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EXHIBIT 10.34 SUPPLY AGREEMENT

Supply Agreement

EXHIBIT 10.34 SUPPLY AGREEMENT | Document Parties: NOVAVAX INC You are currently viewing:
This Supply Agreement involves

NOVAVAX INC

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Title: EXHIBIT 10.34 SUPPLY AGREEMENT
Date: 3/6/2006
Industry: Biotechnology and Drugs     Sector: Healthcare

EXHIBIT 10.34 SUPPLY AGREEMENT, Parties: novavax inc
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Exhibit 10.34

THE REGISTRANT HAS APPLIED FOR CONFIDENTIAL TREATMENT OF CERTAIN PROVISIONS OF
THIS EXHIBIT WITH THE SECURITIES AND EXCHANGE COMMISSION. THE CONFIDENTIAL PORTIONS OF
THIS EXHIBIT ARE MARKED WITH ASTERISKS (
***** ) AND HAVE BEEN OMITTED. THE OMITTED PORTIONS OF
THIS EXHIBIT WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
A REQUEST FOR CONFIDENTIAL TREATMENT.

SUPPLY AGREEMENT

     AGREEMENT, (this “Agreement” ) is dated as of October 18, 2005 by and between Novavax, Inc., a Delaware corporation having its principal place of business at 508 Lapp Road, Malvern, Pennsylvania 19355, (“ Novavax ” or “Supplier” ) and Esprit Pharma, Inc., a Delaware corporation having its principal place of business at 2 Town Center Boulevard, East Brunswick, New Jersey 08816 ( “Esprit” or “Buyer” ). Supplier and Purchaser may be referred to individually as a “Party” or collectively as the “Parties .

     WHEREAS, Supplier has been engaged in the of development, manufacture, and supply of a product to be marketed, distributed and sold under the Estrasorb ® brand by Supplier;

     WHEREAS, on the date hereof, Buyer and Supplier also entered into a license agreement for the license by Supplier to Buyer of certain intellectual property enabling the manufacture sale and use by Purchaser of topically- or transdermally-administered product containing no active ingredient other than17ß estradiol (excluding contraceptive products, Selective Estrogen Receptor Modulators and products administered vaginally, orally, nasally, through the gum or by injection) which utilize Supplier’s micellar nanoparticle technology in the field of women’s health in product that is marketed under Supplier’s NDA #21-371 (the “ License Agreement ”);

     WHEREAS, concurrently with the execution and delivery of this Agreement and the License Agreement, ESPRIT has executed and delivered to NOVAVAX an $8.0 million promissory note due December 30, 2005 constituting a portion of the consideration for the License Agreement (the “ Promissory Note ”);

     WHEREAS, concurrently with the execution and delivery of this Agreement, the License Agreement and the Promissory Note, New Enterprise Associates, Domain Associates, LLC and Apax Partners, or certain of their affiliates (the “ Private Equity Investors ”) have executed and delivered to NOVAVAX an agreement to fund Esprit with the principal amount due under the Promissory Note within ten (10) business days of Esprit’s default of any of its obligations thereunder for the express purpose of satisfying ESPRIT’s obligations under the Promissory Note; and

     WHEREAS, Buyer desires to have Supplier manufacture Product (as defined in Article 1 below) under the Estrasorb ® brand for sale by Buyer or its designee.

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     NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, and for other good and valuable consideration, the receipt and efficiency of which are hereby acknowledge, the parties hereto agree as follows:

ARTICLE 1

DEFINITIONS

     As used throughout this Agreement, each of the following terms shall have the respective meaning set forth below:

      “Affiliate” of a Party shall mean any entity which directly or indirectly controls, is controlled by or is under common control with such entity, and for such purpose “control” shall mean (i) directly or indirectly owning, controlling or holding more than fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest in an entity or (ii) the possession, direct or indirect, of the power to direct or cause the direction of the management or the policies of the entity, whether through the ownership of voting securities, by contract or otherwise. Any such corporation, entity or business structure shall only be considered an Affiliate for so long as such ownership or control exists.

