Document:

exhibit1037

Exhibit 10.37    CERTAIN INFORMATION IDENTIFIED WITH [***] HAS BEEN EXCLUDED FROM  THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE  COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.    -1-  91837512_5  ADVANCED PURCHASE AGREEMENT  This ADVANCED PURCHASE AGREEMENT (this “Agreement”) is made as of   01/19/2021                   (the “Effective Date”), by and between NOVAVAX, INC., incorporated  and registered in the State of Delaware, with a principal place of business at 21 First field Road,  Gaithersburg, Maryland 20878 U.S.A. (“Novavax”), and Her Majesty the Queen in Right of  Canada, as represented by the Minister of Public Works and Government Services, with offices at  10 Wellington St., 4th Floor, Gatineau, QC, K1A0S5, Canada (collectively, “Customer”). Novavax  and Customer may individually be referred to herein as a “Party” and, collectively, as the “Parties.”  RECITALS  WHEREAS, Novavax is currently developing a novel NVX-CoV2373 vaccine, consisting  of a stable, prefusion protein made using its proprietary nanoparticle technology and coformulated  with its proprietary Matrix-MTM adjuvant (the “Product”), which is intended to prevent SARS-  CoV-2 (“COVID-19”) in humans;  WHEREAS, if development of the vaccine is successful and Novavax receives Regulatory  Approval (as defined below) to commercialize the Product in Canada, Novavax intends to  commence commercial manufacture of the Product for supply to, and distribution by, Customer to  individuals in Canada and to Canadian personnel who have been deployed offshore (e.g. members  of the Canadian Armed Forces, Governmental foreign missions, Canadian consulates or embassies  and their respective families) and locally engaged staff and their dependents (collectively, the  “Territory”); a  WHEREAS, in anticipation of Novavax receiving the government issued licenses,  registrations, authorizations and approvals necessary to commercialize the Product in Canada  including Expedited Authorization (as defined below) or any other conditional marketing approval  (“Regulatory Approval”), Customer hereby orders an aggregate number of doses of Product from  Novavax, to be supplied subject to the terms and conditions of this Agreement;  WHEREAS, in reliance on such commitment by Customer, Novavax agrees to commence  commercial manufacture of the Vaccine prior to Regulatory Approval for supply to, and  distribution by, Customer to individuals in the Territory;  NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set  forth below, and for other good and valuable consideration the sufficiency and receipt of which is  acknowledged by each Party, the Parties agree as follows:  1. Effects of COVID-19. Novavax and Customer hereby acknowledge and agree that to make  Vaccine available [***] Novavax will commence manufacture of the Vaccine in advance  of Regulatory Approval and the use, deployment and administration of the Product to  individuals in the Territory will occur under epidemic conditions requiring such use,  

 

   -2-  91837512_5  deployment and administration, and that Customer will be solely responsible for the use,  deployment and administration of Product to individuals in the Territory. The terms and  conditions of this Agreement, including with respect to Product pricing, refund terms,  indemnification and limitations of liability, reflect this understanding.  2. Sale of Product.  2.1. Generally. As of the Effective Date of this Agreement, Customer hereby commits  to purchase from Novavax Fifty-Two Million (52,000,000) doses (the “Aggregate  Amount”) of Product, which pending Regulatory Approval will be supplied in  [***]. Such vials will be labelled in compliance with the applicable portions of the  Food and Drugs Act, any applicable regulations or orders made under it and Health  Canada interpretive guidance thereof.  2.2. Right to Additional Amounts. Prior to the end of the Term of the Agreement,  subject to the terms of this Agreement, Customer has the irrevocable right, but not  obligation, to purchase at multiple times, additional amount of Product from  Novavax up to the additional amount of Product identified in Exhibit A. If  Customer desires to exercise its right under this Section 2.2, Customer will notify  Novavax in writing of the amount of Product Customer desires to procure, and the  Parties will discuss, in good faith, the amount of Product Novavax can provide  Customer based on its current supply. Likewise, if at any time during the Term of  this Agreement, Novavax desires to sell any of the available Product identified in  Exhibit A to a third party, Novavax shall notify Customer of the amount of Product  in question (“Call Amount”). This notification will include relevant information  for Customer to make a decision, including but not limited to, the delivery schedule.  Within [***] of receipt of such notice, Customer will either place an order to  purchase the portion of the Call Amount it desires to procure or notify Novavax it  does not desire to purchase the Call Amount. If Customer fails  to place an order or provide notice to Novavax within such [***], Customer’s  additional amount of doses in the Call amount can be offered to other customer by  Novavax and the amount of doses in the Call Amount will be available to Customer  at a later date based on availabilities. Any amount of Product purchased by  Customer under this Section 2.2. is the “Additional Amount”. The Parties  acknowledge that if the Additional Amount is to be derived from a different  manufacturing site than the one listed in the regulatory authorization, Novavax will  need to obtain additional regulatory approval prior to shipment of the Additional  Amount.  2.3. Customer will use the Product supplied hereunder solely (a) to vaccinate  individuals in the Territory against COVID-19, subject to the immediately  following sentences and (b) all in accordance with the terms and conditions of this  Agreement.  2.3.1. Sale or Donations. Notwithstanding the territory restriction set forth in  subclause 2.3 (a) hereof, subject to Customer’s obligation to indemnify  Novavax as set forth in Section 9.3, Customer may donate or re-sell Product  

 

   -3-  91837512_5  supplied under this Agreement to one or more countries outside of the  Territory, but only if (i) the intended purpose of such donation or resale is  to vaccinate individual in such country(ies) against COVID-19, (ii) [***],  (iii) [***] and (iv) [***].  2.4. Delivery. Novavax intends to deliver monthly shipments of Product to Customer  until the Aggregate Amount (and if applicable, Additional Amount) is supplied.  Based upon Novavax’ projections and expectations as of the Effective Date, the  anticipated quarterly delivery schedule of the Product is set forth in Exhibit B  (“Delivery Schedule”). Customer acknowledges that the Delivery Schedule may  change due to the impact of several variables including, but not limited to, speed of  clinical trial enrollment and accrual of events, manufacturing delays and/or timing  of Regulatory Approval. Novavax will use commercially reasonable efforts to  deliver the Product to Customer in accordance with the Delivery Schedule and will,  on at least on a [***] basis, communicate any anticipated changes to the Delivery  Schedule to Customer. At least [***] in advance of the anticipated initial shipment  under the Delivery Schedule, Novavax will inform Customer in writing of the date  of the initial delivery of Product (“Delivery Start Date”) and provide Customer an  updated Delivery Schedule detailing anticipated amounts and dates of each of  monthly delivery of Product to meet the quarterly amounts identified in the  Delivery Schedule. The Delivery Start Date is expected to be within [***] of the  date the Product receives Regulatory Approval and there is sufficient Conforming  Product in inventory for the complete first quarterly allotment in the Delivery  Schedule, or a lower amount of Confirming Product than planned for the first  quarterly allotment if it is deemed acceptable by Customer.  2.5. Expedited Authorization. If an Expedited Authorization is granted before [***],  then Novavax will use commercially reasonable efforts to revise the Delivery  Schedule to deliver Product to Customer earlier than indicated in the Delivery  Schedule ("Adjusted Delivery Schedule"). “Expedited Authorization” means an  expedited authorization for the Product granted by Health Canada that allows the  Product to be placed on the market in Canada under the authority of the September  16, 2020 Interim Order Respecting the Importation, Sale and Advertising of Drugs  in Relation to COVID-19 or other relevant interim order or regulation or authority.  2.5.1. Novavax Seeking Regulatory Approval. Novavax shall submit its  application for Regulatory Approval in Canada no later than [***] of its  first submission for Regulatory Approval in another priority market (such  as the United States of America or the European Union). In the event that  Novavax fails to submit as stated, then Customer’s sole and exclusive  remedy shall be that it may terminate this Agreement [***] upon written  notice to Novavax and [***] of the paid Advance Payment [***] will  become due and refundable to Customer.  2.6. Variance. Customer hereby acknowledges and agrees that the Delivery Schedule  is an estimate only and that notwithstanding anything herein to the contrary, (a)  the quantity of Product actually delivered [***] may vary within [***] of the  

