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II. GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT

FOR SERVICES

II.1 Definitions

All definitions are contained in Article 1.2

11.2 Roles and responsibilities in the event of a joint tender

In the event of a joint tender submitted by a group of economic operators and where the group does not have legal personality or legal capacity, one member of the group is appointed as leader of the group.

11.3 Severability

Each provision of this APA is severable and distinct from the others. If a provision is or becomes illegal, invalid or unenforceable to any extent, it must be severed from the remainder of the APA. This does not affect the legality, validity or enforceability of any other provisions of the APA, which continue in full force and effect. The illegal, invalid or unenforceable provision must be replaced by a legal, valid and enforceable substitute provision which corresponds as closely as possible with the actual intent of the parties under the illegal, invalid or unenforceable provision. The replacement of such a provision must be made in good faith between the parties. The APA must be interpreted as if it had contained the substitute provision as from its entry into force.

11.4 Provision of services and supplies

11.4.1 All periods specified in the APA are calculated in calendar days, unless otherwise specified.

11.4.2 The Contractor must immediately inform the Commission of any changes in the exclusion situations as declared, according to Article 137 (1) of Regulation (EU) 2018/1046.

11.5 Communication between the parties

II.5.1 Form and means of communication

Any communication of information, notices or documents under the APA must:

(a) be made in writing in paper or electronic format in the language of the contract;

(b) bear the APA number and, if applicable, the Vaccine Order Form number;

(d) be sent by mail or email.

If a party requests written confirmation of an e-mail within a reasonable time, the other party must provide an original signed paper version of the communication as soon as possible.

The parties agree that any communication made by email has full legal effect and is admissible as evidence injudicial proceedings.

11.5.2 Date of communications by mail and email

Any communication is deemed to have been made when the receiving party receives it, unless this APA refers to the date when the communication was sent.

E-mail is deemed to have been received by the receiving party on the day of dispatch of that e-mail, provided that it is sent to the e-mail address indicated in Article 1.9. The sending party must be able to prove the date of dispatch. In the event that the sending party receives a nondelivery report, it must make every effort to ensure that the other party actually receives the communication by email or mail. In such a case, the sending party is not held in breach of its obligation to send such communication within a specified deadline.

Mail sent to the Commission or the Participating Member State is deemed to have been received on the date on which the department responsible referred to in Article 1.9 registers it.

Formal notifications are considered to have been received by the receiving party on the date of receipt indicated in the proof received by the sending party that the message was delivered to the specified recipient.

II.6 Liability

II. 6.1 During the term of this APA, the Contractor or its Affiliates shall self-insure or procure and maintain such types and amounts of insurance to cover liabilities related to its activities under this APA as is normal and customary in the pharmaceutical industry generally for companies that are similarly situated and providing similar manufacturing and supply services. For absolute clarity, this shall not include, nor constitute, product liability insurance to cover any third party/patients claims and such general insurance shall be without prejudice to the Participating Member States’ indemnification obligation as set out in this APA.

11.6.2 Pfizer and BioNTech are jointly and severally liable to the Commission or the Participating Member State for the Implementation of the APA.

11.6.3 The Commission and the Participating Member States shall use commercially reasonable efforts to mitigate both (1) the damages that would otherwise be recoverable from the other pursuant to this APA and the Vaccine Order Forms, and (2) any costs, fees, expenses or losses that may be incurred by the Commission or the Participating Member State, or for which the Contractor may be responsible, under this APA and/or any Vaccine Order Form, by taking appropriate and reasonable actions to reduce or limit the amount of such damages, costs, fees, expenses or losses.

