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SUPPLY AGREEMENT

Supply Agreement

SUPPLY AGREEMENT | Document Parties: NOVAVAX INC | GRACEWAY PHARMACEUTICALS, LLC You are currently viewing:
This Supply Agreement involves

NOVAVAX INC | GRACEWAY PHARMACEUTICALS, LLC

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Title: SUPPLY AGREEMENT
Governing Law: New York     Date: 2/25/2008
Industry: Biotechnology and Drugs     Law Firm: McDermott Will;Cooley Godward     Sector: Healthcare

SUPPLY AGREEMENT, Parties: novavax inc , graceway pharmaceuticals  llc
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Exhibit 10.2
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
SUPPLY AGREEMENT
           THIS SUPPLY AGREEMENT (this “ Agreement ”) dated as of February 19, 2008, by and between NOVAVAX, INC., a Delaware corporation (“ Novavax ”), and GRACEWAY PHARMACEUTICALS, LLC, a Delaware limited liability company (“ Graceway ”). Novavax and Graceway may be referred to individually as a “Party” or collectively as the “Parties”.
           WHEREAS , Novavax has been engaged in the development, manufacture, and supply of the Product (as hereinafter defined);
           WHEREAS , on the date hereof, Graceway and Novavax have entered into an Asset Purchase Agreement (the “ Asset Purchase Agreement ”) for the acquisition by Graceway from Novavax of all rights of Novavax associated with the Product in the Territory; and
           WHEREAS , Graceway desires to have Novavax manufacture and supply, and Novavax desires to manufacture and supply to Graceway, the Product for sale by Graceway or its designees, subject to the conditions hereinafter set forth.
           NOW, THEREFORE, in consideration of the foregoing and of the representations, warranties, mutual covenants and agreements hereinafter set forth and intending to be legally bound hereby, the Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATIONS
          As used throughout this Agreement, each of the following terms shall have the respective meanings set forth below:
          “ Affiliate ” shall mean, with respect to any Person, any other Person that, (a) directly or indirectly is in control of, is controlled by, or is under common control with, the first Person, (b) is an officer, director, trustee, partner (general or limited), employee or holder of ten percent (10%) or more of any class of any voting or non-voting securities or other equity in the first Person, or (c) is an officer, director, trustee, partner (general or limited), employee or holder of ten percent (10%) or more of any class of the voting or non-voting securities or other equity in any Person which directly or indirectly is in control of, is controlled by, or is under common control with, the first Person. For purposes of this definition, “control” (including with correlative meanings “controlled by” and “under common control with”) shall mean possession, directly or indirectly, of either (i) ten percent (10%) or more of the voting power of the securities having ordinary voting power for the election of directors of the first Person, or (ii) the power to direct or cause the direction of the management or policies of the first Person (whether through ownership of securities, partnership interests or any other ownership or debt interests, by contract or otherwise).
          “ Agreement ” shall have the meaning set forth in the Preamble.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
          “ Allergan Agreement ” shall mean the Asset Purchase Agreement dated as of the date hereof among Graceway, Allergan USA, Inc. and Allergan, Inc.
          “ Asset Purchase Agreement ” shall have the meaning set forth in the Preamble.
          “ Bankruptcy Code ” shall have the meaning set forth in Section 7.02 .
          “ Bankruptcy Laws ” shall have the meaning set forth in Section 7.02 .
          “ cGMP ” shall mean good manufacturing practices according to 21 C.F.R. Parts 210 and 211.
          “ Catalent ” shall mean Catalent Pharma Solutions, Inc. as the contract manufacturer of the Product pursuant to the Catalent Agreement.
          “ Catalent Agreement ” shall mean the Facility Reservation Agreement dated February 8, 2002, between Novavax and Catalent, as renewed and amended by that certain letter agreement dated February 12, 2008 between Catalent and Novavax.
          “ Catalent Facility ” shall mean Catalent’s manufacturing facility for the Product located at 3001 Red Lion Road, Philadelphia, Pennsylvania 10014.
          “ Confidential Information ” shall have the meaning set forth in Section 13.01 .
          “ Damages ” shall have the meaning ascribed to such term in Section 16.01 .
          “ Delivery Schedule ” shall have the meaning set forth in Section 4.01(a) .
          “ Expiration Date ” shall have the meaning set forth in Article 6 .
          “ FDA ” means the United States Food and Drug Administration and successor bodies.
          “ Force Majeure Event ” shall have the meaning set forth in Article 11 .
          “ Indemnified Party ” shall have the meaning set forth in Section 16.03 .
          “ Indemnifying Party ” shall have the meaning set forth in Section 16.03 .
          “ Lot ” means approximately [* * *] Units of the Product.
          “ Manufacturing Equipment ” shall mean the Manufacturing Equipment transferred and assigned by Novavax to Graceway pursuant to the Asset Purchase Agreement.
          “ Packaging and Promotional Material ” shall have the meaning set forth in Article 12.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
          “ Person ” or “ person ” means any individual, corporation, partnership, limited liability company, joint venture, trust, unincorporated organization, other form of business or legal entity or governmental authority.
          “ Product ” shall mean Estrasorb, as more fully described on Schedule A to this Agreement, manufactured and packaged in accordance with the Specifications.
          “ Raw Materials ” shall mean the materials, components and packaging required to manufacture and package the Product in accordance with the Specifications.
          “ Raw Materials Inventory ” shall mean the Raw Materials acquired by Graceway pursuant to the Allergan Agreement.
          “ Raw Materials Specifications ” shall mean the specifications for the composition, product safety assurance, manufacture, packaging, and/or quality control of the Raw Materials, as set forth on Schedule B-1 attached hereto and made a part hereof, as the same may hereafter be modified by mutual agreement of the Parties in writing.
          “ Specifications ” shall mean the specifications for the design, composition, product safety assurance, manufacture, packaging, and/or quality control of the Product, as set forth on Schedule B-2 attached hereto and made a part hereof, as the same may hereafter be modified by mutual agreement of the Parties in writing.
          “ Stability Date ” shall have the meaning set forth in Section 10.06 .
          “ Territory ” shall mean the United States, Mexico and Canada.
          “ Third Party Claim ” shall have the meaning set forth in Section 16.03 .
          “ Unit ” means a packaged month of therapy of the Product for an individual end user, consisting of 56 pouches each containing 1.74 grams of the Product.
          “ United States ” shall mean the fifty states of the United States of America and its territories and possessions including Puerto Rico, irrespective of its political structure, and the District of Columbia.
ARTICLE 2
SUPPLY OF THE PRODUCT
          During the term of this Agreement, Novavax shall manufacture and supply exclusively to Graceway those quantities of the Product as set forth in this Agreement. Each Lot manufactured and sold to Graceway hereunder will conform to all Specifications for the Product, and shall be manufactured, tested, released and stored in accordance with cGMPs, applicable FDA and other rules and regulations, and the terms and conditions of this Agreement. Subject to the terms and conditions herein, Novavax will provide, at its sole cost and expense, the facilities, equipment, labor (and supervision thereof) and know-how necessary for the manufacture, testing

