Document:

exhibit1035

Exhibit 10.35    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.    [***] [***]    EXECUTION VERSION                   DATED 22 OCTOBER 2020  NOVAVAX, INC.  AND  THE SECRETARY OF STATE FOR BUSINESS, ENERGY AND INDUSTRIAL  STRATEGY      SARS-COV-2 VACCINE SUPPLY AGREEMENT             

 

    CONTENTS  Clause Page  1. Definitions ......................................................................................................................... 3  2. Governance ...................................................................................................................... 14  3. Facilities .......................................................................................................................... 18  4. Development, Regulatory Obligations and Information Requirements. ......................... 19  5. Manufacture and Supply of Product ................................................................................ 22  6. Production Schedules and Business Continuity .............................................................. 27  7. Ordering ........................................................................................................................... 27  8. Delivery ........................................................................................................................... 29  9. Distribution ...................................................................................................................... 31  10. Risk and Title .................................................................................................................. 32  11. Inspection and Rejection of Product ............................................................................... 32  12. Remedies and Mitigation of Losses ................................................................................ 33  13. Price ................................................................................................................................. 34  14. Invoicing and Payment .................................................................................................... 34  15. Warranty and Undertakings ............................................................................................. 35  16. Future Preparedness ........................................................................................................ 36  17. Anti-Bribery .................................................................................................................... 37  18. Product Security .............................................................................................................. 37  19. Intellectual Property ........................................................................................................ 38  20. Confidentiality ................................................................................................................. 38  21. Indemnities ...................................................................................................................... 43  22. Liability ........................................................................................................................... 44  23. Insurance ......................................................................................................................... 45  24. Force Majeure .................................................................................................................. 45  25. Duration and Termination ............................................................................................... 45  26. Consequences of Termination ......................................................................................... 47  27. Data Protection ................................................................................................................ 48  28. Independent Contractors .................................................................................................. 48  29. Right of Audit, Conflicts of Interest and Prevention of Fraud ........................................ 48  30. Tax Non-Compliance ...................................................................................................... 50  31. Environmental Considerations ........................................................................................ 50  32. Equality, Non-Discrimination and Human Rights .......................................................... 50  33. Supply Chain Rights and Protection ............................................................................... 51  34. Miscellaneous .................................................................................................................. 51  

 

    Schedule 1 Candidate, Product and Specifications .................................................................. 58  Schedule 2 Facilities ................................................................................................................ 59  Schedule 3 Key Performance Indicators and Meeting Schedules ........................................... 60  Schedule 4 Development and Manufacturing Plan .................................................................. 61  Schedule 5 Baselines................................................................................................................ 62  Schedule 6 Delivery Schedule ................................................................................................. 63  Schedule 7 Additional Order Pricing ....................................................................................... 64  Schedule 8 Documentation to Accompany Deliveries ............................................................ 65      

 

  254681-3-31828-v16.0 - 3 - 70-40746871    THIS AGREEMENT ("Agreement") is dated 22 October 2020 and made between:  (1) NOVAVAX, INC., a corporation established under the laws of the state of Delaware  in the US with its primary business address at 21 Firstfield Road, Gaithersburg, MD  20878 ("Novavax"); and  (2) THE SECRETARY OF STATE FOR BUSINESS, ENERGY AND INDUSTRIAL  STRATEGY, acting on behalf of the Crown, whose principal office is at 1 Victoria  Street, London, SW1H 0ET (the "Authority"),  (each a "Party", and collectively the "Parties").  INTRODUCTION  (A) Novavax has discovered and is actively pursuing the clinical development of the  Candidate within the Field in order to file for and secure a Marketing Authorisation for  the Product with the indication in the Field before the Licensing Authority.  (B) Novavax will establish a UK-located supply chain for the Product, including the supply  of Antigen from Fujifilm and the provision of co-formulation, fill/finish, and labelling  services of the Product by [***] (or such alternative suppliers agreed by the Parties  pursuant to this Agreement).   (C) The Authority, on behalf of the Crown, wishes to advance order and secure priority  supplies of the Product, together with other vaccines and other therapeutic products, as  part of its national and international strategy towards vaccination against, treatments  for, and mitigation of the global impact arising from the spread of SARS-CoV-2.    (D) Subject to Novavax actively pursuing Development of the Product, establishing the  UK-located supply chain as set out in this Agreement, and pursuing the filing and grant  of a Marketing Authorisation (and, in consultation with the Authority, any Emergency  Use Authorisation) for the Product in the Territory, the Authority wishes to have  Novavax Manufacture and supply the Product in accordance with the Authority's  requirements as stated herein.  (E) Novavax is willing and, notwithstanding Novavax' other agreements or funding terms  with any Third Party (including the Funding Entities), able to undertake the  Development and Manufacture of the Products and supply to the Authority in  accordance with the terms and conditions of this Agreement.  IT IS AGREED that:  1. DEFINITIONS  1.1 In this Agreement, the following words and expressions shall have the following  meanings:  "Additional Order" has the meaning given in clause 7.3;  "Additional Order Price" means the price per Dose to be supplied pursuant to an  Additional Order calculated in accordance with Schedule 7 and clause 7.4;  

 

  254681-3-31828-v16.0 - 4 - 70-40746871    "Adjuvant" means Novavax' proprietary Matrix‐MTM adjuvant;   "Administering Entity" means any person responsible for administering or having  administered the Product including all Health Service Bodies;  "Affiliate" means, with respect to (i) Novavax, any Person that Controls, is Controlled  by or is under common Control with Novavax from time to time; (ii) any Third Party,  any Person that Controls, is Controlled by or is under common Control with that Third  Party from time to time; and (iii) Authority, any Central Government Body;  "Antigen" means material made using Novavax' technology intended to promote an  immunological response or reaction within the Field which is incorporated in Novavax'  vaccine candidate NVX-CoV2373;  "Applicable Laws" means laws, rules, orders, regulations, ordinances, treaties,  directives, Applicable Standards, rules of national stock exchanges and any other rules  or regulations promulgated by or otherwise having the force of law of any  Governmental Authority or Regulatory Authority in each case in any relevant or  applicable geographical area and/or over any class of persons;      "Applicable Standards" shall mean all applicable cGxP requirements and guidelines  including those issued by the Licensing Authority;  "Authorised Agent" means any authorised agent appointed by the Authority as notified  to Novavax in writing;  "Baselines" means those baselines and targets set against the applicable KPIs set out in  Schedule 5;  "Breaching Party" has the meaning given in clause 25.3.1;  "Business Continuity Event" means any event or issue that could impact on the  operations of Novavax, its Affiliates and Subcontractors, and the ability of Novavax to  supply the Product including, without limitation, any pandemic, any Force Majeure  event, and any circumstances, events, changes or requirement related to the withdrawal  of the UK (or any part of it) from the European Union;  "Business Continuity Plan" means Novavax' business continuity plan which includes  its plans for continuity of the Development, Manufacture and supply of the Product  during any Business Continuity Event;  "Business Day" means any day that is not a Saturday, Sunday or public holiday in  London, England or Washington, DC;  "Candidate" means Novavax' vaccine candidate NVX‐CoV2373, consisting of the  Antigen and including the Adjuvant, as described more fully in Schedule 1, as intended  for the prophylaxis and vaccination against SARS-CoV-2 in humans;  [***];  "Central Government Body" means a body listed in one of the following sub- categories of the UK's Central Government classification of the Public Sector  

 

  254681-3-31828-v16.0 - 5 - 70-40746871    Classification Guide, as published and amended from time to time by the Office for  National Statistics: (i) Government Department; (ii) Non-Departmental Public Body  Assembly Sponsored Public Body (advisory, executive, or tribunal); (iii) Non- Ministerial Department; or (iv) Executive Agency;  "Certificate of Analysis" means the certificate of analysis to accompany each delivery  of Product Delivered to the Authority or Authorised Agent, which certifies that the  Product has been Manufactured, tested and released in compliance with its  Specification, Applicable Standards and Applicable Laws.  "cGCP" or "GCP" means current good clinical practice standards for the design,  conduct, performance, monitoring, auditing, recording, analyses and reporting of  human clinical trials, including as described in the Medicines for Human Use (Clinical  Trials) Regulations 2004 (as amended), Directive 2001/20/EC and the standards  required under Directive 2005/28/EC;  "cGLP" or "cGLP" means current good laboratory practices generally accepted within  the pharmaceutical industry to promote the quality and integrity of data generated in  laboratory testing and to prevent misleading or fraudulent practices, including those  practices described in the Good Laboratory Practices Regulations 1999 and Directive  2004/10/EC;  "cGMP", "GMP" or "Good Manufacturing Practice" means the then-current  principles and guidelines of good manufacturing practice and general biologics  products standards contained in Applicable Laws and guidance including: (i) Directive  2003/94/EC laying down the principles and guidelines of good manufacturing practice  in respect of medicinal products for human use and investigational medicinal products  for human use; (ii) Directive 2001/83/EC laying down the principles and guidelines of  good manufacturing practice for medicinal products; (iii) further guidance as published  by the European Commission in Volume 4 of "The Rules Governing Medical Products  in the European Community"; and (iv) ICH Q7 Guideline, "The Rules Governing  Medicinal Products in the European Union", Volume 4, Part II, in each case as may be  amended from time to time;  "cGVP" or "GVP" means current principles and guidelines of good pharmacovigilance  practice for medicinal products for human use, as set forth in UK Human Medicines  Regulation 2012, Directive 2001/83/EC, Commission Implementing Regulation No  520/2012 and the EMA's Guideline on Good Pharmacovigilance Practice;  "cGxP" or "GxP" means cGMP, cGCP, cGLP and cGVP;   "Clinical Trials" means the clinical trials required to be undertaken for the purposes of  securing a Marketing Authorisation for the Product in the Territory for the indication  in the Field;  "Commercially Reasonable Efforts" means [***];  [***];  "Confidential Information" means any business, commercial or technical information  (in whatever form or media) of either Party that is marked or otherwise indicated as  

 

  254681-3-31828-v16.0 - 6 - 70-40746871    confidential when disclosed or would otherwise be regarded as confidential by a  reasonable business person relating to the business, affairs, technologies, products,  customers, clients or suppliers of that Party or its Affiliates which is provided by or on  behalf of one Party to the other Party pursuant to this Agreement or to which a Party  obtains access as a consequence of entering into or performing this Agreement (in each  case whether before, on, or after the Effective Date).  For the avoidance of doubt, Confidential Information includes: (i) any information or  materials possessed or developed by either Party or their respective Affiliates, whether  possessed or developed before, on, or after the Effective Date, in relation to the Product  and/or services provided hereunder (including know-how, processes, techniques,  specifications, reports, analyses, sources of supply, marketing plans, sales strategies  and pricing information), except for such information that is demonstrably non- confidential in nature; and (ii) any confidential information disclosed by a Party  pursuant to the confidentiality agreement dated 1 June 2020, which shall be deemed  Confidential Information of that Party disclosed under this Agreement. The terms of  this Agreement (but not its existence) will be regarded as the Confidential Information  of both Parties;  "Conforming Product" means Product that has been Manufactured in accordance with,  and meets the requirements of, clause 5.15;  "Control" means: (i) to possess, directly or indirectly, the power to direct the  management or policies of a Person, whether through ownership of voting securities or  by contract relating to voting rights or corporate governance; (ii) to own, directly or  indirectly, fifty per cent. (50%) or more of the outstanding voting securities or other  ownership interest of such Person; or (iii) in the case of a partnership, control of the  general partner, and "Controls" and "Controlled" shall be construed accordingly;   "Crown" means the government of the UK (including the Northern Ireland Assembly  and Executive Committee, the Scottish Government and the Welsh Assembly  Government), including, but not limited to, government ministers, government  departments, government and particular bodies, and government agencies;  "Cure Period" has the meaning given in clause 25.3.1;  “Data Protection Act” means the Data Protection Act 2018 implementing the GDPR;  "Defect" or "Defective" means, in respect of a Product, that it is not compliant with the  Specification, Marketing Authorisation (or Emergency Use Authorisation as  applicable), Applicable Standards, Minimum Remaining Shelf Life at the time of  Delivery, or Applicable Laws, Documentation, batch records, or Applicable Laws;    "Delivery" means delivery (by or on behalf of Novavax) of Conforming Product  pursuant to an Order to the Delivery Location in accordance with clause 8.4.1 (and  "Delivered" and "Deliver" shall be construed accordingly);  "Delivery Location" means the cold chain storage facility within the Territory, as such  facility may be notified in writing to Novavax [***] in advance;  

 

  254681-3-31828-v16.0 - 7 - 70-40746871    "Delivery Schedule" means : (i) for the Priority Order, subject to the Product Delivery  Baselines, the quantities and dates for delivery of such quantities at Schedule 6, as  further refined by the Parties pursuant to clause 8.5; and (ii) for each Additional Order  the schedule for delivery by certain dates of the applicable quantities of Product agreed  between the Parties pursuant to clause 7.4.2; in each case as may be updated by  agreement between the Parties via the Overview Committee in accordance with in  clause 8.2;  "Development" means all activities necessary to develop the Product and support and  maintain the grant of a Marketing Authorisation (and, if applicable, Emergency Use  Authorisation) for the Product in the Territory in the Field;  "Development Activities" means the development activities to be undertaken by or on  behalf of Novavax in respect of the Product as set out in the Development and  Manufacturing Plan;  "Development and Manufacturing Plan" means the plan and estimated timeline  setting out in reasonable and appropriate detail the activities to be undertaken by or on  behalf of Novavax in relation to the Development and Manufacture of Product as  initially set out in Schedule 4 and as may be periodically updated from time to time in  accordance with clause 4.2.2 and 5.2.2 in each case to meet the objectives of this  Agreement to deliver a safe and effective vaccine in the Field for the population in the  Territory, including:  (a) [***];   (b) [***];   (c) [***]; and   (d) [***]  "Devolved Administrations" means the devolved administrations of Scotland, Wales  and Northern Ireland (the Scottish Parliament, the Welsh Assembly and the Northern  Ireland Assembly);  "Documentation" has the meaning given in clause 8.10;  "Dose" means a single individual dose of Product;   "DOTAS" means the Disclosure of Tax Avoidance Schemes rules which require a  promoter of tax schemes to tell HM Revenue and Customs of any specified notifiable  arrangements or proposals and to provide prescribed information on those arrangements  or proposals within set time limits as contained in Part 7 of the Finance Act 2004 and  in secondary legislation made under vires contained in Part 7 of the Finance Act 2004  and as extended to National Insurance Contributions by the National Insurance  Contributions (Application of Part 7 of the Finance Act 2004) Regulations 2012, SI  2012/1868 made under s.132A Social Security Administration Act 1992;  "Effective Date" means the date on which this Agreement is signed by both Parties;  

 

  254681-3-31828-v16.0 - 8 - 70-40746871    “Emergency Use Authorisation” means any emergency use approval issued pursuant  to Regulation 174 of the Human Medicines Regulations 2012 (or any replacement or  superseding legislation);  "Facilities" means each and all of the facilities used in respect of the Manufacturing of  the Product, including those identified in Schedule 2;    "Field" means the vaccination against SARS-CoV-2;  "Force Majeure" means any events beyond a Party's reasonable control, subject to that  Party having taken all reasonable steps (both anticipatory and reactionary) to avoid or  mitigate such risks, such as labour disturbances or labour disputes of any kind, accidents,  failure of any governmental approval required for full performance, civil disorders or  commotions, war, acts of terrorism, acts of God, pandemics other than the SARS-CoV- 2 Pandemic, energy or other conservation measures, explosions, failure of utilities,  mechanical breakdowns, material shortages, default of suppliers or subcontractors, theft,  or other occurrences. For the avoidance of doubt, (i) the withdrawal of the UK from the  European Union and any related circumstances, events, changes or requirements; and  (ii) the pandemic declared in respect of SARS-CoV-2; shall not be deemed an event of  Force Majeure (the "SARS-CoV-2 Pandemic");  "Fraud" any offence under Applicable Laws creating offences in respect of fraudulent  acts, including any fraudulent acts in relation to this Agreement, or defrauding,  attempting to defraud or conspiring to defraud the Crown;  "Fujifilm" means Fujifilm Diosynth Biotechnologies UK Limited having its facilities  at Billingham, Teesside, UK;  "Funding Entity(ies)" means each of (i) The Coalition for Epidemic Preparedness  Innovations and (ii) the U.S. Government;  "GDPR" means the General Data Protection Regulation (Regulation (EU) 2016/679);  "General Anti-Abuse Rule" means: (i) the legislation in Part 5 of the Finance Act 2013;  and (ii) any future legislation introduced into Parliament to counteract tax advantages  arising from abusive arrangements to avoid national insurance contributions;  "Governmental Authority" means any government, supra-national, regional,  regulatory or administrative body, authority, board, commission or agency, including  any corresponding foreign agency or any instrumentality or officer acting in an official  capacity of any of the foregoing, including any court, tribunal or judicial or arbitral  body, or any committee exercising any executive, legislative, regulatory or  administrative functions of government, whether local or national, including the  Regulatory Authorities;  "Government Intervention" has the meaning given in clause 8.8;  "Halifax Abuse Principle" means the principle explained in the CJEU Case C-255/02  Halifax and others;  

 

  254681-3-31828-v16.0 - 9 - 70-40746871    "Health Service Body" means, in so far as they are involved in the administration,  distribution or handling of the Product:  (a) the Department of Health and all divisions and agencies thereof and any  independent NHS board or similar body that may be established including  regional agencies of such board;  (b) a GP (being a medical practitioner providing general medical services or  personal medical services under the National Health Service Act 2006 (c.41)  (whether operating in partnership with others or not));  (c) health service bodies referred to in section 9 of the National Health Service Act  2006 (c.41);  (d) the Secretary of State for Health;  (e) any care trust as defined in section 77 of the National Health Service Act 2006  (c.41);  (f) any NHS foundation trust listed in the register of NHS foundation trusts  maintained pursuant to section 39 of the National Health Service act 2006 (c.41);  (g) any body replacing or providing similar or equivalent services to any of the  above in any area of the UK including any bodies established pursuant to the  Health and Social Care Act 2012 including but not limited to NHS England; and  (h) any statutory successor to any of the above;  "Indemnifying Party" has the meaning given in clause 21.7;  "Indemnitee" has the meaning given in clause 21.7;  "Indirect Tax" means value added, sales, consumption, goods and services taxes or  other similar taxes required by Applicable Law to be disclosed as a separate item on  the relevant invoice including, for the avoidance of doubt, any tax imposed in  compliance with the Council Directive of 28 November 2006 on the common system  of value added tax (Directive 2006/112);  "Initial Term" has the meaning given in clause 25.1;  "Intellectual Property Rights" means all patent rights, supplemental protection  certificates and patent term extensions, trademarks, copyrights, design rights, database  rights, domain names, rights in inventions, confidential information, know-how, trade  names, business names, get-up, logos and trade dress, and all other rights in the nature  of intellectual property rights (whether registered or unregistered) and all applications  and rights to apply for the above, anywhere in the world in each case for their full term  and any extension thereto;  "IT Media" has the meaning given in clause 20.16;  

 

  254681-3-31828-v16.0 - 10 - 70-40746871    "KPI" or "Key Performance Indicators" means the Key Performance Indicators set  out in the Development and Manufacturing Plan, Schedule 3, Schedule 4 and Schedule  5;  "Labelling" means all labels, package inserts (including patient information leaflets),  carton imprints and all other markings on packaging for the Product that are defined as  labels or labelling under the Specifications or otherwise required under Applicable  Laws to market or commercialise the Product for use;  "Licensing Authority" means: (i) the MHRA; and (ii) if it has authority under the  Applicable Laws of the Territory to grant a Marketing Authorisation that has full legal  force in the Territory to authorise commercial use of the Product in the Territory after  its Delivery hereunder, the European Commission following assessment of the relevant  Marketing Authorisation applicable by the European Medicine Agency ("EMA") or  any successor agency thereto with the same authority in the Territory;   "Losses" means any and all liabilities, claims, demands, causes of action, damages,  losses, costs and expenses, including interest, penalties and reasonable legal and  professional fees and disbursements;  "Loss of Supply" has the meaning given in clause 8.8;  "Manufacture", "Manufactured" or "Manufacturing" means all activities involved  in or relating to, as applicable, the manufacturing, quality control testing (including in- process, release and stability testing), processing, Labelling, releasing, packaging,  storage and transport of the Product immediately prior to supply to the Authority  hereunder;  "Marketing Authorisation" means the Regulatory Approval required under  Applicable Laws in the Territory to place the Product on the market for human use  outside of clinical trials but excluding any pricing or reimbursement approvals;  "MHRA" means the Medicines and Healthcare products Regulatory Agency or any  successor agency thereto;   "Minimum Remaining Shelf Life" means the minimum period of time that the Product  may be used pursuant to its Labelling, which period (i) shall be no less than three (3)  months from the date of Delivery of the Product to the Authority; and (ii) is targeted,  subject to ongoing stability studies, to be at least six (6) months from the date of  Delivery of the Product but which, subject to (i) above, will be mutually agreed to by  the Parties prior to initial Delivery of the Product to the Authority;   "Novavax Facilities" means those Facilities which are operated or owned by Novavax  or its Affiliates as identified in Schedule 2 under the heading "Novavax Facilities";    "Novavax Representatives" has the meaning given in clause 17.1;   "Occasion of Tax Non-Compliance" means:  (a) any tax return of Novavax submitted to a Relevant Tax Authority on or after 1  October 2012 is found, on or after 1 April 2013, to be incorrect as a result of:   

 

  254681-3-31828-v16.0 - 11 - 70-40746871    (i) a Relevant Tax Authority successfully challenging Novavax under the  General Anti-Abuse Rule or the Halifax Abuse Principle or under any  tax rules or legislation that have an effect equivalent or similar to the  General Anti-Abuse Rule or the Halifax Abuse Principle; or  (ii) the failure of an avoidance scheme which Novavax was involved in, and  which was, or should have been, notified to a Relevant Tax Authority  under the DOTAS or any equivalent or similar regime; or  (b) any tax return of the Novavax submitted to a Relevant Tax Authority on or after  1 October 2012 gives rise, on or after 1 April 2013, to a criminal conviction in  any jurisdiction for tax related offences which is not spent at the Effective Date  or to a civil penalty for fraud or evasion;  "Orders" means each of the Priority Order and any Additional Orders;  "Oversight Committee" means the joint committee established by the Parties in  accordance with clause 2;  "Person" means an individual, sole proprietorship, partnership, limited partnership,  limited liability partnership, corporation, limited liability company, business trust, joint  stock company, trust, incorporated association, joint venture, Governmental Authority,  or similar entity, institution, body or organisation, including a Regulatory Authority;   "Personal Data" shall have the same meaning as defined in the Data Protection Act;  "Personnel" means the employees, officers, agents and contractors of a Party (or where  the context requires, those of a Party's Affiliates);  [***];  [***];  "Price" means:  (a) [***]; and  (b) for any Doses beyond [***] Doses of Conforming Product supplied pursuant to  this Agreement, the Additional Order Price;  “Priority Order” has the meaning given in clause 7.1;  "Product" means the Candidate to be Developed, including in accordance with the  Development and Manufacturing Plan, and presented in final formulated, labelled and  finished form, for the prophylaxis and vaccination against SARS-CoV-2 in humans;  "Product Delivery Baselines" means the delivery date of the [***] comprising [***];  "Project Manager" has the meaning given in clause 2.1;  "Regulatory Approval" means all licences, registrations, authorisations and approvals  (including approvals of CTAs, MAAs, supplements and amendments, labelling  

