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EXHIBIT 10.26
*** 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
CONFIDENTIAL
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (the "AGREEMENT") is effective as of March
18, 2004 (the "EFFECTIVE DATE") by and between STRUCTURAL GENOMIX, INC., a
Delaware corporation located at 10505 Roselle Street, San Diego, CA 92121
("SGX"), and SERONO INTERNATIONAL SA, a corporation organized under the laws of
Switzerland, located at 15bis chemin des Mines, 1202 Geneva, Switzerland
("SERONO"). SGX and Serono may be referred to herein individually as a "Party"
and collectively as the "Parties."
BACKGROUND
WHEREAS, SGX has expertise in the field of structure directed drug
discovery; and
WHEREAS, Serono is in the business of, and has expertise in, developing,
manufacturing and commercializing biotechnology products; and
WHEREAS, SGX and Serono wish to enter into a collaborative research
program to develop early lead compounds against certain Serono drug targets;
NOW, THEREFORE, in consideration of the foregoing premises and the
covenants, agreements and promises contained in this Agreement, the Parties
hereby agree as follows:
1. DEFINITIONS
1.1 "Affiliate" means, with respect to a Party hereto, a corporation,
company or other entity that controls, is controlled by or under common control
with such Party. The term "control" means the direct or indirect possession of
the power to direct or cause the direction of the management and policies of a
party, whether through the ownership of voting securities, by contract or
otherwise. Control will be presumed if a party owns, either of record or
beneficially, more than fifty percent (50%) of the outstanding shares or
securities (representing the right to vote for the election of directors or
other managing authority) of a corporation, company or other entity. Such
corporation, company or other entity shall be deemed to be an Affiliate only so
long as such control exists.
1.2 "Collaboration" means the research collaboration performed by the
Parties pursuant to Section 2.1.
1.3 "Collaboration Plan" shall have the meaning ascribed in Section 2.1.
1.4 "Collaboration Product" means any Product that incorporates an Early
Lead Compound.
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1.5 "Collaboration Technology" means Patents and Know-How which are
made, conceived or reduced to practice or otherwise discovered or developed by
or on behalf of Serono or SGX, or jointly by or on behalf of Serono and SGX,
during and in the performance of the Collaboration.
1.6 "Commercially Reasonable Efforts" means efforts to develop or
commercialize a product consistent with those efforts Serono would devote, with
the exercise of prudent scientific and business judgment, to a product at a
similar stage of development resulting from its own research efforts, that has
similar commercial potential, a similarly sized market and faces a similar
competitive environment, based on conditions then prevailing.
1.7 "Confidential Information" shall have the meaning ascribed in
Section 6.1.
1.8 "Controls" or "Controlled" means possession of the legal right of a
Party to grant the licenses or sublicenses as provided for herein or to
otherwise disclose proprietary or trade secret information to the other Party,
without violating the terms of any agreement or other arrangement with a Third
Party or misappropriating or infringing the proprietary or trade secret
information of a Third Party.
1.9 "Early Lead Compound" means (a) the [...***...] identified in the
course of the Collaboration from an [...***...] or an [...***...], with the
following characteristics: [...***...], which have been identified in the course
of the Collaboration from an [...***...] or an [...***...], with the
characteristics ([...***...]) through ([...***...]) above, and which the
[...***...]; and (c) [...***...] identified in the course of the Collaboration
from the same [...***...] to which the [...***...] in clauses (a) and (b) belong
that have the characteristics described in clauses ([...***...]) through
([...***...]) above.
1.10 "Early Lead Patent" shall have the meaning ascribed in Section
5.2(b).
1.11 "Elaborated Fragment" means a compound identified in the course of
the Collaboration from an Initial Fragment Hit with the following
characteristics: (i) [...***...]; and (ii) [...***...].
1.12 "First Commercial Sale" means the first sale of a Product to a Third
Party in any country after all required marketing and pricing and/or pricing
reimbursement approvals for such country have been obtained, other than a
transfer or disposition (whether or not for consideration) of such Product for
charitable or promotional purposes or for preclinical, clinical, manufacturing,
regulatory or governmental purposes.