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
(including stability), packaging and supply of the Product to Graceway in accordance with the terms and conditions of this Agreement.
ARTICLE 3
TRANSFER PRICE; PAYMENT TERMS
      3.01 Transfer Price.
          The transfer price of the Product from Novavax to Graceway pursuant to this Agreement will be $ [* * *] per Unit. Such transfer price shall be all inclusive and Graceway shall have no obligation to pay any other amounts to Novavax related to the manufacture and supply of the Product to Graceway pursuant to this Agreement, except as otherwise specifically set forth in this Agreement.
      3.02 Payment Terms.
          Payment terms on all deliveries of the Product to Graceway under this Agreement shall be thirty (30) days from the delivery of an invoice by Novavax for such Product delivery, which invoice shall be provided by Novavax to Graceway on or after the delivery of such Product to Graceway.
ARTICLE 4
LOTS PURCHASED
      4.01 Quantity; Schedule of Delivery.
          (a) Graceway agrees to purchase, and Novavax agrees to manufacture and supply to Graceway, an aggregate amount of [* * *] Lots in accordance with the delivery schedule attached hereto at Schedule 4.01 (the “ Delivery Schedule ”).
          (b) Novavax acknowledges and agrees that all of the Raw Materials Inventory is being held by Novavax at the Catalent Facility. Novavax is permitted to use such Raw Materials Inventory solely in connection with the manufacture of the Product for Graceway pursuant to this Agreement. In the event that the Raw Materials Inventory has expired or lacks sufficient expiration dating (two (2) years), or additional Raw Materials are required for Novavax to manufacture the required Lots for Graceway pursuant to this Agreement, then Novavax will acquire sufficient additional Raw Materials to produce the required Lots without additional expense to Graceway.
      4.02 Conflicts.
          To the extent of any conflict or inconsistency between this Agreement and any order, acknowledgement, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
ARTICLE 5
ADDITIONAL AGREEMENTS
      5.01 Other Affiliates.
          If any other Affiliate of Graceway desires to purchase the Product from Novavax pursuant to the terms of this Agreement, then, upon the execution of a copy of this Agreement by such Affiliate, Novavax shall accord such Affiliate all of the benefits hereof and treat such Affiliate the same as Graceway for the purposes of this Agreement; provided , that this Section 5.01 will not be construed to relieve Graceway of any of its obligations hereunder.
      5.02 Exclusive Rights.
          During the term of this Agreement, Novavax shall supply Graceway, on an exclusive basis, with the Product for sale in the Territory and neither Novavax nor any of its Affiliates shall sell or distribute the Product within the Territory.
      5.03 Insurance.
          Each of Novavax and Graceway agrees to procure and maintain in full force and effect during the term of this Agreement valid and collectible insurance policies of a type and coverage amount consistent with Novavax’s and Graceway’s past practices. Upon Graceway’s request, Novavax shall provide to Graceway a certificate of coverage or other written evidence reasonably satisfactory to Graceway of such insurance coverage. Upon Novavax’s request, Graceway shall provide to Novavax a certificate of coverage or other written evidence reasonably satisfactory to Novavax of such insurance coverage.
      5.04 Personnel.
          During the term of this Agreement, Novavax (itself or through one or more third party contract manufacturers) shall maintain a workforce of appropriate size, training and experience sufficient for the manufacturing, packaging, testing (including stability) and supply of the Product to Graceway pursuant to the terms and conditions of this Agreement, and for the satisfaction of Novavax’s obligations under this Agreement.
      5.05 Manufacturing Equipment.
          Novavax shall use the Manufacturing Equipment solely for purposes of manufacturing and supplying the Product to Graceway pursuant to the terms and conditions of this Agreement. Novavax shall, during the term of this Agreement, clean and maintain the Manufacturing Equipment in good operating condition and repair (ordinary wear and tear excepted) and in accordance with good industry and manufacturing practices and applicable laws, rules and regulations. Novavax shall, at its sole cost and expense, be responsible for maintaining all warranty, service and maintenance agreements related to the Manufacturing Equipment in full force and effect, including all preventative maintenance and calibration

