CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT

HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE

COMMISSION.

Exhibit 10.1

DEVELOPMENT AND SUPPLY AGREEMENT

THIS DEVELOPMENT AND SUPPLY AGREEMENT (this “Agreement”) is made as of this 26th
day of March, 2009 (the “Effective Date”) by and between MediciNova, Inc.,
having a principal place of business at 4350 La Jolla Village Drive, Suite 950,
San Diego, California 92122 (“MediciNova”) and Hospira Worldwide, Inc., having a
principal place of business at 275 North Field Drive, Lake Forest, Illinois
60045 (“Hospira”).

WITNESSETH:

WHEREAS, MediciNova has rights to develop and commercialize the compound MN-221,
a highly-selective ß2-adrenergic receptor agonist, and wishes to develop and
market MN-221 in Hospira’s ADD-Vantage® Drug Delivery System (as further defined
herein);

WHEREAS, MediciNova and Hospira desire that Hospira assist MediciNova in the
development and commercialization of Products; and

WHEREAS, after MediciNova has received an approved New Drug Application from the
U.S. Food and Drug Administration (the “FDA”) or a corresponding new drug
approval in the Territory, the parties desire that Hospira manufacture and sell
to MediciNova its full requirements of Products in accordance with the terms and
conditions set forth herein.

NOW, THEREFORE, in consideration of the premises and the mutual promises and
agreements contained herein, and for other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged by the parties,
MediciNova and Hospira agree as follows.

Article 1     DEFINITIONS

The following words and phrases when used herein with capital letters shall have
the meanings set forth or referenced below:

1.1 “API” shall mean the active pharmaceutical ingredient referred to as MN-221
in bulk form that MediciNova shall deliver to Hospira for incorporation into the
Products (as hereinafter defined) and meeting the applicable Active
Pharmaceutical Ingredient Specifications (as hereinafter defined).

1.2 “API Specifications” shall mean the detailed description and parameters of
the API set forth on Exhibit 1.2, as may be amended from time to time by
MediciNova.

1.3 “ADD-Vantage® Drug Delivery System” shall mean the ADD-Vantage® Vial and the
ADD-Vantage® diluent container to be used in combination to deliver an
intravenous dose of a drug contained in the ADD-Vantage® Vial.

 

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1.4 “ADD-Vantage® Vial(s)” shall mean the drug vial designed and promoted by
Hospira under Hospira trademarks (including the “ADD-Vantage” ® trademark) for
the aseptic transfer of a drug from a vial into a compatible partial-fill,
intravenous fluid container, more fully described in the Product Specifications.

1.5 “Affiliate” shall mean any corporation or non-corporate business entity
which controls, is controlled by, or is under common control with a party to
this Agreement at any time during the term of this Agreement. A corporation or
non-corporate business entity shall be regarded as in control of another
corporation or non-corporate business entity if it owns, or directly or
indirectly controls, in excess of fifty percent (50%) of the voting stock or
membership interests of the other entity or if it possesses, directly or
indirectly, the power to direct or cause the direction of the management and
policies of such corporation or non-corporate business entity, as applicable.

1.6 “Applicable Law” shall mean all applicable laws, rules, regulations,
guidelines, and standards including, without limitation, ICH guidelines, cGMPs
and those relating to the environment, food or drugs and occupational health and
safety, including all enforced or promulgated by the FDA, [***] and any relevant
Regulatory Authority in the Territory.

1.7 “cGMP” shall mean the current good manufacturing practices required by the
FDA and set forth in the United States Federal Food, Drug and Cosmetic Act or
FDA regulations (including, without limitation, 21 C.F.R. Part 210 and Part
211), policies or guidelines in effect at any time during the term of this
Agreement for the manufacture and testing of pharmaceutical products as applied
to the Products, and all corresponding requirements of the [***] and of each
other applicable Regulatory Authority, including, without limitation, relevant
ICH manufacturing guidelines.

1.8 “Commercialization Year” shall mean a period of twelve (12) consecutive
months which, for the first Commercialization Year of this Agreement, shall
commence on the first day of the month after the month of MediciNova’s first
bona fide commercial sale (“Product Launch”) of Products to a non-Affiliate
customer after the Products have received an approved NDA from the FDA or [***]
and each Commercialization Year thereafter shall consist of twelve
(12) consecutive months following the end of the preceding Commercialization
Year.

1.9 “Confidential Information” shall mean the proprietary and confidential
information of a party disclosed under this Agreement, part of a prior
disclosure, or developed hereunder, except any portion thereof which:

(a) is known to the recipient at the time of the disclosure, as evidenced by its
written records or other competent evidence;

 

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Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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(b) is disclosed to the recipient by a third person lawfully in possession of
such information and not under an obligation of nondisclosure;

(c) is published or generally known to the public, either before or after the
date of disclosure through no act or omission on the part of the recipient;

(d) is developed by or for the recipient independently of Confidential
Information disclosed hereunder as evidenced by the recipient’s written records
or other competent evidence; or

(e) is required by law to be disclosed by the recipient, to defend or prosecute
litigation or to comply with governmental regulations, provided that the
recipient gives the other party hereto prompt prior written notice of such legal
requirement, such that such other party shall have the opportunity to apply for
confidential treatment of such Confidential Information, and reasonably
cooperates therewith. The confidential information of MediciNova will be deemed
to include all information concerning the MNOV Project IP and the terms and
existence of this Agreement, as well as all information relating to the API.

1.10 “Hospira IP” shall mean (i) Hospira’s rights and interests in and to issued
patents and pending patent applications without limitation to any country,
including, without limitation, all provisional applications, substitutions,
continuations, continuations-in-part, divisionals, and renewals, all letters
patent granted thereon, and all re-issues, re-examinations and extensions
thereof, and supplemental protection certificates relating thereto whether owned
solely or jointly by Hospira or under which Hospira has or later obtains rights
that permit Hospira to grant sublicenses, which relate to [***]; (ii) [***]; and
(iii) any Improvements to the foregoing.

1.11 “ICH” shall mean International Conference on Harmonisation.

1.12 “Improvements” shall mean any and all new developments by a party in
connection with this Agreement, including, but not limited to, with respect to
Hospira IP, [***] and, with respect to MediciNova IP, [***].

1.13 “MediciNova IP” shall mean: (i) MediciNova’s rights and interests in and to
issued patents and pending patent applications without limitation to any
country, including, without limitation, all provisional applications,
substitutions, continuations, continuations-in-part, divisionals, and renewals,
all letters patent granted thereon, and all re-issues, re-examinations and
extensions thereof, and supplemental protection certificates relating thereto
whether owned solely or jointly by MediciNova, which relate to [***];
(ii) [***]; and (iii) any Improvements to the foregoing.

 

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Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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1.14 New ADD-Vantage® Drug Delivery System” shall mean a changed Hospira drug
delivery system that: [***].

1.15 “NDA” shall mean New Drug Application filed with the FDA guidelines for a
Product.

1.16 [***].

1.17 “Product” or “Products” shall mean the dosage form(s) of the API (as
defined herein) processed, filled, finished, labeled, packaged and inspected by
Hospira in ADD-Vantage® Vials (as defined herein) and supplied to MediciNova as
either an individual vial (“Vial Product”) or in kit form with a 250mL 5%
dextrose solution in an ADD-Vantage® diluent container (each, a “Kit”). For
purposes of clarification, Hospira shall manufacture the Products exclusively
for MediciNova.

1.18 “Product Placebo” shall mean a form of the Product intended for human use
and manufactured fully in accordance with the Product Specifications, but
without the inclusion of the API. For purposes of this Agreement, the terms
“Product” and “Products” shall include Product Placebo unless the context
specifically requires otherwise.

1.19 “Product Specifications” shall mean those product, labeling and performance
specifications for the Products filed with the FDA, [***] or other appropriate
Regulatory Authorities, including Product formulae, labeling, and materials
required for the manufacture of the Products that are to be purchased and
supplied under this Agreement, as such are set forth on Exhibit 1.19, which
specifications may be amended from time to time by the written agreement of the
parties, which agreement will not be unreasonably withheld.

1.20 “Product Supply Commitment” shall have the meaning provided in Section 6.1.

1.21 “Purchase Order” shall mean written orders from MediciNova to Hospira,
which shall specify: (a) the quantity of Products ordered; (b) delivery dates;
and (c) delivery destinations.

1.22 “Regulatory Authority” shall mean, with respect to the Territory, any
federal, state or local or international regulatory agency, department, bureau
or other governmental entity including without limitation the FDA and [***],
which is responsible for issuing approvals, licenses, registrations or
authorizations necessary for the manufacture, use, storage, import, transport or
sale of the Products in the Territory.

1.23 “Specially Regulated Waste” shall mean any hazardous waste, toxic waste,
medical waste, nuclear waste, mixed waste, or other waste materials or
by-products, including waste water, which is subject to or requires special
handling, treatment, storage, or disposal under any federal, state or local laws
or regulations intended to address such types of waste materials that arise from
the manufacture of the Products and is solely attributable to the API.