11.6.4 Limits on liability

(i) Taking into account the unprecedented nature of the current COVID-19 situation and the exceptional circumstances under which the Vaccine shall be delivered, the parties explicitly agree that the Contractor and its Affiliates cannot be held liable for any damages except for proven damages which are suffered by the Commission or the Participating Member States as a direct consequence of a breach by the Contractor or its Affiliates of its obligations under this APA or a Vaccine Order Form, and that the Contractor and its Affiliates shall in any case not be liable for late deliveries (subject to the Contractor’s obligation to use Best Reasonable Efforts as contained in Article 1.6.3), loss of revenue, loss of anticipated savings, loss of business, loss of profit, loss of goodwill, reputational damages, loses from economic disruption or cost of alternative supply.

(ii) Taking into account the Participating Member States’ indemnification obligation as set out in this APA, the parties also explicitly agree that the Contractor shall have no liability to the Commission or the Participating Member States in respect of losses or damages suffered by the Commission or the Participating Member States as a result of any claim by a third party relating to the distribution or use of the Vaccine, save in circumstances where the Contractor would not have been entitled to indemnification under Article 1.12, had such claim by a third party been made against the Contractor.

(iii) The aggregate liability of the Contractor and its Affiliates towards the Commission arising out of or relating to this APA and/or the Vaccine Order Forms (whether arising contractually or extracontractually), shall not exceed a sum equivalent to the Advance Payment actually received by the Contractor.

(iv) The aggregate liability of the Contractor and its Affiliates towards any of the Participating Member States arising out of or relating to this APA and/or the Vaccine Order Form concluded with that Participating Member State (whether arising contractually or extracontractually), shall not exceed a sum equivalent to 50% of the sums actually received by the Contractor under the Vaccine Order Form concluded with that Participating Member State.

(v) For the avoidance of doubt, this provision does not in any way affect the rights of an injured third party (excluding the Commission or any Participating Member State) to claim damages under the applicable Law.

II.6.5 No limitation of liability

(i) Nothing in this APA excludes or limits the liability of either party for:

(a) wilful intent, fraud or fraudulent misrepresentation;

(b) any breach of Article II.9 (Confidentiality);

(d) in the case of a Participating Member State, failure to pay the price for the Product or any other sums properly owing to the Contractor or a Participating Contractor Affiliate under this APA and Vaccine Order Form;

(e) in the case of a Participating Member State, the indemnity given by it under Article 1.12;

(f) in the case of Contractor the circumstances in which the indemnity under Article 1.12 is not available.

11.6.6 Waiver of sovereign immunity

Each Participating Member State represents that it has adequate statutory or regulatory authority and adequate funding appropriation to undertake and completely fulfil the indemnification obligations pursuant to Article 1.12 of this APA.

11.6.7 Recall

In the event of a recall of the Vaccine, the Participating Member States shall be responsible for all costs of any recall or market withdrawal of the Vaccine, including reasonable costs incurred by or on behalf of the Contractor and its Affiliates, except to the extent that such recall or market withdrawal results from one of the situations described in points (i) and (ii) of Article

1.12.1 of this APA, in which event the Contractor shall be responsible for all costs of any recall or market withdrawal of the Vaccine, including reasonable costs incurred by or on behalf of the Commission and Participating Member States.

11.7 Conflict of interest and professional conflicting interests

11.7.1 The Contractor must take all the necessary measures to prevent any situation of conflict of interest or professional conflicting interest.

11.7.2 The Contractor must notify the Commission in writing as soon as possible of any situation that could constitute a conflict of interest or a professional conflicting interest during the Implementation of the APA. The Contractor must immediately take action to rectify the situation.

The Commission may do any of the following:

(a) verify that the Contractor’s action is appropriate;

(b) require the Contractor to take further action within a specified deadline;

11.7.3 The Contractor must pass on all the relevant obligations in writing to:

(a) its personnel which is directly involved in the performance of this APA;

(b) any natural person with the power to represent it or take decisions on its behalf;

The Contractor must also ensure that the persons referred to above are not placed in a situation which could give rise to conflicts of interest.

