Exhibit 10.15
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
RESTRUCTURED AND RESTATED HspE7
COLLABORATION AGREEMENT
AMONG
STRESSGEN DEVELOPMENT CORPORATION
AND
STRESSGEN BIOTECHNOLOGIES
CORPORATION
AND
F.HOFFMANN-LA ROCHE LTD AND
HOFFMANN-LA ROCHE INC.
December 1,
2003
This RESTRUCTURED AND
RESTATED HSPE7 COLLABORATION AGREEMENT (“
Agreement ”) is made as of December 1, 2003 (the
“ Effective Date ”) by and among, on the one
hand, STRESSGEN DEVELOPMENT CORPORATION, a Barbados
corporation, with its principal office at Whitepark House, White
Park Road, P.O. Box 806E, Bridgetown, Barbados (“
Stressgen ”), and STRESSGEN BIOTECHNOLOGIES
CORPORATION, a corporation organized under the laws of Yukon
Territory, Canada, with its principal office at #350 – 4243
Glanford Avenue, Victoria, BC Canada V8Z 4B9 (“ SBC
”), and, on the other hand, F.HOFFMANN-LA ROCHE LTD, a
Swiss corporation, with its principal office at Grenzacherstrasse
124, CH-4070-Basel Switzerland and HOFFMANN-LA ROCHE INC., a
New Jersey corporation, with its principal office at 340 Kingsland
Street, Nutley, New Jersey 07110 (collectively, “
Roche ”).
RECITALS
1.
Stressgen and SBC own intellectual
property rights related to, among other products, HspE7 (as defined
below), which is now in Phase II clinical trials.
2.
Roche has expertise in the
development and commercialization of pharmaceutical
products.
3.
Roche, Stressgen and SBC have
entered into that certain HspE7 Collaboration Agreement, effective
June 21, 2002, pursuant to which the Parties were to
co-develop HspE7 for certain specified indications, share in the
development costs associated therewith, and have Roche
commercialize HspE7 worldwide (the “ Prior Agreement
”).
4.
The Parties now desire to
restructure their collaborative efforts with respect to HspE7, to
provide that Stressgen take the lead in the manufacture, continued
clinical development and commercialization of HspE7 for certain
indications, that Roche be granted an exclusive option to obtain
exclusive, worldwide rights to such product, and that Roche be
granted a license to develop and commercialize a second
generation
1
HspE7 product for certain indications, and have
prepared this Agreement to govern such restructured
arrangement.
AGREEMENT
NOW, THEREFORE,
in consideration of the premises
and the mutual covenants and agreements contained in this
Agreement, the Parties, intending to be legally bound, do hereby
agree as follows:
ARTICLE 1
DEFINITIONS
The following capitalized terms,
whether used in the singular or the plural, shall have the
following meanings as used in this Agreement unless otherwise
specifically indicated:
1.1
“Affiliate” shall mean (a) an entity which owns,
directly or indirectly, a controlling interest in a Party, by stock
ownership or otherwise, (b) any entity which a Party owns a
controlling interest, by stock ownership or otherwise; or
(c) any entity, under direct or indirect common control of a
Party. For purposes of this paragraph, “controlling
interest” and “control” mean ownership of greater
than fifty percent (>50%) of the voting stock permitted to vote
for the election of the board of directors or any other arrangement
resulting in control or the right to control the management and the
affairs of the Party. For purposes of this Agreement,
Genentech, Inc., 1 DNA Way, South San Francisco, California, and
Chugai Pharmaceutical Company, Ltd., 1-9 Kyobashi 2-chome, Chuo-ku,
Tokyo, 104-8301, Japan, shall not be deemed an Affiliate of
Roche.
1.2
“BLA
Filing” shall mean
a Biologics Licensing Application or New Drug Application filed
with the FDA, or the equivalent application to the equivalent
agency in any other country, the filing of which is necessary to
market and sell a Target Product, including all amendments and
supplements to any of the foregoing.
2
1.3
“Control”
shall mean, with respect to any
information or intellectual property right, possession by a Party
of the ability (whether by ownership, license or otherwise) to
grant access, 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 as of the time
such Party would first be required hereunder to grant the other
Party such access, license or sublicense.
1.4
“Confidential
Information” shall
have the meaning set forth in Section 12.1 .
