Exhibit 10.35

*** Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

and 240.24b-2

 

Amended and Restated

Technology License Agreement

 

This Amended and Restated License Agreement (“Amended Agreement”) is entered
into by and between:

 

Mayo Foundation For Medical Education And Research, a Minnesota charitable
corporation, located at 200 First Street SW, Rochester, Minnesota 55905-0001
("MAYO"); and

Nile Therapeutics, Inc., a Delaware corporation, (previously named Nile
Pharmaceuticals, Inc.) located at 63 Bovet Rd. #421, San Mateo,‎ California‎
94402 (“NILE”), each a “Party,” and collectively, “Parties.”

 

WHEREAS, the Parties entered into that certain Technology License Agreement with
respect to a novel chimeric natriuetic peptide known as Cenderitide (“CD-NP”)
dated January 20, 2006 (the “Original CD-NP Effective Date”), which was amended
by that certain amendment dated June 2, 2008 (collectively referred to as the
“Original CD-NP Agreement”);

 

WHEREAS, the Parties entered into that certain Technology License Agreement with
respect to a synthetic natriuretic polypeptide known as “CU-NP” dated June 13,
2008 (the “Original CU-NP Effective Date”)(referred to as the “Original CU-NP
Agreement”);

 

WHEREAS, the Parties are desirous of amending and restating the Original CD-NP
Agreement and the Original CU-NP Agreement in their entirety and creating a
single Amended and Restated Technology Licensee Agreement on the terms set forth
below (the “Amended Agreement”);

 

WHEREAS, MAYO possesses certain intellectual property and know-how relating to
certain Products (as hereinafter defined), including, without limitation, CD-NP
and CU-NP, and desires to make its patent rights available for the development
and commercialization of the Products for public use and benefit;

 

WHEREAS, MAYO is willing to grant, and NILE is willing to accept, an exclusive
license under certain patent rights for the purpose of developing and
commercializing such Products, as set forth below; and

 

WHEREAS, NILE will have the exclusive rights to design, develop, commercialize,
market, sublicense and sell any Products in accordance with the grant of rights
hereunder;

 

 

 

 

Amended and Restated License Agreement   page 2 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

NOW, THEREFORE, in consideration of the foregoing and their mutual covenants set
forth below, the Parties agree as follows:

 

Article 1 - Definitions

 

For purposes of this Amended Agreement, each term defined in this Article will
have the meaning specified for it below and will be applicable both to the
singular and plural forms:

 

1.01“Affiliate”:

 

(a)with respect to MAYO means any corporation or other entity within the same
“controlled group of corporations” as MAYO or its parent, Mayo Clinic. For
purposes of this definition, the term “controlled group of corporations” will
have the same definition as Section 1563 of the Internal Revenue Code as of
November 10, 1998, but will include corporations or other entities which if not
a stock corporation, more than fifty percent (50%) of the board of directors or
other governing body of such corporation or other entity is controlled by a
corporation within the controlled group of corporations of MAYO or Mayo Clinic.
MAYO’s Affiliates include, but are not limited to: Mayo Clinic; Mayo
Collaborative Services, Inc.; Mayo Clinic - Methodist Hospital; Mayo Clinic -
Saint Marys Hospital; Mayo Clinic Florida; Mayo Clinic Arizona; and its Mayo
Clinic Health System entities;

 

(b)with respect to NILE means any corporation or other person controlling,
controlled by or under common control with NILE.

 

(c)The term “control” means the possession, directly or indirectly, of the power
to direct the management and policies of a corporation or person, whether
through the ownership of voting securities, by contract or otherwise. Control
shall be deemed to exist in the case of the ownership, directly or indirectly,
of 50% or more of the equity interests in any such corporation.

 

1.02 “Change of Control” shall mean a merger, consolidation, acquisition or
transfer of all, or substantially all, of the business interests of NILE to
which this Amended Agreement relates (each a “transaction”), where the total of
all shareholders of NILE immediately prior to the effective date of such
transaction beneficially own, immediately following the effective date of such
transaction, securities representing less than 50% of the combined voting power
of the surviving corporation’s then outstanding voting securities.

 

 

 

 

Amended and Restated License Agreement   page 3 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

1.03 “Commercialization” means all steps that must be taken to put a Product on
the market in the Territory after all necessary regulatory approvals have been
obtained, including, without limitation, the manufacturing, marketing,
distribution and/or sublicensing of such Product.

 

1.04 “Confidential Information” means all confidential, unpublished, nonpublic
and/or proprietary information of either Party and its affiliates, whether in
written, printed, verbal or electronic form, including, without limitation:
research and development activities, pre-clinical study information, clinical
trial information and data, product design details and specifications,
databases, equipment, electronic media products, protocols, technology and
know-how, sales and marketing plans, finances and business forecasts,
procurement requirements, vendor information, customer lists, personnel
information, and strategic plans, related to the Development and
Commercialization of a Product provided by one Party to the other in the course
of their activities under this Amended Agreement. Confidential Information will
not include information that: (a) is now, or hereafter becomes generally known
or available to the public through no act or failure to act on the part of the
receiving Party; (b) was acquired by the receiving Party before receiving such
information from the disclosing Party through no breach of any duty of
confidentiality owed to the disclosing Party and without restriction as to its
use or disclosure; (c) is hereafter rightfully furnished to the receiving Party
by a third party without any breach of any duty of confidentiality owed to the
disclosing party and without restriction as to its use or disclosure; or (d) is
information that the receiving Party can document was independently developed by
the receiving Party without any use of the disclosing Party’s Confidential
Information.

 

1.05 “Development” means the process of creating and assembling the data and
files necessary to obtain regulatory approval for a Product including, without
limitation, all pre-clinical and clinical research and trials on such Product.

 

1.06 “Effective Date” means November 14, 2013, the effective date of this
Amended Agreement.

 

1.07 “FDA” means the Food and Drug Administration within the Department of
Health and Human Services of the United States.

 

1.08 “Field” means all therapeutic indications.

 

1.09 “Future Patents” means any patents and/or patent applications claiming
Inventions invented after the Original CD-NP Effective Date, with respect to
CD-NP, and after the

 

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 4 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

  

Original CU-NP Effective Date, with respect to CU-NP, and not identified on
Exhibit A, through any use of the Patent Rights or Know-How licensed hereunder,
which Inventions arise from work conducted by or under the direction of Dr. John
Burnett, alone or jointly with NILE, and any patents and/or patent applications
(including provisional patent applications) in any country corresponding to any
of the foregoing, and all divisions, continuations, continuations-in-part,
reissues, reexaminations, supplementary protection certificates and extensions
thereof, whether domestic or foreign, and any patent that issues thereon. Future
Patents shall be (i) owned by MAYO if invented by MAYO; (ii) owned by NILE if
invented by NILE; or (iii) jointly owned by MAYO and NILE if jointly invented by
MAYO and NILE. For the avoidance of doubt, NILE has been informed […***…].

 

1.10 “Government Rights” means rights, if any, of the United States Government
to the MAYO Patents under Public Law 96-517 and Public Law 98-620, as amended or
augmented by other similar laws.

 

1.11 “IND” means investigational new drug application to be filed with the FDA
or its equivalent in a foreign jurisdiction.

 

1.12 “Invention” shall mean all unpatented, patentable and patented inventions,
discoveries, designs, apparatuses, systems, machines, methods, processes, uses,
devices, models, composition of matter, technical information, trade secrets,
know-how, codes, programs or configurations of any kind which are in the Field.

 

1.13 “Know-How” means all technical information and data, whether or not
patented, presently known or learned, invented, or (a) with respect to CD-NP,
developed by Drs. John Burnett and/or Ondrej Lisy while they are employees of
MAYO; and (b) with respect to CU-NP, developed by Drs. John Burnett and/or
Candace Lee while they are employees of MAYO, and in each case, which is owned
and controlled by Mayo and is useful in the Development and Commercialization of
a Product to the extent that such technical information and data are necessary
or useful for the use or practice of the MAYO Patents or Know-How as permitted
herein. […***…].

