Exhibit 10.2
Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission. Asterisk
denote omissions.
COLLABORATION AND OPTION
AGREEMENT
by and between
Infinity Pharmaceuticals,
Inc.
and
Novartis International
Pharmaceutical Ltd.
Collaboration Agreement —
Confidential
COLLABORATION AND OPTION
AGREEMENT
This Agreement is made this
16 th day of November, 2004 (the “
Effective Date ”) by and between Infinity
Pharmaceuticals, Inc. (“ Infinity ”), a Delaware
corporation with principal offices at 780 Memorial Drive,
Cambridge, Massachusetts 02139, and Novartis International
Pharmaceutical Ltd. (“ Novartis ”), a Bermuda
corporation with principal offices at Hurst Holme, 12 Trott Road,
Hamilton, HM LX, Bermuda. Infinity and Novartis are sometimes
referred to herein individually as a “ Party ”
and together as the “ Parties .”
I NTRODUCTION
WHEREAS, Infinity has developed a
proprietary diversity oriented synthesis methodology to design
novel, three-dimensional, natural compound-like synthetic
compounds;
WHEREAS, Novartis and its Affiliates
possess expertise in discovering, developing, manufacturing,
marketing, and selling pharmaceuticals worldwide;
WHEREAS, Infinity and Novartis
desire to enter into a collaboration, the objectives of which are
the joint design by the Parties of Synthetic Pathways, as defined
herein, and the synthesis by Infinity, using such Synthetic
Pathways, of certain of the Library Compounds, as defined herein
(the “ Collaboration ”);
WHEREAS, each of the Parties,
together with its respective Affiliates, is interested in screening
Library Compounds against Targets with the goal of developing and
commercializing drugs for human therapeutic and other
purposes;
WHEREAS, in the event that Infinity
generates any Lead Programs, as defined herein, using Library
Compounds, then Novartis and its Affiliates shall have the option
to develop, market and sell the same as drugs upon the terms set
forth herein and in a License, Development and Commercialization
Agreement identical in substance to Exhibit A hereto;
and
WHEREAS, in connection with the
Collaboration, Infinity desires to sell, and Novartis Pharma AG, an
Affiliate of Novartis, desires to purchase on the Effective Date
3,333,333 shares of Infinity’s Series C Preferred Stock for
an aggregate purchase price of U.S.$15 million, in accordance with
the terms and conditions of the Stock Purchase Agreement (as
defined herein);
Collaboration Agreement —
Confidential
NOW THEREFORE, in consideration of
the mutual covenants set forth in this Agreement, and other good
and valuable consideration, the Parties agree as
follows:
ARTICLE I
D EFINITIONS
1.1. “Acceptance
Criteria” shall
mean the minimum acceptable criteria set forth in
Section 2.2.4 that each Proposed Compound must meet before
such Proposed Compound can be deemed an Actual Compound.
1.2. “Actual
Compound” shall
mean Proposed Compounds which meet the Acceptance Criteria in
Section 2.2.4 and have been deemed an Actual Compound as set
forth in Section 2.2.6. For purposes of clarity, an Actual
Compound shall also remain a Library Compound.
1.3. “Active
Moiety” shall have
the meaning assigned to that term under 21 CFR 314.108(a), as such
regulation is in effect on the Effective Date, namely: “the
molecule or ion, excluding those appended portions of the molecule
that cause the drug to be an ester, salt (including a salt with
hydrogen or coordination bonds), or other noncovalent derivative
(such as a complex, a chelate or clathrate) of the molecule,
responsible for the physiological or pharmacological action of the
drug substance.”
1.4.
“Affiliate” shall mean, with respect to any Person, any
other Person which directly or indirectly, by itself or through one
or more intermediaries, controls, or is controlled by, or is under
common control with, such Person. The term “control”
(as applied to a Person) means the possession, direct or indirect,
of the power to direct or cause the direction of the management and
policies of a Person, whether through the ownership of voting
securities, by contract or otherwise. Control will be presumed if
one Person owns, either of record or beneficially, at least fifty
percent (50%) of the voting stock of any other Person. Such
other
Collaboration Agreement — Confidential
– Page 2
relationship as in fact results in actual
control over the management, business, and affairs of a Person
shall also be deemed to constitute control; provided ,
however , that no Person shall be deemed to exercise control
over another Person solely because the latter relies on the former
for a majority of its business. A Person will be deemed an
Affiliate only so long as such ownership or control relationship
continues. In the case of Novartis, “Affiliates” shall
also expressly be deemed to include the Novartis Institute for
Functional Genomics, Inc. and the Friedrich Miescher Institute for
BioMedical Research and their respective Affiliates.
1.5. “Background
Intellectual Property” shall have the meaning set forth in
Section 7.1.1(a).
1.6.
“Collaboration” shall have the meaning set forth in the preamble
hereto.
1.7. “Collaboration
Intellectual Property” shall mean Compound Related Intellectual
Property, Compound Intellectual Property and Non-Compound Related
Intellectual Property.
1.8. “Compound Intellectual
Property” shall
have the meaning set forth in Section 3.2.2.
1.9. “Compound Related
Intellectual Property” shall have the meaning set forth in
Section 7.1.2.
1.10.
“Controlled” shall mean, with respect to an Intellectual
Property right, the legal authority or right of a Party (other than
by license pursuant to this Agreement) to grant a license or
sublicense of such intellectual property rights to the other Party,
or to otherwise disclose such proprietary or trade secret
information to such other Party, as applicable, without breaching
the terms of any agreement with a Third Party.
1.11. “Data
Package” shall have
the meaning set forth in Section 3.3.3.
1.12. “Data Receipt
Notice” shall have
the meaning set forth in Section 3.3.4(a).
Collaboration Agreement — Confidential
– Page 3
1.13. “Derivative
Compounds” shall
mean any and all compounds that are modified by chemical and/or
molecular-genetic means from a Library Compound. Analogues of such
compounds and their derivatives shall be included within the scope
of Derivative Compounds.
1.14. “Effective
Date” shall mean
the effective date of this Agreement as set forth on the first
page.
1.15.
“Field” shall
mean all human and veterinary health-care applications including,
but not limited to, research, diagnosis, therapeutics, and
prophylaxis with respect to any indication, together with all
agricultural purposes.
1.16. “Genus
License” shall have
the meaning set forth in Section 3.2.1.
1.17. “Infinity
Compound” shall
have the meaning set forth in Section 3.4(b) and/or
Section 3.5, as applicable.
1.18. “Infinity Compound
Patent” shall have
the meaning set forth in Section 3.2.3.
1.19. “Intellectual
Property” shall
mean all confidential and proprietary data, technical information,
know-how, experience, inventions (whether or not patented and all
Patents claiming such inventions), and trade secrets Controlled by
a Party or its Affiliates.