***CONFIDENTIAL TREATMENT REQUESTED
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1.13 "GLP" means the standards set forth in the current Good Laboratory
Practices regulations promulgated by the U.S. Food and Drug Administration,
published at C.F.R. Part 58, as such regulations may be amended from time to
time, and equivalent foreign regulations or standards as applicable.
1.14 "IND" means an Investigational New Drug application filed with the
U.S. Food and Drug Administration pursuant to 21 C.F.R. Part 312, or any
corresponding foreign application, registration or certification.
1.15 "Initial Fragment Hit" means a compound from the SGX FAST(TM)
screening library shown in a co-crystal structure determined in the course of
the Collaboration to be bound to a Serono Target.
1.16 "Initial Structure" means a [...***...] of a Serono Target which has
the following characteristics: [...***...].
1.17 "Joint Patent" shall have the meaning ascribed in Section 5.2(b).
1.18 "JSC" shall have the meaning ascribed in Section 2.7.
1.19 "Know-How" means all inventions (whether patentable or not),
instructions, designs, formulas, software, materials, compositions, methods,
processes, techniques, improvements, trade secrets, information and data.
1.20 "Milestone" means any or each of the milestone events described in
Sections 3.2 and 3.4.
1.21 "Net Sales" means the total amount received by Serono or its
Affiliates or sublicensees, as the case may be, for sales of Products to Third
Parties (other than sublicensees) in arm's length transactions, less: (i)
ordinary and customary prompt payment and other trade or quantity discounts
actually allowed and taken; (ii) credits or allowances actually granted for
damaged goods, recalls, returns or rejections of Products or for retroactive
price reductions; (iii) charge back payments, reimbursements and rebates,
including government-mandated rebates (including Medicaid rebates); (iv)
freight, postage and duties (including insurance premiums) actually incurred;
and (v) excise taxes, other consumption taxes, customs duties and compulsory
payments to governmental authorities actually paid and separately identified on
the invoice or other documentation maintained in the ordinary course of
business. A "sale" shall include any transfer or other disposition for
consideration, and Net Sales shall include the fair market value of all other
consideration received by Serono or its Affiliates or sublicensees in respect of
any grant of rights to make, use, sell or otherwise distribute Products, whether
such consideration is in cash, payment in kind, exchange or other form.
Transfers or dispositions, whether or not for consideration, of Products for
charitable or promotional purposes or for preclinical, clinical, manufacturing,
regulatory or governmental purposes shall not be deemed "sales." For
clarification, sale of a Product by Serono, its Affiliates
***CONFIDENTIAL TREATMENT REQUESTED
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or sublicensees to another of these entities for resale by such entity to a
Third Party shall not be deemed a sale for purposes of calculating "Net Sales"
hereunder, but the sale of such Product by such entity to such Third Party shall
be deemed to be a sale by such entity of a Product for purposes of calculating
Net Sales hereunder.
If a Product is sold in the form of a combination product containing one or more
products or active ingredients, devices, equipment or components which are
themselves not Products (a "Combination Product"), then for the purpose of
calculating royalties owed under this Agreement on sales of the Combination
Product, Net Sales shall be calculated as follows: first, Serono shall determine
the actual Net Sales of such Combination Product (calculated using the above
described deductions) and then such amount shall be multiplied by the fraction
A/(A+B), where A is the invoice price or fair market value, whichever is
greater, of the actual Product component of such Combination Product, and B is
the total invoice price(s) or fair market value, whichever is greater, of the
other product(s) or active ingredients, devices, equipment or components of such
Combination Product.
1.22 "Patents" means patent applications filed in any country worldwide,
including provisionals, utilities, continuations, continuations-in-part,
divisionals, and substitutions thereof, any patents issued on such applications
as well as any reissue, reexamination, and renewal thereof, any extensions of
term, registrations or confirmation of such patents or patent of addition based
on any such patent, and all foreign counterparts of any of the foregoing.
1.23 "Phase II Trial" and "Phase III Trial" means Phase II and Phase III
human clinical trials conducted in conjunction with the U.S. Food and Drug
Administration marketing approval process for a product, as more fully defined
in 21 C.F.R. Section 312.21(b) and (c), respectively, and (ii) equivalent human
clinical trials conducted pursuant to similar requirements in other countries in
the world.
1.24 "Product" means any product developed by or on behalf of Serono or
its permitted sublicensees that incorporates or is derived from an Early Lead
Compound.