 

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 5 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

1.14 “MAYO Improvements” means (a) with respect to CD-NP, any and all new
developments relating solely to Products made by or arising out of the
laboratories of Drs. John Burnett and Ondrej Lisy, while they were employees of
MAYO during the […***…] following the Original CD-NP Effective Date; and (b)
with respect to CU-NP, any and all new developments relating solely to Products
made by or arising out of the laboratories of Drs. John Burnett and Candace Lee,
while they were employees of MAYO during the […***…] following the Original
CU-NP Effective Date, in each case, including improved methods of manufacture
and production techniques, and shall include, but not be limited to, new or
additional analogs of the Product, therapeutic indications and developments
intended to enhance the safety and efficacy of the Product. The Parties agree
that no MAYO Improvements were made during either, respective, […***…].

 

1.15 “MAYO Patents” means the issued United States and foreign patents and the
pending applications of MAYO […***…] set forth in Exhibit A, attached hereto
(including provisional patent applications) together with any and all
substitutions, extensions, divisionals, continuations, continuations-in-part (to
the extent that the subject matter is disclosed and enabled in the parents), or
foreign counterparts of such patent applications and patents which issue thereon
anywhere in the world, including reexamined and reissued patents, supplementary
protection certificates and extensions thereof, whether domestic or foreign, and
any patent that issues thereon.

 

1.16 “Net Sales” means the gross amount invoiced by NILE, its Affiliates or
Sublicensees for the sale of a Royalty Bearing Product in the Territory to a
third party, less the following:

 

(a)sales, tariff duties, excise or use taxes, value added taxes, directly
imposed on or with reference to particular sales;

 

(b)credits or allowances for defective, rejected or returned Products; and

 

(c)regular trade and discount allowances;

 

provided, however, that sales of Products to hospitals or other institutions to
be used in the conduct of clinical trials shall not be included in the
calculation of Net Sales. Leasing, lending, consigning or any other activity by
means of which a third party acquires the right to possession or use of a
Product will be considered a sale for the purpose of determining Net Sales. If
the Royalty Bearing Product is sold as part of a larger bundle or kit that
incorporates or includes other products in addition to the Royalty Bearing
Product, Net Sales will be computed using an average net selling price of the
Royalty Bearing Product

 

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 6 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

sold separately, or if such net selling price is unavailable, it will be
computed using that part of such sale as the Parties reasonably agree is
allocated to the value of the Royalty Bearing Product as compared to the value
of the larger bundle or kit sold with the Royalty Bearing Product.

 

1.17 “NDA” shall mean a New Drug Application to be filed in the United States
with the FDA or its equivalent in a foreign jurisdiction.

 

1.18 “NILE Improvements” means any and all new developments relating to Products
made by, discovered, or developed by or on behalf of NILE or arising out of
NILE’s laboratories or work conducted by NILE following the Original CD-NP
Effective Date with respect to CD-NP, or following the Original CU-NP Effective
Date with respect to CU-NP, including improved methods of manufacture and
production techniques, and shall include, but not be limited to, new or
additional analogs of the Product, therapeutic indications and developments
intended to enhance the safety and efficacy of the Product. NILE Improvements
shall be owned by NILE. For purposes of clarity, developments of MAYO shall not
be considered as being developed by or on behalf of NILE unless otherwise agreed
in writing by the parties.

 

1.19 “NILE Patents” means the issued United States and foreign patents and the
pending applications of NILE related to the Products as set forth in Exhibit B,
attached hereto (including provisional patent applications) together with any
and all substitutions, extensions, divisionals, continuations,
continuations-in-part (to the extent that the subject matter is disclosed and
enabled in the parents), or foreign counterparts of such patent applications and
patents which issue thereon anywhere in the world, including reexamined and
reissued patents, supplementary protection certificates and extensions thereof,
whether domestic or foreign, and any patent that issues thereon.

 

1.20 “Phase II” means a human clinical trial, the principal purpose of which is
to evaluate the effectiveness of the Product for a particular indication in
patients with the disease and to determine the common short-term side effects
and risks associated with the Product as required in 21 C.F.R. §312. For
purposes of this Amended Agreement, a Phase II study shall be deemed to have
been initiated when the first patient in a new Phase II Study for chronic heart
failure (excluding any clinical trial conducted by NILE prior to the Effective
Date of this Amended Agreement) has been dosed with the Product.

 

1.21 “Phase III” means expanded controlled and uncontrolled human clinical
trials performed after Phase II evidence suggesting effectiveness of the Product
has been obtained, and is intended to gather the additional information about
effectiveness and safety that is needed to evaluate the overall benefit-risk
relationship of the Product and to provide an adequate basis for physician
labeling, as required in 21 C.F.R. §312. If a Phase II/Phase III study is
undertaken, a Phase III study will not be deemed initiated until the Phase II
arm of the study has been completed and the final study report has been
completed. A Phase III study shall be deemed to have been initiated when the
first patient in the Phase III Study has been dosed with the Product.

 

 

 

 

 

 

Amended and Restated License Agreement   page 7 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

1.22 “Product(s)” means any method, service or product within the Field,
utilizing or derived in any manner whatsoever from any of the MAYO Patents, the
manufacture, use, offer for sale, sale or importation of which would infringe
the MAYO Patents or the NILE Patents.

 

1.23 “Reports” means written summaries for each Product generally describing
NILE’s efforts with respect to Development and Commercialization of a Product,
including:

 

(a)tests and research completed;

 

(b)any filings made with any regulatory authorities;

 

(c)any regulatory approvals received;

 

(d)a response to any comments that MAYO has made to any earlier Report,
including NILE’s rationale for rejecting any suggestion contained in such
comments;

 

(e)reports or minutes of any formal meetings with regulatory authorities,
whether convened in person or otherwise; and

 

(f)any other major regulatory event, including but not limited to, placement of
a “clinical hold” on a trial.

 

 

1.24 “Royalty Bearing Product” means any Product that is covered by any Valid
Claim of one or more of the MAYO Patents or, in the case of a CD-NP Product, the
NILE Patents.

 

1.25 “Sublicensee” means an entity to which NILE grants a sublicense under this
Amended Agreement.

 

1.26 “Valid Claim” means an issued claim of any unexpired patent or claim of any
pending patent application included among the MAYO Patents and the NILE Patents,
(i) which has not been held unenforceable, unpatentable or invalid by a decision
of a court or governmental body of competent jurisdiction, (ii) which is
unappealable or unappealed within the time allowed for appeal, (iii) which has
not been rendered unenforceable through disclaimer or otherwise, and (iv) which
has not been lost through an interference proceeding or abandoned; provided,
however, that an unissued claim in a pending application shall not constitute a
Valid Claim beyond […***…] from the filing date of the application in which it
is pending.

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 8 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

1.27 “Territory” means world-wide.

 

Article 2 -- Development and Commercialization

 

2.01 Prior Activities of Nile. The Parties acknowledge that pursuant to the
Original CD-NP Agreement and the Original CU-NP Agreement, NILE implemented a
program for the Development of the Products by:

 

(a)conducting a significant research and development program to develop the
CD-NP Product;

 

(b)expending significant amounts towards the research and development of such
Product; and

 

(c) complying with all applicable laws in performing its obligations under the
Original CD-NP Agreement and the Original CU-NP Agreement, including in
connection with obtaining the regulatory approvals.

 

 

NILE shall have the exclusive right to continue with the Development and
Commercialization of the Products to make, have made, market, sell, import,
export, distribute and otherwise commercialize the Products in the Territory,
subject to the terms of this Amended Agreement.

 

2.02 Scientific Advisory Board. NILE will assemble a Scientific Advisory Board
(“SAB”) consisting of experienced thought leaders in the area of congestive
heart failure. Dr. John Burnett and Dr. Horng Chen will be invited by NILE to
participate with the SAB, subject to restrictions, if any, of MAYO’s
Medical/Industry Committee and Conflict of Interest Committee, and subject to
their reasonable availability.

 

2.03 Development Plans and Reports. NILE agrees to provide MAYO with Reports
semi-annually, within thirty (30) days of June 30th and December 31st of each
calendar year during the Term hereof.