 

  254681-3-31828-v16.0 - 12 - 70-40746871    approvals) issued by any Regulatory Authority which are required for the use,  Development, Manufacture and commercialisation of the Product;  "Regulatory Authority" means any Governmental Authority that is concerned with  the safety, efficacy, reliability, Manufacture, investigation, sale or marketing of the  Product, including the MHRA and its successors and its equivalents and their  successors in the Territory;  "Relevant Tax Authority" means HM Revenue & Customs;  "Representation" has the meaning given in clause 34.10;  "Representatives" has the meaning given in clause 20.2;  "SARS-CoV-2 Pandemic" has the meaning given in the definition of "Force Majeure";  "Specification" means the written specifications for the Manufacture, processing,  packaging, labelling, testing and testing procedures, shipping, storage and supply of the  Product, including characteristics, quality and processing of the Product as set out in  Schedule 1, as such specifications may be amended or replaced from time to time as  permitted under the Development and Manufacturing Plan or otherwise under this  Agreement, and ultimately as compliant and set forth with the applicable Marketing  Authorisation (and, if applicable, an Emergency Use Authorisation) for the Product  granted by the Licensing Authority;  "Subcontractor" has the meaning given in clause 34.7.1;  "Term" has the meaning given in clause 25.1;  "Terminating Party" has the meaning given in clause 25.3;  "Territory" means the UK;  "Third Party" means any Person other than Novavax, the Authority and their  respective Affiliates and permitted successors and assigns;   "UK" means the United Kingdom of Great Britain and Northern Ireland;  "VAT" means: (i) any Indirect Tax chargeable under or pursuant to Council Directive  2006/112/EC of the European Union; or (ii) any value added, turnover, sales, use or  distribution Indirect Tax, or Indirect Tax of a like nature in any jurisdiction outside the  European Union;   "Wilful Misconduct" means [***]; and  [***]  1.2 In this Agreement, the following rules of interpretation shall apply:    1.2.1 the words "hereof", "herein", "hereto" and "hereunder", and words of similar  import, when used in this Agreement, shall refer to this Agreement as a whole  and not to any particular provision of this Agreement;  

 

  254681-3-31828-v16.0 - 13 - 70-40746871    1.2.2 when a reference is made in this Agreement to a clause or schedule, such  reference is to a clause of or a schedule to this Agreement respectively, and all  schedules to this Agreement form a part hereof for all purposes;  1.2.3 the table of contents and headings of this Agreement are for convenience only  and shall not affect the construction of this Agreement;  1.2.4 [***];  1.2.5 any undertaking by, or obligation on, a Party to (i) do any act or thing includes  an undertaking to procure the doing of that act or thing by a Party's Affiliates;  and, (ii) not do any act or thing includes an undertaking not to encourage, solicit,  cause, or assist the doing of that act or thing by any Affiliate or other person;  1.2.6 the words and expressions "holding company", "parent undertaking",  "subsidiary" and "subsidiary undertaking" have the meanings given to them  in the Companies Act 2006;  1.2.7 any reference to a Party or the Parties is to a party or the parties (as the case  may be) to this Agreement and shall include legal successors and/or any  permitted assignees of a party;   1.2.8 any use of the masculine, feminine or neuter gender respectively includes the  other genders and any reference to the singular includes the plural (and vice  versa);   1.2.9 the words "other", "include", "including", "such as" and "in particular" (and  similar expressions) do not connote limitation in any way and will be deemed  to be followed by the phrase "without limitation";  1.2.10 any reference to a "month" means a calendar month, any reference to a "day"  means a calendar day;  1.2.11 any reference to GBP, Pounds Sterling or £ is to the lawful currency from time  to time of the UK and to US Dollars or US$ is to the lawful currency from time  to time of the USA;  1.2.12 any reference to a "statute" or "statutory provision" includes any successor  legislation thereto, regulations promulgated thereunder, any consolidation or re- enactment, modification or replacement thereof, any statute or statutory  provision of which it is a consolidation, re-enactment, modification or  replacement and any subordinate legislation in force under any of the same from  time to time except in each case to the extent that any consolidation, re- enactment, modification or replacement enacted after the date of this Agreement  would extend or increase the obligations, in any manner (and whether financial  obligations or otherwise), of either Party hereunder;  1.2.13 provisions that require that a Party, the Parties or any committee hereunder to  "agree", "consent","approve" or the like will require that such agreement,  consent or approval be specific and in writing, whether by written agreement,  letter, approved minutes or otherwise (excluding e-mail or instant messaging,  but a signed PDF document being acceptable);   

 

  254681-3-31828-v16.0 - 14 - 70-40746871    1.2.14 the term "or" and "and/or" will be interpreted in the inclusive sense commonly  associated with the term "and/or";  1.2.15 the words "notify" and "notification" in this Agreement shall, when referring  to notifications as between the Parties to this Agreement (or their  representatives), mean notify or notification in writing in accordance with  clause 34.1 of this Agreement; and  1.2.16 any reference to "writing" or "written" shall include any modes of reproducing  words in a legible and non-transitory form (including email, but excluding SMS  or temporary messages).  1.3 In case of a conflict between the provisions of any schedule and the provisions of the  main body of this Agreement, the provisions of the main body of this Agreement shall  prevail.  1.4 In this Agreement, the Authority is acting as part of the Crown.  2. GOVERNANCE  Project Managers  2.1 From the Effective Date each Party shall appoint, and provide details to the other Party,  of its project manager ("Project Manager") who shall be responsible for and represent  the applicable Party in day-to-day liaison between the Parties concerning performance  and progress under this Agreement against the KPIs and towards the Baselines. The  Project Managers shall facilitate the relationship between the Parties under this  Agreement and collate matters and issues that may be necessary for referral to the  Oversight Committee. Each Party shall procure that its respective Project Manager shall:  2.1.1 make themselves reasonably available to the other Project Manager for  meetings in accordance with the provisions of this clause 2;  2.1.2 co-operate fully, candidly and transparently with the other Project Manager to  ensure that any actual or potential issues, difficulties or problems encountered  in connection with the Product's Development, supply chain infrastructure,  Manufacture or supply under this Agreement, including as measured against the  KPIs and towards the Baselines, are raised and discussed between Project  Managers promptly and in a timely fashion;  2.1.3 be a person of reasonable management seniority who is part of the relevant  Party's team working on and has good first-hand knowledge of the project  concerning the Product from that Party's perspective; and  2.1.4 ensure that they appraise themselves and keep themselves appraised of all  material matters and issues concerning the project relating to the Product.  2.2 The Project Managers shall: (i) discuss and monitor progress of Development,  Manufacturing and performance under this Agreement against the KPIs and towards  achieving the Baselines; (ii) discuss any changes to the Development and  Manufacturing Plan; (iii) discuss any issues or delays that will or might reasonably  impact Novavax' Delivery of Product in compliance with the Delivery Schedule, and  

 

  254681-3-31828-v16.0 - 15 - 70-40746871    seek to find solutions to the same; and (iv) escalate issues or matters to the Oversight  Committee as appropriate.  2.3 Each Party shall use reasonable efforts to minimise change of its Project Manager, but  any change of a Project Manager shall be notified as soon as reasonably possible in  writing and each Party shall use reasonable endeavours to ensure notice of any change  on no less than [***] prior written notice.    Project Manager Meetings  2.4 The Project Managers shall meet in accordance with the meeting schedule set forth in  Schedule 3 or at such other times as they reasonably elect to do so, via a secure  commercial digital platform (or physically, subject to observing then current social  distancing and travel guidelines). Additionally, either Project Manager may call a  special meeting at any time, provided that the requesting Party uses [***] to provide at  least [***] prior notice to the other Project Manager and, to the extent practicable, such  notice includes a proposed agenda for such meeting.  Each Party will be [***]. As  appropriate, other representatives and consultants of the Parties may attend such  meetings as non-voting participants.   Oversight Committee  2.5 In addition to appointment of Project Managers, the Parties shall establish a wider  oversight committee ("Oversight Committee") that shall be responsible for overseeing  the performance and supply contemplated by this Agreement and for making those  decisions delegated to it in respect of the Delivery Schedule pursuant to this clause 2.   Oversight Committee Responsibilities  2.6 The Oversight Committee shall have responsibility for:  2.6.1 monitoring of, and to encourage and facilitate, ongoing communication and  cooperation between the Parties with respect to the Product and performance  under this Agreement;  2.6.2 monitoring the progress of Development of the Product;  2.6.3 monitoring the progress of Novavax in respect of establishing and validating the  UK and EU supply chain required for the performance of this Agreement, and  the status and operation of the UK and EU supply chain required for the  performance of this Agreement (including attending meetings pursuant to  clauses 5.5, Error! Reference source not found., 5.8 and Error! Reference  source not found.);  2.6.4 overseeing, discussing, and providing input on managing and resolving any  issues, concerns or delays in the Manufacturing or Delivery of Product;   2.6.5 overseeing and reviewing any updates to the Development and Manufacturing  Plan (which updates shall, subject to clause 4.2, be made by Novavax) and the  Parties' obligations pursuant to clauses 5.5 to 5.10;   

 

  254681-3-31828-v16.0 - 16 - 70-40746871    2.6.6 agreeing on the Baselines (other than the Product Delivery Baselines) within  [***] of the Effective Date (or such other period agreed by the Oversight  Committee);  2.6.7 agreeing in good faith any changes to the Delivery Schedule or any change to  the Baselines (other than the Product Delivery Baselines);  2.6.8 agreeing the specific quantities and dates for Delivery of Product pursuant to  clause 8.5;  2.6.9 agreeing to the arrangements for and access to any support or assistance agreed  to be provided by the Authority in accordance with clause 2.16;  2.6.10 resolving disputes referred to it by a Party or Project Manager; and   2.6.11 monitoring Novavax' performance against the Development and Manufacturing  Plan, the KPIs and progress towards meeting the Baselines.  Membership of the Oversight Committee  2.7 The Oversight Committee shall comprise [***] representatives from each of the Parties  and their Affiliates (collectively, the "Members") initially set at [***], or such other  number as the Parties may mutually agree. Each Party may replace any or all of its  Members at any time upon written notice to the other Party provided that any  replacement Members are employees, officers or personnel of that Party (or its  Affiliates), have the appropriate skill and experience to perform the duties of a Member,  and sufficient seniority and authorisation on behalf of the applicable Party to take  decisions arising within the scope of the Oversight Committee.   2.8 Any Member may designate a suitable substitute who is an employee, officer or  personnel of that Party (or its Affiliates) to temporarily attend and perform the functions  of that Member. Each Party may, in its reasonable discretion, invite non-Member  representatives of such Party to attend meetings of the Oversight Committee as a non- voting contributor, provided that such persons are bound by confidentiality obligations  no less stringent than those of clause 20.   Meetings of the Oversight Committee  2.9 The Oversight Committee shall meet [***] following the Effective Date (or, if later,  until [***] or at such other times as the Members may mutually deem appropriate,  provided that, the Oversight Committee shall meet within [***] of referral of a dispute  or issue to the Oversight Committee by a Project Manager in order to resolve the same  (or sooner if required).   2.10 The first Oversight Committee meeting shall be no later than [***] after the Effective  Date.   2.11 The Oversight Committee may meet virtually via a secured commercial digital platform,  or where necessary it may meet physically subject to observing then current social  distancing and travel guidelines. Either Party may also call a special meeting of the  Oversight Committee (via a secure commercial digital platform) upon at least [***]  prior written notice to the other Party, or such shorter period as may be agreed on a  

 

  254681-3-31828-v16.0 - 17 - 70-40746871    meeting-by-meeting basis, if such Party reasonably believes that a significant matter  must be addressed prior to the next regularly scheduled meeting, and such Party shall  provide the Oversight Committee (as applicable) no later than [***] prior to the special  meeting with materials reasonably adequate to enable an informed understanding to be  made by its Members. [***] Project Manager shall be appointed and responsible for  preparing reasonably detailed written minutes of all Oversight Committee meetings,  provided that a [***] Oversight Committee member will be responsible for keeping  written minutes of any matters handled in executive session, which minutes will be  circulated for comment and approval by the Authority.    Decision Making  2.12 Except as otherwise expressly provided in this Agreement, decisions of the Oversight  Committee shall be made by [***]. The presence of at least [***] Members  representing each Party (i.e. a total of at least [***] Members) shall constitute a quorum  of the Oversight Committee. The Members shall endeavour in good faith to reach  agreement on any and all matters to be determined or resolved by the Oversight  Committee. For clarity, subject to clause 4.2.2 and 5.2.2, Novavax shall have sole and  final discretion on the contents of the Development and Manufacturing Plan and any  amendments thereto.  2.13 If at any time, the Oversight Committee is unable to reach a [***] decision within [***]  (or sooner if required) after it has met and attempted to reach such decision, then either  Party may, by written notice to the other, have such matter referred for resolution by an  appropriate senior executive officer of each Party. Within [***] (or sooner if required)  of such notice, the relevant senior executives and member shall meet and attempt to  resolve the dispute by good faith negotiations.  Information Disclosures  2.14 Through the Project Managers and Oversight Committee, [***].   Notifications  2.15 Novavax shall ensure (through its Project Manager or the Oversight Committee) that it  will notify the Authority or the Authority's Project Manager within [***] upon its  knowledge of:  2.15.1 [***];  2.15.2 [***];  2.15.3 [***];  2.15.4 [***];  2.15.5 [***];   2.15.6 [***];   2.15.7 [***];  

 

  254681-3-31828-v16.0 - 18 - 70-40746871    2.15.8 [***]; and  2.15.9 [***].   Authority Support and Assistance  2.16 Through the Oversight Committee or via its Project Manager, Novavax may request in  writing to the Authority reasonable support or assistance from the Authority to facilitate  (but not perform) Novavax' performance of its obligations under this Agreement,  including requests to receive support comprising: (i) access to consultants and  personnel of the Authority which have local knowledge and experience in the  Manufacture and regulatory approval of vaccine products in the UK, (ii) access to the  Authority's network of companies, stakeholders and other relevant subject matter  experts who may help facilitate and assist Novavax in the Manufacture and Delivery of  the Product, and (iii) guidance and other technical support that may be reasonably  available from the Authority.   2.17 The Authority shall act in good faith and use [***] to provide or facilitate introductions  to those who can provide the support or assistance reasonably requested by Novavax  pursuant to this Agreement. Notwithstanding the foregoing, the Authority shall not be  obliged to [***]. The Parties acknowledge and agree that, in respect of any such support  or assistance:  2.17.1 [***];   2.17.2 [***];  2.17.3 the Authority may require Novavax to enter into a separate agreement in respect  of such request at the Authority's reasonable request; and  2.17.4 [***].     2.18 Pharmacovigilance. The Authority will cooperate with regard to the reporting of safety  information involving the Product supplied under this Agreement (including any  Product donated or resold pursuant to clause 9.2) in accordance with Applicable Laws  and Applicable Standards on pharmacovigilance and clinical safety, including, without  limitation, entering into an appropriate pharmacovigilance agreement.  3. FACILITIES  Responsibility for establishing UK Supply Chain  3.1 Novavax shall be responsible [***] for securing Manufacturing Facilities for the  Manufacture of Product, including those within the Territory. It is intended that such  Manufacturing Facilities shall include those operated by Fujifilm (for the Antigen) and,  subject to Novavax' further diligence, [***] for fill/finish activities, each in accordance  with clause 5 below ("Primary Facilities"). If, despite Novavax using Commercially  Reasonable Efforts, one or more of those Primary Facilities cannot be secured on  commercially reasonable terms or they are not suitable for good demonstrable scientific  and technical reasons, the issue shall be communicated to the Oversight Committee for  discussion. In connection with the foregoing, the Authority shall provide reasonable  assistance to Novavax to facilitate establishment of the Primary Facilities as part of the  

 

  254681-3-31828-v16.0 - 19 - 70-40746871    supply chain (or, [***], alternative Facilities to the extent that agreements with Fujifilm  and/or [***] cannot be concluded). However, for the avoidance of doubt, the Authority  shall have no right (on behalf of Novavax) or obligation to contract with or perform any  acts for the Facilities [***] and Novavax shall have ultimate decision-making authority  in regard to all matters related to the Facilities.  Facilities for Manufacture of the Product  3.2 Novavax represents to the Authority that Schedule 2 comprises the complete list of all  Facilities that are or will be involved or required in any aspect of the Manufacturing of  the Product (including the Adjuvant and Antigen) as of the Effective Date. Novavax  agrees to notify the Oversight Committee should any change be made to or new  facilities need to be added to Schedule 2.    Validation Commitment  3.3 Novavax shall ensure that pursuant to its (or its Affiliates') applications for the  Marketing Authorisation (and, if applicable, Emergency Use Authorisation) in respect  of the Product, it and its Affiliates shall use Commercially Reasonable Efforts to qualify  and validate in accordance with Applicable Laws and Applicable Standards (i) the  Facilities for the Manufacture of Product; and (ii) those other facilities being used by  or on behalf of Novavax and its Affiliates for the Manufacture of Product based within  the European Economic Area (EEA) but outside of the Territory, such that Product for  the Territory could be sourced from Manufacture within those other facilities.   Maintenance of Facilities  3.4 Novavax shall:  3.4.1 ensure that the Facilities have, and will throughout the Term continue to hold,  all necessary Regulatory Approvals to operate and to Manufacture Conforming  Product for supply and Delivery under and in accordance with this Agreement;  and  3.4.2 ensure that all Facilities shall meet and operate in accordance with all necessary  Applicable Standards (including GxP) and Applicable Laws for the  Manufacture of Conforming Product.  4. DEVELOPMENT, REGULATORY OBLIGATIONS AND INFORMATION  REQUIREMENTS.  Developing the Product  4.1 Novavax shall use Commercially Reasonable Efforts to Develop the Candidate in order  to secure a Marketing Authorisation (and, if applicable, an Emergency Use  Authorisation) in the Territory for the Product with the indication in the Field in  accordance with the Development and Manufacturing Plan, Applicable Law and  Applicable Standards. Novavax shall measure its progress against the Development and  Manufacturing Plan using the KPIs and Baselines to communicate such progress to the  Oversight Committee.   

 

  254681-3-31828-v16.0 - 20 - 70-40746871    Responsibility for Development and Execution of the Development and Manufacturing  Plan  4.2 The Development and Manufacturing Plan at Schedule 4 and any update thereto shall:  4.2.1 set out details and estimated timelines for the Development of the Product in  accordance with this Agreement;   4.2.2 be consistent with the provisions and objectives of this Agreement to Develop  and Deliver Conforming Product to the Authority pursuant to a Marketing  Authorisation granted in the Territory with an indication in the Field in  accordance with the Delivery Schedule and Baselines; and   4.2.3 not impose obligations on the Authority and/or Authority's Affiliates unless the  Authority has agreed in writing to assume responsibility for such obligations.  4.3 Novavax shall be responsible [***] for the Development of the Product, the  implementation and execution of the Development and Manufacturing Plan and for  undertaking, and having undertaken, all activities to Develop and Manufacture the  Product and to file for and prosecute through to grant a Marketing Authorisation  (including, if applicable, an Emergency Use Authorisation) in the UK for the Product  for an indication within the Field, doing so in accordance with Applicable Standards  and Applicable Law.  4.4 [***]  Updates to the Development and Manufacturing Plan  4.5 The Development and Manufacturing Plan (except for the Delivery Schedule and  Baselines which may only be adjusted in accordance with clause 2.6.6) may be adjusted  and updated by Novavax, as Development progresses, on a reasonable basis and having  regard to achievement of the objective under clause 4.1 and Novavax' obligations in  clause 4.2.   4.6 [***]  Clinical Trials  4.7 Novavax or its Affiliate shall [***] and shall take responsibility for all obligations  imposed on the sponsor of the Clinical Trials undertaken in respect of the Product. The  Authority shall use Commercially Reasonable Efforts to assist Novavax' conduct of the  UK-based Phase III Clinical Trial via facilitating access to the National Institute of  Health Research to facilitate access to clinical trial sites in the UK, principle  investigators, immunology lab testing facilities and personnel, and IRB(s), and by  providing advice and Commercially Reasonable Efforts to facilitate streamlined  Regulatory Approvals (via introductions to the Health Research Authority and MHRA  only). [***]   4.8 Novavax shall ensure that the Clinical Trials undertaken are performed in a professional  and diligent manner, and in accordance with the Applicable Standards relevant to such  trials, including securing all necessary Regulatory Approvals, consents and licences  required for undertaking those Clinical Trials, including those of any ethics committee.   

 

  254681-3-31828-v16.0 - 21 - 70-40746871    Marketing Authorisation Commitments   4.9 Novavax shall (itself or through its Affiliate) use Commercially Reasonable Efforts to  secure a valid Marketing Authorisation from the Licensing Authority for the Product  with the indication in the Field, and any other applicable Regulatory Approvals, each  as required in the Territory for the Development, Manufacture and Delivery of the  Product in the Territory. Once the Marketing Authorisation and any other applicable  Regulatory Approvals are secured, Novavax shall maintain all such Regulatory  Approvals until [***].   4.10 Novavax shall ensure that the Marketing Authorisation granted for the Territory will  include the Facilities as facilities qualified and validated for Manufacture of the Product  to be supplied to the Authority under this Agreement.   4.11 [***]  4.12 Novavax shall, and shall procure that its Affiliates and Subcontractors shall, comply  with all requests and recommendations of the Licensing Authorities and any other  Regulatory Authority in connection with the Product and its Manufacture.  Product Information  4.13 Where reasonably requested by the Authority, Novavax shall [***].  Emergency Use Authorisation  4.14 The Parties acknowledge and agree that Novavax or the Authority may (but shall be  under no obligation to) apply for an Emergency Use Authorisation for the Product with  the Licensing Authority for the Territory for use with the indication in the Field.  However, securing an Emergency Use Authorisation shall not relieve Novavax from  the ongoing obligation to secure a Marketing Authorisation in the Territory for the  Product with the indication in the Field.  Jurisdictional Limitations  4.15 If due to its legal seat of incorporation Novavax is precluded or prevented from  performing any obligations required of it pursuant to this Agreement due to Applicable  Laws or Applicable Standards, including fulfilling any regulatory activities, applying  for, maintaining or holding any Regulatory Approval, or Manufacturing or delivery of  Product, then Novavax shall notify the Authority and shall procure that one or more of  its Affiliates established within the Territory (or another acceptable jurisdiction) or,  with the Authority's prior written consent and solely in connection with holding a  Marketing Authorisation and performing the obligations of a Marketing Authorisation  holder, an approved Third Party service provider, shall fulfil those of Novavax'  obligations under this Agreement that Novavax is otherwise precluded or prevented  from performing. Novavax shall be responsible to the Authority for any performance,  non-performance, act or omission by such Affiliate(s) or Third Party service provider  in connection with the foregoing.  In connection with the foregoing, no later than [***],  Novavax shall notify the Authority of the identity of any Affiliate or approved Third  Party service provider in whose name the Marketing Authorisation will be filed.   