1.5
“Diligent
Efforts” shall mean
the use of at least an equivalent degree of effort and resources
consistent with the exercise of prudent scientific and business
judgment, as applied to other pharmaceutical products of similar
potential and market size by the Party in question, and reflecting
the competitive environment for the development and marketing of a
Target Product.
1.6
“Executive
Officers” shall
mean, for Roche, the Head of the Roche Pharma Division (or a
designee), and for Stressgen, the Chief Executive Officer of
Stressgen (or a designee).
1.7
“FDA”
shall mean the United States Food
and Drug Administration.
1.8
“First Generation
Product” shall mean
any version of a product containing HspE7, developed by or on
behalf of Stressgen initially for the treatment of one or more
Non-GW Indications.
1.9
“ First Generation Product
License Agreement” shall have the meaning set forth in
Section 4.4.
1.10
“GW
Indication” shall
mean treatment or prevention of any one or more of the following
diseases or disorders, caused by any type of the human papilloma
virus: benign internal and external genital and perianal warts,
including those urethral, intravaginal, cervical, rectal and
intra-anal sites.
3
1.11
“HspE7”
shall mean a recombinant DNA-derived
fusion protein containing (a) a human papilloma virus (HPV)
type-16 E7 antigen, antigenic fragment or conjugate thereof and
(b) a bacterial stress protein, including without limitation,
a bacterial stress protein derived from the 65kDa heat shock
protein of Mycobacterium bovis var. BCG (Hsp65), where such
bacterial stress protein is coupled at the C-terminus to the E7
protein of the HPV type 16.
1.12
“IND”
shall mean an application to the
FDA, the filing of which is necessary to commence clinical testing
of Target Products in humans, or the equivalent application to the
equivalent agency in any other country or group of
countries.
1.13
“Invention” shall mean any invention or discovery, whether
or not patentable, made as a result of activities of a Party or the
Parties pursuant to this Agreement, and which relates to a Target
Product. An “Invention” may be made by employees
of Stressgen or SBC solely or jointly with a Third Party (a “
Stressgen Invention ”), by employees of Roche solely
or jointly with a Third Party (a “ Roche Invention
”), or jointly by employees of Stressgen or SBC and Roche
with or without a Third Party (a “ Joint Invention
”), in each instance as determined by U.S. laws of
inventorship.
1.14
“MIT
Agreement” shall
mean that certain License Agreement dated November 3, 1992
between Massachusetts Institute of Technology and the Whitehead
Institute (collectively “ MIT ”) and SBC, as
amended.
1.15
“Naïve Genital Warts
Indication” shall
mean the GW Indication limited to treating naïve patients
having warts that have had no prior drug, ablative or surgical
treatment.
1.16
“Net
Sales” shall mean
the amount remaining after deducting from Adjusted Gross Sales an
amount equal to [***] of Adjusted Gross Sales
As used herein, the term “Adjusted
Gross Sales” shall mean the gross amount invoiced for
sales of Target Products to Third Parties in the Territory by a
Party, its Affiliates and their respective sublicensees to Third
Parties that are not Affiliates or
4
sublicensees of the selling party, less the
following items, as allocable to such Target Product (if not
previously deducted from the amount invoiced):
(a)
volume (quantity)
discounts;
(b)
returns and return reserves
(including allowances actually given for spoiled, damaged,
out-dated, rejected, returned Target Product, withdrawals and
recalls;
(c)
taxes, duties or other governmental
tariffs, including value added or sales taxes, government mandated
exceptional taxes and other taxes directly linked to the gross
sales amount (other than income taxes); and
(d)
rebates (including price reductions,
rebates to social and welfare systems, chargebacks or reserves for
chargebacks, cash rebate incentives, government mandated rebates
and similar types of rebates, for example P.P.R.S,
Medicaid).
Notwithstanding the foregoing,
amounts received by a Party or its Affiliates or sublicensees for
the sale of Target Product among a Party and its Affiliates or
sublicensees for resale shall not be included in the computation of
Net Sales hereunder.
1.17
“Non-GW
Indications” shall
mean treatment or prevention of any human disease or disorder
caused by any type of the human papilloma virus other than the GW
Indication, including the treatment of recurrent respiratory
papillomatosis (“ RRP ”), diagnosed cancer,
benign and precancerous lesions, cervical dysplasia (CIN), anal
dysplasia (AIN), or any orphan drug indication.
1.18
“Option”
or “The Option”
shall have the meaning set forth in
Section 4.1.