 

2.04 Consultation Regarding Reports. MAYO shall review the Reports and promptly
inform NILE if MAYO reasonably believes that the Development or
Commercialization plans presented in the Reports are not adequate for a Product.
NILE and MAYO will mutually confer, provided however, notwithstanding anything
to the contrary herein, NILE has the final decision-making authority regarding
the Development and Commercialization of the Products, provided that, in any
event, if NILE fails to perform its obligations as set forth in Section 7.05
below, MAYO shall have the right to exercise its rights to terminate this
Amended Agreement in accordance therewith.

 

 

 

 

Amended and Restated License Agreement   page 9 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

2.05 Receipt of Regulatory Approval. NILE shall notify MAYO within five (5)
business days of receiving official notice of any regulatory approval for any
Product.

 

Article 3 - Grant of Rights

 

3.01 Grant of Rights. MAYO grants to NILE, within the Field and Territory, an
exclusive, world-wide, royalty-bearing license, with the right to sublicense
pursuant to Section 3.08, under the MAYO Patents and Improvements, and a
nonexclusive right under the Know-How, in each case to develop, make, have made,
use, sell, import, offer to sell and commercialize Products within the Territory
and within the Field.

 

3.02 First Right of Negotiation to Acquire Future MAYO Patents and New
Improvements.

 

(a) With respect to any Future Patents and any improvements related to CD-NP and
CU-NP developed after (i) the expiration of the […***…] commencing on the
Original CD-NP Effective Date with respect to CD-NP, and (ii) the expiration of
the […***…] commencing on the Original CU-NP Effective Date with respect to
CU-NP (“New Improvements”), NILE shall have the exclusive right of first
negotiation for, at NILE’s option, the exclusive or non-exclusive rights to such
Future Patents owned (solely or jointly) by or assigned to MAYO and any New
Improvements owned (solely or jointly) by or assigned to MAYO, not falling
within the definition of MAYO Patents or Improvements hereunder. Such exclusive
first right of negotiation shall be effective as of 1 June 2016, or as of such
date when NILE shall have paid to MAYO all Unpaid Fees. However, prior to the
date that such right of first negotiation shall be effective, upon disclosure to
Mayo Clinic Ventures of any Future Patents or New Improvements, MAYO shall give
NILE written notification thereof and NILE shall have the right to pay all
Unpaid Fees at that time, which payment shall initiate the period for the
exclusive first right of negotiation. Such notification shall be treated as
MAYO’s Confidential Information.

 

(b) As of 1 June 2016, or as of such date when NILE shall have paid to MAYO all
Unpaid Fees, NILE shall have […***…] days thereafter in which to negotiate to
acquire the exclusive or non-exclusive rights to any such Future Patents and/or
New Improvements, such negotiations to be concluded within […***…], unless
extended by written agreement of the Parties. If the Parties are unable to agree
on commercial terms within said

  

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 10 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

[…***…] negotiation period, MAYO shall have no further obligation to NILE and
can freely disclose, dispose of and exploit such Future Patents and/or New
Improvements.

 

3.03 Reservation of Rights. The grant of rights in Section 3.01 is subject to
the government rights of the United States government, if any, in the MAYO
Patents and Know-How, and subject to MAYO’s reservation of rights to make, have
made and use the MAYO Patents and Products on a royalty-free basis for MAYO’s
and its Affiliates’ internal clinical, research and education programs.

 

3.04 Supply of Product. The Parties acknowledge that on January 15, 2013, NILE
delivered to MAYO sufficient quantities of CD-NP to support MAYO’s clinical and
pre-clinical studies until […***…]. MAYO shall continue to support the CD-NP and
CU-NP program through clinical and pre-clinical studies, as may be funded by
grants from the National Institutes of Health and other institutions. Any future
supply of CD-NP or CU-NP will be provided for these purposes by NILE, at NILE’s
cost, if such supply is available for such purposes at the time requested. Such
request shall not be made more than once per calendar year. The Parties
acknowledge that the Product supplied to MAYO has been delivered on an “AS-IS”
basis without warranty of any kind. With respect to any Product delivered to
MAYO by NILE, the following shall apply:

 

(a)Intellectual Property Rights. To the extent that Dr. John Burnett or Dr.
Horng Chen develops or produces any Know-How, New Improvements or other
intellectual property rights related to the Products (collectively “Related
IP”), including Related IP resulting from any clinical trials conducted by MAYO
using the Products, such Related IP shall be subject to the first right of
negotiation granted to NILE hereunder as set forth in Section 3.02 of this
Amended Agreement.

 

(b)Right of Publication. If MAYO wishes to publish, publicly disclose or submit
for publication an article, manuscript, abstract, report, poster, presentation
or other material (collectively “Manuscript”) that includes any information with
respect to any Know-How, New Improvements or other intellectual property rights
related to the Products, including such Related IP resulting from any clinical
trials conducted by MAYO using the Products, as would be reasonably required for
purposes of publication in a peer-reviewed scientific journal, it may do so
subject to the conditions set forth in subsection (i) below.

 

(i)Review Period. MAYO shall deliver a copy of the Manuscript or other materials
intended for publication to NILE at least thirty (30) days prior to the earlier
of publication or submission for publication. NILE will

 

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 11 of 35 Nile Therapeutics// Mayo
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review and respond with its comments, if any, within (30) days of receipt of
such Manuscript or other materials. MAYO shall consider in good faith any
comments submitted by NILE regarding the content thereof and shall delete any
Confidential Information of NILE that NILE requests in writing be deleted. In no
event will any Confidential Information of NILE be released in any Manuscript or
other public release without NILE’s prior written approval.

 

3.05 All Other Rights Reserved. Except as granted in Section 3.01 and 3.02, or
as otherwise expressly granted herein, no other license is granted by MAYO under
any intellectual property rights owned or controlled by MAYO, including any
patents, know-how, copyrights, proprietary information, and trademarks. All such
rights are expressly reserved by MAYO. Except as provided herein, NILE
acknowledges that in no event will this Amended Agreement be construed as an
assignment by MAYO to NILE of any intellectual property rights.

 

3.06 Confidentiality. During the Term, and for a period of […***…], each Party
hereto agrees to keep confidential by not disclosing to any third party any
Confidential Information disclosed by one Party (the “Disclosing Party”) to the
other (the “Receiving Party”). Additionally, each Party agrees not to use, at
any time following the execution of this Amended Agreement, any Confidential
Information of the other Party for its own benefit or for the benefit of any
other person or entity for any purpose other than as is necessary for complying
with the terms and conditions of this Amended Agreement.

 

(a)Nothing contained herein shall restrict or limit the ability of either Party
to provide Confidential Information of the other Party, including, without
limitation, pursuant to a demand by a government or regulatory authority or as
otherwise may be required under applicable securities or other laws or
regulations, provided the Receiving Party shall provide the Disclosing Party
with prompt written notice of such requirement prior to such disclosure to allow
the Disclosing Party to seek a protective order or other remedy where time
permits.  In the event that a protective order or other remedy is not obtained,
or that the Disclosing Party waives compliance with the provisions hereof,
Recipient agrees to furnish only that portion of the Confidential Information
which Recipient reasonably believes is legally required to be furnished. For
purposes of clarity, either Party shall have the right to disclose the terms and
conditions of this Agreement to its professional advisors and other third
parties with whom it is involved in business discussions so long as such third
parties have executed written nondisclosure agreements with the Disclosing
Party. For avoidance of doubt, any violation of the obligations stated in this
Section 3.06 constitutes a material breach of this Amended Agreement.

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 12 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

(b)Notwithstanding any other provision contained in this Amended Agreement, NILE
shall have the right, without obtaining the prior written consent of MAYO, to
disclose the existence of this Amended Agreement in filings made with the any
government agency such as may be required to comply with applicable securities
laws and in communications to its shareholders.

 

(c)The Receiving Party acknowledges and agrees that all of the Disclosing
Party’s Confidential Information is owned solely by the Disclosing Party’s (or
its licensors or Affiliates) and that nothing contained in this Amended
Agreement will be construed as granting any rights to the Receiving Party, by
license or otherwise, to any of the Disclosing Party’s Confidential Information,
all of which rights are specifically reserved by the Disclosing Party. The
Receiving Party further agrees not to copy all or any part of the Confidential
Information or any documentation related thereto except as necessary to support
the performance of the Receiving Party under this Amended Agreement and further,
not to modify, adapt, translate, reverse engineer, decompile, disassemble, or
otherwise attempt to discover any additional information with respect to the
Confidential Information. NO WARRANTIES, EXPRESS OR IMPLIED, ARE MADE BY THE
DISCLOSING PARTY UNDER THIS AGREEMENT WITH RESPECT TO ANY CONFIDENTIAL
INFORMATION DISCLOSED PURSUANT HERETO.