 

  254681-3-31828-v16.0 - 22 - 70-40746871    5. MANUFACTURE AND SUPPLY OF PRODUCT  Manufacturing and Supply Commitment  5.1 Novavax shall, or shall procure its Affiliates shall, Manufacture and supply the Product  to the Authority, and the Authority shall purchase the Product, subject to and in  accordance with the terms and conditions of this Agreement.  Manufacturing Plan  5.2 Novavax shall use Commercially Reasonable Efforts to implement the Manufacturing  activities described in the Development and Manufacturing Plan [***].  Novavax'  progress against the Development and Manufacturing Plan shall be measured by  reference to the KPIs and the Baselines, which shall be communicated to and discussed  within the Oversight Committee. The Development and Manufacturing Plan at  Schedule 4 and any update thereto shall:  5.2.1 set out estimated timelines for technology transfer, engineering and PPQ atches  and the commercial Manufacture of the Product in accordance with this  Agreement;   5.2.2 be consistent with the provisions and objectives of this Agreement to  Manufacture and Deliver commercial supplies of Conforming Product to the  Authority pursuant to a Marketing Authorisation granted in the Territory for an  indication within the Field and in accordance with Priority Supply and the  Delivery Schedule and Baselines; and   5.2.3 not impose obligations on the Authority and/or the Authority's Affiliates unless  the Authority has agreed in writing to assume responsibility for such obligations.  5.3 The Manufacturing activities in the Development and Manufacturing Plan may be  adjusted and updated by Novavax on a reasonable basis and having regard to  achievement of the objective under clause 5.2.2. [***]   Responsibility for Manufacturing and licensing obligations   5.4 Novavax shall be responsible [***] for establishing a supply chain for, and the  Manufacture of, the Product, the implementation and execution of the Manufacturing  under the Development and Manufacturing Plan, and for undertaking, and having  undertaken, all activities required thereunder to Manufacture the Product as  Conforming Product in compliance with Applicable Laws (including securing and  maintaining applicable Regulatory Approvals). [***]  Supply of Antigen   5.5 The Parties agree that their preferred approach is for the Antigen to be manufactured  on behalf of Novavax and its Affiliates by Fujifilm in the UK, but the Authority  acknowledges and agrees that the responsibility for Manufacture of the Product resides  with Novavax, who shall have ultimate decision-making authority in regard to  Manufacture of the Product, including sourcing of Antigen to meet the Delivery  Schedule and Baselines. [***] The Authority shall provide reasonable assistance to  Novavax, for Novavax to secure a timely agreement with Fujifilm in respect of the  

 

  254681-3-31828-v16.0 - 23 - 70-40746871    manufacture of the Antigen required to fulfil the Priority Order, but Novavax shall be  [***] at [***] for securing such agreement or letter of intent or authorisation and such  capacity. Novavax shall use Commercially Reasonable Efforts to conclude an  agreement or letter of intent or authorisation with, and secure sufficient capacity for the  Orders under this Agreement at, Fujifilm (or failing that another facility for  Manufacture of Antigen) no later than [***].   5.6 If Novavax determines [***] that Fujifilm does not have sufficient capacity or  capabilities to perform the activities contemplated by this Agreement within the period  contemplated by the Delivery Schedule, or that the terms offered by Fujifilm, despite  having used Commercially Reasonable Efforts to negotiate the same, are not  commercially reasonable, Novavax shall use Commercially Reasonable Efforts to  secure Antigen manufacturing services and facilities with other CMOs in order to fulfil  Orders pursuant to this Agreement. In selecting CMOs, Novavax shall [***], but the  Parties acknowledge and agree that:   5.6.1 Novavax shall (subject to same being approved under the Marketing  Authorisation issued for the Territory) have the ultimate decision-making  authority and responsibility in regard to where the Product is Manufactured in  the EEA order to meet the Delivery Schedule and Baselines;   5.6.2 any use of facilities outside the EEA are subject to [***]; and  5.6.3 [***]   5.7 If the Authority secures spare capacity at manufacturing facilities suitable for the  Manufacture of the Antigen in excess of the quantity of Antigen required to fulfil the  Priority Order, the Authority may (but is not obliged to) offer such capacity to Novavax,  and Novavax may elect to utilise such capacity on terms to be agreed between the  relevant parties. If Novavax wishes to extend the supply of Antigen from Fujifilm  beyond the Antigen required to fulfil the Priority Order, the Authority shall provide  reasonable assistance to Novavax to assist Novavax in securing such an agreement  [***].   Fill/Finish for Product  5.8 The Product shall be supplied by Novavax (or its Affiliate) as finished, labelled and  quality released drug product in accordance with the Marketing Authorisation. The  Parties agree that their preferred approach is that the co-formulation, fill/finish, and  labelling be undertaken by [***] in the UK at the facilities of [***], subject to capacity  and further due diligence by Novavax, but the Authority acknowledges and agrees that  the responsibility for Manufacture of the Product resides with Novavax, who shall have  ultimate decision-making authority and responsibility in regard to Manufacture of the  Product, including sourcing of fill/finish contractors, in order to meet the Delivery  Schedule and Baselines. [***] The Authority shall provide reasonable assistance to  Novavax to assist Novavax in securing a timely agreement or letter of intent or  authorisation with [***] in respect of such activities, but Novavax shall be [***] for  securing such capacity [***]. Novavax shall use Commercially Reasonable Endeavours  to conclude an agreement or letter of intent or authorisation with and secure capacity at  [***] (or, failing that, another fill/finish facility) no later than [***] .   

 

  254681-3-31828-v16.0 - 24 - 70-40746871    5.9 If Novavax determines [***] that [***] does not have sufficient capacity or capabilities  to perform the activities contemplated by this Agreement within the period  contemplated by the Delivery Schedule, or that the terms offered by [***], despite  having used Commercially Reasonable Efforts to negotiate the same, are not  commercially reasonable, Novavax shall use Commercially Reasonable Efforts to  secure co-formulation, fill/finish, and labelling services and facilities with other CMOs  in order to fulfil Orders pursuant to this Agreement. In selecting CMOs, Novavax shall  [***], but the Parties acknowledge and agree that:   5.9.1 Novavax may use an EEA-based facility for such Manufacture and shall  (subject to same being approved under the Marketing Authorisation issued for  the Territory) have the ultimate decision-making authority and responsibility in  regard to where the Product is Manufactured in the EEA order to meet the  Delivery Schedule and Baselines;   5.9.2 any use of facilities outside the EEA are subject to [***]; and  5.9.3 [***]  Novavax' Use of Excess Antigen Capacity  5.10 Notwithstanding the provisions of clause 5.11 and 5.12 below, if Novavax [***],  despite its Commercially Reasonable Efforts to secure and complete technology  transfer for sufficient fill/finish capacity, where Antigen is manufactured to meet [***]  that [***] exceeds the fill/finish capacity secured from [***] or any alternate fill/finish  provider by Novavax pursuant to clauses 5.8 and 5.9, then Novavax shall be entitled to  export such excess Antigen from the UK provided, in any case, that:  5.10.1 at least [***] Doses of Conforming Product have first been Delivered to the  Authority;   5.10.2 [***]; and   5.10.3 [***].   Alternative Facilities  5.11 Prior to commencement of the full-scale manufacturing of Antigen by Fujifilm (or such  other CMO secured by Novavax pursuant to clause 5.5 and 5.6), Novavax and the  Authority, through the Oversight Committee, shall discuss, acting in good faith, an  interim supply of Conforming Product from Novavax' existing Manufacturing facilities.  The Authority acknowledges that such supply is subject to Novavax' obligations to  CoVax and its Funding Entities.  5.12 If Novavax is delayed from fulfilling, or otherwise limited or unable to fulfil, Orders  from any of the Facilities in the UK, then Novavax shall notify the Authority and use  Commercially Reasonable Efforts to secure Manufacture of Product from other  facilities within its and its Affiliates' EEA-based supply chain (or, [***], facilities in its  supply chain based outside of the EEA) in order to fulfil Orders in accordance with the  Delivery Schedule and Baselines hereunder.    Priority Supply  

 

  254681-3-31828-v16.0 - 25 - 70-40746871    5.13 [***]. Furthermore, Novavax shall ensure that Conforming Product shall be supplied  to the Authority on a priority supply basis, meaning that: `  5.13.1 Novavax will supply the Authority with Conforming Product in full to meet the  total quantity required under the Priority Order prior to supplying any Product  to any other Person in, or for use within, the Territory;   5.13.2 Novavax shall not Manufacture or supply Product for any Third Party outside  of the Territory using any of the Facilities secured pursuant to Novavax'  obligations under this clause 5 until the Priority Order has been satisfied in full  through Delivery to the Authority of sufficient quantities of Conforming  Product to meet the Priority Order (each of clause 5.13.1 and 5.13.2 being "First  Priority Supply"); and  5.13.3 with respect to (i) Additional Orders; or (ii) fulfilment of any Order to be made  from Facilities other than those UK-based Facilities secured pursuant to  Novavax' obligations under this clause 5 (including pursuant to clause 5.12);  then in either case of (i) or (ii) such supply shall be:   (a) made to the Authority at a volume that is proportionately comparable on  a pro-rated basis to each of the volumes being provided to each other  Person being supplied Product ("Pro-Rated Formula") on or broadly  around the same time from the same facilities, such proportion being  calculated by [***]; and   (b) notwithstanding (a) above, in the case of Additional Orders being  Manufactured at the Facilities:  (i) fulfilment of such Orders shall be prioritised, having regard to  meeting the applicable Delivery Schedule, following any other  earlier and confirmed orders to Third Parties; and  (ii) supply of Product to fulfil such Additional Orders from the  Facilities shall be made to the Authority based on the Pro-Rated  Formula, at least as early, if not earlier, than any supply of  Product being made available to any Third Party ordered at or  around the same time as such Additional Orders from the same  Facilities;  (collectively the provisions of this clause 5.13.3 being "Equal Priority  Supply"); and  collectively the First Priority Supply and Equal Priority Supply being "Priority  Supply").   5.14 If Novavax proposes to supply Product to a Third Party outside, and for use outside, of  the Territory before the grant or issuance of a Marketing Authorisation (and, if  applicable, any Emergency Use Authorisation) for the Product in the Territory, then  Novavax shall first notify the Authority of such decision and, subject to Priority Supply,  Novavax shall, at Authority's election (i) supply Product to the Authority pending grant  of the Marketing Authorisation (and, if applicable, an Emergency Use Authorisation)  

 

  254681-3-31828-v16.0 - 26 - 70-40746871    and in quantities in compliance with the outstanding volume of Orders for the Authority;  or (ii) reserve and allocate for the Authority physical volumes of Product in quantities  in compliance with the outstanding volume of Orders for the Authority and hold the  same for Delivery to the Authority immediately upon grant of the Marketing  Authorisation (and, if applicable, Emergency Use Authorisation) or earlier upon the  Authority's written request; or (iii) not take any steps under (i) or (ii) above.  Product Conformance  5.15 Novavax shall ensure that all Product supplied to the Authority (or its agent or designee)  under this Agreement shall:  5.15.1 be Manufactured (including being quality released) and labelled in accordance  with Applicable Law, Applicable Standards, all Documentation and batch  records, quality standards and all Regulatory Approvals;  5.15.2 meet the Specification and shall, until expiry of the Minimum Shelf Life,  continue to comply with the Specification, and meet the Marketing  Authorisation and relevant Regulatory Approvals (subject to the proper storage  and handling of the Product in accordance with the instructions in the SmPC by  Authority or its designees or agents);  5.15.3 be free of any identifiable Defect and shall be unadulterated;   5.15.4 satisfy the Minimum Shelf Life at the time of Delivery; and  5.15.5 be new and have not (i) previously left the control of Novavax or its Affiliates;  (ii) been rejected or returned by any other entity; or (iii) been reprocessed or  reworked; in each case of (i), (ii) and (iii) prior to their supply to the Authority  under this Agreement.  No Exclusive Purchasing Arrangement  5.16 Nothing in this Agreement shall amount to an exclusive purchasing obligation on the  Authority or preclude or restrict the Authority from purchasing any products  whatsoever from Third Parties, including any products that are complementary to,  competitive to, equivalent to, or substitutable for the Product or that are indicated for  or expected to be beneficial for use in the prophylaxis, treatment or vaccination against  SARS-CoV-2.   Manufacturing Failures  5.17 Without excusing or limiting the obligations under clause 5.15 and 8.8, and subject to  notifying the Authority of the use of such alternative facilities, if for any reason related  to the Facilities, Novavax is unable to supply Conforming Product to Authority in  accordance with the Delivery obligations of this Agreement, then Novavax shall instead  source and supply Product from its other supply chain arrangements involved in the  Manufacture of Product for countries outside the Territory and shall ensure that such  Product sourced from those other facilities may be supplied hereunder as Conforming  Product.   

 

  254681-3-31828-v16.0 - 27 - 70-40746871    6. PRODUCTION SCHEDULES AND BUSINESS CONTINUITY  Production Schedules  6.1 On a [***] basis Novavax shall provide the Oversight Committee with the then most  current and accurate production schedule for the Manufacture of Product that is the  subject of this Agreement, which shall include the status of Facility reservations and  stock levels of Antigen, Adjuvant, formulated drug substance and final (but unlabelled)  Product.  Business Continuity Plan  6.2 Novavax and its Affiliates currently have in place and shall, in consultation with the  Authority within [***] of the Effective Date, further develop, implement and thereafter  keep current, a reasonable risk management programme for the Facilities and  Manufacture and Delivery of the Product, including a Business Continuity Plan. At the  Authority's request, Novavax shall make a copy of the current Business Continuity Plan  available to the Authority, or its representatives, for review. Novavax shall keep the  Business Continuity Plan under review and shall update the same from time to time as  reasonably appropriate.  6.3 Novavax shall:   6.3.1 test its Business Continuity Plan at reasonable intervals, and in any event no less  than [***], and update it to address any material failures; and  6.3.2 use Commercially Reasonable Efforts to ensure that its and its Affiliates'  Business Continuity Plan complies, on an ongoing basis, with any specific and  reasonable business continuity requirements, as may be discussed pursuant to  the Oversight Committee.  6.4 For the avoidance of doubt, having a Business Continuity Plan and its implementation  does not relieve Novavax (or its Affiliates) from the Manufacturing and supply  obligations under this Agreement.  7. ORDERING  Priority Order  7.1 Within [***] following the Effective Date the Authority shall submit to Novavax a  written order for sixty million (60,000,000) Doses of the Product (the "Priority  Order"), [***].    7.2 Novavax shall accept the Priority Order in writing, and the confirmed Priority Order  shall be binding upon the Parties and subject to the terms and conditions set out in this  Agreement. [***].  

 

  254681-3-31828-v16.0 - 28 - 70-40746871    Additional Orders  7.3 During the Term, the Authority may from time to time request additional Doses of the  Product (each a "Additional Order").    7.4 If the Authority requests an Additional Order:   7.4.1 [***];  7.4.2 the Parties shall, acting reasonably and in good faith, agree a mutually  acceptable delivery schedule for the Additional Order (which for the purposes  of this Agreement shall become the Delivery Schedule applicable to such  Additional Order);   7.4.3 the Authority shall submit an order for the Additional Order which reflects the  quantity and delivery schedule agreed by the Parties, together with the  Authority's order number, VAT number, and invoice address; and  7.4.4 Novavax shall accept such Additional Order in writing.    7.5 An Additional Order shall be binding upon the Parties in accordance with the terms and  conditions set out in this Agreement. All other terms and conditions (including any  terms and conditions which the Authority or Novavax purports to apply under any order,  acceptance, specification or other document attached to any order or acceptance form)  are hereby excluded.  Reduced Volume  7.6 The Authority shall be entitled, on written notice to Novavax, to cancel or reduce (in  whole or part) the Doses of the Product ordered in [***] or any Additional Order (such  reduction being the "Reduced Volume"):   (a) following any actual or reasonably threatened and/or reasonably  anticipated material Loss of Supply (which will include for the  avoidance of doubt an interruption in production which will reasonably  be expected to result in a subsequent interruption in deliveries) which  has not been remedied by Novavax within [***], by an amount equal to  the amount subject to such Loss of Supply;   (b) following any adjustment or variation of the Development and  Manufacturing Plan, any adjustment or variation of Specification or  Marketing Authorisation; or   (c) subject to clause 8.6.2 and 8.6.3, any actual or reasonably threatened  and/or anticipated failure to meet the Delivery Schedule or  (notwithstanding adjustment of the Delivery Schedule) the Product  Delivery Baselines.   Following such adjustment the Parties shall agree in good faith a revised Delivery  Schedule for the remaining volumes of Doses of Product to be Delivered, which shall  be set as close in time to the original Delivery Schedule as is reasonably possible (and  is compliant with principles of Priority Supply) and if agreement cannot be reasonably  

 

  254681-3-31828-v16.0 - 29 - 70-40746871    reached the Authority may further adjust [***] or Additional Order pursuant to this  clause.  7.7 The effect of the Reduced Volume shall be automatically binding on the Parties and the  total Price payable under this Agreement shall be decreased by the Reduced Volume of  the Doses of the Product (a "Price Reduction") and Novavax shall have no further  obligation to provide such Reduced Volume of Doses. Novavax shall promptly refund  any Price Reduction (to the extent already paid by the Authority) to the Authority.   7.8 Following any change in accordance with the foregoing or pursuant to clauses 8.8 or  12, each of the Orders shall thereafter reflect the new volume of Product adjusted  according to this clause.  7.9 If the Authority elects to receive a Reduced Volume, the sole and exclusive remedy of  the Authority in respect of that Reduced Volume shall take the form of the Price  Reduction provided that this shall not relieve Novavax for any liability in respect of  any material breach (if applicable) of this Agreement, including its failure to use  Commercially Reasonable Efforts where expressly required under this Agreement.  8. DELIVERY  Delivery Schedule  8.1 Subject to the provisions of this clause 8, Novavax shall Deliver Conforming Product  to the Authority or its Authorised Agent in the volumes and timelines set out in the  applicable Delivery Schedule.  8.2 If due to events beyond Novavax' reasonable control the Product is not going to be  Delivered, in any material way, in accordance with the Delivery Schedule, then  Novavax shall [***] notify the Oversight Committee and, provided Novavax has used  Commercially Reasonable Efforts to Deliver in accordance with the Delivery Schedule  the Oversight Committee, shall discuss a reasonable and proportionate amendment to  the Delivery Schedule recognising that [***] delivery of the Product is a fundamental  requirement for the Authority. The Delivery Schedule may only be updated and refined  during the Term with the written agreement of the Oversight Committee (such consent  not to be unreasonably withheld or delayed)], subject always to (i) the Product Delivery  Baselines and (ii) the Delivery Schedule conforming with Novavax' obligations to  supply Product in accordance with Priority Supply. For the avoidance of doubt, if a  failure of Novavax not to use Commercially Reasonable Efforts in accordance with its  obligations under this Agreement directly resulted in Novavax' request for such change  to the Delivery Schedule, such failure shall entitle the Authority to withhold its consent  to any change to the Delivery Schedule.  Authority's Authorised Agents   8.3 Where and insofar as expressly stated in writing by the Authority to Novavax, the  Authority may appoint one or more Authorised Agents to act on the Authority's behalf  in relation to part or all of this Agreement, including to receive one or more Deliveries  of any Product (or part thereof). Novavax shall work and co-operate reasonably with  each Authorised Agent appointed by the Authority upon such notification.  