1.19
“Other HPV Fusion
Protein” shall mean
a fusion protein (or any nucleic acid sequences and vectors and
host cells containing nucleic acid sequences encoding such protein)
that [***].
5
1.20
“Party”
shall mean, individually, on the one
hand, Stressgen and SBC and on the other hand, Roche, and “
Parties ” shall mean collectively, Stressgen and SBC
and Roche.
1.21
“Patents”
shall mean (a) United States
patents, re-examinations, reissues, renewals, extensions and term
restorations, and foreign counterparts thereof, and
(b) pending applications for United States patents, including,
without limitation, provisional applications, continuations,
continuations-in-part, divisional and substitute applications,
including, without limitation, inventors’ certificates, and
(c) any and all foreign counterparts of (a) and
(b).
1.22
“Phase II Clinical
Trial” shall mean
the second phase of human clinical trials required by the FDA to
gain evidence of efficacy of Target Product in a target population,
and to determine common short term side effects and risks for
Target Product, as described in 21 CFR 312.21(b), as it may be
amended (or its successor regulation).
1.23
“Phase III Clinical
Trial” shall mean
the third phase of human clinical trials required by the FDA to
gain evidence of efficacy of Target Product in a target population,
and to obtain expanded evidence of safety for Target Product that
is needed to evaluate the overall benefit-risk relationship of
Target Product and provide an adequate basis for physician
labeling, as described in 21 CFR 312.21(c), as it may be amended
(or its successor regulation).
1.24
“[***]
Indication” shall
mean the GW Indication limited to [***].
1.25
“Regulatory
Approval” shall
mean any and all approvals, licenses, registrations or
authorizations (including pricing and reimbursement approvals) of
any national or international or local regulatory agency,
department, bureau or other governmental entity, whether or not
conditional, that are necessary for the commercial sale of a Target
Product in a regulatory jurisdiction in the Territory and obtained
as a result of activities under this Agreement.
6
1.26
“Second Generation
Product” shall mean
any product containing HspE7, developed by or on behalf of Roche
for the GW Indication, or where allowed pursuant to
Section 6.8, a Non-GW Indication.
1.27
“Start of Phase
II” shall mean the
date that a patient is first dosed in a Phase II Clinical Trial for
Target Product, as a result of activities under this
Agreement
1.28
“Start of Phase
III” shall mean the
date that a patient is first dosed in a Phase III Clinical Trial
for Target Product, as a result of activities under this
Agreement
1.29
“Stressgen
Know-How” shall
mean, to the extent necessary or useful for the manufacture,
development or commercialization of Target Products in the
Territory, all data, knowledge and information Controlled by
Stressgen or SBC, including, without limitation, materials,
samples, manufacturing data, toxicological data, pharmacological
data, clinical data, formulations, specifications, quality control
testing data, market research, and submissions and correspondence
to and from governmental agencies with regard to Target Products,
but excluding information contained within the Stressgen Patent
Rights.
1.30
“Stressgen Patent
Rights” shall mean
all Patents that Stressgen Controls as of the Effective Date or
during the Term, including, without limitation, Patents that claim
Stressgen Inventions and/or Joint Inventions, which, in the absence
of the license granted, or to be granted pursuant to the Option, to
Roche under this Agreement, would be infringed by the making,
using, selling, offer for sale or importation of Target Products in
the Territory.
1.31
“Target
Product” shall mean
either the First Generation Product and/or the Second Generation
Product, as the context requires.
1.32
“Term”
shall have the meaning set forth in
Section 15.1 .
1.33
“Territory” shall mean all countries of the
world.
1.34
“Third
Party” shall mean
any Person other than a Party, its Affiliates and
sublicensee.
7
1.35
“Trademarks” shall mean all trademarks, trade names and trade
dress owned or controlled by Stressgen and used in connection with
the sale by Stressgen under this Agreement of First Generation
Product in the Territory.
1.36
“Valid
Claim” shall mean a
claim in any (a) unexpired and issued Stressgen Patent Right
that has not been disclaimed, revoked or held invalid or
unenforceable by a final unappealable decision of a court of
government agency of competent jurisdiction or (b) pending
patent application that is a Stressgen Patent Right which patent
application has been on file with the applicable patent office for
no more than [***] years from the earliest date to which the patent
application claims its earliest priority.