1.25 "Project Team" shall have the meaning ascribed in Section 2.7.
1.26 "Regulatory Approval" means the approval of a Regulatory Authority
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.
1.27 "Regulatory Authority" means (a) the U.S. Food and Drug
Administration or (b) any regulatory body with similar regulatory authority in
any other jurisdiction anywhere in the world.
1.28 "Royalty Term" shall have the meaning ascribed in Section 3.6.
1.29 "Serono Background Technology" means all Patents and Know-How owned
or Controlled by Serono which are: (a) existing on the Effective Date or
discovered or developed during the Term of the Collaboration (i) outside of the
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CONFIDENTIAL
Collaboration or (ii) within the Collaboration but are of general application
(for example, have application to other proteins in addition to the Serono
Targets); and (b) necessary for the conduct of the Collaboration. Any Serono
Background Technology shall be deemed Confidential Information of Serono subject
to the rights and obligations set forth in Article 6 hereunder.
1.30 "Serono Co-Crystal Structure" means the [...***...] of the
[...***...] of a [...***...] with a [...***...], made in the course of the
Collaboration, which has the following characteristics: (i) [...***...] (i.e.,
the last [...***...] or is [...***...]); (ii) [...***...] in the [...***...];
(iii) [...***...]% [...***...] and [...***...]% in the [...***...]; (iv)
[...***...]; (v) [...***...] ([...***...]) [...***...] and (vi) [...***...] of
the [...***...] of the [...***...] is [...***...] a [...***...].
1.31 "Serono Compound" means an active small molecule ligand that is
provided by Serono to SGX for inclusion in the Collaboration that is not
publicly known to bind to, inhibit or modulate the Serono Target to which it is
intended to be bound under the Collaboration.
1.32 "Serono Materials" means the biological and chemical materials
embodying Serono Targets, Serono Compounds and any protein, clone or vector used
to express Serono Targets, in each case, which are owned or Controlled by
Serono. Any Serono Materials shall be deemed Confidential Information of Serono
subject to the rights and obligations set forth in Article 6 hereunder.
1.33 "Serono Target(s)" means the protein targets listed in the attached
Exhibit A, as this Exhibit may be amended from time to time under Section 2.4.
1.34 "SGX Background Technology" means all Patents and Know-How owned or
Controlled by SGX which are (a) existing on the Effective Date or discovered or
developed during the Term of the Collaboration (i) outside of the Collaboration
or (ii) within the Collaboration but are of general application (for example,
have application to other proteins in addition to the Serono Targets); and (b)
necessary for the conduct of the Collaboration. Any SGX Background Technology
shall be deemed Confidential Information of SGX subject to the rights and
obligations set forth in Article 6 hereunder.
1.35 "SGX Co-Crystal Structure" means a [...***...] of the [...***...] of
a [...***...] with an [...***...], an [...***...] or an [...***...], made in the
course of the Collaboration, which has the following characteristics: (i)
[...***...] (i.e., the [...***...] or is [...***...]); (ii) [...***...] in the
[...***...]; (iii) [...***...]% [...***...]and [...***...]% in the [...***...];
(iv) [...***...]; (v) [...***...] ([...***...]) [...***...] and (vi) the
[...***...] of the [...***...] of the [...***...], [...***...] or [...***...] is
[...***...] in a [...***...].
***CONFIDENTIAL TREATMENT REQUESTED
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1.36 "SGX Materials" means the biological and chemical materials
embodying any Initial Structure, SGX Co-Crystal Structure, Serono Co-Crystal
Structure or Early Lead Compound, in each case which are owned or Controlled by
SGX and are developed in the course of the Collaboration. Any SGX Materials
shall be deemed Confidential Information of SGX subject to the rights and
obligations set forth in Article 6 hereunder.
1.37 "Term of the Collaboration" means the period commencing on the
Effective Date, and terminating twenty-four (24) months thereafter, unless
extended by mutual agreement of the Parties.
1.38 "Third Party or Third Parties" means any individual, corporation,
limited liability company, partnership, association, trust, unincorporated
organization, other entity or government or political subdivision thereof other
than Serono or SGX or their respective Affiliates.
