Exhibit 10.2
COLLABORATION
AGREEMENT
This Agreement is entered into as of April 27,
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 :
MEDIMMUNE, INC.
, a Delaware corporation, having its
principal place of business at One MedImmune Way, Gaithersburg, MD
20878
(hereinafter referred to as “
Licensee ”).
WITNESSETH
WHEREAS, SGI owns or controls intellectual property
rights relating to technology useful for linking proprietary
[***] to other molecules, such as antibodies, capable of
directing such [***] 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 Agreement (as such term is defined below);
WHEREAS, Licensee wishes to obtain an exclusive worldwide
license under SGI’s patent rights and know-how related to
SGI’s proprietary [***] 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 [***] 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 [***]
for use with certain of Licensee’s antigens and
antibodies.
NOW, THEREFORE
, in consideration of the mutual
covenants and obligations set forth herein, the Parties hereto,
intending to be legally bound, agree as follows:
|
[***]
|
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.
|
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.
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
“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:
Schedule A
- Research Plan.
Schedule B
-
SGI Patents.
Schedule C
-
SGI In-Licenses.
Schedule D
-
Designated Antigens and Exclusive
Antigens.
1.1.6
“Antibody” or
“Antibodies” means any and all antibodies, or
[*** ], including, but not limited to, [***
].
1.1.7
“Antigen” means any [*** ].
1.1.8 [*** ] .
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 “Calendar
Quarter” means any
of the three-month periods beginning January 1, April 1, July 1 and
October 1 in any year.
1.1.11 “Change in
Control” has the
meaning set forth in Section 16.1.
1.1.12
“Claims” has
the meaning set forth in Section 14.1.1.
1.1.13 “Combination
Product” means any
Licensed Product and [*** ].
1.1.14 “Confidential
Information” has
the meaning set forth in Section 8.1.
|
[***]
|
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.
|
2
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 as
provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
1.1.16 “Cost of
Goods” shall mean
with respect to Drug Conjugation Materials supplied to Licensee (a)
for manufacturing activities performed by Third Parties,
SGI’s reasonably documented out-of-pocket costs incurred in
such manufacture and supply of Drug Conjugation Materials, as well
as SGI’s 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
providing such goods or services, which shall include costs of the
following: [*** ].
1.1.17 “Designated
Antigen(s)” means
the [***] Antigens, excluding the [*** ], that are
designated as such in accordance with Section 2.5 of this
Agreement.
1.1.18 “Drug Conjugation
Material(s)” means
(a) any and all [*** ], including, but not limited to, the
[*** ], and (b) any [***] that are useful in
[*** ].
1.1.19 “Drug Conjugation
Technology” means
Drug Conjugation Materials and uses thereof, including [***
], and methods for producing Drug Conjugation Materials and
attaching Drug Conjugation Materials to [***] and the
[*** ], and uses thereof.
1.1.20 “Effective
Date” means the
date set forth in the first line of this Agreement.
1.1.21
“EMEA” means
the European Medicines Agency and any successor agency(ies)
thereto
1.1.22 “Events of Force
Majeure” has the
meaning set forth in Article 15.
1.1.23 “Exclusive
Antigen(s)” means
collectively, the [*** ].
1.1.24 “Exclusive
License(s)” has the
meaning set forth in Section 3.2.
1.1.25 “Exclusive License
Maintenance Fee” has the meaning set forth in Section
6.2.
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 any successor
agency(ies) 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
|
[***]
|
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
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.
1.1.30 “First Exclusive
Antigen” means
[*** ].
1.1.31 “FTE
Fees” has the
meaning set forth in Section 6.1.2.
1.1.32
“GAAP” means
generally accepted accounting principles in the United
States.
1.1.33 “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.
1.1.34
“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.
1.1.35
“Indemnitee” has the meaning set forth in Section
14.2.
1.1.36
“Indemnitor” has the meaning set forth in Section
14.2.
1.1.37 “Initial
Agreement” means
the Research Collaboration Agreement effective [ ***] by and
between the Parties, as amended.
1.1.38
“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.
