from time to time to add the patents and patent
applications Controlled by SGI covering New Technologies or
Improvements in accordance with this Section 3.3.
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-10-
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 , 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 to this Agreement to the extent SGI
Technology includes technology sublicensed under the BMS
Agreement.
3.4.2 SGI will not enter into any amendment to an SGI
In-License that imposes additional monetary obligations on Licensee
or materially reduces the scope of the licenses granted to Licensee
hereunder without the prior written consent of Licensee.
3.5 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 in the Territory, to enable SGI to conduct the Research
Program.
ARTICLE 4 - TECHNOLOGY
DISCLOSURE
4.1 Disclosure of Drug Conjugation
Technology . During the Research Program Term, SGI shall
(a) disclose to Licensee such SGI Know-How as is reasonably
useful to enable Licensee to use the Drug Conjugation Materials and
Drug Conjugation Technology as provided in the Research Plan or to
practice the Exclusive License on the terms, 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 research, 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) [***],
(b) [***], and (c) [***].
5.2 Joint Research
Meetings . During the
Research Program Term, SGI and Licensee shall hold joint meetings,
from time to time, in accordance with the Research Plan, to discuss
and consult on research and development activities of the Research
Program, by video conference, teleconference or face to face, as
mutually agreed between the Parties.
5.3 Funding and Progress Reports .
Except as set forth herein, as between SGI and Licensee, [***].
Licensee shall keep SGI informed in a timely manner as to the
progress of the development of Licensed Products. Beginning on
[***], and [***] thereafter within [***] following the end of each
[***], 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
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-11-
Licensed Products. Such reports shall be deemed
Licensee’s Confidential Information for the purposes of
Article 8.
5.4 Manufacturing
. Except as otherwise
expressly set forth in this Agreement, Licensee shall be
responsible for all manufacturing and supply of Licensed Products.
Notwithstanding the foregoing, at any time during the Term of this
Agreement [***]. Licensee shall [***]. In the event SGI [***], the
Parties shall [***], including [***].
ARTICLE 6 - FEES, MILESTONES
AND ROYALTIES .
6.1 Research Fees . Licensee shall pay
to SGI the following amounts in consideration of the Research
Program:
6.1.1 Within [***] of the Effective Date, Licensee
shall pay to SGI the sum of Four Million U.S. Dollars ($4,000,000)
by wire transfer of immediately available funds (the “ ADC
Access Fee ”).
6.1.2 Licensee shall pay SGI at an annual rate of
[***] per FTE who performs research, development, consultation or
support work as requested by Licensee pursuant to this Agreement
(the “ FTE Fees ”). Commencing upon the [***] of
the Effective Date and upon [***] thereafter, the FTE Fees will
[***] in accordance with the [***]. The Parties agree that the
total FTE Fees for the first [***] of the Research Program Term
shall not exceed an amount [***] without the written consent of
Licensee; provided, however, that SGI shall not be required to
provide any services requested by Licensee under this Agreement if
such services would exceed the limit set forth above unless
Licensee provides its written consent and agrees to reimburse SGI
for such excess FTE Fees. Upon renewal of the Research Program Term
as provided for in Section 2.2 above, Licensee and SGI shall
mutually agree upon a budget for FTE Fees to be incurred during
such [***] renewal period. Licensee shall also pay SGI for all Drug
Conjugation Materials supplied by SGI to Licensee hereunder at the
rate of [***] of SGI’s Cost of Goods therefor (the “
Supply Fees ”). The FTE Fees and the Supply Fees are
collectively referred to herein as the “ Research Fees
”. Within [***] after the end of each [***], SGI shall submit
a report to Licensee supporting the calculation of the Research
Fees due for such Calendar Quarter (a “ Research Fees
Report ”). Licensee shall pay all Research Fees to SGI
within [***] of receipt of each Research Fees Report.
6.2 License Maintenance Fees .
Licensee shall be required to make a payment to SGI in the sum of
[***] by wire transfer of immediately available funds (the “
Exclusive License Renewal Fee ”) on [***] of the
Effective Date until Licensee receives the first Regulatory
Approval for a Licensed Product in the Territory. Notwithstanding
the foregoing, the Exclusive License Renewal Fee will be offset by
the amount of any payments made under Section 6.5 of this
Agreement during the [***] period preceding the date on which an
Exclusive License Renewal Fee is due. If Licensee fails to make any
payment required by this Section 6.2 within [***] after
written notice thereof from SGI, then the Exclusive License will
terminate immediately.
6.3 Royalties Payable by Licensee . In
consideration for the Exclusive License granted to Licensee herein,
during the Royalty Term, and subject to Sections 6.4.2 and
6.4.3,
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
-12-
Licensee shall pay to SGI royalties on Net Sales
of Licensed Products on a Licensed Product by Licensed Product
basis. Such royalties shall be paid at the following rates as set
forth below:
(a) [***] of the first [***] in aggregate [***] of
each [***] in each [***];
(b) [***] of the portion of aggregate [***] of each
[***] between [***] and [***] in each [***];
(c) [***] of the portion of aggregate [***] of each
[***] in excess of [***] in each [***]; and
(d) In establishing the royalty structure of this
Section 6.3, the Parties recognize, and Licensee acknowledges,
the substantial value of the various actions and investments
undertaken by SGI prior to the Effective Date. Such value is
significant and in addition to the value of SGI’s grant to
Licensee of the Exclusive License pursuant to Section 3.1, as
it enables the rapid and effective development and
commercialization of the Licensed Products in the Territory.
Therefore, the Parties agree that the royalty payments calculated
as a percentage of [***] (plus the fees and milestone payments
provided for elsewhere herein) provide fair compensation to SGI for
these additional benefits.
(e) If and for so long as there is a [***], then the
[***]:
|
|
|
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
|
[***]
|
6.4 Third Party Royalties
.
6.4.1 Licensee shall be solely responsible for paying
all royalties owed to Third Parties by either Licensee or SGI on
account of sales of Licensed Products, including royalties owed due
to use of the SGI Technology. SGI represents and warrants that
(i) [***], (ii) it has provided Licensee with
true and complete copies, except for certain redactions, of all
agreements and amendments to the extent such agreements are
relevant to determining the amount of royalties owed and
(iii) [***].
6.4.2 If the sum of (a) the royalties payable by
Licensee, its Affiliates or Sublicensees to SGI under [***],
(b) the Existing Third Party Royalties payable by Licensee,
its
[***] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested
with