1.40 "Valid Claim" means a claim of an issued and unexpired patent, which
has not been held invalid or unenforceable by a court or other governmental
agency of competent jurisdiction, after any applicable appeal, or time for
appeal, is concluded, and which has not lapsed, been abandoned, withdrawn,
canceled, disclaimed or admitted to be invalid or unenforceable through reissue,
reexamination or otherwise.
2. COLLABORATION.
2.1 Collaboration. Subject to the terms and conditions of this
Agreement, Serono and SGX will use commercially reasonable and diligent efforts
to conduct the Collaboration in accordance with the collaboration plan attached
to this Agreement as Exhibit A (the "Collaboration Plan") including the timeline
set forth therein. The Parties shall begin the performance of the Collaboration
promptly following the Effective Date but no later than thirty (30) days
thereafter. SGX shall have principal responsibility for the conduct of the
Collaboration, and Serono shall provide consultation, advice and such research
effort as may be deemed appropriate by the JSC and accepted by Serono. The JSC
shall review and coordinate each Party's activities with respect to the
Collaboration.
2.2 Provision of Serono Materials and Background Technology. At Serono's
discretion, promptly following the Effective Date and during the Term of the
Collaboration, Serono will provide SGX, at Serono's expense, with reasonable
quantities of such available Serono Materials and other Serono Background
Technology as are necessary for the conduct of the Collaboration by SGX;
PROVIDED, HOWEVER, that Serono is able to provide such Serono Materials and
Serono Background Technology without paying any royalties or other fees to Third
Parties.
2.3 Provision of SGX Materials, SGX Background Technology and
Collaboration Technology. Subject to payment by Serono to SGX under Sections
3.2(a), (d), (e) or (f) for achievement of the applicable Milestone, SGX will
promptly provide Serono with reasonable quantities of SGX Materials, and with
the SGX Background
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Technology and Collaboration Technology associated with such Milestone,
including those deliverables set forth on Exhibit B, to the extent reasonably
necessary for Serono to conduct research and development activities. SGX will
have no obligation to provide quantities of SGX Materials to Serono with respect
to the Initial Structures and SGX Co-Crystal Structures that are the subjects of
such Milestones beyond the quantities required for Serono to reproduce such
Initial Structures and SGX Co-Crystal Structures. Serono will not provide SGX
Materials to any Third Party without SGX's prior written consent. The SGX
Materials will be delivered to Serono Ex Works (Incoterms 2000). Nothing in this
Section 2.3 shall be construed as affecting in any way the scope of the licenses
granted to Serono under Section 4.1.
2.4 Designation of Additional Targets. Prior to the first anniversary of
the Effective Date, Serono may in its discretion, nominate by written notice to
SGX up to an additional [...***...] ([...***...]) protein targets which Serono
would like to include in The Collaboration. SGX will have a period of two (2)
weeks from receipt of such notice to reject (in writing) the inclusion of such
nominated proteins if any such protein is the subject of an existing research
program at SGX, if SGX has existing contractual obligations to a Third Party
with respect to such protein that would prevent its inclusion in the
Collaboration or otherwise reasonably determines in good faith that such
inclusion would present a conflict of interest for SGX, or if SGX reasonably
determines in good faith that determination of an Initial Structure with respect
to such protein is unlikely to be completed with the resources and timelines
contemplated under this Collaboration (and in such event, SGX will provide
Serono with an explanation of the basis for such determination). Any protein
nominated by Serono and not rejected by SGX under this Section 2.4 will be
deemed a Serono Target. In the event any protein is rejected by SGX, then Serono
may nominate a replacement protein target in accordance with the terms of this
Section 2.4; PROVIDED, HOWEVER, that such nomination may occur after the
[...***...] anniversary of the Effective Date.
2.5 Determination of Serono Co-Crystal Structures. In the event that
during the Term of the Collaboration Serono desires SGX to perform
co-crystallization of any Serono Targets with Serono Compounds, Serono will
provide SGX with at least thirty (30) days prior written notice and thereafter
will provide SGX with batches of at least [...***...] ([...***...]) Serono
Compounds per batch, which may be directed to any one or more of the Serono
Target(s) indicated in such notice, and upon receipt of each batch of
[...***...] ([...***...]) such Serono Compounds, SGX will use commercially
reasonable and diligent efforts to perform co-crystallization in accordance with
the Collaboration Plan within thirty (30) days of such receipt. Each Serono
Compound provided under this Section 2.5 wILL be provided in an amount of at
least five (5) milligrams and will have the following characteristics: (i)
solubility > 5mM in DMSO and (ii) potency against the Serono Target of <10mM.
