5.

SENSITIVE
RELEASABLE TO: Need to know basis

(b) On reasonable notice and as reasonably requested, AstraZeneca shall enable
the Commission (or an independent expert appointed by the Commission as set
forth below) to access all clinical trial data (including communications and
correspondence with Regulatory Authorities and bodies to include all audit
observations, inspection reports, meeting minutes, and all AstraZeneca
commitments and responses) and all data relevant to the manufacturing of the
Vaccine; provided, that AstraZeneca is permitted to share such information with
the Commission; and provided, further, that if AstraZeneca is not permitted to
share such information with the Commission, it shall use its Best Reasonable
Efforts to obtain permission to share such information. If the Commission chooses
to access such information through a third party, such third party must be an
independent expert in the applicable field, the Commission shall notify
AstraZeneca of such expert in advance, and such expert shall be subject to Section
15 of this Agreement. The Commission shall choose another expert if AstraZeneca
provides reasonable justification upon which such expert should not be permitted
access to such information.

Manufacturing and Supply.

5.1. Initial Europe Doses. AstraZeneca shall use its Best Reasonable Efforts to
manufacture the Initial Europe Doses within the EU for distribution, and to deliver to
the Distribution Hubs, following EU marketing authorization. as set forth more fully in
Section 7.1, approximately 020
1 2021, and (iii) the remainder of the Initial Europe

  
 
    

Doses by the end of

5.2. Optional Doses. The Commission shall have an option to increase its order on
behalf and in the name of the Participating Member States of the Vaccine Doses by an
additional 100 million Doses (“Optional Doses”). In order to exercise such option, the
Commission shall deliver an irrevocable notice to AstraZeneca exercising such option
within f delivery by AstraZeneca to the Commission of the first
Phase III Trial report that includes efficacy and safety data. The Optional Doses shall

be delivered to the Participating Member States following delivery of the Initial Europe
Doses and no earlier char, EEE] As a condition to exercising the
Optional Doses, the Commission must provide the necessary information on allocation
ofthe full 100 million Optional Doses among the Participating Member States.

 
 

5.3. Additional Doses. AstraZeneca shall consider in good faith any request for
additional Vaccine Doses made by the Participating Member States, but shall not be
required to manufacture and supply Vaccine Doses in excess of the Initial Europe
Doses and the Optional Doses (“Additional Doses”). The Commission and the
Participating Member States recognize that it may not be possible for AstraZeneca to
manufacture any Additional Doses prior to

5.4. Manufacturing Sites. AstraZeneca shall use its Best Reasonable Efforts to
manufacture the Vaccine at manufacturing sites located within the EU (which, for the
purpose of this Section 5.4 only shall include the United Kingdom) and may
manufacture the Vaccine in non-EU facilities, if appropriate, to accelerate supply of the