 

   -4-  91837512_5  Aggregate Amount and (b) the actual date of delivery may vary within [***] of  the delivery date projected by Novavax pursuant to the updated Delivery  Schedule provided to Customer pursuant to Section 2.44. Novavax will use  commercially reasonable efforts to inform Customer of any variance in a  quarterly allotment at least [***] prior to the expected first monthly delivery for  doses from the impacted quarterly allotment.  2.7. Failure to Supply. If Novavax receives Regulatory Approval for the Product and  thereafter fails to supply Customer with the quantity of Product units specified for  a particular calendar quarter as set out in the Delivery Schedule, or, if applicable,  the Adjusted Delivery Schedule, within the timeframe permitted by Section 2.6,  then Novavax will [***] to Customer, in writing, the cause of the inability to supply  and present Novavax’s good faith remedial plan, which should include [***]  (“Remedial Plan”). Where such inability to supply results from Novavax’s inability  to manufacture or source sufficient quantities of Product to supply all of its  customers, Novavax shall allocate to Customer [***] for the period of short supply.  2.7.1. If the Remedial Plan does not resolve such inability or failure to supply to  within [***] of the first missed monthly delivery giving rise to the plan, the  Customer may [***], cancel delivery of any Product scheduled for delivery  [***].  2.7.2. If failure to supply is still ongoing after [***] of the initial missed monthly  delivery giving rise to the plan, Customer may upon written notice to  Novavax cancel future deliveries and terminate the Agreement.  2.7.3. [***].  2.7.4. The remedies in this Section 2.7 shall be Customer’s sole recourse and  Novavax’s entire liability with respect to any failure to supply.  2.8. Inconsistent Terms. All terms and conditions contained in any prior or subsequent  oral or written communication or order, that are different from or in addition to this  Agreement are hereby rejected by the Parties and will neither expand nor modify  either Party’s obligations under this Agreement.  2.9. Regulatory. Notwithstanding Section 2.8 (Inconsistent Terms) in the event of any  conflict between this Agreement and any applicable provision of the Food and  Drugs Act (including any provision made under it), the Food and Drugs Act will  prevail; provided, that in the event that a conflict between the terms of this  Agreement and any applicable provision of the Food and Drugs Act exists or arises,  (i) the Party determining that such conflict exists or arises will give [***] written  notice (and in any event, within [***] of such determination) to the other Party, (ii)  the Parties will cooperate in good faith to resolve any such conflict, including  altering any resulting delivery schedules or remedies, and (iii) will negotiate a  replacement provision that complies with the applicable Food and Drugs Act but  preserves the intent of the Parties as provided hereunder (if necessary).  

 

   -5-  91837512_5  2.10. Support Obligations. During the Term of the Agreement, Novavax agrees to  provide the Product Support obligations specified in Exhibit D.  3. Delivery and Inspection  3.1. Delivery, Title and Risk of Loss. Product will be delivered [***] to the delivery  destinations in Canada set forth on Exhibit B hereto (the “Points of Entry”). Risk  of loss and title to Product shall pass to Customer [***]. For clarity, Customer will  be solely responsible for ensuring it has the necessary approvals for importing  Product into the Territory and for distributing Product in the Territory.  3.2. Inspection. Customer (or its designee) shall, [***] (the “Inspection Period”)  following Novavax’s delivery of Product to the Point of Entry, visually inspect such  delivery to confirm that the Product has been supplied in the correct quantity and  constitutes Conforming Product (as defined below). Notwithstanding the foregoing,  Customer may request to extend the Inspection Period for an additional [***] and  Novavax will reasonably and in good faith consider such extension request and  provide written notice of approval to Customer if granted. If Customer determines  that any shipment of Product contains missing or non-Conforming Product, then  Customer must notify Novavax of the missing Product or reject the portion of the  applicable delivery that constitutes non-Conforming Product, as applicable, by  providing Novavax with written notice of such rejection during the Inspection  Period. If a delivery of Product has not been rejected by Customer prior to expiry  of the Inspection Period, Customer agrees that its remedies are limited to the  warranty process set out in this paragraph if a Latent Defect (as defined below) is  subsequently discovered. Notwithstanding the acceptance process established  herein, in the event the failure of Product to constitute Conforming Product is not  reasonably discoverable through customary visual inspection during the Inspection  Period (each, a “Latent Defect”), Customer will have [***] following the discovery  of the Latent Defect to make a warranty claim on the non-Conforming Products  pursuant to Section 4.1 by providing Novavax with written notice of such Latent  Defect; provided that Product may not be rejected for a Latent Defect beginning  [***] prior to expiry of the shelf-life for the applicable  Product.  4. Product Warranty.  4.1. Limited Product Warranty. Novavax warrants to Customer that, [***], such  Product will (a) conform to the specifications for such Product as set out in the  Regulatory Approval; (b) conform to the specifications set forth on Exhibit C hereto  (the “Specifications”) and (c) have been manufactured in accordance with current  good manufacturing practice (cGMP) as defined under applicable laws (Product  satisfying clauses (a)-(c) hereof, “Conforming Product”). In case of a conflict  between (a) and (b), (a) will take priority. Any claims by Customer that Product  fails to meet this warranty set forth in this Section 4.1 must be made by Customer  within [***] of its discovery of such deficiency, but in no event later than [***]  prior to expiry of the shelf-life for the applicable Product.  

 

   -6-  91837512_5  4.2. Remedies for Non-Conforming Product. If Novavax accepts Customer’s rejection  of Product as set forth in Section 3.2, accepts Customer’s warranty claim in Section  4.1 or if the Independent Expert determines that any Product is non-Conforming  Product as set forth in Section 4.3, then Novavax shall, at Customer’s option and at  no additional charge to Customer, either (a) replace the non-Conforming Product  [***] or (b) credit or refund the pro-rated amount paid of the Total Price of such  non-Conforming Product. If Novavax so requests, Customer shall, [***], return any  non-Conforming Product to Novavax; otherwise, Customer shall dispose of  Product in compliance with applicable laws and regulations.  4.3. Disputes. If Novavax disputes Customer’s rejection of Product as set forth in  Section 3.2 or Section 4.1, then Novavax will provide Customer written notice of  such dispute no later than [***] after the date of the notice from Customer that a  Product is non-Conforming Product. Such dispute shall be resolved by having an  independent, qualified third party expert (the “Independent Expert”), as selected by  Novavax and acceptable to Customer (such acceptance not to be reasonably  withheld or delayed) promptly test, analyze or otherwise evaluate the Product  subject to the dispute to determine whether the Product in question meets the  criteria specified in the warranty set forth in Section 4.1. The non-prevailing Party  shall bear all out-of-pocket costs and expenses associated with the Independent  Expert’s determination, including any reasonable out-of-pocket costs incurred by  the prevailing Party in connection therewith.  4.4. Disclaimer. THE REMEDIES SET FORTH IN SECTION 4.2 SHALL BE  CUSTOMER’S SOLE AND EXCLUSIVE REMEDY AND NOVAVAX’S  ENTIRE LIABILITY FOR NON-ACCEPTANCE OF PRODUCT UNDER  SECTION 3.2 OR ANY BREACH OF THE LIMITED WARRANTY SET  FORTH IN SECTION 4.1.  5. Payment Terms.  5.1. Advance Payment. Customer shall pay to Novavax a total upfront payment of USD  [***] (the “Advance Payment”). Customer acknowledges that in consideration of  Novavax’s commitment to manufacture Product in advance of Regulatory  Approval, [***] of the Advance Payment is non-refundable. The remaining [***]  of the Advance Payment is refundable only as provided in Sections 2.7.3, 8.2.2,  8.2.3, and 8.3.1.  5.2. Price. Customer shall purchase the Product from Novavax at the Per-Unit Price for  Product as set forth on Exhibit A (the “Price”). The Price shall be firm for the Term.  The Price is exclusive of any and all governmental taxes, including without  limitation, VAT, customs, charges or levies of every kind (“Taxes”) that Novavax  may be required to collect or pay upon sale, transfer or shipment of Product to the  Point of Entry under any applicable laws or regulations, but inclusive of [***].  Customer will be solely responsible for all such taxes, charges and levies, including  any interest and penalties. If Customer is required under the law of any jurisdiction  to deduct or withhold any sum of Taxes imposed on or in respect of any amount  