Upon completion of each Serono Co-Crystal Structure, SGX will promptly provide
Serono with quantities of the SGX Materials associated with the Serono
Co-Crystal Structure, and with the SGX Background Technology and Collaboration
Technology associated with such Serono Co-Crystal Structure, including those
deliverables set forth on Exhibit B, to the extent reasonably necessary for
Serono to conduct research and development activities. SGX will have no
obligation to provide quantities of SGX Materials to Serono with respect to the
Serono Co-Crystal Structures
***CONFIDENTIAL TREATMENT REQUESTED
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beyond the quantities required for Serono to reproduce such Serono Co-Crystal
Structures. The Serono Co-Crystal Structures will be delivered to Serono Ex
Works (Incoterms 2000). Prior to the expiration of the Term of the
Collaboration, the Parties will discuss in good faith extending the
Collaboration for [...***...] ([...***...]) [...***...] after the Term of the
Collaboration to permit SGX to perform co-crystallization of the additional
Serono Targets designated pursuant to Section 2.4 with Serono Compounds to be
proVIDED bY Serono. Nothing in this Section 2.5 shall be construed as affecting
in any way the scope of the licenses granted to Serono under Section 4.1.
2.6 Records; Reports. SGX shall prepare and maintain complete and
accurate written records, accounts, notes, reports and data with respect to all
work conducted in the performance of the Collaboration in conformity with
standard industry practices. SGX shall notify Serono promptly upon the
completion of an Initial Structure for a Serono Target or upon the determination
of an SGX Co-Crystal Structure, and will provide the JSC, at its request, for
its review, all information regarding such SGX Co-Crystal Structures which is
reasonably required for the JSC to determine the achievement of Milestones.
Promptly upon completion of the Collaboration, SGX shall provide a final written
report of its activities during the Collaboration and the results thereof.
2.7 Joint Steering Committee.
(a) Establishment. SGX and Serono will establish a Joint Steering
Committee ("JSC") to oversee the Collaboration promptly following the Effective
Date but no later than fifteen (15) days thereafter.
(b) Membership; Decisions. The JSC shall comprise two (2)
representatives from Serono and two (2) representatives from SGX, designated by
the Parties promptly following the Effective Date but no later than fifteen (15)
days thereafter. Each Party may replace its JSC representatives at any time,
with written notice to the other Party. Each Party shall have one vote on the
JSC. The JSC will strive to reach consensus on any matters requiring a decision
by it; PROVIDED, HOWEVER, that in the event of any dispute, the decision shall
be made by [...***...] reasonably taking into consideration the position of
[...***...].
(c) Project Team. The JSC shall establish a project team (the
"Project Team") comprising at least two (2) representatives from Serono and two
(2) 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 Serono 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 from time to time via videoconference or in
person, 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
***CONFIDENTIAL TREATMENT REQUESTED
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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.
(d) Responsibilities. The JSC will review and supervise the
performance of the Collaboration and supervise the Project Team. The JSC will be
responsible for (i) monitoring research progress during the Collaboration and
ensuring open exchange between the Parties with respect to Collaboration
activities; (ii) designating compounds as Early Lead Compounds in accordance
with the criteria in Section 1.9 and (iii) determining the achievement of
Milestones under Section 3.2. Any changes to the Collaboration Plan which
materially alter the nature or scope of the Collaboration must be agreed in
writing by the Parties. SGX will not engage the services of any Third Party to
perform any activities under the Collaboration outside of the United States
without the prior approval of the JSC.
(e) Meetings. The JSC shall meet via videoconference or in person,
on a quarterly basis (alternating between San Diego, CA, U.S.A., and Geneva,
Switzerland or as the JSC may otherwise agree), to discharge its
responsibilities. Serono may also direct that any additional meetings are held
that it reasonably believes are necessary for the optimal conduct of the
Collaboration. Meetings of the JSC may be held only if a quorum of at least one
(1) representative of each Party participates. SGX will call the JSC meetings
and will prepare the initial draft of an agenda for each meeting, which shall
include the most recent report from the Project Team, and will submit the draft
to Serono for comments a reasonable period before the scheduled meeting date.