ARTICLE 2
AMENDMENT AND RESTATEMENT OF PRIOR AGREEMENT
The Prior Agreement is hereby amended and
replaced in its entirety with this Agreement. As a result,
all licenses and rights conveyed to, and obligations undertaken by,
either Party pursuant to the Prior Agreement are hereby terminated
(except for any payment obligations which accrued prior to the
Effective Date) and replaced with those licenses, options, and
obligations undertaken by the Parties pursuant to this
Agreement. It is further understood and agreed that
Confidential Information subject to the Prior Agreement shall be
considered Confidential Information under the Agreement.
ARTICLE 3
STRESSGEN RIGHTS TO FIRST GENERATION PRODUCT
3.1
Stressgen Rights.
As of the Effective Date,
Stressgen shall have all rights to, and be solely responsible for,
but shall not be obligated to undertake, all non-clinical and
clinical development, process development and manufacture of the
First Generation Product and obtaining Regulatory Approval therefor
in the Territory, subject to the restrictions set forth in
Section 3.2 and Article 4 . Stressgen
shall (a) be solely responsible for all interactions with
Regulatory Authorities, (b) hold and own all INDs, BLAs and
other filings for Regulatory Approval of the First Generation
Product in the
8
Territory, and (c) have the sole right to
market, sell and otherwise commercialize the First Generation
Product in the Territory and to book and retain all resulting
sales, except as otherwise provided under the First Generation
Product License Agreement and Article 4 of this
Agreement if Roche exercises its Option. It is also
understood and agreed that Stressgen shall have the right to into
enter into discussions and negotiations and to execute any
agreement with any Third Party with respect to the development of
the First Generation Product anywhere in the Territory,
notwithstanding the Option.
3.2
GW Indication.
If: (a) the Option has
not lapsed, or (b) the Second Generation Product License
remains in effect, then Stressgen shall not develop the First
Generation Product for the GW Indication; provided however, that
Stressgen shall have at all times the right to [***]. If:
(1) Roche elects not to exercise the Option, or the Option
lapses unexercised, and (2) the Second Generation Product
License is terminated for any reason, then Stressgen shall have the
right to develop the First Generation Product for any and all
indications, including the GW Indication.
3.3
Costs.
Stressgen shall be solely
responsible for any and all costs incurred in connection with the
development of the First Generation Product, except as otherwise
provided under the terms of this Agreement and the First Generation
Product License Agreement if Roche exercises its Option.
3.4
Assistance with Manufacture of
Batch Material.
(a)
In connection with the transfer of
manufacturing from Roche to Stressgen, as commenced pursuant to the
Prior Agreement, Roche has or shall, [***]. If Stressgen
requests in writing that Roche manufacture such material, Roche
will provide to Stressgen [***]. Thereafter, should Stressgen
desire that Roche [***]. Upon such delivery, Stressgen shall
[***] so provided to Stressgen.
(b)
Once the obligations of
subsection (iv) of Section 3.4(a) above have been
fulfilled, Roche shall have [***]. To support manufacturing
transfer to a contract manufacturer of Stressgen’s choice,
Roche shall [***] the use of such material,
9
unless such liability results from a failure by
Roche to manufacture in accordance with the master production
records. [***].
3.5
Roche Right to Review
BLA. Promptly
after Stressgen submits a BLA Filing for the First Generation
Product, Stressgen shall notify Roche in writing. Upon the
reasonable request of Roche, Stressgen shall make available to
Roche a copy of such BLA filing, including all submitted
documentation, in either electronic or printed form, as
available. Roche shall be permitted to conduct reasonable due
diligence, upon reasonable notice to Stressgen, with respect to the
First Generation Product beginning at the time it is provided with
notice of the BLA Filing and continuing until [***] after the BLA
Approval Date (defined in Section 4.2 below).
ARTICLE 4
ROCHE OPTION TO FIRST GENERATION PRODUCT
4.1
Option Grant.
Subject to
Sections 4.7 and 4.9 , Stressgen hereby grants
to Roche an exclusive option (the “ Option ”) to
enter into the First Generation Product License
Agreement.
4.2
Option Exercise Period
. Upon the first approval by
the FDA of the BLA for the First Generation Product (the “
BLA Approval Date ”), Stressgen shall notify Roche in
writing. Commencing on the date Roche receives notice of the
BLA Approval Date, Roche shall have a period of [***] (“
Notice Period ”) within which to notify Stressgen in
writing whether Roche desires either (a) to immediately
exercise the Option, or (b) to extend the period of time in
which to so exercise the Option until [***] (the “
Extension Date ”). During the Notice Period,
Roche shall have the right to continue the due diligence commenced
prior to the BLA filing under Section 3.5 . If
Roche so notifies Stressgen that it does not desire to exercise the
Option, or if during the Notice Period Roche fails to notify
Stressgen in writing that it desires to extend the period of time
in which to exercise the Option, then the Option shall
terminate.
