EXHIBIT 10.36

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

AGREEMENT

 

Agreement (the “Agreement”), dated December 18, 2018 (the “Agreement Effective
Date”), by and between Novartis International Pharmaceutical Ltd. (“Novartis”)
and AVEO Pharmaceuticals, Inc. (“AVEO”).  Novartis and AVEO are separately
referred to as a “Party” and are collectively referred to as the “Parties”.  

 

Background

 

Novartis and AVEO were parties to a License Agreement, dated August 13, 2015
(the “License Agreement”) pursuant to which AVEO licensed to Novartis certain
intellectual property rights Controlled by AVEO relating to a group of
antibodies that bind to Growth Differentiation Factor 15 (“GDF15”), including an
antibody referred to as AV-380 by AVEO (and NIK937 by Novartis) as well as the
antibodies identified on Exhibit A to the License Agreement, together with any
modified or derivative form of any such antibodies, including any fragment of,
pegylated version of (whether or not including amino acid changes) and any other
chemically modified versions (including associated amino acid substitutions) of
such antibodies, and any fused or conjugated versions of any of the foregoing
(the “Licensed Antibodies”).  On June 28, 2018, Novartis sent a notice of
termination of the License Agreement to AVEO, which became effective (pursuant
to the License Agreement’s terms) on August 27, 2018 (the “Date of
Termination”).  AVEO has indicated that it intends to continue development of
the Licensed Antibodies, and the Parties are entering into this Agreement to
memorialize certain understandings between the Parties with respect to the
License Agreement and Novartis’ support of the further development of the
Licensed Antibodies by AVEO.

 

The Parties agree as follows:

 

Section 1.Definitions.

 

(a)Definitions.  Unless the context otherwise requires, the terms in this
Agreement with initial letters capitalized, will have the meanings set forth
below, or the meaning as designated in the indicated places throughout this
Agreement.  Capitalized terms not otherwise defined herein have the same meaning
as in the License Agreement.  

 

 

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“Accounting Standards” means, with respect to AVEO, US GAAP (United States
Generally Accepted Accounting Principles and means, with respect to Novartis,
IFRS (International Financial Reporting Standards), in each case as generally
and consistently applied throughout the Party’s organization. Each Party will
promptly notify the other Party in the event that it changes the Accounting
Standards pursuant to which its records relating to this Agreement are
maintained; provided, however, that each Party may only use internationally
recognized accounting principles (e.g., IFRS, US GAAP, etc.).

 

“Affiliate” means, with respect to a Party, any Person that controls, is
controlled by, or is under common control with that Party.  For the purpose of
this definition, “control” will mean, direct or indirect, ownership of 50% or
more of the shares of stock entitled to vote for the election of directors, in
the case of a corporation, or 50% or more of the equity interest in the case of
any other type of legal entity, status as a general partner in any partnership,
or any other arrangement whereby the entity or person controls or has the right
to control the board of directors or equivalent governing body of a corporation
or other entity, or the ability to cause the direction of the management or
policies of a corporation or other entity, or otherwise has “control” over the
relevant entity as set forth in applicable Accounting Standards, as amended from
time to time.  In the case of entities organized under the laws of certain
countries, the maximum percentage ownership permitted by law for a foreign
investor may be less than 50%, and in such case such lower percentage will be
substituted in the preceding sentence if such foreign investor has the power to
direct the management and policies of such entity.

 

“AVEO Indemnitees” has the meaning set forth in Section 6(b).  

 

“BLA” means a Biologics License Application in the United States for
authorization to market the Product, as defined in the applicable laws and
regulations and filed with the FDA.

 

“Commercialize” means to market, promote, distribute, import, export, offer to
sell and/or sell Product, and “Commercialization” means commercialization
activities relating to Product, including activities relating to marketing,
promoting, distributing, importing, exporting, offering for sale and/or selling
the Licensed Antibodies.  

 

“Control” or “Controlled” means, with respect to any Know-How, Patent Rights,
other intellectual property rights, or any proprietary or trade secret
information, the legal authority or right (whether by ownership, license or
otherwise, other than by a license granted under this Agreement) of a Party or
its Affiliates, to grant a license or a sublicense of or under such Know-How,
Patent Rights, or intellectual property rights to another Person, or to
otherwise disclose such proprietary or trade secret information to another
Person, without breaching the terms of any agreement with a Third Party or
misappropriating the proprietary or trade secret information of a Third Party.

 

“Claims” means all Third Party demands, claims, actions, proceedings and
liability (whether criminal or civil, in contract, tort or otherwise) for
losses, damages, reasonable legal costs and other reasonable expenses of any
nature whatsoever.

 

 

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“Develop” or “Development” means drug development activities, including, without
limitation, test method development and stability testing, assay development and
audit development, toxicology, formulation, quality assurance/quality control
development, statistical analysis, clinical studies, packaging development,
regulatory affairs, and the preparation, filing and prosecution of BLAs and
MAAs.