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
programs and agreements during the term of this Agreement. Graceway, as the owner of the Manufacturing Equipment, shall bear the risk of loss of the Manufacturing Equipment, but subject to Novavax’s compliance with its obligations under this Agreement.
ARTICLE 6
TERM
          Subject to the survival provisions of Section 17.12 , the term of this Agreement shall commence on the date hereof and, unless terminated earlier pursuant to Article 7 , shall remain in effect until the later of the following dates (the “ Expiration Date ”): (a) July 31, 2008, or (b) such time that Novavax has delivered, and Graceway has accepted in accordance with the terms of this Agreement, the aggregate number of Lots set forth in Section 4.01 .
ARTICLE 7
TERMINATION
      7.01 Breach.
          This Agreement may be terminated, prior to the Expiration Date, by either Party by giving written notice of its intent to terminate and stating the grounds therefor if the other Party shall materially breach or materially fail in the observance or performance of any representation, warranty, guarantee, covenant or obligation under this Agreement. The Party receiving such notice shall have sixty (60) days from the date of receipt thereof to cure the breach or failure; provided , that the cure period for a failure to make timely payment hereunder shall be only thirty (30) days. If the Party receiving such notice does not cure such breach or failure within such cure period, then this Agreement shall automatically terminate effective as of the end of such period.
      7.02 Insolvency, Etc.
          This Agreement may be terminated, prior to the Expiration Date, upon thirty (30) days advance written notice by either Party: (a) in the event that the other Party hereto shall (i) apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of itself or of all or a substantial part of its property, (ii) make a general assignment for the benefit of its creditors, (iii) commence a voluntary case under the United States Bankruptcy Code, as now or hereafter in effect (the “ Bankruptcy Code ”), (iv) file a petition seeking to take advantage of any law (the “ Bankruptcy Laws ”) relating to bankruptcy, insolvency, reorganization, winding-up, or composition or readjustment of debts, or (v) take any corporate action for the purpose of effecting any of the foregoing; or (b) if a proceeding or case shall be commenced against the other Party hereto in any court of competent jurisdiction, seeking (i) its liquidation, reorganization, dissolution or winding-up, or the composition or readjustment of its debts, (ii) the appointment of a trustee, receiver, custodian, liquidator or the like of the Party or of all or any substantial part of its assets, or (iii) similar relief under any Bankruptcy Laws, or an order, judgment or decree approving any of the foregoing shall be