1.20. “Investors’
Rights Agreement” shall mean that certain Third Amended and
Restated Investors’ Rights Agreement dated as of the
Effective Date.
1.21. “Joint Steering
Committee” shall
have the meaning set forth in Section 2.3.1.
1.22. “Lead
Criteria” shall
have the meaning set forth in Section 3.3.2.
1.23. “Lead
Program” shall mean
any Library Compounds, together with all Derivative Compounds (and
together with any and all compounds having the same Active Moiety
as such Library Compounds or Derivative Compounds), which:
(a) are discovered during the course of screening and initial
optimization of the Library Compounds against a Target by Infinity
or its Affiliates; (b) meet the Lead Criteria; and
(c) Infinity wishes to further optimize. A Lead Program may be
composed of one or more Lead Series.
Collaboration Agreement — Confidential
– Page 4
1.24. “Lead
Series” shall mean
the structurally-related Derivative Compounds contained in a Lead
Program. Each Lead Series shall contain at least [**] chemical
entities.
1.25. “Library
Compound” shall
mean any chemical entity that may be synthesized through the
synthetic transformations defining a Synthetic Pathway.
1.26. “License
Agreement” shall
mean the License, Development and Commercialization Agreement,
identical in substance to Exhibit A hereto, to be executed
by Infinity and Novartis with respect to Optioned Lead
Program(s).
1.27. “Non-Acceptance
Notice” shall have
the meaning set forth in Section 2.2.5(a).
1.28. “Non-Acceptance
Notice Period” shall have the meaning set forth in
Section 2.2.5(a).
1.29. “Non-Compound Related
Intellectual Property” shall have the meaning set forth in
Section 7.1.3.
1.30. “Novartis Reserved
Target” shall have
the meaning set forth in Section 3.1.2(b)(iii).
1.31.
“Option” shall have the meaning set forth in
Section 3.3.1.
1.32. “Optioned Lead
Program” shall mean
any Lead Program as to which Novartis has exercised its
Option.
1.33.
“Patents” means all existing patents and patent
applications and all patent applications hereafter filed, including
any continuation, continuation-in-part, divisional, provisional or
any substitute applications, any patent issued with respect to any
such patent applications, any reissue, reexamination, renewal or
extension (including any supplementary protection certificate) of
any of the foregoing patents, and any confirmation patent or
registration patent or patent of addition based on any of the
foregoing patents, and all foreign counterparts of any of the
foregoing.
Collaboration Agreement — Confidential
– Page 5
1.34.
“Person” means any individual, corporation, partnership,
association, joint-stock company, trust, unincorporated
organization or government or political subdivision
thereof.
1.35. “Proposed
Compounds” shall
mean that subset of Library Compounds that the Joint Steering
Committee determines are to be synthesized by Infinity during the
Collaboration pursuant to Section 2.2.3.
1.36.
“Scaffold” shall mean a skeletal core of a molecule with
designated chemical functionality through which variable
substituents can be attached through standard organic chemical
transformations, and that the Joint Steering Committee designates
as part of the Collaboration. Stereochemical variations in the
Scaffold shall be considered the same Scaffold. For clarity,
representative examples of compounds that would be inside or
outside of a particular Scaffold are described in Exhibit
B .
1.37. “Stock Purchase
Agreement” shall
mean that Stock Purchase Agreement dated as of the Effective Date
by and between Infinity and Novartis Pharma AG, an Affiliate of
Novartis.
1.38. “Synthetic
Pathway” shall mean
any sequence of chemical transformations that create a Scaffold,
and that the Joint Steering Committee designates as part of the
Collaboration.
1.39.
“Target” shall mean any biological entity identified as
being potentially involved in one or more disease
states.
1.40. “Third
Party” shall mean
any Person that is not a Party or an Affiliate of any
Party.
1.41. “Threshold
Date” shall have
the meaning set forth in Section 3.1.2(b).
Collaboration Agreement — Confidential
– Page 6
ARTICLE II
T HE C OLLABORATION
2.1. Commencement;
Direction.
The Collaboration shall commence on
the Effective Date. The Joint Steering Committee shall direct the
conduct of the Collaboration.
2.2. Library Design and
Synthesis.
2.2.1. Synthetic Pathways . During the course of
the Collaboration, the Joint Steering Committee shall design, and
Infinity shall deliver Actual Compounds from, no fewer than [**]
and no more than [**] Synthetic Pathways.
2.2.2. Library Compounds . The Joint Steering
Committee shall design Synthetic Pathways, Scaffolds and their
associated Library Compounds so as not to overlap with compounds
outside the scope of the Collaboration that are then in or under
development for the compound collection of a Party or its
Affiliates. The vote by each Party’s representatives to the
Joint Steering Committee approving the designation of a Synthetic
Pathway and Scaffold shall be deemed a representation by such Party
that such Synthetic Pathway and Scaffold do not overlap with
compounds outside the scope of the Collaboration that are then in
or under development for the compound collection of such Party or
its Affiliates. Upon approval, each Synthetic Pathway and Scaffold,
together with representative examples and any written descriptions
shall be attached and incorporated hereto as Exhibit
C .
2.2.3. Proposed Compounds . The Joint Steering
Committee shall identify the chemical entities to be synthesized by
Infinity (the “ Proposed Compounds ”). Infinity
shall not synthesize more than [**] Actual Compounds using any [**]
Synthetic Pathway. Infinity shall synthesize, on average, between
[**] and [**] micromoles of each Proposed Compound. It is the
expectation of the Parties that Infinity will provide Novartis with
[**] micromoles of each Proposed Compound; provided ,
however , that for no more than [**] percent ([**]%) of the
Proposed Compounds generated in connection with any Synthetic
Pathway, Infinity may provide Novartis with an amount greater than
or equal to [**], but less than [**], micromoles of each such
Proposed Compound. In no event will Infinity provide Novartis with
fewer than [**] micromoles of any Proposed Compound.
Collaboration Agreement — Confidential
– Page 7
2.2.4. Acceptance Criteria . Infinity will
deliver to Novartis only Proposed Compounds that, in
Infinity’s reasonable judgment, meet the following Acceptance
Criteria:
(a) The quantities of Proposed
Compounds delivered to Novartis shall be no less than as set forth
in Section 2.2.3.
(b) Each Proposed Compound shall be
at least [**] percent ([**]%) pure, as defined by HPLC-MS UV at 210
nm. In the event that the Joint Steering Committee determines that
HPLC-MS UV is not an appropriate detection method for a Proposed
Compound, its purity shall instead be determined by HPLC-MS
ELSD.
(c) Infinity will provide Proposed
Compounds to Novartis in barcoded Whatman plates (96-deepwell, 1
ml) with Platelock™ heat-sealed foil covers from Velocity11
(or other comparable sealing, mutually agreed by the Parties).