4.3
Exercise of Option
. If during the Notice Period
Roche notifies Stressgen that it desires to immediately exercise
the Option, then Roche shall exercise the Option
10
by paying to Stressgen the Option Exercise Fee
within thirty (30) days after the end of the Notice
Period.
If during the Notice Period Roche
notifies Stressgen that it desires to extend the period of time in
which to so exercise the Option until the Extension Date, then
Roche shall exercise such right by paying to Stressgen a one-time,
nonrefundable, non-creditable amount of [***] within thirty (30)
days after the end of the Notice Period. In such instance,
Roche may subsequently exercise the Option by paying to Stressgen
the Option Exercise Fee on or before the Extension Date.
4.4
Effect of Option Exercise; First
Generation Product License Agreement. If Roche exercises the Option, then the Parties
agree immediately thereafter [***] Appendix A shall nonetheless be
binding upon the Parties, and shall serve as the First Generation
Product License Agreement.
4.5
Stressgen Right to Book
Sales. Stressgen
shall have the right, notwithstanding Roche’s exercise of the
Option, to sell all First Generation Product in the United States
and Canada for a period of three (3) full years following the later
of (a) BLA Approval for the First Generation Product, or
(b) if Roche has extended the Option pursuant to
Section 4.2, the date of exercise of the Option by
Roche (the “ Stressgen Sales Period ”).
During the Stressgen Sales Period, Stressgen shall be solely
responsible for all activities related to selling the First
Generation Product, at its own expense, including taking orders,
booking all sales, distributing the First Generation Product, and
handling invoicing, inventory, receivables, managing relationships
with the trade, returns, reimbursements, and charge-backs, customer
complaints and inquiries with respect to the First Generation
Product.
4.6
Stressgen Rights to Promote after
Exercise of Option . If Roche exercises the Option, then
Stressgen shall retain the right, but not the obligation, following
the Stressgen Sales Period, to promote the First Generation Product
in the United States to physicians prescribing for treatment of
RRP; provided, however, that Stressgen shall inform Roche in
writing [***] of its intention to exercise such right.
Stressgen shall also retain the right, but not the
obligation, to co-promote with Roche
11
the First Generation Product in the United
States to physicians prescribing for any other Non-GW Indications
(to be more fully described in the First Generation Product License
Agreement and a commercialization plan to be agreed upon by the
Joint Commercialization Committee described in Appendix A).
Stressgen shall be responsible for the training and compensation of
all Stressgen sales representatives devoted to promoting the First
Generation Product, and Roche shall provide Stressgen with
appropriate promotional materials for such co-promotion efforts, at
no cost to Stressgen.
4.7
Stressgen [***].
(a)
Notwithstanding the grant to Roche
of the Option, and the Second Generation Development License,
commencing upon the Effective Date and extending until the earlier
of: (i) the exercise by Roche of the Option; or
(ii) the receipt by Stressgen of [***], Stressgen shall have
the right to enter into discussions and negotiations and to execute
an agreement [***]; provided, however , that in no event
shall Roche have the right to [***]
(b)
[***] As used herein, an
“Accepted Process” means a process that (A) Stressgen
represents in writing to Roche is the final process for manufacture
of the First Generation Product and intended to be the process it
will use for commercial production of the First Generation Product,
if approved; and (B) has been reviewed and accepted by the FDA for
the commencement of Phase III Clinical Trials of the First
Generation Product. Any amounts paid by Roche pursuant to
Sections 6.2 and 6.3 with respect to the Second
Generation Development License [***]
(c)
Effect on
Option. If
Stressgen [***] shall cause the immediate termination of the Option
with respect to that portion of the Territory [***]
(d)
Effect on Second Generation
Product License. In
addition, if Stressgen [***] Stressgen shall have the right, upon
written notice to Roche, to terminate Roche’s license to the
Second Generation Product, as set forth in Article 6, as
follows. If Stressgen [***] prior to the time that Roche has
paid any amount to Stressgen pursuant to Section 6.2 ,
Stressgen shall have the right to terminate the
12
Second Generation Development License (as
defined in Section 6.1), without any payment to Roche.