 

“EMA” means the European Medicines Agency or any successor entity thereto.

 

“Exclusivity Product” has the meaning set forth in Section 5(a).  

 

“FDA” means the United States Food and Drug Administration or any successor
entity thereto.

 

“Field” means the treatment and prevention of diseases and other conditions in
all indications in humans.  

 

“ICC” has the meaning set forth in Section 9(e).

 

“Indemnification Claim Notice” has the meaning set forth in Section 6(c)(ii).

 

“Indemnified Party” has the meaning set forth in Section 6(c)(ii).

 

“Indemnifying Party” has the meaning set forth in Section 6(c)(ii).

 

“Information” means all Know-How and other proprietary information and data of a
financial, commercial or technical nature which the disclosing Party, its
Affiliates, or its or their licensors has supplied or otherwise made available
to the other Party or its Affiliates, whether made available orally, in writing
or in electronic form, including information comprising or relating to concepts,
discoveries, inventions, data, designs or formulae in relation to this
Agreement.

 

“Know-How” means all technical information, know-how and data, including
inventions (whether patentable or not), discoveries, trade secrets,
specifications, instructions, processes, formulae, materials, expertise and
other technology applicable to compounds, formulations, compositions, products
or to their manufacture, development, registration, use or commercialization or
methods of assaying or testing them or processes for their manufacture,
formulations containing them, compositions incorporating or comprising them and
including all biological, chemical, pharmacological, biochemical, toxicological,
pharmaceutical, physical and analytical, safety, quality control, manufacturing,
preclinical and clinical data, instructions, processes, formulae, expertise and
information, regulatory filings and copies thereof, relevant to the development,
manufacture, use or commercialization of and/or which may be useful in studying,
testing, development, production or formulation of products, or intermediates
for the synthesis thereof.

 

 

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“MAA” means an application for the authorization to market the Licensed
Antibodies in any country or group of countries outside the United States, as
defined in the applicable laws and regulations and filed with the Regulatory
Authority of a given country or group of countries.

 

“Material” has the meaning set forth in Section 3.

 

“Novartis Indemnitees” has the meaning set forth in Section 6(a).  

 

“Patent Rights” means all patents and patent applications, including all
divisionals, continuations, substitutions, continuations-in-part,
re-examinations, reissues, additions, renewals, extensions, registrations,
supplemental protection certificates, utility models, design patents and the
like of any of the foregoing.

 

“Person” means any individual, partnership, limited liability company, firm,
corporation, association, trust, unincorporated organization or other entity.

 

“Product” means pharmaceutical products consisting of or incorporating one or
more of the Licensed Antibodies.

 

“Regulatory Authority” means any governmental authority or agency responsible
for authorizing or approving the marketing and/or sale of biologic products in a
jurisdiction (e.g., the FDA, EMA, the Japanese Ministry of Health, Labour and
Welfare, and corresponding national or regional regulatory agencies or
organizations).

 

“Third Party” means any Person other than a Party or an Affiliate of a Party.

 

(b)Interpretation.  In this agreement unless otherwise specified

 

(i)“includes” and “including” will mean respectively includes and including
without limitation

 

(ii)a Party includes its permitted assignees and/or the respective successors in
title to substantially the whole of its undertaking;

 

(iii)a statute or statutory instrument or any of their provisions is to be
construed as a reference to that statute or statutory instrument or such
provision as the same may have been or may from time to time hereafter be
amended or re-enacted

 

(iv)words denoting the singular will include the plural and vice versa and words
denoting any gender will include all genders

 

(v)the Exhibits and other attachments form part of the operative provision of
this Agreement and references to this Agreement shall, unless the context
otherwise requires, include references to the Exhibits and attachments

 

 

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(vi)the headings in this Agreement are for information only and will not be
considered in the interpretation of this Agreement

 

(v)general words will not be given a restrictive interpretation by reason of
their being preceded or followed by words indicating a particular class of acts,
matters or things; and

 

(vi)the terms and conditions of this Agreement are the result of negotiations
between the Parties and that this Agreement will not be construed in favor of or
against any Party by reason of the extent to which any Party participated in the
preparation of this Agreement.

 

Section 2.Payment.

 

In consideration of the mutual releases included in this Agreement and to
support AVEO’s further Development of the Licensed Antibodies, Novartis will
make a one time payment of USD$2.3 million, which will be paid on or before
January 2, 2019.  For the avoidance of doubt, this payment will not be subject
to offset or reduction for any payments previously made by Novartis in
connection with the License Agreement.  Notwithstanding Section 12.2(i) of the
License Agreement, the Material will be transferred to AVEO at no charge.

 

Section 3.Supply of Material.