 

-4-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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1.24 “Technology” shall mean and include any and all unpatented proprietary
ideas, inventions, patents, patent applications, discoveries, Confidential
Information, trade secrets, biologic materials, data, results, formulae,
designs, specifications, methods, processes, formulations, techniques, ideas,
know-how, technical information (including, without limitation, structural and
functional information), process information, pre-clinical information, clinical
information, and any and all proprietary biological, chemical, pharmacological,
toxicological, pre-clinical, clinical, assay, control, manufacturing data and
materials.

1.25 “Territory” shall mean [***].

1.26 “Third Party” shall mean a party other than Hospira or MediciNova and their
respective Affiliates.

1.27 “Waste” shall mean all waste, rejects, improper goods, garbage, refuse,
remainder, residue, waste water or other discarded material, including solid,
liquid, semisolid, or contained gaseous material that arises from the
manufacture of the Products, including but not limited to, rejected, excess or
unsuitable materials, API and Products, all to the extent solely attributable to
the API. The term Waste shall not include any Specially Regulated Waste.

Article 2     PRODUCT DEVELOPMENT PROJECT

2.1 General. In accordance with a Letter of Intent dated [***] (the “LOI”) which
has expired as of the date hereof, the parties have undertaken a Product
development project (the “Project”) consisting of certain of the development
activities set forth in Exhibit 2.1. The objective of the Project shall be for
Hospira to assist in the development of the Products and to assist MediciNova in
obtaining an approved NDA (and/or foreign equivalents) covering the Products.
The parties acknowledge and agree that all such development work referred to in
Exhibit 2.1 and all payments relating thereto, shall be subject to the terms and
conditions of this Agreement. Upon completion of the Project, Hospira shall
manufacture and deliver the Products to MediciNova for ultimate commercial sale
by MediciNova as a human pharmaceutical product, as herein provided. Hospira
shall otherwise manufacture and deliver clinical Products as ordered by
MediciNova.

2.2 Commercially Reasonable Efforts. Each party shall use its commercially
reasonable efforts to successfully complete the Project [***]. However, the
parties agree and understand that neither party hereto [***], provided such
agreement and understanding will not in any way lessen either party’s
obligations to fulfill its duties hereunder.

 

-5-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Article 3     PAYMENT FOR HOSPIRA’S DEVELOPMENT EFFORTS

3.1 Development Fee. To reimburse Hospira for the development work related to
the Project, MediciNova shall pay to Hospira development fees set forth in
Exhibit 2.1 (the “Development Fee”). The Development Fee shall be paid to
Hospira in accordance with the payment schedule set forth in Exhibit 3.1.

3.2 Changes in Project Scope. If changes occur in the Project or the Product
Specifications or if technical difficulties require that Hospira perform either
additional work or repeat work, the parties shall consult and agree to execute
written amendments to the scope of work. Each amendment shall detail the
requested changes to the applicable tasks, responsibilities, duties, budgets,
timelines or other matters relating to scope of work for this Agreement. Hospira
shall provide MediciNova with cost estimates for such work. If MediciNova
approves in writing such amendment and estimated costs, Hospira shall perform
such work and, if such changes or technical difficulties are not attributable to
Hospira’s acts or omissions, MediciNova shall pay the agreed-upon additional
costs for such work within thirty (30) days of completion of such work.
Hospira’s estimate of the costs for such additional work or repeat work shall be
based on the full time equivalent rates for Hospira personnel (“FTE Rates”) as
set forth in Exhibit 3.2, plus out-of-pocket costs for reasonable travel and
sustenance, materials and supplies, or such other costs agreed by the parties
prior to the commencement of the additional work or repeat work.

3.3 Development Supplies. After MediciNova selects its final Product
formulations, concentration, and fill volume and the parties mutually agree to
the final Product Specifications, such agreement of Hospira not to be
unreasonably withheld, Hospira will provide to MediciNova all development
supplies of Products ordered by MediciNova at the prices set forth on
Exhibit 5.8. MediciNova shall issue a purchase order for any such development
supplies at least [***] before the required delivery date.

Article 4     MEDICINOVA’S REGULATORY SUBMISSIONS

4.1 Regulatory Approvals. MediciNova will advise Hospira of all document
requirements in support of its NDA, [***] and similar applications required by
relevant Regulatory Authorities, including amendments, license applications,
supplements and maintenance of the same. Hospira shall comply with all
reasonable requests of MediciNova in providing appropriate documentation and
will assist MediciNova in preparation of submissions to Regulatory Authorities
designated by MediciNova in support of MediciNova’s regulatory submissions in
the Territory. All regulatory submission preparation currently to be performed
by Hospira for MediciNova is specified in Exhibit 2.1.

 

-6-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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4.2 Review. Hospira shall have the right to review and consult on those specific
portions of MediciNova’s proposed regulatory submissions directly relating to
Hospira’s packaging or manufacturing procedures before the submissions are filed
with appropriate Regulatory Authorities. Hospira shall complete its review of
the submissions within sixty (60) days for submissions in English, or within
ninety (90) days for submissions not in English, after receipt of a proposed
regulatory submission. Hospira shall consult with and advise MediciNova in
responding to questions from Regulatory Authorities regarding MediciNova’s
submission(s) for the Products, as well as provide all reasonable assistance
requested by MediciNova in connection with the writing, filing, prosecution and
maintenance of its regulatory filings. MediciNova shall be the sole owner of any
regulatory submission filed pursuant to this Agreement. MediciNova shall provide
to Hospira for its files a final copy of those specific portions of MediciNova’s
proposed regulatory submissions directly relating to Hospira’s development work,
manufacturing procedures or other activities under this Agreement of any such
regulatory submission(s).

4.3 Expansion of the Territory/International Filings. In the event that
MediciNova decides to pursue the expansion of the Territory beyond [***],
Hospira shall fully cooperate with all relevant support that it can reasonably
provide for such expansion including, without limitation, regulatory support for
filings, packaging and product development, labeling, and inspections.
MediciNova agrees that all such activities will be paid for by MediciNova at
rates to be agreed by the Parties, which rates shall reasonably reflect pricing
charged to its other customers for similar services. [***]. MediciNova shall own
and be fully responsible for all regulatory filings for countries for any such
expanded Territory, provided that if Hospira believes that it or its customers
might realize some strategic or commercial benefit or advantage from such
filings, the Parties may agree in writing that Hospira will defray a portion of
the costs for the expansion of the Territory.

4.4 Access to Drug Master Files. Hospira hereby grants MediciNova reference
rights to all Drug Master Files (“DMFs”) necessary to support MediciNova’s
applications for marketing authorizations of the Products. To effect this,
Hospira shall execute all documentation helpful or required for reference
(“Letters of Authorization”) which shall be delivered to the appropriate
Regulatory Authorities permitting such Regulatory Authorities to reference
Hospira’s DMFs in their review of MediciNova’s Product marketing applications.
Hospira shall send copies of such Authorization Letters to MediciNova. Hospira
shall update its DMFs annually and shall inform MediciNova prior to any
modifications thereto in order to permit MediciNova to amend or supplement any
affected regulatory applications and filings for the Products.

4.5 User Fees. MediciNova shall pay any FDA (or foreign equivalent, if
applicable) user fees which may become payable for the Products.

 

-7-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Article 5     MANUFACTURE AND SUPPLY OF PRODUCTS

5.1 Purchase and Sale of Products. Pursuant to the terms and conditions of this
Agreement and for the duration of this Agreement, Hospira shall manufacture,
sell and deliver to MediciNova its total worldwide requirements for the Products
and MediciNova shall purchase and take delivery of its total worldwide
requirements of Products exclusively from Hospira.

5.2 Obligation to Manufacture. Hospira guarantees to MediciNova that for [***]
from the Effective Date (the “Guarantee Period”) it will supply to MediciNova
Product using the ADD-Vantage® Drug Delivery System (whether as Vial Product or
Kits) and it will not cease production of the Product utilizing the ADD-Vantage®
Drug Delivery System during the Guarantee Period. [***].

5.3 New ADD-Vantage® Drug Delivery System.

(a) Subject to Hospira’s obligation to manufacture Product for the Guarantee
Period, which shall not be altered in any way by this Section 5.3, if during the
term of this Agreement, Hospira develops and commercializes a New ADD-Vantage®
Drug Delivery System and desires to discontinue manufacture of the Products as
part of an overall determination to discontinue manufacturing of the
ADD-Vantage® Drug Delivery System, Hospira agrees to give MediciNova no less
than [***] written notice prior to such determination. In connection therewith,
Hospira grants to MediciNova [***].

(b) If (i) [***]; (ii) [***]; or (iii) [***], then MediciNova shall have, at its
option, the right to terminate this Agreement upon [***] written notice to
Hospira or to have Hospira continue to manufacture the Products for MediciNova
for so long as Hospira continues to manufacture the ADD-Vantage® Drug Delivery
System.

5.4 Government Approvals. Notwithstanding any other provision of this Agreement,
Hospira shall have no obligation to manufacture, sell or deliver Products to
MediciNova and MediciNova shall have no obligation to purchase and take delivery
of the Products for commercial sale in a specific country until MediciNova has
obtained all necessary Regulatory Authorities’ approvals required to sell the
Products in such country. However, Hospira agrees to manufacture and supply
those quantities of the Products requested in Purchase Orders by MediciNova that
are helpful or reasonably necessary for development of each Product and to build
MediciNova’s inventory in anticipation of commercial launch of the Products and
[***].