 

   -7-  91837512_5  due or payable to Novavax, the Taxes shall be paid and borne by Customer for  Customer’s own account. “Total Price” means the Per-Unit Price multiplied by the  Aggregate Amount and includes the Additional Amount if the Right for Additional  Amount is exercised by Customer.  5.3. [***]. [***].  5.4. Invoices. Novavax shall submit invoices to Customer for the Total Price as follows  (a) the Advance Payment shall be invoiced [***] and (b) the Delivery Price shall  be invoiced [***], which invoices shall be directed to the Contracting Authority  and Technical Authority as defined in Section 6.1 and 6.2 of this Agreement (or to  such other person or address if Customer notifies Novavax in writing pursuant to  Section 14.2 that invoices should be sent to such other person or address). Further,  the original and email copy of all invoices must also forwarded to the Public Health  Agency of Canada for certification and payment at:  Public Health Agency of Canada  P2P Invoices  200 Eglantine Driveway  Jeanne Mance Building  18th floor, RM 1855C  Ottawa Ontario  K1A OK9  Email: [***]  5.5. Each invoice for the Delivery Price shall reflect the actual quantities of Product  shipped to the Point of Entry, together with the per-unit Delivery Price [***] and  the total Delivery Price [***] to be paid under such invoice.  5.5.1. All amounts set forth in each invoice for Product not rejected pursuant to  Section 3.2 shall be payable by Customer within [***] of the date of  Customer’s acceptance pursuant to Section 3.2, which will be made to  Novavax, addressed as indicated on the applicable invoice, and made in  United States Dollars. In the event Customer disputes all or any portion of  an invoice submitted to it in accordance with this Section 5, then such  dispute shall be resolved in accordance with Section 14.6. Customer will  not be required to pay any amount disputed in good faith, unless and until  such amount is finally determined to be owed to Novavax in accordance  with the dispute resolution procedure set forth in Section 14.6. No interest  shall be accrued on amounts disputed in good faith.  5.5.2. A payment is considered overdue on [***] following the date of Customer’s  acceptance of Product pursuant to Section 3.2 and interest will be paid  automatically in accordance with section 5.5.3. If the content of the invoice  and its substantiating documentation are not materially in compliance of any  the applicable invoicing requirements communicated to Novavax,  

 

   -8-  91837512_5  Customer will notify Novavax within [***] of receipt of the applicable  invoice. The [***] payment period begins again upon acceptance of the  revised invoice or the replacement or corrected Product if Product is  rejected pursuant to Section 3.2. Failure by Customer to notify Novavax  within [***] will only result in the date specified to apply for the sole  purpose of calculating interest on overdue accounts.  5.5.3. For the purpose of this section:  5.5.3.1. "Average Rate" means the simple arithmetic mean of the Bank  Rates in effect at 4:00 p.m. Eastern Time each day during the  calendar month immediately before the calendar month in which  payment is made;  5.5.3.2. "Bank Rate" means the rate of interest established from time to  time by the Bank of Canada as the minimum rate at which the Bank  of Canada makes short term advances to members of the Canadian  Payments Association;  5.5.3.3. "date of payment" means the date of the negotiable instrument  drawn by the Receiver General for Customer to pay any amount  under the Agreement;  5.5.3.4. an amount becomes "overdue" when it is unpaid on [***]  following the day on which it is due and payable according to the  Agreement.  5.5.3.5. Customer will pay to Novavax simple interest at the Average Rate  plus [***] per year on any amount that is overdue, from the date  that amount becomes overdue until the day before the date of  payment, inclusive. Novavax is not required to provide notice to  Customer for interest to be payable.  5.5.4. Customer will pay interest in accordance with this section only if Customer  is responsible for the delay in paying Novavax. Customer will not pay  interest on overdue advance payments; however, Novavax shall be entitled  to withhold shipments until overdue advance payments are received.  5.5.5. Novavax will maintain appropriate records and supporting documentation  regarding sales of Product hereunder, that includes but is not limited to all  invoices, receipts and vouchers. Novavax must retain records, including  bills of lading and other evidence of transportation or delivery, for all  deliveries made under the Agreement, to confirm that each invoice is  limited to the actual quantities of Product shipped to the Point of Entry,  which will be records and documentation will be maintained by Novavax  for [***] following shipment of the relevant Product. Customer will have  the right, upon reasonable advanced notice to Novavax, during normal  business hours, to inspect any such records at the place such records are  

 

   -9-  91837512_5  normally kept. Novavax must provide all reasonably required facilities for  any audit and inspection and must furnish information as the representatives  of Customer may reasonably request from time to time require to perform a  complete audit of the Agreement. In the event any such inspection reveals  an overpayment by Customer, Novavax will [***] credit Customer the  amount of such overpayment against future orders for Product, unless there  are no such future orders, in which case, Novavax will [***] refund  Customer for the amount of such overpayment.  6. Authorities and Representatives.  6.1. Contracting Authority  (a) The Contracting Authority for this Agreement is:  Name: [***]  Telephone: [***]  Email address: [***]  (b) The Contracting Authority is responsible for the management of the Agreement on  behalf of Customer and the Contracting Authority must authorize any changes to  the Agreement in writing. Novavax must not perform, and shall not be obligated to  perform, work in excess of or outside the scope of the Agreement based on verbal  or written requests or instructions from anybody other than the Contracting  Authority.  6.2. Technical Authority  (a) The Technical Authority for this Agreement is:  Name: [***]  Telephone: [***]  Email address: [***]  (b) The Technical Authority is the representative of the department or agency for  whom the Product is being carried out under the Agreement and is responsible for  all matters concerning the technical content of the Product under the Agreement.  Technical matters may be discussed with the Technical Authority, however the  Technical Authority has no authority to authorize changes to the scope of the  Product. Changes to the scope of the Product can only be made through a mutually  agreed written contract amendment issued by the Contracting Authority and signed  by both Parties.  