      “cGMP” shall mean good manufacturing practices according to 21 CFR Parts 210 and 211.

     “ CPI ” shall mean United States Department of Labor, Bureau of Labor Statistics, Consumer Price Index, All Urban Consumers, United States City Average, All Items, (1982-84=100) excluding the food and energy components, or the successor index that most closely approximates the CPI.

      “Cardinal” shall mean Cardinal Health Inc. as the contract manufacturer of the Product pursuant to the Cardinal Agreement.

      “Cardinal Agreement” shall mean the letter agreement between Cardinal, Supplier and Buyer of even date herewith.

      “Cardinal Facility” shall mean Cardinal’s manufacturing facility for the Product located at 3001 Red Lion Rd., Philadelphia, Pa. 10014

      “Damages” shall have the meaning ascribed to such term in Section 16.01.

      “FDA” means the United States Food and Drug Administration and successor bodies.

      “Intellectual Property Rights” shall mean the intellectual property, trade secrets, know-how, technology and information, whether or not protected by patents, to the extent required in the reasonable judgment of Supplier to manufacture the Product.

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      “License Agreement” shall mean the license agreement referred to in the second recital of this Agreement.

     “ Net Sales “ has the meaning ascribed to such term in the License Agreement.

      “Permitted Raw Materials Inventory” shall have the meaning ascribed to such term in Section 8.03(b).

      “Product” shall mean Estrasorb, as more fully described on Schedule A to this Agreement, manufactured and packaged in accordance with the Specifications (hereinafter defined).

      “Raw Materials” shall mean the materials, components, and packaging required to manufacture and package the Product in accordance with the Specifications.

      “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 attached hereto and made a part hereof, as the same may hereafter be modified by mutual agreement of the parties in writing.

      “Supply Year” shall mean each consecutive 365-day period (or 366-day period in the event of a leap year) during the Term, commencing on the date of this Agreement.

      “Territory” shall mean the United States, Mexico and Canada.

      “Term” shall have the meaning ascribed to such term in Article 6.

     “ Unit of Product ” means a month of therapy of Product for an individual end user.

ARTICLE 2

SUPPLY OF PRODUCT

     During the Term, Supplier shall supply Buyer with those quantities of Product as ordered by Buyer pursuant to this Agreement, subject to the ordering procedures set forth in Article 4 below. Supplier shall sell Product exclusively to Buyer for sale in the Territory . Each Product sold hereunder will conform to the Specifications for such Product. Subject to the terms and conditions herein, Supplier will provide the facility, equipment , labor, and supervision necessary for the production of the Product in sufficient quantities as required herein.

ARTICLE 3

PRICES FOR PRODUCT

     3.01 Transfer Price . The transfer price of Product from Novavax to Esprit during any Supply Year will be equal to (i) $***** per Unit of Product for the first $***** of Net Sales in such Supply Year and (ii) $***** per Unit of Product for the excess over the first $***** of Net

 

 

 

 

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Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

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Sales for such Supply Year. Notwithstanding anything to the contrary contained herein, the transfer price of Product from Novavax to Esprit (a) that constitutes samples (including current sample inventory) as designated by Novavax, will be $***** per week of therapy of Product for an individual end user of Product and (b) that constitutes short-dated trade inventory (in stock for equal to or less than one year from the date of packaging) as designated by Novavax and as set forth on Schedule 3.01 attached hereto will be $***** per Unit of Product. All transfer prices referred to in this Section 3.01 shall be increased (on a compounded basis) on ***** and ***** by and amount equal to the product of (i) the then current transfer price and (ii) *****. For the remainder of the Term, the transfer price of Product from Novavax to Esprit will be *****% of Novavax’s fully burdened manufacturing cost. The parties agree that the aggregate amount contemplated by clause (b) above will be paid in cash by wire transfer on the date of this Agreement.

     3.02 Payment Terms . Payment terms on all orders shall be ***** (*****) days from the date of invoice. Invoicing shall occur upon shipment.