 

  254681-3-31828-v16.0 - 30 - 70-40746871    Delivery  8.4 Novavax shall:   8.4.1 deliver the Product [***] ("Delivery") with Delivery being complete upon [***];  8.4.2 ensure that the total volume of Doses of the Product set forth in the Orders (as  may be amended) shall be Delivered;   8.4.3 ensure that Delivery of Product shall not be made earlier than:   (a) subject to clause 8.6.2, the applicable dates set forth in the Delivery  Schedule without the agreement of the Authority; or  (b) the date of grant or issuance of a Marketing Authorisation for the  Product in the Territory, unless Delivery is requested earlier by the  Authority,  and any Delivery (or attempted Delivery) of Product earlier than the applicable  date set forth in the Delivery Schedule or before grant/issuance of a Marketing  Authorisation (unless requested earlier by Authority) may be [***].  8.5 Notwithstanding Novavax' obligation to Deliver the Priority Order (and any Additional  Order) in the quantities and during the periods set forth in the Delivery Schedule, for  each instalment set out in the Delivery Schedule, the Oversight Committee may agree  to further refine the timing for Delivery of that specific instalment and the quantities.   8.6 Without prejudice to the Authority's rights under clause 7.6 (which may be exercised at  any time), Novavax shall not be in breach of its obligation to comply with the Delivery  Schedule if:  8.6.1 there is a delay in Novavax securing the Marketing Authorisation (and, if  applicable, any Emergency Use Authorisation) for the Product in the Territory  provided that (i) Novavax, its Affiliates and Subcontractors used Commercially  Reasonable Efforts in their respective activities to file for and secure the grant  or issuance of the same; and (ii) delay was not caused by the breach of this  Agreement or the negligence of, Novavax, its Affiliates or Subcontractors;   8.6.2 there is any minor variance of dates of Delivery compared to the Delivery  Schedule of up to [***] due to the unpredictable nature of the Manufacturing of  the Products, so long as such variance is agreed with the Authority in writing at  least [***] prior to the scheduled Delivery date for such Products as set out in  the Delivery Schedule (a "Grace Period");  8.6.3 there is any minor variance in quantity of Doses Delivered compared to the  quantities in the Delivery Schedule of up to [***]; or  8.6.4 the Parties agree, from time to time and by mutual consent, to vary the Delivery  Schedule.  Delays and Loss of Supply  

 

  254681-3-31828-v16.0 - 31 - 70-40746871    8.7 Novavax shall [***] from the issue being identified) notify the Authority in writing of  any actual or anticipated delay or change to the Delivery Schedule or any actual or  anticipated delay in Delivery of Product against the Delivery Schedule.  8.8 Without prejudice to clause 7.6, if the Authority's supply is materially interrupted,  delayed or deferred due to (i) any orders or directions pursuant to the US Defense  Production Act, or as a consequence of any other government interventions  ("Government Interventions"); (ii) demands or obligations from Funding Entities or  other Third Parties; or (iii) commitments accepted by Novavax; (collectively a "Loss  of Supply") and such Loss of Supply is not promptly remedied by Novavax within  twenty (20) Business Days, then in either case, the Authority shall be entitled:  8.8.1 to terminate this Agreement pursuant to clause 25.4; and  8.8.2 as its sole and exclusive remedy to recoup [***] provided to Novavax, provided  however, that:   (a) if the Loss of Supply is caused by Government Intervention then  Novavax shall only be required to refund such monies to the Authority  to the extent the [***]; or  (b) if the Loss of Supply is caused for reasons under (ii) or (iii) of the  definition above, sub-paragraph (a) shall not relieve Novavax for any  liability if the cause under (ii) or (iii) above results from any material  breach (if applicable) of this Agreement, including its failure to use  Commercially Reasonable Efforts where expressly required under this  Agreement.  Receipt following Delivery  8.9 The Authority or its Authorised Agent shall arrange for the Delivery Location to be  ready for receipt of the Product in accordance with the Delivery Schedule. Delivery  shall be deemed complete when the Product has been [***]. If the Delivery Location  cannot receive the Product on the agreed Delivery date, then Novavax shall keep and  store the same in accordance with the applicable storage guidelines and requirements  for up to [***].  Following that [***] period, unless a further storage period is otherwise  agreed between the Parties (at the Authority's cost and risk), Novavax shall Deliver the  Product to the Delivery Location (whether or not the Delivery Location can receive the  Product).   8.10 All Deliveries of the Product supplied hereunder shall, at the time of Delivery or  reasonably in advance of the Delivery of the Product, be accompanied by the  documentation specified in Schedule 8 (the "Documentation").  9. DISTRIBUTION  9.1 Once Product is Delivered by Novavax in the UK, the Authority or its designees shall  be responsible for and shall control and direct the onward distribution of the Product.  9.2 Novavax agrees and acknowledges that the Authority may donate or resell Product  Delivered to the Authority that is in excess of its requirements to other countries,  governments and charitable organisations including the ACT Accelerator, but only if  

 

  254681-3-31828-v16.0 - 32 - 70-40746871    (i) the intended purpose of such donation or resale is to vaccinate individuals against  SARS-CoV-2; (ii) such Product can be placed on the market in such country(ies) in  accordance with Applicable Law (which for the avoidance of doubt does not require  Novavax to seek any Regulatory Approval in such country(ies)); (iii) the Authority is  not in material breach of this Agreement; and (iv) the Authority has paid to Novavax  the Price for such Product. In addition, the Authority expressly acknowledges and  agrees that, in connection with any donation or resale or Product to a country(ies)  outside of the Territory as aforesaid, that (A) the Authority shall be solely responsible  for shipping, transporting and otherwise delivering the donated or resold Product to  such country(ies) (including the cost of importing, exporting and customs clearance)  and that Novavax will have no obligation to assist the Authority with the foregoing or  to otherwise assist the Authority with distribution of the Product within such  country(ies), (B) the Authority shall be solely responsible for initiating and  implementing any Product recalls in such country(ies), (C) the Product warranties set  forth in this Agreement solely apply to the sale of Product to Authority under this  Agreement, (D) the donation or reselling of any Product by Authority does not reduce  or remove any obligation or right of the Authority or right or obligation of Novavax  under this Agreement, and (E) Novavax shall have no indemnification obligation under  this Agreement with respect to such Product once it is donated or resold, and (F) no  Confidential Information of Novavax shall be disclosed.  10. RISK AND TITLE  10.1 Risk of loss or damage and title to Products supplied under this Agreement shall pass  to the Authority upon Delivery of the Product to the Authority pursuant to clause 8.    11. INSPECTION AND REJECTION OF PRODUCT  Inspection & Rejection  11.1 Upon the [***], the Authority (or, on its behalf, its Authorised Agent) will inspect the  Product and review the Documentation, and notify Novavax in writing [***] of the  Delivery of the Product and receipt of the Documentation) if it rejects the Product  ("Rejected Product"). [***] [***]  11.1.1 [***]; or  11.1.2 [***];  [***] Should the Authority notify Novavax pursuant to this clause 11.1, the Authority  shall make available for collection by Novavax samples of the Rejected Product to  Novavax (or its nominated agent) for collection and testing.   Independent Laboratory  11.2 In the event of a disagreement concerning whether Product has any Defect or is  Conforming Product, Novavax shall notify the Authority within [***] of its receipt of  the Authority's notice of such Rejected Products. Novavax and the Authority shall use  their respective reasonable endeavours to resolve such disagreement [***]. If the parties  are unable to amicably resolve the disagreement, such dispute shall be resolved by  having an independent, mutually acceptable, qualified third party expert (the  

 

  254681-3-31828-v16.0 - 33 - 70-40746871    "Independent Expert") promptly examine the Product that is the subject of the dispute.  [***] The findings of the Laboratory shall be final and binding on the Parties other than  in the event of manifest error.  12. REMEDIES AND MITIGATION OF LOSSES  12.1 Novavax acknowledges the critical importance that the Authority places on ensuring  that Products are delivered free of Defect, in conformance with clause 5.15, and in  accordance with Priority Supply and the Delivery Schedule.   Rejected Product  12.2 In respect of any Rejected Product, provided that the Authority notifies Novavax of  such Defect in accordance with clause 11.1, Novavax shall at the Authority's election:  12.2.1 upon such Rejected Product being made available for collection by Novavax or  resolution of any disagreement as to whether or not the Rejected Product is  Defective, refund the Authority's payment for such Rejected Product calculated  on a pro-rated basis according to the number of Product units returned as  Rejected Product; or  12.2.2 at no additional cost to the Authority, replace the Rejected Product with an  identical quantity of Conforming Product, subject to the Parties agreeing on a  Delivery date for such replacement Product, which Novavax shall use  Commercially Reasonable Efforts to Deliver on an expedited basis, and   the Rejected Product shall be made available for collection and disposal by Novavax,  [***]. Without prejudice to clause 12.3, the remedies set forth in this clause 12.2 shall  be the sole and exclusive remedy of the Authority in regard to Rejected Product that  has not been distributed, used or administered by the Authority.  Failure to Deliver Conforming Product  12.3 If Novavax does not Deliver Conforming Products in accordance with the Delivery  Schedule (or, where notified, within the applicable Grace Period) other than where such  failure to Deliver is due to the default of the Authority or its Authorised Agents, then  the Authority shall, upon written notice to Novavax:  12.3.1 be entitled to refuse or cancel Delivery of any such Products not Delivered in  accordance with the Delivery Schedule [***]; and  12.3.2 be entitled to a refund, calculated on a pro-rated basis of the Price, for those  Products (i) Delivered with a Defect (where the Authority elected to receive a  replacement remedy pursuant to clause 12.2.2 but that replacement was not  Conforming Product); (ii) not Delivered; or (iii) which have been refused  Delivery or had their Delivery cancelled in accordance with clause 12.3.1.   If Authority elects to exercise its remedy in this clause 12.3, and subject to clause 12.2.1,  it shall be the sole and exclusive remedy of the Authority in regard to failure to Deliver  Conforming Product [***].   

 

  254681-3-31828-v16.0 - 34 - 70-40746871    13. PRICE  [***]  13.1 [***].   13.2 [***].  13.3 [***].  Currency  13.4 The Price payable by the Authority under this Agreement shall be payable in US Dollars.   14. INVOICING AND PAYMENT  [***]  14.1 Novavax shall invoice the Authority on or after the later of (i) Novavax' acceptance of  the Priority Order; and (ii) the entry of Novavax into the supply agreements or letters  of intent or authorisation with each of Fujifilm and [***] (as contemplated in clauses  5.5 and 5.8 or, if applicable, alternative CMOs for the Manufacture of the Antigen  and/or fill/finish of the Product in accordance with clauses 5.6 and/or 5.9) for [***],  which amount shall be off-set and credited against future payments due to Novavax in  respect of [***].   14.2 The Parties acknowledge and agree that [***] by the Authority in clause 14.1 shall be  off-set one hundred per cent. (100%) against the amount payable by the Authority for  the first [***] Doses of Conforming Product Delivered pursuant to [***].  [***]  14.3 [***]  Invoicing   14.4 Novavax shall invoice the Authority for [***].   Payment Terms  14.5 The Authority shall pay each invoice properly submitted in accordance with this  Agreement and the invoice schedule within [***] after the date of the applicable invoice.   14.6 All payments due to a Party under this Agreement:  14.6.1 are exclusive of any VAT which may be chargeable, which, if properly  chargeable, the paying Party shall pay in addition at the rate and in the manner  for the time being prescribed by Applicable Law and subject to the other Party  providing a valid and accurate VAT invoice;  14.6.2 shall be made by transfer to such US or UK bank account as the receiving Party  may from time to time notify in writing to the paying Party; and  

 

  254681-3-31828-v16.0 - 35 - 70-40746871    14.6.3 shall be made in full and cleared funds, subject to any deduction or withholding  which must be made under Applicable Laws.    Disputes and Late Payments  14.7 The Authority shall raise any queries with respect to an invoice within fifteen [***] of  receipt. Where Authority raises a query with respect to an invoice, the Parties shall  liaise with each other and agree a resolution to such query within [***] days of the  query being raised. If the Parties are unable to agree a resolution within [***] the query  being raised, the dispute shall be referred to dispute resolution in accordance with the  dispute resolution procedure prescribed in this Agreement. For the avoidance of doubt,  the Authority shall not be in breach of any of any of its payment obligations under this  Agreement in relation to any queried or disputed invoice sums unless the process  referred to in this clause 14.7 has been followed and it has been determined that the  queried or disputed invoice amount is properly due to Novavax and the Authority has  then failed to pay such sum within [***] following such determination.   14.8 The Authority shall pay all amounts not in dispute. If the Authority fails to pay any  amount payable under this Agreement by the due date for payment, then without  prejudice to any other rights or remedies that Novavax may have interest shall accrue  on that amount [***].  15. WARRANTY AND UNDERTAKINGS  15.1 Novavax warrants and undertakes to the Authority that:    15.1.1 it shall maintain a properly documented system of quality controls and processes  (including quality management systems) covering all aspects of its obligations  under this Agreement (including those it may subcontract to others) and shall at  all times comply with such quality controls and processes and not amend them  in material manner without notifying the Authority in writing at least [***] in  advance of such change (such notice to include the details of the consequences  which follow such change being implemented).  15.2 Novavax further represents, warrants, and undertakes to the Authority that:   15.2.1 it has the right and authority to enter into this Agreement and that it has the  capability and capacity to fulfil its obligations under this Agreement;  15.2.2 it is a properly constituted limited liability company and that it is fully  empowered by the terms of its constitutional documents to enter into and to  carry out its obligations under this Agreement and the documents referred to  therein;  15.2.3 to its knowledge there are no pending or threatened actions or proceedings  before any court or administrative agency which would materially adversely  affect the financial condition, business or operations of Novavax;  15.2.4 there are no material agreements existing to which Novavax is a party which  prevent Novavax from entering into this Agreement, or which would prevent  Novavax from fulfilling [***] on the terms of this Agreement (including any  agreement with a Funding Entity);   

 

  254681-3-31828-v16.0 - 36 - 70-40746871    15.2.5 all necessary actions to authorise the execution of and performance of its  obligations under this Agreement have been taken before such execution; and  15.2.6 it shall: (i) take reasonable steps to identify if there is any slavery or human  trafficking in its supply chains accordingly to Applicable Law; (ii) notify the  Authority promptly if it becomes aware of any actual or suspected incidents of  slavery or human trafficking in its supply chains; and (iii) conduct its business  without use of any slavery or human trafficking.  15.3 Novavax also warrants that, at the time of their delivery, title to the Product supplied  under this Agreement will pass to the Authority as provided in this Agreement free and  clear of any security interest, lien, charge or other encumbrance.  Record Keeping  15.4 Novavax shall (and shall procure that its Affiliates shall) maintain all records and  reports with respect to the Manufacture and supply of the Product (and in relation to  the provision of any other services) under this Agreement as required by Applicable  Laws and in any event for a minimum period of [***] following the termination or  expiry of this Agreement.   Product Recall  15.5 Novavax and the Authority (or its designee) shall co-operate with respect to initiating  and implementing any Product recalls (i) required by controlling Regulatory  Authorities; (ii) that are precautionary withdrawals implemented due to an underlying  concern regarding the Product; and (iii) voluntary withdrawals requested by the  Authority for reasons other than those under (i) or (ii). Novavax shall be responsible  for implementing a recall required by the controlling Regulatory Authority or a  precautionary recall under (ii) above, and the Authority shall be responsible for  implementing any recall it voluntarily elects to make under (iii) above. Each Party, as  applicable, shall (a) handle such matters in a timely, prudent and skilful manner, in  compliance with all Applicable Law; and (b) keep the other Party informed in a timely  manner with respect to the recalling Party's activities in regard to all such recalls and  market withdrawals.   15.6 All costs incurred in responding to recalls and market withdrawals shall be borne:   15.6.1 [***];  15.6.2 [***], or  15.6.3 [***].  16. FUTURE PREPAREDNESS  Through the Oversight Committee, the Parties shall discuss in good faith the terms and  arrangements for a longer partnership with potential funding by the Authority for the  development and supply of other potential pandemic preparedness vaccine products  (including but not limited to Novavax' seasonal influenza vaccine or a pandemic  derivative thereof).   

 

  254681-3-31828-v16.0 - 37 - 70-40746871    17. ANTI-BRIBERY  17.1 Each Party represents:   17.1.1 on behalf of itself, its Affiliates, and its and their respective Personnel (together  with such Party, the "Party Representatives") that its Party Representatives  have not in relation to this Agreement:   (a) committed (directly or indirectly) any offence under any anti-bribery or  anti-corruption laws (including the Bribery Act 2010 and/or the Foreign  Corrupt Practices Act);   (b) offered, given or agreed to give any Personnel of the other Party any gift  or consideration of any kind as an inducement or reward for doing or not  doing or for having done or not having done any act in relation to the  obtaining or performance of this or any other agreement with the other  Party; or  (c) in connection with this Agreement paid or agreed to pay any commission  other than a payment, except as permitted under Applicable Law, (each  of (a), (b) and (c) being a "Prohibited Act").   17.2 Each Party represents that:  17.2.1 it has in place reasonably adequate training and compliance procedures to  prevent bribery and corruption as contemplated by Applicable Laws; and  17.2.2 it, its Affiliates, and their respective Personnel shall not knowingly take any  action that will, or would reasonably be expected to, cause the other Party or its  Affiliates to be in violation of any such laws or policies.  17.3 If a Party or its Party Representatives (or anyone acting on its or their behalf) has done  or does any of the Prohibited Acts or has committed or commits any offence under any  anti-bribery or anti-corruption laws in relation to this or any other agreement with the  other Party:  17.3.1 such act shall be treated as a material breach of this Agreement; and  17.3.2 any termination under this clause 17.3 shall be without prejudice to any right or  remedy that has already accrued, or subsequently accrues, to the non-breaching  Party.  18. PRODUCT SECURITY  18.1 The Authority (or, on its behalf, its Authorised Agent) shall be responsible for  destruction of all Conforming Product in its possession for which the shelf life has  expired. Novavax shall be responsible for destruction of all Products that have Defects.  In complying with its respective destruction obligations, the applicable Party shall  undertake such destruction within mutually acceptable timelines, and prior to the  destruction the applicable Party possessing the applicable Product shall hold the same  securely pending destruction. Each Party shall keep a record of any destruction it  undertakes and shall [***] issue certificates of destruction to the other Party upon  

 

  254681-3-31828-v16.0 - 38 - 70-40746871    request. Such records shall be kept for a period of the longer of [***] or the term  required by Applicable Laws or Applicable Standards.   18.2 The Authority shall comply with all Applicable Laws relating to the traceability of  pharmaceutical products in accordance with Novavax' specifications, standards,  strategy and instructions applied by Novavax to all of its distributors of medicinal  products from time to time. Any amendment to such specifications, standards, strategy  or instructions shall be implied after a reasonable timeline agreed with the Authority.  18.3 The Authority warrants and undertakes that it will not alter or modify any Product in  any way (including Labelling and packaging but excluding any transportation  packaging) after delivery to the Delivery Locations.  18.4 After Delivery, all Products shall be: (i) stored securely by the Authority (or its  Affiliate); and (ii) delivered, shipped and distributed by the Authority (or its Affiliate)  in a secure manner appropriate to the transportation route and destination, in each case  (i) and (ii) to guard against and deter theft, diversion, tampering or substitution (with,  for example, counterfeits).    19. INTELLECTUAL PROPERTY  19.1 Neither Party will gain any rights of ownership to or use of any property or Intellectual  Property Rights owned by the other (whether by virtue of this Agreement, by  implication or otherwise).  19.2 Novavax warrants to the Authority that either it is the sole proprietor and legal and  beneficial owner of all Intellectual Property Rights in the Product or it is licensed by  the relevant owners to Manufacture and supply the Product in accordance with this  Agreement.   19.3 Novavax warrants and represents to the Authority that, as of the Effective Date, it is not  aware that any receipt, keeping, sale and use of the Product in the Territory in  accordance with this Agreement would infringe any Intellectual Property Rights of any  Third Party.   20. CONFIDENTIALITY  20.1 Each Party shall treat the Confidential Information of the other Party as strictly  confidential and not disclose it to any Third Party for any purpose whatsoever without  obtaining the prior written consent of the other Party and not make use of the  Confidential Information of the other Party or any part thereof other than as permitted  under this Agreement, in each case other than to conduct its activities under this  Agreement and as expressly permitted under this clause 20. Each Party agrees to treat  such Confidential Information with at least the same care and in the same manner as its  own secret and valuable information.  20.2 Novavax may disclose all or any part of the Confidential Information to its Affiliates,  and to its and its Affiliates' respective Personnel and suppliers ("Representatives") as  necessary to enable Novavax' performance under this Agreement, provided, however,  that it ensures that such Representatives comply with the provisions of this clause 20.  The Authority may disclose all or any part of the Confidential Information to  

 

  254681-3-31828-v16.0 - 39 - 70-40746871    Authorised Agents, Central Government Bodies and the Devolved Administrations  ("Representatives") as necessary to enable the Authority's performance under this  Agreement, provided, however, that it ensures that such Representatives comply with  the provisions of this clause 20.    20.3 The confidentiality obligations and use restrictions set forth in clause 20.1 shall not  apply to:  20.3.1 information that is or becomes generally available to the public (other than as a  result of its disclosure by the receiving Party in breach of this clause 20);  20.3.2 information that was available to the receiving Party or its Representatives on a  non-confidential basis before disclosure by the disclosing Party;  20.3.3 information that was, is or becomes available to the receiving Party or its  Representatives on a non-confidential basis from a Third Party who, to the  receiving Party's or the relevant Representative's knowledge, is not bound by a  confidentiality agreement with the disclosing Party or otherwise prohibited  from disclosing the information to the receiving Party or the Representative;   20.3.4 information that is developed by or for the receiving Party or its Representatives  independently of the information disclosed by the disclosing Party; or  20.3.5 the disclosure of which is required to ensure the compliance of the Authority  with any law including, but not limited to, the Freedom of Information Act 2000  (c.36) ("FOIA"), Codes of Practice on Access to Government Information, on  the Discharge of Public Authorities' Functions or on the Management of  Records ("Codes of Practice") or the Environmental Information Regulations  2004 (SI 2004/3391) ("Environmental Regulations"), provided, however, that  the Authority has provided reasonable advance notice of the impending  disclosure to Novavax and provided further that it shall only disclose the  Confidential Information to the extent strictly necessary.  20.4 Novavax agrees that:  20.4.1 without prejudice to the generality of clause 20.3.5, the provisions of this clause  20 are subject to the respective obligations and commitments of the Authority  and any Authorised Agent, Central Government Body, Administering Entity  and Devolved Administration (as the case may be) under the FOIA, the Codes  of Practice and the Environmental Regulations;  20.4.2 the decision on whether any exemption applies to a request for disclosure of  recorded information is [***]; and  20.4.3 where the Authority or an Administering Entity or Devolved Administration is  managing a request as referred to in clause 20.4.2, Novavax shall co-operate  with the Authority and any Authorised Agent, Central Government Body,  Administering Entity or Devolved Administration making the request and shall  respond within [***] of any request by it for assistance in determining how to  respond to a request for disclosure.  20.5 Novavax shall:   

 

  254681-3-31828-v16.0 - 40 - 70-40746871    20.5.1 transfer any request for information, as defined under section 8 of the FOIA  and/or the Environmental Regulations, to the Authority or an Authorised Agent,  Central Government Body, Administering Entity or Devolved Administration  as soon as practicable after receipt and in any event within [***] of receiving a  request for information;  20.5.2 provide the Authority or an Authorised Agent, Central Government Body,  Administering Entity or Devolved Administration with a copy of all information  in its possession or power in the form that the Authority or an Authorised Agent,  Central Government Body, Administering Entity or Devolved Administration  requires within [***] of the Authority or an Authorised Agent, Central  Government Body, Administering Entity or Devolved Administration  requesting that information; and  20.5.3 provide all necessary assistance as reasonably requested by the Authority or an  Authorised Agent, Central Government Body, Administering Entity or  Devolved Administration to enable the Authority or an Authorised Agent,  Central Government Body, Administering Entity or Devolved Administration  to respond to a request for information within the time for compliance set out in  section 10 of the FOIA.  20.6  Subject to clause 20.5 above:   20.6.1 Novavax hereby gives consent for the Authority to publish this Agreement in  its entirety (but with any information which is exempt from disclosure in  accordance with the provisions of the FOIA and or the Environmental  Information Regulations redacted, and subject to clause 20.6.3 any other  redactions agreed by the Parties), including from time to time agreed changes  to this Agreement, to the general public; and   20.6.2 the Authority hereby gives consent for Novavax to publish this Agreement as  required by the SEC (but with any information which is exempt from disclosure  redacted unless disclosure is required by the SEC, and subject to clause 20.6.3  any other redactions agreed by the Parties); and  20.6.3 the Parties shall cooperate in good faith to agree the scope of redactions and to  address each Party's concerns as regards information which the other Party  intends not to redact (but subject always to each Party's obligations to disclose  as set out above).  20.7 The Authority may, at its sole discretion, redact information from this Agreement prior  to publishing for one or more of the following reasons:  20.7.1 national security;  20.7.2 Personal Data;  20.7.3 confidential information protected by Intellectual Property Rights;  20.7.4 Third Party confidential information;  20.7.5 IT security; or  

 

  254681-3-31828-v16.0 - 41 - 70-40746871    20.7.6 prevention of fraud.  20.8 The Authority may consult with Novavax to inform its decision regarding any  exemptions and/or redactions but [***]. Novavax shall assist and cooperate with the  Authority to enable the Authority to publish this Agreement. The Authority will follow  its own internal policies together with any applicable guidelines, including any  published by the Treasury, the Cabinet Office or the Information Commissioner.  20.9 The Authority or an Authorised Agent, Central Government Body, Administering  Entity or Devolved Administration [***] consult Novavax in relation to any request for  disclosure of Novavax' Confidential Information in accordance with all applicable  guidance.  20.10 Each Party acknowledges that damages resulting from disclosure of the Confidential  Information not permitted hereby would be an insufficient remedy. Novavax  acknowledges and agrees that the Authority shall be [***].  20.11 Each Party may disclose Confidential Information (including this Agreement) of the  other Party to the extent that such disclosure is:  20.11.1required by Applicable Laws, such as filing with securities regulators, or by an  order of a Governmental Authority; provided that the receiving Party (where it  is legally permitted to do so) shall first have given notice to the disclosing Party  and given the disclosing Party a reasonable opportunity to seek a protective  order or other form of confidential treatment for the information, or obtain  assurances that the information be used only for the purposes for which the order  was issued, and the receiving Party shall thereafter disclose only that portion of  the information required to be disclosed in order to comply;  20.11.2to a Regulatory Authority as reasonably necessary for the purposes of any filing,  application or request for any marketing authorisation, licence or other  Regulatory Approval made by or on behalf of Novavax or its Affiliates in  respect of the Product;   20.11.3made by or on behalf of the receiving Party to legal, financial or other  professional advisors, in each case for the purposes of advising on this  Agreement and/or on the transactions contemplated hereby and thereby;  provided however that, in each case, such Persons shall be subject to obligations  of confidentiality and non-use with respect to such Confidential Information and  may only use such information for the purpose of assessing such transaction or  providing such advice (as the case may be); or  20.11.4for the purposes of any legal proceedings brought pursuant to clause 34.11.2;  provided that the Party making disclosures to a Third Party (other than a Governmental  Authority) pursuant to clause 20.11.3 or clause 20.11.4 shall ensure that each Third  Party recipient is bound by obligations of confidentiality no less restrictive than those  contained in this Agreement and shall be liable to the other Party for any breach of such  confidentiality obligations by the relevant recipient.  