1.1.39 “Joint
Patents” has the
meaning set forth in Section 9.2.2.
1.1.40
“Liabilities” has the meaning set forth in Section
14.1.1.
1.1.41 “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 [*** ]: (a) the manufacture, use, sale, offer
for sale or import of which would [***]; or (b) which
[*** ].
1.1.42 “Licensed Technology
Acquisition Agreement” has the meaning set forth in Section
3.6.1.
|
[***]
|
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.
|
4
1.1.43 “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 [*** ].
1.1.44 “Licensee ADC
Patents” means all
patent applications and patents that are Controlled by Licensee
that claim Licensee ADC Know-How.
1.1.45 “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) [*** ], or (b) [*** ].
1.1.46 “Licensee
Indemnitee” has the
meaning set forth in Section 14.1.1.
1.1.47 “Licensee
Materials” means
any tangible chemical, biological or physical materials that are
furnished by or on behalf of Licensee to SGI in connection with
this Agreement.
1.1.48 “Licensee
Patents” means all
patent applications and patents that claim Licensee
Know-How.
1.1.49 “Licensee
Proprietary Antigen” means an Antigen for which Licensee Patents
(excluding Licensee ADC Patents) would reasonably be expected to
[*** ].
1.1.50 “Net
Sales” means, as to
each Calendar Quarter, the gross invoiced sales prices charged for
all Licensed Products sold by Licensee, its Affiliates and
Sublicensees to independent Third Parties during such Calendar
Quarter, after [*** ]:
All of the [***] shall be determined in
accordance with GAAP. In the event that Licensee, its Affiliates or
Sublicensees make any adjustments to [ ***] have been
reported pursuant to this Agreement, the adjustments shall be
reported and reconciled in the next report and payment of any
royalties due.
|
[***]
|
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
In the event a Licensed Product is sold as a [
*** ], for the purposes of determining royalty payments,
shall be determined by [*** ], in each case during the
applicable royalty reporting period or, if sales of the ADC
[***] 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 [*** ].
1.1.51
“Option” has
the meaning set forth in Section 3.3.
1.1.52 “Option
Period” means the
period commencing on the Effective Date and continuing for [
***] thereafter; provided that the Option Period
shall terminate when Licensee [*** ], and further provided,
that the Option Period shall continue for [*** ].
1.1.53
“Parties” means Licensee and SGI, and
“Party” means either of them.
1.1.54
“Patent(s)” means all patents and patent applications in any
country, including divisions, continuations, continuations in part,
reissues, renewals, registrations, confirmations, reexaminations,
extensions, supplementary protection certificates and the
like.
1.1.55 “Phase I Clinical
Trial ” means a
clinical trial in which there is a first administration of a
candidate drug in humans that would satisfy the requirements of 21
C.F.R. 312.21(a).
1.1.56 “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 that would
satisfy the requirements of 37 C.F.R. 312.21(b).
1.1.57 “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 that would satisfy the requirements of 37
C.F.R. 312.21(c).
1.1.58 “Program
Invention” means
any [*** ]; provided , that any Program Invention
made pursuant to the [*** ].
1.1.59 “Proposed
Disclosure” has the
meaning set forth in Section 8.3.1.
1.1.60
“Publication” has the meaning set forth in Section
8.4.
1.1.61 “Reduction
Amount” has the
meaning set forth in Section 6.5.4.
1.1.62 “Regulatory
Approval” means
final regulatory approval in a country (including, where
applicable, pricing approval in the event that actual sales in that
country 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.
|
[***]
|
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
1.1.63
“Reports” has
the meaning set forth in Section 7.1.1.
1.1.64 “Research
Fees” has the
meaning set forth in Section 6.1.2.
1.1.65 “Research Fees
Report” has the
meaning set forth in Section 6.1.2.
1.1.66 “Research
License” has the
meaning set forth in Section 3.1.
1.1.67 “Research
Plan” means the
plan for the Research Program agreed upon by the Parties and
attached hereto as Schedule A , as amended from time to time
by mutual agreement of the Parties.