If Stressgen [***] after the time that Roche has paid any amount to
Stressgen pursuant to Section 6.2 , but before Roche
has paid to Stressgen the [***] payment due under Section 6.3,
Stressgen shall have the right to terminate all of Roche’s
rights in and to the Second Generation Product as granted under
Section 6.1 , provided it pays to Roche an amount equal
to [***] of all amounts paid by Roche to Stressgen pursuant to
Section 6.2.
4.8
Roche Promotion Rights During
Stressgen Sales Period. If Roche exercises the Option and desires
to participate in the promotion of the Product in the U.S. and/or
Canada, at its own cost, during the Stressgen Sales Period, then
Roche shall so notify Stressgen, and Stressgen upon such
notification shall meet and negotiate in good faith: (a) a
commercialization plan for the co-promotion of the Product by Roche
and Stressgen in the United States and/or Canada during the
remainder of the Stressgen Sales Period; and (b) a mechanism
for compensating Roche based upon [***].
4.9
Stressgen Right to Terminate
Option [***]
(a)
During the period commencing upon
the Effective Date and until the first to occur of (i) [***] (ii)
[***] as defined below, or (iii) December 31, 2005, following
the [***], Stressgen or its successor in interest shall have the
right, upon written notice to Roche, to terminate the Option [***];
provided, that if, as of the effective date of such termination,
[***].
(b)
As used in this Agreement, [***]
shall mean either:
[***]
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ARTICLE 5
RIGHTS TO OTHER FUSION PROTEINS
5.1
Option to Obtain Right of First
Negotiation for Cancer. Upon reasonable request of Roche, Stressgen
agrees to meet and negotiate with Roche the terms of a
collaboration and/or license agreement with respect to the
development and/or commercialization of one or more Other HPV
Fusion Proteins, or fragments or conjugates thereof, for treatment
of cancers related to or stemming from HPV (the “Cancer
Rights”). In addition, following the date on which
Roche has paid to Stressgen at least [***] pursuant to
Section 6.2 , and continuing until December 31,
2006, Roche shall have the option, upon written notice and payment
of an additional [***] to Stressgen, to enter into exclusive
negotiations with Stressgen with respect to the Cancer Rights
worldwide, for a period of one-hundred twenty (120) days following
such written notice and payment, it being understood that such
agreement to negotiate does not imply any obligation on the part of
Stressgen or Roche to consummate a transaction with respect to the
Cancer Rights.
5.2
Option to Obtain Right of First
Negotiation for HCV. Upon reasonable request of Roche, SBC
agrees to meet and negotiate with Roche the terms of a
collaboration and/or license agreement with respect to the
development and/or commercialization of one or more fusion proteins
containing both a Hepatitis C Virus (HCV) antigen and a bacterial
stress protein for treatment of Hepatitis C (the “HCV
Rights”). In addition, following the date on which
Roche has paid to SBC at least [***] pursuant to
Section 6.2 , and continuing until December 31,
2006, Roche shall have the option, upon written notice and payment
of an additional [***] to SBC, to enter into exclusive negotiations
with Stressgen with respect to the HCV Rights worldwide, for a
period of one-hundred twenty (120) days following such written
notice and payment, it being understood that such agreement to
negotiate does not imply any obligation on the part of SBC or Roche
to consummate a transaction with respect to the HCV
Rights.
5.3
Notwithstanding Roche’s option
to acquire the right to negotiate exclusively with Stressgen and
SBC granted in Section 5.1 and 5.2, if:
(a)
SBC undergoes [***], Stressgen or
its successor in interest shall have the right, upon written notice
to Roche, to terminate Roche’s options to obtain
14
such exclusive negotiation rights under Sections
5.1 and 5.2, to the extent such options are unexercised at the
[***]; or
(b)
Stressgen terminates the Second
Generation Product License pursuant to Section 4.7(d), then
the such termination shall cause the immediate termination of
Roche’s options to obtain such exclusive negotiation rights
under Sections 5.1 and 5.2, to the extent such options are
unexercised as of [***]; or
(c)
[***] of SBC and Stressgen,
Stressgen shall have the right, upon written notice to Roche, to
terminate Roche’s options to obtain such exclusive
negotiation rights under Sections 5.1 and 5.2, to the extent such
options are unexercised as of the execution of such Third Party
Collaboration Agreement. As used herein, [***] the technology
and intellectual property Controlled by SBC and Stressgen relating
to the use of the immunostimulatory powers of heat shock proteins
and recombinant technology to fuse, or covalently link, a stress
protein with a protein antigen to create a single hybrid protein
designed to trigger the immune system to recognize that
antigen.
