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CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT
HAVE BEEN REDACTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE
COMMISSION.
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Exhibit 10.1
DEVELOPMENT AND SUPPLY
AGREEMENT
T HIS D EVELOPMENT AND S UPPLY A GREEMENT (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” ).
W ITNESSETH :
W
HEREAS
, 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);
W HEREAS , MediciNova and Hospira desire that Hospira
assist MediciNova in the development and commercialization of
Products; and
W HEREAS , 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.
N OW ,
T HEREFORE
, 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
D EFINITIONS
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.
-1-
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;
-2-
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.
(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.
-3-
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.
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.
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
P RODUCT
D EVELOPMENT P ROJECT
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.
Article 3
P AYMENT FOR H OSPIRA ’ S D EVELOPMENT E FFORTS
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
M EDICI N OVA ’ S R EGULATORY S UBMISSIONS
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.
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.
Article 5
M ANUFACTURE AND S UPPLY OF P RODUCTS
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.
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.
(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.
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.
(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
O RDERS AND F ORECASTS
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.
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 specifyin