II.8 Representations and warranties

11.8.1 Mutual representations and warranties

The parties each represent and warrant to each other the following:

(i) Organization and authority. They have full right, power and authority to enter into this APA and to perform their respective obligations under this APA;

(ii) No conflicts or violations. The execution and delivery of this APA by such party and the performance of such party’s obligations hereunder (i) do not conflict with or violate any laws existing as of the date of entry into force of the APA and applicable to such party and (ii) do not conflict with, violate, breach or constitute a default under, and are not prohibited or materially restricted by, any contractual obligations of such party existing as of the date of entry into force of the APA; and

(iii) Valid execution. Such party is duly authorised to execute and deliver this APA, and the person executing this APA on behalf of such party is duly authorised to execute and bind such party to the terms set forth herein.

The above warranties shall also be given by the Participating Member States in respect

of the Vaccine Orders Forms and their obligations contained therein.

11.8.2 Warranties of either party

The Contractor warrants to the Commission and the Participating Member States that:

(i) at the time of delivery, the Vaccine (except for any non-compliance or failure to meet the relevant standard or requirement that could not be reasonably discovered given the state of medical, scientific or technical knowledge at the time when the Contractor delivered the Vaccine):

(a) complies with the Specifications;

(b) has been manufactured in accordance with current Good Manufacturing Practice; and

(ii) subject to the Contractor’s disclaimer of non-infringement of intellectual property rights of a third party, it has good title to the Contracted Doses delivered to the Participating Member States pursuant to this APA and shall pass such title to the Participating Member States free and clear of any security interests, liens, or other encumbrances.

In the event of any breach of the Contractor’s warranties or undertakings relating to the Vaccine, the Commission’s and the Participating Member States’ sole and exclusive remedy will be for the Contractor to deliver replacement Vaccine in the circumstances provided in Article 1.6.14.

The Commission warrants that the APA is awarded and each Vaccine Order Form is concluded in accordance with applicable Laws.

11.8.3 Anti-bribery/anti-corruption

The parties represent and warrant that, beyond the mutual consideration set forth in this APA, neither they nor their agents have provided or requested, or will provide or request, any additional incentive or benefit to or from the other party or its agents to induce either party to enter into this APA or perform any part of this APA.

The Contractor has not made, and will not make, in the performance of this APA directly or indirectly any payment, offer, promise, or authorisation of payment of money or anything of value to a government official, political party, candidate for political office, or any other person, and has not sought and will not seek improperly or corruptly to influence any government official, political party, candidate for political office, or any other person, in order to gain an improper business advantage.

11.8.4 No other warranty

Except to the extent set out expressly in this APA, all conditions, warranties or other terms which might have effect between the parties or be implied or incorporated into this APA (whether by statute, common law or otherwise) are hereby excluded to the fullest extent permitted by applicable Law. Without prejudice to the general nature of the previous sentence, unless this APA specifically states otherwise and to the maximum extent permitted by applicable Law, the Contractor expressly disclaims any representations or warranties with respect to the Vaccine, including, but not limited to, any warranties or undertaking as to noninfringement of intellectual property rights of a third party.

II.9 Confidentiality

II. 9.1 Neither the Commission, a Participating Member State nor the Contractor shall, at any time, without the disclosing party’s prior written consent, disclose to any third party any of the other party’s Confidential Information.

11.9.2 The Commission, the Participating Member State and the Contractor shall:

(a) use such Confidential Information solely for the purposes for which it was provided;

(b) take all reasonable precautions to prevent any unauthorised use or disclosure;

(c) not disclose or distribute any Confidential Information to any third party except as and to the extent authorised in writing to do so by the disclosing party.

11.9.3 The receiving party shall be permitted to disclose Confidential Information that is required or requested to be disclosed by a governmental authority pursuant to applicable law in connection with any other legal or administrative proceeding, provided that it (i) notifies the disclosing party of any such disclosure requirement or request as soon as practicable and (ii) furnishes only that portion of the Confidential Information which, in the opinion of the receiving party or their legal counsel, is responsive to such requirement or request and (iii) asks the court or other public body, if applicable, to treat the Confidential Information as confidential.

