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 00000 Xxxxxxx Xxxxxx, Xxx Xxxxx, XX 00000
("SGX"), and SERONO INTERNATIONAL SA, a corporation organized under the laws of
Switzerland, located at 00xxx xxxxxx xxx Xxxxx, 0000 Xxxxxx, Xxxxxxxxxxx
("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.
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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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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 [...***...].
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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
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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:
MILESTONES AMOUNT
---------- ------
(a) Completion of [...***...] for a Serono Target U.S. $[...***...] per Serono Target
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(b) Determination of an SGX Co-Crystal Structure U.S. $[...***...] per Serono Target
containing the first [...***...] for a Serono Target
(c) Determination of an SGX Co-Crystal Structure U.S. $[...***...] per Serono Target
containing the first [...***...] for a Serono Target
(d) Determination of an SGX Co-Crystal Structure U.S. $[...***...] per Serono Target; PROVIDED,
containing the first [...***...] 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 SGX Co-Crystal Structure for a U.S. $[...***...] per Serono Target
Serono Target containing the [...***...] as
described in Section 1.9 (b)
(f) Determination of a SGX Co-Crystal Structure for U.S. $[...***...] per Serono Target
a Serono Target containing the [...***...] as
described in Section 1.9 (b)
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:
MILESTONES AMOUNT
---------- ------
(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. $[...***...]
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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 there is no Valid Claim of a Patent
that would be infringed by the use, import, offer for sale or sale of the
applicable Product in a particular country, then Serono shall pay or cause to be
paid to SGX [...***...] of the amounts otherwise due under subsections (a) and
(b) above for such Product in such country, and in the event that such a Valid
Claim of a Patent subsequently issues, upon such issuance, Serono shall pay or
cause to be paid to SGX [...***...] percent ([...***...]%) of the amounts due
under subsections (a) and (b) above and, in the event Serono receives a
[...***...] or [...***...] from a Third Party with respect to the Patent
including such Valid Claim pursuant to 35 U.S.C. Section. 154(d) or analogous
foreign rights, Serono shall further pay or cause to be paid to SGX the
remaining [...***...] percent ([...***...]%) of the amounts due under
subsections (a) and (b) above during the period from the [...***...] of the
applicable Product to the date of the issuance of such Valid Claim. In addition,
notwithstanding the foregoing, in the event that the use, import, offer for sale
or sale of a Product is covered by an [...***...] in the United States, Japan
and all countries in the European Union, then royalties shall be payable
pursuant to subsection (a) above for each country in which such Product is used,
imported, offered for sale or sold whether or not the use, import, offer for
sale or sale of such Product is covered by an [...***...] in such country.
Similarly, in the event that the use, import, offer for sale or sale of a
Product is covered by a [...***...] in the United States, Japan and all
countries in the European Union, then royalties shall be payable pursuant to
subsection (b) above for each country in which such Product is used, imported,
offered for sale or sold whether or not the use, import, offer for sale or sale
of such Product is covered by a [...***...] in such country.
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) an exclusive, worldwide, royalty-bearing 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) an exclusive, worldwide, perpetual, royalty-free 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) a non-exclusive, worldwide, royalty-free 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) a non-exclusive, worldwide, royalty-free 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 and SGX Co-Crystal Structures containing Early Lead
Compounds and to utilize Early Lead Compounds as contemplated under this
Agreement and (ii) SGX's interest in SGX Background Technology developed in the
course of the Collaboration to make, have made, use, import, offer for sale and
sell Products.
4.2 Cross Licenses. Each Party hereby grants to the other, a
non-exclusive, non-transferable, royalty-free license to practice and use the
Serono Background Technology, the SGX Background Technology and such Party's
interest in the Collaboration Technology solely to conduct the Collaboration;
PROVIDED, HOWEVER, that Serono is able to grant such license to the Serono
Background Technology without paying any royalties or other fees to Third
Parties.
4.3 Sublicenses. Serono may sublicense the rights granted in Section
4.1(b), (c) and (d) with respect to Serono Co-Crystal Structures to its
Affiliates and to Third Parties. Serono may sublicense the rights granted in
Sections 4.1(a), (c) and (d) with respect to Products, Early Lead Compounds and
SGX Co-Crystal Structures containing Early Lead Compounds to its Affiliates and
to Third Parties. Each such sublicense granted by Serono shall be consistent
with all of the terms and conditions of this Agreement. Serono as the
sublicensor shall remain responsible for all of each such sublicensee's
obligations under this Agreement.
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4.4 Product Development. On or before January 1 of each year during the
term of the Agreement, Serono will provide SGX with a written report summarizing
its activities in connection with the development of Products. Serono will
provide prompt written notice to SGX of the achievement of Milestones under
Section 3.4.
4.5 Diligence. With respect to each Serono Target, Serono will use, or
cause to be used, Commercially Reasonable Efforts to bring at least one Product
that is directed to inhibiting or modulating the activity of such Serono Target
to the market as soon as reasonably practicable, (ii) obtain regulatory
approvals to market such Product, and (iii) after obtaining regulatory approvals
to market such Product, to meet the market demand therefor; and will promptly
notify SGX in writing upon the discontinuance of any such activities.
4.6 Lack of Diligence.
(a) Termination of Rights. In the event that Serono (i) fails to
use or cause to be used Commercially Reasonable Efforts to develop and meet
market demand for at least one Product for a particular Serono Target in
accordance with Section 4.5 above, or (ii) notifies SGX that it will not
conduct, or cause to be conducted, further activities with respect to at least
one Product for a particular Serono Target pursuant to Section 4.5 above, then
SGX may terminate Serono's rights and licenses under this Agreement with respect
only to Early Lead Compounds and corresponding Collaboration Products for such
Serono Target.
(b) Sole Remedy. In such event, Serono will have no further rights
and licenses to such Early Lead Compounds and corresponding Collaboration
Products pursuant to this Agreement and SGX will thereafter have the exclusive
right pursuant to the intellectual property licensed hereunder (subject to any
sublicenses previously granted by Serono) as its sole remedy and in lieu of any
other rights or remedies it may otherwise have under Section 9.2 of this
Agreement or by law or in equity, to develop and commercialize such Early Lead
Compounds and corresponding Collaboration Products, alone or with Third Parties.
(c) Collaboration Technology License. In addition to SGX's receipt
of the rights described in Section 4.6(b) above, at SGX's request, Serono shall
grant to SGX an exclusive (subject to any sublicenses previously granted by
Serono), worldwide, royalty bearing license (with the right to grant
sublicenses) under Serono's interest in any Collaboration Technology (other than
that which constitutes Serono Background Technology) owned or Controlled by
Serono to the extent necessary to make, have made, use, import, offer for sale
and sell an applicable Collaboration Product. Such license shall be subject to a
royalty obligation to Serono of [...***...] percent ([...***...]%) of Net Sales
(with SGX being substituted for Serono in the definition of "Net Sales") that
shall be payable with respect to each such Collaboration 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
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Product in such country, (ii) ten (10) years after the First Commercial Sale of
such Product in such country or (iii) ten (10) years after the grant of such
license.