 

  254681-3-31828-v16.0 - 42 - 70-40746871    20.12 Nothing in this clause 20 shall prevent the Authority from disclosing Confidential  Information where it is required to do so by judicial, administrative, governmental or  regulatory process in connection with any action, suit, proceedings or claim or  otherwise by Applicable Law. Nothing in this Agreement shall prevent the Authority  from disclosing Confidential Information:  20.12.1to any contracting authority as defined in Regulation 2 of the Public Contracts  Regulations 2015 ("Contracting Authority"). All Contracting Authorities  receiving such Confidential Information shall be entitled to further disclose the  Confidential Information to other Contracting Authorities on the basis that the  information is confidential and is not to be disclosed to a Third Party which is  not part of any Contracting Authority;   20.12.2to any consultant, contractor or other person engaged by the Authority or any  person conducting an Office of Government Commerce gateway review;  20.12.3for the purpose of the examination and certification of the Authority's accounts;  or  20.12.4for any examination pursuant to Section 6(1) of the National Audit Act 1983 of  the economy, efficiency and effectiveness with which the Authority has used its  resources.   20.13 The Authority may disclose the Confidential Information of Novavax:  20.13.1 on a confidential basis to any Central Government Body for any proper purpose  of the Authority or of the relevant Central Government Body;   20.13.2 to Parliament and Parliamentary Committees or if required by any  Parliamentary reporting requirement;  20.13.3 [***];  20.13.4 on a confidential basis to a professional adviser, consultant, supplier or other  person engaged by any of the entities described in clause 20.13.1 (including any  benchmarking organisation) for any purpose relating to or connected with this  Agreement;   20.13.5 on a confidential basis for the purpose of the exercise of its rights under this  Supply Agreement, including the audit rights pursuant to clause 29; or  20.13.6 on a confidential basis to a proposed successor body in connection with any  assignment, novation or disposal of any of its rights, obligations or liabilities  under this Agreement,  and for the purposes of the foregoing, references to disclosure on a confidential basis  shall mean disclosure subject to a confidentiality agreement or arrangement containing  terms no less stringent than those placed on the Authority under this clause 20.  20.14 The Authority and Novavax agree not to issue any press releases or public  announcements concerning this Agreement or its terms without the prior written  consent of the other Party as to the form, timing and content of any such release or  

 

  254681-3-31828-v16.0 - 43 - 70-40746871    announcement, except as required by Applicable Laws, including disclosure required  by any securities exchange.  20.15 Subject to clause 20.16, on expiry or termination of this Agreement or at any time at  the disclosing Party's request, the receiving Party shall return to the disclosing Party all  copies containing Confidential Information of the disclosing Party or, at the disclosing  Party's option, destroy all copies of such Confidential Information. The return or  destruction of the Confidential Information of the disclosing Party will not affect the  receiving Party's obligation to observe the confidentiality and non-use restrictions in  respect of that Confidential Information set out in this Agreement.  20.16 Each Party may keep one (1) copy of Confidential Information for evidence purposes  at a secure place subject to the confidentiality and non-use obligations provided in this  clause 20. The aforementioned return and destruction obligation shall not apply to  electronic copies of Confidential Information which are rightfully contained in  computers, word processors, communication systems and system-backup media  (collectively "IT Media") which do not need to be destroyed or returned, provided that  such IT Media are: (i) overwritten in the ordinary course of their reuse; or (ii) at all  times maintained in confidence and not readily accessible and the receiving Party shall  treat such copies as confidential in accordance with this clause 20.  20.17 This clause 20 shall remain in force without limit in time in respect of Confidential  Information which comprises Personal Data or which relates to a patient, his or her  treatment and/or medical records. Save as aforesaid, the obligations in this clause 20  shall last for [***].  21. INDEMNITIES  By Authority   21.1 [***].  21.2 [***]:  21.2.1 [***];  21.2.2 [***]; or  21.2.3 [***].  21.3 [***]:   21.3.1 [***]; or  21.3.2 [***].  By Novavax  21.4 [***]:   21.4.1 [***];   

 

  254681-3-31828-v16.0 - 44 - 70-40746871    21.4.2 [***]; and  21.4.3 [***].  21.5 [***].   21.6 [***].  Conduct of Claims  21.7 [***]:  21.7.1 [***];  21.7.2 [***];  21.7.3 [***];  21.7.4 [***]; and  21.7.5 [***].  [***].   22. LIABILITY  22.1 [***].  22.2 [***]:    22.2.1 [***]; or   22.2.2 [***].  22.3 [***]:  22.3.1 [***];   22.3.2 [***];   22.3.3 [***];  22.3.4 [***]; or  22.3.5 [***].  22.4 [***]:  22.4.1 [***]; and,  22.4.2 [***].  22.5 [***].  

 

  254681-3-31828-v16.0 - 45 - 70-40746871    22.6 [***].  23. INSURANCE  Novavax shall take out and maintain with a reputable commercial insurer such types  and amounts of liability insurance to cover liabilities related to its activities under this  Agreement for product liability claims, and for such other losses as are normal and  customary in the pharmaceutical industry generally for Persons similarly situated, and  shall upon request provide to the Authority evidence of its insurance coverage. Such  policies shall include product liability insurance, clinical trial insurance, manufacturing  insurance and general liability insurance, and shall remain in effect throughout the  Territory and the [***].  24. FORCE MAJEURE  24.1 If a Party is prevented from or delayed in performing any of its obligations under the  Agreement by a Force Majeure then:  24.1.1 the relevant obligations under this Agreement shall be suspended for as long as  the Force Majeure continues and the affected Party shall not be in breach of this  Agreement or otherwise liable for any such failure or delay in the performance  of such obligations;  24.1.2 [***] after the start of the Force Majeure, the affected Party shall notify the  other Party of the nature of the Force Majeure and the likely effects of the Force  Majeure on its ability to perform its obligations under this Agreement; and  24.1.3 [***] after the end of the Force Majeure, the affected Party shall notify the other  Party that the Force Majeure has ended, and shall resume performance of its  obligations under this Agreement.  25. DURATION AND TERMINATION   25.1 This Agreement commences and takes effect on the Effective Date and shall continue  until the date falling one hundred and twenty (120) days after the last date on which the  total quantity of Conforming Product equal to the volumes in the Priority Order is last  Delivered in full to Authority (the "Initial Term"), unless and to the extent this  Agreement is (i) extended under clause 25.2 or (ii) terminated earlier by a Party or the  Parties in accordance with the provisions of this clause 25 (the "Term").   25.2 If an Additional Order is agreed between the Parties in accordance with clause 7.4, the  term of this Agreement shall automatically be extended to [***].  25.3 Either Party (the "Terminating Party") shall be entitled to terminate this Agreement  before the expiry of the Term [***] and upon written notice to that effect to the other  Party, for material breach, if:  25.3.1 subject to clause 25.3.2, the other Party (the "Breaching Party") fails to  materially comply with any of the obligations under this Agreement and fails to  remedy the violation or breach within [***] (in each case, the "Cure Period"),  after having been notified in advance in writing by the Terminating Party. In  

 

  254681-3-31828-v16.0 - 46 - 70-40746871    such event, the right of the Terminating Party to claim damages for breach of  contract shall remain unaffected; and  25.3.2 the Breaching Party may during the Cure Period commence legal proceedings  to challenge the validity of the termination, in which case, termination shall not  occur until the court makes a decision (which decision is not capable of appeal  or which is not appealed within the time limited allowed for appeal) that the  event(s) specified in the Terminating Party's written notice does entitle the  Terminating Party to terminate this Agreement.   25.4 The Authority shall be entitled to terminate this Agreement before the expiry of the  Term [***] and upon [***] written notice to that effect to Novavax:   25.4.1 if the Authority, acting reasonably and in good faith, objects to any material  change to the Development and Manufacturing Plan on the basis that such  change will or is reasonably likely to result in (i) a material delay in securing a  Marketing Authorisation for the Product in the Territory with an indication in  the Field or (ii) a failure to Deliver  quantities of the Confirming Product in all  material respects to the Product Delivery Baselines;  25.4.2 if there is any Loss of Supply;   25.4.3 the [***] is not fulfilled with Conforming Product by the Product Delivery  Baselines; or  25.4.4 the application for the Marketing Authorisation is refused or is not granted by  the date in the applicable Baseline.  25.5 The Authority shall be entitled to terminate this Agreement before the expiry of the  Term [***] and upon written notice to that effect to Novavax, as detailed below and to  the extent permitted by Applicable Laws, if:    25.5.1 any resolution is passed, or application made, in relation to Novavax for a  moratorium on the payment of its debts, or for its dissolution, liquidation,  winding-up or administration; or  25.5.2 a receiver, liquidator, administrator or administrative receiver (or equivalent  officer) is appointed over Novavax or its undertaking or all or a substantial part  of its assets; or  25.5.3 Novavax suffers any event in any jurisdiction to which it is subject that has an  effect equivalent or similar to any of the events described in this clause 25.5;  and/or  25.5.4 Novavax ceases or threatens to cease to carry on business.  25.6 The Authority shall be entitled to terminate this Agreement before the expiry of the  Term [***] and upon written notice:   25.6.1 if Novavax undergoes a change of control equivalent to [***] without the prior  written consent of the Authority and the Authority shall be entitled to withhold  such consent if, in the reasonable opinion of the Authority, the proposed change  

 

  254681-3-31828-v16.0 - 47 - 70-40746871    of control will have a material impact on the performance of this Agreement or  the reputation of the Authority;  25.6.2 if Novavax purports to assign, subcontract, novate, create a trust in or otherwise  transfer or dispose of this Agreement in breach of its terms, including those at  clauses 34.5 and 34.7;  25.6.3 Novavax commits a material breach of its obligation to notify the Authority of  any Occasion of Tax Non-Compliance as required by clause 30, or Novavax  fails to provide details of proposed mitigating factors as required by clause 30  [***]; or  25.6.4 the Agreement should not have been awarded to Novavax in view of a serious  infringement of obligations under European law declared by the Court of Justice  of the European Union under Article 258 of the Treaty on the Functioning of  the EU.  26. CONSEQUENCES OF TERMINATION  26.1 Upon expiry or termination of this Agreement:   26.1.1 the proportion of the Order concerning Conforming Product that has not been  Delivered at the date of termination shall be cancelled;   26.1.2 Novavax shall be entitled to payment from the Authority for amounts that are  due under this Agreement which have not otherwise been paid by the Authority  in respect of the Price for Conforming Product that has been Delivered pursuant  to this Agreement, which the Authority shall pay within [***] of the date of  invoice for the same (to the extent the Authority has not already done so);  26.1.3 Novavax shall refund to the Authority [***] (in accordance with clause 14.2)  against Conforming Product Delivered pursuant to this Agreement or otherwise  repaid to the Authority by Novavax ("[***]") within [***] of the termination  date, except that where this Agreement is terminated pursuant to clause 25.4.2,  clause 8.8.1 shall apply;  26.1.4 each Party shall use Commercially Reasonable Efforts to mitigate both (i) the  damages that would otherwise be recoverable from the other pursuant to this  Agreement, and (ii) any costs, fees, expenses or losses that may be incurred by  a Party, or for which a Party may be responsible, under this Agreement, by  taking appropriate and reasonable actions to reduce or limit the amount of such  damages, costs, fees, expenses or losses; and   26.1.5 any provision of this Agreement which expressly or by implication is intended  to come into or continue in force, including clauses 1, 2.18, 4.9, 4.10, Error!  Reference source not found., 9, 11, 12, 13, 14, 18, 20, 21, 22, 23, 26, 29 and  34 shall remain in full force and effect.  26.2 Expiry or termination of this Agreement for any reason shall be without prejudice to  either Party's other rights and remedies or to any accrued rights and liabilities as the  date of such expiry or termination which shall survive such termination or expiry.  

 

  254681-3-31828-v16.0 - 48 - 70-40746871    27. DATA PROTECTION  27.1 The following shall apply if Novavax processes any Personal Data pursuant to this  Agreement:   27.1.1 Novavax shall comply with the Data Protection Act, the GDPR and any other  applicable data protection legislation. In particular Novavax agrees to comply  with the obligations placed on the Authority by the Principle (f) (the "Integrity  Principle") set out in the Data Protection Act and the GDPR, namely:  (a) to maintain technical and organisational security measures sufficient to  comply at least with the obligations imposed on the Authority by the  Integrity Principle;  (b) only to process Personal Data for and on behalf of the Authority, in  accordance with the instructions of the Authority and for the purpose of  performing its obligations under this Agreement and to ensure  compliance with the Data Protection Act and GDPR; and  (c) to allow the Authority to audit Novavax' compliance with the  requirements of this clause 27 on reasonable notice and/or to provide the  Authority with evidence of its compliance with the obligations set out in  this clause 27.  27.2 Both Parties agree to use all reasonable efforts to assist each other to comply with the  Data Protection Act and the GDPR. For the avoidance of doubt, this includes Novavax  providing the Authority with reasonable assistance in complying with subject access  requests served on the Authority and Novavax consulting with the Authority prior to  the disclosure by Novavax of any Personal Data in relation to such requests.  28. INDEPENDENT CONTRACTORS  Novavax is acting as an independent contractor under this Agreement. Nothing in this  Agreement or any circumstances associated with it or its performance give rise to any  relationship of agency, partnership or employer and employee between the Authority  and Novavax or between the Authority and any Novavax Representative, nor authorise  either Party to make or enter into any commitments for or on behalf of the other Party.  29. RIGHT OF AUDIT, CONFLICTS OF INTEREST AND PREVENTION OF  FRAUD  29.1 Novavax shall keep secure and maintain for the Term of this Agreement and [***], or  such longer period as may be agreed between the Parties, full and accurate records of  all matters relating to this Agreement.  29.2 Novavax shall grant to the Authority or its Authorised Agents, such access to those  records as they may reasonably require in order to check Novavax' compliance with  this Agreement for the purposes of:  29.2.1 the examination and certification of Novavax' accounts; or  

 

  254681-3-31828-v16.0 - 49 - 70-40746871    29.2.2 any examination pursuant to section 6(1) of the National Audit Act 1983 of the  economic efficiency and effectiveness with which the Authority has used its  resources.  29.3 The Comptroller and Auditor General may examine such documents as he may  reasonably require which are owned, held or otherwise within the control of Novavax  and may require Novavax to provide such oral and/or written explanations as he  considers necessary. This clause does not constitute a requirement or agreement for the  examination, certification or inspection of the accounts of Novavax under section  6(3)(d) and 6(5) of the National Audit Act 1983.  29.4 The Authority shall have the right to audit Novavax' compliance with this Agreement.  Novavax shall permit or procure permission for the Authority or its authorised  representative during normal business hours having given advance notice of no less  than [***], access to [***] premises and facilities, books and records used in the  performance of Novavax' obligations under this Agreement.  29.5 Should Novavax subcontract any of its obligations under this Agreement, Novavax  shall use Commercially Reasonable Efforts to obtain for the Authority the right to audit  (including but not limited to a financial audit and a full manufacturing audit) and inspect  such Affiliate or Third Party. Novavax shall use Commercially Reasonable Efforts to  procure permission for the Authority or its authorised representative during normal  business hours no more than [***] having given advance notice of no less than [***],  access to any premises and facilities, books and records used in the performance of  Novavax' obligations under this Agreement, including any that are subcontracted to  such Third Party. Novavax shall cooperate with such audit and inspection and  accompany the Authority or its authorised representative if requested.  29.6 Novavax shall take appropriate steps to ensure that neither Novavax nor any staff is  placed in a position where, in the reasonable opinion of the Authority, there is or may  be an actual conflict, or a potential conflict, between the pecuniary or personal interests  of Novavax and the duties owed to the Authority under the provisions of this Agreement.  Novavax will disclose to the Authority full particulars of any such conflict of interest  which may arise.  29.7 The Authority reserves the right to terminate this Agreement [***]. The actions of the  Authority pursuant to this clause 29.7 shall not prejudice or affect any right of action  or remedy which shall have accrued or shall thereafter accrue to the Authority.  29.8 Novavax shall take all reasonable steps to prevent Fraud by staff and Novavax  (including its shareholders, members and directors) in connection with the receipt of  monies from the Authority. Novavax shall notify the Authority [***] if it has [***] to  suspect that any Fraud has occurred or is occurring or is likely to occur.   29.9 If Novavax or its staff commits Fraud in relation to this or any other contract with the  Crown (including the Authority) the Authority may:   29.9.1 terminate this Agreement and [***]; or   29.9.2 [***].  

 

  254681-3-31828-v16.0 - 50 - 70-40746871    30. TAX NON-COMPLIANCE  30.1 If, at any point during the Term of this Agreement, an Occasion of Tax Non- Compliance occurs, Novavax shall:   30.1.1 notify the Authority in writing of such fact within [***] of its occurrence; and   30.1.2 [***] provide to the Authority:   (a) details of the steps which Novavax is taking to address the Occasion of  Tax Non-Compliance and to prevent the same from recurring, together  with any mitigating factors that it considers relevant; and  (b) such other information in relation to the Occasion of Tax Non- Compliance as the Authority may reasonably require.  31. ENVIRONMENTAL CONSIDERATIONS  31.1 Novavax shall comply in all material respects with applicable environmental laws and  regulations in force from time to time in relation to the Product. Without prejudice to  the generality of the foregoing, in respect of Product supplied in the Territory under this  Agreement Novavax shall:  31.1.1 comply with any obligations imposed on it in relation to the Product by the  Producer Responsibility Obligations (Packaging Waste) Regulations 2007 (SI  2007/871) (or any other equivalent legislation giving effect in any part of the  European Economic Area to the Packaging and Packaging Waste Directive  94/62/EC as amended); and  31.1.2 without prejudice to the Novavax' other obligations under this Agreement, label  all units of the Product, and the packaging of those units, to highlight mandatory  environmental and safety information as required by Applicable Laws.  31.2 Novavax shall [***] respond to and meet all reasonable requests by the Authority for  information evidencing Novavax' compliance with the provisions of this clause 31 in  the Territory including the weight and type of packaging according to material types  used in relation to the Product.  32. EQUALITY, NON-DISCRIMINATION AND HUMAN RIGHTS  32.1 Novavax shall not, to the extent applicable to its activities in relation to this Agreement:  32.1.1 engage in any prohibited conduct as defined in part 2 chapter 2 of the Equality  Act 2010 (c.15) (the "Equality Act") in relation to any protected characteristic  (as defined in section 4 of the Equality Act) where this would contravene any  provisions of the Equality Act, including part 3 (goods and services) and part 5  (employment);   32.1.2 do (or omit to do) anything else that would amount to a contravention of the  Equality Act including part 8 (prohibited conduct: ancillary) and chapter 3 part  5 (equality of terms); or  

 

  254681-3-31828-v16.0 - 51 - 70-40746871    32.1.3 do (or omit to do) anything else that would amount to a contravention of any  equivalent legislation.  32.2 Novavax shall notify the Authority [***] of any investigation of or proceedings against  Novavax under the Equality Act or any predecessor legislation and shall cooperate fully  and [***] with any requests of the person or body conducting such investigation or  proceedings, including allowing access to any documents or data required, attending  any meetings and providing any information requested.  32.3 Novavax shall use Commercially Reasonable Efforts to include in any agreement with  a Subcontractor entered into after the Effective Date to provide services or products  solely in connection with this Agreement obligations substantially similar to those  imposed on Novavax by this clause 32.  32.4 Novavax shall: (i) comply in all material respects with applicable current employment  legislation with respect to its employees engaged in relation to this Agreement; and (ii)  ensure that its employees are provided with appropriate employment and equality  training as required by Applicable Laws.  32.5 Novavax shall, and shall use reasonable endeavours to ensure that its employees or  agents and/or Subcontractors shall, at all times, act in a way which is compatible with  the Convention rights within the meaning of Section 1 of the Human Rights Act 1998  (c.42).  33. SUPPLY CHAIN RIGHTS AND PROTECTION  33.1 From the Effective Date, Novavax shall implement reasonable due diligence procedures  prior to contracting with any Subcontractors or any other participants in its supply  chains, in order to satisfy itself that there is no slavery or human trafficking in its supply  chains.  33.2 Novavax shall notify the Authority [***] it becomes aware of any actual or suspected  slavery or human trafficking in a supply chain which has a connection with this  Agreement, and shall promptly use [***] to remove any such slavery or human  trafficking from its supply chain.  33.3 In relation to any contracts concluded by Novavax after the Effective Date with  Subcontractors where the domicile of the Subcontractor is in the Territory, Novavax  shall use Commercially Reasonable Efforts (i) to include payment terms that are no  longer than [***] from the date of the receipt of a valid and undisputed invoice from  the Subcontractor; and (ii) to agree late payment interest on the same terms as set forth  herein.  34. MISCELLANEOUS  34.1 Notices  34.1.1 All communications relating to this Agreement shall be in writing and delivered  by hand or sent by post to the Party concerned at the relevant address set out in  this clause 34.1 below (or such other address as may be notified from time to  time in accordance with this clause 34.1 by the relevant Party to the other Party).   Any communication shall take effect:  

 