11.9.4 The receiving party shall disclose Confidential Information only to such of its representatives who have a need to know such Confidential Information to fulfil its obligations under this APA; provided, however, before any disclosure of Confidential Information, the receiving party shall bind its representatives receiving such Confidential Information to a written agreement of confidentiality at least as restrictive as contained in this APA; and prior to any disclosure, the receiving party shall instruct its representatives of the confidential nature of, and to maintain the confidentiality of, the Confidential Information. The receiving party shall be responsible for all actions of its representatives, including any breach of the terms hereof, regardless of whether or not such representatives remain employed or in contractual privity with the receiving party.

11.9.5 Notwithstanding the foregoing, in all cases, (a) the Participating Member States may not disclose any of the financial or indemnification provisions contained in this APA, including the price per dose of Vaccine or refundability of the Advance Payment or any information that could reasonably ascertain the price per dose of Vaccine, without the prior written consent of the Contractor, and (b) the Contractor may disclose Confidential Information to their Affiliates without prior written consent of the Participating Member States.

11.9.6 The confidentiality obligations set out in this Article II.9 are binding on the Commission, the Participating Member State and the Contractor during the Implementation of the APA and for as long as the information or documents remain confidential unless:

(a) the disclosing party agrees to release the receiving party from the confidentiality obligation earlier;

(b) the Confidential Information or documents become public through other means than a breach of the confidentiality obligation;

11.9.7 The Contractor must obtain from any natural person with the power to represent it or take decisions on its behalf, as well as from third parties involved in the Implementation of the APA a commitment that they will comply with this Article. At the request of the Commission, the Contractor must provide a document providing evidence of this commitment.

11.9.8 Neither this APA nor the performance by either party hereunder shall transfer to the receiving party any proprietary right, title, interest or claim in or to any of the disclosing party’s Confidential Information (including, but not limited to, any intellectual property rights subsisting therein) or be construed as granting a license in its Confidential Information.

11.9.9 The provisions of this Article II.9 shall survive the termination or expiration of this APA for a period of ten (10) years, except with respect to any information that constitutes a trade secret (as defined by the applicable Law), in which case the recipient of such information will continue to be bound by its obligations under this Article II. 9 for so long as such information continues to constitute a trade secret, but in no event for a period of less than the ten (lO)-year period specified above.

11.9.10 The Contractor acknowledges that the Commission is subject to requirements laid down under Regulation (EC) 1049/2001.The Commission commits that it will consult with the Contractor on any disclosure request concerning documents containing Confidential Information as provided for in Article 4(4) of said Regulation.

11.10 Announcements and publicity

The parties shall consult together on the timing, contents and manner of any press release relating to the execution of this APA. Other than the foregoing, no party shall make, or permit any person to make, any public announcement concerning the existence, subject matter or terms of this APA or a Vaccine Order Form, the wider transactions contemplated by them, or the relationship between the parties, without the prior written consent of the other party (such consent not to be unreasonably withheld or delayed), except (i) as required by law, any governmental or regulatory authority (including, without limitation, any relevant securities exchange), any court or other authority of competent jurisdiction; or (ii) on terms that are consistent and do not go further than the matters covered in any agreed press release. For clarity, unless consent is granted pursuant to this clause II. 10, no announcement or disclosure will include or infer the price per dose or the Q4 2020 volumes agreed in the Delivery Schedule or contain information that would be material to the Contractor.

A party shall not use the name, trade name, service marks, trademarks, trade dress or logos of the other party in publicity releases, advertising or any other publication, without the other party’s prior written consent in each instance, provided, however, that consent is granted for public announcements pursuant to above sub-clause (ii) in this Article II. 10.

