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EXHIBIT 10.22
*** TEXT OMITTED AND FILED SEPARATELY
PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST
UNDER 17 C.F.R. SECTION 200.80(b)(4)
AND RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED
COLLABORATION AGREEMENT
THIS
COLLABORATION AGREEMENT (the "AGREEMENT") is made and entered into
as
of August 20, 2004 (the "SIGNING DATE") by
and between STRUCTURAL GENOMIX, INC.
located at 10505 Roselle Street, San Diego,
CA 92121 ("SGX"), and F. HOFFMANN-LA
ROCHE LTD, located at Grenzacherstrasse
124, 4070 Basel, Switzerland, and
HOFFMANN-LA ROCHE INC., located at 340
Kingsland Street, Nutley, New Jersey
07110, USA ( "ROCHE"). SGX and Roche may be
referred to herein individually as a
"Party" and collectively as the
"Parties."
BACKGROUND
WHEREAS,
SGX is in the business of structure directed drug discovery;
WHEREAS,
Roche is in the business of discovering, developing,
manufacturing and commercializing
pharmaceuticals;
WHEREAS,
SGX and Roche wish to enter into a collaborative research
program
to identify and generate lead compounds
against certain targets; and
NOW,
THEREFORE, in consideration of the foregoing and the covenants
and
promises contained in this Agreement, the
Parties hereby agree as follows:
1. DEFINITIONS
1.1
"Affiliate"
means
(a) an
organization, which directly or indirectly controls a party
to this Agreement;
(b) an
organization, which is directly or indirectly controlled by
a party to this Agreement;
(c) an
organization, which is controlled, directly or indirectly,
by the ultimate parent company of a
party.
Control as per 1.1 (a) to 1.1(c) is defined
as owning more than fifty percent of
the voting stock of a company or having
otherwise the power to govern the
financial and the operating policies or to
appoint the management of an
organization. With respect to Roche the
term "Affiliate" shall not include
Genentech, Inc., 1 DNA Way, South San
Francisco, California 94080-4990, U.S.A.
("Genentech") or Chugai Pharmaceutical Co.,
Ltd, 1-9, Kyobashi 2-chome, Chuo-ku,
Tokyo, 104-8301, Japan ("Chugai"),
respectively,
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unless Roche opts for such inclusion of
Genentech and/or Chugai by giving
written notice to SGX.
1.2
"Clinical
Candidate Selection" means the first dose in an animal GLP
toxicology study.
1.3
"Collaboration"
means the activities conducted by the Parties in
connection with the Collaboration Plan.
1.4
"Collaboration
Plan" means the plan of research attached as Exhibit
A to this Agreement, as may be amended from
time to time by the JSC in
accordance with Section 2.6.
1.5
"Collaboration
Product" means any product that comprises or contains
or is developed or manufactured based on a
Licensed Compound.
1.6
"Collaboration
Target" means the protein target known as
[...***...], or the additional target
selected pursuant to Section 2.4. D).
1.7
"Commercially
Reasonable Efforts" mean efforts consistent with those
generally utilized by companies of a
similar size for their own internally
developed pharmaceutical products of
similar market potential, at a similar
stage of their product life taking into
account the existence of other
competitive products in the market place or
under development, the proprietary
position of the product, the regulatory
structure involved, the anticipated
profitability of the product and other
relevant factors. With respect to Roche,
it is understood that such Product
potential may change from time to time based
upon changing scientific, business and
marketing and return on investment
considerations. Notwithstanding the
foregoing, the Parties also acknowledge that
Roche (and its Affiliates) do not always
seek to market its own products in
every such country or seek to obtain
regulatory approval in every such country
or for every potential indication. As a
result, the exercise by Roche of
Commercially Reasonable Efforts is to be
determined by judging its efforts taken
as a whole.
1.8
"Controls" or
"Controlled" means possession of the ability to grant
the licenses or sublicenses as provided for
herein, without violating the terms
of any agreement or other arrangement with
a Third Party.
1.9
"Derived
Compound" means an analog, homolog, isomer, isostere or
other derivative that Roche makes from,
derives from or bases upon any compound
within the Early Lead Series by one or more
modifications that results in a
compound having a superior profile against
an [...***...] target, in one or more
respects, as a candidate for further
development than the compound within the
Early Lead Series from which it is derived
and which is identified, by or on
behalf of Roche or any of its Affiliates or
sub-licensEeS during the Term of the
Collaboration or within [...***...]
