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DEVELOPMENT AND SUPPLY AGREEMENT

Supply Agreement

DEVELOPMENT AND SUPPLY AGREEMENT | Document Parties: MEDICINOVA INC | Hospira Worldwide, Inc You are currently viewing:
This Supply Agreement involves

MEDICINOVA INC | Hospira Worldwide, Inc

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Title: DEVELOPMENT AND SUPPLY AGREEMENT
Governing Law: New York     Date: 3/30/2009
Industry: Conglomerates     Law Firm: Sheppard Mullin     Sector: Conglomerates

DEVELOPMENT AND SUPPLY AGREEMENT, Parties: medicinova inc , hospira worldwide  inc
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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

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.

 

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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.


(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.


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.

 

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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.


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.

 

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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.


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 .

 

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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.


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.

 

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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.


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 [***].

 

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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.


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.

 

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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.


(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.

 

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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.


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.

 

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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.


(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.

 

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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.


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


 
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