 

Novartis will make available for pick up by AVEO the material and associated
documentation identified on Exhibit A (the “Material”) within [**] after the
later of (i) the Agreement Effective Date, or (ii) the date that AVEO provides
all information and data reasonably necessary to transfer the Material in
compliance with applicable law and/or cGMP (to the extent applicable); provided,
however, notwithstanding the foregoing, and to the extent required by cGMP and
the Parties’ respective Quality Assurance functions, cGMP Material will be
transferred only following the execution of a commercially reasonable Quality
Agreement between the Parties (as described below).  The Material will be
transferred Ex Works (Incoterms 2010) and except as provided on Exhibit A, is
transferred “as is” and without representation or warranty of any kind and
Novartis disclaims any implied warranties of merchantability or fitness for a
particular purpose with respect to the Material; provided, however, that
Novartis represents that, with respect to materials manufactured in accordance
with cGMP, Novartis handled, stored and transported, and, until it is picked up
by AVEO, will continue to handle, store and transport, the Material in
accordance with cGMP for biological products. The Parties will enter into a
commercially reasonable Quality Agreement with respect to the cGMP Material
following the execution of this Agreement.  Novartis will share with AVEO all
material safety data sheets and customs value information that is reasonably
available to Novartis, including without limitation Licensed Antibodies-specific
information, as is reasonably necessary to permit AVEO to pick up the
Material.  AVEO will be solely responsible for any re-testing associated with
the Material prior to use.  Upon pick up by AVEO, Novartis will have no further
obligation to replace lost or damaged material or to provide additional services
with respect to such Material.

 

 

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Section 4.Licenses and Know How Transfer.

 

(a)Novartis represents and warrants that, as of the Agreement Effective Date,
neither it nor any of its Affiliates have filed any patent application or
otherwise Control any Patent Rights that claim or cover the Licensed Antibodies
or their use.

 

(b) Novartis and its Affiliates hereby grant to AVEO a perpetual, irrevocable,
exclusive, worldwide, fully paid-up license, with the right to grant
sublicenses, under all Know-How Controlled by Novartis and its Affiliates and
sublicensees as of the Date of Termination, that are specifically related to the
Development, manufacture and Commercialization of Products in the Field.

 

(c)Novartis shall, no later than [**] after the Agreement Effective Date, to the
extent permitted by applicable law, complete the transfer to AVEO or its
designee, solely for the Development, manufacture and Commercialization of
Products in the Field, all right, title, and interest in and to all finalized
preclinical and clinical reports and data, and all other supporting data,
including pharmacology, toxicology, chemistry and biology data, and documented
technical and other information or materials Controlled by Novartis and its
Affiliates and sublicensees to the extent related specifically to the
Development, manufacture and Commercialization of Products in the
Field.  Novartis will use commercially reasonable efforts to promptly complete
any non-finalized reports, and transfer such reports in final form after
completion.  Novartis may retain a single copy of all such items for its records
as required by applicable law.  Novartis will not be required to transfer
generalized technologies or SOPs, except to the extent they specifically relate
to the Development or Commercialization of Products in the Field.

 

(d)Novartis represents and warrants that neither it nor any of its Affiliates
Control any Regulatory Filings or Regulatory Approvals, or records of any
interactions with Regulatory Authorities, related to Products in the Field as of
the Date of Termination.

 

(e)Novartis represents and warrants that it is not a party to any license
agreement relating to Licensed Antibodies in the Field (other than this
Agreement).

 

(f)For a period of [**] following the Agreement Effective Date, Novartis will
provide such assistance as may be reasonably necessary to transfer manufacturing
documents, reports, methods, standards, protocols and materials that are used by
Novartis and its Affiliates in the manufacture of the Licensed Antibodies, and
cooperate with AVEO in reasonable respects to transfer to AVEO, or AVEO’s
designated contract manufacturer, the manufacturing technologies (including all
relevant Know-How) that are used in the manufacture of the Licensed
Antibodies.  For the avoidance of doubt, the assistance set forth in this
Section 4(f) is limited to interpretation or content of the Novartis Know How
that is transferred to AVEO, and in no event will Novartis be required to
conduct additional experiments or research in connection with its activities as
described in this Section 4(f).  

 

 

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(g)Novartis understands and agrees that the study reports, CMC reports,
certificates and other materials and documentation transferred by Novartis
hereunder or under the License Agreement may be used in a future IND or other
submission to a Regulatory Authority, and agrees to satisfy any reasonable
request for documentation or audit in connection with such regulatory submission
or by such Regulatory Authority with respect to such studies, reports,
certificates, documentation and materials.