1.1.68 “Research
Program” means the
research program conducted during the Research Program Term
pursuant to Article 2.
1.1.69 “Research Program
Term” the period
that is [*** ].
1.1.70 “Royalty
Term” means, on an
Exclusive Antigen-by-Exclusive Antigen basis and country-by-country
basis, the period commencing on the First Commercial Sale of the
first Licensed Product for an Exclusive Antigen in a country and
ending upon the tenth (10 th ) anniversary of the date of First
Commercial Sale of such first Licensed Product for such Exclusive
Antigen in such country, regardless of the number of different
Licensed Products for that Exclusive Antigen being sold in such
country; provided , however , that if after such
tenth (10 th ) anniversary a Licensed Product
infringes a Valid Claim of an issued SGI Patent licensed to
Licensee under this Agreement in such country, the Royalty Term
shall continue in such country while such infringement
exists.
1.1.71 “Second Exclusive
Antigen” means a
Designated Antigen, other than the First Exclusive Antigen, for
which Licensee exercises the Option for an Exclusive License under
Article 3 of this Agreement.
1.1.72 “SGI
Indemnitee” has the
meaning set forth in Section 14.1.1.
1.1.73 “SGI
In-Licenses” means
the following agreements between SGI and the indicated Third
Parties: (a) the [***].
1.1.74 “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 are owned, in whole or in
part, by SGI or its Affiliates on, before or after the Effective
Date or are licensed to SGI as of the Effective Date or that are
licensed to SGI under a Licensed Technology Acquisition Agreement
after the Effective Date.
1.1.75 “SGI
Patents” means any
and all Patents: (a) that are owned in whole or in part by SGI or
its Affiliates, or licensed to SGI or its Affiliates as of the
Effective Date, (b) that become owned in whole or in part by SGI or
its Affiliates at any time during the Term, or (c) that are
licensed to SGI or its Affiliates after the Effective Date under a
Licensed 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.
|
7
Acquisition Agreement, in each case
to the extent that such Patents would be infringed by (a) Drug
Conjugation Technology and/or the discovery, development,
manufacture or use thereof or (b) an Antibody linked to Drug
Conjugation Material or the discovery, development, manufacture or
use thereof. SGI Patents include, but are not limited to, rights to
the Patents set forth in Schedule B .
1.1.76 “SGI
Technology” means
the SGI Patents and the SGI Know-How.
1.1.77
“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, which term does not
include Licensee’s distributors.
1.1.78 “Supply
Fees” has the
meaning set forth in Section 6.1.2.
1.1.79 “Technology
Acquisition Agreement” shall mean any agreement entered into after the
Effective Date between SGI or its Affiliates and a Third Party
under which SGI or its Affiliates is granted a license to (a) any
of such Third Party’s Patents that cover Drug Conjugation
Technology or (b) any of such Third Party’s Know-How that
reasonably relates to the foregoing.
1.1.80
“Term” has
the meaning set forth in Section 13.1.
1.1.81
“Territory” means all countries in the world.
1.1.82 “Third
Party” means any
person or entity other than Licensee, SGI and their respective
Affiliates.
1.1.83 “Valid
Claim” means (a) an
unexpired claim of an issued patent which has not been cancelled,
abandoned, disclaimed, or revoked and has not been found to be
unpatentable, invalid or unenforceable by an unreversed and
unappealable or unappealed decision of a court or other authority
in the subject country; or (b) a pending claim of an application
for a patent that is being maintained in good faith and which
application has been pending for less than [ ***] from the
earliest priority date to which such application is
entitled.
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 or 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;
|
[***]
|
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
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;
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;
1.2.7 The singular includes the plural and vice versa
except if the context is otherwise; and
1.2.8 The word “or” is used in the
inclusive sense and includes the conjunctive and disjunctive
(and/or).
ARTICLE 2 - RESEARCH PROGRAM
2.1 Conduct of the Research
Program .
2.1.1 Licensee intends to conduct a Research Program,
with SGI’s support, to evaluate and select ADCs targeting the
Designated Antigens and Exclusive Antigens for development and
commercialization by Licensee as Licensed Products, as more fully
described in the Research Plan.