ARTICLE 4

FORECASTS, CAPACITY; ORDERS

     4.01 Forecasts; Capacity; Capital Expenditures . At the beginning of each calendar quarter during the Term, Buyer shall provide Supplier with a binding written forecast of Buyer’s requirements for Product for the shorter of the following 12 months or the remainder of the Term (each, a “ Rolling 12 Month Forecast ”). Each Rolling 12 Month Forecast will be binding within a range of + *****% of the stated amount within such Rolling 12 Month Forecast; provided that the first three months of the each Rolling 12 Month Forecast will be binding without reference to the foregoing range. Attached hereto as Appendix 1 is an initial binding forecast for Product to be purchased pursuant to this Agreement between the date of this Agreement and the placement of subsequent purchase orders for Product in accordance with Section 4.02, below. Appendix 2 sets forth the capacity expectation for Buyer’s requirements during the Term on a monthly basis ( “Capacity” ). The parties understand and agree that any capital expenditures, incurred by Supplier in connection with the performance of its obligations under this Agreement will be borne by Supplier, it being understood that Supplier and Buyer will consult in good faith regarding any such capital expenditure prior to its incurrence. Notwithstanding anything to the contrary contained herein, the parties understand and agree that up to $***** of incremental expenses related to increasing manufacturing Capacity shall be borne by Buyer. The parties further understand that the foregoing forecasts and Capacity shall include both sample and trade quantities of Product. Supplier will use commercially reasonable efforts to meet Buyers demand for Product.

     4.02 Change Orders . Quarterly requirements contained in any 12 Month Rolling Forecast may be changed with ***** days prior written notice from Buyer to Supplier provided that Supplier consents to such change order in writing (which consent may be withheld by Supplier in its sole discretion)

 

 

 

 

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Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

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     4.03 Example . For illustrative purposes only, assuming execution and delivery of this Agreement on September 30, 2005, Buyer will deliver (i) its first 12 Month Rolling Forecast on October 1, 2005 for the succeeding 12 month period and (ii) its second 12 Month Forecast on December 31, 2005 for the succeeding 12 month period. Quarterly requirements contained in the forecasts will be binding, subject to change in accordance with Section 4.01 and Section 4.02.

     4.04 Conflicts . To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.

ARTICLE 5

ADDITIONAL UNDERSTANDINGS OF THE PARTIES

     5.01 Other Affiliates . If any other Affiliate of Buyer desires to purchase the Product from Supplier under the terms of this Agreement, then, upon the execution of a copy of this Agreement by such Affiliate, Supplier shall accord such Affiliate all of the benefits hereof and treat such affiliate as a Buyer for the purposes of this Agreement; provided, however, that this section will not be construed to relieve Esprit of any of its obligations hereunder

     5.02 Exclusive Rights . During the Term, Supplier shall supply Buyer, on an exclusive basis, with the Product for sale in the Territory and neither Supplier nor any of its Affiliates shall sell or distribute the Product.

     5.03 Metered Dose Delivery . Notwithstanding anything to the contrary contained herein, the parties understand and agree that Supplier is developing developed a metered dose bottle for the administration of Estrasorb ( “Metered Dose Delivery” ) and that the parties will, commencing on the date hereof, initiate the development and implementation of Metered Dose Delivery. The parties understand and agree that costs and expenses of the development and implementation of Metered Dose Delivery will be borne as follows: (a) the first $***** by Esprit and (b) any amount in excess of $***** by Novavax. All such costs and expenses will be paid by the applicable Party as such costs and expenses are incurred. The parties will work together in good faith to launch Metered Dose Delivery by *****.

     5.04 Insurance . Each of Supplier and Buyer agrees to procure and maintain in full force and effect during the Term valid and collectible insurance policies of a type and coverage amount consistent with Supplier’s and Buyer’s past practice prior to the date hereof. Should Supplier require additional insurance to be carried by Buyer, any incremental cost will be for the account of Buyer. Buyer’s and Supplier’s existing policies are listed on Schedule D attached hereto. Upon Buyer’s request, Supplier shall provide to Buyer a certificate of coverage or other written evidence reasonably satisfactory to Buyer of such insurance coverage. Upon Supplier’s request, Buyer shall provide to Supplier a certificate of coverage or other written evidence reasonably satisfactory to Supplier of such insurance coverage.