Except as provided above, each Party will be responsible for paying its own
expenses in connection with participating in the meetings of the JSC. SGX shall
prepare and deliver to the members of the JSC, within thirty (30) days after the
date of each meeting, minutes of such meeting setting forth, among other things,
all decisions of the JSC. Serono may suggest changes or amendments to the
minutes, and may provide a supplement addressing activities at the meeting which
are not reported in the minutes, which shall be distributed to the Parties and
filed with the meeting minutes.
3. CONSIDERATION
3.1 Technology Access Payment. Within thirty (30) days of the Effective
Date, Serono will pay, or cause to be paid, to SGX the sum of U.S.$100,000.
3.2 Research Milestone Payments. Within sixty (60) days of the date of
achievement of the applicable Milestone during the Term of the Collaboration,
Serono will pay, or cause to be paid, to SGX the following non-refundable
Milestone payments, on a Serono Target-by-Serono Target basis:
<TABLE>
<CAPTION>
MILESTONES AMOUNT
---------- ------
<S> <C>
(a) Completion of [...***...] for a Serono Target U.S. $[...***...] per Serono Target
</TABLE>
***CONFIDENTIAL TREATMENT REQUESTED
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<TABLE>
<S> <C>
(b) Determination of an [...***...] containing the first U.S. $[...***...] per Serono Target
[...***...] for a Serono Target
(c) Determination of an [...***...] containing the first U.S. $[...***...] per Serono Target
[...***...] for a Serono Target
(d) Determination of an [...***...] containing the first U.S. $[...***...] per Serono Target; PROVIDED,
[...***...] for a Serono Target HOWEVER, if an [...***...] for a Serono Target is
identified directly from an [...***...], the payment
under this Section 3.2(d) will be U.S. $[...***...]
(e) Determination of a [...***...] for a Serono Target U.S. $[...***...] per Serono Target
containing the [...***...] as described in Section
[...***...] ([...***...])
(f) Determination of a [...***...] for a Serono Target U.S. $[...***...] per Serono Target
containing the [...***...] as described in Section
[...***...] ([...***...])
</TABLE>
3.3 Serono Co-Crystal Payments. As consideration for the
co-crystallization activities to be performed by SGX pursuant to Section 2.5,
Serono will pay, or cause to be paid, to SGX U.S. $[...***...] for each batch of
[...***...] ([...***...]) Serono compounds delivered to SGX pursuant to Section
2.5. SGX will invoice Serono on a quarterly basis for this amount upon delivery
of the Serono Compounds, and Serono will pay SGX within sixty (60) days of
receipt of such invoice.
3.4 Development Milestones. Within sixty (60) days of achievement of
each of the applicable Milestones, in consideration of the rights granted
hereunder, Serono will pay, or cause to be paid, to SGX the following
non-refundable Milestone payments for each Product, on a Product-by-Product
basis:
<TABLE>
<CAPTION>
MILESTONES AMOUNT
---------- ------
<S> <C>
(a) Initiation of [...***...] U.S. $[...***...]
(b) [...***...] of [...***...] U.S. $[...***...]
(c) The [...***...] of the [...***...] in a [...***...] U.S. $[...***...]
(d) The [...***...] of the [...***...] in a [...***...] U.S. $[...***...]
(e) [...***...] of [...***...] U.S. $[...***...]
</TABLE>
***CONFIDENTIAL TREATMENT REQUESTED
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Each Milestone payment under this Section 3.4 shall be due only if the Product
achieving such Milestone is the first Product derived from its corresponding
Early Lead Compound to achieve the Milestone associated with such payment and is
either: (i) if directed primarily against a Serono Target, the first Product
directed primarily against the Serono Target in connection with which its
corresponding Early Lead Compound was identified, to achieve the Milestone
associated with such payment, or (ii) if directed primarily against another
target, the first Product directed primarily against such other target to
achieve the Milestone associated with such payment.