 

(d)The Receiving Party agrees that its obligations hereunder are necessary and
reasonable to protect the Disclosing Party’s business interests and that the
unauthorized disclosure or use of the Disclosing Party’s Confidential
Information may cause irreparable harm and significant injury, the degree of
which may be difficult to ascertain. The Receiving Party further acknowledges
and agrees that in the event of any actual or threatened breach of this Amended
Agreement, the Disclosing Party may have no adequate remedy at law and
accordingly, that the Receiving Party may have the right to seek an immediate
injunction enjoining any breach or threatened breach of this Amended Agreement,
as well as the right to pursue any and all other rights and remedies available
at law or in equity for such breach or threatened breach.

 

(e)This Agreement shall apply to any Confidential Information disclosed to the
Receiving Party after the Original CD-NP Effective Date and to Confidential
Information disclosed earlier to the extent the parties began discussions prior
to the Effective Date.

 

 

 

 

 

Amended and Restated License Agreement   page 13 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

(f)Upon the request of the Disclosing Party, the Receiving Party will promptly
return to the Disclosing Party or destroy (at the Disclosing Party’s option) all
material embodying Confidential Information in its possession or under its
control, including all written material, software, CD’s, DVD’s or other medium
on which Confidential Information is stored and the like, and all copies and
derivatives thereof. Notwithstanding the foregoing, the Receiving Party may
retain in its legal files one copy of the Confidential Information solely to
support compliance with the Agreement. Notwithstanding the foregoing, it is
acknowledged that copies that reside on computer system backups will not be
destroyed. Retention of information on a backup computer system beyond the
period of protection shall not relieve the Receiving Party of its non-disclosure
and non-use obligations.

 

3.07 Availability of Product to MAYO. Once a Product becomes commercially
available, to the extent permitted by law, NILE will provide Products to MAYO
and their Affiliates solely for it and their use for internal clinical, research
and education programs in the Field at most favored nation pricing, i.e. no more
than the lowest price available to NILE’s commercial customers for the Products
for use in the Field.

 

3.08 Sublicensee Actions. NILE may enter into sublicensing agreements under the
MAYO Patents and Future Patents, Know-How and New Improvements, if applicable.
NILE shall not receive, or agree to receive, anything of value in lieu of cash
or equity as consideration from a third party under a sublicense agreement
without the prior written consent of MAYO. For purposes of clarity, Sublicense
consideration shall not include (a) any amounts paid to NILE specifically
designated for co-development purposes, pre-clinical and clinical research and
development of the Product, (b) any amounts paid to NILE for product
manufacturing, or (c) purchases of debt or equity securities of NILE. NILE
agrees that any sublicense agreement shall (i) contain provisions at least as
favorable to MAYO for the protection of MAYO’s rights and the limitation of
MAYO’s liability exposure as the terms of this Amended Agreement, including
without limitation with respect to name use, limitation of liability and
indemnification and development and commercialization obligations commensurate
in scope as those set forth for NILE in this Amended Agreement, (ii) to the
fullest extent applicable, contain all rights and obligations due to MAYO
contained in this Amended Agreement, (iii) name MAYO as a third party
beneficiary and (iv) not permit the sublicensee to grant further sublicenses,
provided, however, that a sublicensee may grant further sublicenses with MAYO’s
prior, written, express consent. NILE shall be and remain responsible for
enforcing such sublicensees’ obligations under the respective sublicense
agreement, and any action by a sublicensee that would, if conducted by NILE, be
a breach of this Amended Agreement, shall be deemed a breach of this Amended
Agreement by NILE; provided, however, that NILE shall have sixty (60) days after
notice from MAYO of any such breach in which to cure the same. NILE shall
ascertain, calculate, audit and collect all royalties that become payable by
such sublicensee hereunder and take appropriate enforcement action against such
Sublicensee for any failure to pay or to properly calculate payments. Any
purported sublicense in violation of this Section 3.08 shall be void. NILE shall
furnish to MAYO a true and complete copy of each sublicense agreement and each
amendment thereto, within thirty (30) days after the sublicense or amendment has
been executed, which copy shall be the Confidential Information of NILE.

 

 

 

 

Amended and Restated License Agreement   page 14 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

Article 4 - Consideration and Royalties

 

4.01Initial Consideration and Other Payments to MAYO.

 

(a)The Parties acknowledge that upon execution of the Original CD-NP Agreement,
NILE paid MAYO an up-front payment of […***…] as consideration for entering into
the Original CD-NP Agreement. This initial payment is nonrefundable and is not
an advance or creditable against any royalties otherwise due under this Amended
Agreement.

 

(b)The Parties acknowledge that upon execution of the Original CU-NP Agreement,
NILE paid MAYO an up-front payment of […***…] as consideration for entering into
the Original CU-NP Agreement. This initial payment is nonrefundable and is not
an advance or creditable against any royalties otherwise due under this Amended
Agreement.

 

(c)The Parties acknowledge that pursuant to the Original CD-NP Agreement, NILE
issued to MAYO 827,651 shares of NILE common stock.

 

(d)The Parties acknowledge that pursuant to the Original CD-NP Agreement, on
MAYO’s behalf and at MAYO’s direction, NILE issued 551,767 shares of NILE common
stock to Florida Research Heart Foundation.

 

(e)The Parties acknowledge that pursuant to the Original CU-NP Agreement, NILE
issued to MAYO 49, 689 shares of NILE Common Stock.

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 15 of 35 Nile Therapeutics// Mayo
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(f)The Parties acknowledge that pursuant to Section 4.03 of the Original CD-NP
Agreement, NILE issued to MAYO an additional 63,478 shares of NILE Common Stock
in relation to the Discovery Translation Award to Dr. Burnett.

 

(f)The Parties acknowledge that in July 2008, pursuant to the Original CD-NP
Agreement, NILE made a milestone payment of $400,000 to MAYO.

 

(g)The Parties acknowledge and agree that no further milestone payments shall be
due to MAYO under the Original CD-NP Agreement or the Original CU-NP Agreement.

 

(h)Upon execution of this Amended Agreement, NILE shall issue to MAYO four
hundred thousand (400,000) shares of NILE’s unregistered Common Stock as
additional consideration for the grants of rights hereunder with respect to
CD-NP.

 

(i)Upon execution of this Amended Agreement, NILE shall issue to MAYO five
hundred thousand (500,000) shares of NILE’s unregistered Common Stock as
additional consideration for the grants of rights hereunder with respect to
CU-NP.

 

The stock to be provided in accordance with Section 4.01 (h and i) shall be
issued to MAYO and, subject to compliance with applicable federal and state
securities laws, to MAYO employees and third parties, as directed by MAYO. All
stock shall be remitted to MAYO for distribution.

 

4.02 Milestone Payments. Upon the occurrence of an event listed below, NILE will
make the following payments to MAYO:

[…***…]

 

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 16 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

[…***…]

 

4.03 Earned Royalties.

 

(a)CD-NP Products. NILE or its Sublicensees will pay MAYO […***…] of the Net
Sales of Royalty Bearing CD-NP Products covered by at least one Valid Claim of
the MAYO Patents or the NILE Patents in the Territory in which the Product is
sold. The Earned Royalties shall be payable in accordance with Section 5.01.
Royalty Bearing CD-NP Products transferred to MAYO or its Affiliates are not
considered transfers for purposes of determining Net Sales or for calculating
Earned Royalties. No Earned Royalties are due MAYO on transfers to MAYO or MAYO
Affiliates.