 

-8-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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5.5 API.

(a) Supply. Hospira shall manufacture the Products for MediciNova from API that
MediciNova shall supply to Hospira at no cost, unless Hospira is responsible for
the supply of replacement API (whether in bulk or Product form) in accordance
with Section 5.5(e) below. MediciNova shall supply API to Hospira in quantities
sufficient to satisfy Hospira’s gross manufacturing requirements of the Products
on a schedule agreed by the parties. At no time will MediciNova be required to
provide Hospira more than [***]. Hospira shall use the API received from
MediciNova only for the development work contemplated by this Agreement and the
manufacture of the Products for MediciNova. MediciNova shall deliver the API
[***] to Hospira’s manufacturing facility, pursuant to no-cost purchase orders
that Hospira issues to MediciNova. Within thirty (30) days of Hospira’s receipt
of any API supplied by MediciNova hereunder, Hospira shall: (i) perform an
identification test on the API and confirm the shipment quantity; and
(ii) notify MediciNova of any inaccuracies with respect to quantity or of any
claim that any portion of the shipment fails the identification test. In the
event Hospira notifies MediciNova of any deficiency in the quantity of API
received, [***]. In the event Hospira notifies MediciNova that the API shipment
does not conform to the API Specifications, MediciNova shall have the right to
confirm such findings at Hospira’s manufacturing location or a sample will be
sent to MediciNova for testing if requested by MediciNova. If MediciNova
determines that such shipment of API conformed to the API Specifications, the
parties shall submit samples of such shipment to a mutually acceptable
independent laboratory for testing. If such independent laboratory determines
that the shipment conformed to the API Specifications, Hospira shall bear all
expenses of shipping and testing such shipment samples. If MediciNova or such
independent laboratory confirms that such shipment did not meet the API
Specifications, MediciNova shall replace, at no cost to Hospira, the portion of
the API shipment which does not conform to the API Specifications and bear all
expenses of shipping and testing the shipment samples.

(b) API Title. MediciNova shall retain title to the API at all times. Subject to
the limitation in Section 5.5(e), risk of loss or damage to the API shall remain
with Hospira while the API is in its control; provided, however, that all
quantities of API have been properly shipped to Hospira and that MediciNova has
fully disclosed to Hospira all conditions reasonably necessary for the safe
handling, storage, use and disposal of the API.

(c) Specified Uses. Hospira agrees that the API shall: (i) only be used as
specified in writing by MediciNova and not for any other purpose; (ii) only be
made accessible to those employees of Hospira who need access in order to carry
out the manufacturing of the Products; (iii) be used in compliance at all times
with all Applicable Laws; (iv) be carefully secured and not be transferred to
any Affiliate or third party without the explicit prior written consent of
MediciNova; (v) not be reverse engineered; and (vi) not be subjected to testing
procedures, except as specified in this Agreement or otherwise agreed in writing
by the parties.

 

-9-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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(d) Records. Hospira shall maintain detailed records of the location and use of
the API while it is in its possession and shall provide MediciNova a reasonable
accounting of the same upon request.

(e) Replacement. In the event of any loss or damage of any API delivered
hereunder or the failure of the Products to meet Product Specifications,
MediciNova shall supply to Hospira at no cost replacement API according to the
terms set forth in Section 5.5(a), [***].

5.6 Dedicated Equipment Costs. If non-standard, specialized equipment
(including, but not limited to specialized equipment to manufacture Products) is
required to manufacture the Products for MediciNova, Hospira shall pay the cost
of such equipment subject to MediciNova’s prior approval of such costs. Hospira
shall advise MediciNova of specialized equipment that is unique to and required
for the Project and the manufacture of the Products and the estimated costs
associated with the purchase, installation and validation of such equipment.
After MediciNova approves such costs, Hospira shall install and validate the
equipment and bill MediciNova for the associated costs. MediciNova shall make
payment to Hospira no later than thirty (30) days after MediciNova receives an
invoice from Hospira. Title to the equipment shall be in MediciNova’s name. All
such equipment paid for by MediciNova shall be owned solely by MediciNova;
provided, however, that such equipment shall remain at Hospira’s [***] facility
(or such other Hospira facility mutually agreed to by the parties) and shall be
available for Hospira’s use solely in connection with the manufacture of
Products for MediciNova. Hospira shall not use such equipment for any other
purpose, shall not transfer such equipment to any third party or other location,
shall not purport to convey or grant to any third party an interest in such
equipment and shall not take any action inconsistent with MediciNova’s ownership
of such equipment. During the term of this Agreement, Hospira shall be
responsible for maintaining, servicing and insuring such equipment to the same
extent and in the same manner as Hospira maintains services and insures its own
equipment. Hospira shall maintain appropriate records regarding the use,
maintenance and service of such equipment. If Hospira wishes to use the
specialized equipment for manufacture of products other than the Products for
MediciNova, Hospira shall promptly notify MediciNova, and Hospira and MediciNova
shall meet and discuss the technical and practical ramifications of such use and
appropriate compensation to MediciNova, provided MediciNova may withhold its
consent for such use in its sole discretion.

5.7 Product Labeling. Hospira shall label the Products in accordance with label
copy that MediciNova provides. Such copy may be modified from time to time by
MediciNova. MediciNova shall reimburse Hospira for Hospira’s actual costs of
making any label copy changes and for the reasonable agreed cost of any labeling
that Hospira is unable to use due to such label copy changes.

 

-10-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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5.8 Off-Site Waste. If necessary, Hospira shall hire, direct and pay all
reasonable agreed costs for a waste contractor to remove all Waste from
Hospira’s manufacturing facility for the Products consistent with the Products’
Material Safety Data Sheets (“MSDS”). The reasonable, agreed costs associated
with the removal of Specially Regulated Waste shall be borne by MediciNova.
Hospira shall only dispose of Specially Regulated Waste at sites and through
waste management vendors that have been approved in writing by MediciNova, whose
approval shall not be withheld unreasonably. Hospira shall document the
destruction of any Specially Regulated Waste in writing and provide copies of
such written documentation to an authorized representative of MediciNova.
MediciNova maintains the right, but not the obligation, to witness the actual
disposal of Specially Regulated Waste. MediciNova shall, upon request by
Hospira, provide the MSDS for the API and the MSDS for the Products to Hospira.
All other costs for waste disposal shall be Hospira’s.

5.9 Delivery. Hospira shall deliver the Products to MediciNova, [***]. Risk of
loss over the Products shall pass to MediciNova at the time when they are made
available to MediciNova’s designated carrier at Hospira’s facility loading dock.
Shipment shall be via a carrier designated by MediciNova. For shipments to
destinations outside the United States, MediciNova shall be the exporter of
record. [***].

5.10 Price and Payment.

(a) Price. Hospira shall invoice MediciNova for the Products delivered by
Hospira at the prices set forth on Exhibit 5.8. Prices are firm through [***].
Beginning [***] and on each succeeding [***] during the term hereof, prices may
be increased by Hospira. Price increases shall be effective for deliveries
beginning [***] of each calendar year. Such increases shall not exceed the
lesser of (i) [***]; and (ii) [***].

(b) Payment. Hospira shall invoice MediciNova upon shipment of the Products
following release by Hospira’s Quality Assurance department in accordance with
the Quality Agreement. MediciNova shall make payment net thirty (30) days from
the date of receipt of Hospira’s invoice.

(c) Taxes. Any federal, state, county or municipal sales or use tax, excise,
customs charges, duties or similar charge, or any other tax assessment (other
than that assessed against income), license, fee or other charge lawfully
assessed or charged on the purchase by MediciNova of the Products sold pursuant
to this Agreement shall be paid by MediciNova.

(d) Process Rework. Process rework created as a result of MediciNova’s changes
shall be billed separately at a reasonable fee mutually agreed upon in writing.
Reprocess work required as a result of Hospira’s acts or omissions shall be
without charge, upon the request of MediciNova.

 

-11-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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(e) Sub-lots. Should MediciNova desire Hospira to split a manufacturing lot of
the Products into several sub-lots during packaging, there will be a split fee
of [***].

(f) Storage Fee. A storage fee shall be due and payable to Hospira if MediciNova
stores Product at Hospira’s plant for more than two (2) weeks after Product’s
final release; provided, that such release is made in accordance with
MediciNova’s requested delivery dates for the Products. The fee shall be [***].