(d) Serono Intellectual Property License. In addition, at SGX's
request, the Parties shall negotiate in good xxxxx x xxxxx by Serono to SGX of
an exclusive (subject to any sublicenses previously granted by Serono),
worldwide, royalty-bearing license under Serono's interest in any Patents or
Know How (other than those within the Collaboration Technology) owned or
Controlled by Serono to the extent necessary to make, have made, use, import,
offer for sale and sell such Collaboration Product. Such license shall contain
such customary representations, warranties, covenants and agreements
satisfactory in form and substance to the Parties and their legal advisors as
are necessary or appropriate for transactions of this type. For the avoidance of
doubt, such obligation to negotiate in good faith does not impose on either
Party an obligation to enter into an agreement for the grant of such a license,
if the Parties cannot agree through such good faith negotiation on the terms and
conditions of such license.
4.7 Non-Use.
(a) Non-Kinases. For a period of [...***...] ([...***...])
[...***...] from the date of determination by SGX in the course of the
Collaboration of an Initial Structure of a Serono Target which is not a protein
kinase, SGX will not use, or permit any Third Party to use, any Collaboration
Technology covering such Initial Structure for any purpose other than the
conduct of the Collaboration; PROVIDED, HOWEVER, that in the event that prior to
the determination by SGX of the Initial Structure of such Serono Target or
during the [...***...] ([...***...]) [...***...] period after such
determination, a crystal structure of such Serono Target enters the public
domain other than through a breach of this Agreement by SGX, the provisions of
this Section 4.7(a) will not apply to such Serono Target.
(b) Kinases. For a period of [...***...] ([...***...]) [...***...]
from the date of determination by SGX in the course of the Collaboration of an
Initial Structure of a Serono Target which is a protein kinase, SGX will not
engage in any drug discovery or co-crystallization activities with or for the
benefit of a Third Party utilizing any Collaboration Technology covering such
Initial Structure, and for a period of [...***...] ([...***...]) [...***...]
from the date of determination by SGX in the course of the Collaboration of such
an Initial Structure, SGX will not, subject to existing contractual obligations,
permit a Third Party to use any Collaboration Technology covering such Initial
Structure for any purpose; PROVIDED HOWEVER, that in the event that prior to the
determination by SGX of the Initial Structure of such Serono Target or during
the [...***...] ([...***...]) [...***...] period after such determination, a
crystal structure of such Serono Target enters the public domain other than
through a breach of this Agreement by SGX, the provisions of this Section 4.7(b)
will not apply to such Serono Target.
(c) Elaborated Fragments. For so long as Serono is continuing to
use [...***...] in accordance with Section 4.5 to [...***...] for a particular
[...***...] that is [...***...]the activity of a specific [...***...], SGX
[...***...] from
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which the [...***...] was derived to develop [...***...], [...***...].
(d) Drug Discovery. During the Term of the Collaboration, SGX will
not conduct drug discovery directed at any Serono Target other than pursuant to
the Collaboration.
4.8 Limitations. Notwithstanding anything to the contrary in this
Agreement, (i) SGX will have no obligation to provide Serono with any
information or materials relating to the Initial Structure of the Serono Target
[...***...] and (ii) the licenses granted by SGX to Serono under this Agreement
will not include any Collaboration Technology or SGX Background Technology
covering the Initial Structure of [...***...], until such time as SGX has
obtained the right to provide such information, materials and licenses to
Serono, at which point SGX will provide Serono with prompt written notice of
having obtained such right. In the event that SGX has achieved the Milestones
and Serono has paid SGX any or all of the applicable payments under Sections
3.2(b), (c) and (d) with respect to the Serono Target [...***...], SGX
represents that, as promptly as its Third-Party obligations in existence on the
Effective Date permit, SGX will obtain the right to provide Serono with SGX
Materials, Collaboration Technology and SGX Background Technology covering the
Initial Structure of [...***...] as described in Section 2.3 and to grant Serono
a license to Collaboration Technology and SGX Background Technology covering the
Initial Structure of [...***...] pursuant to Section 4.1, and upon provision to
[...***...] and [...***...] covering such [...***...] and the [...***...],
[...***...] under [...***...] with respect to [...***...].
5. INTELLECTUAL PROPERTY
5.1 Ownership of Technology.
(a) Ownership by SGX. Title to all Collaboration Technology made,
conceived, first reduced to practice or discovered or developed solely by or on
behalf of SGX shall be owned solely by SGX.
(b) Ownership by Serono. Title to all Collaboration Technology
made, conceived, first reduced to practice or discovered or developed solely by
or on behalf of Serono shall be owned solely by Serono.
(c) Joint Ownership. Title to all Collaboration Technology made,
conceived, first reduced to practice or discovered or developed jointly by or on
behalf of Serono and SGX shall be jointly owned by Serono and SGX, each with an
undivided one-half interest. Each Party agrees to execute in a timely manner
such documents as the other Party may request to document and perfect joint
ownership of such Collaboration Technology.
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(d) Law. Inventorship of inventions and, subject to the terms of
this Agreement, ownership rights with respect thereto shall be determined in
accordance with the patent laws of the United States.
5.2 Patent Prosecution.
(a) Background Technology. SGX shall be responsible, at its sole
discretion and expense, for the preparation, filing, prosecution and maintenance
of the Patents within the SGX Background Technology, in countries selected by
SGX, and for conducting any interferences, reexaminations, reissues, and
oppositions, or requesting any patent term extensions relating thereto. Serono
shall be responsible, at its sole discretion and expense, for the preparation,
filing, prosecution and maintenance of the Patents within the Serono Background
Technology, in countries selected by Serono, and for conducting any
interferences, reexaminations, reissues, and oppositions, or requesting any
patent term extensions relating thereto.
(b) Collaboration Technology.
(i) Joint Patents. [...***...] shall be responsible, at its
sole discretion and expense, for the preparation, filing, prosecution and
maintenance of Patents made, conceived or first reduced to practice jointly by
or on behalf of Serono and SGX that are within the Collaboration Technology or
that claim Know-How within the Collaboration Technology (other than that which
constitutes SGX Background Technology or Serono Background Technology) ("Joint
Patents"). Joint Patents include Patents on which at least one SGX Inventor is a
named inventor, and Patents that claim priority to an application on which at
least one SGX Inventor is a named inventor. An SGX Inventor is any person who
has a duty to assign inventions to SGX.