 

(b)CU-NP Products. NILE or its Sublicensees will pay MAYO […***…] of the Net
Sales of Royalty Bearing CU-NP Products covered by at least one Valid Claim of
the MAYO Patents in the Territory in which the Product is sold, in each case,
where such Patents pertain to CU-NP. The Earned Royalties shall be payable in
accordance with Section 5.01. Royalty Bearing CU-NP Products transferred to MAYO
or its Affiliates are not considered transfers for purposes of determining Net
Sales or for calculating Earned Royalties. No Earned Royalties are due MAYO on
transfers to MAYO or MAYO Affiliates. If in any calendar year, NILE or a
Sublicensee, makes 

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 17 of 35 Nile Therapeutics// Mayo
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  payments other than those required in this Agreement in order to obtain or
maintain license rights necessary to develop, make, have made, use, offer to
sell, import or otherwise commercialize a Royalty Bearing CU-NP Product, NILE or
its Sublicensee shall have the right to deduct such payments from the Royalties
otherwise payable hereunder with respect to such Royalty Bearing CU-NP Product,
provided that the Royalties to be paid hereunder shall not be reduced to less
than […***…] in such calendar year, and provided further, that no such reduction
shall apply if such payments are made solely in respect of licenses for
technology separate from the Products themselves, such as a delivery system.    
(c)Only one royalty shall be due and payable for the manufacture, use or sale of
a Royalty Bearing Product, irrespective of the number of claims within the
Patents that would be infringed by the manufacture, use or sale of a Royalty
Bearing Product.

 

4.04 License Maintenance Fees. Subject to the abatement provisions set forth in
Section 4.05 of this Amended Agreement, in order for NILE to maintain its
exclusive license, NILE will be required to pay MAYO a License Maintenance Fee
of […***…] per calendar year for each of CD-NP and CU-NP until the first patient
is dosed in a Phase III clinical trial of CD-NP or CU-NP, as applicable, after
which such License Maintenance Fee shall increase to […***…] in each calendar
year thereafter for each of CD-NP and CU-NP, until termination or expiration of
this Amended Agreement. The License Maintenance Fees shall be due on or before
the 17th day of January during each calendar year during the Term so long as
this Amended Agreement remains in force and effect. Except as otherwise provided
in Section 4.05, the failure to pay License Maintenance Fees shall be considered
a material breach of this Amended Agreement.

 

4.05 Temporary Financial Relief. The Parties hereby acknowledge and agree that
pursuant to the terms of the Original CD-NP Agreement and the Original CU-NP
Agreement, as of the Effective Date of this Amended Agreement, NILE owes MAYO
the negotiated sum of […***…] for past due Know-How fees, lab work, License
Maintenance Fees and MAYO Patent prosecution and maintenance fees (collectively,
the “Unpaid Fees”). Subject to satisfaction by NILE of the payment terms in
Exhibit C and Section 8.01, the Parties agree that any additional fees and
amounts owing, whether or not billed, accrued or incurred prior to the date of
this Amended Agreement are hereby waived and extinguished. MAYO hereby further
waives any and all breaches and defaults by NILE occurring under the Original
CD-NP Agreement and the Original CU-NP Agreement prior to the Effective Date of
this Amended Agreement including, without limitation, defaults for nonpayment of
the Unpaid Fees. NILE shall repay the Unpaid Fees, with interest, as specified
in Exhibit C.

 

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 18 of 35 Nile Therapeutics// Mayo
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4.06 Interest. Any payment that is not made on or before the date when due under
this Amended Agreement shall accrue interest thereon from and including such
date and until but excluding the date of payment. The interest rate will be set
at a per annum rate equal to LIBOR plus two per-cent (2%) for a one-year deposit
in U.S. dollars as of the day the payment became due and shall be annually reset
to the LIBOR rate existing on each anniversary date thereafter until paid.

 

4.07 Taxes. NILE is responsible for all applicable taxes (other than net income
taxes), duties, import deposits, assessments, and other governmental charges,
however designated, that are now or hereafter will be imposed by any authority
in or for the Territory, based on or relating to:

 

(a)the Product or use of the MAYO Patents by NILE and/or NILE’s Sublicensees; or

 

(b) the import of the Product into the Territory by NILE and/or NILE’s
Sublicensees.

 

Notwithstanding the foregoing, NILE shall not be responsible for any taxes
arising from transactions to which MAYO or any of its Affiliates may be parties
exclusive of transactions with NILE.

 

4.08 No Deductions for Taxes. Except as otherwise stated herein, or unless
otherwise agreed to in writing by MAYO and NILE, all payments to be made by NILE
to MAYO under this Amended Agreement represent net amounts MAYO is entitled to
receive, and shall not be subject to any deductions or offsets by NILE for any
reason whatsoever unless otherwise specifically set forth in this Amended
Agreement. NILE, however, is not responsible for any payments, including income
tax, required to be paid by MAYO on funds received from or on behalf of NILE.

 

4.09 U.S. Currency. All payments to MAYO under this Amended Agreement will be
made by draft drawn on a United States bank, and payable in United States
dollars.

 

4.10 Material Breach. It shall be a material breach of this Amended Agreement if
NILE shall fail to make any payment pursuant to Article 4 of this Amended
Agreement when such payment is due or by the end of any applicable cure period.

 

 

 

 

Amended and Restated License Agreement   page 19 of 35 Nile Therapeutics// Mayo
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Article 5 - Accounting and Reports

 

5.01 Royalty Reports and Payments. NILE will, after Commercialization of at
least one Product, deliver to MAYO on or before July 15th and January 15th of
each calendar year a written report for the previous 6-month period (i.e.
January – June and July – December, respectively) stating, for each Product and
for each country in the Territory in which there are Net Sales:

 

(a)the number of Products sold during the period covered by the written report;

 

(b)a description of all deductions from gross receipts applied to determine Net
Sales;

 

(c)the amount of royalties due thereupon for the period covered by the written
report; and

 

(d)the exchange rates used to calculate the royalties due.

 

Each such report shall be accompanied by the royalty payment due for such
6-month period in accordance with this Article 5.

 

5.02 Audit Rights. NILE agrees to maintain the Records and to require any
permitted Sublicensees to maintain the Records. "Records" mean complete and
accurate records showing clearly all transactions that are relevant to any
sales, costs, expenses and payments under this Amended Agreement, to be kept in
a manner consistent with generally accepted accounting principles and standard
operating procedures. MAYO shall have the right, at its expense, through a
certified public accountant or like person reasonably acceptable to NILE, to
examine the records of NILE and its Sublicensees during regular business hours
before the Termination or expiration of this Amended Agreement and for three (3)
years thereafter, provided that such examination shall not take place more often
than once a year and shall be limited to a report on the accuracy of royalty
statements and payments. If the audit report for any License Year discloses an
underpayment discrepancy in royalties owed by NILE and royalties paid by NILE to
MAYO that exceeds five percent (5%) of total Net Sales or Sublicense Revenue
made until the date of completion of the audit, NILE shall pay the reasonable
expense of the audit and pay to MAYO the entire amount of the discrepancy plus
interest within thirty (30) days from the date upon which MAYO notified NILE of
the discrepancy. Interest shall be computed at the rate which is set forth in
Section 4.06 above. Discrepancies in royalty payments for a License Year
identified by the audit report amounting to less than five percent (5%) shall be
paid by the end of the calendar quarter in which the audit was made.

 

 

 

 

Amended and Restated License Agreement   page 20 of 35 Nile Therapeutics// Mayo
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Article 6 – Representations, Warranties and Indemnification

 

6.01 Representations and Warranties.

 

(a) MAYO hereby represents and warrants to the best of its counsel’s knowledge
the following:

 

(i)MAYO has the full right and power to perform the obligations and grant the
License set forth in this Agreement;

 

(ii)There are no outstanding agreements, assignments or encumbrances in
existence inconsistent with the provisions of this Amended Agreement.

 

(iii)Subject to Section 3.03, MAYO owns or possesses all right, title and
interest in and to the MAYO Patents free and clear of all liens, charges,
encumbrances or other restrictions or limitations of any kind whatsoever.

 

(iv)Subject to Section 3.03, there are no licenses, options, restriction, liens,
rights of third parties, disputes, royalty obligations, proceedings or claims
relating to, affecting, or limiting its rights or the rights of NILE under this
Amended Agreement, which imposes obligations upon MAYO or gives any rights to
MAYO which, in either case, would adversely affect the rights of NILE or the
obligations of MAYO under this Amended Agreement.