Novartis shall provide the Whatman plates to Infinity. If the
Platelock™ heat-sealed foil covers from Velocity11 are used,
Infinity shall provide them. If other materials are used, the
Parties will mutually agree on which Party shall supply such other
materials. The Proposed Compounds shall be provided in [**] with
eighty-eight (88) Proposed Compounds per plate in columns 1-11
and with column 12 empty.
(d) The plates will be shipped on
dry ice to the shipping destination indicated by Novartis, via a
carrier selected in advance by Novartis, FOB Infinity’s
facility in Cambridge, the cost of which shall be borne by
Novartis.
(e) Contemporaneously with its
delivery of the Proposed Compounds, Infinity shall deliver to
Novartis an accurate structural description for each Proposed
Compound in an electronic format reasonably acceptable to
Novartis.
(f) Contemporaneously with its
delivery of the Proposed Compounds, Infinity will also deliver
electronic copies of its production notebooks which contain
Synthetic Pathway information related to the Proposed Compounds
that is reasonably necessary to allow Novartis to
Collaboration Agreement — Confidential
– Page 8
synthesize the Proposed Compounds, which
production notebooks include without limitation all information
regarding the reaction conditions, necessary reagents, materials,
and the like used by Infinity to synthesize the Library Compounds
and any intermediates made by Infinity. Such notebooks shall be
delivered in an electronic format reasonably acceptable to
Novartis.
2.2.5. Non-Acceptance of a Proposed Compound
.
(a) In the event that Novartis, in
its reasonable discretion, determines that a Proposed Compound does
not meet the Acceptance Criteria, it shall so notify Infinity in
writing (the “ Non-Acceptance Notice ”) within
[**] calendar days of the delivery of such Proposed Compound (the
“ Non-Acceptance Notice Period ”).
(b) Novartis shall disclose in any
Non-Acceptance Notice which Acceptance Criteria were not achieved.
The Parties will share the data necessary to resolve differences
over whether the Acceptance Criteria were met and shall refer any
unresolved disputes to the Joint Steering Committee pursuant to
Section 2.4.2.
(c) Infinity may, in its sole
discretion, attempt to address the unachieved Acceptance Criteria
disclosed in the Non-Acceptance Notice, and may then resubmit the
relevant Proposed Compound to Novartis, along with other Proposed
Compounds, in accordance with the procedure specified in
Section 2.2.4. The timetable set forth in subsection
(a) shall apply to the resubmitted Proposed Compound as if it
were being submitted to Novartis for the first time.
(d) If a Proposed Compound is
ultimately rejected by the Joint Steering Committee, then Novartis
shall delete structural and related information with respect to
such Proposed Compound from Novartis’ databases and return to
Infinity all remaining Proposed Compound material which is not in
Novartis’ screening format. Novartis may continue to include
such material in screens; provided , however , that
Novartis shall not conduct research on such rejected Proposed
Compounds nor determine the structure of such Proposed Compound
through any analytical or other method.
Collaboration Agreement — Confidential
– Page 9
(e) Notwithstanding the foregoing,
any Proposed Compound that is the subject of a Non-Acceptance
Notice or has been rejected by the Joint Steering Committee shall
remain a Library Compound for purposes of this
Agreement.
2.2.6. Acceptance as an Actual Compound . In the
event that Novartis does not provide Infinity with a Non-Acceptance
Notice in respect of a particular Proposed Compound within the
relevant Non-Acceptance Notice Period, such Proposed Compound, upon
expiration of the Non-Acceptance Notice Period, shall automatically
be deemed to be an Actual Compound.
2.2.7. Diligence Obligations . Prior to the [**] anniversary of the Effective
Date, Infinity shall synthesize and deliver to Novartis [**] Actual
Compounds; provided , however , that should Infinity
not deliver [**] Actual Compounds to Novartis by such anniversary
date, then Infinity shall not be in breach of this diligence
obligation; provided further that Infinity shall
continue using commercially reasonable efforts to synthesize Actual
Compounds thereafter until Infinity shall have synthesized and
delivered [**] Actual Compounds to Novartis, unless otherwise
agreed upon in writing between the Parties.
2.2.8. Payment for Actual Compounds . Upon
submission by Infinity of a corresponding invoice, Novartis shall
pay Infinity U.S.$[**] per Actual Compound, which amount shall be
payable within [**] calendar days of receipt of such invoice;
provided , however , that in each case, Infinity
shall not submit any invoices (other than the final invoice of the
Collaboration) until the aggregate amount owed by Novartis equals
or exceeds U.S.$[**].
2.3. Joint Steering
Committee.
2.3.1. Composition . Upon execution of this
Agreement, Infinity and Novartis will establish a Joint Steering
Committee (the “ Joint Steering Committee ”),
which shall consist of an equal number of executives or scientists
as may be designated by each Party from time to time. The Joint
Steering Committee shall initially have six (6) members. The
Committee Chair will be appointed from among the members of the
Joint Steering Committee designated by Novartis.