([...***...]) years after the Term of the
Collaboration ends. The term "Derivative"
shall not include any derivatives made
by Roche or any of its Affiliates or
sub-licensees without the use of SGX
BackgroUnD Technology.
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1.10
"Development Event"
means any of the events described in Section
3.3.
1.11
"Early Lead Series"
means the collection of compounds within a
single chemical series identified in the
course of the Collaboration either: (a)
(i) which contains compounds that satisfy
the criteria described in Part 1 of
Exhibit B, (ii) in which each of the
criteria in Part 2 of Exhibit B are covered
by compounds within the series taken as a
whole (but not necessarily by any one
compound), and (iii) is designated by the
JSC as an "Early Lead Series" under
Section 2.4(a); or (b) which is designated
by the JSC as an "Early Lead Series"
under Section 2.4(b).
1.12
"Effective Date" means
October 1, 2004.
1.13
"First Commercial
Sale" means the first sale of a Collaboration
Product to a Third Party following the
receipt of any Regulatory Approval
required for the sale of Collaboration
Product.
1.14
"Fragment" means a
compound used in the SGX FAST(TM) screen.
1.15
"Initiation" means the
first dosing of the first patient in the
applicable clinical study.
1.16
"JSC" has the meaning
ascribed such term in Section 2.6.
1.17
"Know-How" means all
ideas, inventions, instructions, designs,
processes, formulas, software, materials,
methods, processes, techniques, and
data and all intellectual property rights
therein. 1.18 "Licensed Compound"
means a compound within an Early Lead
Series or a Derived Compound.
1.19
"Net Sales" "Adjusted
Gross Sales" means the amount of gross sales
of the Product invoiced by Roche, its
Affiliates and its sub-licensees to
independent third parties less deductions
of returns (including allowances
actually given for spoiled, damaged,
out-dated, rejected, returned Product sold,
withdrawals and recalls) and return
reserves, rebates (price reductions, rebates
to social and welfare systems, charge backs
and charge back reserves, government
mandated rebates and similar types of
rebates e.g., P.P .R.S, Medicaid), cash
discounts, volume (quantity) discounts
granted at the time of invoice, taxes
(value added or sales taxes, government
mandated exceptional taxes and other
taxes directly linked to the gross sales
amount). "Net Sales" means the amount
calculated by subtracting from the amount
of Adjusted Gross Sales a lump sum
deduction of [...***...] percent
([...***...]%) of Adjusted Gross Sales in lieu
of those sales related deductions which are
not accounted for on a product by
product basis (e.g. outward freights,
postage charges, transportation insurance,
packaging materials for dispatch of goods,
custom duties, bad debt, discounts
granted later than at the time of
invoicing). Notwithstanding the foregoing,
amounts received by Roche, its Affiliates
and sub-licensees for the sale of
Product among Roche, its Affiliates or
sub-licensees for resale shall not be
included in the computation of Adjusted
Gross Sales and Net Sales.
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1.20
"Patent Rights" means
patent applications filed in any country
worldwide, including provisionals,
utilities, continuations (in whole or in
part), divisionals, reissues,
reexaminations, and foreign counterparts thereof,
any patents issued on such applications and
any extensions of term,
registrations or confirmations of such
patents. 1.21 "Phase 1", "Phase 2" and
"Phase 3" means Phase 1, Phase 2 and Phase
3 clinical trials, respectively, in
each case as prescribed by the U.S. Food
and Drug Administration or any
successor entity (the "FDA"), and agencies
of other governments of other
countries having similar jurisdiction over
the development, manufacturing and
marketing of pharmaceuticals.
1.22
"Regulatory Approval"
means the approval of the U.S. Food and Drug
Administration or any regulatory body with
similar regulatory authority in any
other jurisdiction in the world, necessary
for the marketing and sale of a
pharmaceutical or biotechnology product in
the United States, one or more
countries in the European Union or Japan
1.23 "Roche Background Technology"
means Patent Rights and Know-How which are
owned or Controlled by Roche on the
Effective Date or during the Term of the
Collaboration and are necessary for the
conduct of the Collaboration, including
without limitation, Roche Materials.