(ii) Serono Patents. [...***...] shall also be responsible,
at its sole discretion and expense, for the preparation, filing, prosecution and
maintenance of Patents including Joint Patents within the Collaboration
Technology (other than that which constitutes SGX Background Technology or
Serono Background Technology) covering Serono Co-Crystal Structures ("Serono
Patents"). SGX shall assign all its right, title and interest in and to any
Serono Patents to Serono and shall execute such documents of transfer or
assignment and perform such acts as may be reasonably necessary to transfer
ownership of such Serono Patents to Serono and to enable Serono to file,
prosecute, and maintain the Serono Patents.
(iii) Early Lead Patents. [...***...] shall also be
responsible, at its expense, for the preparation, filing, prosecution and
maintenance of Patents (excluding Joint Patents) within the Collaboration
Technology (other than that which constitutes SGX Background Technology or
Serono Background Technology) covering Early Lead Compounds and SGX Co-Crystal
Structures containing Early Lead Compounds ("Early Lead Patents") in the United
States and in such other countries as it may determine in its sole discretion.
(iv) SGX Patents. [...***...] shall be responsible, at its
sole discretion and expense, for the preparation, filing, prosecution and
maintenance of
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Patents (excluding Joint Patents) within the Collaboration Technology (other
than that which constitutes SGX Background Technology or Serono Background
Technology) with the exception of such Collaboration Technology covering Serono
Co-Crystal Structures, SGX Co-Crystal Structures containing Early Lead Compounds
or Early Lead Compounds ("SGX Patents").
(v) Prosecution and Maintenance. The Parties will cooperate to
prepare and prosecute patent applications for Early Lead Patents with the goal
of obtaining a broad scope of protection for the relevant subject matter. Serono
will use commercially reasonable efforts to obtain a broad scope of protection
for Early Lead Compounds without compromising Serono's or SGX's interests in the
Collaboration and will consider in good faith all comments provided by SGX with
respect to the filing, prosecution and maintenance of Early Lead Patents. In the
event that Serono elects not to file a patent application for an Early Lead
Patent in the United States within [...***...] ([...***...]) [...***...] of the
date the underlying invention is reduced to practice, SGX shall have the right
to file, prosecute and maintain such patent application in any country. SGX
shall promptly notify Serono of the conception or reduction to practice of any
invention during and in the performance of the Collaboration. Furthermore, in
the event that Serono elects not to file any patent applications for an Early
Lead Patent in Japan or any country in Europe or to prosecute or maintain any
Patents that are Early Lead Patents in the United States, Japan or any country
in Europe, Serono shall give SGX not less than [...***...] ([...***...])
[...***...] notice before any relevant deadline, and SGX shall have the right to
pursue, at its sole discretion and expense, filing, prosecution and maintenance
of such Patents in such country. The Party responsible for prosecution and
maintenance of Patents under this Section 5.2(b) (the "Responsible Party"),
shall keep the other Party (the "Non-Responsible Party") informed as to the
status of such patent matters, including by providing the Non-Responsible Party
the opportunity, at the Non-Responsible Party's expense, to review documents
with respect to Early Lead Patents to be filed in any patent office at least
thirty (30) days before filing and to comment thereon, and the Responsible Party
shall consider in good faith any such comments. At the Responsible Party's
request and expense, the Non-Responsible Party will reasonably cooperate and
assist the Responsible Party in the preparation, filing and prosecution of
patent applications claiming Collaboration Technology and in the event of an
interference, reissue, reexamination, opposition or request for patent term
extension with respect to such patent applications or patents issuing therefrom,
including by making such Party's employees or agents available to the
Responsible Party and signing or causing to have signed all documents relating
to such Patents. At each Party's expense, patent counsel or any other
representative designated by each Party will meet (in person, by telephone or
videoconference) upon request by either Party, unless otherwise agreed in
writing, during the Term of the Collaboration, and the pendency of any Early
Lead Patents, to coordinate, discuss, review and implement patent filing and
prosecution strategy.
5.3 Patent Enforcement. In the event either Party becomes aware of any
infringement of an Early Lead Patent or a Joint Patent or a claim that such
patent is invalid and unenforceable, it shall promptly notify the other Party
hereto. Serono shall have the sole right, at its sole discretion and expense, to
take any and all steps to xxxxx the infringement or contest the challenge of
Early Lead Patents and Joint Patents. SGX will
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cooperate with Serono, at Serono's request, including by joining such proceeding
as a party if required by applicable law, with fees and costs related to the
litigation to be borne by Serono. In the event Serono elects not to pursue
abatement of infringement or challenge of an Early Lead Patent or Joint Patent,
Serono shall give SGX not less than [...***...] ([...***...]) [...***...] notice
before any relevant deadline and SGX shall have the right to pursue, at its sole
discretion and expense, such activitieS. Should SGX pursue such activities,
Serono will cooperate with SGX, at its request, with fees and costs related to
the litigation to be borne by SGX. Neither Party shall settle or otherwise
compromise any such proceeding in a way that adversely affects the other Party's
rights or interests with respect to Early Lead Compounds or Products without
such Party's prior written consent. [...***...] by the [...***...] pursuant to
this Section 5.3, [...***...], [...***...].
6. CONFIDENTIALITY AND PUBLICITY
6.1 Confidential Information. Except as provided herein, the Parties
agree that, for the term of this Agreement and for [...***...] ([...***...])
years thereafter, the receiving Party, or any Affiliate thereof, shall not
publish or otherwise disclose and shall not use except pursuant to this
Agreement, any information or material furnished to it by the other Party
pursuant to this Agreement which if disclosed in tangible form is marked
"Confidential" or with other similar designation to indicate its confidential or
proprietary nature, or if disclosed orally is confirmed as confidential or
proprietary by the Party disclosing such information at the time of such
disclosure or within thirty (30) days thereafter ("Confidential Information").
Collaboration Technology (other than that which constitutes SGX Background
Technology) covering Early Lead Compounds, SGX Co-Crystal Structures containing
Early Lead Compounds, and Serono Co-Crystal Structures shall be deemed to be
Confidential Information of Serono. Each Party shall have the right to disclose
Confidential Information to its Affiliates and shall obtain written agreements
from each of its and its Affiliates' employees and agents who perform the
Collaboration, which agreements shall obligate such persons to similar
obligations of confidentiality and non-use. Notwithstanding the foregoing, it is
understood and agreed that Confidential Information shall not include
information or material that, in each case as demonstrated by written
documentation:
(a) was already known to the receiving Party, or an Affiliate
thereof, other than under an obligation of confidentiality, at the time of
disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving Party, or an Affiliate thereof, in breach of this
Agreement; or
(d) was subsequently lawfully disclosed to the receiving Party, or
an Affiliate thereof, by a person other than a Party hereto or independently
developed by the
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receiving Party or an Affiliate thereof, without reference to any Confidential
Information disclosed by the disclosing Party.