(g) Acceptance of Products/Replacement of Nonconforming Shipment. MediciNova
shall have a period of [***] from the date of its receipt of a shipment of the
Products to inspect and reject such shipment for nonconformance with the Product
Specifications. If MediciNova rejects such shipment, it shall promptly so notify
Hospira and provide to Hospira samples of such shipment for testing. If Hospira
tests such shipment and determines that it did conform to the Product
Specifications, the parties shall submit samples of such shipment to a mutually
acceptable independent laboratory for testing. If such independent laboratory
determines that the shipment conformed to the Product Specifications, MediciNova
shall bear all expenses of shipping and testing such shipment samples. If
Hospira or such independent laboratory confirms that such shipment did not meet
the Product Specifications, Hospira shall replace, at no cost to MediciNova,
that portion of a Product shipment which does not conform to the Product
Specifications, and shall bear all expenses of shipping and testing the shipment
samples. Any nonconforming portion of any shipment shall be destroyed as
directed by Hospira, at Hospira’s expense. Any Products that MediciNova does not
reject pursuant to this Section 5.10(g) shall be deemed accepted with respect to
meeting Product Specifications, and all claims with respect to the Products not
conforming with the Product Specifications shall be deemed waived by MediciNova,
except as to latent defects which are not reasonably discoverable. MediciNova
shall not be required to pay Hospira for any Product which has been finally
rejected pursuant to this Section 5.10(g). Hospira shall replace all finally
rejected Product at no additional cost to MediciNova as soon as reasonably
possible after receipt of test results confirming nonconformance with the
Product Specifications.

Article 6     ORDERS AND FORECASTS

6.1 [***] Product Supply Forecast. For the sake of clarity, the provisions of
this Article 6 apply only to commercial Products and not to Products to be used
in clinical trials. For capacity planning purposes, [***] prior to Product
Launch, MediciNova shall provide Hospira with a written forecast of MediciNova’s
total annual requirements of the Products for [***]. Thereafter, by [***] of
each calendar year, MediciNova shall update such rolling [***] forecast of its
requirements of the Products for the period commencing on [***]. Hospira shall
provide a written confirmation of its receipt of the forecast and will allocate
its annual capacity to manufacture the Products for MediciNova. Such forecast
shall constitute Hospira’s Product supply commitment (“Product Supply
Commitment”) for each of the calendar years covered by the forecast.

 

-12-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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6.2 First Year Estimate. MediciNova shall, within [***] after submitting its NDA
application for regulatory approval of Product, provide Hospira with a written
estimate of MediciNova’s [***] requirements of the Products to be supplied by
Hospira for the first Commercialization Year. Hospira acknowledges that such
quantities are estimates only and are nonbinding.

6.3 First Order. Hospira and MediciNova shall cooperate fully in estimating and
scheduling production for the first commercial order of Products to be placed by
MediciNova with Hospira in anticipation of regulatory approval of the Products.

6.4 First Firm Order. MediciNova shall place its first firm order approximately
[***] in advance of the anticipated Product regulatory approval date or desired
Product availability date. At the same time, MediciNova shall provide to Hospira
MediciNova’s estimate of its monthly requirements of the Products to be supplied
by Hospira for the next succeeding [***].

6.5 Rolling Forecast. Thereafter, MediciNova shall provide quarterly to Hospira
a rolling [***] forecast of requirements of the Products to be supplied by
Hospira. The first [***] of such forecast shall constitute a binding commitment
upon MediciNova to purchase such quantities and MediciNova shall issue,
concurrently with such forecast, Purchase Orders for the [***] of that forecast
which were not included in the firm order period of the previous forecast (“Firm
Purchase Orders”). The remaining [***] of such forecast shall consist of
MediciNova’s reasonable best estimate projection of its Product requirements for
that period.

6.6 Purchase Orders.

(a) MediciNova shall submit each Purchase Order to Hospira at least [***] prior
to the requested delivery date of the Products. Cumulative Purchase Orders with
respect to any Firm Purchase Order period shall be not less than the amount of
the Firm Purchase Order.

(b) Each Purchase Order or any acknowledgment thereof, whether printed, stamped,
typed, or written shall be governed by the terms of this Agreement and none of
the provisions of such purchase order or acknowledgment shall be applicable
except those specifying Product and quantity ordered, delivery dates, special
shipping instructions and invoice information.

(c) At all times during the term of this Agreement, Hospira shall use its
commercially reasonable efforts to meet the delivery dates set forth in each
Purchase Order. In the event that Hospira believes it may miss a delivery date
in a purchase order submitted by MediciNova, Hospira shall promptly give
MediciNova written notice of the same specifying in detail the reasons for the
late delivery. In such case, Hospira may deliver Products up to fifteen
(15) days following the specified delivery date.

 

-13-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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6.7 Purchase Order Acceptance. As soon as practicable but no later than thirty
(30) days after receipt of MediciNova’s Purchase Orders issued in accordance
with Section 6.6, Hospira shall confirm to MediciNova its acceptance of the
purchase order, delivery date and quantity of Product ordered by MediciNova.
Notwithstanding anything to the contrary herein, Hospira may reject a Purchase
Order only if it: (a) calls for the delivery of Product for which sufficient
quantities of API have not been delivered or will not be delivered by MediciNova
or its designee in accordance with Section 5.5(a) or such shorter time as
otherwise reasonably required for manufacture; or (b) sets forth a delivery
schedule that is inconsistent with Section 6.6(a).

6.8 Minimum Purchase Requirement. Beginning at the first Commercialization Year,
MediciNova covenants to purchase from Hospira not less than [***] (the “Minimum
Purchase Requirement”). [***].

6.9 Obligation to Supply Additional Product. Hospira shall be obligated to
supply MediciNova up to [***] more Product than previously forecasted or ordered
in Purchase Orders. Hospira shall not be obligated to supply additional
quantities over and above the [***] excess; provided, however, that Hospira
shall, until MediciNova’s orders in the aggregate reach the applicable annual
Product Supply Commitment, use reasonable commercial efforts to produce and
deliver to MediciNova said additional quantities above the [***] within [***] of
issuance of the Purchase Orders for such additional quantities.

6.10 Firm Commercial Order Changes or Cancellations.

(a) If MediciNova requests changes to Purchase Orders of Products within the
Purchase Order timeframe, Hospira shall attempt to accommodate the changes
within reasonable manufacturing capabilities and efficiencies. If Hospira can
accommodate such change, Hospira shall advise MediciNova of the costs associated
with making any such change and MediciNova shall be deemed to have accepted the
obligation to pay Hospira for such costs if MediciNova indicates in writing to
Hospira that Hospira should proceed to make the change. If Hospira cannot
accommodate such change, MediciNova shall be bound to the original Purchase
Order.

(b) If MediciNova cancels a Firm Purchase Order, [***].

(c) If MediciNova does not supply sufficient API to manufacture such order,
other than as a result of API loss due to the negligence, willful misconduct or
breach of Hospira, [***]. Notwithstanding anything to the contrary contained
herein, all Products paid for by MediciNova shall count toward the Minimum
Purchase Requirement of the Products, including, without limitation, any
payments made in the event of a cancellation.

 

-14-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Article 7     QUALITY

7.1 Quality Control. Hospira shall apply its quality control procedures and
in-plant quality control checks on the manufacture of the Products for
MediciNova in the same manner as Hospira applies such procedures and checks to
products bearing like qualities to the drug manufactured for sale by Hospira. In
addition, Hospira will test and release the Products in accordance with the test
methods described in Exhibit 7.1 to ensure that the Products conform to the
Product Specifications. The parties may change the test methods from time to
time by mutual agreement. Hospira shall provide for each lot of Product
purchased pursuant to this Agreement a certificate of manufacturing compliance
which will certify that the lot of Product was manufactured in accordance with
the Product Specifications and cGMPs, as the same may be amended from time to
time.

7.2 Quality Agreement. The parties shall enter into a quality agreement
substantially in the form of the agreement attached hereto as Exhibit 7.2 within
one-hundred and twenty (120) days following the Effective Date.

7.3 Audit Rights.

(a) MediciNova shall have the right, upon sixty (60) days prior written notice
to Hospira, to conduct, at its expense and during normal business hours, a
quality assurance audit and inspection of Hospira’s records and production
facilities relating to the manufacturing, assembly and/or packaging of the
Products. Except as provided in Section 7.3(b), such audits shall, assuming the
full cooperation of Hospira, (a) be limited to not more than two (2) auditors
appointed or representing MediciNova, (b) last for not more than two (2) days
per facility and (c) may be conducted not more than one (1) time per calendar
year. If MediciNova wishes to perform not-for-cause audits more often than once
per year or over a period in excess of two (2) days, MediciNova shall pay
Hospira [***]. Any auditors that are not employees of MediciNova shall be
required to enter into confidentiality agreements with Hospira and MediciNova
containing terms of confidentiality at least as stringent as those set forth in
Article 11 hereof.

(b) MediciNova shall have the right to conduct additional audits in response to
incidents/deviations associated with the manufacture/testing of the Products,
given that a reasonable advanced notice is provided to Hospira. Visits by
MediciNova to Hospira production facilities may involve the transfer of
Confidential Information, and any such Confidential Information shall be subject
to the terms of Article 11 hereof. The results of such audits and inspections
shall be considered Confidential Information under Article 11 and shall not be
disclosed to Third Parties, including, but not limited to, the FDA, unless
required by law and only then upon prior written notice to Hospira, to the
extent practicable.