Collaboration Agreement — Confidential
– Page 10
2.3.2. Meetings; Purposes . The Joint Steering
Committee shall hold its first meeting within thirty
(30) calendar days after the Effective Date. At its first
meeting, the Joint Steering Committee shall outline a process to
ensure that the first Synthetic Pathway(s), the scope of the
resulting Library Compounds and the Proposed Compounds to be
synthesized by Infinity from such Synthetic Pathways are approved
as quickly as possible so that Infinity can initiate synthesis of
such Proposed Compounds. Thereafter, the Joint Steering Committee
shall meet quarterly, or with such other frequency, and at such
times, as may be established by the Joint Steering Committee, at
the offices of Infinity in Cambridge, Massachusetts or Novartis in
Basel, Switzerland or Cambridge, Massachusetts ( provided
that no more than one meeting per calendar year shall be held in
Basel, Switzerland without the consent of the Parties), for the
following purposes:
(a) Determining the number of
Synthetic Pathways,
(b) Determining the design of
Synthetic Pathways, Scaffolds, the resulting Library Compounds, and
the Proposed Compounds to be synthesized by Infinity;
(c) Ensuring that Library Compounds
will be designed so as not to overlap with compounds then in, or
under development for, either Party’s (or its
Affiliates’) compound collections outside of the
Collaboration;
(d) Determining the Lead Criteria
and the Data Package, on a Target by Target basis, for each Target
screened by Infinity pursuant to Article III for which the Option
applies (it being understood that such determinations shall be
made, whenever possible, at regularly scheduled meetings of the
Joint Steering Committee, but in no event more than [**] days after
Infinity has proposed such Target to Novartis in writing; and
provided , however , that if the Lead Criteria and
Data Package are not determined within such [**] day period, then
the criteria specified in Sections 3.3.2 and 3.3.3, respectively,
shall apply);
(e) Providing general oversight of
the entire Collaboration between Infinity and Novartis, including
periodic review of the overall goals and strategy of the
Collaboration;
Collaboration Agreement — Confidential
– Page 11
(f) Attempting to resolve any
disagreement between the Parties hereunder, including disputes
relating to an assertion pursuant to a Non-Acceptance Notice that a
Proposed Compound has failed to meet Acceptance Criteria, and
discussion and resolution, if possible, of any other deadlocked
issues submitted to it;
(g) Addressing any matters raised
under relevant provisions of the License Agreement;
(h) With respect to a Lead Series
which is subject to the Option, determining whether Infinity shall
have the right, if Infinity requests such right, to file Patent
applications, under Infinity’s name and at Infinity’s
expense, directed to such Lead Series, including any Actual
Compounds in such Lead Series, prior to the expiration of the [**]
day Option exercise period or Novartis’ declining the Option
for such Lead Series, it being understood that: (i) Novartis
and Infinity shall cooperate in the drafting and filing of such
Patent application; (ii) such Patent application shall be
subject to the conditions set forth in Section 3.2.3 (except
if Novartis shall decide otherwise); and (iii) if Novartis
exercises its Option with respect to such Lead Program, such Patent
applications shall be assigned to Novartis, and Infinity shall
cause its Affiliates, employees and/or consultants to so assign
such Patent applications;
(i) Determining whether HPLC-MS UV
at 210 nm is the appropriate purity detection method for a
synthesized compound described in Sections 2.2.4(b), 3.3.2(a) or
3.3.4(c);
(j) Determining whether to protect
(through filing for and maintenance of intellectual property
protection and/or the enforcement or defense thereof, as
applicable) the Compound Related Intellectual Property;
and
(k) Making any changes to the
Acceptance Criteria set forth in Section 2.2.4.
2.4. Decisions of the Joint
Steering Committee; Resolution of Disputes.
2.4.1. The Joint Steering Committee shall make
decisions unanimously where possible, but at least by majority
vote, with respect to the matters described in Sections 2.3.2(d),
(h) and (j). In the event of a deadlock with respect to such
matters, Novartis shall have the deciding vote.
Collaboration Agreement — Confidential
– Page 12
2.4.2. The unanimous vote of the Joint Steering
Committee shall be required in order to make decisions with respect
to the matters described in Sections 2.3.2(a), (b), (c), (e), (f),
(i) and (k). In the event that the Joint Steering Committee is
deadlocked as to any of these issues, then the Parties may have the
issue referred to the Chief Scientific Officer of Infinity and the
Vice President of Global Discovery Chemistry of the Novartis
Institutes for BioMedical Research, Inc. (or their equivalent) for
good faith resolution. Notwithstanding the foregoing, with respect
to Section 2.3.2(c), in no event shall either Party have the
right to force the other Party to accept the design of a Synthetic
Pathway or Scaffold which such other Party represents would overlap
with compounds then in, or under development for, such other
Party’s (or its Affiliates’) compound collections
outside of the Collaboration.
2.4.3. The unanimous vote of the Joint Steering
Committee shall be required in order to make decisions with respect
to the matter described in Section 2.3.2(g). In the event that
the Joint Steering Committee is deadlocked as to this issue, then
the Parties may have the issue referred to the Chief Executive
Officer of Infinity and the President of the Novartis Institutes
for BioMedical Research, Inc. (or their equivalent) for good faith
resolution.
2.5. Additional Assistance by
Infinity.
2.5.1. Third Party Improvements . In the event
that a Third Party, for or on behalf of Infinity, makes any
improvements to reagents, materials, and the like which are
necessary for Novartis to synthesize an Actual Compound, Infinity
shall, at no cost to Novartis, grant Novartis any required
permissions or licenses from Infinity to use such improvements to
the extent Infinity Controls such improvements and will use
reasonable efforts to help Novartis secure access to such
improvements from such Third Party on business terms comparable to
those afforded Infinity.
2.5.2. Hosting of Novartis Scientists
. Infinity shall, [**], provide work
space and support on its premises for up to [**] Novartis
scientists for an aggregate of up to [**] calendar days each (it
being understood that such period shall refer to the total number
of days each scientist is hosted on the Infinity premises, and not
necessarily a period of [**] consecutive calendar days), in
increments of at least [**] calendar days per visit, in order to
assist Novartis in
Collaboration Agreement — Confidential
– Page 13
connection with the resynthesis of Actual
Compounds; provided that Novartis shall reimburse Infinity
for any reasonable, documentable expense for reagents and
consumables used by such Novartis scientists in connection with
such resynthesis. Each such visit by a Novartis scientist shall be
scheduled at least [**] weeks in advance.
2.5.3. Provision of Infinity Chemist . At the
request of Novartis and on Novartis’ premises, Infinity shall
provide a chemist, reasonably acceptable to Novartis, for up to
[**] per Synthetic Pathway, to assist Novartis with the resynthesis
of Actual Compounds related to such Synthetic Pathway. The
provision of such chemist shall be [**], provided that
Novartis shall reimburse Infinity for any reasonable, documentable
out-of-pocket and travel expenses incurred by such chemist in
connection therewith. Each such visit by an Infinity chemist shall
be scheduled at least [**] weeks in advance.
2.6. Exchange of
Information.
2.6.1. Status of Collaboration . Infinity and
Novartis will share information with the Joint Steering Committee,
no less frequently than at the quarterly meetings of the Joint
Steering Committee, reasonably necessary to facilitate mutual
understanding of the status of the Collaboration and
decision-making in connection therewith.
2.6.2. Misuse of Background Intellectual
Property . Neither Party shall use the Background Intellectual
Property of the other (excluding information which is no longer
subject to confidentiality restrictions under Article IV by reason
of the exceptions set forth in Sections 4.2(a), (c),
(d) and (e)) for any purpose, including the filing of Patents
containing such information, without the other Party’s
written consent, other than for carrying out the Collaboration or
discharging its responsibilities under the License Agreement, or as
otherwise permitted hereunder or under the License
Agreement.
2.6.3. Restrictions on Rights . Neither Party shall be entitled to receive
information from the other Party concerning Intellectual Property
discovered or developed by that Party outside the Collaboration or
otherwise unrelated to design and synthesis of Synthetic Pathways,
Scaffolds, Library Compounds, or Lead Programs under this Agreement
or the
Collaboration Agreement — Confidential
– Page 14
License Agreement; except that, with
respect to each Proposed Compound, Infinity shall also disclose to
Novartis in a timely manner any and all Intellectual Property
(including, without limitation, know-how and/or technology which it
discovers or develops regarding the Synthetic Pathways and/or
Scaffolds) which Infinity used to synthesize such Proposed
Compound.
2.7. Exclusivity; Freedom of
Action.