6.2 Permitted Disclosures. Notwithstanding the provisions of
Section 6.1 above, each Party hereto may use and disclose the other's
Confidential Information to the [...***...] in [...***...] or [...***...],
[...***...], complying with applicable [...***...], submitting information to
[...***...] or other [...***...], making a [...***...] of its rights hereunder,
filing for [...***...] of a Product or otherwise performing its [...***...] or
[...***...] hereunder, including [...***...] with respect to the [...***...];
PROVIDED, HOWEVER, that if a Party is required to make any such disclosure of
the other [...***...], to the extent it may legally do so, it will give
[...***...] to the other Party of such disclosure so that the other Party
[...***...] of such Confidential Information [...***...] (whether through
[...***...]).
6.3 Publication. Any public disclosure (oral, written or graphic)
by either Party describing the scientific results of the Collaboration will
[...***...] and [...***...] of the other Party [...***...] ([...***...])
[...***...] for publication or other public disclosure; PROVIDED, HOWEVER, SGX
may [...***...] information regarding the [...***...] under the Collaboration
and the [...***...] in the course of the Collaboration, provided Serono is given
the opportunity to review in advance any such disclosure to ensure that
[...***...]. If the reviewing Party so requests, the proposed public disclosure
[...***...] ([...***...]) [...***...] from the date of each request for the
[...***...] related to the proposed public disclosure. Promptly following the
Effective Date, the parties will jointly discuss and agree on a press release to
be made by SGX regarding the execution and subject matter of this Agreement.
Thereafter, the Parties will [...***...] on any further statements to the public
regarding the subject matter of this Agreement, except with respect to
disclosures required by [...***...], and provided further that notwithstanding
the above, [...***...] will have the right to disclose the terms of this
Agreement [...***...]. Any disclosure by either Party of the subject matter of
this Agreement other than the disclosures specifically permitted pursuant to
this Section 6.3 [...***...] in the performance of such Party's obligations
hereunder. If in the [...***...] of a [...***...] a public disclosure with
respect to this Agreement is [...***...], then the disclosing Party will provide
the other Party [...***...] of such intended announcement, and [...***...] under
the circumstances will [...***...] relative to the nature and scope of such
intended announcement. If either Party concludes that a copy of this Agreement
must be filed with the [...***...], it will provide the other Party a
[...***...], will provide the other Party an [...***...] on such proposal and
will give [...***...] by the other Party relating to such filing.
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7. INDEMNIFICATION
7.1 Indemnification of SGX. Serono shall indemnify, defend, and hold
harmless SGX, its directors, officers, and employees and the successors and
assigns of any of the foregoing (the "SGX Indemnitee(s)") from and against all
losses, costs, expenses (including payment of reasonable attorneys' fees and
other expenses of litigation), liabilities and damages (including settlement
amounts) finally awarded, with respect to any claim, suit or proceeding (any of
the foregoing, a "Claim") brought by a Third Party against an SGX Indemnitee, to
the extent arising out of or relating to: (a) a breach of Serono's
representations and warranties under Section 8; (b) any Products developed,
manufactured, used, sold or otherwise distributed by or on behalf of Serono, its
Affiliates or sublicensees utilizing any Collaboration Technology (including
product liability claims); (c) the use pursuant to this Agreement by SGX of
Initial Structures, Serono Co-Crystal Structures, SGX Co-Crystal Structures
(except to the extent such Claim arises from the use of SGX Background
Technology), a Serono Target, DNA coding for a Serono Target, Serono Materials
or a Serono Compound; or (d) the negligence or willful misconduct of Serono,
except, in each case, to the extent caused by the negligence or willful
misconduct of an SGX Indemnitee.
7.2 Indemnification of Serono. SGX shall indemnify, defend and hold
harmless Serono, its Affiliates, their directors, officers, employees and
licensees, and the successors and assigns of any of the foregoing (the "Serono
Indemnitee(s)") from and against any losses, costs, expenses (including payment
of reasonable attorneys' fees and other expenses of litigation), liabilities and
damages (including settlement amounts) finally awarded, with respect to any
Claims (as defined in Section 7.1 above) brought by a Third Party against a
Serono Indemnitee, to the extent arising out of or relating to: (a) a breach of
SGX's representations and warranties under Section 8; (b) the use pursuant to
this Agreement by Serono, its Affiliates or sublicensees of SGX Materials,
Initial Structures, Serono Co-Crystal Structures or SGX Co-Crystal Structures to
the extent such Claim arises from the use of SGX Background Technology; or (c)
the negligence or willful misconduct of SGX, except, in each case, to the extent
due to the negligence or willful misconduct of a Serono Indemnitee.
7.3 Indemnification Procedures. An SGX Indemnitee or a Serono Indemnitee
(either an "Indemnitee") that intends to claim indemnification under this
Article 7 shall promptly notify the indemnifying Party (the "Indemnitor") in
writing of any claim in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall have sole control of the defense
and/or settlement thereof, provided that the Indemnitee may participate in any
such proceeding with counsel of its choice at its own expense. In no event,
however, may the Indemnitor compromise or settle any claim or suit in a manner
which admits fault or negligence on the part of any Indemnitee without the prior
written consent of such Indemnitee. The indemnity agreement in this Article 7
shall not apply to amounts paid in settlement of any Claim if such settlement is
effected without the consent of the Indemnitor, which consent shall not be
withheld
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unreasonably. The failure to deliver written notice to the Indemnitor within a
reasonable time after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any liability to
the Indemnitee under this Article 7 but the omission so to deliver written
notice to the Indemnitor shall not relieve the Indemnitor of any liability that
it may have to any Indemnitee other than under this Article 7. The Indemnitee
under this Article 7, its employees and agents or those of the affiliated Party,
as applicable, shall cooperate fully with the Indemnitor and its legal
representatives and provide full information in the investigation, defense or
settlement of any Claim covered by this indemnification. Neither Party shall be
liable for any costs or expenses incurred by the other Party without its prior
written authorization.
7.4 No Consequential Damage. IN NO EVENT SHALL EITHER PARTY OR ANY OF
ITS AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR
SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES,
WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE,
including loss of profits or revenue, or claims of customers of any of them or
other Third Parties for such or other damages; PROVIDED, HOWEVER, that the
foregoing limitation shall not apply to indemnification obligations under this
Article 7.
