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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.
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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 shall grant