 

-15-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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

Hospira also agrees to allow the FDA or other relevant Regulatory Authorities to
conduct any audit which the FDA or other relevant Regulatory Authorities
require, and Hospira agrees to reasonably cooperate with the FDA and other
Regulatory Authorities in connection with any such audit. In the event that any
audit or inspection reveals that Hospira failed to meet cGMPs or the Product
Specifications, Hospira will be responsible, at Hospira’s expense, for:
(a) conducting an investigation to define the probable causes for the failure;
(b) providing an acceptable cGMP investigation report to MediciNova for review;
and (c) achieving compliance with cGMPs and the Product Specifications.

7.4 Notification of Inspection. In the event the FDA or other Regulatory
Authority notifies Hospira that it intends to visit or inspect its facilities
relating to the manufacture of Product or storage of API, the following shall
apply: (a) Hospira shall immediately provide notice of such visit or inspection
to MediciNova; (b) Hospira shall permit a representative of MediciNova to be
present at the facility during such visit or inspection; (c) Hospira shall
permit such representative of MediciNova to be present at, and participate in,
each daily wrap up session for such inspection and the post-inspection wrap up
session for such inspection; (d) Hospira promptly shall provide MediciNova with
copies of all written materials, including, without limitation, copies of any
Notice of Inspection (FDA Form 482), other notice of inspection, notice of
violation, other similar notice or Inspectional Observations (FDA Form 483)
received by Hospira relating to such inspection; and (e) Hospira shall provide
MediciNova with advance copies of all proposed responses to any such
inspections, notices or actions, shall permit MediciNova reasonable opportunity
to review and comment on each such response, shall reasonably consider
MediciNova’s reasonable comments thereon and shall provide MediciNova with
copies of each such response as submitted. In addition, Hospira shall advise
MediciNova immediately if an authorized agent of the FDA or other Regulatory
Authority visits any Hospira facilities relating to the manufacture of Product
or storage of API without prior notice. Hospira shall furnish to MediciNova the
report by such agency of any such visit within thirty (30) days of Hospira’s
receipt of such report.

7.5 Customer Representative in Plant.

(a) In addition to the audit rights stated in Section 7.3, MediciNova, at its
own expense, shall have the right to appoint a technician to be assigned to each
Hospira facility where any Product or component thereof is manufactured,
assembled or packaged (“Customer Representative in Plant”) at such times and for
such periods as, in the opinion of MediciNova, is necessary to monitor
compliance with this Agreement, or to coordinate and advise on the proper
manufacture of the Products by Hospira. While at the Hospira facility, the
Person in the Plant shall have access solely to such areas of the Hospira
facility in accordance with Hospira’s Customer Representative in Plant
guidelines that are: (i) reasonably related

 

-16-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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

to the manufacture of the Product; (ii) food- service areas; (iii) designated
office space as may be allocated to the Customer Representative in Plant by
Hospira; (iv) public areas within the facility; or (v) as otherwise authorized
by Hospira. The Customer Representative in Plant shall comply with all
applicable Hospira policies and procedures (including without limitation all
Hospira security policies and procedures and the Customer Representative in
Plant guidelines) as provided to MediciNova in writing. MediciNova hereby
represents that any and all of its employees visiting the Hospira facility shall
be bound by terms of confidentiality no less restrictive than those set forth in
Article 11. In accordance with Hospira’s Customer Representative in Plant
guidelines, any MediciNova Customer Representative in Plant must be escorted at
all times when in manufacturing areas of the Hospira facility.

(b) With respect to any Customer Representative in Plant, Hospira shall provide
at no cost to MediciNova: (i) an on-site office; (ii) a conference room (if
necessary for meetings), access to which shall be available per the scheduling
process used by Hospira employees; (iii) parking facilities and toilet
facilities; as well as (iv) reasonable access to and use of telephone, facsimile
and photocopying services necessary to perform any activities relating to the
manufacturing, storage and/or quality testing of the Product at each Hospira
facility.

7.6 Notification of Complaints. MediciNova shall notify Hospira promptly of any
Product complaints involving Hospira’s manufacture or packaging in sufficient
time to allow Hospira to evaluate the complaints and assist MediciNova in
responding to such complaints.

7.7 Product Recalls. In the event: (a) any Regulatory Authority or other
national government authority issues a request, directive or order that the
Products be recalled; (b) a court of competent jurisdiction orders such a recall
or withdrawal; or (c) MediciNova or Hospira reasonably determines that the
Products should be recalled or withdrawn, the parties shall take all appropriate
corrective actions, and shall cooperate in any governmental investigations
surrounding the recall. In the event that such recall results from the breach of
Hospira’s express warranties under this Agreement or its negligence or willful
misconduct, Hospira shall be responsible for promptly replacing the quantity of
Products that were recalled at no cost to MediciNova or reimbursing MediciNova
for the total cost of the Products that were recalled. In addition, Hospira
shall be responsible for [***]. To the extent that the recall does not result
from the breach of Hospira’s express warranties under this Agreement, or its
negligence or willful misconduct, MediciNova shall be responsible for the
expenses of the recall and Hospira will have no obligation to replace recalled
Products.

 

-17-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Article 8     WARRANTIES; COVENANTS AND INDEMNIFICATION

8.1 MediciNova’s Warranties.

(a) MediciNova represents and warrants to Hospira that all API delivered to
Hospira pursuant to this Agreement shall, at the time of delivery, not be
adulterated or misbranded within the meaning of the Federal Food, Drug and
Cosmetic Act, as amended, (the “Act”) or within the meaning of any applicable
state or municipal law in which the definitions of adulteration and misbranding
are substantially the same as those contained in the Act, as the Act and such
laws are constituted and effective at the time of delivery and will not be an
article which may not under the provisions of Sections 404 and 505 of the Act be
introduced into interstate commerce.

(b) MediciNova further warrants to Hospira that API supplied to Hospira
hereunder shall meet the API Specifications set forth on Exhibit 1.2.

(c) MediciNova further warrants that all specifications, including API
Specifications and Product Specifications, that MediciNova provides to Hospira
shall conform to the NDA or foreign equivalents that MediciNova files with the
appropriate Regulatory Authorities.

(d) MediciNova further represents and warrants to Hospira that MediciNova’s
performance of its obligations under this Agreement will not result in a
material violation or breach of any agreement, contract, commitment or
obligation to which MediciNova is a party or by which it is bound and will not
conflict with or constitute a default under its corporate charter or bylaws.

(e) MediciNova further represents and warrants that it will not sell the
Products into any jurisdiction for ultimate commercial use by end users in that
jurisdiction unless and until it receives the necessary Regulatory Authority
approvals for such sale.

8.2 Hospira’s Warranties and Covenants.

(a) Hospira represents and warrants to MediciNova that the Products Hospira
delivers to MediciNova pursuant to this Agreement shall: (i) at the time of
delivery, not be adulterated or misbranded within the meaning of the Act or
within the meaning of any applicable state or municipal law in which the
definitions of adulteration and misbranding are substantially the same as those
contained in the Act, as the Act and such laws are constituted and effective at
the time of delivery; (ii) will be an article which may under the provisions of
Sections 404 and 505 of the Act be introduced into interstate commerce; and
(iii) for Vial Products, have at the date of delivery an expiry date of not less
than [***], assuming [***] of total shelf life, and [***] assuming [***] of
total shelf life; and (iv) for Kits, have at the date of delivery an expiry date
of not less than [***], assuming [***] of total shelf life for the ADD-Vantage
diluent container.

 

-18-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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(b) Hospira further represents and warrants to MediciNova that the Products
Hospira delivers to MediciNova pursuant to this Agreement shall, at the time of
delivery, be free from defects in material and workmanship and shall have been
manufactured: (i) in accordance and conformity with the Product Specifications;
and (ii) in compliance with all Applicable Law.

(c) Hospira further represents and warrants to MediciNova that Hospira’s
performance of its obligations under this Agreement will not result in a
material violation or breach of any agreement, contract, commitment or
obligation to which Hospira or its Affiliates is a party or by which it is bound
and will not conflict with or constitute a default under its Certificate of
Incorporation or corporate bylaws. Hospira shall obtain and maintain all
licenses and permits useful or necessary in order to meet its obligations
hereunder.

(d) The foregoing warranties shall not extend to any nonconformity or defect to
the extent that such nonconformity or defect relates to or is caused by API as
supplied by MediciNova to Hospira.

(e) Hospira further represents and warrants that it shall perform all
obligations hereunder in compliance with all Applicable Laws, Hospira’s standard
operating procedures, and consistently high standards of workmanship and
professionalism. With respect to Product delivered hereunder, Hospira has, and
shall have, all the rights necessary to manufacture and sell as part of the
Product the ADD-Vantage® Drug Delivery System components.

(f) EXCEPT AS SET FORTH IN THIS AGREEMENT, HOSPIRA MAKES NO OTHER WARRANTIES,
EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS. ALL OTHER WARRANTIES,
INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY HOSPIRA, PROVIDED THE
FOREGOING IN NO WAY LESSENS THE FORCE, COVERAGE OR EFFECT OF ANY WARRANTY SET
FORTH IN THIS AGREEMENT.