 

(h)The Parties acknowledge that, in connection with the activities described in
this Agreement, Novartis will not assign or transfer any agreements that it has
with any Third Parties service providers or vendors relating to the
Material.  At AVEO’s request, Novartis will provide a letter of authorization to
any such relevant Third Parties informing such Third Parties that the Material
is now owned by and in the control of AVEO and authorizing such Third Parties to
perform manufacturing, stability and other services on behalf of AVEO with
respect to the Material, including authorization for the use and transfer to
AVEO of all relevant Know-How related to the Material, pursuant to separate
agreements to be negotiated by AVEO and such Third Parties.  Following [**]
after the Agreement Effective Date, AVEO will have sole responsibility for such
Third Party activities.

 

Section 5.Non-competition.

 

(a)For a period of three years following the Agreement Effective Date, neither
Novartis nor any of its Affiliates will, anywhere in the world, directly or
indirectly, Develop, manufacture or Commercialize any anti-GDF15 antagonist
antibody or any modified or derivative form of any such antibody, including any
active fragment of, pegylated version of (whether or not including amino acid
changes) and any other chemically modified versions (including associated amino
acid substitutions) of such antibody, and any fused or conjugated versions of
any of the foregoing (the “Exclusivity Product”) (or license or collaborate with
a Third Party to do any of the foregoing) in the Field, except as necessary to
perform its obligations hereunder; provided, however, that notwithstanding the
foregoing, Novartis will retain the right to use the Exclusivity Product for
research purposes only.

 

(b)Novartis represents that, as of the Agreement Effective Date, it and its
Affiliates are not engaged and have no plans to engage in the Development or
Commercialization of (a) any Exclusivity Product, or (b) any product for the
treatment, prevention or prophylaxis of cachexia, decreased appetite or body
weight, which binds to the GDF15 receptor and is a GDF15 antagonist.  

 

 

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Section 6.Indemnity; Limitation of Liability.

 

(a)Indemnification by AVEO.  AVEO will indemnify and hold Novartis, its
Affiliates, and their respective officers, directors and employees (“Novartis
Indemnitees”) harmless from and against any Claims against them to the extent
arising or resulting from actions by AVEO, its Affiliates and sublicensees, and
their respective employees, agents and subcontractors, in connection with the
Development, manufacture or Commercialization of the Licensed Antibodies;
provided, however, that AVEO will not be obliged to so indemnify, defend and
hold harmless the Novartis Indemnitees for any Claims for which Novartis has an
obligation to indemnify AVEO Indemnitees pursuant to Section 6(b) or to the
extent that such Claims arise from the breach, negligence or willful misconduct
of Novartis or the Novartis Indemnitee.

 

(b)Indemnification by Novartis.  Novartis will indemnify and hold AVEO, its
Affiliates, and their respective officers, directors and employees (“AVEO
Indemnitees”) harmless from and against any Claims against them to the extent
arising or resulting from the breach of any of the covenants, warranties or
representations made by Novartis to AVEO under this Agreement or the License
Agreement; provided, however, that Novartis will not be obliged to so indemnify,
defend and hold harmless the AVEO Indemnitees for any Claims for which AVEO has
an obligation to indemnify Novartis Indemnitees pursuant to Section 6(a) or to
the extent that such Claims arise from the breach, negligence or willful
misconduct of AVEO or the AVEO Indemnitee.

 

(c)Indemnification Procedure.

 

(i)For the avoidance of doubt, all indemnification claims in respect of a
Novartis Indemnitee or AVEO Indemnitee will be made solely by Novartis or AVEO,
respectively.  

 

(ii)A Party seeking indemnification hereunder (“Indemnified Party”) will notify
the other Party (“Indemnifying Party”) in writing reasonably promptly after the
assertion against the Indemnified Party of any Claim or fact in respect of which
the Indemnified Party intends to base a claim for indemnification hereunder
(“Indemnification Claim Notice”), but the failure or delay to so notify the
Indemnifying Party will not relieve the Indemnifying Party of any obligation or
liability that it may have to the Indemnified Party, except to the extent that
the Indemnifying Party demonstrates that its ability to defend or resolve such
Claim is adversely affected thereby.  The Indemnification Claim Notice will
contain a description of the claim and the nature and amount of the Claim (to
the extent that the nature and amount of such Claim is known at such
time).  Upon the request of the Indemnifying Party, the Indemnified Party will
furnish promptly to the Indemnifying Party copies of all correspondence,
communications and official documents (including court documents) received or
sent in respect of such Claim.  