1.24
"Roche Materials"
means all biological and chemical materials,
including but not limited to the biological
and chemical materials embodying the
Collaboration Target, any protein, clone or
vector used to express the
Collaboration Target, assay protocols and
materials, and any compounds provided
by Roche to SGX for the purpose of
performing the Collaboration Plan.
1.25
"Royalty Term" means
the obligation of Roche to pay royalties under
Section 3.4 shall continue for each
Collaboration Product on a Collaboration
Product-by-Collaboration Product and
country-by-country basis, until the later
of (i) the expiry of the last Valid Claim
in such country claiming such
Collaboration Product and (ii) [...***...]
years after the First Commercial Sale
of such Collaboration Product. With regard
to the calculation of the [...***...]
year period, the EU shall be considered as
one country.
1.26
"SGX Background
Technology" means Patent Rights and Know-How which
are owned or Controlled by SGX on the
Effective Date or during the Term of the
Collaboration and are necessary for the
conduct of the Collaboration or the
exercise of Roche's license rights under
Section 4.1(a), including without
limitation compounds within Early Lead
Series, but excluding any methods or
technologies comprising SGX's fragment
based FAST(TM) lead discovery
technologies, other than synthetic
protocols required for the synthesis of
compounds contained within Early Lead
Series.
1.27
"SGX Materials" means
(1) the biological and chemical materials
embodying compounds within an Early Lead
Series or a structure of the
Collaboration Target; and (2) any protein,
clone, or vector used to express the
Collaboration Target;
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in each case which are developed by SGX in
the course of the Collaboration for
the purpose of performing the Collaboration
Plan.
1.28
"Term of the
Collaboration" means the period commencing on the
Effective Date, and terminating on the
[...***...] anniversary of the Effective
Date, which period may be extended by up to
[...***...] ([...***...]) months at
Roche's discretion, upon writteN
NOTICE.
1.29
"Third Party or Third
Parties" means any entity other than Roche or
SGX or their respective Affiliates.
1.30
"Valid Claim" means a
claim in any (i) unexpired and issued Patent
Right owned or Controlled by SGX or Roche
claiming composition of matter of
compounds that has not been (x) held
permanently revoked, unenforceable or
invalid by a final unappealable decision of
a court or government agency of
competent jurisdiction over such claim or
(y) admitted to be invalid or
unenforceable through disclaimers, consent
decrees or otherwise, or (ii) pending
patent application that is a Patent Right
owned or Controlled by SGX or Roche
claiming composition of matter of
compounds.
2. COLLABORATION.
2.1
Collaboration.
Subject to the terms and conditions of this Agreement
Roche and SGX will use commercially
reasonable efforts to conduct the
Collaboration in accordance with the
Collaboration Plan.
2.2
Provision of
Roche Background Technology. Promptly following the
Signing Date and during the Term of the
Collaboration, Roche will provide SGX
with reasonable quantities of such Roche
Materials and other Roche Background
Technology as agreed to by Roche that are
necessary for the conduct of the
Collaboration by SGX.
2.3
Provision of SGX
Background Technology. During the Term of the
Collaboration, SGX will provide Roche with
reasonable quantities of available
SGX Materials and other SGX Background
Technology as agreed by the JSC necessary
for Roche to conduct the Collaboration and
exercise its applicable rights under
Article 4.1(a).
2.4
Early Lead
Series.
(a) During the
Term of the Collaboration, in accordance with the
Collaboration Plan, SGX will provide the
JSC with details (and materials for
testing by Roche) of any collection of
compounds identified in the Collaboration
which SGX believes to meet the criteria for
an Early Lead Series in Section
1.10(a)(i) and (ii). Within thirty (30)
days following review of the data by the
JSC, the JSC will formally designate any
such collection of compounds as an
Early Lead Series if the collection meets
the required criteria in Section
1.10(a)(i) and (ii) and if such collection
of compounds is patentably distinct
from any previously designated Early Lead
Series.
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Upon designation by the JSC of any such
Early Lead Series, SGX will provide
Roche with any information or materials,
generated under the Collaboration
concerning such Early Lead Series,
including but not limited to X-ray
diffraction data, protocols for chemical
synthesis, and all assay data, which
has not already been provided.