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
entered and continue unstayed for a period of sixty (60) days; or (c) an order for relief against the other Party hereto shall be entered in an involuntary case under the Bankruptcy Code.
      7.03 Effect of Termination.
          (a) Notwithstanding the termination of this Agreement for any reason, each Party hereto shall be entitled to recover any and all Damages which such Party shall have sustained by reason of the breach by the other Party hereto of any of the terms of this Agreement. Termination of this Agreement for any reason shall not release either Party hereto from any liability which at such time has already accrued or which thereafter accrues from a breach or default prior to such termination, nor affect in any way the survival of any other right, duty or obligation of either Party hereto which is expressly stated elsewhere in this Agreement to survive such termination. In the case of a termination under Section 7.01 above, the non-defaulting Party may pursue any remedy available in law or in equity with respect to such breach, subject to the terms of Section 17.01 .
          (b) In the event that this Agreement expires or is terminated for any reason, Novavax shall return to Graceway (at no cost to Graceway) any Raw Materials Inventory that has not been utilized prior to the expiration or earlier termination of this Agreement. Novavax shall deliver, and Graceway shall accept delivery of, any such Raw Materials Inventory within five (5) days after such expiration or termination of this Agreement to a location designated by Graceway. Such delivery shall be F.O.B. Catalent Facility.
      7.04 Cleaning and Restoration of Manufacturing Equipment.
          (a) Prior to or promptly after the expiration or termination of this Agreement, Novavax shall (i) clean the Manufacturing Equipment in accordance with good industry and manufacturing practices and applicable laws, rules and regulations; (ii) restore the Manufacturing Equipment to the condition that existed as of the date of this Agreement (ordinary wear and tear excepted); (iii) disconnect, disassemble and make the Manufacturing Equipment available for removal from the Catalent Facility; and (iv) make its personnel reasonably available to assist Graceway in said removal. Graceway shall remove the Manufacturing Equipment from the Catalent Facility within forty-five (45) days after receiving written notice from Novavax that the Manufacturing Equipment is ready for transport. Novavax shall be solely responsible for all costs and expenses incurred by it (including, without limitation, rent and other non-routine costs incurred to clean, handle or decommission the Manufacturing Equipment irrespective of when incurred) in complying with its obligations under this Section 7.04(a) ; provided , that Graceway agrees to reimburse Novavax for up to Two Hundred Fifty Thousand Dollars ($250,000) of such costs and expenses to the extent supported by reasonably detailed documentation (excluding any rent expenses with respect to the period prior to June 30, 2008).
          (b) Novavax shall be responsible for complying with the terms of the Catalent Agreement that are applicable to Novavax’s obligations hereunder, including terms related to (i) the use, maintenance, occupancy or possession of the Catalent Facility, (ii) the cleaning and removal of the Manufacturing Equipment from the Catalent Facility, and (iii) the restoration of