 

   -10-  91837512_5  6.3. Novavax Representatives  (a)  General enquiries:  Name: [***]  Telephone No.: [***]  E-mail address: [***]  (b)  Delivery follow-up:  Name: [***]  Telephone No.: [***]  E-mail address: [***]  7. Intellectual Property. As between Customer and Novavax, Customer hereby acknowledges  and agrees that all rights, title and interests in, to and under any intellectual property that  relate to the Product are and shall remain the sole and exclusive property of Novavax. This  Agreement does not grant Customer and right, title or interest in, to or under any such  intellectual property or any other intellectual property owned or controlled by Novavax.  To the extent Customer, directly or indirectly, creates, discovers, reduces to practice or  otherwise generates intellectual property relating to Product in connection with the  activities contemplated by this Agreement, such intellectual property will be solely owned  by Novavax. Customer shall assign, and hereby does assign, to Novavax all such  intellectual property, and will take reasonable actions requested by Novavax, [***], to  record and confirm Novavax’s ownership thereof, including executing formal  documentation evidencing Novavax’s ownership thereof.  8. Term; Termination; Effects of Termination.  8.1. Term. This Agreement shall become effective upon the Effective Date and, unless  sooner terminated as set forth in Section 8.2, shall continue in force and effect until  Novavax has delivered to the Points of Entry and Customer has accepted an amount  of Product equal to the Aggregate Amount (the “Term”). In the event that Customer  exercises its right as per Section 2.2 (Right for Additional Amounts), the Term will  automatically be extended to the end of the last delivery and acceptance under the  revised Delivery Schedule provided by Novavax for the Additional Amount  ordered.  8.2. Termination.     

 

   -11-  91837512_5  8.2.1. Material Breach. A Party may terminate this Agreement at any time prior to  expiration of the Term upon written notice to the other Party if the other  Party materially breaches this Agreement and such breach is not cured  within [***] of written notice to the breaching Party describing such breach  (excluding a failure by Customer to pay an undisputed amount when due,  which must be cured within [***] of Novavax’s notice that Customer has  failed to pay); provided, however, that if such breach (excluding a failure  by Customer to pay an undisputed amount when due) is not reasonably  curable within such [***] period and the breaching Party is using good faith  efforts to cure such breach during such [***] period, then the breaching  Party will have an additional [***] to cure such breach. Notwithstanding  the foregoing, if the breaching Party has a bona fide dispute as to whether  such breach has occurred or has been cured, it will so notify the non- breaching Party in writing and the cure period will be tolled until such  dispute is resolved pursuant to Section 14.6. Upon a final determination of  breach or failure to cure, the breaching Party will have the remainder of the  cure period to cure such breach.  8.2.2. Regulatory Approval. On or before [***], if Novavax fails to receive  Regulatory Approval of the Vaccine in the Territory or Novavax abandons  the development of the Product or Novavax withdraws its application for  Regulatory Approval in Canada, then Customer’s sole and exclusive  remedy shall be that it may terminate this Agreement [***] upon written  notice to Novavax and [***] of the paid Advance Payment will become due  and refundable to Customer. Novavax will refund such amount within [***]  of receipt of such termination notice.  8.2.3. Product Seizure. To the extent that Novavax fails to deliver Product Doses  to Customer as a result of Product seizure by another country, Novavax  shall, to the extent that replacement Product is not available in a timeframe  acceptable to Customer, in Customer’s sole and absolute discretion and as  Customer’s sole recourse and Novavax’s entire liability, return to Customer  a minimum of [***] up to [***] of the paid Advance Payment for the  Product that was not delivered to Customer.  8.3. Effects of Expiration or Termination. As of the effective date of expiration or any  early termination of this Agreement, (a) neither Party shall be relieved of any  obligation that accrued prior to such effective date of termination, (b) except as  otherwise expressly provided herein, all rights and obligations of each Party  hereunder will cease and (c) each Party shall return or destroy all Confidential  Information of the other Party that is in its possession pursuant to the requirements  of Section 13.6.  8.3.1. Breach by Novavax. In the event this Agreement is terminated pursuant to  Section 8.2.1 after the first delivery due to a breach by Novavax, the  Delivery Price for Conforming Product delivered to Customer in addition  to the Advance Payment, shall become [***] due and payable to Novavax,  

 

   -12-  91837512_5  if not already paid by the Customer. Payment for quantities of Product not  delivered to Customer as of the effective date of any such termination will  not be paid by Customer. [***] of the paid Advance Payment for such  Product units not delivered will be reimbursed at the discretion of Customer.  8.3.2. Breach by Customer. In the event this Agreement is terminated by Novavax  pursuant to Section 8.2.1 due to a breachby Customer, [***], shall become  [***] due and payable to Novavax.  9. Regulatory Matters.  9.1. Regulatory Assistance. Customer agrees to provide reasonable assistance to  Novavax in obtaining Regulatory Approval for the Product in the Territory. The  progress and outcome of the Regulatory Approval is wholly dependent on Novavax  and the data it supplies to the Regulatory Approval authorities. Novavax  acknowledges and agrees, and Customer represents to Novavax, that Customer will  not influence decisions from the regulatory authorities to avoid conflict of interests  regarding Novavax obtaining Regulatory Approval for the Product.  9.2. Product Recall or Withdrawal  9.2.1. This section is subject to section 21.3 of the Food and Drugs Act. In the  event of a recall or a withdrawal of the Product, Novavax must notify  Customer [***] from such recall or withdrawal, as the case may be, and  must collect and destroy the delivered, recalled, or withdrawn Product  [***], unless otherwise agreed to by the Parties.  9.2.2. Novavax must, upon the request of Customer, replace [***] any recalled or  withdrawn Product [***], subject to Product availability as procured by  Customer from Novavax.  9.2.3. If full replacement is not available in a timeframe acceptable to Customer,  then Customer may, in addition to and without prejudice to any other  remedy available, choose from one of the following options for the quantity  of the Product affected:  9.2.3.1. full reimbursement of the Delivery Price, determined pro-rata for  doses not replaced; or  9.2.3.2. partial replacement and partial reimbursement or partial credit  under the Agreement of Delivery Price, determined pro-rata for  those doses not replaced.  Reimbursement and/or credit under this clause shall be made or applied, as  applicable, by Novavax within [***] of Customer’s written notice of which  option it selects.  9.3. Indemnification.  

 

   -13-  91837512_5  9.3.1. By Customer. Notwithstanding any contrary provision of this Agreement  and to the fullest extent not prohibited by applicable laws, Customer will  defend, indemnify and hold harmless Novavax and its affiliates and its or  their respective officers, directors, employees, agents and contractors (each  a “Novavax Indemnitee”) from and against any and all claims, demands,  causes of action, damages, losses, liabilities, costs, expenses (including  legal fees and litigation expenses), penalties, fines, settlements and  judgments (collectively, “Losses”) resulting from a claim (each, a “Claim”)  arising out of or in connection with any one or more of [***].  Notwithstanding any provision of this Agreement to the contrary, the  provisions of this Section 9.3.1 shall apply and be binding on Customer  regardless of whether any defect in the Product causing any Losses  originates from the testing, development, manufacture, delivery, export,  import, distribution, sale, offer for sale, administration, use or deployment  of the Product. [***].  9.3.2. Procedure. Any Novavax Indemnitee shall [***] notify Customer in writing  of any Claim made against the Indemnified Party, specifying the basis given  for such Claim; provided that [***]. Customer shall, upon giving written  notice to a Novavax Indemnitee within [***] after its receipt of any notice  of a Claim from the Novavax Indemnitee, undertake the defense of or,  [***]. The election by Customer, pursuant to this Section to undertake the  defense of a Claim shall not preclude the Novavax Indemnitee from  participating or continuing to participate in such defense, so long as [***].  10. Third Party Intellectual Property Infringement. IN THE EVENT THAT THE PRODUCTS  INFRINGE ANY THIRD PARTY’S INTELLECTUAL PROPERTY RIGHTS,  NOVAVAX’S SOLE OBLIGATION AND LIABILITY AND BUYER’S SOLE  REMEDY IS EXPRESSLY LIMITED TO NOVAVAX REFUNDING TO CUSTOMER  ANY AMOUNTS PAID FOR THE INFRINGING PRODUCT. IN THE EVENT OF  SUCH INFRINGEMENT, CUSTOMER WILL, AT NOVAVAX’S REQUEST, RETURN  THE INFRINGING PRODUCT TO NOVAVAX, AT NOVAVAX’S COST.  11. Representations and Covenants.  11.1. Mutual Representations. Each Party hereby represents and warrants to the other  Party, as of the Effective Date, that:  11.1.1. it has all requisite power and authority, corporate or otherwise, to execute,  deliver and perform this Agreement;  11.1.2. this Agreement is a legal and valid obligation binding upon such Party and  enforceable in accordance with its terms;  11.1.3. the execution, delivery and performance of this Agreement by such Party  does not conflict with any agreement, instrument or understanding, oral or  written, to which such Party is bound, nor violate any applicable law or any  order, writ, judgment, injunction, decree, determination or award of any  