 

 

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(iii)Subject to the provisions of Sections 6(c)(iv) and (v) below, the
Indemnifying Party will have the right, upon written notice given to the
Indemnified Party within [**] after receipt of the Indemnification Claim Notice
to assume the defense and handling of such Claim, at the Indemnifying Party’s
sole expense, in which case the provisions of Section 6(c)(iv) below will
govern.  The assumption of the defense of a Claim by the Indemnifying Party will
not be construed as acknowledgement that the Indemnifying Party is liable to
indemnify any indemnitee in respect of the Claim, nor will it constitute a
waiver by the Indemnifying Party of any defenses it may assert against any
Indemnified Party’s claim for indemnification.  In the event that it is
ultimately decided that the Indemnifying Party is not obligated to indemnify or
hold an Indemnitee harmless from and against the Claim, the Indemnified Party
will reimburse the Indemnifying Party for any and all costs and expenses
(including attorneys’ fees and costs of suit) and any losses incurred by the
Indemnifying Party in its defense of the Claim.  If the Indemnifying Party does
not give written notice to the Indemnified Party, within [**] after receipt of
the Indemnification Claim Notice, of the Indemnifying Party’s election to assume
the defense and handling of such Claim, the provisions of Section 6(c)(v) below
will govern.  

 

(iv)Upon assumption of the defense of a Claim by the Indemnifying Party: (A) the
Indemnifying Party will have the right to and will assume sole control and
responsibility for dealing with the Claim; (B) the Indemnifying Party may, at
its own cost, appoint as counsel in connection with conducting the defense and
handling of such Claim any law firm or counsel reasonably selected by the
Indemnifying Party; (C) the Indemnifying Party will keep the Indemnified Party
informed of the status of such Claim; and (D) the Indemnifying Party will have
the right to settle the Claim on any terms the Indemnifying Party chooses;
provided, however, that it will not, without the prior written consent of the
Indemnified Party, agree to a settlement of any Claim which could lead to
liability or create any financial or other obligation on the part of the
Indemnified Party for which the Indemnified Party is not entitled to
indemnification hereunder or which admits any wrongdoing or responsibility for
the claim on behalf of the Indemnified Party.  The Indemnified Party will
cooperate with the Indemnifying Party and will be entitled to participate in,
but not control, the defense of such Claim with its own counsel and at its own
expense.  In particular, the Indemnified Party will furnish such records,
information and testimony, provide witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be reasonably
requested in connection therewith.  Such cooperation will include access during
normal business hours by the Indemnifying Party to, and reasonable retention by
the Indemnified Party of, records and information that are reasonably relevant
to such Claim, and making the Indemnified Party, the Indemnitees and its and
their employees and agents available on a mutually convenient basis to provide
additional information and explanation of any records or information provided.  

 

 

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(v)If the Indemnifying Party does not give written notice to the Indemnified
Party as set forth in Section 6(c)(iii) or fails to conduct the defense and
handling of any Claim in good faith after having assumed such, the Indemnified
Party may, at the Indemnifying Party’s expense, select counsel reasonably
acceptable to the Indemnifying Party in connection with conducting the defense
and handling of such Claim and defend or handle such Claim in such manner as it
may deem appropriate.  In such event, the Indemnified Party will keep the
Indemnifying Party timely apprised of the status of such Claim and will not
settle such Claim without the prior written consent of the Indemnifying Party,
which consent will not be unreasonably withheld.  If the Indemnified Party
defends or handles such Claim, the Indemnifying Party will cooperate with the
Indemnified Party, at the Indemnified Party’s request but at no expense to the
Indemnified Party, and will be entitled to participate in the defense and
handling of such Claim with its own counsel and at its own expense.  

 

(d)Mitigation of Loss.  Each Indemnified Party will take and will procure that
its Affiliates take all such reasonable steps and action as are necessary or as
the Indemnifying Party may reasonably require in order to mitigate any Claims
(or potential losses or damages) under this Section 6.  Nothing in this
Agreement will or will be deemed to relieve any Party of any common law or other
duty to mitigate any losses incurred by it.

 

(e)Limitation of Liability.  NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE
LIABLE IN CONTRACT, TORT, NEGLIGENCE BREACH OF STATUTORY DUTY OR OTHERWISE FOR
ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR FOR ANY
ECONOMIC LOSS OR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE
EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A
CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS SECTION 6.

 

Section 7.Mutual Release; Non-disparagement.

 

(a)Release.  Each of the Parties, for itself, and on behalf of its officers,
directors, employees, agents, Affiliates, and successors and assigns hereby
remises, releases and forever discharges the other Party and its officers,
directors, employees, agents, Affiliates, and successors and assigns from all
claims, suits, actions, charges, demands, judgments, costs and executions
present and future, known or unknown, both legal and equitable in any manner
arising out of the License Agreement and/or the Development of the Licensed
Antibodies; provided, however, that notwithstanding anything herein to the
contrary, this Agreement shall not remise, release, discharge, terminate,
modify, or otherwise cause to expire any obligation or remedy arising under or
resulting from Section 14 of the License Agreement.  The Parties acknowledge
that in executing this Agreement, they have carefully reviewed and had the
opportunity to review the terms of this Agreement with counsel of their choice
and are fully aware of the extent of their rights and obligations under this
Agreement. The Parties further acknowledge that the language of this Agreement
shall not be considered as an admission of liability, wrongdoing, or anything
improper.