3.5 Royalties. In consideration of the rights granted hereunder, Serono
shall pay, or cause to be paid, to SGX the greater of the following royalty
payments, as applicable, on Net Sales on a Product-by-Product and
country-by-country basis:
(a) [...***...] percent ([...***...]%) of Net Sales of Products in
the event that the use, import, offer for sale or sale of such Product is
covered in such country by an Early Lead Patent made, conceived or reduced to
practice solely by or on behalf of SGX; or
(b) [...***...] percent ([...***...]%) of Net Sales of Products in the
event that the use, import, offer for sale or sale of such Product is covered in
such country by a Joint Patent.
Notwithstanding the above, in the event that [...***...], [...***...],
[...***...], then Serono shall [...***...] to SGX [...***...] of the amounts
[...***...] in such country, and in the event that such a [...***...], upon such
[...***...], [...***...] percent ([...***...]%) of the amounts due under
[...***...] and, in the event Serono receives a [...***...] or [...***...] from
a Third Party with respect to the [...***...] including such [...***...] or
analogous [...***...], [...***...] to SGX the remaining [...***...] percent
([...***...]%) of the amounts [...***...] above during the period from the
[...***...] of the applicable Product to the date of the issuance of such
[...***...]. In addition, notwithstanding the foregoing, in the event that the
[...***...], [...***...], [...***...] is covered by an [...***...] in the United
States, Japan and all countries in the European Union, then [...***...] to
subsection [...***...] above for each country in which [...***...], [...***...],
[...***...] whether or not the [...***...], [...***...], [...***...] is covered
by an [...***...] in such country. Similarly, in the event that the [...***...],
[...***...], [...***...] by a [...***...] in the United States, Japan and all
countries in the European Union, then [...***...] to subsection [...***...]
above for each country in which [...***...], [...***...], [...***...] whether or
not the use, [...***...], [...***...] is covered by a [...***...].
3.6 Royalty Term. The obligation of Serono to pay royalties under
Section 3.5 with respect to a Product shall begin with the First Commercial Sale
of such Product
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and continue for such Product, on a country-by-country basis, until the later of
(i) such time as there are no Valid Claims of an Early Lead Patent or Joint
Patent in such country that would be infringed by the use, import, offer for
sale or sale of such Product in such country or (ii) [...***...] ([...***...])
years after the First Commercial Sale of such Product in such country (such
period the "Royalty Term").
3.7 Third Party Royalties. In the event that Serono, its Affiliates or
sublicensees are required to pay royalties to a Third Party for patent licenses
necessary to use or practice Collaboration Technology covering Early Lead
Compounds or SGX Co-Crystal Structures containing Early Lead Compounds for the
purpose of making, using, selling, offering to sell or importing Products,
Serono may offset up to [...***...] percent ([...***...]%) of such amounts due
Third Parties against payments due SGX under Section 3.5 above; PROVIDED,
HOWEVER, that Serono 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.
3.8 Withholding Taxes. SGX shall be responsible for any and all income
or other taxes required to be withheld from any of the royalty and other
payments made by Serono under this Agreement and shall provide Serono any
information necessary to determine the taxes that should be withheld and paid.
Any tax that Serono, its Affiliates or sublicensees are required to withhold and
pay on behalf of SGX with respect to the royalties and other payments due under
Sections 3.1 through 3.5 shall be deducted from and offset against said payments
prior to remittance to SGX; PROVIDED, HOWEVER, that in regard to any tax so
deducted, Serono shall give or cause to be given to SGX such assistance as may
reasonably be necessary to enable SGX to claim exemption therefrom or credit
therefor, and in each case, Serono shall furnish to SGX proper evidence of the
taxes paid on its behalf. In the event that Serono [...***...] by a party
located in a [...***...] or [...***...] and as a result [...***...] incremental
to that which it would have incurred if such payments were made by a party
located in the United States or [...***...], then Serono shall [...***...] to be
[...***...] to the extent necessary so that the [...***...] after the
[...***...] the [...***...] without the imposition of such [...***...].