8. REPRESENTATIONS AND WARRANTIES
8.1 Each Party. Each Party represents, warrants and covenants to the
other (i) that it has the legal power, authority and right to enter into this
Agreement and to perform its respective obligations under this Agreement; (ii)
that it is not a Party to any agreement or arrangement with any Third Party or
under any obligation or restriction which in any way limits or conflicts with
its ability to fulfill any of its obligations under this Agreement (including
granting the licenses in Article 4), and that it shall not enter into any such
agreement or arrangement during the term of this Agreement; and (iii) that each
employee or person engaged in the Collaboration on behalf of Serono or SGX has
entered into a written agreement which provides for the assignment to Serono or
SGX, respectively, of all inventions and discoveries made, conceived or reduced
to practice by such employee or person during the course of his or her
employment or engagement with Serono or SGX.
8.2 SGX. SGX represents and warrants to Serono that to its actual
knowledge as of the Effective Date it owns or possesses adequate licenses or
other rights to practice and use all SGX Background Technology and to grant the
licenses granted to Serono hereunder and that the practice and use of the SGX
Background Technology by SGX will not infringe or misappropriate the
intellectual property of any Third Party.
8.3 Disclaimer. SGX and Serono specifically disclaim any guarantee that
the Collaboration will be successful, in whole or in part. The failure of the
Parties to solve structures or to identify compounds will not constitute a
breach of this Agreement. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, SERONO AND SGX MAKE NO REPRESENTATIONS AND EXTEND NO
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WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE SGX BACKGROUND
TECHNOLOGY, THE SERONO BACKGROUND TECHNOLOGY OR THE COLLABORATION TECHNOLOGY OF
EACH PARTY, INCLUDING ANY WARRANTY OF NON-INFRINGEMENT OF THE INTELLECTUAL
PROPERTY OR OTHER RIGHTS OF ANY THIRD PARTY.
9. TERM AND TERMINATION
9.1 Term of the Agreement. The term of this Agreement shall commence on
the Effective Date and, unless terminated earlier, will terminate upon the
expiration of the Royalty Terms for all Products under Section 3.6 at which time
the licenses granted to Serono under Section 4.1 shall become fully paid,
irrevocable and perpetual.
9.2 Termination for Cause. Either Serono or, subject to Section 4.6, SGX
may terminate this Agreement by written notice stating such Party's intent to
terminate, in the event the other Party shall have materially breached or
defaulted in the performance of any of its obligations hereunder, and such
default shall have continued for sixty (60) days after written notice thereof
was provided to the breaching Party by the nonbreaching Party.
9.3 Effect of Termination.
(a) Accrued Rights and Obligations. Termination or expiration of
this Agreement for any reason shall be without prejudice to any rights which
shall have accrued to the benefit of a Party prior to such termination or
expiration. Termination or expiration of this Agreement for any reason shall not
release any Party hereto from any liability which, at the time of such
termination, has already accrued to the other Party, which is attributable to a
period prior to such termination or which is expressly indicated to survive
termination or expiration of this Agreement nor preclude either Party from
pursuing all rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Agreement, including rights under the United
States Bankruptcy Code.
(b) Return of Confidential Information. Upon any termination of
this Agreement, SGX and Serono shall promptly return to the other Party or
destroy all Confidential Information received from the other Party, except to
the extent required to exercise any continuing rights of such Party (and in any
event, except for one copy of such Confidential Information which may be
retained solely for archival purposes).
(c) Licenses.
(i) In the event of termination of this Agreement by either
Party pursuant to this Article 9, the licenses granted to SGX and Serono in
Section 4.2 shall terminate concurrently.
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(ii) In the event of termination of this Agreement by SGX
pursuant to Section 9.2, the licenses granted Serono under Sections 4.1 (a), (c)
and (d) (other than with respect to Serono Co-Crystal Structures) will terminate
concurrently.
(d) Inventory. Upon any termination of this Agreement, Serono and
its Affiliates and sublicensees shall be entitled, during the next nine (9)
months, to sell any inventory of Products which remains on hand as of the date
of the termination, so long as Serono pays to SGX the royalties applicable to
said subsequent sales in accordance with the terms and conditions set forth in
this Agreement.
(e) Sublicenses. In the event this Agreement terminates for any
reason, each of Serono's sublicensees at such time shall continue to have the
rights and license set forth in their sublicense agreements; PROVIDED, HOWEVER,
that such sublicensee agrees in writing that SGX is entitled to enforce all
relevant terms and conditions of such sublicense agreement directly against such
sublicense.
(f) Survival. The provisions of Articles 5, 6, 7, 8, and 10 and
Sections 3.5, 3.7-3.13, 4.6, 4.8 and 9.3 and, subject to Section 9.3(c) above,
Section 4.1 shall survive the expiration or termination of this Agreement for
any reason.
9.4 No Termination upon SGX's Bankruptcy. All licenses granted under
this Agreement by SGX are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101 of the U.S. Bankruptcy Code. The Parties
agree that Serono, as licensee of such rights under this Agreement, shall retain
and may fully exercise all of its rights and elections under the U.S. Bankruptcy
Code. The Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against SGX under the U.S. Bankruptcy Code, Serono
shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and the same, if not already in its possession, shall be
promptly delivered to it (i) upon any such commencement of a bankruptcy
proceeding upon Serono's written request therefor, unless SGX elects to continue
to perform all of its obligations under this Agreement, or (ii) if not delivered
under (i) above, following the rejection of this Agreement by or on behalf of
SGX upon written request therefor by Serono. In the event of the commencement of
a bankruptcy proceeding by or against SGX under the Bankruptcy Code and so long
as such proceeding continues, SGX will not, without Serono's prior written
consent, sell, transfer, assign or otherwise dispose of, or purport to sell,
transfer, assign or otherwise dispose of, any right, title or interest in, to or
under the Collaboration Technology (other than that which constitutes the SGX
Background Technology) or the SGX Background Technology that is necessary for
Serono to exercise its rights under this Agreement, if those rights would be
impaired in any material respect by such sale, transfer, assignment or other
disposition.
10. MISCELLANEOUS
10.1 Governing Law. This Agreement and all acts and transactions pursuant
hereto and the rights and obligations of the Parties hereto shall be governed,
construed
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and interpreted in accordance with the laws of the State of Delaware, without
reference to rules of conflicts or choice of laws. Any claim or controversy
arising out of or related to this Agreement or any breach hereof may be
submitted by either Party to a court of applicable jurisdiction in the State of
Delaware, and each Party hereby consents to the jurisdiction and venue of such
court
10.2 Notices. Any notice required or permitted by this Agreement shall be
in writing and shall be sent by internationally recognized courier or personal
delivery, or by fax with confirming letter sent under the conditions described
above, in each case addressed to the other Party at the address shown below or
at such other address for which such Party gives notice hereunder. Such notice
shall be deemed to have been given when delivered:
If to SGX:
Structural Genomix, Inc.
00000 Xxxxxxx Xxxxxx
Xxx Xxxxx, XX 00000
Facsimile: 000 000 0000
Attn: Chief Executive Officer
Copy to: Corporate Counsel
If to Serono:
Serono International S.A.