11.1 1 Processing of personal data

11.11.1 Processing of personal data by the Commission

Any personal data included in or relating to the APA, including its implementation, shall be processed in accordance with Regulation (EU) 2018/1725. Such data shall be processed solely for the purposes of the implementation, management and monitoring of the APA by the data controller. For the purpose of this provision, the data controller for the Commission shall be the Director-General of the European Commission's Directorate-General for Health and Food Safety. The data protection notice is available at https://ec.europa.eu/info/data-protection-public-procurement-procedures en.

The Contractor or any other person whose personal data is processed by the data controller in relation to this APA has specific rights as a data subject under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, rectify or erase their personal data and the right to restrict or, where applicable, the right to object to processing or the right to data portability.

Should the Contractor or any other person whose personal data is processed in relation to this APA have any queries concerning the processing of its personal data, it shall address itself to the data controller. They may also address themselves to the Data Protection Officer of the data controller. They have the right to lodge a complaint at any time to the European Data Protection Supervisor.

II. 11.2 Processing of personal data by the Contractor

The processing of personal data by the Contractor shall meet the requirements of Regulation (EU) 2016/679 and be processed solely for the purposes set out by the Controller.

11.12 Subcontracting

II. 12.1 The Contractor may not subcontract and have the APA implemented by third parties beyond the third parties already mentioned in its tender without prior written notification to the Commission. For the avoidance of doubt, it is agreed that the entities mentioned under points a) to f) of section 2.4.2 of the Commissions’ tender specifications shall not be considered subcontractors for the purpose of this Article II. 12 and that they can be involved in the service delivery by the Contractor.

II. 12.2 In the case of subcontracting, the Contractor remains bound by its contractual obligations and is solely responsible for the Implementation of the APA.

II. 12.3 The Contractor must ensure that the subcontract does not affect the rights of the Commission and the Participating Member States under this APA.

II. 12.4 The Commission may request the Contractor to replace a subcontractor found to be in a situation provided for in points (d) and (e) of Article II. 16.1.

11.13 Amendments

II. 13.1 Any amendment to the APA or a Vaccine Order Form must be made in writing before all contractual obligations have been fulfilled. A Vaccine Order Form does not constitute an amendment to the APA.

II. 13.2 No amendment can make changes to the APA or a Vaccine Order Form that might alter the initial conditions of the procurement procedure or result in unequal treatment of tenderers or contractors.

11.14 Assignment

Neither this APA nor any interest hereunder will be assignable by a party without the prior written consent of the other party, except as follows: (a) Pfizer may assign its rights and obligations under this APA by way of sale of itself or the sale of the portion of its business to which this APA relates, through merger, sale of assets and/or sale of stock or ownership interest, provided that the assignee will expressly agree to be bound by Pfizer’s obligations under this APA and that such sale is not primarily for the benefit of its creditors, (b) Pfizer may assign its rights and obligations under this APA to any of its Affiliates, provided that the assignee will expressly agree to be bound by Pfizer’s obligations under this APA and that the Contractor will remain liable for all of its rights and obligations under this APA. In addition, the Contractor may assign its rights and obligations under this APA to a third party where the Contractor or its Affiliate is required, or makes a good faith determination based on advice of counsel, to divest a Product in order to comply with Law or the order of any governmental authority as a result of a merger or acquisition, provided that the assignee will expressly agree to be bound by the Contractor’s obligations under this APA. The Contractor will promptly notify the Commission of any assignment or transfer. This APA will be binding upon the successors and permitted assigns of the parties and the name of a party appearing herein will be deemed to include the names of such party’s successors and permitted assigns to the extent necessary to carry out the intent of this APA. For the purposes of this Article 11.14, any references to “the Contractor” shall be interpreted as references to “Pfizer and/or BioNTech”. For the purposes of the Vaccine Order Form, any references to the “APA” in this Article 11.14 shall be interpreted as references to the “Vaccine Order Form”.