11

* SENSITIVE RELEASABLE TO: Need to know basis Vaccine in Europe; provided, that AstraZeneca shall provide prior written notice of such non-EU manufacturing facilities to the Commission which shall include an explanation for such determination to use non-EU manufacturing facilities. If AstraZeneca is unable to deliver on its intention to manufacture the Initial Europe Doses and/or Optional Doses under this Agreement in the EU, the Commission or the Participating Member States may present to AstraZeneca, CMOs within the EU capable of manufacturing the Vaccine Doses, and AstraZeneca shall use its Best Reasonable Efforts to contract with such proposed CMOs to increase the available manufacturing capacity within the EU. The manufacturing site planning is set out in Schedule A. 5.5.       Reporting. AstraZeneca shall notify the Commission as soon as (a) it selects initial manufacturing sites and (b) it changes any of its manufacturing sites for the Vaccine. 6.   Acquisition of Materials and Services. 6.1.       Materials. The Commission and the Participating Member States shall use their Best Reasonable Efforts to enable AstraZeneca to timely supply the Initial Europe Doses. AstraZeneca shall secure the supply of all drug substances needed and drug product capacity (if required) as well as components critical to the development, manufacture, and supply of the Initial Europe Doses (e.g. glass vials/stoppers, media, etc.). Notwithstanding the foregoing, the Commission and the Participating Member States shall, on the request of AstraZeneca and in accordance with all Applicable Laws and within the framework of their competencies, use Best Reasonable Efforts to assist AstraZeneca in securing the supply of any drug substances needed and drug filling and finishing capacity as well as components for the development, manufacture, and supply of the Initial Europe Doses. 6.2.       Capacity Limitations. In the event AstraZeneca's ability to fulfill its obligations under this Agreement is impeded by a competing agreement entered into by or on behalf of the Commission, AstraZeneca shall promptly inform the Commission. While AstraZeneca shall continue to use Best Reasonable Efforts to engage with its own contract manufacturers and suppliers to utilize the capacity and/or components, the Commission will assist in finding a mutually acceptable solution for this Agreement and the competing agreement. To the extent AstraZeneca’s performance under this Agreement is impeded by any such competing agreements, AstraZeneca shall not be deemed in breach of this Agreement as a result of any such delay due to the aforementioned competing agreement(s). 6.3.       Reporting and Notification to the Commission. AstraZeneca will report to the Commission in regular intervals on whether it has been able to secure the supply of all drug substances needed and drug product capacity (if required) as well as components critical to the development, manufacture, and supply of the Initial Europe Doses (e.g. glass vials/stoppers, media, etc.). AstraZeneca will promptly notify the Commission if it encounters difficulties in this regard that place at significant risk AstraZeneca’s ability to manufacture or sell the Vaccine Doses as contemplated by this Agreement. 12

* SENSITIVE RELEASABLE TO: Need to know basis 7.   Funding Process and Audit. 7.1.       Generally. The Commission and the Participating Member States shall provide funding to enable AstraZeneca to: (i) harness sufficient drug substance and drug filling and finishing capacity in Europe, (ii) advance procurement of critical components including glass vials/stoppers, media, and other critical components to supply finished product of the Vaccine, and (iii) fill, finish and package the final Vaccine for distribution (the “Funding”). The Commission and the Participating Member States shall provide the Funding in an amount equal to the estimated Cost of Goods which at the Effective Date is estimated to be                     for the Initial Europe Doses. 7.2.       Initial Funding. In partial consideration of the Vaccine Dose purchase rights granted by AstraZeneca to the Commission acting on behalf and in the name of the Participating Member States hereunder, the Commission shall pay to AstraZeneca a fixed amount equal to 336 million Euros, as an estimate of the Upfront Costs as set forth in Schedule A (the “Initial Funding”) as follows: (a) The Commission shall pay to AstraZeneca two-thirds of the Initial Funding (first Installment) within five (5) working days of the Effective Date; and (b) The Commission shall pay to AstraZeneca one-third of the Initial Funding (second Installment) within twenty (20) days following the receipt from AstraZeneca of relevant evidence of the use of the first Installment and a relevant progress report of... 7.3.       Subsequent Funding. The Participating Member States shall pay the Fill/Finish/Packaging Costs, storage and distribution costs of the Vaccine, destruction for any material produced at risk, and costs and expenses directly incurred for, or fairly ... in accordance with Schedule A and Sections 7.4 and 10.3 and the Order Forms (the “Subsequent Funding”). 7.4.       Mechanism for Updated Total Costs of Goods. (a) The Parties agree that, notwithstanding any other provision of this Agreement, and while AstraZeneca acknowledges its obligation is to supply the Vaccine Doses at no profit, AstraZeneca shall not be requested or required to supply the Vaccine Doses at a loss. The Parties further agree that the estimated Upfront Costs of 336 million Euros and Fill/Finish/Packaging Costs of                     Euros (for a total estimated Cost of Goods of                     Euros) were determined based upon available estimates at the Effective Date for the Initial Europe Doses. 13

* SENSITIVE RELEASABLE TO: Need to know basis (b) To the extent that the total Cost of Goods exceed the estimated amount of 870 million Euros by less than 20%, , AstraZeneca shall provide an updated purchase and payment schedule to the Commission, which shall state the delivery schedule of the Initial Europe Doses and the corresponding amounts payable by the Participating Member States, (c) If AstraZeneca becomes aware that the estimated Cost of Goods are reasonably expected to exceed 870 million Euros by 20% or more then AstraZeneca shall notify the Commission of such excess and provide the relevant evidence in this respect. Following such notice, AstraZeneca and the Commission shall agree to a payment or other mechanism which will result in AstraZeneca supplying the Participating Member States with a number of Doses without incurring a loss. Such mechanism may include a reduction in the number of Doses and/or a further increase in Price Per Dose. (d) If following the finalization of the matters contemplated hereby, documentary evidence provided by AstraZeneca indicates that the Cost of Goods for the Initial Europe Doses sold is less than 870 million Euros or the Participating Member States pai... 14