ARTICLE 6
GRANT OF SECOND GENERATION PRODUCT RIGHTS TO
ROCHE
6.1
License Grant to
Roche. As of the
Effective Date (a) Stressgen grants, and shall cause its
Affiliates to grant, to Roche a non-exclusive, worldwide (excluding
Canada) license, including a license under the MIT Agreement, under
the Stressgen Patent Rights and the Stressgen Know-How to develop,
manufacture, have manufactured, use, and import the Second
Generation Product for the GW Indication; and (b) SBC grants,
and shall cause its Affiliates to grant, to Roche a non-exclusive
license, including a license under the MIT Agreement, under the
Stressgen Patent Rights and the Stressgen Know-How to develop,
manufacture, have manufactured, use, and import the Second
Generation Product in Canada for the GW Indication (collectively,
the “ Second Generation Development License
”). The Second Generation Development License shall
terminate on March 31, 2005, unless extended
15
as provided in Sections 6.2 and
6.3 , or terminated as provided in Sections 4.7(d)
or 4.9 .
6.2
Roche Right to Maintain
License.
(a)
On or before [***], Roche shall have
the right to maintain the Second Generation Development License by
either (i) paying to Stressgen [***] to maintain the Second
Generation Development License until [***], or (ii) paying to
Stressgen [***] to maintain the Second Generation Development
License until the earlier of: (A) Roche exercising its
rights under Section 6.3 ; or (B) [***], subject
to Sections 4.7 and 4.9 . If Roche elects
to maintain the Second Generation Development License under
clause (a) of the preceding sentence, then, by paying to
Stressgen an additional payment of [***], Roche shall have the
right to maintain the Second Generation Development License until
the earlier of: (1) Roche’s exercising its rights
under Section 6.3 ; or (2) the earlier to occur of
(a) [***]; or (b) [***]; or (c) [***].
(b)
If Roche does not maintain its
Second Generation Development License, either because
(i) [***] it does not [***] or [***] Roche does not [***],
then the Second Generation License shall terminate.
6.3
Right to Make Exclusive the
Second Generation Development License.
(a)
If the Second Generation Development
License has been maintained beyond [***] as provided in
Section 6.2 , then, by payment to Stressgen of the
one-time, nonrefundable amount of [***] by no later than the first
to occur of: (i) [***]; or (ii) [***], Roche shall
have the right to retain such license, which shall become an
exclusive worldwide license, subject to Stressgen’s rights
under Sections 4.7 and 4.9 .
(b)
If Roche exercises its rights under
this Section 6.3 for payment of [***], Stressgen and
SBC hereby grant to Roche the exclusive right to use, import,
manufacture, or have manufactured the Second Generation Product;
provided, however, that such grant shall in no way be construed as
impinging or otherwise
16
affecting the rights of Stressgen and SBC to
use, import, manufacture or have manufactured the First Generation
Product as provided in Article 3 .
(c)
If the Second Generation Development
License has been maintained beyond [***] as provided in
Section 6.2 , and Roche does not [***] by no later than
the first to occur of: (i) [***]; or (ii) [***],
then the Second Generation Development License shall
terminate.
6.4
Milestone Payments for
Maintenance of Exclusive License. If the Second Generation Development License has
been made exclusive as provided in Section 6.3 , then
Roche shall pay to Stressgen the following one-time, nonrefundable
amounts indicated below, within thirty (30) days after the first
occurrence for the Later Stage Second Generation Product of each of
the following events for GW Indications and receipt of an invoice
from Stressgen:
|
Event
|
|
Payment (millions of
dollars)
|
|
|
|
|
|
1. [***]
|
|
[***]
|
|
2. [***]
|
|
[***]
|
|
3. [***]
|
|
[***]
|
|
3. [***]
|
|
[***]
|
|
Total:
|
|
[***]
|
Roche shall promptly notify
Stressgen in writing of the occurrence of the specified event for
the Second Generation Product. Stressgen shall send Roche an
invoice of the relevant amount, and Roche shall pay Stressgen the
invoiced amount within thirty (30) days after receipt of the
invoice. All payments set forth in this
Section 6.4 shall be non-creditable, except payment 3,
of which [***] shall be creditable by Roche against sales-based
payments owed Stressgen pursuant to Section 6.10
;
17
provided, however, that in no event shall the
sales-based payments owed to Stressgen thereunder be reduced below
[***] of that otherwise due and owing, subject to
Section 8.4 . If Roche does not pay such
milestone amount within such thirty (30) day period, then all
rights granted under the Second Generation Development License
shall terminate.