 

 

 

 

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Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

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     5.05 Personnel . During the Term, Supplier shall maintain a workforce of appropriate size, training and experience sufficient in the reasonable judgment of Supplier for manufacturing the Product in an amount not to exceed Capacity. If Buyer requires additional personnel for maintaining its equipment and facilities and otherwise necessary to fulfill Supplier’s other obligations hereunder, the incremental cost thereof will be borne solely by Buyer. The parties agree that the personnel requirements associated with the performance of Buyer’s obligations hereunder are set forth on Appendix 3 attached hereto.

     5.06 Product Returns . All Product returns and all costs and expenses associated therewith (a) for Products sold prior to the date hereof will be for the account of Supplier; (b) for Products sold on or after the date hereof will be for the account of Buyer; and (c) for partial lot #092304T17 will be for the account of Supplier. Medicaid chargebacks and rebates (a) occurring within the first ***** days after the date hereof will be for the account of Supplier and (b) occurring thereafter will be for the account of Buyer.

ARTICLE 6

TERM; EFFECTIVE DATE

     The term of this Agreement shall commence on the date hereof and remain in effect until ***** (the “Expiration Date” ), unless sooner terminated as expressly provided under this Agreement (the “Term” ). Notwithstanding anything to the contrary contained herein, this Agreement will be effective as follows: with respect to Esprit’s obligation under the last sentence of Section 3.01 and under Section 5.03, the date of this Agreement and (b) with respect to all other terms and conditions of this Agreement, the Business Day immediately following the satisfaction in full of Esprit’s obligations to pay principal and interest under the Promissory Note on the Maturity Date (as defined therein).

ARTICLE 7

TERMINATION

     7.01 Breach . This Agreement may be terminated, prior to the Expiration Date, by either Party by giving 90 days 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 the notice shall have 75 days from the date of receipt thereof to cure the breach or failure. Notwithstanding anything to the contrary contained herein, payment defaults will have a ten (10) day cure period. In the event such breach or failure is cured, the notice shall be of no effect.

     7.02 Termination of License Agreement . Subject to earlier expiration or termination, this Agreement will terminate simultaneously with the termination of the License Agreement.

 

 

 

 

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Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

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     7.03 Insolvency, Etc. This Agreement may be terminated, prior to the Expiration Date, upon 30 days written notice by either Party: (i) in the event that the other Party hereto shall (a) 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, (b) make a general assignment for the benefit of its creditors, (c) commence a voluntary case under the United States Bankruptcy Code, as now or hereafter in effect (the “Bankruptcy Code” ), (d) 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 (e) take any corporate action for the purpose of effecting any of the foregoing; or (ii) if a proceeding or case shall be commenced against the other Party hereto in any court of competent jurisdiction, seeking (a) its liquidation, reorganization, dissolution or winding-up, or the composition or readjustment of its debts, (b) 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 (c) similar relief under any Bankruptcy Laws, or an order, judgment or decree approving any of the foregoing shall be entered and continue unstayed for a period of 60 days; or (iii) an order for relief against the other Party hereto shall be entered in an involuntary case under the Bankruptcy Code.

     7.04 Effect of Termination . 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 expiration or 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.

     (a) In the event that this Agreement expires or is terminated for any reason (other than Supplier’s material breach, gross negligence or willful misconduct), Buyer shall be responsible for purchasing from Supplier (at Supplier’s cost) such Permitted Raw Materials Inventory conforming with the Specifications to the extent such Permitted Raw Materials Inventory has not been fully utilized prior to the expiry or earlier termination of this Agreement, provided that such Permitted Raw Materials Inventory has a shelf life of not more 365 days. Buyer shall accept delivery of any such Permitted Raw Materials Inventory within five days after such expiration or termination at the location designated by Buyer. If Buyer instructs Supplier to scrap any such Permitted Raw Material Inventory, Buyer shall pay for such Permitted Raw Materials Inventory as provided in the immediately preceding sentence plus reimburse Supplier’s incremental expenses directly related to the proper disposition of the scrapped Permitted Raw Materials Inventory.