 

   -14-  91837512_5  court or governmental body or administrative or other agency presently in  effect and applicable to such Party; and  11.1.4. in the performance of this Agreement, it shall comply with all applicable  laws.  11.2. Novavax’s Covenant. Novavax hereby covenants to Customer that, at the time of  delivery to the Points of Entry, Customer will have good title to the delivered  Products, free and clear of all liens, encumbrances and security interests.  11.3. Disclaimer. EXCEPT FOR THOSE REPRESENTATIONS, WARRANTIES AND  COVENANTS EXPRESSLY SET FORTH IN SECTION 4.1 OR THIS SECTION  11, TO THE FULLEST EXTENT NOT PROHIBITED BY APPLICABLE LAW,  NOVAVAX EXPRESSLY DISCLAIMS ALL OTHER REPRESENTATIONS,  WARRANTIES AND COVENANTS OF ANY KIND, WHETHER EXPRESS  OR IMPLIED, WRITTEN OR ORAL, BY FACT OR LAW, INCLUDING ANY  IMPLIED REPRESENTATIONS, WARRANTIES AND COVENANTS OF  MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,  SATISFACTORY QUALITY, NON-INFRINGEMENT AND ANY  REPRESENTATIONS OR WARRANTIES OR CONDITIONS OR  GUARANTEES ARISING FROM STATUTE, COURSE OF DEALING OR  USAGE OF TRADE. EACH PARTY ACKNOWLEDGES THAT IT HAS NOT  ENTERED INTO THIS AGREEMENT IN RELIANCE UPON ANY  WARRANTY OR REPRESENTATION. FURTHER, THE PARTIES HEREBY  ACKNOWLEDGE AND AGREE THAT NOTHING CONTAINED IN THIS  AGREEMENT SHALL BE CONSTRUED AS A WARRANTY, EITHER  EXPRESS OR IMPLIED, THAT NOVAVAX WILL OBTAIN A POSITIVE  CLINICAL OUTCOME OR THAT THE PRODUCT WILL RECEIVE  REGULATORY APPROVAL FOR COMMERCIAL USE  12. Limitation of Liability.  12.1. [***]. [***].  12.2. Cap On Damages. EXCEPT WITH RESPECT TO CLAIMS FOR, UNDER OR  ARISING OUT OF (A) A PARTY’S BREACH OF SECTION 1312, (B) A  PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR FRAUD OR  (C) CLAIMS FOR WHICH A PARTY HAS AN INDEMNIFICATION  OBLIGATION PURSUANT TO SECTION 9.3, IN NO EVENT WILL  NOVAVAX’ LIABILITY TO CUSTOMER EXCEED [***].  13. Confidential Information.  13.1. Definition. “Confidential Information” means any and all non-public or proprietary  information provided by or on behalf of a Party to the other Party in connection  with this Agreement, whether or not marked as “CONFIDENTIAL” or  “PROPRIETARY,” and whether provided prior to, on or after the Effective Date,  including all technical, scientific, business and other know-how, information, trade  

 

   -15-  91837512_5  secrets, methods, processes, practices, formulae, instructions, techniques, designs,  drawings, data or results, but expressly excluding any information that (a) at the  time of disclosure, is in the public domain, (b) after disclosure, becomes part of the  public domain by publication or otherwise, through no fault of the receiving Party  or its affiliates, (c) at the time of disclosure, is already in the receiving Party’s or  its affiliates’ possession, except through prior disclosure by the disclosing Party,  without any obligation of confidentiality or any restriction on its use, and such  possession can be properly documented by the receiving Party or its affiliates in its  written records, and was not made available to the receiving Party or its affiliates  by any person or party owing an obligation of confidentiality to the disclosing  Party, (d) is rightfully made available to the receiving Party or its affiliates from  sources independent of the disclosing Party and (e) is independently discovered or  developed by or on behalf of the receiving Party or its affiliates without the aid, use  of, access to or application of any Confidential Information of the disclosing Party.  For clarity, specific aspects or details of Confidential Information will not be  deemed to be within the public domain or in the possession of the receiving Party  merely because the Confidential Information is embraced by more general  information in the public domain or in the possession of the receiving Party.  13.2. Obligation to Maintain in Confidence; Permitted Disclosure. Each Party agrees to  (a) protect and maintain in confidence the disclosing Party’s Confidential  Information using the same degree of care that it employs to protect the  confidentiality of its own confidential information (but never less than a reasonable  standard of care), (b) not disclose to any person or entity any the disclosing Party’s  Confidential Information; provided that the receiving Party may disclose such  Confidential Information to its affiliates and to its and their officers, directors,  employees, contractors or agents who are bound by confidentiality obligations at  least as restrictive as those set forth in this Section 13 and who reasonably need to  know such Confidential Information in the performance of the receiving Party’s  obligations under this Agreement, (c) ensure the full compliance of each of its  affiliates and its and their officers, directors, employees, contractors or agents who  have access to the disclosing Party’s Confidential Information with the  confidentiality and non-use obligations in this Section 13 and (d) not use such  Confidential Information for any purpose other than performing its obligations  under this Agreement. Each Party acknowledges and agrees that its failure to  comply with the provisions of this Section 13 may cause irreparable harm to the  other Party that cannot be adequately compensated for in damages and, accordingly,  that each Party will be entitled to claim, in addition to any other remedies available  to it, interlocutory and permanent injunctive relief to restrain any anticipated,  present or continuing breach of this Section 13 without the need to post bond or  other security. The terms of this Agreement will be the Confidential Information of  both Parties.  13.3. Notwithstanding Section 13.2, Customer will be permitted to disclose Confidential  Information of Novavax for the purposes of government administration and  operations, including for the purposes of vaccination program planning and  vaccination program administration in collaboration with the Provinces and  

 