  254681-3-31828-v16.0 - 52 - 70-40746871    (a) if hand delivered, upon being handed personally to the addressee (or,  where the addressee is a corporation, any one of its directors or its  secretary) or being left in a letter box or other appropriate place for the  receipt of letters at the relevant Party's address as set out below;  (b) if sent by first class registered post, at 10 a.m. on the second (2nd)  Business Day after posting or if overseas by international recorded post,  at 10 a.m. on the fifth (5th) Business Day after posting.  No notice served by email shall be effective.  34.1.2 A notice sent by post (or the envelope containing it) shall not be deemed to be  duly posted for the purposes of this clause 34.1 unless it is put into the post  properly stamped or with all postal or other charges in respect of it otherwise  prepaid.  For Notices to the Authority:  Secretary of State, Department for Business, Energy and Industrial Strategy  1 Victoria Street  Westminster  London   SW1H 0ET    Attn: [***]   With a copy to: Permanent Secretary, Department for Business, Energy &  Industrial Strategy at the above address.  For Notices to Novavax:  Novavax, Inc.  21 Firstfield Road  Gaithersburg, MD 20878  U.S.A.  Attn: [***]  34.2 Variation and Waiver  34.2.1 No amendment or variation of the terms of this Agreement shall be effective  unless it is made or confirmed in a written document signed by both Parties to  this Agreement.  34.2.2 Any waiver of any right, obligation or remedy under, or compliance with or  breach of any provision of, this Agreement must be expressly stated in writing  to be such a waiver, must specify the right, remedy, obligation, provision or  breach to which it applies and must be signed by an authorised signatory of each  of the Parties granting the waiver. If either Party waives any right, obligation or  remedy under, or compliance with or breach of any provision of, this Agreement,  it can still enforce that right, obligation or provision, or claim that remedy  subsequently and that waiver shall not be deemed to be a waiver of any  

 

  254681-3-31828-v16.0 - 53 - 70-40746871    subsequent breach of that or any other provision or of any other right, obligation  or remedy.  34.2.3 The rights and remedies of either Party in respect of this Agreement shall not  be diminished, waived or extinguished by the granting of any indulgence,  forbearance or extension of time by either Party to the other nor by any failure  to ascertain or exercise, or any delay in ascertaining or exercising, any such  rights or remedies.  34.2.4 The discontinuance, abandonment or adverse determination of any proceedings  taken by either Party to enforce any right or any provision of this Agreement  shall not operate as a waiver of, or preclude any exercise or enforcement or (as  the case may be) further or other exercise or enforcement by that Party of, that  or any other right or provision.  34.2.5 Unless expressly provided otherwise in this Agreement, all references in this  clause 34.2 to any right or remedy shall include any power, right or remedy  conferred by this Agreement on, or provided by law or otherwise available to,  the relevant Party; and any right not being exercised shall include any partial  exercise of that right and any circumstances in which the relevant Party does  not insist on the strict performance of any provision of this Agreement.  34.2.6 The giving by either Party of any consent to any act which by the terms of this  Agreement requires that consent shall not prejudice the right of that Party to  withhold or give consent to the doing of any similar act.  34.3 Counterparts  34.3.1 This Agreement may be executed in any number of counterparts, and by the  Parties on separate counterparts, but shall not be effective until each Party has  executed at least one (1) counterpart. Each counterpart shall constitute an  original of this Agreement, but all the counterparts shall together constitute the  one agreement.  34.3.2 Delivery of a copy of this Agreement together with an executed signature page  of a counterpart in AdobeTM Portable Document Format (PDF) sent by  electronic mail shall take effect (subject to clause 34.12) as delivery of an  executed counterpart of this Agreement. If this method is adopted, without  prejudice to the validity of this Agreement, each Party shall provide the other  with a hard copy original of that executed counterpart as soon as reasonably  practicable thereafter.  34.4 Invalidity  Each provision of this Agreement is severable and distinct from the others. The Parties  intend that each of those provisions shall be and remain valid and enforceable to the  fullest extent permitted by Applicable Laws. If all or any part of any such provision is  held to be, or at any time becomes to any extent invalid, illegal or unenforceable for  any reason under any enactment or rule of law, it shall to that extent be deemed not to  form part of this Agreement but (except to that extent in the case of that provision) it  and all other provisions of this Agreement shall continue in full force and effect and  

 

  254681-3-31828-v16.0 - 54 - 70-40746871    their validity, legality and enforceability shall not be affected or impaired as a result,  subject to the operation of this clause 34.4 not negating the commercial intent and  purpose of the Parties under this Agreement.  34.5 Assignment   34.5.1 The Authority may assign or transfer, in whole or in part, this Agreement or any  of its rights and obligations under this Agreement to one or more of its Affiliates;  provided that if any such Affiliates fails to assume all obligations of Authority  so assigned or transferred hereunder, Novavax shall have the right to terminate  this Agreement by written notice with immediate effect.  34.5.2 Novavax may, but only with the Authority's prior written consent (which  consent shall not be unreasonably withheld or delayed), assign or transfer, in  whole or in part, this Agreement or any of its rights and obligations under this  Agreement to one or more of its Affiliates. Novavax will procure that, before  any assignee subsequently ceases to be a member of Novavax' Group, the  assignee shall assign back to Novavax for the purposes of this clause, as much  of the benefit of this Agreement as has been assigned to it.  34.5.3 Novavax may, but only with the Authority's prior written consent (which  consent shall not be unreasonably withheld or delayed), assign or transfer, in  whole or in part, this Agreement or any of its rights and obligations under this  Agreement to any Third Party, but otherwise may not assign this Agreement, in  whole or part, to any Third Party.  34.5.4 Any permitted assignment or transfer by one Party shall be effective only if the  relevant assignee confirms in writing to, and upon receipt by, the other Party  that it shall fully adhere to all the provisions of this Agreement as if it were an  original party to this Agreement.  34.5.5 This Agreement shall be binding on and inure for the benefit of the successors  and permitted assignees of the Parties.  34.6 Change of Control  34.6.1 If Novavax undergoes a change of control equivalent to or within the meaning  of sections 450 and 451 of the Corporation Tax Act 2010 (other than for an  intra-group change of control) without the prior written consent of the Authority  then, without prejudice to clause 25.6.1, upon the Authority's request Novavax  shall procure a legally binding guarantee from the parent entity of the party  acquiring control of Novavax in favour of the Authority to guarantee and  undertake to procure the continued performance by Novavax of this Agreement.  34.7 Subcontracting  34.7.1 Novavax may, without the need for the Authority's consent but subject to clause  34.7.2, subcontract or delegate its obligations or services to be provided under  this Agreement to one or more of its Affiliates and/or to any Third Party  consultant or contractor, including Fujifilm and [***] (a "Subcontractor").   

 

  254681-3-31828-v16.0 - 55 - 70-40746871    34.7.2 Novavax shall at all times remain responsible and liable to the Authority for the  acts or omissions of Novavax' Affiliates and Subcontractors to whom Novavax  subcontracts or delegates any of its obligations, as if those acts or omissions  were of its own.  34.8 No Rights of Third Parties  Save as provided in this Agreement, including pursuant to clause 21.4, a person who is  not a Party to this Agreement shall not have any rights under the Contracts (Rights of  Third Parties) Act 1999 to enforce any term of this Agreement. Notwithstanding any  rights any third party may have by virtue of the foregoing, the Parties to this Agreement  may vary, amend or terminate this Agreement without seeking the consent of any Third  Party whose rights may be affected.  34.9 Costs  Except as set forth herein, each Party will be responsible for all costs incurred by it or  on its behalf in connection with this Agreement.  34.10 Entire Agreement  This Agreement, and any agreement or document referred to in it, together with the  schedules herein, contains the entire agreement between the Parties with respect to the  subject matter of this Agreement, and supersedes all previous agreements and  understandings between the Parties with respect to that subject matter including the  Heads of Terms between the Parties dated 13 August 2020. Each Party acknowledges  that, in entering into this Agreement and the agreements and documents referred to in  it, it does not rely on any statement, representation, assurance or warranty (whether it  was made negligently or innocently) of any person (whether a Party to this Agreement  or not) which is not expressly set out in this Agreement or those documents (a  "Representation"), and that it shall have no cause of action against the other Party  arising out of any Representation except in respect of any fraudulent misrepresentation  by the other Party. Each Party agrees that the confidentiality agreement dated 1 June  2020 between the Parties is unaffected by this clause, provided that confidential  information disclosed under that agreement may be used and deemed disclosed  pursuant to this Agreement.  34.11 Governing Law and Jurisdiction  34.11.1This Agreement and any issues, disputes or claims arising out of or in  connection with it (whether contractual or non-contractual in nature, including  claims in tort or for breach of any statute or Applicable Law) shall be governed  by and construed in accordance with [***] law.  34.11.2If a dispute arises between the Parties in connection with or relating to this  Agreement (a "Dispute"), either Party shall have the right to refer such Dispute  to senior representatives (namely [***]) for attempted resolution by good faith  negotiations during a period of [***]. Any final decision mutually agreed to by  such senior officers in writing shall be conclusive and binding on the Parties.    

 

  254681-3-31828-v16.0 - 56 - 70-40746871    34.11.3Subject to clause 34.11.2, each Party irrevocably submits to the exclusive  jurisdiction of the [***] courts to settle any dispute which may arise under or in  connection with this Agreement or the legal relationships established by this  Agreement.  34.12 Delivery of Agreement  The Parties do not intend this Agreement to be delivered by, or to become legally  binding on, any of them until the date of this Agreement is written at its head,  notwithstanding that one or more of them may have executed this Agreement prior to  that date being inserted.  IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed in two (2)  counterparts by their respective duly authorised representatives as of the date set forth at the  beginning of this Agreement.     

 

  254681-3-31828-v16.0 - 57 - 70-40746871    SIGNED by                                                       ,  Authorised Signatory for and on behalf of  NOVAVAX, INC.      )  )  ) .../s/ [***]..........    SIGNED by                                                       ,  Authorised Signatory for and on behalf of  THE SECRETARY OF STATE FOR  BUSINESS, ENERGY AND  INDUSTRIAL STRATEGY  )  )  )   )  )  .../s/ [***]................   [***]   [***]         

 

    SCHEDULE 1  CANDIDATE, PRODUCT AND SPECIFICATIONS  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the the candidate,  product and specifications has not been filed. The Registrant agrees to furnish supplementally  a copy of any omitted schedules to the Securities and Exchange Commission upon request;  provided, however, that the Registrant may request confidential treatment of omitted items.]    

 

    SCHEDULE 2  FACILITIES  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the facilities has not  been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules  to the Securities and Exchange Commission upon request; provided, however, that the  Registrant may request confidential treatment of omitted items.]      

 

    SCHEDULE 3  KEY PERFORMANCE INDICATORS AND MEETING SCHEDULES  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the key performance indicators and meeting schedules has not been  filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules to the Securities and Exchange Commission upon  request; provided, however, that the Registrant may request confidential treatment of omitted items.]                    

 

    SCHEDULE 4  DEVELOPMENT AND MANUFACTURING PLAN  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the development and  manufacturing plan has not been filed. The Registrant agrees to furnish supplementally a  copy of any omitted schedules to the Securities and Exchange Commission upon request;  provided, however, that the Registrant may request confidential treatment of omitted items.]      

 

    SCHEDULE 5  BASELINES  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the baselines has not  been filed. The Registrant agrees to furnish supplementally a copy of any omitted schedules  to the Securities and Exchange Commission upon request; provided, however, that the  Registrant may request confidential treatment of omitted items.]    

 

    SCHEDULE 6  DELIVERY SCHEDULE  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the delivery schedule  has not been filed. The Registrant agrees to furnish supplementally a copy of any omitted  schedules to the Securities and Exchange Commission upon request; provided, however, that  the Registrant may request confidential treatment of omitted items.]       

 

    SCHEDULE 7  ADDITIONAL ORDER PRICING  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the additional order  pricing has not been filed. The Registrant agrees to furnish supplementally a copy of any  omitted schedules to the Securities and Exchange Commission upon request; provided,  however, that the Registrant may request confidential treatment of omitted items.]    

 

    SCHEDULE 8  DOCUMENTATION TO ACCOMPANY DELIVERIES  [Pursuant to Regulation S-K, Item 601(a)(5), this Schedule setting forth the documentation to  accompany deliveries has not been filed. The Registrant agrees to furnish supplementally a  copy of any omitted schedules to the Securities and Exchange Commission upon request;  provided, however, that the Registrant may request confidential treatment of omitted items.]exhibit1036

Exhibit 10.36    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.    EXECUTION VERSION      ADVANCED PURCHASE AGREEMENT  This ADVANCED PURCHASE AGREEMENT (this “Agreement”) is made as of 31  December 2020 (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 The Commonwealth of Australia as  represented by the Department of Health, with offices at Scarborough House, 1 Atlantic Street,  Woden, ACT 2606, Australia (“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 “Vaccine”), which is intended to prevent  SARS-CoV-2 (“COVID-19”) in humans;  WHEREAS, Novavax intends to seek government issued licenses, registrations,  authorizations and approvals necessary to commercialize the Vaccine, including without  limitation, emergency exemptions, Authorisations or provisional approvals (“Regulatory  Approval”) to permit use of the Vaccine in Australia (the “Territory”);  WHEREAS, in advance of Regulatory Approval in the Territory, Customer wishes to  pre-order an aggregate number of doses of Vaccine from Novavax designed to vaccinate [***], 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 in the Territory and that the use, deployment and  administration of the Vaccine by Customer to individuals in the Territory will occur under  COVID-19 pandemic conditions.  The terms and conditions of this Agreement, including  with respect to Product pricing, refund terms, indemnification and limitations of liability,  reflect this understanding.  

 

EXECUTION VERSION    -2-  70472309_1  2. Sale of Product.  2.1. Generally.  During the Term, Customer hereby commits to purchase from Novavax  the Vaccine, which will be supplied in [***] (the “Product”), in an amount equal to  the aggregate quantity of Vaccine doses set forth in Exhibit A (the “Aggregate  Amount”).  If during the Term Customer desires to purchase an additional quantity  of Vaccine doses, up to the Maximum Aggregate Additional Amount identified in  Exhibit A, then Customer shall notify Novavax in writing, and the Parties will  negotiate, in good faith, whether Novavax has supply sufficient to provide the  requested additional quantity of Vaccine doses at the time of Customer’s request.   If the Parties agree on the quantity of, and Delivery Schedule for, an additional  amount of Vaccine doses (“Additional Amount”), Customer shall issue a Purchase  Order for the Additional Amount in accordance with Section 2.3.1.  2.2. Use, Donation and Resale.  2.2.1. Use.  Novavax grants Customer the right to use any Product supplied  hereunder (a) solely to vaccinate individuals in the Territory against  COVID-19, subject to Section 2.2.2 and Section 2.2.3, and (b) in accordance  with the terms and conditions of this Agreement.  2.2.2. Donation and Resale.  Notwithstanding the territory restriction set forth in  Section 2.2.1 and subject to Customer’s obligation to indemnify Novavax  as set forth in Section 9, Novavax grants Customer the right to donate or  resell some or all of the Product to one or more countries outside of the  Territory or an organisation (including an NGO) that Customer may  determine in its absolute discretion (“Regional Partners”), provided that (i)  the intended purpose of such donation or resale is to vaccinate individuals  against COVID-19, (ii) [***], (iii) [***] and (iv) [***].  2.2.3. Conditions for Donation and Resale.  Customer expressly acknowledges  and agrees that, in connection with any donation or resale of Product to a  Regional Partner:  (A) [***], (B) [***], (C) [***], and (D) [***]. Customer  acknowledges and agrees Customer shall be responsible for [***].  2.3. Purchase Order.  2.3.1. Purchase Order.  Within [***] of the Effective Date, Customer will deliver  a purchase order (“Purchase Order”) for the Aggregate Amount to Novavax  together with the Customer’s order number and invoice address.  If  Customer elects to purchase an Additional Amount, it will deliver a  Purchase Order for the Additional Amount to Novavax together with the  Customer’s order number and invoice address.  2.3.2. Confirmation.  Provided the Purchase Order contains accurate quantity and  pricing information in accordance with Section 2.3.1, Novavax will confirm  a Purchase Order within [***] of receipt; provided, however, that Novavax  

 

EXECUTION VERSION    -3-  70472309_1  will be deemed to have accepted a Purchase Order if no confirmation is  received prior to the expiry of such [***] period.  2.4. Delivery.  Novavax intends to deliver monthly shipments of Product to Customer  until the Aggregate Amount is supplied.  Based upon Novavax’s 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 in the  Territory.  Novavax will use reasonable endeavours to deliver, or ensure that the  Sponsor delivers, the Product to Customer in accordance with the Delivery  Schedule and will, on at least a [***] basis, communicate any anticipated changes  to the Delivery Schedule to Customer including any anticipated variances permitted  by Section 2.5. At least [***] in advance of each anticipated shipment under the  Delivery Schedule, Novavax will confirm to the Customer in writing the date of  delivery of the Product.  Delivery of the first shipment of Product under the  Delivery Schedule is expected to be a date as soon as practicable after receipt of  Regulatory Approval in the Territory when sufficient Product is available for the  first shipment in the Delivery Schedule.  Novavax will [***] notify Customer in  writing by email when the Product is available for Delivery and for Customer’s  inspection.  2.5. Variance.  Without limiting Section 2.6, 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 Vaccine actually delivered each Calendar  Quarter may vary by [***] of the Aggregate Amount and (b) the actual date of  delivery may vary within [***] of the delivery date projected by Novavax pursuant  to Section 2.4; provided that Novavax first notifies Customer of such variances  [***] in advance of each anticipated shipment of Product under the Delivery  Schedule.  2.6. Short Supply.  If Novavax receives Regulatory Approval in the Territory, but  reasonably believes that it will not be able to supply Customer with quantities of  Vaccine within the variances permitted by Section 2.5, then Novavax shall [***]  notify Customer in writing of such circumstances, including [***] (“Remedial  Plan”).  Where such inability to supply results from Novavax’s inability to  manufacture or source sufficient quantities of Vaccine doses to supply all of its  customers, Novavax shall deliver to Customer [***] for the period of short supply.   Novavax shall consider in good faith any reasonable changes to the Remedial Plan  proposed by Customer.  2.6.1. If the Remedial Plan does not resolve such inability or failure to supply to  within [***] of the first missed or under delivery giving rise to the Remedial  Plan, the Customer may, [***], cancel delivery of the Product that was  scheduled for delivery [***].  

 

EXECUTION VERSION    -4-  70472309_1  2.6.2. If failure to supply is still ongoing after [***] of the initial missed or under  delivery giving rise to the Remedial Plan, Customer may upon written  notice to Novavax cancel future deliveries of Product and terminate the  Agreement.  2.6.3. If Customer elects to cancel delivery of Product pursuant to this Section  2.6, [***].  Subject to Section 7.2.2 and Section 7.5, the remedies in this  Section 2.6 shall be Customer’s sole recourse and Novavax’s entire  liability with respect to any failure to supply.  2.7. Inconsistent Terms.  All terms and conditions contained in any prior or subsequent  oral or written communication, including terms and conditions contained in the  Purchase 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.  2.8. Non-exclusivity of arrangements.  Novavax acknowledges and agrees that the  arrangement under this Agreement is non-exclusive and Customer may acquire any  product comparable to the Vaccine under any process or arrangement and from any  vaccine supplier as it sees fit and by entering this Agreement Customer is not  restricted from entering into any international or multilateral agreements for supply  of product comparable to the Vaccine.  3. Delivery and Acceptance  3.1. Delivery, Title and Risk of Loss.  Product will be delivered to a point of entry in  Australia mutually agreed by the Parties, acting reasonably (the “Point of Entry”).   Product will not be delivered until after all import and customs clearance  requirements in respect of the Products have been completed, including the batch  testing and release process required by the TGA, and Novavax (or Sponsor) has  provided all Delivery Documents to Customer.  Novavax will [***] notify, or  ensure that the Sponsor notifies, Customer in writing when Product is ready for  collection by Customer (or its nominee) at the Point of Entry.  Delivery of the  Product will be deemed to take place [***].  Title to Product shall pass to Customer  [***].  For clarity, Novavax (and Sponsor, as applicable) will be [***] for  importing Product into the Territory (excluding payment of any customs duties,  which shall be the [***] of the Customer), obtaining a batch release letter from the  TGA (including [***]) and unloading Product from the transportation carrier at  Point of Entry.  [***]; if Customer fails to handle the Product with due care,  maintain cold chain requirements throughout the Acceptance Period and that failure  results in damage to the Product or otherwise causes such Product to be unsuitable  for use, then Customer acknowledges and agrees the resultant damage will not be  cause for non-Acceptance under Section 3.4. After Acceptance, Customer will be  solely responsible for distributing Product in the Territory.  

 

EXECUTION VERSION    -5-  70472309_1  3.2. Delivery Documents.  [***], Novavax will provide, or ensure that Sponsor  provides, to Customer the usual documentation provided for the Product, including  [***] (“Delivery Documents”).  3.3. Cooperation.  Novavax agrees to cooperate, and ensure that Sponsor cooperates,  with the TGA including in relation to the testing of the Product including in relation  to requisite batch testing requirements.  Novavax agrees that the TGA may provide  Customer with information relating to the Product, including information relating  to the testing contemplated by this Section 3.3 and Novavax’s manufacturing  process and supply chain in respect of the Product (including details of any Special  Vendors).  3.4. Acceptance.  Customer (or its nominee) will, [***] after Customer is notified under  Section 3.1 that the Product is ready for collection and Novavax (or Sponsor) has  provided all Delivery Documents to Customer (“Acceptance Period”), visually  inspect such delivery to confirm that the Product has been supplied in the correct  quantity and appears, from a visual inspection only, to constitute Conforming  Product.  Notwithstanding the foregoing, Customer may request to extend the  Acceptance Period for an additional [***] period with reasonable advance notice  and a detailing of the circumstances for such extension and Novavax will  reasonably and in good faith consider such extension request and provide written  notice of approval to Customer if granted.  Without limiting any other rights  Customer may have at Law or under this Agreement, if Customer determines that  any shipment of Product contains any non-Conforming Product, then Customer  shall have the right to reject the portion of the applicable delivery that constitutes  non-Conforming Product by providing Novavax with written notice of such  rejection prior to the expiry of the Acceptance Period.  Customer will be deemed to  have accepted a delivery of Product if not rejected prior to expiry of the Acceptance  Period.  4. Product Warranty.  4.1. Limited Product Warranty.  Novavax warrants to Customer that, upon delivery of  Product to the Point of Entry, Product will (a) materially conform to the  specifications for such Product as set forth on Exhibit C hereto (the  “Specifications”) and be free from defects (including any latent defects), (b)  comply with the applicable Regulatory Approval in the Territory for such Vaccine,  including shelf-life requirements and any other conditions, requirements or  directions of the TGA, and (c) have been manufactured, packaged, handled, stored,  transported and cold-chain maintained in accordance with the Specifications,  Novavax’s relevant standard operating procedures in relation to the manufacture  and delivery of the Product, and cGMP.  Product satisfying clauses (a)-(c) hereof,  “Conforming Product”.  Any claims by Customer that the Product fails to meet  this warranty must be made by the Customer within [***] of Acceptance of the  Product as set forth in Section 3.4.  