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ARTICLE 8

DELIVERY; INVENTORY.

     8.01 Delivery . All charges for packing, hauling, storage, bar coding, and transportation to point of delivery are not included in the Transfer Price and Transfer Price shall be F.O.B. Cardinal Facility (i.e., Buyer will pay for shipment). All shipments must be accompanied by a packing slip which describes the articles, states the purchase order number and shows the shipment’s destination. Supplier agrees to promptly forward the original bill of lading or other shipping receipt for each shipment in accordance with Buyer’s instructions. Supplier further agrees to promptly render, after delivery of goods or performance of services, correct and complete invoices to Buyer, and to accept payment by check or at Buyer’s discretion, other cash equivalent (including electronic transfer of funds).

     8.02 Shipment . The risk of loss with respect to Product shall remain with Supplier until the point at which any such Product is delivered to the loading dock at the Cardinal Facility. Supplier will pack all 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.

     8.03 Inventory . (a) Supplier will maintain inventory of Product on a first-in, first-out basis. In no event shall Supplier be required to, and Supplier will not, order more than ***** months’ Raw Materials at Capacity and Supplier will use commercially reasonable efforts to manage such inventory as efficiently as possible.

     (b) To shorten lead times hereunder and to support variations in demand, as and if necessary, Supplier shall during the Term maintain such inventory of Raw Materials as are reasonably required to manufacture and package Product in accordance with the Specifications in a quantity equivalent to ***** (*****) month of Buyer’s forecasted purchase volume (the foregoing amount of inventory which conforms to the Specifications being hereinafter referred to collectively as the “Permitted Raw Material Inventory” ) or such other specific amount of Permitted Raw Material Inventory as may be agreed to by both parties in writing in advance. Supplier’s purchase price and the cost of carrying Permitted Raw Material Inventory shall be for the account of Buyer. The quantity of Permitted Raw Material Inventory shall be adjusted by Supplier as needed based upon Buyer’s average monthly purchase volume as forecasted in Buyer’s rolling forecast. In the event that Buyer’s requirements for Product materially exceed Buyer’s current forecasted needs, Supplier shall draw from the Permitted Raw Material Inventory to meet such excess requirements. Supplier shall then replenish the Permitted Raw Material Inventory within ***** days.

 

 

 

 

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Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

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ARTICLE 9

INSPECTION

     Buyer shall have the right, upon reasonable notice to Supplier and during regular business hours, to inspect and audit not more than ***** per ***** month period the facilities being used by Supplier for production and storage of the Product to assure compliance by Supplier with cGMP and applicable FDA and other rules and regulations and with other provisions of this Agreement. Supplier shall notify Buyer as promptly as practicable of any audit, review or inspection by any regulatory authority relating, directly or indirectly, to the Product, and shall in any event notify Buyer of any such audit, review or inspection within 24 hours of Supplier’s first being informed of any such event. Supplier and Buyer will work together to remedy or cause the remedy of any deficiencies which may be noted in any such audit or, if any such deficiencies can not reasonably be remedied within such seven day period, develop a written plan to remedy such deficiencies as soon as possible; and the costs of such remedy shall be borne by the Supplier.

ARTICLE 10

DEFECTIVE PRODUCT/INSPECTIONS/TESTING

     10.01 Disposition of Defective Product . Buyer shall notify Supplier of the existence and nature of any non-compliance or defect and Supplier shall have a reasonable opportunity, not to exceed ***** days from receipt of notification, to inspect such defective Product and provide Buyer with detailed written instructions to return or dispose of such defective Product. Buyer shall have no obligation to pay for any Product that is subject to such a claim of non-compliance or defect. If Supplier fails to so inspect and instruct Buyer as to the disposition of such defective Product, Buyer may dispose of such defective Product as it sees fit and Supplier shall promptly (i) reimburse Buye


 
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