   -16-  91837512_5  Territories of Canada and its vaccine logistics provider, and in the exercise of  Crown privileges. For greater clarity, this includes reporting to the Parliament of  Canada, for public safety and national security purposes and for proactive  disclosure required or permitted by applicable law. Any such disclosure of  Confidential Information under this Section 13.3 will be limited to only that  Confidential Information that is required to be disclosed under applicable law, and  under and in compliance with the privacy, confidentiality and proactive disclosure  policy regimes of the Government of Canada and in accordance with the Health  Products and Food Branch of Health Canada practices. For the avoidance of doubt,  the protections afforded to Novavax pursuant to Section 13.4 shall apply to  disclosures of Confidential Information made by Customer pursuant to this Section  in event Customer is compelled by law to disclose such Confidential Information.  13.4. Disclosures Required by Law. Each Party may disclose the Confidential  Information of the other Party to the extent that such disclosure is required to be  disclosed pursuant to applicable law (including the rules of any stock exchange) or  a valid order of a court of competent jurisdiction or a supra-national, national,  regional, state, provincial or local governmental body of competent jurisdiction.  Prior to making any such disclosure, the receiving Party shall promptly advise the  disclosing Party of the requirement to disclose as soon as the receiving Party  becomes aware that such a requirement might become effective in order that, where  possible, the disclosing Party may seek a protective order or such other remedy as  the disclosing Party may consider appropriate in the circumstances. The receiving  Party shall reasonably cooperate with the disclosing Party (at the disclosing Party’s  cost) to the extent allowed by the applicable law in seeking a protective order or  other relief. The receiving Party shall disclose only that portion of the disclosing  Party’s Confidential Information that it is required to disclose.  13.5. Survival. The provisions of this Section 13 shall survive for a period of [***] from  the date of any expiration or termination of this Agreement, but shall survive [***]  with respect to any Confidential Information that is a trade secret for as long as  such information remains a trade secret.  13.6. Return or Destruction. A Party may request that the other Party return or destroy  any of its Confidential Information that is in the other Party’s possession at any  time upon written notice to the other Party except for information submitted to  Health Canada for regulatory purposes and subject to the Health Products and Food  Branch of Health Canada practices. Upon expiration or termination of this  Agreement, each Party shall return or destroy, at the other Party’s written election,  all Confidential Information of the other Party that is in its possession as of the date  of expiration or termination. Notwithstanding the foregoing, each Party may retain  [***] of the other Party’s Confidential Information to ensure its compliance with  this Agreement, and no Party will be required to destroy copies of the other Party’s  Confidential Information that are included on disaster recover/backup tapes that are  maintained by a Party pursuant to a bona fide disaster recovery plan. If requested  by a Party, the returning or destroying Party will certify in writing to the other Party  that such return or destruction has occurred.  

 

   -17-  91837512_5  14. Miscellaneous.  14.1. Force Majeure. Each Party’s obligations of performance under this Agreement will  be temporarily suspended and excused for the period of interruption to the extent  any failure of performance is due to (a) fire, earthquake, storm (including  hurricanes, snow storms, blizzards or ice storms), hail, flood, act of war or  terrorism, riot, civil commotion, pandemic (other than COVID-19, except to the  extent that the effects of COVID-19 causes a material change on the resources such  Party will use to perform its obligations under the Agreement materially adversely  change following the Effective Date), epidemic (other than COVID-19, except to  the extent that the effects of COVID-19 causes a material change on the resources  such Party will use to perform its obligations under the Agreement materially  adversely change following the Effective Date) or embargo, (b) changes to  applicable law or (c) any other cause or event beyond the reasonable control of such  Party (collectively, a “Force Majeure”). The affected Party will [***] notify the  other Party of the anticipated period of interruption due to a Force Majeure and will  take all reasonable measures to forthwith remedy the interruption.  14.2. Notices. Any notice given under this Agreement must be in writing and delivered  either to the addresses set forth below in person or via overnight courier (or to such  other addresses of which the Parties may from time to time be notified in writing),  with a PDF copy sent by email:  If to Novavax:  Novavax, Inc.  20 Firstfield Road  Gaithersburg, MD 20878  U.S.A.  Attn: [***]  Email: [***]  If to Customer:  As per Section 6.1 Contracting Authority of this Agreement.  Such notice will be deemed to have been given as of the date delivered by hand, on  the second (2nd) Business Day (at the place of delivery) after deposit with an  internationally recognized overnight delivery service or upon written  acknowledgement of the receiving Party.  14.3. Entire Agreement. This Agreement, including any schedules or exhibits hereto,  contains the entire and exclusive agreement between the Parties in connection with  the subject matter thereof and supersede all prior and collateral agreements,  understandings, communications, representations and warranties between the  Parties in relation thereto, including without limitation, the Memorandum of  Understanding between the Parties dated August 27, 2020.  

 

   -18-  91837512_5  14.4. Amendment. No amendment or modification or supplement of this Agreement,  including this provision, will be valid unless made in a writing signed by an  authorized representative of each Party specifically referring to this Agreement.  14.5. Public Announcements. The Parties agree to determine jointly the contents of any  public announcement informing the public about the existence of this Agreement  between the Parties and, except as may be required by law or the rules of any  national securities exchange, neither Party shall issue or cause the issuance of any  such public announcement without the express prior approval of an executive  officer of each Party.  14.6. Dispute Resolution; Equitable Relief.  14.6.1. With respect to any, dispute or controversy (“Dispute”) between the Parties  and arising in whole or in part in connection with this Agreement, including  whether a breach has occurred or been appropriate cured, the Parties shall  first use good faith efforts to resolve such Dispute and, if such Dispute is  not resolved within [***] from the date such Dispute arose, then Customer  may submit the Dispute to binding arbitration in [***] or Novavax may  submit the Dispute to binding arbitration in [***]. All matters so submitted  to arbitration will be settled by three (3) arbitrators in accordance with the  [***]. In the event of a conflict between [***] and this Agreement, this  Agreement shall govern. Each Party will designate an arbitrator and the  Parties will cause the designated arbitrators to mutually agree upon and to  designate a third arbitrator who will serve as chairperson. The Parties shall  arrange for a hearing to occur and be completed within [***] after the  appointment of the third (3rd) arbitrator, which hearing shall last no longer  than [***], unless the arbitral panel believes a longer period is required, in  which case the hearing may last [***]. The Parties will cause the arbitrators  to decide the matter to be arbitrated within [***] after the close of evidence  unless the chairperson arbitrator determines, at the request of any Party or  on his or her own initiative, that such time period should be extended, in  which case such time period may not be extended beyond an additional  [***] period. The final decision of the majority of the arbitrators shall be in  writing, in all events follow governing law and will be furnished to all the  Parties in such dispute. Judgment on such decision may be entered in any  court having jurisdiction.  14.6.2. Notwithstanding any other terms of this Agreement, either Party may seek  a preliminary injunction or other provisional equitable relief in any court of  competent jurisdiction if, in its reasonable judgment, such action is  necessary to avoid irreparable harm as permitted by applicable law.  14.7. Governing Law. This Agreement is made subject to the laws of [***], without  regard to any conflict of laws principles. The United Nations Convention on  Contracts for the International Sale of Goods and the United Nations Convention  on the Limitation Period in the International Sale of Goods, if otherwise applicable,  

 

   -19-  91837512_5  each as the same may be amended or superseded, are hereby expressly excluded  and will not be applicable to this Agreement.  14.8. Assignment. Neither Party will assign all or any portion of this Agreement or any  right or obligation under this Agreement without the other Party’s prior written  consent, which consent will not be unreasonably withheld or delayed. Any  unauthorized assignment by a Party will be null and void of no force or effect. This  Agreement will bind and inure to the benefit of the successors and permitted assigns  of the respective Parties.  14.9. Survival. In order that the Parties may fully exercise their rights and perform their  obligations in connection with this Agreement, any provisions of this Agreement  that are required to ensure such exercise or performance (including any obligations  accrued as of the termination date) or which are intended by their terms or by  necessary implication to survive will survive the expiration or termination of this  Agreement, including Sections 5 (with respect to accrued but unpaid amounts), 2.3,  7, 9.3, 9.3, 10, 13, 13, 14.2, 14.3, 14.6, 14.7, 14.9, 14.11, 14.12 and 14.13.  14.10. Waiver. Failure of either Party to exercise any right it has under this Agreement on  one or more occasions will not operate or be construed as a waiver by such Party  of its right to exercise the same right on another occasion. Any waiver must be in a  writing signed by the waiving Party.  14.11. Severability. If any provision of this Agreement will be adjudicated to be invalid or  unenforceable by a court of competent jurisdiction, it is the Parties’ intent that the  remaining provisions of this Agreement will remain in full force and effect and the  affected provision or portion thereof will be deemed modified so that it is  enforceable to the maximum extent permissible to reflect as closely as possible the  intentions of the Parties as evidenced from the provisions of this Agreement.  14.12. Independent Relationship of Parties; No Third-Party Beneficiary. The relationship  of Novavax and Customer is that of independent contractors and under no  circumstances will a Party, its agents or employees be partners, agents or  representatives of another Party. Except as otherwise expressly provided in this  Agreement, including any indemnification or limitation of liability provision,  nothing in this Agreement will be construed as creating any direct or beneficial  right in or on behalf of any third party.  14.13. Interpretation; Section Headings. For purposes of this Agreement, (a) the plural will  include the singular and the singular the plural, (b) any gender will include any  other gender, (c) the terms “included” or “including” or any variation are not words  of exclusion and will be read to include “without limitation,” (d) the terms “hereof”  or “herein” or any variation are intended to apply to this Agreement as a whole, (e)  the word “or” is not exclusive and will be interpreted to have the meaning  commonly associated with the phrase “and/or,” (f) references to any applicable law,  rule or regulation, or article, section or other division thereof, will be deemed to  include the then-current amendments thereto or any replacement or successor  