3.9 Reports; Payments. The royalties due under Section 3.5 shall be paid
quarterly within sixty (60) days after the close of each calendar quarter in
which such royalties are earned. With each such quarterly payment, Serono shall
furnish SGX a royalty statement setting forth in reasonable detail on a
country-by-country and Product-by-Product basis: (i) the total number of units
of each Product sold hereunder for the quarterly period for which the royalties
are due; (ii) the calculation of Net Sales pursuant to Section 1.19; (iii) the
royalties due SGX in such calendar quarter; and (iv) details of payments (if
any) to Third Parties pursuant to Third Party licenses as described in Section
3.7 above. For any calendar quarter after the First Commercial Sale of a
Product, if no royalties are due, Serono shall so report. Any such quarterly
report shall be deemed
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Confidential Information of Serono subject to the rights and obligations set
forth in Article 6.
3.10 Currency Conversion. All amounts required to be paid under this
Agreement shall be paid in United States dollars. Royalties earned shall first
be determined in the currency of the country in which they are earned and then
converted to their equivalent in United States currency using the standard
exchange rate methodology for the translation of foreign currency sales into
United States dollars customarily used by Serono in its accounting practice.
3.11 Late Payments. Any payments or portions thereof due hereunder which
are not paid on the date such payments are due shall bear interest until paid 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. This Section 3.11 shall in no way limit any
other remedies available to SGX.
3.12 Legal Restrictions. If at any time legal restrictions prevent the
remittance by Serono of all or any part of royalties on Net Sales in any
country, Serono shall have the right and option to make such payment by
depositing the amount thereof in local currency to an account in the name of SGX
in a bank or other depository in such country. Serono shall consult with SGX
regarding, and promptly notify SGX of, any and all such arrangements.
3.13 Audits. Serono shall maintain accurate books and records which
enable the calculation of royalties payable under this Agreement to be verified.
Serono shall maintain the books and records for each quarterly period for two
(2) years after the submission of the corresponding report under Section 3.9.
Upon [...***...] ([...***...]) [...***...] prior notice to Serono, independent
accountants selected by SGX, reasonably acceptable to Serono, may have access to
Serono's books and records after executing a reasonable confidentiality
agreement, during Serono's normal business hours at mutually agreed times to
conduct a review or audit no more than once per calendar year, for the sole
purpose of verifying the accuracy of Serono's payments and compliance with this
Agreement. Records for any calendar year may only be audited once. The
accounting firm shall report to SGX only whether there has been a royalty
underpayment or overpayment and, if so, the extent thereof. Any such inspection
shall be at SGX's expense; PROVIDED, HOWEVER, in the event that an inspection
reveals an underpayment of [...***...] percent ([...***...]%) or more for any
calendar year, Serono shall pay the costs of the inspection. Serono shall
promptly pay to SGX any underpayment identified in such audit, with interest
from the date such amount(s) were due at a rate equal to the lesser of the prime
rate reported by the Chase Manhattan Bank, New York, New York, plus [...***...]
percent ([...***...]%) or the maximum amount permitted by law. SGX shall
promptly pay to Serono any overpayment identified in such audit.
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4. LICENSES
4.1 License to Serono. Subject to the terms and conditions of this
Agreement, SGX hereby grants to Serono the following licenses:
(a) [...***...], [...***...], [...***...] license (with the right
to grant sublicenses in accordance with Section 4.3 below) under SGX's interest
in the Collaboration Technology (other than that which constitutes SGX
Background Technology) covering Early Lead Compounds and SGX Co-Crystal
Structures containing Early Lead Compounds to make, have made, use, import,
offer for sale and sell Products.
(b) [...***...], [...***...], [...***...], [...***...] license
(with the right to grant sublicenses in accordance with Section 4.3 below) under
SGX's interest in the Collaboration Technology (other than that which
constitutes SGX Background technology) covering Serono Co-Crystal Structures to
practice and use such Collaboration Technology for any purpose.
(c) [...***...], [...***...], [...***...] license (with the right
to grant sublicenses in accordance with Section 4.3 below) under SGX's interest
in the Collaboration Technology (other than that which constitutes SGX
Background Technology) covering Initial Structures to practice and use such
Collaboration Technology for any purpose.
(d) [...***...], [...***...], [...***...] license (with the right
to grant sublicenses in accordance with Section 4.3 below) under (i) SGX's
interest in all SGX Background Technology to practice and use the SGX Background
Technology solely to the extent necessary to reproduce Initial Structures,
Serono Co-Crystal Structures a