Infinity will collaborate on the
Synthetic Pathways with Novartis solely. For the avoidance of
doubt, and except as otherwise set forth in this Agreement or the
License Agreement, either Party and any of its Affiliates shall be
free, alone or together with Third Parties, to pursue the
identification, development or commercialization of chemical
entities that modulate any Target, free of any obligation to the
other Party not expressly stated in this Agreement or the License
Agreement (but subject to any Intellectual Property rights of such
other Party not expressly granted in this Agreement or the License
Agreement).
ARTICLE III
I NTELLECTUAL P ROPERTY R IGHTS ;
O PTION TO D EVELOP AND C OMMERCIALIZE
3.1. Use Rights with Respect to
Library Compounds.
3.1.1. Novartis’ Ownership and Use Rights with
Respect to Library Compounds . Novartis shall be the sole owner
of all Actual Compounds, including Infinity Compounds. Subject to
the other terms and conditions of this Agreement, Novartis and its
Affiliates shall have the right, alone or with Third Parties, to
make, use, sell, offer to sell, export, import, license and
distribute any and all Library Compounds for research, development,
and commercialization purposes; provided that during the
term of this Agreement, Novartis and its Affiliates may not sell,
offer to sell, export, import, license or distribute the Library
Compounds as libraries per se. Notwithstanding the foregoing, a
sale, an offer for sale, an exportation, an importation, a license
or a distribution of the Library Compounds as part of a larger
asset transfer or transaction shall not be deemed “a sale, an
offer for sale, an exportation, an importation, a license or a
distribution as a library” hereunder.
Collaboration Agreement — Confidential
– Page 15
3.1.2. Infinity’s Use Rights with Respect to
Library Compounds .
(a) Subject to the other terms and
conditions of this Agreement (including, without limitation,
Section 3.3.5), Infinity shall have the right to screen
Library Compounds against any Target; provided that Infinity
may not sell or otherwise provide such Library Compounds to any
Third Party (except that Infinity may (i) provide Library
Compounds to subcontractors working on Infinity’s behalf to
fulfill Infinity’s obligations under this Agreement and
(ii) sell, license or otherwise distribute to Third Parties
Library Compounds specifically identified as included in a Lead
Program with respect to a Target (other than a Novartis Reserved
Target) for which Novartis has declined its Option, for which the
relevant [**] day Option exercise period has expired, or for which
Novartis does not have an Option).
(b) Prior to the [**] anniversary of
the Effective Date or the [**] anniversary of the acceptance by
Novartis of the [**] Actual Compound, whichever is later (the
“ Threshold Date ”), Infinity shall be
restricted with respect to screening Library Compounds, as
follows:
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(i)
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Infinity shall
offer all Lead Programs to Novartis pursuant to the
Option.
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(ii)
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Prior to
screening, Infinity must disclose the Target proposed to be
screened or the other screening efforts to be undertaken, as
applicable, in writing to a Novartis representative selected by the
Joint Steering Committee. In the event that such screening efforts
are not directed to a particular Target, then Infinity shall notify
the Novartis representative selected by the Joint Steering
Committee promptly upon the identification of the modulated
Target(s) resulting from such screening efforts, and the conditions
set forth in Section 3.3 shall apply regardless of when such
Target(s) is identified.
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Collaboration Agreement — Confidential
– Page 16
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(iii)
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If, at the time
of disclosure, Novartis has a discovery program or proposed program
regarding the proposed Target, or if Novartis is screening or
otherwise committing scientific effort and resources to study the
Target which effort and resources are consistent with
Novartis’ other Target programs or is planning to screen or
otherwise study the Target during the next [**] months, then
Novartis will so notify Infinity in writing within [**] calendar
days after such disclosure that the proposed Target of such
screening is a “ Novartis Reserved Target ,” in
which case the provisions of Section 3.3.5(b) with respect to
Novartis Reserved Targets shall apply.
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(c) For the avoidance of doubt, Lead
Programs resulting from screening Library Compounds prior to the
Threshold Date shall be subject to Sections 3.3.5.
3.2. Patent Rights and License
Grants with Respect to Library Compounds, Actual Compounds and
Infinity Compounds.
3.2.1. Patent Rights and License Grants to Library
Compounds that are not Actual Compounds or Infinity
Compounds . At any time,
either Party or its Affiliates may file or obtain Patents with
respect to claims (specific or generic) covering Library Compounds
that are not Actual Compounds or Infinity Compounds (including
claims as to the use or manufacture thereof), subject to an
automatic grant to the other Party and its Affiliates under such
Patents of a worldwide, perpetual (subject to the last sentence of
this Section 3.2.1), non-exclusive, fully-paid, royalty-free
license (with the right to sublicense) to conduct research with
respect to such Library Compounds in the Field, it being understood
that the purpose of such research is the development of products in
the Field. In the case of Library Compounds that are not Infinity
Compounds, Infinity shall automatically grant Novartis and its
Affiliates, under the genus claims of Infinity’s composition
of matter claims in such Patents covering such Library Compounds
and their manufacture, a perpetual (subject to the last sentence of
this Section 3.2.1), worldwide, non-exclusive, fully-paid,
royalty-free license (with right to sublicense), to research,
develop,
Collaboration Agreement — Confidential
– Page 17
commercialize, make, use, manufacture, export,
import, offer to sell and sell such Library Compounds in the Field
(the “ Genus License ”); provided ,
however , that: (a) this license shall not apply with
respect to uses against any Target that was the basis of a Lead
Program for which Novartis has declined to exercise its Option or
for which the relevant [**] day Option exercise period has expired;
and (b) for such Infinity programs arising from screening
Library Compounds after the Threshold Date (and therefore for which
no Option applies), this license shall not apply with respect to
Targets for which one or more Library Compounds are exemplified in
such Patents, by way of actual examples, to modulate such Targets
as their primary mechanism of action. The foregoing licenses shall
survive any termination or expiration of this Agreement, except if
such termination is caused by the breach of the Party receiving
such license.
3.2.2. Patent Rights and License Grants with Respect to
Actual Compounds .
Novartis or its Affiliates shall have the sole right to obtain
Patents with respect to claims (whether specific or generic)
covering Actual Compounds (including, without limitation, claims as
to the manufacture or use thereof) that are not Infinity Compounds
(the “ Compound Intellectual Property ”), except
as set forth in Section 2.3.2(h), subject to an automatic
grant to Infinity and its Affiliates under such Patents of a
perpetual, worldwide, non-exclusive, fully-paid, royalty-free
license (with the right to sublicense) to conduct research with
respect to such Actual Compounds in the Field. The foregoing
license shall survive any termination or expiration of this
Agreement, except if such termination is caused by Infinity’s
breach.