 

(v)There is no claim, pending or threatened, of infringement, interference or
invalidity regarding, any part or all of the MAYO Patents and their use as
contemplated in the underlying patent applications as presently drafted or as
contemplated under this Amended Agreement.

 

(vi)MAYO has provided, or shall provide prior to the execution of this Amended
Agreement, a copy of all pending patents and applications related to CD-NP and
CU-NP.

 

 

 

(b)NILE hereby represents and warrants to the best of its knowledge it does not
know of any prior art that NILE would have the obligation to disclose pursuant
to Section 7.04 hereto.

 

6.02 No Warranties. Notwithstanding the foregoing, nothing in this Amended
Agreement will be construed as:

 

 

 

 

Amended and Restated License Agreement   page 21 of 35 Nile Therapeutics// Mayo
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(a)a warranty or representation by MAYO as to the validity or scope of any of
the MAYO Patents; or

 

(b)an obligation to bring or to prosecute actions against third parties for
infringement of the MAYO Patents; or

 

(c)a warranty or representation that the manufacture, use, sale, offer for sale
or importation of any Product or the use or practice of any of the MAYO Patents
are free from infringement or misappropriation of a third party’s intellectual
property rights.

 

 

6.03 Disclaimer. MAYO HAS NOT MADE AND PRESENTLY MAKES NO PROMISES, GUARANTEES,
REPRESENTATIONS OR WARRANTIES OF ANY NATURE, DIRECTLY OR INDIRECTLY, EXPRESS OR
IMPLIED, REGARDING THE MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT FOR THE PRODUCTS OR MAYO PATENTS. THE KNOW-HOW AND MAYO PATENTS
PROVIDED OR LICENSED UNDER THIS AMENDED AGREEMENT ARE PROVIDED "AS IS," "WITH
ALL FAULTS," AND "WITH ALL DEFECTS".

 

NILE is solely responsible for determining whether the MAYO Patents and Know-How
provided or licensed hereunder have applicability or utility in NILE’s
manufacturing and design activities. NILE assumes all risk and liability in
connection with such determination.

 

6.04 Indemnification.

 

(a)Indemnification by NILE. NILE will defend, indemnify, and hold harmless MAYO
and MAYO’s Affiliates from any and all third party claims, actions, demands,
judgments, losses, costs, expenses, damages and liabilities (including but not
limited to reasonable attorneys’ fees and other out-of-pocket expenses incurred
in litigation) (collectively, “Claims”), regardless of the legal theory
asserted, arising out of or connected with: (a) the use by NILE of the MAYO
Patents, MAYO Future Patents, Know-How or New Improvements, if any, furnished or
licensed under this Amended Agreement; (b) the development, design, manufacture,
distribution, use, sale, or other disposition of products, including Products,
by NILE or its transferees; and (c) any act or omission of NILE, including any
clinical trial funded or conducted by NILE, unless such Claims are judicially
determined to have arisen out of the negligence or willful misconduct of MAYO or
its Affiliates. As used herein, MAYO and its Affiliates include the trustees,
officers, agents, and employees of MAYO and its Affiliates. NILE will, during
the Term, carry occurrence-based business liability insurance, including
products liability (when applicable), in an amount and for a time period
sufficient to cover the liability assumed by NILE hereunder, such amount being
at least Three Million Dollars (US $3,000,000), provided that a lesser amount
shall be acceptable to MAYO until such time as the Product enters into human
clinical trials. In addition, such policy will name MAYO as an additional-named
insured party.

 

 

 

 

Amended and Restated License Agreement   page 22 of 35 Nile Therapeutics// Mayo
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(b)Indemnification by MAYO. MAYO will defend, indemnify, and hold harmless NILE
and NILE’s Affiliates from any and all third party claims, actions, demands,
judgments, losses, costs, expenses, damages and liabilities (including but not
limited to reasonable attorneys’ fees and other out-of-pocket expenses incurred
in litigation) (collectively, “Claims”), regardless of the legal theory
asserted, arising out of or connected with: (a) the use by MAYO of any drug
products provided by NILE pursuant hereto in any pre-clinical or clinical trial
funded or conducted by MAYO, unless such Claims are judicially determined to
have arisen out of the negligence or willful misconduct of NILE or its
Affiliates. As used herein, NILE and its Affiliates include the trustees,
officers, agents, and employees of NILE and its Affiliates and successors in
interest. MAYO will, during the Term, carry occurrence-based liability insurance
and contractual liability, in an amount and for a time period sufficient to
cover the liability assumed by MAYO hereunder, such amount being at least
[…***…].

 

(c)Procedure. With respect to any Claim giving rise to indemnification
hereunder, the indemnitee shall be required to tender the defense thereof to the
indemnifying Party and the indemnifying Party shall have the right to assume
sole control of the defense, settlement or disposition thereof, including,
without limitation, the selection of defense counsel. The indemnitee shall be
required to fully cooperate with the indemnifying Party in the defense and
settlement of all such Claims at the indemnifying Party’s request and expense.
If the indemnifying Party assumes any such defense, the indemnifying Party shall
not be liable for any legal or other expenses subsequently incurred directly by
the indemnitee in connection with such defense. So long as the indemnifying
Party is diligently conducting the defense of the claim, (i) the indemnitee will
not consent to the entry of any judgment or enter into any settlement with
respect to the Claim without the prior written consent of the indemnifying
Party, and (ii) the indemnifying Party will not consent to the entry of any
judgment or enter into any settlement with respect to the Claim without the
prior written consent of the indemnitee, which consent will not be unreasonably
withheld or delayed; provided, however, that such consent of the indemnitee will
not be required if the judgment or settlement contains a full release of Claims
against the indemnitee and does not contain any admission of wrongdoing by the
indemnitee. Notwithstanding any other provision of this subsection, if an
indemnitee withholds its consent to a bona fide settlement offer, where but for
such action the indemnifying Party could have settled such Claim, the
indemnifying Party will be required to indemnify the indemnitee only up to a
maximum of the bona fide settlement offer for which the indemnifying Party could
have settled such claim.

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 23 of 35 Nile Therapeutics// Mayo
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6.05 Additional Waivers. IN NO EVENT WILL EITHER PARTY’S LIABILITY OF ANY KIND
INCLUDE ANY SPECIAL, INDIRECT, INCIDENTAL, OR FUTURE DAMAGES, EVEN IF SUCH PARTY
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO CASE WILL MAYO’S
LIABILITY OF ANY KIND EXCEED THE TOTAL AMOUNTS WHICH HAVE ACTUALLY BEEN PAID TO
MAYO BY NILE AS OF THE DATE OF FILING OF THE ACTION AGAINST MAYO WHICH RESULTS
IN THE SETTLEMENT OR AWARD OF DAMAGES.

 

Article 7 - Term and Termination

 

7.01 Term. Unless sooner terminated, this Amended Agreement shall continue in
full force and effect until the later of (a) the expiration of the last to
expire Valid Claim contained in the MAYO Patents, or (b) the 20th anniversary of
this Amended Agreement. Upon such expiration, NILE shall be deemed to have a
fully paid-up license to any Know-How as provided in Section 3.01 herein.

 

7.02 Material Breach. MAYO shall be entitled to terminate this Amended Agreement
at any time based upon material breach if NILE has failed to cure such material
breach within […***…] of receipt of notice by NILE from MAYO that NILE is in
breach. Any such notice from MAYO shall identify with specificity the basis for
its assertion of material breach.

 

7.03 Termination for Other than Material Breach. NILE may terminate this Amended
Agreement without cause upon ninety (90) days prior written notice to MAYO.

 

7.04 Termination for Challenge. MAYO may terminate this Amended Agreement by
transmitting a notice of termination to NILE in the event NILE challenges the
validity or enforceability of any of the MAYO Patents Rights in any manner;
provided, however, that notwithstanding anything contained in this Section 7.04,
if NILE believes that it has the obligation under applicable law to disclose
prior art to any applicable patent authority or office, such disclosure shall
not be deemed a challenge for purposes of this Section 7.04 and MAYO shall not
have the right to terminate the licenses granted pursuant to this or any other
agreement. NILE will notify MAYO of any disclosure made by it pursuant to this
Section.