 

EXECUTION VERSION    -6-  70472309_1  4.2. Remedies For Non-Conforming Product.  If Novavax accepts Customer’s rejection  of Product as set forth in Section 3.4, 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 Novavax’s option and at  no additional charge to Customer, either (a) replace the non-Conforming Product or  (b) credit or refund the Price of such non-Conforming Products.  If Novavax so  requests, Customer shall, [***], return any non-Conforming Products to Novavax;  otherwise, Customer shall dispose of Product in compliance with applicable Laws  [***].  4.3. Disputes.  If Novavax disputes Customer’s rejection of Product pursuant to Section  3.4 or Customer’s warranty claim pursuant to Section 4.1, then Novavax will  provide Customer written notice of such dispute (“Warranty Dispute Notice”) no  later than [***] after the date of the notice from Customer that it does not Accept  the Product or that Product is non-Conforming Product.  Such dispute shall be  resolved by having an independent, mutually acceptable, qualified third party  expert (the “Independent Expert”) promptly examine the Product subject to the  dispute.  Failing agreement in writing of an Independent Expert within [***] of  receipt of the Warranty Dispute Notice, the Independent Expert will be (a) [***].   If a person is nominated by [***] as the Independent Expert under this Section 4.3,  the Parties agree to do all things reasonably necessary to effect that nomination  (including signing the person’s engagement letter, agreeing to indemnify the person  and agreeing to pay the fees and expenses of the person) [***].  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 AND SECTION  4.3 SHALL BE CUSTOMER’S SOLE AND EXCLUSIVE REMEDY AND  NOVAVAX’S ENTIRE LIABILITY FOR NON-ACCEPTANCE OF PRODUCT  UNDER SECTION 3.4 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 an upfront payment of [***] of  the Total Price as set forth on Exhibit A (the “Advance Payment”) in accordance  with this Section 5. [***].  [***] of the Advance Payment is non-refundable.  The  remaining [***] of Advance Payment (“Refundable Portion”) is refundable only as  provided in Section 2.6.3, Section 7.2.2 and Section 7.5.  5.2. Price.  The Total Price, Per-Unit Price and Per-Unit Delivery Price (each excluding  GST) for Product are as set forth on Exhibit A (collectively, the “Price”).  The Price  includes [***].  Any additional shipping charges, including charges for expedited  shipping, more frequent deliveries or multiple locations, will be agreed between the  Parties and charged to the Commonwealth.  The Price is exclusive of any and all  governmental taxes, including, without limitation, GST, value added tax, customs,  

 

EXECUTION VERSION    -7-  70472309_1  charges or levies of every kind that may apply upon sale, transfer, importation or  shipment of Product to the Point of Entry under any applicable Laws but excluding  any GST, valued added tax or similar tax payable in respect of importation of the  Product into Australia to the extent that the importer is entitled to a full credit for  such tax and excluding taxes on income.  Subject to those exceptions, Customer  will be solely responsible for all such taxes, charges and levies to the extent they  relate to supply of Product to Customer.  5.3. [***].  [***].  5.4. Invoices.  Novavax shall submit invoices to Customer for (a) the Advance Payment  upon [***] which invoices shall be directed to the following person and address (or  to such other person or address if Customer notifies Novavax in writing pursuant  to Section 13.2 that invoices should be sent to such other person or address):  [***]  Each invoice must include the following information:  (a) Customer’s order  number, as set out in the Purchase Order and (b) details of the contract point of  contact (including the name of the current point of contact).  Novavax must provide  all invoices in a soft copy format that is a Word, Excel, JPEG, PDF, PNG, TIFF,  EML, CSV or CFDI file.  Invoices shall be deemed to be received when the sender  receives a confirmation from [***] confirming receipt.  If an invoice is found to  have been rendered incorrectly after it has been paid, any underpayment or  overpayment will be recoverable by or from Novavax, as the case may be, and,  without limiting recourse to other available remedies, may be offset against any  amount subsequently due to Novavax.  Each invoice for a delivery of Product shall  reflect the actual quantities of Vaccine shipped to the Point of Entry, together with  the Per-Unit Delivery Price, the total Delivery Price and the total amount of GST  (if any) to be paid under such invoice.  All amounts set forth in each invoice (a) for  the Advance Payment shall be payable within [***], and made in United States  Dollars (“USD”).  For clarity, Customer will not be responsible for paying any bank  charges.  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 13.6. Customer will not be required to pay any amount  disputed in good faith, unless such amount is finally determined to be owed to  Novavax in accordance with the dispute resolution procedure set forth in Section  13.6, in which case, such amount will bear interest at the rate of [***].  Except as  expressly set out in this Agreement or required by Law, no offset or deduction from  any invoice is permitted.  5.5. GST.  5.5.1. Unless this Agreement expressly states otherwise, all consideration to be  provided under this Agreement is exclusive of GST.  

 

EXECUTION VERSION    -8-  70472309_1  5.5.2. If a Party (the “Supplying Party”) makes a supply under or in connection  with this Agreement in respect of which GST is payable (“Taxable  Supply”), the recipient of the Taxable Supply (“Recipient”) must, subject  to the prior receipt of a tax invoice, pay to the Supplying Party, an additional  amount equal to the GST payable on the Taxable Supply.  This Section 5.5  does not apply to GST payable in respect of importations.  5.5.3. If a Party must reimburse or indemnify another party for a Loss, the amount  to be reimbursed or indemnified is first reduced by any input tax credit the  other Party (or the representative member of a GST group of which is other  Party is a member) is entitled to for the Loss, and then increased in  accordance with Section 5.5.2.  5.5.4. If an adjustment event occurs in relation to a Taxable Supply, the Supplying  Party must issue an adjustment note to the Recipient in relation to that  Taxable Supply within [***] after becoming aware of the adjustment.  5.5.5. A term which has a defined meaning in the GST Law has the same meaning  when used in this Section 5.5, unless the contrary intention appears.  5.5.6. This Section 5.5 will survive the termination of this Agreement.  5.6. Withholdings.  If a Law requires Customer to withhold or deduct an amount in  respect of Taxes from a payment made to Novavax pursuant to this Agreement,  then Customer agrees to pay an additional amount required to be withheld or  deducted to the relevant Agency in accordance with the applicable Law and to  provide evidence of payment thereof to Novavax.  6. 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 Rights  that relate to the Vaccine are and shall remain the sole and exclusive property of Novavax.   Except as otherwise set out in this Agreement, Novavax does not grant Customer and right,  title or interest in, to or under any such Intellectual Property Rights or any other intellectual  property owned or controlled by Novavax.  However, Novavax grants Customer a  royalty-free, worldwide, non-exclusive license under Novavax’s Intellectual Property  Rights to use the Vaccine solely for the purposes of distributing Vaccine in the Territory  [***] in accordance with this Agreement.  Novavax grants Customer a royalty-free,  world-wide, non-exclusive license (including the right to sub-license to third parties acting  on Customer’s behalf) to use, reproduce, publish, electronically transmit and distribute any  Agreement Material solely for the purposes of fulfilling Customer’s purposes under this  Agreement and for the Customer’s reporting and accountability requirements.  For the  avoidance of doubt, this does not include Intellectual Property Rights relating to the  development, construction or manufacture of the Vaccine itself.  To the extent Customer,  directly or indirectly, creates, discovers, reduces to practice or otherwise generates  Intellectual Property Rights in the Vaccine, such Intellectual Property Rights will be solely  owned by, and immediately vest on creation in, Novavax.  Customer shall assign, and  hereby does assign, to Novavax all such Intellectual Property Rights, and will take  

 

EXECUTION VERSION    -9-  70472309_1  reasonable actions requested by Novavax, [***], to record and confirm Novavax’s  ownership thereof, including if requested by Novavax executing formal documentation  evidencing Novavax’s ownership thereof.  7. Term; Termination; Effects of Termination.  7.1. Term.  This Agreement shall become effective upon the Effective Date and, unless  sooner terminated as set forth in Section 7.2, shall continue in force and effect until  the later of (a) the end of the Pandemic Period, (b) the date that is three (3) years  from the Effective Date; (c) Novavax has delivered to Customer an amount of  Product equal to the Aggregate Amount (the “Term”).  7.2. Termination.  7.2.1. Material Breach.  7.2.1.1.Customer Termination.  Customer may terminate this Agreement at  any time prior to expiration of the Term upon written notice to  Novavax if Novavax materially breaches this Agreement and (a)  such breach is not cured within [***] of written notice to Novavax  describing such breach and requiring Novavax to cure the breach or  (b) the breach is not capable of being cured (for the avoidance of  doubt, failure to meet a deadline shall not be considered a breach not  capable of being cured).  7.2.1.2.Novavax Termination.  Novavax may terminate this Agreement at  any time prior to expiration of the Term upon written notice to  Customer if Customer (a) materially breaches Section 2.2, Section  6 or Section 12 and such breach is (i) not cured within [***] of  Novavax providing written notice to the Customer requiring the  Customer to cure the breach or (ii) not capable of being cured (for  the avoidance of doubt, failure to meet a deadline shall not be  considered a breach not capable of being cured); or (b) fails to pay  an undisputed amount when due and such breach is not cured within  [***] of Novavax providing written notice to the Customer  requiring the Customer to cure the breach.  The Parties agree that  Novavax may only terminate this Agreement pursuant to this  Section 7.2.1.2.  7.2.2. Regulatory Approval.  If Novavax fails to receive Regulatory Approval of  the Vaccine in the Territory on or before [***] then Customer may  terminate this Agreement [***] upon written notice to Novavax.   Customer’s sole and exclusive remedy for Novavax’s failure to receive  Regulatory Approval of the Vaccine in the Territory are those set out in this  Section 7.2.2 and Section 7.5.  7.3. Customer Termination.  Without prejudice to its rights under this Agreement and  at Law, Customer may terminate this Agreement, by notice in writing to Novavax,  

 

EXECUTION VERSION    -10-  70472309_1  [***] if Novavax (a) suffers an Insolvency Event and fails to emerge within [***]  of initiation of such Insolvency Event; (b) ceases to carry on its business; (c) suffers  a change in Control or assigns or novates its rights otherwise than in accordance  with the requirements of this Agreement; or (d) disposes of the whole or any  material part of its assets or business (whether in a single transaction or a series of  related or unrelated transactions), other than to carry out a reconstruction or  amalgamation of the corporate group constituting Novavax and its Related Bodies  Corporate and which has a material adverse effect on Novavax’s ability to supply  the Vaccine as contemplated under this Agreement.  7.4. ARTG registration.  Without prejudice to its rights at Law, Customer may terminate  this Agreement by notice in writing to Novavax, [***] if, [***].  7.5. Effects of Expiration or Termination.  Upon expiry of the Term 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 12.5. If  this Agreement is terminated under Section 7.2.1.1 (provided such termination is  related to Novavax’s failure to deliver Product), 7.2.2 or 7.4, Novavax must refund  to Customer the Refundable Portion of the Advance Payment attributable to the  undelivered Product as at the date of termination within [***] of receipt of a  termination notice under that Section.  In the event Novavax terminates this  Agreement pursuant to Section 7.2.1.2, Customer must pay all amounts due and  payable to Novavax pursuant to Agreement as at the date of termination.  8. Development and Regulatory Matters.  8.1. Development of Vaccine.  The Parties acknowledge and agree that Novavax will  use reasonable endeavours to develop the Vaccine, but the successful development  of the Vaccine is not guaranteed.  8.2. Labelling.  Novavax must ensure that all Product is labelled and packaged in  accordance with the applicable Regulatory Approval, Specifications and GMP  standards, and otherwise in compliance with TGA labelling requirements unless an  Exemption applies.  8.3. Approach to Regulatory Approval.  Novavax shall use commercially reasonable  efforts to obtain, and ensure that Sponsor obtains, Regulatory Approval of the  Vaccine in the Territory from the TGA, including (a) Authorisation, (b) GMP  clearance from the TGA or equivalent regulator to manufacture the Vaccine  overseas, in order to meet the requirements of the TG Act with regard to  manufacture of the Vaccine (“GMP Clearance”) and (c) to the extent the Vaccine  is required to be registered on the ARTG under the TG Act and is not Exempt,  registration of the Vaccine on the ARTG, [***].  Novavax will notify Customer in  writing (email being sufficient) when the Vaccine is granted any Regulatory  

 

EXECUTION VERSION    -11-  70472309_1  Approval in the Territory and provide to Customer evidence of any Authorisations,  GMP Clearance and registration of the Vaccine on the ARTG for the purposes of  this Section 8.3. Customer and Novavax both acknowledge that regulatory  harmonization and streamlined logistics requirements, including packaging,  labelling, and post-marketing requirements across all participating high income  countries (HICs), is of the utmost importance to the timely approval and delivery  of a COVID-19 vaccine during the pandemic.  Customer acknowledges that any  country-specific requirements in the Territory regarding packaging, labelling, or  release logistics may delay delivery of Product.  8.4. Documentation.  Novavax shall prepare and maintain, and ensure that the Sponsor  prepares and maintains, all documentation required by the TGA in relation to the  safety, manufacture, delivery and storage of Product, including batch records and  file samples, properly stored, from each lot or batch of Product manufactured and  shipped under this Agreement as well as shipping records for each batch shipped  (including records of cold-chain compliance).  Upon request, such documentation  will [***] be made available to Customer (in English) for review.  In addition,  Novavax will maintain appropriate records and supporting documentation to  confirm that each invoice is limited to the actual quantities of Product shipped to  the Point of Entry, which records and documentation will be maintained by  Novavax for [***], following Acceptance of the relevant batch of Product by  Customer pursuant to Section 3.4. Customer will have the right, [***], to inspect  any such records.  Customer may appoint an independent person to assist in  inspections during normal business hours at the place such records are normally  kept.  In the event any such inspection reveals an overpayment by Customer,  Novavax will [***] credit Customer the amount of such overpayment against future  deliveries of Product, unless there are no such future deliveries, in which case,  Novavax will [***] refund Customer for the amount of such overpayment.  8.5. Regulatory Assistance.  Customer will, within the framework of its competencies,  reasonably support Novavax in obtaining Regulatory Approval for the Vaccine in  the Territory, including accelerated Regulatory Approval processes.  The Parties  acknowledge, and Customer represents to Novavax, that TGA is part of Customer  but operates independently in accordance with the TG Act and that, in entering into  this Agreement, Customer is not acting as, or influencing the TGA or in any  regulatory capacity.  8.6. Recalls.  Novavax must [***] notify Customer of any issues that could potentially  lead to a recall of the Product and provide all relevant information to Customer  [***].  As distributor of the Product in the Territory, Customer (or its nominee)  shall use reasonable endeavours to assist Novavax in implementing any Product  recalls (a) required by controlling regulatory agencies and (b) voluntary  withdrawals requested by Novavax, with respect to each, in the Territory.  Novavax  shall initiate and handle, or ensure that Sponsor initiates and handles, any recalls in  a timely, prudent and skillful manner, in compliance with all applicable Laws.   Novavax will, at the [***] of Customer, [***] (a) replace any recalled and  unexpired Product if it has supply of Product that can be made available or (b)  

 

EXECUTION VERSION    -12-  70472309_1  refund or credit the Price attributable to the recalled and unexpired Product (and in  any case within [***] unless otherwise agreed by Novavax and Customer).  All  costs incurred in responding to recalls and market withdrawals shall be borne by  [***].  8.7. Summary reports.  Until delivery of the Aggregate Amount, Novavax will provide  Customer with a written report, on a minimum [***] basis or other period agreed  between the Parties (“Summary Report”) that details:  [***].  The Parties  acknowledge that the Summary Report is intended to be a high-level update  regarding the progress of the Vaccine development and supply, and may include  Confidential Information.  Novavax will, at the request of Customer, provide a brief  verbal discussion of each Summary Report.  Novavax or third party confidential  information contained in a Summary Report will be treated as Novavax’s  Confidential Information for the purposes of Section 12.  8.8. Notifications.  Novavax must [***] notify Customer in writing if (a) [***].   Novavax must [***] and fully inform the TGA in respect of any information  required to be supplied to the TGA under the TG Act in respect of the Vaccine, and,  if requested by Customer, it will supply such information upon request to Customer.  8.9. Manufacturing Facilities.  Novavax may not supply Product under this Agreement  from facilities other than the Manufacturing Facilities without first obtaining  approval from the TGA for an alternative manufacturing site and obtaining  Customer’s prior written consent.  If Novavax seeks consent to supply Product from  facilities other than the Manufacturing Facilities, and has obtained approval from  the TGA to use an alternative manufacturing site, Customer’s consent may not be  unreasonably withheld and will be deemed to have been provided if (a) the request  is made in writing and complies with the requirements set out in Section 13.2 and  (b) Customer fails to provide consent or notify Novavax that it does not provide  consent within [***] after receipt of the request.  8.10. Specifications.  Novavax will provide to Customer on a confidential basis (a) the  draft Specifications provided to the TGA with the application for Regulatory  Approval, within [***] of submitting that application to the TGA; and (b) the final  Specifications which are the specifications for the Product determined by Novavax  and approved by the TGA, reflecting data arising from the trials (including safety  and efficacy requirements) and the Regulatory Approval, within [***] of the  granting of the Regulatory Approval by the TGA.  9. Indemnification.  9.1. By Customer.  Notwithstanding any contrary provision of this Agreement and to  the fullest extent not prohibited by applicable Laws Customer (“Indemnifying  Party” for the purposes of this Section 9.1) will release and indemnify Novavax and  its affiliates, Sponsor and its or their respective officers, directors, employees,  agents and contractors (each an “Indemnified Party” for the purposes of this Section  9.1) from and against any and all claims, demands, causes of action, damages,  

 

EXECUTION VERSION    -13-  70472309_1  losses, liabilities, costs, expenses (including legal fees and litigation expenses),  penalties, fines, settlements and judgments (collectively, “Losses”) resulting from  a Claim to the extent that Claim is 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 indemnity shall apply and be binding on Indemnifying Party  regardless of whether any defect in Product causing any Losses originates from the  testing, development, manufacture, delivery, export, import, distribution, sale, offer  for sale, administration, use or deployment of Product.  [***].  Indemnifying  Party’s liability for any Losses under this Section shall be reduced proportionally  to the extent the relevant Losses would have been avoided or mitigated but for the  Indemnified Party’s failure to take reasonable steps to mitigate those Losses.  9.2. Deed Poll.  The rights under Section 9.1 are for the benefit of, and may be exercised  by, the Sponsor.  This document takes effect as a deed poll in favour of the Sponsor  and is enforceable by the Sponsor.  9.3. Procedure.  Any Indemnified Party shall [***] notify Indemnifying Party in writing  of any Claim made against an Indemnified Party, specifying the basis given for  such Claim; provided that [***].  Indemnifying Party shall, within [***] after  receiving notice of a Claim from the Indemnified Party, notify the Indemnified  Party whether Indemnifying Party elects to undertake the defense of or, [***].  The  election by Indemnifying Party to undertake the defense of a Claim shall not  preclude the Indemnified Party from participating or continuing to participate in  such defense, so long as the Indemnified Party [***].  If Indemnifying Party elects  not to defend or settle the Claim itself, the Indemnified Party may assume the  defense of the Claim, in which case Indemnifying Party shall, [***].  Novavax  acknowledges that the Commonwealth must comply with government policy in the  conduct of litigation (including the Legal Services Directions 2017 made under  section 55ZF of the Judiciary Act 1903 (Cth)).  9.4. Third Party Intellectual Property Infringement.  In the event that Product is found  to infringe any third party Intellectual Property Rights, the Parties will discuss in  good faith potential solutions to permit the ongoing supply of Product by Novavax  and use by Customer.  10. Representations and Covenants.  10.1. Mutual Representations.  Each Party hereby represents and warrants to the other  Party, as of the Effective Date, that:  10.1.1. it has all requisite power and authority, corporate or otherwise, to execute,  deliver and perform this Agreement;  10.1.2. this Agreement is a legal and valid obligation binding upon such Party and  enforceable in accordance with its terms;  10.1.3. the execution, delivery and performance of this Agreement by such Party  does not conflict with any agreement, instrument or understanding, oral or  

 

EXECUTION VERSION    -14-  70472309_1  written, to which such Party is bound, nor violate any applicable Law or any  order, writ, judgment, injunction, decree, determination or award of any  court or governmental body or administrative or other agency presently in  effect and applicable to such Party; and  10.1.4. in the performance of this Agreement, it shall comply with all applicable  Laws.  10.2. Novavax’s Covenant.  Novavax hereby covenants to Customer that, at the time of  delivery to the Point of Entry, Customer will have good title to the delivered  Products, free and clear of all liens, encumbrances and security interests.  10.3. Disclaimer.  EXCEPT FOR THOSE REPRESENTATIONS, WARRANTIES  AND COVENANTS EXPRESSLY SET FORTH IN SECTION 4.1 OR THIS  SECTION 10, 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 IN THE TERRITORY.  11. Limitation of Liability.  11.1. [***].  [***].  12. Confidential Information.  12.1. 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 or to which a Party obtains access as a consequence of entering  into or performing this Agreement (in each case whether before, on or after the  Effective Date), whether or not marked as “CONFIDENTIAL” or  “PROPRIETARY,” and whether provided prior to, on or after the Effective Date,  including all technical, scientific, business, commercial and other know-how,  information, trade secrets, methods, processes, practices, formulae, instructions,  techniques, designs, drawings, data or results, but expressly excluding any  

 

EXECUTION VERSION    -15-  70472309_1  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.  12.2. 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 of the disclosing  Party’s Confidential Information without prior written approval from the disclosing  Party; provided that the receiving Party may disclose such Confidential Information  to its affiliates, and to its and their officers, directors, employees, contractors,  agents, Australian, State and Territory government entities as necessary, Ministers,  Ministerial advisers, professional advisors or consultants who are bound by  confidentiality obligations at least as restrictive as those set forth in this Section 12  and who reasonably need to know such Confidential Information in the  performance of the receiving Party’s obligations under this Agreement, or for the  purpose of governmental reporting including requests for information by the  responsible Minister, a House of the Parliament of the Commonwealth of Australia  or Parliamentary Committee and provided such information is designated as  ‘Confidential’ (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 12 and (d) not use such Confidential Information for any  purpose other than performing its obligations under this Agreement.  The Customer  may disclose all or any part of the Confidential Information to the extent necessary  to enable Customer’s performance under this Agreement and its distribution,  administration, and use of Product, provided, however, that it ensures that any  receiving party are bound by confidentiality obligations at least as restrictive as  those set forth in this Section 12. Each Party acknowledges and agrees that its  failure to comply with the provisions of this Section 12 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  

 

EXECUTION VERSION    -16-  70472309_1  remedies available to it, interlocutory and permanent injunctive relief to restrain  any anticipated, present or continuing breach of this Section 12 without the need to  post bond or other security.  The terms of this Agreement will be the Confidential  Information of both Parties.  12.3. Disclosures Required by Law.  Subject to the remainder of this Section 12.3, each  Party may disclose the Confidential Information of the other Party to the extent that  such disclosure is, in the reasonable opinion of the receiving Party’s legal counsel,  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) 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.  12.4. Survival.  The provisions of this Section 12 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.  12.5. 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.  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 including 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.  13. Miscellaneous.  13.1. 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 caused by (a) fire, earthquake, storm (including  hurricanes, snow storms, blizzards or ice storms), hail, flood, act of war or  terrorism, riot, civil commotion, pandemic, epidemic or embargo, (b) any other  event or omission beyond the reasonable control of such Party (collectively, a  