8.3 Mutual Warranties – Debarment. Each party hereby certifies it does not and
shall not employ, contract with or retain any person directly or indirectly to
perform any of its obligations relating to this Agreement if such person is
debarred under 21 U.S.C. 335a (a) or (b) or other equivalent laws, rules,
regulations or standards of any other jurisdiction. Upon written request of a
party, the other party shall, within ten (10) business days, provide written
confirmation that it has complied with the foregoing obligation. Each party
agrees to promptly disclose in writing to the other party if any employee or
agent is debarred, or if any action or investigation is pending or, to the best
of its knowledge, threatened, relating to the debarment of it or any person
performing services related to this Agreement.

 

-19-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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8.4 Indemnification by Hospira. Hospira shall indemnify, defend and hold
harmless MediciNova, its Affiliates, officers, directors and employees from and
against all claims, causes of action, suits, costs and expenses (including
reasonable attorney’s fees), losses or liabilities of any kind related to this
Agreement and asserted by third parties to the extent such claims arise out of
or are attributable to: (a) Hospira’s breach of this Agreement; (b) the
ADD-Vantage® Drug Delivery System; (c) any violation of any proprietary right of
any Third Party relating to Hospira’s manufacturing processes or the
ADD-Vantage® Drug Delivery System; or (d) any negligent or wrongful act or
omission on the part of Hospira, its employees, agents or representatives or any
latent defect in the Products to the extent attributable to Hospira.

8.5 Indemnification by MediciNova. MediciNova shall indemnify, defend and hold
harmless Hospira, its Affiliates, officers, directors and employees from and
against all claims, causes of action, suits, costs and expenses (including
reasonable attorney’s fees), losses or liabilities of any kind related to this
Agreement and asserted by third parties to the extent such claims arise out of
or are attributable to: (a) MediciNova’s breach of this Agreement; (b) any
violation of any proprietary right of any Third Party relating to the API
Specifications or the composition of API; (c) the use of or lack of safety or
efficacy of the API as supplied by MediciNova; or (d) any negligent or wrongful
act or omission on the part of MediciNova, its employees, agents or
representatives.

8.6 Conditions of Indemnification. If either party seeks indemnification from
the other hereunder, it shall promptly give notice to the other party of any
such claim or suit threatened, made or filed against it which forms the basis
for such claim of indemnification and shall cooperate fully with the other party
in the investigation and defense of all such claims or suits. The indemnifying
party shall have the option to assume the other party’s defense in any such
claim or suit with counsel reasonably satisfactory to the other party. No
settlement or compromise shall be binding on a party hereto without its prior
written consent, such consent not to be unreasonably withheld.

8.7 No Consequential Damages. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES
RESULTING FROM ANY BREACH OF THIS AGREEMENT EVEN IF THE PARTY HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES, PROVIDED THE FOREGOING SHALL NOT APPLY TO
LOSSES RELATED TO THIRD PARTY CLAIMS; BREACHES OR ARTICLES 9 OR 11; OR WILLFUL
MISCONDUCT, GROSS NEGLIGENCE OR FRAUD.

 

-20-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Article 9     INTELLECTUAL PROPERTY RIGHTS

9.1 Grant License. Hospira hereby grants to MediciNova an exclusive license
under the Hospira IP and the Hospira marks to test, have tested, develop, have
developed, market, have marketed, promote, have promoted, sell, have sold, use,
and have used the Products supplied by Hospira to MediciNova in accordance with
this Agreement. MediciNova shall not use any Hospira IP and the Hospira marks,
except as authorized by Hospira hereunder.

9.2 Project Inventions. Except as provided in Section 9.1, Hospira has granted
no license, express or implied, to MediciNova to use the Hospira IP or other
patents, know-how, trade secrets, proprietary information or other intellectual
property rights that are proprietary to Hospira. With respect to any inventions,
Improvements, or Technology developed or conceived by Hospira pursuant to or in
connection with this Agreement (“Project IP”), (i) MediciNova is hereby the sole
and exclusive owner of [***] (“MNOV Project IP”) and (ii) Hospira shall be the
owner of [***] (“Hospira Project IP”). Ownership of all other Project IP shall
be determined by U.S. law (“Other Project IP”). Hospira hereby grants to
MediciNova a world-wide, royalty-free nonexclusive license to (i) the Hospira
Project IP for use with API and (ii) the Other Project IP for any purpose.
Hospira shall assign, and does hereby assign, to MediciNova all of its right,
title and interest in and to such MNOV Project IP. Hospira agrees to execute
such documents and take such actions as MediciNova may from time to time
reasonably request to effect the foregoing assignment. However, MediciNova shall
grant to Hospira, and does hereby grant to Hospira an exclusive, perpetual,
fully paid, worldwide royalty-free license, with the right to sublicense to
Affiliates and Third Parties under the MNOV Project IP and the MediciNova IP for
the purpose of the manufacture of the Products exclusively for MediciNova,
provided all such Affiliates and Third Parties shall be approved by MediciNova
in writing.

9.3 MediciNova’s Proprietary Rights. Except as set forth in the final sentence
of Section 9.2, MediciNova has granted no license, express or implied, to
Hospira to use MediciNova’s IP, proprietary know-how or other proprietary
rights. All MediciNova IP transferred to Hospira hereunder and Project IP
developed hereunder shall be deemed to be the Confidential Information of
MediciNova and subject to the non-use and non-disclosure obligations described
in Article 11.

Article 10     TERM AND TERMINATION

10.1 Term. This Agreement shall commence on the Effective Date and, unless
earlier terminated as provided below, shall expire at the end of the tenth
(10th) Commercialization Year thereafter (the “Initial Term”). Unless otherwise
terminated in accordance with this Article 10, this Agreement shall be
automatically extended for additional terms of two (2) years each (each, a
“Renewal Term”) and may be terminated anytime after the Initial Term by either
party providing the other with at least twelve (12) months prior written notice
of termination.

 

-21-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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10.2 Termination of the Project. The parties may terminate the Project upon
written agreement, which written agreement shall not be unreasonably withheld
for a period of more than [***] from notice, if a party determines in good faith
that the development of the Products is not technically feasible despite each
party’s commercially reasonable efforts to develop Products for commercial sale.
If the Project is terminated, Hospira shall advise MediciNova of Hospira’s
actual development costs of the Project incurred prior to such termination.
MediciNova shall pay Hospira for all reasonable and documented development costs
incurred to the date the termination notice is received or the prorated
milestone that is applicable.

10.3 Failure to Obtain Regulatory Approval. Either party may terminate this
Agreement by giving to the other party two (2) months’ prior written notice if
the Product has not received regulatory approval for commercial sale by [***].

10.4 General Termination Rights. Either party may terminate this Agreement as
follows:

(a) immediately by providing written notice upon the bankruptcy or the
insolvency of the other party; or

(b) by giving to the other party sixty (60) days’ prior written notice upon the
breach of any warranty or any other material provision of this Agreement by the
other party if the breach is not cured within sixty (60) days after written
notice thereof to the party in default.

10.5 MediciNova Termination. MediciNova may terminate this Agreement by giving
Hospira [***] prior written notice if MediciNova decides to cease development or
commercialization of Product.

10.6 Hospira Termination. If in any [***] consecutive Commercialization Years
MediciNova (i) waives some or all of Hospira’s manufacturing and delivery
obligations and pays Hospira for Product instead of taking delivery of some or
all the Product constituting its relevant Minimum Purchase Requirement as
permitted in Section 6.8 hereof and (ii) the waiver covers Product equal to more
than [***] of MediciNova’s total Minimum Purchase Requirement for each of the
relevant [***] consecutive Commercialization Years, then Hospira may terminate
this Agreement upon [***] prior written notice to MediciNova.

 

-22-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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10.7 Accrued Payment Obligations. Termination of this Agreement shall not
relieve either Party of any liability which has accrued prior to the effective
date of such termination, nor prejudice either Party’s right to obtain
performance of any obligation provided for in this Agreement, which by its
express terms or context survives termination, provided that (i) with respect to
a termination pursuant to Section 10.3, MediciNova shall be obligated to
purchase all Product ordered pursuant to Firm Purchase Orders, assuming that
production of Product will be wound down promptly and ceased as soon as
reasonably practicable by Hospira, (ii) with respect to a termination by
MediciNova pursuant to Section 10.4, MediciNova shall not be obligated to
purchase any further Product, but may it may require Hospira to fill all
outstanding Firm Purchase Orders, as well as provide to MediciNova enough
Product to meet some or all of its Product Supply Commitment as such commitment
exists on the date of termination, (iii) with respect to a termination by
Hospira pursuant to Section 10.4, MediciNova shall be required to purchase all
outstanding Firm Purchase Orders, (iv) with respect to a termination by
MediciNova pursuant to Section 10.5, MediciNova shall be obligated to purchase
all Product ordered pursuant to Firm Purchase Orders, assuming that production
of Product will be wound down promptly and ceased as soon as reasonably
practicable by Hospira and (vi) with respect to a termination by Hospira
pursuant to Section 10.6, MediciNova shall be required to purchase all Product
ordered pursuant to Firm Purchase Orders, assuming that production of Product
will be wound down promptly and ceased as soon as reasonably practicable by
Hospira. Upon termination pursuant to this Article 10, unless termination is by
MediciNova pursuant to Section 10.4, MediciNova shall reimburse Hospira for
Hospira’s cost of all supplies purchased and on hand or on order, if such
supplies were ordered by Hospira based on Firm Purchase Orders or MediciNova’s
estimates of its requirements of the Products, and such supplies cannot be
reasonably used by Hospira for other purposes, provided reimbursement shall not
be for more than three (3) months of supplies specific to Products, or otherwise
cancelled at no cost by Hospira. Hospira shall invoice MediciNova for all
amounts due hereunder. Payment shall be made pursuant to Section 5.9.