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 24 of 35 Nile Therapeutics// Mayo
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7.05 Termination for Development Delay. MAYO may terminate this Amended
Agreement by transmitting a notice of termination to NILE in the event NILE or a
Sublicensee (a) has not initiated the next clinical trial of a CD-NP Product
within […***…] after the Effective Date of this Amended Agreement or (b) has not
initiated a clinical trial of a CU-NP Product within […***…] after the Effective
Date of this Amended Agreement. For purposes of clarity, initiation of a
clinical trial shall be deemed to have occurred when the first person enrolled
in the clinical trial has been dosed with the Product. The selection of the
Product to be evaluated in the next clinical trial shall be at the sole
discretion of NILE or its Sublicensee, and the initiation of such clinical trial
shall constitute full satisfaction of NILE’S diligence obligations under this
Agreement with respect to the Products. If MAYO transmits a notice of
Termination for Development Delay, then NILE shall transfer to MAYO (a) whatever
rights NILE has in pre-clinical and clinical studies related to the Products;
and (b) any rights NILE may have in any active INDs related to the Products. If
MAYO fails to transmit a notice of termination to NILE to terminate this Amended
Agreement and NILE then initiates a clinical trial of a Product, then upon such
initiation, MAYO’S right to terminate for a development delay shall be
extinguished and of no further force or effect.

 

7.06 Insolvency of Company. MAYO shall have the right to terminate this Amended
Agreement by transmitting a notice of termination to NILE in the event NILE
ceases conducting business in the normal course, files for bankruptcy
protection, makes a general assignment for the benefit of creditors, admits in
writing its inability to pay its debts as they are due, permits the appointment
of a receiver for its business or assets, or avails itself of or becomes subject
to any proceeding under any statute of any governing authority relating to
insolvency or the protection of rights of creditors. In such event, NILE will
provide copies (or the originals if available) of all toxicity, efficacy and
other data generated by NILE and NILE will transfer to MAYO any rights NILE may
have in any active INDs related to Products.

 

7.07 Effect of Termination. Upon termination of this Amended Agreement, all
rights granted herein will immediately revert to MAYO with no further notice or
action required on MAYO’s behalf. NILE shall also transfer to MAYO those items
and rights set forth in Section 7.05(a) and (b) above and other data generated
solely by NILE (including by contractors or agents on their behalf) in the
course of NILE's efforts to develop Products or obtain governmental approval for
the sale of Products, for use in connection with the development and
commercialization of Products. For purposes of clarity, NILE shall not be
obligated to transfer to MAYO any rights it may have in the NILE Patents.

 

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 25 of 35 Nile Therapeutics// Mayo
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7.08 Survival. The following obligations survive the expiration or termination
of this Amended Agreement:

(a)NILE's obligation to supply reports covering the time period up to the date
of termination or expiration;

(b)MAYO’s right to receive payments, fees, and royalties accrued or accruable
from payment at the time of any termination or expiration;

 

(c)NILE's obligation to maintain records after termination for the period
required by applicable law, and MAYO’s right to have those records inspected
during such period;

 

(d)any cause of action or claim of MAYO, accrued or to accrue, because of any
action or omission by NILE for a period of […***…] after the termination;

 

(e)any cause of action or claim of NILE, accrued or to accrue, because of any
action or omission by MAYO for a period of […***…] after the termination;

 

(f)NILE’s obligations stated in Sections 3.06 and 3.08; Sections 7.07, 7.09 and
7.10; and the applicable sections of Articles 6 and 10; and

 

(g)MAYO’s obligations stated in Section 3.06, 7.09 and 7.10 and the applicable
sections of Articles 6 and 10.

 

 

 

7.09 Inventory. NILE shall notify MAYO within thirty (30) days of the effective
date of termination of this Amended Agreement the amounts, if any, of Product
that NILE, its Sublicensees and distributors then have in inventory in each
country or Territory. At MAYO’s election, NILE, its Sublicensees and
distributors may sell the Product in that country or Territory if NILE pays any
royalties due thereon in accordance with Sections 4.03 and 5.01. In the event
that MAYO does not permit the sale of the inventory, MAYO will direct NILE to
return the inventory to MAYO or to destroy the inventory; provided that MAYO
shall pay to NILE the full then current market price thereof, including the cost
of shipping, insurance and costs of destruction, if any.

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 26 of 35 Nile Therapeutics// Mayo
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7.10 Return of Confidential Information. Within thirty (30) days of the
effective date of termination of this Amended Agreement, each of the Parties
shall return all of the other Party's Confidential Information, including all
copies thereof; provided, however, that each Party shall be entitled to retain
one copy of all such Confidential Information in its legal department so that
any continuing obligations of confidentiality may be determined.

 

Article 8 – Filing, Prosecution and Maintenance of the MAYO Patents.

 

8.01      Filing, Prosecution and Maintenance of the MAYO Patents. Following
execution of this Amended Agreement, NILE shall be responsible for the
prosecution and maintenance of all MAYO Patents and MAYO Patent applications, at
NILE’s expense, using counsel reasonably acceptable to MAYO, and shall keep MAYO
informed of prosecution. NILE shall also be responsible for paying any
prosecution and maintenance fees of all MAYO Patents and MAYO Patent
applications now existing and included in this Amended Agreement, which services
were rendered after April 1, 2013.

 

8.02 Term Extension for the MAYO PATENTS. NILE will have the sole right to
decide on which of the MAYO Patent(s) to obtain a patent term extension;
provided that NILE will consider MAYO’s input on the matter.

 

Article 9 – MAYO Patent Enforcement

 

9.01 Third Party Litigation. In the event a third party institutes a suit
against NILE for patent infringement involving a Product, NILE will promptly
inform MAYO and keep MAYO regularly informed of the proceedings. In the event
the third party sues or joins MAYO, NILE will have the right to control the
defense of the suit provided, however, that MAYO may be represented by counsel
of its own selection, and at its own expense. Each Party will bear its own costs
of the suit and with respect to any suit defended by NILE, NILE will be entitled
to all sums recovered, after each party has been reimbursed for its respective
legal fees and costs. If NILE declines to defend the action, MAYO shall have the
right to control the defense of the suit provided, however, that NILE may be
represented by counsel of its own selection, and at its own expense. With
respect to any suit defended by MAYO, MAYO will be entitled to all sums
recovered, after each party has been reimbursed for its respective legal fees
and costs.

 

9.02 Infringement by Third Party. NILE and MAYO will promptly inform the other
Party in writing of any alleged infringement of any MAYO Patent and provide the
other Party with available evidence of such infringement, and MAYO and NILE will
have the right to

institute an action for infringement of the MAYO Patents consistent with the
following:

 

 

 

 

Amended and Restated License Agreement   page 27 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

(a)If MAYO and NILE agree to institute suit jointly, then the suit will be
brought in the names of both parties. NILE will exercise control over such
action, provided, however, that MAYO may, if it so desires, be represented by
counsel of its own selection, and at its own expense.

 

(b)In the absence of an agreement to institute a suit jointly, NILE may
institute suit and, at its option, join MAYO as a plaintiff. In that event, NILE
will bear the entire cost of such litigation, including attorneys' fees. MAYO
will cooperate reasonably with NILE, except financially, in such litigation.
NILE will not settle or enter into a voluntary disposition of the action without
MAYO’s prior written consent, which consent shall not be unreasonably withheld.

 

(c)In the absence of an agreement to institute a suit jointly, and if NILE
determines not to institute a suit, as provided in paragraph (b) of this Section
9.02, then MAYO may institute suit and, at its option, join NILE as a plaintiff
in the litigation. MAYO will bear the entire cost of such litigation, including
attorneys' fees. NILE will cooperate reasonably with MAYO, except financially,
in such litigation. MAYO will not settle or enter into a voluntary disposition
of the action without NILE’s prior written consent, which consent shall not be
unreasonably withheld.

 

(d)Absent an agreement to the contrary, any recovery from any such action shall
(i) first be applied to reimburse the costs and expenses of the Party bringing
the action; (ii) second, to reimburse the costs and expenses of the other Party
in connection with the action; and (c) […***…].

 

(e)If either Party institutes a suit under this Section 9.02 and then decides to
abandon the suit, it will first provide timely written notice to the other Party
of its intention to abandon the suit, and the other Party, if it wishes, may
continue prosecution of such suit, provided, however, that the sharing of
expenses and the treatment of any recovery in such suit will be agreed-upon
separately by the Parties.