(b) In the event
that a collection of compounds does not meet all
of the criteria in Part B of Exhibit B,
upon the request of SGX, the JSC may
designate such collection as an Early Lead
Series, notwithstanding that all of
the criteria have not been met.
(c) Roche shall
have the right, but not the obligation to accept
more than three Early Lead Series under the
Collaboration.
(d) If by the
start of the [...***...] month, SGX has not
commenced Fragment elaboration for the
Collaboration Target, Roche has the right
to nominate a substitute target in
consultation with SGX. Upon acceptance of
such substitute target bY the JSC, such
target shall be deemed a Collaboration
Target.
2.5
Records;
Reports. At least quarterly during the Term of the
Collaboration SGX will have the obligation
to prepare and provide to the JSC a
detailed written report summarizing the
progress of the work performed by SGX in
the course of the Collaboration during the
preceding quarter. Promptly upon
expiry of the Term of the Collaboration,
SGX shall provide a final written
report summarizing its activities during
the Collaboration and the results
thereof. Upon the written request of Roche
and not more than once in each
calendar year, SGX will permit Roche, at
Roche's expense, to have access during
normal business hours to those records of
SGX that may be necessary to verify
the basis for any other payments
hereunder.
2.6
Joint Steering
Committee.
(a) Formation.
SGX and Roche will establish a joint steering
committee ("JSC") to oversee the
Collaboration.
(b) Membership.
The JSC shall be comprised of three (3)
representatives from Roche and three (3)
representatives from SGX, designated by
the Parties promptly following the
Effective Date. Each Party may replace its
JSC representatives at any time, with
written notice to the other Party. The JSC
may name additional members to the JSC from
time to time so long as each Party
has an equal number of members. In
addition, with prior mutual approval, either
Party may invite non-voting employees,
consultants or scientific advisors to
attend meetings of the JSC. One of the
three Roche representatives shall be the
appointed Roche Global Alliance Director.
The Global Alliance Director will act
as the primary contact person for all
non-scientific matters including payment,
third party license and patent related
matters.
(c) Decisions.
Each Party shall have one vote on the JSC. All
decisions of the JSC shall be made by
unanimous vote. Any matter which the JSC
is unable to agree upon shall be submitted
to the Chief Executive Officer of SGX
and the
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Head of Pharma Partnering of Roche for
resolution. All decisions that cannot be
agreed upon by the SGX CEO and the Roche
Head of Pharma Partnering shall be made
by [...***...] reasonably taking into
consideration the position of [...***...],
excluding decisions relating to the
activities carried out by [...***...] under
the Collaboration Plan, which will be made
by [...***...] reasonably taking into
consideration the position of
[...***...].
(d) Project
Team. The JSC shall establish a project team (the
"Project Team") comprising at least three
(3) representatives from Roche and
three (3) representatives from SGX,
designated by the Parties promptly following
the Effective Date. The JSC may expand the
size of the Project Team, in its sole
discretion, provided that the Project Team
shall always comprise an equal number
of representatives from Roche and SGX. Each
Party may replace its Project Team
representatives at any time, with written
notice to the other Party. The Project
Team will direct the performance of the
Collaboration and shall meet to
discharge its responsibilities via
videoconference, teleconference or in person
on an at least bi-weekly basis, or as the
Project Team may agree. Meetings of
the Project Team may be held only if a
quorum of at least one (1) representative
of each Party participates. Within thirty
(30) days of the end of each calendar
quarter the Project Team shall submit a
quarterly report to the JSC describing
the performance of the Collaboration during
such calendar quarter. Each Party
will be responsible for paying its own
expenses in connection with participating
in the meetings of the Project Team.
(e)
Responsibilities. The JSC will review, and monitor the
performance of the Collaboration. The JSC
will be responsible for (i)
supervising the Project Team, (ii)
modifying or amending the Collaboration Plan
as appropriate subject to the final
sentence of this Section 2.6(e); (iii)
confirming the achievement of the event in
Section 3.2(a) and designating
compound collections as Early Lead Series
in accordance with Section 2.4. Any
amendments to the Collaboration Plan which
alter the financial terms or
materially alter the nature or scope of the
Collaboration must be agreed in
writing by the Parties.