11.15 Force majeure

II. 15.1 If a party is affected by Force majeure, it must immediately notify the other party, stating the nature of the circumstances, their likely duration and foreseeable effects.

II. 15.2 A party is not liable for any delay or failure to perform its obligations under the APA or Vaccine Order Form if that delay or failure is a result of Force majeure. If the Contractor is unable to fulfil its contractual obligations owing to Force majeure, it has the right to remuneration only for the services actually provided.

II. 15.3 The parties must take all necessary measures to limit any damage due to Force majeure and shall use commercially reasonable efforts to avoid or minimize the delay in performance of their respective obligations affected by Force majeure.

11.16 Suspension of the implementation of the APA

11.16.1 Suspension by the Contractor

If the Contractor or a Participating Contractor Affiliate is affected by Force majeure, it may suspend the provision of the services under a Vaccine Order Form.

The Contractor or the Participating Contractor Affiliate must immediately notify the Commission of the suspension. The notification must include a description of the Force majeure and state when the Contractor or the Participating Contractor Affiliate expects to resume the provision of services.

The Contractor or the Participating Contractor Affiliate must notify the Commission as soon as it is able to resume performance of the Vaccine Order Form, unless the Commission has already terminated the APA or the Vaccine Order Form.

11.16.2 Suspension by the Commission or the Participating Member State

Pursuant to the Financial Regulation, the Commission or the Participating Member State may suspend the Implementation of the APA or performance of a Vaccine Order Form or any part of it:

(a) if the procedure for awarding the APA or a Vaccine Order Form or the Implementation

of the APA proves to have been subject to Irregularities, Fraud (in the sense of the Financial Regulation) or breach of obligations;

(b) in order to verify whether the presumed Irregularities, Fraud (in the sense of the Financial Regulation) or breach of obligations have actually occurred.

The Commission or the Participating Member State in question must formally notify the Contractor of the suspension and the reasons for it. Suspension takes effect on the date of formal notification, or at a later date if the formal notification so provides.

The Commission or the Participating Member State in question must notify the Contractor as soon as the verification is completed whether:

(a) it is lifting the suspension; or

(b) it intends to terminate the APA or a Vaccine Order Form under Article II. 17.1, (f) or

C).

The Contractor is not entitled to compensation for suspension of any part of the APA or a Vaccine Order Form. For the avoidance of doubt, the Contractor shall not be under any obligation to deliver any Contracted Doses during the suspension period, and the Delivery Schedule shall be adjusted to take into account the period of such suspension. Equally for the avoidance of doubt, the Contractor shall complete the delivery of any Contracted Doses that were already in transit on the date of the formal notification or at the later date indicated in the formal notification.

11.17 Termination of the APA

II.17.1 Grounds for termination by the Commission

The Commission may terminate the APA or the Participating Member State may terminate any on-going Vaccine Order Form (depending on whether the event affects the APA or the Vaccine Order Form) solely in the following circumstances:

(a) in the event any of the circumstances referred to in Articles I.6.3(iii), I.6.3(v) or I.6.3(vi) occur;

(b) if the Contractor does not implement the APA or perform the Vaccine Order Form in accordance with material aspects of the APA or the Vaccine Order Form (as applicable) or is otherwise in material breach of another substantial contractual obligation;

(c) if the Contractor repeatedly refuse to sign Vaccine Order Forms without cause. Termination of three or more Vaccine Order Forms in these circumstances also constitutes grounds for termination of the APA;

(d) if the Contractor or any person that assumes unlimited liability for the debts of the Contractor is in one of the situations provided for in points (a) and (b) of Article 136(1) of the Financial Regulation⁵;

(e) if the Contractor or any Related person is in one of the situations provided for in points

Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial mles applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, OJ L 193 of 30.7.2018, p.l httos://eur-lex.eurona.eu/legal-content/EN/TXT/?aid=1544791836334&nri=CELF.X:32018R1046