 

 9.03 MAYO Patent Marking. To the extent commercially feasible and customary in
the trade, NILE will mark all Products that are manufactured or sold under this
Amended Agreement with the number of each issued patent within the MAYO Patents
and/or NILE Patents that cover such Product(s). Any such marking will be in
conformance with the patent laws and other laws of the country of manufacture or
sale.

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 28 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

Article 10 – General Provisions

 

10.01 Name Use. This Amended Agreement does not convey any right to use any of
the other Party’s names or logos other than where required by law, rule or
regulation. Neither Party may use publicly for publicity, promotion, or
otherwise, any logo, name, trade name, service mark or trademark of the other
Party or its Affiliates, or any simulation, abbreviation or adaptation of the
same, or the name of any of the other Party’s employee or agent without such
other Party’s prior, written, express consent other than where required by law,
rule or regulation. MAYO’s marks include, but are not limited to, the terms
“MAYO®” and “MAYO CLINIC®.” Any violation of this Section 10.01 constitutes a
material breach of this Amended Agreement. Upon execution of this Amended
Agreement, representatives of the Parties shall agree upon a mutually acceptable
form of disclosure that can be utilized by either of them without obtaining the
prior consent of the other Party.

 

10.02 Assignment. NILE may assign its rights and obligations under this Amended
Agreement to (a) an Affiliate or (b) a third party in conjunction with an
acquisition or Change of Control; in each case without MAYO's prior written
consent; provided that NILE shall remain responsible for the performance of its
assignee, the assignee agrees to assume and be bound by the provisions of this
Amended Agreement in writing and NILE promptly notifies MAYO of such assignment.
MAYO's written consent, which shall not be unreasonably withheld, conditioned or
delayed, shall be required prior to any other assignment of NILE's rights or
obligations hereunder. Any other purported assignment is void.

 

10.03 Waiver. The failure of a Party to complain of any default by another Party
or to enforce any of such Party’s rights, no matter how long such failure may
continue, will not constitute a waiver of the Party’s rights under this Amended
Agreement. The waiver by a Party of any breach of any provision of this Amended
Agreement shall not be construed as a waiver of any subsequent breach of the
same or any other provision. No part of this Amended Agreement may be waived
except by the further written agreement of the Parties.

 

10.04 Governing Law and Jurisdiction. This Agreement shall be governed by and
construed under the laws of the State of Delaware, without regard to its
conflict of law provisions. To the extent the substantive and procedural law of
the United States would apply to this Agreement, it supersedes the application
of Delaware law.

 

 

 

 

Amended and Restated License Agreement   page 29 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

10.05 Headings. The headings of articles and sections used in this document are
for convenience of reference only, and shall not affect the meaning or
interpretation of this Amended Agreement.

 

10.06 Notices. All notices and other business communications between the Parties
related to this Amended Agreement shall be in writing, shall be sent by
(a) first class mail, certified, (b) nationally recognized courier service, (c)
personal delivery or (c) facsimile or electronic mail, and in each case shall be
addressed to the Parties at the addresses set forth below or to such other
address(es) as may be furnished by written notice in the manner set forth
herein. Notice shall be deemed to have been served 48 hours after posting.
Notices delivered by personal service or courier shall be deemed served on the
documented date of delivery and if sent by facsimile or electronic transmission,
on the day when the fax or e-mail was sent to the other Party provided that the
sending Party has a confirmed receipt and that the deemed day of receipt of the
notice by receiving Party was on a working day of the receiving Party and within
business hours, otherwise, it will be deemed received on the following working
day. Notices shall be sent to the following:

 

If to MAYO:         Mayo Foundation for Medical Education and Research        
Mayo Clinic Ventures         200 First Street SW         Rochester, Minnesota
55905-0001         Attn: Ventures Operations         Telephone:507-293-3900  
COPY TO:   Facsimile:507-284-5410   Mayo Legal  
Email:intellectualproperty@mayo.edu   Attn: General Counsel       Telephone:
507-284-2650       Facsimile: 507-284-0929

 

 

If to NILE:

Nile Therapeutics, Inc.

63 Bovet Rd. #421

San Mateo,‎ CA‎ 94402

Attn: […***…]

Telephone: […***…]

Email: […***…]

 

*Confidential Treatment Requested

 

 

 

 

Amended and Restated License Agreement   page 30 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

Notices sent by certified mail shall be deemed delivered on the third day
following the date of mailing. A Party may change its address or facsimile
number by giving written notice in compliance with this section.

 

10.07 Limitation of Rights Created. This Amended Agreement is intended only to
benefit the Parties hereto and is not intended to confer upon any other person
any rights or remedies hereunder.

 

10.08 Independent Contractors. It is mutually understood and agreed that the
relationship between the Parties is that of independent contractors. No Party is
the agent, employee, or servant of the other. Except as specifically set forth
herein, no Party shall have or exercise any control or direction over the
methods by which the other Party performs work or obligations under this Amended
Agreement. Further, nothing in this Amended Agreement is intended to create any
partnership, joint venture, or lease, expressly or by implication, between the
Parties.

 

10.09 Entire Agreement. This Amended Agreement constitutes the final, complete
and exclusive agreement between the Parties with respect to its subject matter
and supersedes all past and contemporaneous agreements, promises, and
understandings, whether oral or written, between the Parties including the
Original Agreement.

 

10.10 Binding Effect. This Amended Agreement shall be binding upon and inure to
the benefit of the Parties, their heirs, legal representatives, successors and
assigns.

 

10.11 Severability. In the event any provision of this Amended Agreement is held
to be invalid or unenforceable, the remainder of this Amended Agreement shall
remain in full force and effect as if the invalid or unenforceable provision had
never been a part of this Amended Agreement.

 

10.12 Amendments. This Amended Agreement may not be amended or modified except
by a writing signed by the Parties and identified as an amendment to this
Amended Agreement.

 

10.13 Construction. The Parties agree to all of the terms of this Amended
Agreement and have had the opportunity to review it thoroughly prior to its
execution. That one Party or another may have drafted all or a part of this
Amended Agreement will not cause this Amended Agreement to be read more strictly
against the drafting Party. This Amended Agreement, and any changes to it, will
be interpreted on the basis that the Parties contributed equally to the drafting
of all of its parts.

 

 

 

  

Amended and Restated License Agreement   page 31 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

10.14 Nondisclosure. Except as permitted herein, neither Party will disclose any
of the terms of this Amended Agreement without the express, prior, written
consent of the other Party, or unless required by law or a regulatory authority.

 

10.15 Counterparts. This Amended Agreement shall become binding as of the
Effective Date when any one or more counterparts hereof, individually or taken
together, shall bear the signatures of each of the Parties hereto. This Amended
Agreement may be executed in any number of counterparts, each of which shall be
an original as against any Party whose signature appears thereon but all of
which together shall constitute but one and the same instrument.

 

 

IN WITNESS WHEREOF, MAYO and NILE have caused this Amended Agreement to be
signed as of the Effective Date by their respective representatives.

 

Mayo Foundation for Medical       Education and Research:   Nile Therapeutics,
Inc.:                   /s/ Daniel D. Estes   /s/ Daron Evans   Daniel D. Estes
  Daron Evans   Assistant Treasurer   Chief Financial Officer           November
14, 2013   November 11, 2013   Date   Date           Read, Understood and
Agreed:                       /s/ John C. Burnett, M.D.   November 14, 2013  
John C. Burnett, M.D.   Date  

 

 

 

 

Amended and Restated License Agreement   page 32 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

EXHIBIT A

 

MAYO PATENTS

 

[…***…]

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 33 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

[…***…]

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 34 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

EXHIBIT B

 

PATENTS OWNED AND CO-OWNED BY NILE

 

[…***…]

 

 

*Confidential Treatment Requested

 

 

 

Amended and Restated License Agreement   page 35 of 35 Nile Therapeutics// Mayo
Execution Copy 14 November 2013

 

 

 

EXHIBIT C

 

REPAYMENT SCHEDULE FOR UNPAID FEES

 

[…***…]

 

*Confidential Treatment Requested