(f) Meetings.
The JSC shall meet at least quarterly. The Parties
shall mutually agree upon times and places
for such meetings (alternating
between San Diego, CA and Palo Alto, CA, or
as the JSC may otherwise agree), to
discharge its responsibilities. If mutually
agreed by the Parties, such meeting
may be held via videoconference or
teleconference. Each Party will be
responsible for paying its own expenses in
connection with participating in the
meetings of the JSC. The JSC shall prepare
written minutes of each meeting and a
written record of all JSC decisions,
whether made at a JSC meeting or otherwise.
2.8 Permitted Activities.
(a) By SGX. SGX
agrees that SGX will not use any Confidential
Information of Roche to replicate any Roche
Material for any purpose other than
as provided herein and shall destroy all
proprietary Roche Materials after
expiry of the Term of the
Collaboration.
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(b) By Roche.
After the expiry of the Collaboration, Roche shall
destroy all chemical materials within the
SGX Materials received from SGX and
not designated as Early Lead Series under
this Agreement.
3. CONSIDERATION
3.1
Research
Fees.
(a) Within
thirty (30) days after the Effective Date Roche will
pay to SGX a non-refundable, non-creditable
upfront fee of $[...***...].
(b) During the
Term of the Collaboration, Roche will pay to SGX
research payments of $[...***...] per
calendar quarter, payable on the first day
of each calendar quarter, commencing on the
Effective Date.
3.2
Research Events.
Within thirty (30) days of the date of achievement
of the applicable research event described
below during the Term of the
Collaboration, Roche will pay, to SGX the
following non-refundable and
non-creditable event payments:
(a)
The first
crystal structure that reveals density of
a Fragment bound to the Collaboration Target
with at least [...***...] A resolution, where data
completeness in the final resolution shell is
greater than or equal to [...***...]%, and the fragment
position and orientation is clearly interpretable
$[...***...]
(b)
upon designation
by the JSC of the first
Early Lead Series
$[...***...]
(c)
upon designation
by the JSC of each subsequent
Early Lead Series
$[...***...]
per series
3.3
Development
Events. Within thirty (30) days of the date of
achievement of the applicable Development
Event described below, Roche will pay
to SGX the following non-refundable event
payments on a Collaboration
Product-by-Collaboration Product basis:
(a)
Clinical
Candidate Selection
$[...***...]
(b)
Initiation of
Phase 1
$[...***...]
(c)
Initiation of
Phase 2
$[...***...]
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(d)
Initiation of
Phase 3
$[...***...]
(e)
Receipt of first
Regulatory Approval
$[...***...]
Roche shall make each of such payments only
once for the first occurrence of the
requisite event for the Collaboration
Product regardless of how many times the
event may be subsequently achieved with the
particular Collaboration Product.
Roche shall make each of such payments for
the first Collaboration Product to
achieve the applicable event, provided that
(i) if Roche ceases all development
of a particular Collaboration Product after
having made one or more payments
with respect to such Collaboration Product
under this Section 3.3 following
accomplishment of any Development Event,
there shall be no payment due upon the
accomplishment of that same Development
Event with respect to a subsequent
Collaboration Product; and (ii) if Roche
has received Regulatory Approval for a
Collaboration Product and continues
development of an additional Collaboration
Product ("Subsequent Product"), payments
will be due under this Section 3.3 for
the achievement of Development Events by
the Subsequent Product (including those
Development Events which may have been
achieved by the Subsequent Product prior
to such receipt of Regulatory
Approval).
3.4
Royalties. Roche
will pay to SGX during the Royalty Term the
following royalties on Net Sales of
Collaboration Products by or on behalf of
Roche or its Affiliates or Sublicensees on
a Collaboration
Product-by-Collaboration Product basis on
the following tiers:
Net Sales up to US $[...***...]
[...***...]%
Net Sales from US $[...***...] to US $[...***...]
[...***...]%
Net Sales over US $[...***...]