00 xxx xxxxxx xxx Xxxxx
0000 Xxxxxx, Xxxxxxxxxxx
Facsimile: 00-00-000-0000
Attn: Senior Executive Vice President, Business Development
Copy to: General Counsel
10.3 Force Majeure. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses (except for payment obligations)
on account of failure of performance by the defaulting Party if the failure is
occasioned by war, strike, civil commotion, acts of terrorism, fire, Act of God,
earthquake, flood, lockout, embargo, governmental acts or orders or
restrictions, failure or delay of transportation, failure of suppliers
(including energy suppliers), or any other reason where failure to perform is
beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of the nonperforming Party and the nonperforming Party has
exerted all reasonable efforts to avoid or remedy such force majeure and to
resume performance of its obligations hereunder as soon as practicable;
PROVIDED, HOWEVER, that in no event shall a Party be required to settle any
labor dispute or disturbance.
10.4 No Implied Rights. Only the rights granted pursuant to the express
terms of this Agreement shall be of any legal force or effect. No other rights
shall be created by implication, estoppel or otherwise.
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10.5 Assignment. This Agreement shall not be assignable by either Party
to any Third Party without the written consent of the other Party hereto, except
either Party may assign this Agreement, without such consent, to (i) an
Affiliate or (ii) an entity that acquires all or substantially all of the
business or assets of such Party to which this Agreement pertains, whether by
merger, reorganization, acquisition, sale, or otherwise.
10.6 Partial Invalidity. When possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under applicable
law, but if any provision of this Agreement is held to be invalid by a court of
competent jurisdiction, such provision will be ineffective only to the extent of
such prohibition or invalidity, without invalidating the remainder of this
Agreement, unless the invalid provision is of such essential importance to this
Agreement that it may be reasonably presumed that the Parties would not have
entered into this Agreement without the invalid provision. The Parties agree to
renegotiate in good faith any provision held invalid and to be bound by the
mutually agreed substitute provision in order to produce to the maximum extent
possible the effect originally intended by the Parties.
10.7 Independent Contractors. The relationship of Serono and SGX
established by this Agreement is that of independent contractors, and nothing
contained in this Agreement shall be construed to (i) give either Party the
power to direct or control the day-to-day activities of the other, (ii)
constitute the Parties as partners, joint venturers, or otherwise as
participants in a joint or common undertaking, or (iii) allow a Party to create
or assume any obligation on behalf of the other Party for any purpose
whatsoever.
10.8 No Waiver. No waiver of any term or condition of this Agreement
shall be valid or binding on either Party unless agreed in writing by the Party
to be charged. The failure of either Party to enforce at any time any of the
provisions of the Agreement, or the failure to require at any time performance
by the other Party of any of the provisions of this Agreement, shall in no way
be construed to be a present or future waiver of such provisions, nor in any way
to affect the right of either Party to enforce each and every such provision
thereafter.
10.9 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which
together shall constitute one instrument.
10.10 English Language. This Agreement has been prepared in the English
language and the English language shall control its interpretation.
10.11 Entire Agreement; Amendment. This Agreement, including the Exhibits
attached hereto, constitutes the entire agreement of the Parties with respect to
the subject matter hereof, and supersedes all prior or contemporaneous
understandings or agreements, whether written or oral, between Serono and SGX
with respect to such subject matter. No amendment or modification hereof shall
be valid or binding upon the Parties unless made in a writing referencing this
Agreement and signed by the duly authorized representatives of both Parties.
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10.12 Exports. This Agreement is made subject to any restrictions
concerning the export of materials and technology from the United States which
may be imposed upon either Party to this Agreement from time to time by the
United States Government. SGX and Serono agree not to export or re-export,
directly or indirectly, any information, technical data, the direct product of
such data, samples or equipment received or generated under this Agreement in
violation of any applicable export control laws or governmental regulations.
10.13 Rules of Construction. The use in this Agreement of the term
"including" means "including, without limitation." Unless the context otherwise
requires, the use in this Agreement of the term "or" means "and/or." The words
"herein," "hereof," "hereunder," and other words of similar import refer to this
Agreement as a whole, including the Exhibits, and not to any particular section,
subsection, paragraph, subparagraph or clause contained in this Agreement. All
references to sections and Exhibits mean those sections of this Agreement and
Exhibits attached to this Agreement, except where otherwise stated. The use
herein of the masculine, feminine or neuter forms shall also denote the other
forms and any reference to the singular or plural shall include the other, in
each case unless the context otherwise requires.
IN WITNESS WHEREOF, the undersigned are duly authorized to execute and
deliver this Agreement on behalf of Serono and SGX as applicable as of the day
and year first above written.
SERONO INTERNATIONAL S.A. STRUCTURAL GENOMIX, INC.
By: /s/ Xxxxxxx Xxxxxxxxxx By: /s/ Xxx Xxxxxx
---------------------------------- ----------------------------------
Name: Xxxxxxx Xxxxxxxxxx Name: Xxx Xxxxxx
-------------------------------- --------------------------------
Title: Authorized Representative Title: Chief Executive Officer
------------------------------- -------------------------------
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EXHIBIT A - COLLABORATION PLAN
OVERALL GOAL
The initial goal of the collaboration is to generate Early Lead Compounds for
three targets; [...***...], [...***...], and [...***...]. The three initial
projects will proceed in parallel. Serono may nominate an additional [...***...]
targets for year [...***...]. the research plans for these targets will be
established upon their selection and shall include such activities as Serono may
direct, following consultation with SGX, including all or any of the following:
generation of Early Lead Compounds, determination of Initial Structures, and
determination of Serono Co-Crystal Structures.
Details for each target are given below.
TARGET PLANS
[...***...]
The projected timeline for this project is [...***...] months as illustrated in
Figure 1.
PROTEIN PRODUCTION AND CRYSTALLOGRAPHY
The crystal structure of [...***...] has been determined by a number of research
groups. Many of these structures have been deposited into the Protein Data Bank
(PDB) with diffraction in the [...***...] range. SGX will use information from
these publications to reproduce this crystal structure. SGX already has isolated
a [...***...] for the [...***...] of this protein. Specifically, SGX plans to:
- Generate [...***...] with [...***...]. Since both [...***...] and
[...***...] ([...***...]) [...***...], SGX believes it is essential to
[...***...] in [...***...]. Based on [...***...], a [...***...]
([...***...]) [...***...] as the [...***...].[...***...] that end
[...***...], [...***...] will also be chosen.
- [...***...] these [...***...] into [...***...].[...***...] will allow
production of [...***...] and [...***...]. In this way [...***...] can be
produced for [...***...] many of which will [...***...] to [...***...] in
[...***...],
- Examine [...***...] and [...***...] of these [...***...].