10.8 Return of Inventory. In the event of any termination, Hospira shall return
any remaining inventory of API and Products to MediciNova at MediciNova’s
expense, unless such termination shall have been as a result of a breach of this
Agreement by Hospira, in which case such inventory shall be returned at
Hospira’s expense.

10.9 Return of Equipment. Upon expiry or termination of this Agreement, Hospira
will ship all dedicated equipment purchased by Hospira in accordance with
Section 5.6 to a location specified by MediciNova at MediciNova’s cost and
expense. In the event MediciNova does not wish to take possession of such
dedicated equipment, Hospira will dispose of such equipment.

10.10 Files and Records. Upon the expiration or termination of this Agreement,
Hospira shall promptly make available to MediciNova copies of all manufacturing
and batch records relating to the Product and shall store the originals or
electronic copies of such documents and records according to cGMPs in accordance
with Hospira’s internal quality procedures and Applicable Laws.

 

-23-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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10.11 Survival. Expiration or early termination of this Agreement shall not
relieve either party of any obligations that it may have incurred prior to
expiration or early termination and all covenants and agreements contained in
this Agreement, which by their terms or context are intended to survive, will
continue in full force and effect, including without limitation,
Sections 5.5(c), 7.3, 7.4, 7.6, 7.7, 8, 9, 10.7-10.11, 11, and 12 (to the extent
relevant).

Article 11     CONFIDENTIAL INFORMATION

11.1 Nondisclosure. It is contemplated that in the course of the performance of
this Agreement each party may, from time to time, disclose Confidential
Information to the other. Hospira agrees that, except as expressly provided
herein, it shall not disclose Confidential Information received from MediciNova,
and shall not use Confidential Information disclosed to it by MediciNova, for
any purpose other than to fulfill Hospira’s obligations hereunder. MediciNova
agrees that, except as expressly provided herein, it shall not disclose
Confidential Information received from Hospira, and shall not use Confidential
Information disclosed to it by Hospira, for any purpose other than to fulfill
MediciNova’s obligations hereunder. MediciNova shall have the right to share the
terms of this Agreement and this Agreement with its current and potential
collaborators, partners, and investors who are obligated to keep its terms
confidential.

11.2 Exceptions to Duty of Nondisclosure. Notwithstanding the above, nothing
contained in this Agreement shall preclude MediciNova from utilizing
Confidential Information as may be necessary in prosecuting patent rights
related to Product, obtaining governmental marketing approvals, or complying
with other governmental laws and regulations or court orders (provided that the
party disclosing such information uses reasonable efforts to seek confidential
treatment of such information. The obligations of the parties relating to
Confidential Information shall expire ten (10) years after the termination of
this Agreement. In addition, if either party, based on the advice of its
counsel, determines that this Agreement, or any of the other documents executed
in connection herewith, must be filed with the Securities and Exchange
Commission (“SEC”), then such party shall have the right to file this Agreement
(or such other documents) with the SEC, provided that such party notifies the
other party reasonably in advance of such filing and uses commercially
reasonable efforts to obtain confidential treatment of the material terms and
conditions of this Agreement (consistent with Applicable Law).

11.3 Return of Confidential Information. Upon termination of this Agreement, the
receiving party shall, if so requested by the disclosing party, promptly return
to the disclosing party the originals and all copies of any Confidential
Information (including all extracts, summaries and derivatives thereof) then in
the receiving party’s possession or under the receiving party’s control.
Notwithstanding the foregoing, the receiving party may retain one (1) copy of
such Confidential Information for legal archival purposes, provided that such
copy shall be kept confidential after the termination or expiration of this
Agreement.

 

-24-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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

11.4 Handling and Reconstruction of and Access to Confidential Information. Each
party will maintain the originals or electronic copies of all documents
containing disclosing party’s Confidential Information according to its own
internal quality procedures, cGMP and Applicable Laws. Accordingly, each party
will ensure that such procedures incorporate and maintain appropriate safety and
facility procedures, data security procedures and other safeguards against the
destruction, loss, or alteration of the disclosing party’s Confidential
Information in the possession of the receiving party, including procedures for
the recovery and reconstruction of lost Confidential Information. At no time
will the receiving party store or hold the disclosing party’s Confidential
Information in a form or manner not promptly accessible to the disclosing. Each
party agrees that it will not withhold from the other any Confidential
Information as a means of resolving a dispute.

11.5 Public Announcements. Neither party shall make any public announcement
concerning the transactions contemplated herein, or make any public statement
which includes the name of the other party or any of its Affiliates, or
otherwise use the name of the other party or any of its Affiliates in any public
statement or document without the prior written consent of the other party,
except as may be required by law, regulation, including SEC regulation, or
judicial order, in which case the party required to make the public announcement
or public statement shall use commercially reasonable efforts to obtain the
approval of the other party as to form, nature and extent of the public
announcement or public statement prior to issuing the same.

11.6 Injunctive Relief. In the event of a breach or threatened breach by a party
of any provision of this Article, the other Party shall be authorized and
entitled to obtain from any court of competent jurisdiction equitable relief,
whether preliminary or permanent, in addition to any other rights or remedies to
which such party may be entitled in law or equity.

Article 12     MISCELLANEOUS

12.1 Force Majeure and Failure of Suppliers.

(a) Excusable Delay. Any delay in the performance of any of the duties or
obligations of either party hereto (except the payment of money) shall not be
considered a breach of this Agreement and the time required for performance
shall be extended for a period equal to the period of such delay, provided that
such delay has been caused by or is the result of any acts of God, acts of a
public enemy or other terrorist acts, insurrections, riots, embargoes, labor
disputes, including strikes, lockouts, job actions, boycotts, fires, explosions,
floods, shortages of material or energy, or other unforeseeable causes beyond
the control and without the fault or negligence of the party so affected. The
effected party shall give prompt notice

 

-25-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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to the other party of such cause and a good faith estimate of the continuing
effect of the force majeure condition and duration of the affected party’s
nonperformance, and shall take promptly whatever reasonable steps are necessary
or appropriate to relieve the effect of such cause(s) as rapidly as possible.
Subject to the provisions of Section 12.1(b), if a force majeure prevents
Hospira from manufacturing Products ordered by MediciNova hereunder for more
than six (6) months, then MediciNova may terminate this Agreement immediately
without further obligation to Hospira.

(b) Transfer of Production. If Hospira becomes subject to a force majeure event
which prevents or substantially interferes with manufacture of the Products at
Hospira’s manufacturing facility, the parties shall mutually agree on
implementation of an agreed-upon action plan to transfer production of the
Products to another Hospira facility. The parties shall, after the execution of
this Agreement and at the request of either party, meet to discuss and define
such an action plan.

(c) Failure of Suppliers. The parties understand and agree that MediciNova will
approve in advance, which approval shall not be unreasonably withheld, the
suppliers chosen by Hospira to supply the excipient and (excepting the
components of the ADD-Vantage® Drug Delivery System) the primary container
packaging component. MediciNova shall have no liability to Hospira for such
suppliers nor shall MediciNova be deemed to be in breach of this Agreement if a
supplier is unable to supply excipients and components to Hospira. Hospira shall
be fully responsible for the timely and complete performance of all the
suppliers it utilizes in connection herewith.

 

-26-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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12.2 Notices. All notices hereunder shall be delivered as follows:
(a) personally; (b) by facsimile and confirmed by first class mail (postage
prepaid); (c) by registered or certified mail (postage prepaid); or (d) by
overnight courier service, to the following addresses of the respective parties:

 

If to MediciNova:    With a copy to:

4350 La Jolla Village Drive

Suite 950

San Diego, California 92122

Attention: Richard Gammans, Ph.D.

Telephone: (858) 622-9750

Facsimile: (858) 373-7000

  

Blaine Templeman

Sheppard, Mullin, Richter & Hampton LLP

30 Rockefeller Plaza, Suite 2400

New York, New York 10112

Telephone: (212) 332-3854

Facsimile: (212) 332-1204

If to Hospira:    With copy to:

Hospira, Inc.

275 North Field Drive

Lake Forest, Illinois 60045

Attn: Vice President & General Manager

Contract Manufacturing

Facsimile: (224) 212-3210

  

Hospira, Inc.

Attention: General Counsel

Building H1; Department NLEG

275 N. Field Drive

Lake Forest, Illinois 60045

Fax: (224) 212-2086

Notices shall be effective upon receipt if personally delivered or delivered by
facsimile and confirmed by first class mail, on the fifth business day following
the date of registered or certified mailing or on the first business day
following the date of or delivery to the overnight courier. A party may change
its address listed above by written notice to the other party.