2.1.1 SGI shall use commercially reasonable efforts to
conduct work in accordance with the Research Plan, in a good
scientific manner, and in compliance in all material respects with
all requirements of applicable laws, rules and regulations and all
applicable Good Laboratory Practice to attempt to achieve its
objectives efficiently and expeditiously.
2.1.3 SGI shall maintain records in sufficient detail
and in good scientific manner appropriate for regulatory purposes
and the purpose of establishing and perfecting intellectual
property (including patent rights), which shall fully and properly
reflect all work done and results achieved in the conduct of the
Research Plan. Licensee shall have the right during normal business
hours and upon reasonable notice, to inspect and copy all such
records of SGI. At Licensee’s reasonable request, SGI shall
arrange for employees and/or consultants of Licensee involved in
the activities contemplated under the Research Plan to visit the
offices and laboratories of SGI during normal business hours and
upon reasonable notice, to discuss the Research Plan and its
results in detail with the technical personnel and consultants of
SGI.
2.2 Term of the Research
Program . The term of
the Research Program shall be for the Research Program Term, unless
terminated earlier in accordance with Article 13.
|
[***]
|
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
2.3 Delivery of Drug
Conjugation Materials . In support of the Research Program, during the
Research Program Term, SGI will deliver Drug Conjugation Materials
to Licensee that are available to SGI 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
[***] 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.
2.4 SGI Preparation of
ADCs . The Parties
acknowledge that SGI and Licensee have [*** ]. In order to
identify the lead candidate for the First Exclusive Antigen and to
identify the Second Exclusive Antigen during the Research Program
Term, SGI will prepare and deliver to Licensee mutually agreed upon
research quantities of ADCs using the Drug Conjugation Materials
that are available to SGI targeted to the First Exclusive Antigen
and to [*** ].
2.5 Availability of
Antigens .
2.5.1 Licensee shall provide SGI with a [*** ],
which Licensee desires to [***] for purposes of this
Agreement and [*** ], SGI shall notify Licensee in writing
whether the Exclusive License described in Article 3 of this
Agreement is available with respect to such Antigen and hereby
notifies Licensee that, with respect to the Antigen listed on
Schedule D attached hereto, an Exclusive License is
available as of the Effective Date. 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 [*** ].
2.5.2 During the [***] after the Effective
Date, Licensee shall have the [*** ].
2.6 Additional Activities
under Research Program . Upon mutual written agreement of the Parties,
the Research Program may also include technical assistance by SGI
with respect to the [*** ].
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 that was requested by Licensee in
writing (including by email); provided that Licensee’s
failure to request particular research efforts or assistance from
SGI in writing shall not preclude Licensee’s payment
obligations hereunder if SGI can reasonably demonstrate that such
research efforts or assistance were in fact requested orally or in
some other manner by an authorized employee or agent of
Licensee.
2.8 Supply of Licensee
Materials . From time
to time during the Research Program 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.
|
[***]
|
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
2.9 Books and
Records . SGI shall
keep full and accurate records and books of account containing all
particulars that may be reasonably necessary for the purpose of
determining the FTEs that are charged to Licensee pursuant to this
Agreement. Such books of account shall be kept by SGI at its places
of business and, with all necessary supporting data shall, for the
[***] following the end of the calendar year to which each
shall pertain be open for inspection by an independent certified
accountant selected by Licensee and reasonably acceptable to SGI
upon reasonable notice during normal business hours at [***]
for the sole purpose of verifying FTEs charged in compliance with
this Agreement, but in no event more than [***] each
calendar year and limited to the records of the [***]
preceding the inspection. All information and data offered shall be
used only for the purpose of verifying FTEs charged to Licensee. In
the event that such inspection shall indicate in any calendar year
that the charges paid by Licensee were overstated by [***]
or more, then [***] shall pay the cost of the inspection.
Licensee will invoice SGI for any overpayments, which shall become
due and payable no later than [***] after receipt of an
invoice from Licensee.