 

 

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(b)Non-disparagement.  Subject to applicable law, neither the Parties nor any of
their respective officers, directors, employees, agents, Affiliates, and
successors and assigns, will in any way publicly disparage, call into disrepute,
defame, slander or otherwise criticize the other Party or such other Party’s
Affiliates officers, directors, employees, agents, Affiliates, or any of their
products or services, in any manner that would damage the business or reputation
of such other Party or its Affiliates, to the extent related to the License
Agreement and/or the Licensed Antibodies.

 

Section 8.Confidentiality.  

 

(a)Subject to the other provisions of this Section 8, all Information disclosed
by a Party or its Affiliates under this Agreement will be maintained in
confidence and otherwise safeguarded by the recipient Party.  The recipient
Party may only use the Information for the purposes of this Agreement and
pursuant to the rights granted to the recipient Party under this
Agreement.  Subject to the other provisions of this Section 8, each Party will
hold as confidential such Information of the other Party or its Affiliates in
the same manner and with the same protection as such recipient Party maintains
its own confidential information.  Subject to the other provisions of this
Section 8, a recipient Party may only disclose Information of the other Party to
employees, agents, contractors, consultants and advisers of the Party and its
Affiliates and sublicensees and to Third Parties to the extent reasonably
necessary for the purposes of, and for those matters undertaken pursuant to,
this Agreement; provided that such Persons are bound to maintain the
confidentiality of the Information in a manner consistent with the
confidentiality provisions of this Agreement.

 

(b)Exceptions.  The obligations under this Section 8 will not apply to any
information to the extent the recipient Party can demonstrate by competent
evidence that such information:

 

(i) is (at the time of disclosure) or becomes (after the time of disclosure)
known to the public or part of the public domain through no breach of this
Agreement by the recipient Party or its Affiliates;

 

(ii) was known to, or was otherwise in the possession of, the recipient Party or
its Affiliates prior to the time of disclosure by the disclosing Party or any of
its Affiliates;

 

(iii)is disclosed to the recipient Party or an Affiliate on a non-confidential
basis by a Third Party who is entitled to disclose it without breaching any
confidentiality obligation to the disclosing Party or any of its Affiliates; or

 

(iv)is independently developed by or on behalf of the recipient Party or its
Affiliates, as evidenced by its written records, without reference to the
Information disclosed by the disclosing Party or its Affiliates under this
Agreement.

 

 

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Specific aspects or details of Information will not be deemed to be within the
public domain or in the possession of the recipient Party merely because the
Information is embraced by more general information in the public domain or in
the possession of the recipient Party.  Further, any combination of Information
will not be considered in the public domain or in the possession of the
recipient Party merely because individual elements of such Information are in
the public domain or in the possession of the recipient Party unless the
combination and its principles are in the public domain or in the possession of
the recipient Party.

 

(c)In addition to disclosures allowed under Section 8(a) and 8(b), either Party
may disclose Information belonging to the other Party or its Affiliates to the
extent such disclosure is necessary in the following instances: (i) filing or
prosecuting Patent Rights; (ii) in connection with Antibodies filings with a
Regulatory Authority; (iii) prosecuting or defending litigation as permitted by
this Agreement; (iv) complying with applicable court orders or governmental
regulations; (v) fulfilling such Party’s obligations under the In-licensed AVEO
Technology Agreements; or (vi) to the extent otherwise necessary or appropriate
in connection with exercising the license and other rights granted to it
hereunder.  

 

(d)In addition, AVEO may disclose Information of Novartis to Third Parties as
may be necessary or useful in connection with the Development, manufacture or
Commercialization of the AVEO Antibodies and/or Product(s) on the condition that
any such Third Parties agree to be bound by confidentiality and non-use
obligations no less rigorous than those contained in this Agreement.  

 

(e)In the event the recipient Party is required to disclose Information of the
disclosing Party by law or in connection with bona fide legal process, such
disclosure will not be a breach of this Agreement; provided that the recipient
Party (i) informs the disclosing Party as soon as reasonably practicable of the
required disclosure; (ii) limits the disclosure to the required purpose; and
(iii) at the disclosing Party’s request and expense, assists in an attempt to
object to or limit the required disclosure.

 

Section 9.Miscellaneous.

 

(a)Assignment.  Neither Party may assign its rights and obligations under this
Agreement without the other Party’s prior written consent, except that either
Party may (i) assign its rights and obligations under this Agreement or any part
hereof to one or more of its Affiliates; or (ii) assign this Agreement in its
entirety to a successor to all or substantially all of its business or assets to
which this Agreement relates. Any permitted assignee will assume all obligations
of its assignor under this Agreement (or related to the assigned portion in case
of a partial assignment). Any attempted assignment in contravention of the
foregoing will be void. Subject to the terms of this Agreement, this Agreement
will be binding upon and inure to the benefit of the Parties and their
respective successors and permitted assigns.