3.2.3. Patent Rights and License Grants with Respect to
Infinity Compounds . In
the event that Infinity designates an Actual Compound as an
Infinity Compound pursuant to the terms of Section 3.4(b) or
Section 3.5, as applicable, Novartis shall automatically
assign to Infinity, for patenting purposes only, Novartis’
rights in such Infinity Compound, and shall automatically grant
Infinity and its Affiliates a worldwide, exclusive even as to
Novartis, fully-paid, royalty-free license (with the right to
sublicense) under its interest in the Collaboration Intellectual
Property to research, develop, commercialize, use, manufacture,
import, export, offer to sell and sell such Infinity Compounds in
the Field. Infinity shall have the sole right, at
Collaboration Agreement — Confidential
– Page 18
Infinity’s expense, to file, prosecute and
maintain Patents with respect to claims covering Infinity Compounds
(including claims as to the manufacture or use thereof) (an “
Infinity Compound Patent ”); provided that:
(i) each individual Infinity Compound Patent shall not claim
Infinity Compounds (including claims as to the manufacture or use
thereof) derived from more than [**] Synthetic Pathway and shall
respect the conditions set forth in Section 3.4(b)(i) through
(v); and (ii) in the event an Infinity Compound Patent
erroneously covers an Actual Compound, Infinity shall grant to
Novartis and its Affiliates under such Infinity Compound Patent a
worldwide, exclusive even as to Infinity, fully-paid, royalty-free
license (with right to sublicense) to research, develop,
commercialize, use, manufacture, import, export, offer to sell and
sell such Actual Compounds in the Field, and the research license
granted to Infinity pursuant to Section 3.2.2 shall not be
applicable with respect to such Actual Compound. For the avoidance
of doubt, any claims covering an Actual Compound: (a) in a
Lead Series which is subject to the Option for which the relevant
[**] day Option exercise period has not yet expired nor been
declined by Novartis shall not be considered erroneous if:
(1) Infinity has been permitted the right to file and obtain
Patents with respect to such Lead Series pursuant to
Section 2.3.2(h), and (2) Infinity designates such Actual
Compounds as Infinity Compounds within [**] days after Novartis has
declined its Option with respect to such Lead Series or for which
the relevant [**] day Option exercise period has expired;
(b) in a Lead Series which was subject to the Option which
Option Novartis had declined or for which the relevant [**] day
Option exercise period has expired shall not be considered
erroneous if Infinity designates such Actual Compounds as Infinity
Compounds pursuant to Section 3.4(b); or (c) with respect
to Infinity’s screening activities directed at the Library
Compounds which are conducted after the Threshold Date shall not be
considered erroneous if Infinity designates such Actual Compounds
as Infinity Compounds pursuant to Section 3.5. In addition,
Infinity shall automatically grant to Novartis and its Affiliates a
worldwide, non-exclusive, full-paid, royalty-free license (with the
right to sublicense) under its interest in the Infinity Compound
Patents, the Collaboration Intellectual Property and the Background
Intellectual Property to conduct research with respect to the
relevant Infinity Compound in the Field. For the avoidance of
doubt, the Genus License shall be applicable to its related
Infinity Compound Patent with respect to claims covering
Library
Collaboration Agreement — Confidential
– Page 19
Compounds that are not Actual Compounds or
Infinity Compounds. The foregoing licenses shall survive any
termination or expiration of this Agreement, except if such
termination is caused by the breach of the Party receiving the
license.
3.3. Option with Respect to Lead
Programs.
3.3.1. Exclusivity . For Lead Programs developed
from screening Library Compounds prior to the Threshold Date,
Novartis shall have the exclusive right (the “ Option
”) to obtain a worldwide, exclusive license (with right to
sublicense) on a Target-by-Target basis, to develop and
commercialize any such Lead Program in the Field, under the terms
and conditions set forth in the License Agreement.
3.3.2. Lead Criteria . Prior to the Threshold
Date, and before Infinity commences screening a Target (or when a
Target is identified as set forth in 3.1.2(b)(ii)), the Joint
Steering Committee shall determine, pursuant to
Section 2.3.2(d), the appropriate assays and criteria (the
“ Lead Criteria ”) that will trigger
Novartis’ Option with respect to such Lead Program comprised
of one or more Lead Series, such Lead Criteria to include at least
the following:
(a) [**], as applicable, and
purification (>[**]% purity by HPLC-MS UV 210 nm; in the event
that the Joint Steering Committee determines that HPLC-MS UV is not
an appropriate detection method, then purity shall instead be
determined by HPLC-MS ELSD), in each case, of at least [**]
chemical entities per Lead Series;
(b) [**] in an enzymatic assay or
other primary assay;
(c) [**] in a cellular or functional
assay than that found in the enzymatic assay or other primary
assay;
(d) evidence of [**]; and
(e) evidence of [**].
3.3.3. Data Package . Infinity shall deliver to
Novartis the following information and materials with respect to
such Lead Program (collectively, the “ Data Package
”):
(a) Data evidencing achievement of
all Lead Criteria set forth in Section 3.3.2; and
Collaboration Agreement — Confidential
– Page 20
(b) The following data for the most
potent compound of each Lead Series: (i) [**]; (ii) [**];
(iii) [**]; (iv) [**]and (v) [**].
3.3.4. Exercise of an Option .
(a) Novartis shall have [**]
calendar days after receipt of the Data Package in which to provide
written notice to Infinity (the “ Data Receipt Notice
”) as to whether the Data Package is complete and whether the
Lead Criteria have been achieved with respect to the relevant Lead
Program, each as reasonably determined by Novartis. If Novartis has
not provided a Data Receipt Notice to Infinity within such [**] day
period, the Data Package shall be deemed to be complete and the
Lead Criteria shall be deemed to have been achieved with respect to
the Lead Program.
(b) If Novartis reasonably
determines that the Data Package is incomplete or that the Lead
Criteria have not been achieved, then Infinity may perform
additional research as necessary and resubmit the Data Package;
provided that Novartis shall have additional [**] calendar
day periods to evaluate each such resubmission.