- [...***...] for [...***...] and [...***...]. The latter will include
[...***...] to monitor [...***...] and [...***...].
- Carry out [...***...] to obtain [...***...].
- Carry out [...***...] around published conditions to [...***...] for
[...***...]; [...***...] may [...***...] this [...***...]
- [...***...] at SGX-CAT and [...***...].
- Determine [...***...] is most suited to [...***...] and [...***...] for
[...***...].
BIOCHEMISTRY
SGX will establish and validate a [...***...] biochemical enzymatic assay(s).
Serono and SGX shall consult regarding the identification of appropriate assays
and reagents that are available Serono Materials. Assays under consideration for
[...***...] are:
***CONFIDENTIAL TREATMENT REQUESTED
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Continuous [...***...] Assay Using [...***...] Substrate
[...***...] will catalyze the hydrolysis of [...***...] to yield [...***...] and
[...***...] ([...***...]). The [...***...]-dependent production of [...***...]
can be monitored [...***...] by measuring the time-dependent increase of
fluorescence at [...***...]nm.
Fluorescence Polarization Assay
The availability of good commercial sources of [...***...] antibodies and
well-characterized substrate peptide should allow for the development of a
simple [...***...] assay for [...***...]. An efficient [...***...] substrate
such as [...***...] could be labeled at either the N- or C-terminus with a
[...***...] appropriate for [...***...] (i.e. [...***...] or [...***...]).
[...***...] antibody would then be added to measure the extent of [...***...] by
a decrease in the observed [...***...].
Commercial Assay Options
[...***...] sells a homogeneous [...***...] assay kit ([...***...], [...***...])
that uses their proprietary [...***...] technology with [...***...] as the
readout. This represents the fastest route to attaining an assay in the
short-term. This assay comes configured with purified enzyme from [...***...]
but that reagent could be substituted with SGX-produced protein. In addition,
SGX may opt to simply purchase the [...***...] reagent for use in SGX's
formatted [...***...] assay as described in the paragraph above. [...***...]
biotechnology sells a [...***...] based assay system for [...***...]. The
[...***...] and [...***...] reagent are both available from [...***...]
([...***...]).
IDENTIFICATION OF INITIAL FRAGMENT HITS
- SGX will [...***...] screen compounds from the SGX FAST(TM) library by
soaking approximately [...***...] samples into [...***...] crystals.
- In parallel, SGX will screen the SGX FAST(TM) library (individually) at a
compound concentration of [...***...] against [...***...] with a
biochemical enzymatic assay. Hits will be followed up with [...***...]
determination.
- SGX will conduct the following studies as needed: (1) [...***...] for
[...***...] detected from [...***...] if not [...***...] in the
[...***...], (2) [...***...] measurement for [...***...] detected from
[...***...] if not [...***...] in the [...***...].
- A [...***...] search of the [...***...] will be conducted for a
preliminary assessment of [...***...].
- The results of the [...***...] search will be discussed by the JSC which
shall agree upon those [...***...] to be selected for further elaboration
after consideration of the recommendation of the Project team.
IDENTIFICATION OF ELABORATED FRAGMENTS
- One or more [...***...] will be selected by the JSC for [...***...],
[...***...], and [...***...] (appropriate presentation of [...***...]).
- [...***...] are [...***...] into [...***...] and [...***...] on the
[...***...]:
***CONFIDENTIAL TREATMENT REQUESTED
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1. [...***...] from [...***...] at each [...***...] are [...***...].
2. [...***...] of each [...***...] are [...***...] in the [...***...]
of the [...***...] and [...***...], based on the [...***...] of the
[...***...].
3. Each [...***...] is [...***...] in the [...***...] of [...***...].
4. [...***...] with [...***...] ([...***...]) [...***...] or
[...***...] ([...***...]) are [...***...].
5. [...***...] are [...***...] with [...***...] binding [...***...] and
[...***...] for [...***...].
- SGX will [...***...], [...***...], using the [...***...] (for example, for
a [...***...], [...***...], [...***...] - approximately [...***...] per
[...***...]).[...***...] will be [...***...] ([...***...]) [...***...].
- SGX will [...***...] in the [...***...] at a compound concentration of
[...***...] (the exact concentration will be based on the activity of the
[...***...]) and follow up [...***...].
- SGX will [...***...] and [...***...] their [...***...] to [...***...] and
[...***...] the [...***...] for [...***...] of [...***...] and
[...***...].
- The results of the [...***...] search will be discussed by the JSC which
shall agree upon those [...***...] to be selected for [...***...] after
consideration of the recommendation of the [...***...].
- As appropriate, and after discussion and agreement at the JSC, the
selected [...***...] will be [...***...] ([...***...]) [...***...]
(determined by the JSC). The JSC shall determine whether the [...***...]
will be run by [...***...], [...***...] or an [...***...].
OPTIMIZATION OF [...***...] TO [...***...]
- SGX will computationally select [...***...] for all points of [...***...]
to design [...***...], [...***...] where [...***...] positions are
[...***...] (approximately [...***...]).
- SGX will synthesize [...***...].
- SGX will test analogs against [...***...] at a compound concentration of
[...***...] (the exact concentration will be based on the [...***...]) and
follow up [...***...] and [...***...] for [...***...], as discussed and
agreed upon by the JSC.
- The [...***...] will be [...***...] of up to [...***...] ([...***...])
[...***...] (determined by the JSC). The JSC shall determine whether the
[...***...] will be run by [...***...], [...***...]or an [...***...].
- SGX will conduct a [...***...] including [...***...] from [...***...]
through [...***...].
***CONFIDENTIAL TREATMENT REQUESTED
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[...***...]
FIGURE 1. [...***...]
***CONFIDENTIAL TREATMENT REQUESTED
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[...***...]
The projected timeline for this project is [...***...] to [...***...] months as
illustrated in figure 2.
PROTEIN PRODUCTION AND CRYSTALLOGRAPHY
The crystal structure of [...***...] is not in the [...***...]. However, SGX has
determined the structures of [...***...] and [...***...] at [...***...]. These
kinases, when compared to structures in the [...***...], are the closest to
[...***...], with identities in the kinase domain In the low [...***...]% range.
Based on this information, SGX believes that [...***...] and [...***...] are
likely to give good guidance both on the boundaries for [...***...] and on the
residues that likely will need to be deleted to remove the loop insert in the
[...***...] kinase domain.
SGX will use this information to attempt to produce the [...***...] crystal
structure. Specifically, SGX's goals will be to:
- [...***...] with [...***...] based on the [...***...] and
[...***...]. Since both [...***...] and [...***...] for [...***...]
are desired, it will be essential to test a [...***...] of
[...***...] in [...***...],
- [...***...] for [...***...] based on the [...***...] and [...***...]
shown below,
[...***...]