 

   -20-  91837512_5  applicable law, rule or regulation thereof and (g) the word the word “will” shall be  construed to have the same meaning and effect as the word “shall.” The section  headings used herein are intended for convenience of reference only and will not  be considered in interpreting this Agreement. This Agreement shall be deemed to  be the joint work product of the Parties and any rule of construction that a document  shall be interpreted or construed against a drafter of such document shall not be  applicable.  14.14. English Language. This Agreement shall be written and executed in, and all other  communications under or in connection with this Agreement shall be in, the English  language. Any translation into any other language shall not be an official version  thereof, and in the event of any conflict in interpretation between the English  version and such translation, the English version shall control.  14.15. Counterparts. This Agreement and all exhibits and schedules hereto may be  executed and delivered by the Parties in one or more counterparts, each of which  will be an original, and each of which may be delivered by facsimile, e-mail or  other functionally equivalent electronic means of transmission and those  counterparts will together constitute one and the same instrument.  15. Bio-Manufacturing.  15.1. Definitions:  15.2. Bio-Manufacturing consists of:  15.2.1. “Drug Substance Manufacturing” means the manufacture of Novavax  adjuvant or nanoparticle bulk drug substance via [***]; and  15.2.2. “Final Formulation, Filling and Finishing” means the formulation of the  drug substance with adjuvant and the subsequent filling, inspection,  labelling and packaging of the final drug product.  15.3. Novavax acknowledges the potential benefits of Bio-Manufacturing in Canada and  agrees to work in good faith with the Government and/or the private sector of  Canada to establish a mutually beneficial contract manufacturing relationship(s) in  Canada for one or more Novavax vaccines, including for Drug Substance  Manufacturing and/or Final Formulation, Filling and Finishing.  16. Logistic Provider For Canada.  16.1. Customer has appointed [***] as the subcontractor with respect to the performance  of importation into Canada, storage and transportation within Canada of the  Products. [***] holds a Drug Establishment Licence authorizing it to import the  drug. To ensure full compliance with Good Distribution Practice throughout the  supply chain, Novavax and [***] will need to enter into a Quality Agreement prior  to first delivery of Product.  

 

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    [Signature Page to Advanced Purchase Agreement]  91837512_5  IN WITNESS WHEREOF, the parties hereto by their duly authorized officers have  executed this Agreement as of the Effective Date.  CUSTOMER  By:/s/ Anita Anand      Minister Anita Anand   Printed Name     Title: Minister of Public Works and  Government Services    NOVAVAX, INC.  By:/s/ John A Herrmann III      John A. Herrmann III   Printed Name  EVP, CLO   Title:  01/19/2021    

 

    91837512_5  EXHIBIT A  PRODUCTS  Aggregate Amount:  52 million doses  Product Name  Total Price  (= [***])  Per-Unit  Price  per unit Delivery Price  (= [***])  NVX-CoV2373 USD$ [***] USD[***] USD[***]      Additional Amount:  24 million doses  Product Name  Total Price  (= [***])  Per-Unit  Price  per-unit Delivery Price  (= [***])  NVX-CoV2373 USD[***] USD[***] USD[***]      

 

    91837512_5  EXHIBIT B  DELIVERY SCHEDULE  [Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit setting forth the delivery  schedule has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted  exhibits to the Securities and Exchange Commission upon request; provided, however, that the  Registrant may request confidential treatment of omitted items.]  

 

    91837512_5  EXHIBIT C  SPECIFICATIONS  [Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit setting forth the specifications  has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted exhibits  to the Securities and Exchange Commission upon request; provided, however, that the Registrant  may request confidential treatment of omitted items.]    

 

    91837512_5    EXHIBIT D  SUPPORT OBLIGATIONS  1. Distribution in Canada  Novavax must deliver the Product to, as a minimum, the destinations specified in Exhibit B in  accordance with the directions of Customer.  2. Packaging  Novavax must properly label and package the Product in compliance with the Food and Drugs Act  (Canada) and any regulations, orders or instruments made thereunder, for the approved Product  authorized for sale in Canada.  To the extent a waiver of serialization is not available from Health Canada, Novavax will include  bar codes on shipping package, secondary and primary package which includes variable data and  which complies with GS1 standards that will enable tracking and tracing of Product from shipment  to administration or other requirements specified by Health Canada.  Unless otherwise agreed to in writing, smallest available package must not contain more than [***]  doses  3. Maintenance of the Cold Chain During Transportation and the Use of Cold Chain  Monitors  The Product is a refrigerator-stable product, i.e. stored at 2-8 degrees Celsius, which permits  leveraging standard vaccine distribution and delivery infrastructure.  4. Adverse Event Following Immunization (AEFI) Reporting Requirement  Novavax must comply with all AEFI reporting requirements.  5. Customer Service  (a) Novavax must identify a bilingual (English and French) Customer Support Contact, and  maintain a bilingual customer support desk (reached via a toll free telephone number and  an e-mail account) throughout a declared pandemic period to provide [***] customer  support to Customer and to health care providers (“Requestors”).  (b) The Customer Support Contact or Support Desk must, as a minimum:  

 

     91837512_5  (i) Be reachable Monday through Friday from [***] Newfoundland Standard Time to  [***] Newfoundland Standard Time, with adjustments as necessary for daylight  savings time  (ii) Respond to general enquiries on product information concerning the use of the  vaccine, its indications, contraindications, dosage and administration, drug  interactions, storage and handling requirements;  (iii) Provide scientific and technical advice and guidance in response to detailed  technical and scientific questions;  (i) Provide up-to-date information on product holds or suspensions and on product  recalls and withdrawals;  (ii) Provide technical advice concerning the continued ability to use vaccine which has  experienced a cold chain excursion;  (iii) Provide order status including real-time tracking of shipments; and  (iv) Log reports received on adverse events following immunization.    (c) For general enquiries, such as those regarding order tracking and status, product  information, storage and administration, etc., a response must be communicated to the  Requestor [***]. Enquiries of a scientific or technical nature that require more detailed  review and investigation by Novavax may take longer; however, Novavax must inform the  Requestor of the steps being taken to respond to the enquiry and of the expected timeline  for a complete response.  (d) Where requested, responses should be provided in writing.  (e) Novavax must provide the Customer with an emergency contact and telephone number for  any urgent enquiries that occur outside the regular business hours listed above, such as for  urgent scientific or technical information or to report an adverse event. Novavax  representative must call-back the Requestor within [***].  6. Logistics Support  Novavax must, as a minimum:  (a) Provide to the Contracting Authority and the Technical Authority advance notice of  production and delivery schedules (e.g. expected availability, timely updates on status of  announced schedules, immediate notification of interruptions or delays in production and  delivery schedules, etc.); and  (b) Initiate and coordinate product holds, recalls or withdrawals, if necessary including  coordinating trace back through the automated identification of vaccine products (AIVP);  