(c) If Novartis determines that the
Data Package is complete and that the Lead Criteria have been
achieved, then, in the Data Receipt Notice, Novartis may select
chemical entities in each Lead Program as set forth in 3.3.2(a) for
synthesis (up [**] milligrams of purified material) and delivery by
Infinity to Novartis for further biological testing which may
include the following: (i) confirmation of activity in primary
and cellular systems; (ii) hERG channel inhibition using patch
clamp assay; (iii) in vivo efficacy and PK; (iv) detailed
metabolism studies; and (v) other studies at Novartis’
discretion. In addition, Infinity will provide access to screening
data, if required by Novartis. Within [**] business days after
receipt of the request, Infinity will provide Novartis with a quote
for the expected length of time and the cost to provide each such
chemical entity. Infinity will base such quotation on an FTE rate
of U.S.$[**] per month to synthesize and deliver such chemical
entities and in no case shall the quotation exceed
Collaboration Agreement — Confidential
– Page 21
U.S.$[**] per chemical entity. Novartis shall
have [**] calendar days in which to accept or reject such quote in
writing. If Novartis does not accept such quote within such [**]
day period, Infinity shall have no obligation to synthesize such
compounds and deliver the related information. If Novartis accepts
such quote within such [**] day period, Infinity will use its
commercially reasonable efforts to provide such synthesized
compounds within [**] weeks after receipt of Novartis’
written acceptance of such quote. Each such synthesized compound
shall be greater than [**] percent ([**]%) pure as determined by
HPLC-MS UV 210 nm. In the event that the Joint Steering Committee
determines that HPLC-MS UV is not an appropriate detection method,
then purity shall instead be determined by HPLC-MS ELSD. With each
such synthesized compound delivered, Infinity shall also
contemporaneously provide a certificate of analysis including the
HPLC chromatogram, proton and carbon NMR spectra and detailed
synthetic protocol used for the synthesis.
(d) It shall be the responsibility
of the Novartis representatives of the Joint Steering Committee to
communicate to Infinity if Novartis chooses, in its sole
discretion, to exercise the Option. The Novartis representatives of
the Joint Steering Committee may involve other employees or
consultants of Novartis and its Affiliates in this process, on a
need-to-know basis and subject to the provisions of Article IV, as
is reasonably necessary to determine whether or not to exercise the
Option.
(e) Novartis shall have [**]
calendar days from receipt of the last requested samples meeting
the criteria described in subsection (c), or, if either no samples
are requested or samples are requested but Novartis does not accept
Infinity’s quote therefor pursuant to subsection (c), [**]
calendar days from receipt of the Data Receipt Notice, to exercise
its Option with respect to the relevant Lead Program. Novartis may
exercise such Option by delivery to Infinity of written notice of
exercise, specifying the Lead Program as to which such Option is
being exercised, in which case, once the License Agreement is
executed, Novartis shall have the exclusive right to file,
prosecute and maintain Patents in its name covering inventions
relating to the Lead Program as provided in the License Agreement.
The Parties shall then promptly execute the License Agreement, the
terms of which, upon such execution, shall be
incorporated
Collaboration Agreement — Confidential
– Page 22
by reference into, and shall be a part of, this
Collaboration Agreement, pursuant to which terms, Infinity will
grant Novartis and its Affiliates a worldwide, exclusive even as to
Infinity license (with the right to sublicense), to develop and
commercialize the Lead Program as an Optioned Lead Program under
Infinity’s Background Intellectual Property and under
Infinity’s rights and interest in the Collaboration
Intellectual Property in the Field. If an Option has previously
been exercised with respect to another Lead Program and a License
Agreement is in effect with respect to that Lead Program, then the
License Agreement will be amended to reflect the addition of
another Lead Program as an Optioned Lead Program.
3.3.5. Restrictions on Commercialization or
Partnering .
(a) Any Target . Until such
time as Novartis affirmatively declines its Option for a Lead
Program, or until the expiration of the relevant [**] day Option
exercise period, whichever comes first, Infinity shall not, subject
to Section 2.3.2(h), file any Patent covering such Lead
Program, commercialize such Lead Program or collaborate with a
Third Party (except subcontractors working on Infinity’s
behalf in connection with its obligations hereunder) with respect
to the development or commercialization of such Lead
Program.
(b) Novartis Reserved Targets
. If Novartis does not exercise its Option for a Lead Program with
respect to any Target that is a Novartis Reserved Target, then
Infinity shall not, subject to Section 2.3.2(h), file any
Patent covering such Lead Program (or otherwise shall assign such
Patent to Novartis), or pursue further development or
commercialization of such Lead Program, including any Derivative
Compounds of such Lead Program, whether alone or with a Third
Party.
3.4. Declined Options on Targets
Other Than Novartis Reserved Targets.
If Novartis does not exercise its
Option with respect to any Target that is not a Novartis Reserved
Target during the [**] day Option exercise period or Novartis
affirmatively declines such Option, then the following shall
apply:
(a) Upon request from Infinity,
Novartis shall provide Infinity any data it has generated in
connection with evaluation of such Lead Program pursuant to
Section 3.3.4(c), and
Collaboration Agreement — Confidential
– Page 23
shall automatically grant to Infinity a
non-exclusive license to use such data for research, development
and commercialization purposes, and shall return to Infinity any
remaining amounts of compounds that had been provided by Infinity
under Section 3.3.4(c) for evaluation of such Lead
Program.
(b) Prior to initiating further lead
optimization activities with respect to such Lead Program or from
time to time thereafter during the term of this Agreement, and to
the extent necessary to protect Infinity’s intellectual
property rights in such Lead Program, Infinity may select and
designate Actual Compounds within such Lead Program as “
Infinity Compounds ,” provided that Infinity
notifies Novartis of the same in writing and provides Novartis an
electronic data file containing each such proposed Infinity
Compound and Novartis has not, within [**] days of such
notification, represented to Infinity in writing that such Actual
Compounds are already covered, specifically or generically, by a
Novartis Patent claiming inventions created before Novartis’
receipt of the Data Package for such Lead Program; and
provided , further , that:
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(i)
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Prior to the
[**] anniversary of the Effective Date, there shall be no more than
[**] Infinity Compounds at any time;
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(ii)
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After the [**]
but prior to the [**] anniversary of the Effective Date, there
shall be no more than [**] Infinity Compounds at any
time;
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(iii)
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After the [**]
anniversary of the Effective Date, there shall be no more than [**]
Infinity Compounds at any time (including after the Threshold
Date);
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(iv)
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In no event may
more than [**] Infinity Compounds be derived from any single
Synthetic Pathway (including after the Threshold Date);
and
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(v)
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Infinity may
redesignate Infinity Compounds as Actual Compounds by providing
written notice and an electronic data file containing each such
Infinity Compound of the same to Novartis, in which case the total
number of Infinity Compounds shall be reduced by those redesignated
as Actual Compounds.
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Collaboration Agreement — Confidential
– Page 24
(c) For purposes of clarity,
Infinity Compounds also remain Actual Compounds.
3.5. Designation of Infinity
Compounds During the Term of this Agreement and After The Threshold
Date.