12.3 Choice of Law/Venue/Jurisdiction. This Agreement shall be construed,
interpreted and governed by the laws of the State of New York, excluding its
choice of law provisions. The United Nations Convention on the International
Sale of Goods is hereby expressly excluded.

12.4 Collaborations. Notwithstanding anything to the contrary herein, Hospira
agrees that MediciNova shall have the right to enter into partnerships,
collaborations or alliances with third parties who may engage in joint (with
MediciNova) or unilateral development, marketing and promoting of Product (each,
a “Collaboration Development Partner”).

12.5 Assignment. Neither party shall assign this Agreement nor any part thereof
without the prior written consent of the other party; provided, however:
(a) either party may assign this Agreement to one of its wholly-owned
subsidiaries or its parent corporation without such consent; (b) either party,
without such consent, may assign this Agreement in connection with the transfer,
sale or divestiture of substantially all of its business to which this Agreement
pertains or in the event of its merger or consolidation with another company;
and (c) MediciNova may assign this Agreement to a Collaboration Development
Partner. Any permitted assignee shall assume all obligations of its assignor
under this Agreement. No assignment shall relieve any party of its
responsibility hereunder.

 

-27-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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12.6 Entire Agreement. This Agreement, together with the Exhibits referenced and
incorporated herein, constitute the entire agreement between the parties
concerning the subject matter hereof and supersede all written or oral prior
agreements or understandings with respect thereto. The LOI has expired as of the
Effective Date.

12.7 Severability. This Agreement is subject to the restrictions, limitations,
terms and conditions of all applicable governmental regulations, approvals and
clearances. If any term or provision of this Agreement shall for any reason be
held invalid, illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other term or provision
hereof, and this Agreement shall be interpreted and construed as if such term or
provision, to the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.

12.8 Waiver-Modification of Agreement. No waiver or modification of any of the
terms of this Agreement shall be valid unless in writing and signed by
authorized representatives of both parties. Failure by either party to enforce
any such rights under this Agreement shall not be construed as a waiver of such
rights, nor shall a waiver by either party in one or more instances be construed
as constituting a continuing waiver or as a waiver in other instances.

12.9 Hospira Insurance. Hospira will procure and maintain, at its own expense,
for the duration of the Agreement, and for five (5) years thereafter if written
on a claims made or occurrence reported form, the types of insurance specified
below with carriers rated A-:VII or better with A. M. Best or like rating
agencies:

(a) Workers’ Compensation accordance with applicable statutory requirements and
shall provide a waiver of subrogation in favor of MediciNova;

(b) Employer’s Liability with a limit of liability in an amount of not less than
[***];

(c) Commercial General Liability including premises operations, products &
completed operations, blanket contractual liability, personal injury and
advertising injury including fire legal liability for bodily injury and property
damage in an amount not less than [***] per occurrence and [***] in the
aggregate;

(d) Commercial Automobile Liability for owned, hired and non-owned motor
vehicles with a combined single limit in an amount not less than [***] each
occurrence;

 

-28-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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(e) Excess Liability including products liability with a combined single limit
in an amount of not less than [***] per occurrence and in the aggregate;

(f) Commercial Crime or Fidelity Bond in an amount of not less than [***] per
occurrence and in the aggregate.

Hospira shall include MediciNova as additional insured with respect to such
policies. Prior to commencement of services, and annually thereafter, Hospira
shall furnish to MediciNova certificates of insurance evidencing the insurance
coverages stated above and shall require at least thirty (30) days written
notice to MediciNova prior to any cancellation, non-renewal or material change
in said coverage. In the case of cancellation, non-renewal or material change in
said coverage, Hospira shall promptly provide to MediciNova a new certificate of
insurance evidencing that the coverage meets the requirements in this
Section 12.9. Hospira agrees that its insurance shall act as primary and
noncontributory from any other valid and collectible insurance maintained by the
other party. Hospira may, at its option, satisfy, in whole or in part, its
obligation under this Section 12.9 through its self-insurance program, provided
that Hospira has the financial wherewithal to support such self insurance.

12.10 MediciNova Insurance. MediciNova will procure and maintain, at its own
expense, for the duration of the Agreement, and for five (5) years thereafter if
written on a claim made or occurrence reported form, the types of insurance
specified below with carriers rated A- VII or better with A. M. Best or like
rating agencies:

(a) Workers’ Compensation accordance with applicable statutory requirements and
shall provide a waiver of subrogation in favor of Hospira;

(b) Employer’s Liability with a limit of liability in an amount of not less than
[***];

(c) Commercial General Liability including premises operations, product
liability, products & completed operations, personal injury and advertising
injury including fire legal liability for bodily injury and property damage:
(i) during the Product development stage, in an amount not less than [***] per
occurrence and not less than [***] in the aggregate; and (ii) during
commercialization of the Products in the Territory, in an amount not less than
[***] per occurrence and not less than [***] in the aggregate;

(d) Commercial Automobile Liability for owned, hired and non-owned motor
vehicles with a combined single limit in an amount not less than [***] each
occurrence;

(e) Commercial Crime or Fidelity Bond in an amount of not less than [***] per
occurrence and in the aggregate including an endorsement for third party
liability without the requirement of a conviction.

 

-29-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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(f) Property in Transit insurance in an amount not less than [***].

Hospira shall be an additional insured with respect to such policies. Prior to
commencement of services, and annually thereafter, MediciNova shall furnish
Hospira certificates of insurance evidencing the insurance coverages stated
above and shall require at least thirty (30) days written notice to Hospira
prior to any cancellation, non-renewal or material change in said coverage. In
the case of cancellation, non-renewal or material change in said coverage,
MediciNova shall promptly provide to Hospira a new certificate of insurance
evidencing that the coverage meets the requirements in this Section 12.10.
MediciNova agrees that its insurance shall act as primary and noncontributory
from any other valid and collectible insurance maintained by the other party.
MediciNova may, at its option, satisfy, in whole or in part, its obligation
under this Section 12.10 through its self-insurance program, provided that
MediciNova has the financial wherewithal to support such self insurance.

12.11 Exhibits. All Exhibits referred to herein are hereby incorporated by
reference.

12.12 Further Actions. The Parties shall duly execute and deliver, or cause to
be duly executed and delivered, such further instruments, and to do and cause to
be done such further acts, that may be necessary to carry out the provisions and
purposes of this Agreement, notwithstanding any expiration or termination of
this Agreement.

12.13 Subcontracting. Hospira shall not assign, subcontract or delegate any of
its rights or obligations under this Agreement without the express prior written
authorization of MediciNova. Hospira shall cause any such authorized
subcontractor to be subject by contract to the same restrictions, exceptions,
obligations, reports, termination provisions and other provisions contained in
this Agreement as are applicable to Hospira. Hospira shall remain primarily
obligated for all acts and omissions of any of its subcontractors as if Hospira
had performed the subcontracted obligations itself, and shall guarantee the
performance of the same.

12.14 Successors; Assigns. This Agreement shall be binding upon and inure to the
benefit of the Parties hereto and each of their respective successors and
permitted assigns.

12.15 Independent Contractor. This Agreement shall not be deemed to create any
partnership, joint venture, or agency relationship between the Parties. Each
Party shall act hereunder as an independent contractor, and its agents and
employees shall have no right or authority under this Agreement to assume or
create any obligation on behalf of, or in the name of, the other Party. All
persons employed by a Party shall be employees of such Party and not of the
other Party, and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.

 

-30-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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12.16 Counterparts. This Agreement may be executed by original or facsimile
signature in two (2) or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.

12.17 Headings. The headings used in this Agreement are for convenience only and
are not a part of this Agreement.

IN WITNESS WHEREOF, the parties intending to be bound by the terms and
conditions hereof have caused this Agreement to be signed by their duly
authorized representatives as of the date first above written.

 

HOSPIRA WORLDWIDE, INC.     MEDICINOVA, INC. By:   /s/ Anthony N. Cacich     By:
  /s/ Richard E. Gammons Name:   Anthony N. Cacich     Name:   Richard E.
Gammons Title:   Vice President & General Manager,     Title:   Chief
Development Officer   Contract Manufacturing      

 

-31-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 1.2

API Specifications

[***]

 

-32-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 1.19

Product Specifications

[***]

 

-33-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 2.1

Development Fees Structure

[***]

 

-34-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 3.1

Payment Schedule

[***]

 

-35-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 3.2

FTE Rates

Hospira shall use the following FTE Rates in calculating additional costs for
Change Orders and/or additional work:

[***]

 

-36-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 5.8

Product Prices

[***]

 

-37-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 7.1

Product Test Methods

The parties will adopt and implement appropriate Product testing and release
methods in accordance with the Quality Agreement to be attached to this
Agreement as Exhibit 7.2. Upon adoption and implementation, such testing and
release methods will be appended to this Exhibit 7.1 and will be made an
integral part of this Agreement.

 

-38-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.

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Exhibit 7.2

Form of Quality Agreement

[***]

 

-39-

 

Certain information in this exhibit, marked by brackets and asterisks [***], has
been omitted and will be filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. Confidential treatment has been requested with respect to the omitted
portions.