* SENSITIVE RELEASABLE TO: Need to know basis 7.5.      Method of Payments. All payments to AstraZeneca under this Agreement shall be made by deposit of Euros by wire transfer of immediately available funds in the requisite amount to such bank account as AstraZeneca may from time to time designate by written notice to the Commission and the Participating Member States. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to this Agreement, Payments for shipments of Doses shall be due and payable within                     following invoicing for such Doses. 7.6.      Audits and protection of EU financial interests. (a) During the term of the Agreement and for a period of (5) years after termination or expiration of the Agreement, AstraZeneca shall permit the Commission to perform or request an audit of the Cost of Goods of the Initial Europe Doses (and any Optional Doses and Additional Doses, to the extent applicable), no more than                                          . The Commission shall use its Best Reasonable Efforts to ensure that those audits are conducted by an internationally recognized certified public accounting firm authorised on its behalf. AstraZeneca, its affiliates or subcontractors involved in the performance of the Agreement, shall make available to such third-party auditor, upon request, any pertinent documents or information for the purpose of verifying production costs of the Initial Europe Doses (and any Optional Doses and Additional Doses, to the extent applicable). Any such audit shall be conducted on reasonable advanced notice to AstraZeneca, and during normal operating hours in a manner to minimize disruption to AstraZeneca's business. (b) AstraZeneca must keep all original documents stored on any appropriate medium, including digitised originals, if allowed by the national law, for a period of five (5) years starting from the last payment made under the last Order Form. (c) In accordance with Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspection carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office, the European Anti- Fraud Office may carry out investigations, including on the spot checks and inspections, to establish whether there has been fraud, corruption or any other illegal activity under the contract affecting the financial interests of the Union. Findings arising from an investigation may lead to criminal prosecution under national law. The investigations may be carried out at any moment during the performance of the contract and up to five years starting from the payment of the balance of the last Order Form issued under this APA. (d) Without increasing or decreasing the rights existing under Applicable Laws, the Parties acknowledge that the Court of Auditors and the European Public 15

* SENSITIVE RELEASABLE TO: Need to know basis 2 Prosecutor’s Office established by Council Regulation (EU) 2017/1939 (‘the EPPO’) also have rights of access, audits and investigations under Applicable Laws. 7.7.      Late Payments. In the event the Commission or the Participating Member States fail to pay any amount payable under this Agreement or the Order Form within twenty (20) days of the due date for any such payment, without prejudice to any other rights or remedies that AstraZeneca may have hereunder: (a) interest shall accrue on that outstanding amount for the period beginning on the due date for payment and ending on the date of actual payment at the rate applied by the European Central Bank for its principal refinancing operations in euros (the reference rate) plus five points. The reference rate is the rate in force, as published in the C series of the Official Journal of the European Union, on the first day of the month in which the payment period ends, and the maximum rate permitted by Applicable Law, for the period from the due date for payment until the date of actual payment; and (b) without prejudice to Section 7.7(a) and subject to giving the Commission or the Participating Member States twenty (20) days prior written notice of its intention to do so, AstraZeneca shall be entitled to suspend its obligations under this Agreement towards the Commission (if the Commission is defaulting) or the defaulting Participating Member States until such time as any unpaid amounts have been paid in full. 8.        Delivery, Allocation, Distribution and Storage. 8.1.      Delivery. (a) AstraZeneca shall notify the Alliance Manager and Representative of each Participating Member State in good time prior to such time that AstraZeneca expects Doses to be available. Such notification shall include an estimate of the total number of Doses expected to be available for delivery and the expected dates that such Doses will be available to be shipped to the Distribution Hubs designated by the Participating Member States. In the case of a delivery of Initial Europe Doses, the number of Doses in such delivery shall be allocated to the Participating Member States                    based on the Binding Allocation; provided, that AstraZeneca shall not be required to make any deliveries to any Participating Member States where the delivery size would be less than one batch ( ). In the case of Optional Doses, the number of Optional Doses in such delivery shall be allocated to the Participating Member States            based on the allocation of total Optional Doses defined by the Commission in its notice of Section 5.2. Within                       of receiving such notification, each Participating Member State shall send to AstraZeneca a 2 Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office 16