 

 

--------------------------------------------------------------------------------

 

(b)Extension to Affiliates.  Each party will have the right to extend the
rights, immunities and obligations granted in this Agreement to one or more of
its Affiliates.  All applicable terms and provisions of this Agreement will
apply to any such Affiliate to which this Agreement has been extended to the
same extent as such terms and provisions apply to the Parties hereto.  Each
party will remain primarily liable for any acts or omissions of its Affiliates.

 

(c)Severability.  Should one or more of the provisions of this Agreement become
void or unenforceable as a matter of law, then this Agreement will be construed
as if such provision were not contained herein and the remainder of this
Agreement will be in full force and effect, and the Parties will use their
commercially reasonable efforts to substitute for the invalid or unenforceable
provision a valid and enforceable provision which conforms as nearly as possible
with the original intent of the Parties.

 

(d)Governing Law and Jurisdiction.  This Agreement will be governed by and
construed under the laws of the Commonwealth of Massachusetts, USA, without
giving effect to the conflicts of laws provision thereof.  The United Nations
Convention on Contracts for the International Sale of Goods (1980) will not
apply to the interpretation of this Agreement.

 

(e)Dispute Resolution.  Any unresolved disputes between the Parties relating to,
arising out of or in any way connected with this Agreement or any term or
condition hereof, or the performance by either Party of its obligations
hereunder, whether before or after termination of this Agreement, will be
resolved by final and binding arbitration.  Whenever a Party will decide to
institute arbitration proceedings, it will give written notice to that effect to
the other Party.  Arbitration will be held in Boston, Massachusetts, USA,
according to the commercial rules of the International Chamber of Commerce
(“ICC”).  The arbitration will be conducted by a panel of three arbitrators
appointed in accordance with ICC rules; provided that each Party will within
[**] after the institution of the arbitration proceedings appoint an arbitrator,
and such arbitrators will together, within [**], select a third arbitrator as
the chairman of the arbitration panel, each arbitrator will have significant
experience in the biopharmaceutical business.  If the two initial arbitrators
are unable to select a third arbitrator within such [**] period, the third
arbitrator will be appointed in accordance with ICC rules.  The arbitrators will
render their opinion within [**] of the final arbitration hearing.  No
arbitrator (nor the panel of arbitrators) will have the power to award punitive
damages under this Agreement and such award is expressly prohibited; provided,
however, that the arbiter may, in its discretion, require the losing Party to
pay the reasonable costs and expenses of the prevailing party in connection with
such arbitration proceeding.  Decisions of the panel of arbitrators will be
final and binding on the Parties.  Judgment on the award so rendered may be
entered in any court of competent jurisdiction.

 

 

--------------------------------------------------------------------------------

 

(f)Force Majeure.  In the event that either Party is prevented from performing
its obligations under this Agreement as a result of any contingency beyond its
reasonable control (“Force Majeure”), including but not limited to, any actions
of governmental authorities or agencies, war, hostilities between nations, civil
commotions, riots, national industry strikes, lockouts, sabotage, shortages in
supplies, energy shortages, fire, floods and acts of nature such as typhoons,
hurricanes, earthquakes, or tsunamis, the Party so affected will not be
responsible to the other Party for any delay or failure of performance of its
obligations hereunder, for so long as Force Majeure prevents such
performance.  In the event of Force Majeure, the Party immediately affected
thereby will give prompt written notice to the other Party specifying the Force
Majeure event complained of, and will use commercially reasonable efforts to
resume performance of its obligations.  Notwithstanding the foregoing, if such a
Force Majeure induced delay or failure of performance continues for a period of
more than three consecutive months, either Party may terminate this Agreement
upon written notice to the other Party.

 

(g)Waivers and Amendments.  The failure of any Party to assert a right hereunder
or to insist upon compliance with any term or condition of this Agreement will
not constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other Party.  No waiver will be
effective unless it has been given in writing and signed by the Party giving
such waiver.  No provision of this Agreement may be amended or modified other
than by a written document signed by authorized representatives of each Party.

 

(h)Relationship of the Parties.  Nothing contained in this Agreement will be
deemed to constitute a partnership, joint venture, or legal entity of any type
between AVEO and Novartis, or to constitute one as the agent of the
other.  Moreover, each Party will not construe this Agreement, or any of the
transactions contemplated hereby, as a partnership for any tax purposes.  Each
Party will act solely as an independent contractor, and nothing in this
Agreement will be construed to give any Party the power or authority to act for,
bind, or commit the other.