2.10 Disclaimers
. EXCEPT AS MAY BE
EXPRESSLY PROVIDED IN THIS AGREEMENT, 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. EXCEPT AS MAY BE EXPRESSLY
PROVIDED IN THIS AGREEMENT, 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 . Subject to
the terms and conditions of this Agreement, SGI grants to Licensee
a non-exclusive, worldwide, royalty-free license under the SGI
Technology solely to conduct the Research Program as set forth in
the Research Plan with respect to ADCs for Designated Antigens (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 sell an ADC with respect to an Antibody
for a Designated Antigen. Except for Patents owned by Licensee
pursuant to Section 9.1, [*** ], subject to the terms and
conditions of this Agreement. [*** ]. The Research License
shall continue for the Research Program Term, unless earlier
terminated pursuant to Article 13; provided that the Research
License shall terminate in the event Licensee exercises its Option
for the Second Exclusive License pursuant to the terms
hereof.
|
[***]
|
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
3.2 Exclusive License
Grants .
3.2.1 Subject to the terms and conditions of this
Agreement, SGI agrees to grant and hereby grants to Licensee an
exclusive (even as to SGI), royalty-bearing license under the SGI
Technology, with the right to sublicense as permitted in Section
3.5, to discover, research, develop, have developed, make, have
made, import, use, offer for sale, and sell Licensed Products
within the Field in the Territory (with respect to each Exclusive
Antigen, an “ Exclusive License ” and, for the
First Exclusive Antigen and the Second Exclusive Antigen,
collectively, the “ Exclusive Licenses ”). Each
Exclusive License shall continue for the Royalty Term thereof,
unless earlier terminated pursuant to Article 13. It is expressly
understood and agreed that the Exclusive License with respect to
Licensed Product for the First Exclusive Antigen is effective as of
the Effective Date and that the Exclusive License with respect to
the Second Exclusive Antigen shall automatically take effect on the
Option Exercise Date.
3.2.2 Licensee acknowledges that Licensee has been
granted a license with respect to SGI Patents and SGI Know-How. As
a result, pursuant to this Agreement, during the Royalty Term,
Licensee has agreed to pay royalties to SGI based on Net Sales of
Licensed Product.
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 a Designated Antigen as the Second Exclusive Antigen
(the “ Option ”) during the Option
Period.
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 of
the Designated Antigen that is the Second Exclusive Antigen.
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 is automatically
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 Rights to
Sublicense .
3.5.1 Licensee shall have the right to grant
sublicenses of each Exclusive License to any Affiliate or Third
Party with respect to any Licensed Product. Licensee agrees to
contractually obligate each Sublicensee to comply with all terms of
this Agreement, the SGI In-Licenses and any Licensed Technology
Acquisition Agreements, in each of such cases, that are applicable
to a 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.
3.5.2 Licensee shall notify SGI of each sublicense
under an Exclusive License 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.
3.5.3 [*** ].
|
[***]
|
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
3.6 Technology Acquisition
Agreements .
3.6.1 Technology Acquisition
Agreements . During
the Term, if SGI proposes or desires to enter into a Technology
Acquisition Agreement in order to obtain a license to one or more
Patents that cover or potentially cover a Licensed Product that is
being developed, marketed or sold by Licensee or its Affiliates or
a Sublicensee, SGI [*** ]. After entering into any
Technology Acquisition Agreement (whether or not covering
technology referred to in the previous sentence), SGI [***
]. In each Technology Acquisition Agreement, SGI [*** ].
Upon such written notice from Licensee that Licensee is sublicensed
under such Technology Acquisition Agreement, such Technology
Licensee Agreement shall automatically become a “ Licensed
Technology Acquisition Agreement .” [***
].
3.6.2 Amendment of Schedule
B . Schedule
B shall be amended from
time to time to add the patents and patent applications licensed
under Licensed Technology Acquisition Agreements.
3.7 Compliance with SGI
In-Licenses and Licensed Technology Acquisition Agreements
.