* SENSITIVE RELEASABLE TO: Need to know basis confirmatory notification (including confirmation of delivery instructions to the distribution hub for each Participating Member State as set forth in the Order Form) (“Distribution Hubs”). (b) Following receipt of such notification, AstraZeneca shall issue an invoice to the Participating Member States. Each Participating Member State shall pay such invoice in accordance with Section 7.5. AstraZeneca and the Representative for each Participating Member State shall work together to identify the final delivery schedule for such Doses taking into account the goal of creating an efficient delivery of the Doses. Each Participating Member State shall identify only one Distribution Hub and delivery to each Distribution Hub will be a minimum of one batch as defined in Section 8.1(b) of finished drug product. Delivery at each Distribution Hub will occur                                  The delivery costs shall be borne by the Participating Member States. The Participating Member States shall reimburse AstraZeneca within                   of being invoiced therefor. 8.2.      Suspension of payments: In case of non-delivery or late delivery past the firm delivery date, the obligation of payment will be suspended. The obligation of payment will resume once the delivery has been completed. In that case, the Commission and/or the Participating Member State will notify AstraZeneca in writing of such late payment and the reason therefor. 8.3.      Allocation. (a) No later than thirty (30) days following the Effective Date, the Commission shall deliver to AstraZeneca a final and binding written allocation of Initial Europe Doses between the Participating Member States (the “Binding Allocation”), which Initial Europe Doses must equal 300 million. The number of Initial Europe Doses set forth in the Binding Allocation shall be the total number of Initial Europe Doses that each Participating Member State is required to purchase pursuant to this Agreement. (b) In the event that the Commission does not provide a Binding Allocation within the thirty (30) days period or the number of Doses set forth in the Binding Allocation does not equal 300 million, then, unless otherwise agreed in writing by the Commission and AstraZeneca, the binding allocation of the Initial Europe Doses shall be made on a pro-rata basis to reflect the respective populations of each of the Participating Member States utilizing the population estimate as of 10 July 2020 reported by the statistical office of the European Union, Eurostat. In the event there is an excess of supply of the Initial Europe Doses and Optional Doses, the Participating Member States shall keep their shared rights in the Initial Europe Doses, and shall determine their best use of such excess doses, reserving the possibility to donate them to lower or middle income countries or public institutions and to donate or resell, at no profit, such doses to other European countries that agree to be bound by the terms and conditions of this Agreement applicable to a Participating Member State. 17

* SENSITIVE RELEASABLE TO: Need to know basis (c) The Participating Member States may also resell, at no profit, Initial Europe Doses and/or Optional Doses to European countries that are not Member States if such other European countries agree to be bound by the terms and conditions of this Agreement applicable to a Participating Member State. Should such resale take place, the Participating Member States concerned shall reimburse the Commission the part corresponding to the Initial Funding in accordance with Sections 7.2 and 7.4(a). 18