- [...***...] and [...***...] into [...***...]. These [...***...] will
allow production of [...***...]- and [...***...] and with
[...***...]. In this way [...***...] of [...***...] for [...***...]
and [...***...] and by so doing increase the likelihood of
[...***...] a [...***...] of the [...***...] with [...***...] and
[...***...],
- Examine [...***...] and [...***...] of [...***...],
- [...***...] for [...***...] and [...***...]. The latter will include
[...***...] to monitor [...***...] and [...***...],
- [...***...] to obtain [...***...] for [...***...]. If none of the
above [...***...] in a [...***...], [...***...], the effects of
[...***...], for example, in the [...***...] of the [...***...],
***CONFIDENTIAL TREATMENT REQUESTED
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- [...***...] to [...***...] the [...***...]; [...***...] to
[...***...],
- [...***...] at SGX-CAT and [...***...],
- Determine [...***...] is most suited to [...***...] and [...***...]
for [...***...].
BIOCHEMISTRY
SGX will [...***...] and [...***...] a [...***...] assay. Serono and SGX shall
consult regarding the identification of [...***...] assays and [...***...] that
are available Serono Materials. Assays under consideration for [...***...] are:
Continuous [...***...] Coupled Assay
SGX will assess the feasibility of developing a continuous [...***...] assay for
[...***...] using the [...***...] ([...***...]) coupled system. SGX will first
determine which, if any, of [...***...] is [...***...]. It may be required for
[...***...] to use inactive [...***...] as the [...***...] in such a system.
[...***...] FRET Assay
SGX has developed a proprietary and [...***...] that does not require
[...***...]. SGX will initially evaluate the [...***...] by surveying
[...***...] under several [...***...] using several [...***...]. If suitable
conditions can be identified, a [...***...] will be employed.
IDENTIFICATION OF INITIAL FRAGMENT HITS
As described for [...***...]
IDENTIFICATION OF ELABORATED FRAGMENTS
As described for [...***...]
OPTIMIZATION OF ELABORATED FRAGMENTS TO EARLY LEAD COMPOUNDS
As described for [...***...]
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[...***...]
FIGURE 2. [...***...].
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[...***...]
The projected timeline for this project is [...***...] to [...***...] months as
illustrated in Figure 3.
PROTEIN PRODUCTION AND CRYSTALLOGRAPHY
To SGX's knowledge the crystal structure of [...***...] has not been previously
determined. Efforts are ongoing at SGX to obtain this structure. Once an initial
structure has been obtained SGX will determine if the crystal form is suited to
[...***...] and will [...***...]; if the [...***...] is [...***...] then
[...***...].
BIOCHEMISTRY
SGX will establish and validate an [...***...] assay. Serono and SGX shall
consult regarding the identification of [...***...] assays and [...***...] that
are available [...***...]. Assays under consideration for [...***...] are:
Continuous [...***...] Coupled Assay
SGX will assess the feasibility of developing a continuous enzymatic assay for
[...***...] using the [...***...] ([...***...]) coupled system. SGX will first
determine which, if any, of [...***...] is applicable. SGX will also assess the
ability of its [...***...] to [...***...] in the coupled assay system.
[...***...] FRET Assay
SGX will initially evaluate the feasibility of developing an [...***...] by
surveying our proprietary [...***...] under several [...***...] using
[...***...]. If suitable conditions can be identified, a [...***...] will be
employed.
Commercial Assay Options
[...***...] sells a homogeneous [...***...] ([...***...],[...***...]) that uses
their proprietary [...***...] technology with [...***...] as the readout. This
represents the fastest route to attaining an assay in the short-term. This assay
comes configured with [...***...] from [...***...] but that reagent [...***...]
with [...***...]. In addition, SGX may opt to simply [...***...] for use in
[...***...].
IDENTIFICATION OF INITIAL FRAGMENT HITS
As described for [...***...], subject to the section describing presentation to
the JSC below
IDENTIFICATION OF ELABORATED FRAGMENTS
As described for [...***...], subject to the section describing presentation to
the JSC below
OPTIMIZATION OF ELABORATED FRAGMENTS TO EARLY LEAD COMPOUNDS
As described for [...***...], subject to the section describing presentation to
the JSC below
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PRESENTATION OF INITIAL FRAGMENT HITS, ELABORATED FRAGMENTS AND EARLY LEAD
COMPOUNDS FOR [...***...] TO THE JSC
[...***...] will be communicated as [...***...]-[...***...], similar to
[...***...]: [...***...] for the [...***...] will be [...***...] and [...***...]
will be [...***...] with [...***...] including the [...***...] and [...***...]
([...***...], [...***...], [...***...]). The JSC will select [...***...] for
generating these [...***...], which may also include [...***...].
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[...***...]
FIGURE 3. [...***...].
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DETERMINATION OF SERONO [...***...]
Serono Compounds delivered to SGX by Serono will be [...***...] and/or
[...***...] with the [...***...], as appropriate, in order to [...***...] for
the [...***...] of [...***...].
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EXHIBIT B - DELIVERABLES
INITIAL STRUCTURES
- Protocols for [...***...] and [...***...] and [...***...], these protocols
should be [...***...] to [...***...] of the [...***...] by [...***...].
- [...***...] (e.g., [...***...], [...***...]) [...***...] for [...***...]
and [...***...].
- [...***...] and [...***...] with [...***...].
- [...***...] with [...***...] and [...***...]; [...***...], [...***...],
etc.
- [...***...], with [...***...].
EARLY LEAD COMPOUNDS
- Protocols for [...***...] and [...***...], these protocols should be clear
enough to [...***...] of the [...***...] ([...***...]).
- [...***...] (e.g., [...***...], [...***...]) [...***...] for [...***...]
and [...***...] ([...***...]).
- [...***...] and [...***...] with [...***...] ([...***...] and [...***...])
- [...***...] with [...***...] and [...***...]; [...***...], [...***...],
etc.
- [...***...] containing [...***...], with relevant [...***...].
- [...***...] (i.e. [...***...], [...***...], etc.).
- [...***...] with [...***...], [...***...], etc.
- [...***...] performed on [...***...] ([...***...], [...***...], etc.).
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SERONO CO-CRYSTAL STRUCTURES
- Protocols for [...***...] and [...***...], these protocols should be clear
enough to [...***...] of the [...***...] ([...***...]).
- [...***...] (e.g., [...***...], [...***...]) [...***...] for [...***...]
and [...***...] ([...***...]).
- [...***...] and [...***...] with [...***...] ([...***...] and
[...***...]).
- [...***...] with [...***...] and [...***...]; [...***...], [...***...],
etc).
- [...***...] containing [...***...], with [...***...].
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