 

     91837512_5  provide clear and concise instructions on the activities necessary to implement the hold,  recall or withdrawal; and provide regular updates on the status of same;  7. Support in the Management of Cold Chain Excursions  As a minimum, Novavax must:  (a) provide all published information on the stability of the product including continued  stability if subject to temperature fluctuations (outside of recommended storage conditions);  (b) clearly state all of the information required on a specific cold chain excursion to allow  Novavax to properly assess the excursion;  (c) provide clear and consistent written responses on the question of continued use of vaccine  following an excursion; and  (d) provide a written assessment on the viability of continued use of vaccine following an  excursion within [***] of receipt of a request for assistance.  8. Technical Information and Data  (a) During the Term, Novavax will upon written request, make available to the Technical  Authority, who may in confidence make copies and take extracts therefrom, those reports,  communications, etc. received from Health Canada which are exchanged for purposes of  Regulatory Approval of the Vaccine. If requested, Novavax will make available to the  Technical Authority on a confidential basis, where available, data and technical information  concerning the Product being delivered under the Agreement, including such information  as:  (i) Clinical trial data – Canadian and International;  (ii) Product safety data – Canadian and International; and  (iii) Product quality and stability data.    The Parties shall mutually agree on the scope of such data and information exchange in  advance, taking into consideration the Technical Authority’s need to understand the clinical,  safety, quality and stability profile of the Product and Novavax’ desire to provide such data  and information in a manner that minimizes administrative burden and disruption to its  operations.  (b) Unless specifically prohibited by Novavax in writing, the information and data provided  will be shared, on a confidential and need to know basis, within the Public Health Agency  of Canada and Health Canada, as well as with Provincial and Territorial public health  officials and experts in the field who provide public health advice to these officials,  including but not limited to the National Advisory Committee on Immunization (NACI),  to inform recommendations regarding the use of vaccine. Any information or data shared  

 

     91837512_5  in this manner will contain the notices provided by Novavax concerning the confidential  or proprietary nature of the material submitted and the restrictions with respect to  publication or further dissemination. If Customer wishes to present some aspect of the  information or data in a scientific forum it will obtain the prior permission of Novavax in  writing.  9. Timely Lot Release, Novavax’s Responsibility  Novavax must submit all vaccine lots to Health Canada and such other information as required by  Health Canada so as to ensure that the release of lots by Health Canada will occur early enough to  allow Novavax to meet the delivery requirements of the Agreement.  10. Novavax Reporting on Production and Delivery  Novavax must provide both the Contracting Authority and the Technical Authority with [***]  written updates on the status of production and delivery. The Parties will cooperate to determine  what details the Contracting Authority requires and what details Novavax has the capability on  which to report. The information provided must be sufficiently detailed so as to allow Customer  time to plan for vaccine availability. Without limiting the generality of the foregoing, Novavax  will make commercially reasonable efforts to provide information on:  (i) [***];  (ii) [***];  (iii) [***];  (iv) [***]; and  (v) [***].    Where multiple lot numbers apply, all applicable lot numbers should be provided.Document

						
	Exhibit 10.41

Certain information identified with [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

		
		Applied Technologies Center
315 Sigma Drive
Summerville, SC  29486
www.ati.org

			
	

September 10, 2020
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD  20878
Attention:    [***]
Subject:        Modification No. 02 to Project Agreement No. 01; MCDC2011001
Reference:    MCDC Base Agreement No. 2020530
Dear [***]:
THIS MODIFICATION NO. 02 TO UNDEFINITIZED PROJECT AGREEMENT (UPA) NO. 01 (“Modification”) is made effective as of the later date of signature below (the “Modification Effective Date”) by and between Novavax, Inc. (“Project Agreement Holder”) and Advanced Technology International (“MCDC CMF”).
WHEREAS, Project Agreement Holder and MCDC CMF are parties to that certain Undefinitized Project Agreement No. 01 (“UPA”) under MCDC Base Agreement No: 2020-530 (“Base Agreement”); and
WHEREAS, Project Agreement Holder and MCDC CMF desire to modify and clarify certain provisions of the UPA.
NOW THEREFORE, in consideration of the mutual promises and covenants hereinafter set forth and other good and valuable consideration, the receipt of which is hereby acknowledged by the parties, the parties hereto agree that the UPA is amended by this Modification as follows:
DESCRIPTION OF MODIFICATION
1)    The Project Title section of the Project Agreement is amended to reflect the correct project identifier as indicated in bold below:
PROJECT TITLE: MCDC2011-001; Rapid Advanced Development to Large Scale Manufacturing of NVX-CoV-2373
2)    The Attachments clause of the Project Agreement is hereby amended to read as indicated in bold below:
12. ATTACHMENTS
Attachments listed herein are hereby incorporated by reference into this Undefinitized Project Agreement.
A.  Statement of Work, “Adjuvanted Recombinant COVID-19 Vaccine Development”
B.  Report Requirements
C.  FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020)
92634972_5

3)     The Health Resource Priority and Allocations Systems (HRPAS) clause of the Project Agreement is hereby incorporated as indicated below:
18.  Health Resource Priority and Allocations Systems (HRPAS)

92634972_5

In order to ensure the success of the Project Agreement Holder’s efforts, a priority rating is incorporated into the project agreement for the procurement of raw materials, consumables, repair parts, and major end item assemblies by the Project Agreement Holder under Title I of the HRPAS.
Priority Rating: Defense Production Act (DPA) Title I - “DO-HR”
Each rated order executed by the Project Agreement Holder must include the following:
(a)  The priority rating: DPA Title I - “DO-HR”;
(b)  A required delivery date or dates. The words “immediately” or “as soon as possible” do not constitute a delivery date;
(c)  The written signature on a manually placed order, or the digital signature or name on an electronically placed order, of an individual authorized to sign rated orders for the person placing the order; and
(d)  A statement that reads in substance:
(1)  This is a rated order certified for national defense use, and you are required to follow all the provisions of the Health Resources Priorities and Allocations System regulation at 45 CFR part 101.

(2)  If the rated order is placed in support of emergency preparedness requirements and expedited action is necessary and appropriate to meet these requirements, the following sentences should be added following the statement set forth in paragraph (d)(1) of this section:
i. This rated order is placed for the purpose of emergency preparedness. It must be accepted or rejected within two (2) days after receipt of the order if:
A.  The order is issued in response to a hazard that has occurred; or
B.  If the order is issued to prepare for an imminent hazard, as specified in HRPAS § 101.33(e).
Except as provided herein, all Terms and Conditions of the referenced MCDC Base Agreement, Project Agreement, and preceding modifications remain unchanged and in full force and effect.
The Project Agreement Holder is required to sign this document and return to Advanced Technology International to finalize this action.
												
	Novavax, Inc.	Advanced Technology International
	By:	/s/ John Herrmann III	By:	[***]
	Name:	John Herrmann III	Name:	[***]
	Title:	EVP, CLO	Title:	Contracts Administrator
	Date:	09/11/2020	Date:	11 Sep 2020 4:28 PM

92634972_5

Attachment C
FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020)
This page is intentionally left blank.  Please see separate Attachment C.
[Pursuant to Regulation S-K, Item 601(a)(5), this attachment setting forth FAR Clause 52.204-25 has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted exhibits to the Securities and Exchange Commission upon request; provided, however, that the Registrant may request confidential treatment of omitted items.]

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