 

 

--------------------------------------------------------------------------------

 

(i)Notices.  All notices, consents, waivers, and other communications under this
Agreement must be in writing and will be deemed to have been duly given when:
(a) delivered by hand (with written confirmation of receipt); or (b) when
received by the addressee, if sent by an internationally recognized overnight
delivery service (receipt requested), in each case to the appropriate addresses
set forth below (or to such other addresses as a Party may designate by notice):

 

If to AVEO:

 

AVEO Pharmaceuticals, Inc.

One Broadway, 14th Floor

Cambridge, Massachusetts 02142 USA

Attn:  Chief Executive Officer

 

with a required copy to:

 

AVEO Pharmaceuticals, Inc.

One Broadway, 14th Floor

Cambridge, Massachusetts 02142 USA

Attn:  General Counsel

 

If to Novartis:

 

Novartis International Pharmaceutical Ltd

Lichtstrasse 35

CH-4056 Basel

Switzerland

 

with a required copy to:

 

Novartis Institutes for BioMedical Research, Inc.

250 Massachusetts Avenue

Cambridge, MA 02139 USA

Attn:  General Counsel

 

(j)Further Assurances.  Novartis and AVEO will execute, acknowledge and deliver
any and all such other documents and take any such other action as may be
reasonably necessary to carry out the intent and purposes of this Agreement.

 

(k)Compliance with Law.  Each Party will perform its obligations under this
Agreement in accordance with all applicable laws.  No Party will, or will be
required to, undertake any activity under or in connection with this Agreement
which violates, or which it believes, in good faith, may violate, any applicable
law.

 

 

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(l)Entire Agreement.  The provisions of this Agreement are for the sole benefit
of the Parties and their successors and permitted assigns, and they will not be
construed as conferring any rights to any third party (including any third party
beneficiary rights).

 

(m)Entire Agreement.  This Agreement, together with its Exhibits and schedules,
sets forth the entire agreement and understanding of the Parties as to the
subject matter hereof and supersedes all proposals, oral or written, and all
other prior communications between the Parties with respect to such subject
matter, with the exception of the surviving provisions of the License Agreement,
as described above in Section 6(a).

 

(n)Cumulative Remedies.  No remedy referred to in this Agreement is intended to
be exclusive, but each will be cumulative and in addition to any other remedy
referred to in this Agreement or otherwise available under law.  

 

[Signature Page Follows]

 

--------------------------------------------------------------------------------

 

In witness whereof, the Parties, intending to be bound, have caused this
Agreement to be executed by their duly authorized representatives.

 

NOVARTIS INTERNATIONAL PHARMACEUTICAL LTD.

 

AVEO PHARMACEUTICALS, INC.

 

 

 

 

 

 

By:

/s/ Sylvain Beltzung

 

By:

/s/ Michael P. Bailey

 

 

 

 

 

Name:

Sylvain Beltzung

 

Name:

Michael P. Bailey

 

 

 

 

 

Title:

Head Finance NIBR Europe

 

Title:

President & CEO

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ Gerald Burg

 

 

 

 

 

 

 

 

Name:

Gerald Burg

 

 

 

 

 

 

 

 

Title:

BPA Manager NIBR Finance

 

 

 

 

 

--------------------------------------------------------------------------------

 

Exhibit A

 

Drug Substance manufacturing

 

Clinical batch

Clinical batch

Batch Name

[**]

[**]

Date of manufacture

[**]

[**]

Place of manufacture

[**]

[**]

Batch Size

[**]

[**]

Batch type

[**]

[**]

Primary Packaging

Bottles

[**]

[**]

Composition

[**]

[**]

Current stock

[**]

[**]

Current location

[**]

[**]

 

Drug Product manufacturing

 

Toxicological batch

Clinical batch

Clinical batch

Batch Name

[**]

[**]

[**]

Date of manufacture

[**]

[**]

[**]

Place of manufacture

[**]

[**]

[**]

Theoretical Batch

Size (according CofA)

[**]

[**]

[**]

Drug Substance batch

used

[**]

[**]

[**]

Batch type

[**]

[**]

[**]

Primary Packaging

Vial

[**]

Stopper

[**]

Cap

[**]

Composition

[**]

[**]

[**]

Fill volume

[**]

[**]

[**]

Current stock

[**]

[**]

[**]

Current location

[**]

[**]

[**]

 

 

--------------------------------------------------------------------------------

 

Novartis Reference manufacturing

 

[**]

Original DS

[**]

Date of manufacture

[**]

Place of manufacture

[**]

Batch Size

[**]

Release  and retest analysis

[**]

Primary Packaging

Bottles

Fill volume

[**]

Composition

[**]

Actual stock*

[**]

*Quantity is subject to change and is current as of Nov 16, 2018. All available
stock that is in procession of Novartis to be provided.

 

Master Cell Bank

Amount

of vials

Current

location

Comment

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]