[...***...]%
3.5
Combination
Products. In the event the Collaboration Product is sold
as part of a combination product containing
a Licensed Compound and one or more
other pharmaceutically active ingredients,
the Net Sales of the Collaboration
Product shall be determined by multiplying
the Net Sales (as determined in the
manner described above) of the combination
product by the fraction A/B, where A
is the weighted average sale price of the
Collaboration Product containing the
Licensed Compound alone as a
pharmaceutically active ingredient (in the same
strength as contained in the combination
product) when sold separately in
finished form, and B is the weighted
average sale price of the Collaboration
Product sold as part of a combination
product when sold separately in finished
form. In the event that such average sale
price cannot be determined for the
Collaboration Product containing the
Licensed Compound alone as a
pharmaceutically active ingredient, Net
Sales shall be mutually agreed by the
parties based on the relative value
contributed by each pharmaceutically active
ingredient contained in such Collaboration
Product, and such agreement shall not
be unreasonably withheld.
3.6
Third Party
Royalties. In the event that Roche, is required to pay
royalties to a Third Party for licenses to
composition of matter patents
claiming compounds within an Early Lead
Series, Roche may offset up to
[...***...] percent ([...***...]%) of such
amounts due
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Third Parties against payments due SGX
under Section 3.4 above; PROVIDED,
HOWEVER, that Roche may not offset these
amounts against more than [...***...]
percent ([...***...]%) of the royalties
otherwise due SGX in any calendar
quarter. Any amount that has not been so
offset may be offset against royalties
due in subsequent calendar quarters,
subject to the limitation set forth in the
previous sentence.
3.7
Withholding
Taxes. All amounts due under this Agreement shall be
paid without deduction, set-off or
counterclaim and shall be made in full
without deduction of income, value added or
other taxes, charges or duties that
may be imposed. If any payment due under
this Agreement is or will be subject to
any tax, including withholding tax, Roche
shall pay to SGX the amount that will
ensure SGX receives and retains a net sum
equal to the payment it would have
received had the payment not been subject
to such tax.
3.8
Reports;
Payments. The royalties due under Section 3.4 shall be paid
quarterly within forty-five (45) days after
the close of each calendar quarter,
or earlier if practicable, immediately
following each quarterly period in which
such royalties are earned. With each such
quarterly payment, Roche shall furnish
SGX a royalty statement setting forth in
reasonable detail Collaboration
Product-by- Collaboration Product basis:
(i) Adjusted Gross Sales; (ii) Net
Sales; and (iii) the royalties due SGX in
such quarter.
3.9
Currency
Conversion. All amounts required to be paid under this
Agreement shall be paid in United States
dollars. Whenever calculation of Net
Sales requires conversion from any foreign
currency, Roche shall convert the
amount of Net Sales in foreign currencies
as computed in the Roche's central
Swiss Francs Sales Statistics for the
countries concerned. Roche shall first
convert the amount of Net Sales into Swiss
Francs and then into United States
dollars, using the YTD average exchange
rate, in accordance with Roche's then
current standard practices.
3.10
Late Payments. Any
payments or portions thereof due hereunder which
are not paid on the date such payments are
due, shall bear interest at the rate
equal to the lesser of the prime rate as
reported by the Chase Manhattan Bank,
New York, New York, plus [...***...]
percent ([...***...]%) or the maximum
amount permitted by law, compounded
monthly. This Section 3.10 shall in no way
limit any other remedies available to
SGX.
3.11
Audits. Roche shall
maintain accurate books and records which enable
the calculation of royalties payable under
this Agreement to be verified. Roche
shall maintain the books and records for
each quarterly period for three (3)
years after the submission of the
corresponding report under Section 3.8. Upon
thirty (30) days prior notice to Roche,
Roche's independent accountants,
reasonably acceptable to SGX, may have
access to Roche's books and records after
executing a reasonable confidentiality
agreement, during Roche's normal business
hours at mutually agreed times to conduct a
review or audit no more than once
per calendar year, and no more than once
with respect to any time period, for
the sole purpose of verifying the accuracy
of Roche's payments and compliance
with this Agreement. The accounting firm
shall report to SGX only whether there
has been a royalty underpayment and, if so,
the extent thereof. Any such
inspection shall be at SGX's expense,
however, in the event that an inspection
reveals
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underpayment of 5% or more in any audit
period, Roche shall pay the costs of the
inspection. Roche shall promptly pay to SGX
any underpayment identified in such
audit, with interest from the date such
amount(s) were due at the prime rate
reported by the Chase Manhattan Bank, New
York, New York plus [...***...]
percent ([...***...]%). The failure of SGX
to request verification of any
payment calculation during which
corresponding records are required to be
retained under this Section 3.11 shall be
considered acceptance of such
reporting by SGX.