Infinity may select and designate as
Infinity Compounds those Actual Compounds necessary to protect
Infinity’s intellectual property rights in lead optimization
efforts resulting from screening activities directed at the Library
Compounds which are conducted after the Threshold Date;
provided that Infinity notifies Novartis of the same in
writing and provides Novartis an electronic data file containing
each such proposed Infinity Compound and Novartis has not, within
[**] days of such notification, represented to Infinity in writing
that such Actual Compounds are already covered, whether with
generic or specific claims, by a Patent Controlled by Novartis or
its Affiliates that was filed before Novartis’ receipt of
such notification; and provided further that there
shall be neither more than [**] Infinity Compounds at any time nor
shall more than [**] Infinity Compounds be derived from any single
Synthetic Pathway. Infinity may redesignate Infinity Compounds as
Actual Compounds by providing written notice and an electronic data
file containing each such Infinity Compound of the same to
Novartis, in which case the total number of Infinity Compounds
shall be reduced by those redesignated as Actual
Compounds.
3.6. No Designation of Infinity
Compounds After the Term of this Agreement.
After expiration or termination of
this Agreement, (a) Infinity shall no longer have the right to
select and designate any Actual Compounds as Infinity Compounds,
and (b) Infinity shall not patent (whether with generic or
specific claims) any Actual Compounds. After expiration or
termination of this Agreement, Infinity shall have the right to
screen Library Compounds against any Target; provided that
Infinity may not sell or otherwise provide such Library Compounds
to any Third Party (except to subcontractors working on
Infinity’s behalf).
Collaboration Agreement — Confidential
– Page 25
ARTICLE IV
C ONFIDENTIALITY
4.1. Undertaking.
During the term of this Agreement,
each Party (the “ Receiving Party ”) shall keep
confidential, and other than as provided herein shall not use or
disclose, directly or indirectly, any trade secrets, confidential
or proprietary information, or any other knowledge, information,
documents or materials, disclosed to the Receiving Party by the
other Party (the “ Proprietary Party ”), whether
in tangible or intangible form, the confidentiality of which such
Proprietary Party takes reasonable measures to protect, including
but not limited to Collaboration Intellectual Property.
(a) The Receiving Party shall take
any and all lawful, reasonable measures to prevent the unauthorized
use and disclosure of such information, and to prevent unauthorized
Persons from obtaining or using such information. With the prior
written consent of the Proprietary Party, the Receiving Party may,
however, use and disclose such information to exercise its rights
to file, prosecute and maintain Patents within the Collaboration
Intellectual Property as permitted by this Agreement.
(b) The Receiving Party further
agrees to refrain from directly or indirectly taking any action
which would constitute or facilitate the unauthorized use or
disclosure of such information. The Receiving Party may disclose
such information to its Affiliates, officers, employees and agents,
to authorized licensees and sublicensees, and to subcontractors in
connection with the Receiving Party’s obligations hereunder,
to the extent necessary to enable such Persons to perform their
obligations hereunder or under the applicable license, sublicense
or subcontract, as the case may be; provided that such
Affiliates, officers, employees, agents, licensees, sublicensees
and subcontractors have entered into appropriate confidentiality
agreements for secrecy and non-use of such information which by
their terms shall be enforceable by injunctive relief. In the event
any such Persons violate such agreements with respect to such
information, the Receiving Party shall enforce such
agreements.
Collaboration Agreement — Confidential
– Page 26
(c) The Receiving Party shall be
liable for any unauthorized use and disclosure of such information
by its Affiliates, officers, employees and agents and any such
licensees, sublicensees and subcontractors.
4.2. Exceptions.
Notwithstanding the foregoing, the
provisions of Section 4.1 shall not apply to knowledge,
information, documents or materials that the Receiving Party can
conclusively establish:
(a) were generally available to the
public at the time of disclosure or become generally available to
the public without the Receiving Party’s breach of any
obligation owed to the Proprietary Party;
(b) are permitted to be disclosed by
the prior written consent of the Proprietary Party;
(c) were known by the Receiving
Party at the time of disclosure, or have become known to the
Receiving Party from a source other than the Proprietary Party,
other than by breach of an obligation of confidentiality owed to
the Proprietary Party;
(d) are disclosed by the Proprietary
Party to a Third Party without restrictions on its
disclosure;
(e) are independently developed by
the Receiving Party without breach of this Agreement or any other
confidentiality agreement between the Parties or between a Party
and an Affiliate of the other Party, without reference to or
reliance upon knowledge, information or materials of the
Proprietary Party; or
(f) are required to be disclosed by
the Receiving Party to comply with applicable laws or regulations,
to submit registration filings, to defend or prosecute litigation
or patents or to comply with governmental regulations,
provided that the Receiving Party provides prior written
notice of such disclosure to the Proprietary Party and takes
reasonable and lawful actions to avoid or minimize the degree of
such disclosure.
Collaboration Agreement — Confidential
– Page 27
4.3. Publicity.
The Parties have agreed upon the
timing and content of the initial press release relating to this
Agreement and the transactions contemplated herein. The Parties
will agree upon the timing and content of any other press release
or other public communications relating to this Agreement and the
transactions contemplated herein.
Except to the extent already
disclosed in that initial press release or other public
communication, no public announcement concerning the existence or
the terms of this Agreement or concerning the transactions
described herein shall be made, either directly or indirectly, by
Infinity or Novartis, except as may be legally required by
applicable laws, regulations, or judicial order, without first
obtaining the approval of the other Party and agreement upon the
nature, text, and timing of such announcement.
The Party desiring to make any such
public announcement shall provide the other Party with a written
copy of the proposed announcement in sufficient time prior to
public release to allow such other Party to comment upon such
announcement, prior to public release.
Notwithstanding the foregoing,
either Party may disclose: (a) to bona fide potential or
actual licensees or sublicensees only those terms of this Agreement
that are reasonably necessary to disclose in connection with a
license or sublicense as permitted this Agreement; and (b) to
bona fide potential or actual investors, lenders, investment
bankers, acquirors, acquirees, or merger partners, and to such
Party’s consultants and advisors, only those terms of this
Agreement that are reasonably necessary in connection with a
proposed equity or debt financing, acquisition or business
combination of such Party.
4.4. Survival.
The provisions of this Article IV
shall survive for [**] years after the termination or expiration of
this Agreement.
Collaboration Agreement — Confidential
– Page 28
4.5. Equitable
Relief.
The Receiving Party agrees that any
breach of this Article IV may cause the Proprietary Party
substantial and irreparable injury and, therefore, in the event of
any such breach, in addition to other remedies that may be
available, the Proprietary Party shall have the right to specific
performance and other injunctive and equitable relief.
ARTICLE V
P UBLICITY
Each of Novartis and Infinity, and
their respective Affiliates, agree not to publish or publicly
present any results, data, or scientific findings with respect to
the Collaboration without the prior written consent of the Joint
Steering Committee; provided , however , that, either
Party may, without such consent, file and prosecute Patent
applications as permitted by this Agreement. In the event of
information already within the public domain, consent shall not be
unreasonably withheld if sought at least [**] calendar days prior
to planned submission for publication or oral presentation. In all
other instances during the term of this Agreement, publication
shall be presumed t