 

EXECUTION VERSION    -17-  70472309_1  “Force Majeure”); provided that the non-performing Party is without fault in  causing the failure or delay, and the failure or delay could not have been prevented  by reasonable precautions and cannot reasonably be circumvented by the  non-performing Party at its reasonable expense through the use of alternate sources,  work around plans or other means.  The onus of establishing a Force Majeure event  rests on the Party asserting that a Force Majeure event exists.  The non-performing  Party will [***] notify the other Party of the anticipated period of interruption due  to a Force Majeure, and describe at a reasonable level of detail the circumstances  causing the delay, and will take all reasonable measures to forthwith remedy the  interruption and recommence performance whenever and to whatever extent  possible without delay.  Each Party acknowledges and agrees that the effects of  COVID-19 may be considered a Force Majeure to the extent it satisfies the  requirements of this Section 13.1. If a delay or failure of Novavax to perform its  obligations due to an event of Force Majeure exceeds [***].  13.2. 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:  Scarborough House  1 Atlantic Street  Woden  ACT 2606  Australia  Attn:  [***]  Email:  [***]  Copy:  [***]    Such notice will be deemed to have been given:  (a) if delivered by post, on the  second (2nd) business day (at the place of delivery) after posting with an  internationally recognized overnight delivery service or (b) if sent by email, upon  written acknowledgement of the receiving Party.  13.3. Entire Agreement.  This Agreement, including any schedules or exhibits hereto,  contains the entire and exclusive agreement between the Parties in connection with  

 

EXECUTION VERSION    -18-  70472309_1  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 Heads of Terms  between the Parties dated 4 November 2020.  13.4. 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.  13.5. Public Announcements.  Novavax agrees not to issue any press release or other  public statement relating to this Agreement or otherwise disclosing the discussions  in relation to this Agreement, entry into, existence and/or contents of this  Agreement or the transactions contemplated hereby without the prior written  consent of the Customer, except to the extent required by applicable Laws or stock  exchange rules, in which case the Customer shall be given advance written notice  of such disclosure.  Novavax will consult the Customer prior to issuing any press  release or other public announcement with respect to this Agreement.  Subject to  compliance with Section 12, Customer is not restricted from making a public  announcement and other public statements as to the entry into, existence and/or  general contents of this Agreement or the transactions contemplated hereby and,  where reasonably practicable, agrees to provide Novavax advance written notice of  any such public announcement.  13.6. Dispute Resolution; Equitable Relief.  13.6.1. 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 either Party  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  [***].  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  

 

EXECUTION VERSION    -19-  70472309_1  Parties in such dispute.  Judgment on such decision may be entered in any  court having jurisdiction.  13.6.2. 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.  13.7. Governing Law.  This Agreement is made subject to the laws of [***].  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, each as the same may be amended or superseded, are hereby  expressly excluded and will not be applicable to this Agreement.  13.8. Assignment.  Neither Party will assign (including by change of Control) 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.  13.9. 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 and  Section 5.5), 6, 7.5, 8, 9, 11, 12, 13.2, 13.3, 13.5, 13.6, 13.7, 13.9, 13.11, 13.12,  13.13, 13.17 and 16.  13.10. 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.  13.11. 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.  13.12. 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 Section 9.2 and any indemnification or limitation of liability  

 

EXECUTION VERSION    -20-  70472309_1  provision, nothing in this Agreement will be construed as creating any direct or  beneficial right in or on behalf of any third party.  13.13. 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  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.  13.14. 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.  13.15. 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.  13.16. Manufacturing in the Territory.  In the event that onshore manufacturing capacity  becomes available in the Territory, Customer will notify Novavax, and the Parties  will discuss, in good faith, the terms on which Novavax could manufacture Product  in the Territory, for the purposes of supplying Product to Customer under this  Agreement.  13.17. Liability for Sponsor.  The acts or omissions of the Sponsor will be deemed to be  the acts or omissions of Novavax, and Novavax will be responsible and liable for  those acts and omissions in all circumstances, irrespective of whether (a) Novavax  authorised the acts or omissions; (b) the acts or omission were willful, deliberate,  illegal or fraudulent; or (c) the acts or omissions were in contravention of  instructions.  14. Insurance.  

 

EXECUTION VERSION    -21-  70472309_1  14.1. Insurance Requirements.  On or before [***], Novavax must take out and maintain  such types and amounts of liability insurance to cover liabilities relating to its  activities under this Agreement as is normal and customary in the pharmaceutical  industry generally, including the following insurance cover:  (a) general products liability insurance, covering legal liability to pay for  personal injury arising out of or in any way connected with the Vaccine,  having a limit of indemnity of not less than USD[***] per occurrence and  in annual aggregate; and  (b) to the extent required by Law, workers’ compensation insurance in respect  of Novavax’s liability for any Loss or Claim by a person employed or  otherwise engaged, or deemed to be employed or otherwise engaged, by  Novavax in connection with the performance of the terms of this  Agreement.  14.2. Insurance Terms.  The policy or policies of insurance arranged in accordance with  this Section 14 must be maintained for a period of [***] after the expiration of the  Term.  14.3. Evidence of Insurance.  Novavax will upon request by Customer [***] provide  certificates of insurance evidencing the insurances required to be effected or  maintained by Novavax pursuant to this Agreement and such certificates must  record the name of the insurer or the insurers, the insured, the type of policy, the  policy number, the policy expiry date and the amount of cover and deductible.  15. Subcontracting.  Novavax may subcontract the whole, or any part, of its obligations under  this Agreement without the prior written consent of Customer, provided that (a) Novavax  notifies Customer of any subcontract of the whole or any part of its obligations under this  Agreement [***]; (b) Novavax shall remain responsible and liable for the acts or omissions  of its subcontractors, as if they were acts or omissions of Novavax.  16. Privacy.  16.1. Privacy Obligations.  Novavax does not intend to collect Personal Information in  performance of its obligations under this Agreement.  To the extent Novavax  collects, uses or discloses Personal Information in performance of this Agreement,  Novavax agrees (a) to use or disclose Personal Information only in accordance with  applicable Laws, (b) not to do any act or engage in any practice which, if done or  engaged in by Customer, would be in breach of the requirements of Division 2 of  Part III of the Privacy Act, (c) not to use or disclose Personal Information or engage  in an act or practice that would breach Australian Privacy Principle 7 (direct  marketing) of Schedule 1 of the Privacy Act unless the use or disclosure is  authorised by this Agreement or is necessary, directly or indirectly, to discharge an  obligation under this Agreement, (d) to [***] notify Customer if Novavax becomes  aware of a breach of any of the obligations contained in, or referred to in, this  Section 16, whether by Novavax or any subcontractor, (e) to comply with  

 

EXECUTION VERSION    -22-  70472309_1  applicable Law, or (f) any directions, guidelines determinations or  recommendations referred to in, or relating to the matters set out in applicable  government policy as provided within this Agreement, to the extent that they are  not inconsistent with the requirements of this Section 16, and (g) to ensure that any  employee of Novavax who is required to deal with Personal Information for the  purposes of this Agreement is made aware of the obligations of Novavax set out in  this Section 16.  16.2. Subcontracts.  Novavax agrees to ensure that any subcontract entered into for the  purpose of processing Personal Information under this Agreement contains  provisions to ensure that the subcontractor has the same awareness and obligations  as Novavax has under this Section 16, including the requirement in relation to  subcontracts.  16.3. Data Breaches.  Novavax must notify Customer within [***] after it becomes  aware, and keep Customer informed (a) of an obligation under the Privacy Act to  report a breach (including an eligible data breach) in respect of its handling of  Personal Information to the Information Commissioner or any third party; (b) that  the Information Commissioner has started any action under the Privacy Act relevant  to Novavax and the Agreement including (i) that the Information Commissioner is  investigating a complaint against Novavax, (ii) an audit by the Information  Commissioner, (iii) a request by the Information Commissioner to be given access  to Novavax’s premises, or (iv) an injunction or other order against Novavax being  sought by the Information Commissioner, in each case, to the extent relevant to the  supply of the Vaccines under this Agreement.  Novavax shall (A) act in accordance  with any with Customer’s reasonable instructions in any related correspondence  with the Information Commissioner or the relevant third party and keep Customer  informed of the conduct, progress and outcome of any above outlined action  including any determination made by the Information Commissioner, (B) ensure  that Customer is kept informed of any assessment (or requirement to make an  assessment) of a suspected eligible data breach, (C) take all reasonable measures,  promptly and in accordance with the timeframes in the Privacy Act, including  assisting Customer in any investigations to determine whether an eligible data  breach has occurred, or if there are reasonable grounds to suspect and eligible data  breach has occurred, and the requirements to notify the Information Commissioner  and any third parties in respect of such eligible data breach, and (D) work with  Customer to agree, who will issue notification of the eligible data breach to the  Information Commissioner and relevant third parties if the eligible data breach is  relevant to both Novavax and Customer.  16.4. Survival.  The provisions of this Section 16 shall survive expiration or termination  of this Agreement.  17. Commonwealth requirements  17.1. Freedom of Information.  Novavax must comply with, and must do such things as  may be reasonably necessary to assist Customer to comply with, the Freedom of  

 

EXECUTION VERSION    -23-  70472309_1  Information Act 1982 (Cth) and Freedom of Information Amendment (Reform) Act  2010 (Cth) (together the “FOI Act”).  If required under the FOI Act, Customer will  provide Novavax with a reasonable opportunity to avail itself of any applicable  protections that are available to Novavax under the FOI Act, including the an  opportunity to consult and make submissions in relation to Novavax’s trade secrets  and other commercially valuable information contained in any Customer response  to a request under the FOI Act.  For the avoidance of doubt, Customer Confidential  Information, Health Data and Customer documentation or other material will, to  the extent applicable, be deemed to be documents of, and in the possession of,  Customer for the purposes of the application of the FOI Act.  17.2. Anti-terrorism  17.2.1. Novavax must comply with its obligations (if any) under Part 4 of the  Charter of United Nations Act 1945 (Cth) and the Charter of United Nations  (Dealing with Assets) Regulations 2008 (Cth).  17.2.2. Novavax must comply with all applicable Laws dealing with the supply of  goods, services and information to foreign nationals or institutions,  including under the Customs Act 1901 (Cth) and the Weapons of Mass  Destruction (Prevention of Proliferation) Act 1995 (Cth).  17.2.3. Novavax acknowledges that it is an offence to knowingly make any funds  or assets available to a person or organisation on the list of all persons and  entities who are subject to targeted financial sanctions under Australian  sanctions law, available at  https://www.dfat.gov.au/international-relations/security/sanctions/Pages/c onsolidated-list.  17.2.4. If Novavax holds assets or funds belonging to a person or organisation on  the list of persons and entities designated as terrorists, Novavax must  immediately freeze those assets in accordance with all applicable Law.  17.3. Anti-money laundering.  Novavax must comply with its obligations (if any) under  the Anti-Money Laundering and Counter-Terrorism Financing Act 2006 (Cth) or  similar applicable Laws.  17.4. Commonwealth policies:  In so far as is reasonably practicable, Novavax must use  its [***] to comply with any other Commonwealth policies or codes of conduct as  notified to Novavax in writing by Customer from time to time to the extent such  policies are applicable to Novavax’s obligations under this Agreement.  17.5. Work health and safety.  Novavax must ensure that Novavax personnel carry out  work under this Agreement in a manner which:  17.5.1. does not pose any avoidable health or physical safety risk to Customer  personnel, Novavax personnel, or any other person;  

 

EXECUTION VERSION    -24-  70472309_1  17.5.2. complies at all times with all applicable work health and safety and  workplace diversity legislation and any other applicable Laws where such  personnel are located; and  17.5.3. when using or accessing facilities of Customer complies with Australian  Government policies on work health and safety.  For more information see:   https://info.australia.gov.au/information-and-services/jobs-and-workplace/ whs-workplace-health-and-safety.  18. Definitions  18.1. Acceptance has the meaning given in Section 3.4 and Accept has the same  meaning.  18.2. Acceptance Period has the meaning given in Section 3.4.  18.3. Additional Amount has the meaning given in Section 2.1.  18.4. Advance Payment has the meaning given in Section 5.1.  18.5. Agency means (a) government or government department or other body; (b) a  governmental, semi-governmental or judicial person; or (c) a person (whether  autonomous or not) who is charged with the administration of a Law, and unless  stated otherwise, includes Commonwealth, State and Territory Agencies.  18.6. Aggregate Amount has the meaning given in Section 2.1.  18.7. Agreement Material means non-confidential documents, information, data or  other material owned by Novavax or a third party (a) which are delivered to  Customer in accordance with this Agreement, including any reports; or (b) copied  or derived by Customer from documents referred to in clause (a) of this definition,  but excludes all Intellectual Property Rights in the Vaccine.  18.8. ARTG means Australian Register of Therapeutic Goods.  18.9. Australian Disputes Centre has the meaning given in Section 4.3.  18.10. Authorisation means the approvals from the TGA for the Vaccine, which may  initially be granted under an expedited marketing authorisation process but which  may include additional requirements or directions of the TGA including  requirements under the TG Act or other conditions on which the TGA grants the  Authorisation (unless an Exemption applies) and Authorised has the  corresponding meaning.  18.11. Calendar Quarter means the calendar quarters specified in the Delivery Schedule  set forth in Exhibit B.  

 

EXECUTION VERSION    -25-  70472309_1  18.12. Certificate of Analysis means the certificate of analysis to accompany the Product  delivered to the Customer, which certifies that the Product has been manufactured  and tested in compliance with its Specification.  18.13. Claim means any claim, suit, proceeding, cause of action or demand of any kind,  including those which are prospective or contingent and those the amount of which  is not ascertained or ascertainable.  18.14. Commonwealth means the Commonwealth of Australia.  18.15. Commonwealth Record means a Commonwealth record as defined in the  Archives Act 1983 (Cth).  18.16. Confidential Information has the meaning given in Section 12.1.  18.17. Conforming Product has the meaning given in Section 4.1.  18.18. Control means (a) to possess, directly or indirectly, the power to direct the  management or policies of a person, whether through ownership of voting securities  or by contract relating to voting rights or corporate governance, or (b) to own,  directly or indirectly, fifty percent (50%) or more of the outstanding voting  securities or other ownership interest of such person, or (c) in the case of a  partnership, control of the general partner, and “Controls” and “Controlled” shall  be construed accordingly.  18.19. Controller has the meaning it has in the Corporations Act.  18.20. Corporations Act means the Corporations Act 2001 (Cth).  18.21. COVID-19 as the meaning given in the Recitals.  18.22. Delivery Documents has the meaning given in Section 3.2.  18.23. Delivery Price means the Per Unit Delivery Price multiplied by the number of  Vaccine doses delivered.  18.24. Delivery Schedule has the meaning given in Section 2.4.  18.25. Effective Date means the date of this Agreement.  18.26. Exemption means an exemption under the TG Act.  Exempt and Exempting have  a corresponding meaning.  18.27. GMP Clearance has the meaning given in clause 8.3.  18.28. Good Manufacturing Practice or GMP or cGMP means the current good  manufacturing practice determined under section 36 of the TG Act.  

 

EXECUTION VERSION    -26-  70472309_1  18.29. Gross Negligence means an act or omission done with reckless disregard for a legal  duty, whether consciously or not, for the consequences of the act or omission.  18.30. GST has the same meaning as in the GST Law.  18.31. GST Act means the A New Tax System (Goods and Services Tax) Act 1999 (Cth).  18.32. GST Law has the same meaning as in the GST Act and any regulations made  pursuant to that Act.  18.33. Health Data means all data and information relating to Customer and its respective  operations, facilities, customers, personnel, assets or programs, in connection with  the Agreement in whatever form that data or information may exist and whether or  not it was generated by or processed by or on behalf of Customer, or is stored in  any Commonwealth Record.  18.34. Indemnified Party has the meaning given in Section 9.  18.35. Indemnifying Party has the meaning given in Section 9.  18.36. Independent Expert has the meaning given in Section 4.3.  18.37. Information Commissioner has the meaning given in section 3A of the Australian  Information Commissioner Act 2010 (Cth).  18.38. Insolvency Event means, in respect of a person, any of the following events (a) it  is (or states that it is) an insolvent under administration or insolvent (each as defined  in the Corporations Act); or (b) it is in liquidation, in provisional liquidation, under  administration or wound up or has had a Controller appointed to its property; or (c)  it is subject to any arrangement (including a deed of company arrangement or  scheme of arrangement), assignment, moratorium, compromise or composition,  protected from creditors under any statute, or dissolved (in each case, other than to  carry out a reconstruction or amalgamation while solvent on terms approved by the  financier); or (d) an application or order has been made, resolution passed, proposal  put forward or any other action taken, in each case in connection with that person,  in respect of any of the above clauses; or (e) it is taken (under section 459F(1) of  the Corporations Act) to have failed to comply with a statutory demand; or (f) it is  the subject of an event described in section 459C(2)(b) or section 585 of the  Corporations Act (or it makes a statement from which the Financier reasonably  deduces it is so subject); or (g) it is otherwise unable to pay its debts when they fall  due; or (h) something having a substantially similar effect to any of the things  described in the above clauses happens in connection with that person under the  law of any jurisdiction.  18.39. Intellectual Property Rights means copyrights, and all rights in relation to  inventions, patents, registered and unregistered trade marks (including service  marks), registered designs, circuit layouts, and all other rights resulting from  

 

EXECUTION VERSION    -27-  70472309_1  intellectual activity in the industrial, scientific, literary or artistic fields and includes  the right to apply for registration of any such rights.  18.40. Law means any applicable statute, regulation, by-law, ordinance or subordinate  legislation in force from time to time anywhere including in Australia and overseas,  whether made by a State, Territory, the Commonwealth, or a local government, and  includes the common law and equity as applicable from time to time.  18.41. Loss has the meaning given in Section 9.1.  18.42. Manufacturing Facilities means the drug substance, adjuvant and fill finish  manufacturing facilities used to manufacture the Vaccine supplied to Customer  under this Agreement as listed in Exhibit D and approved by the TGA or which  have otherwise received GMP Clearance acceptable to the TGA, and updated in  accordance with Section 8.9.  18.43. Maximum Aggregate Additional Amount means the maximum amount of  additional Vaccine doses that Customer is permitted to order under this Agreement  in addition to the Aggregate Amount.  18.44. Pandemic Period means the COVID-19 pandemic period as declared by the World  Health Organization.  18.45. Personal Information means information or an opinion (including information or  an opinion forming part of a database), whether true or not, and whether recorded  in a material form or not, about a natural person whose identity is apparent, or can  reasonably be ascertained from the information or opinion.  18.46. Per Unit Delivery Price means, after the Advance Payment is made, the remainder  of the Per Unit Price that is payable in respect of each Vaccine dose delivered as  set forth in Exhibit A.  18.47. Per Unit Price means the purchase price per Vaccine dose as set forth in Exhibit  A.  18.48. Point of Entry has the meaning given in Section 3.1.  18.49. Price has the meaning given in Section 5.2.  18.50. Privacy Act means the Privacy Act 1988 (Cth).  18.51. Product has the meaning given in Section 2.1 and includes any Additional Amount.  18.52. Purchase Order means an order submitted by Customer in accordance Section 2.3  to purchase Product.  18.53. Refundable Portion has the meaning given in Section 5.1.  

 

EXECUTION VERSION    -28-  70472309_1  18.54. Regional Partner has the meaning given in Section 2.2.2.  18.55. Regulatory Approval has the meaning given in the Recitals.  18.56. Related Body Corporate has the meaning it has in the Corporations Act.  18.57. Remedial Plan has the meaning given in Section 2.7.  18.58. Special Vendor means a supplier of raw material that is key to the manufacture of  Vaccine (including vial manufacturers), as listed in Exhibit D and updated in  accordance with Section 13.4.  18.59. Specifications has the meaning given in Section 4.1.  18.60. Sponsor means the person or company appointed by Novavax to import the  Vaccine in Australia and perform the duties of a Sponsor under the TG Act.  18.61. Sponsor Agreement means a legally binding term sheet or agreement between  Novavax and Sponsor relation to the importation of the Vaccine in the Territory.  18.62. Taxes means taxes, levies, imposts, charges and duties (including stamp and  transaction duties) imposed by any Agency together with any related interest,  penalties, fines and expenses in connection with them, except if imposed on, or  calculated having regard to, the net income of Customer.  18.63. Term has the meaning given in Section 7.1.  18.64. Territory has the meaning given in the Recitals.  18.65. TGA means the Therapeutic Goods Administration.  18.66. TG Act means the Therapeutic Goods Act 1989 (Cth).  18.67. Total Price means the total amount payable by Customer to Novavax for the  Product purchased as set forth in Exhibit A.  18.68. USD has the meaning given in Section 5.4.  18.69. Vaccine has the meaning given in the Recitals.  18.70. Warranty Dispute Notice has the meaning given in Section 4.3.  18.71. Willful Misconduct has the meaning given in Section 9.1.  EXECUTED as an agreement and, in respect of Section 9.1 only, as a deed poll in favour of the  Sponsor.  [Remainder of page intentionally blank.]  

 

EXECUTION VERSION    -29-  70472309_1    

 

  [Signature Page to Advanced Purchase Agreement]  IN WITNESS WHEREOF, the Parties hereto by their duly authorized officers have  executed this Agreement as of the Effective Date.   NOVAVAX, INC.   By: /s/ John A. Herrmann III    John A. Herrmann III    Printed Name   EVP, CLO    Title:  SIGNED by an authorised representative for  The Commonwealth of Australia acting  through and represented by the Department  of Health (ABN 83 605 426 759) in the  presence of:     /s/ Mark Nelson  /s/ Caroline Edwards  Signature of witness  Signature of authorised signatory  Mark Nelson  Caroline Edwards  Name of Witness (block letters)  Name of authorised signatory (block letters)  Date: 31/12/2020  Acting Secretary    Position of authorised signatory      

 

  70472309_1  EXHIBIT A  PRODUCT  Price  Aggregate Amount:  51 million doses of the Vaccine  Product Name  Total Price  (= [***] (excluding GST)  Per-Unit  Price  (excluding  GST)  Per Unit Delivery Price  (= [***] (excluding GST)  NVX-CoV2373 USD [***] USD [***] USD [***]  Advance Payment for Aggregate Amount:  USD [***] (excluding GST)  Maximum Aggregate Additional Amount:  Up to 10 million doses  Product Name  Total Price  (=[***] (excluding GST)  Per-Unit  Price  (excluding  GST)  Per Unit Delivery Price  (= [***] (excluding GST)  NVX-CoV2373 USD [TBD based on order] USD [***] USD [***]  Advance Payment for Additional Amount:  [***]% of Total Price of Additional Amount      

 

  70472309_1  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.]    

 

  70472309_1  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.]      

 

  70472309_1  EXHIBIT D  NOVAVAX  [Pursuant to Regulation S-K, Item 601(a)(5), this Exhibit setting forth the manufacturing  facilities and special vendors 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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