4. LICENSES
4.1
Licenses to
Roche. Subject to the terms and conditions of this
Agreement, SGX hereby grants to Roche, the
following licenses:
(A) [...***...], [...***...],
[...***...] license (with the right
to grant sublicenses in accordance with
Section 4.3 below) under SGX's Patent
Rights and Know-How in Early Lead Series,
to make, have made, use, import, offer
for sale and sell Collaboration
Products.
(B) [...***...],
[...***...], [...***...] license (with the right
to grant sublicenses in accordance with
Section 4.3 below) under SGX's interest
in SGX Background Technology relating to
Early Lead Series, to use and modify
such SGX Background Technology solely as
necessary for Roche to exercise its
rights under Section 4.1(a) above.
4.2
Cross Licenses.
Each Party hereby grants to the other, a
non-exclusive, non-transferable,
royalty-free license to use and practice Roche
Background Technology and SGX Background
Technology, solely to conduct the
Collaboration.
4.3.
Sublicenses. Roche may
sublicense the rights granted in Section 4.1
to its Affiliates and to Third Parties who
are bona fide collaborators of Roche
with respect to the Early Lead Series for
which rights are being sublicensed.
Each such sublicense granted by Roche shall
be consistent with all of the terms
and conditions of this Agreement. Roche as
the sublicensor, shall remain
responsible for all of each such
sublicensee's obligations under this Agreement.
4.4
Product
Development. During the term of this Agreement, Roche will
keep SGX informed of its activities in
connection with the development of Early
Lead Series' and Collaboration Products,
including without limitation, the
achievement of events under Section 3.3. On
a half-yearly basis up to Initiation
of Phase 1 trials, and on a yearly basis
thereafter during the term of the
Agreement, Roche will provide SGX with a
written summary report detailing such
events and activities. When a registration
package requesting approval for
commercial sale of any Collaboration
Product is first filed in any country, and
when approval is received, Roche will
immediately notify SGX in writing.
***CONFIDENTIAL TREATMENT REQUESTED
11
<PAGE>
4.5
Diligence. Roche
will use Commercially Reasonable Efforts to
discover and develop Early Lead Series and
commercialize Collaboration Products
including using Commercially Reasonable
Efforts to bring at least one
Collaboration Product to the market, to
obtain Regulatory Approval to market
such Collaboration Product, to launch and
market such Collaboration Product and
promote and meet the market demand
therefor. Notwithstanding the above, Roche
will have the right at its sole discretion
to discontinue development of an
Early Lead Series and/or commercialization
of a Collaboration Product in any
country on written notice to SGX, subject
to Section 4.6.
4.6
Lack of
Diligence. In the event that Roche fails to use or continue
to use diligent efforts to actively develop
at least one Early Lead Series or at
least one Collaboration Product in
accordance with Section 4.5 above, or
notifies SGX that it will not conduct
further development or commercialization
with respect to a at least one Early Lead
Series or at least one Collaboration
Product, then SGX may terminate Roche's
rights under this Agreement with respect
to Early Lead Series upon written notice to
Roche, provided that Roche will have
a period of [...***...] ([...***...])
months following receipt of such notice to
demonstrate to SGX's reasonable
satisfaction that it has not failed to use or
continue to use diligent efforts in
accordance with Section 4.5 or to initiate
diligent efforts in accordance with Section
4.5. In the event that Roche's
rights terminate pursuant to this Section
4.6, the Parties will negotiate in
good faith for a period of [...***...]
days, immediately following the
termination of Roche's rights by SGX, (i)
at Roche's option, an agreement under
which SGX would receive compensation from
Roche and would not develop and
commercialize an Early Lead Series or
Collaboration Products developed
therefrom, or (ii) the appropriate
consideration for a license grant (as
described below) from Roche to SGX. In the
event that the Parties do not reach
an agreement under subsection (i) above,
SGX will thereafter have the exclusive
right to develop and commercialize Early
Lead Series and corresponding
Collaboration Products alone or with Third
Parties. and Roche sh