6.5
Exclusive Commercialization
License. If the
Second Generation Development License has been made exclusive as
provided in Section 6.3 and Roche timely makes all
payments set forth in Section 6.4 , then effective only
in such event, Stressgen hereby grants to Roche the exclusive right
to use, sell, offer to sell, market, promote and otherwise
commercialize the Second Generation Product for the GW Indication,
which such license shall extend, on a country-by-country basis,
until the last to expire Valid Claim covering the manufacture, use,
sale, offer for sale or importation of the Second Generation
Product (the “ Second Generation Commercial License
”), unless earlier terminated as provided
hereunder.
6.6
Diligent Efforts by
Roche . Following
Roche’s exercise of its rights under Section 6.3
, Roche agrees to use Diligent Efforts to develop, obtain
Regulatory Approval for, and commercialize the Second Generation
Product. In the event Roche determines that Roche or its
Affiliates is no longer able, or ceases to desire, to develop,
obtain Regulatory Approval for, or commercialize the Second
Generation Product, for any reason, then Roche shall so notify
Stressgen in writing, and the Second Generation Commercial License
shall terminate.
6.7
Stressgen Development
Assistance. Roche
may request that Stressgen conduct studies with respect to Second
Generation Product or other matters involving cofactors or other
antigens. If Stressgen has the capacity at the time of such
request, then Stressgen shall perform such studies at an FTE rate
of [***] per year.
6.8
Rights to Expand Second
Generation Commercial License to Non-GW Indications.
If Roche obtains the Second
Generation Commercial License pursuant to Section 6.5 ,
and in the further event that the [***], Roche shall have the right
to so notify Stressgen in writing that it desires to expand the
Second Generation
18
Commercial License to include the right to [***]
for one or more Non-GW Indications. In such event, Stressgen agrees
that it [***].
6.9
Restrictions on
Roche.
(a)
Unless and until Roche obtains the
right to develop the Second Generation Product for Non-GW
Indications as provided under Section 6.8 , Roche shall
not itself, nor shall it permit any third party to, conduct any
clinical trials of the Second Generation Product for Non-GW
Indications in the Territory, or market, promote or
advertise the use of the Second Generation Product for Non-GW
Indications in the Territory, or use any tradename, trademark or
trade dress, in connection with the marketing and sale of the
Second Generation Product that is substantially similar to the
Trademarks so as to create a likelihood of confusion in the market
place as to the origin of the Second Generation Product, absent an
agreement in writing by the Parties to the contrary. It is
expressly understood and agreed by Roche that, even if Roche
exercises the Option, the foregoing restrictions shall remain in
place unless otherwise agreed in writing by Stressgen in order to
permit Stressgen to recognize the anticipated economic value of its
license to Roche of the First Generation Product pursuant to the
Option and as contemplated under this Agreement.
(b)
Roche hereby acknowledges that
Articles II, V, VII, VIII, IX, X, XII, XIII and XV of the MIT
Agreement shall be binding upon Roche, its Affiliates and their
respective sublicensees as if each of them were a party to the MIT
Agreement. In particular, Roche agrees and understands that
SBC’s exclusive rights, privileges and license under the MIT
Agreement, and therefore Roche’s sublicense under the MIT
Agreement shall terminate upon expiration or abandonment of all
issued patents and filed applications within the Patent Rights (as
defined in the MIT Agreement), unless the MIT Agreement is earlier
terminated in accordance with the provisions of the MIT
Agreement. Roche hereby acknowledges that SBC’s license
under the MIT Agreement is expected to terminate on
[***].
(c)
The Second Generation Commercial
License granted to Roche hereunder shall include the right to grant
sublicenses to its Affiliates and Third Parties
19
under such rights and licenses, in whole or in
part. If Roche grants such a sublicense, Roche shall ensure
that all of the applicable terms and conditions of this Agreement
shall apply to the Affiliate or Third Party sublicensee to the same
extent as they apply to Roche for all purposes. Roche assumes
full responsibility for the performance of all obligations so
imposed on such Affiliate or Third Party sublicensee and will
itself account to Stressge