3.7.1 Licensee, its Affiliates and Sublicensees shall
comply with all obligations, covenants and conditions of the SGI
In-Licenses and Licensed Technology Acquisition Agreements
applicable to Licensee and its Affiliates and Sublicensees and,
subject to Section 3.7.2 and Section 12.3, any amendments thereto
following written disclosure thereof to Licensee, that apply under
each of the SGI In-Licenses and/or Licensed Technology Acquisition
Agreements. 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.
3.7.2 SGI will [***] hereunder or [***
].
3.8 [ ***] .
3.8.1 [***].
3.8.2 [***].
ARTICLE 4 - TECHNOLOGY
DISCLOSURE
During the Term, SGI shall (a)
promptly disclose to Licensee all SGI Know-How licensed to Licensee
that is reasonably useful to enable Licensee to use the Drug
Conjugation Materials and Drug Conjugation Technology to practice
the Research License and Exclusive Licenses, including
manufacturing, analytical and formulation methods and procedures,
and shall also provide regular updates regarding SGI Patents, in
each case 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;
provided that after the expiration of the Research Program
Term, SGI’s obligations hereunder shall be limited to
disclosure of information relating to Licensee’s ongoing
development, manufacturing, clinical trials,
|
[***]
|
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.
|
13
regulatory and other matters reasonably
associated with Licensed Products, and shall not include
SGI’s continued disclosure to Licensee for research purposes
of new Drug Conjugation Materials and/or Drug Conjugation
Technology developed after expiration or termination of the
Research Program Term. Licensee shall pay to SGI for such
assistance under this Article 4 an amount equal to the FTE Fees in
accordance with Section 6.1.2 for SGI employees providing such
assistance; [*** ]. Notwithstanding the foregoing, during
the Term but after expiration or termination of the Research
Program Term, SGI will, upon request from Licensee on no more than
an annual basis, provide a [***]. For the purposes of
clarity, this Article 4 does not reduce the scope of the licenses
granted to Licensee pursuant to this Agreement.
ARTICLE 5 - DEVELOPMENT AND COMMERCIALIZATION;
MANUFACTURING
5.1 Diligence
.
5.1.1 Licensee agrees to use commercially reasonable
efforts to, at its expense, develop a Licensed Product for the
First Exclusive Antigen and for the Second Exclusive Antigen, if a
Second Exclusive Antigen is selected by Licensee, in the United
States, and thereafter as set forth in Section 5.1.5 in Europe and
Japan.
5.1.2 If, in any calendar year, Licensee or its
Affiliate(s) and/or a Sublicensee and/or a collaborator of Licensee
(including work of SGI under the Research Program), alone or
together, has [***] for such Exclusive Antigen:
If, in a calendar year, Licensee
[*** ].
5.1.3 Subject to Section 5.1.4, in the event that
Licensee [***] by written notice to Licensee within
[***] after the end of the applicable calendar year, unless
[***] after such notice.
|
[***]
|
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.
|
14
5.1.4 If Licensee receives a notice under Section
5.1.3, Licensee shall have the [*** ].
5.1.5 It is expressly understood that Licensee
[*** ]. In the event that Licensee fails to exert
commercially reasonable efforts to develop a Licensed Product for
an Exclusive Antigen in [*** ].
5.1.6 Licensee agrees to use commercially reasonable
efforts to market and sell Licensed Product in each country in
which Regulatory Approval is obtained therefor.
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 progress of
the development of Licensed Products.
5.3 Manufacturing
. Except as otherwise
expressly set forth in this Agreement, Licensee shall be
responsible for all manufacturing and supply of the Licensed
Products. Notwithstanding the foregoing, SGI shall (a) [***]
and (b) [*** ]. If SGI has an [*** ]. In the event
SGI agrees to [*** ]. In addition, if requested by Licensee,
SGI shall provide Licensee with reasonable consultation in working
with any Third Party that is manufacturing Drug Conjugation
Materials or ADCs, subject to reimbursement in accordance with
Section 6.1.2 for any consultation provided.
5.4 Development and
Commercialization .
Licensee shall have the sole right within its discretion to
determine all matters with respect to research, development,
manufacturing and commercialization of Licensed
Products.
ART