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
the Catalent Facility as required by Catalent, whether under the Catalent Agreement or otherwise.
      7.05 Transfer Assistance.
          (a) During the term of this Agreement and for ninety (90) days after the acceptance by Graceway of the last Lot (per the Delivery Schedule), Novavax shall, at Graceway’s request, assist Graceway with (i) the relocation of the Manufacturing Equipment to a new location and the installation of the Manufacturing Equipment at such new location such that the Manufacturing Equipment is fully operational at such new location for the manufacturing of the Product in accordance with the Specifications and (ii) designating alternative supplier(s) of the Product and qualifying and enabling Graceway, any alternative supplier(s) and supplier’s manufacturing sites to manufacture and supply the Product in accordance with all applicable laws, Product approvals and Specifications, including (A) the transfer and disclosure of, and enablement of such parties and sites with respect to technology and (B) the provision of relevant technical documentation, technical expertise, and development reports and/or historical documentation reasonably necessary for the transfer and qualification of both analytical methodologies and manufacturing processes with respect to such parties and sites. All such assistance shall be provided during Novavax’s normal business hours at times and locations to be mutually agreed upon by the Parties.
           (b) Novavax shall make any technically qualified individuals with knowledge of the manufacture of the Product available, at a rate of [* * *] per hour, to provide the assistance described in Section 7.05(a) above. Such individuals shall remain as employees of Novavax, and nothing herein shall be construed to impose upon Graceway any obligations as an employer of any such individual.
      7.06 Transfer of Records.
          Upon the expiration or termination of this Agreement, Novavax shall promptly deliver to Graceway all documentation, records and files in Novavax’s possession related to the manufacturing, testing and/or release of the Product, whether generated before or during the term of this Agreement, including all regulatory reports, validation documents, batch record history and stability and Product complaint databases.
ARTICLE 8
SHIPMENT AND DELIVERY; INVENTORY AND RAW MATERIALS
      8.01 Shipment and Delivery.
          (a) All shipments of the Product pursuant to this Agreement shall be F.O.B. Catalent Facility (i.e., Graceway will pay for shipment). All shipments must be accompanied by a packing slip which describes the articles and shows the shipment’s destination. Novavax agrees to promptly forward the original bill of lading or other shipping receipt for each shipment in accordance with Graceway’s instructions. Novavax further agrees to promptly render, after

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
delivery of goods or performance of services, correct and complete invoices to Graceway, and to accept payment by check or, at Graceway’s discretion, other cash equivalent (including electronic transfer of funds).
          (b) The risk of loss with respect to the Product shall remain with Novavax until the point at which such Product is delivered to the loading dock at the Catalent Facility. Novavax will pack all the Product ordered hereunder in a manner suitable for shipment and sufficient to enable the Product to withstand the effects of shipping, including handling during loading and unloading.
          (c) Novavax shall provide to Graceway upon each shipment of each Lot the following: (i) Novavax’s standard certificate of analysis for each Lot certifying that the delivered batch contained in the Lot is in conformance with all the

 
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