* SENSITIVE RELEASABLE TO: Need to know basis 8.4.       Distribution by Participating Member States. Upon and after delivery by AstraZeneca to the respective Distribution Hubs, the Participating Member States shall be responsible for transportation and distribution of the Vaccine Doses allocated to them. For clarity, the Cost of Goods for the Initial Europe Doses shall not include any costs incurred in the distribution of the Vaccine Doses, which costs shall be entirely covered by the Participating Member States. 8.5.       Storage and Destruction. Pursuant to Section 8.1 of this Agreement, AstraZeneca will provide the Participating Member States with at least five (5) working days’ notice of when the Doses are available for delivery. In the event a Participating Member State fails to permit AstraZeneca to deliver the Doses to the relevant Distribution Hub, the Participating Member State concerned shall be responsible for all storage costs for such Doses. In such event, AstraZeneca will agree to store the Vaccine for up to an additional                                                                (at the Participating Member State’s cost, including the cost of any amounts required to insure the Doses during such period). After such                                   period, AstraZeneca may continue to store such Doses at the Participating Member State’s cost if the relevant Member State agrees to this. To the extent that either Party does not agree to continue to store the Doses, AstraZeneca may sell the Doses to a third party or destroy the Doses at the cost of the Participating Member State for which the Doses are being stored. The Participating Member States shall reimburse AstraZeneca for all costs associated with distribution, storage, and destruction of the Doses within being invoiced therefor provided that AstraZeneca provides to the relevant Participating Member State specific evidence for such costs. 9.   Pricing. 9.1.       Initial Doses. AstraZeneca shall manufacture and supply to the Participating Member States the Initial Europe Doses at a price equal to their total Cost of Goods, with no profit or loss for AstraZeneca, which, as of the Effective Date, is estimated at shall be paid by the Commission and by the Participating Member States. This estimated amount shall be paid through the Initial Funding and Fill/Finish/Packaging Costs according to the terms of Sections 7.1, 7.2 and 7.3 of this Agreement. 9.2.       Optional Doses. In the event the Commission exercises the option on behalf of and in the name of the Member States to obtain the Optional Doses in accordance with Section 5.2, AstraZeneca shall manufacture and supply the Optional Doses at a price equal to their Cost of Goods (i.e., the full price is calculated without any credit based on the Initial Funding). 9.3.       Additional Doses. AstraZeneca shall provide any agreed Additional Doses at Cost of Goods until 1 July 2021, unless AstraZeneca determines in good faith that the COVID-19 Pandemic has not ceased as of 1 July 2021, in which case AstraZeneca shall p... 19

* SENSITIVE RELEASABLE TO: Need to know basis 10.   Regulatory Matters. 10.1.     Compliance; Assistance. AstraZeneca shall be responsible for timely complying with all legal requirements of approval processes of the clinical trials and the market authorization of the Vaccine in the Member States. Notwithstanding the foregoing, the Commission and the Participating Member States shall use Best Reasonable Efforts, within the framework of their competencies, to support AstraZeneca in providing accelerated quality and current Good Manufacturing Practices facility approvals and OMCL testing if the requirements of safety, quality and efficacy of the Vaccine allow it to do so and are fully met. The Commission and the Participating Member States shall use their Best Reasonable Efforts to support, within the framework of their competencies, AstraZeneca in its Best Reasonable Efforts to achieve for the Vaccine fast access to the European population through pan-European access mechanisms, including accelerated regulatory approval processes. 10.2.     Reporting. AstraZeneca shall promptly inform the Commission if, in the process of reviewing the results or progress of AstraZeneca’s clinical trials, AstraZeneca reasonably determines that the ongoing or planned clinical trials by AstraZeneca and its partners are not likely to be sufficient for approval of the Vaccine by the Commission. 10.3.     Post-Launch Safety and Risk Management Studies. In the event that post- launch safety or risk management studies for the Vaccine are (i) required by the EMA, (ii) required by another Regulatory Authority and relied upon by EMA for approval, or (iii) otherwise required or advisable to be conducted for the benefit of any Participating Member States in AstraZeneca’s reasonable discretion, 11.   Intellectual Property. 11.1.      Ownership. The Commission acknowledges that AstraZeneca has pre-existing obligations to its upstream licensor and throughout the term of this Agreement, may incur obligations to its CMOs and other contractors in respect of patents, know-how and ... The Commission acknowledges and agrees that as between the Parties, (i) AstraZeneca shall be the sole owner of all intellectual property rights generated during the development, manufacture, and supply of the Vaccine, including all Know-How (collectively, the “Vaccine IP Rights”), and (ii) AstraZeneca shall be entitled to exclusively exploit any such Vaccine IP Rights. All rights not expressly granted by AstraZeneca hereunder are reserved by AstraZeneca. 11.2.     IP Rights Following Abandonment. The Commission, or any third party designated by the Commission, shall have the right to obtain a license or sublicense from AstraZeneca for the Vaccine IP Rights to the extent reasonably necessary to 20