(f) if the procedure for awarding the APA or the Implementation of the APA prove to have been subject to Irregularities, Fraud (in the sense of the Financial Regulation) or breach of obligations;

(g) if the Contractor is in a situation that does constitute a Conflict of interest or a Professional conflicting interest which would have a material adverse impact on the performance of the APA;

(h) in case of a change regarding the exclusion situations listed in Article 136 of Regulation (EU) 2018/1046 that calls into question the decision to award the contract;

(i) in the event of Force majeure, where either resuming implementation is impossible or the necessary ensuing amendments to the APA or a Vaccine Order Form would mean that this APA is no longer fulfilled to a substantial degree or result in a substantially unequal treatment of tenderers or contractors.

II. 17.2 Grounds for termination by the Contractor

The Contractor may terminate the APA or any on-going Vaccine Order Form solely in the following circumstances:

(a) if the Commission or the Participating Member State does not implement the APA or perform the Vaccine Order Form in accordance with material aspects of the APA or the Vaccine Order Form (as applicable) or is otherwise in material breach of another substantial contractual obligation, including the Commission’s obligation to communicate the allocation of the Contracted Doses, the Commission’s obligation to pay the Advance Payment, the Participating Member States’ obligation to submit a duly completed Vaccine Order Form in accordance with the allocation, the Participating Member States’ obligation to accept delivery of the Contracted Doses, and the Participating Member States’ obligation to pay the price of the Contracted Doses; or

(b) in the event any of the circumstances referred to in Articles I.6.3(iii), I.6.3(v) or I.6.3(vi) occur.

II. 17.3 Procedure for termination

A party must formally notify the other party of its intention to terminate the APA or a Vaccine Order Form and the grounds for termination.

The other party has 30 days following the date of receipt to submit observations, including the measures it has taken or will take to continue fulfilling its contractual obligations. Failing that, the decision to terminate becomes enforceable the day after the time limit for submitting observations has elapsed in the event the grounds giving rise to termination have not been cured.

If the other party submits observations, the party intending to terminate must formally notify it. II. 17.4 Effects of termination

Within 60 days of the date of termination, the Contractor must submit any invoice required for services that were provided before the date of termination. The Advance Payment will be refunded to the Commission if either party terminates the APA pursuant to Article I.6.3(iii) or

Article 1.6.3(v), and the Advance Payment for Contracted Doses not delivered will be refunded to the Commission if either party terminates the APA pursuant to Article 1.6.3 (vi).

The termination or expiration of this APA shall not affect the survival and continuing validity of Articles 1.1,1.2,1.4,1.6.7,1.6.9,1.6.11,1.6.12,1.6.14,1.6.16,1.7 to 1.9,1.11 to 1.14, II.3, II.5, II.6, II.8.2, II.8.4, II.9 to 11.11, 11.15, II.17.4, 11.18 to 11.28, Attachment 3 (Delivery Specification) and Attachment 5 (Return and Disposal of Product Materials) or of any other provision which is expressly or by implication intended to continue in force after such termination or expiration.

Expiry or termination of this APA 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; provided that the Contractor shall have no liability for any failure to deliver the Contracted Doses in accordance with any estimated delivery dates set forth herein.

11.18 Invoices, value added tax and e-invoicing

II.18.1 Invoices and value added tax

Invoices must contain the Contractor’s or the Participating Contractor Affiliate’s (or leader’s in the case of a joint tender) identification data, the amount, the currency and the date, as well as the APA reference and reference to the Vaccine Order Form.

Invoices must indicate the place of taxation of the Contractor or the Participating Contractor Affiliate (or leader in the case of a joint tender) for value added tax (VAT) purposes and must specify separately amounts not including VAT and amounts including VAT.

The Commission is exempt from all taxes and duties, including VAT, in accordance with Articles 3 and 4 of the Protocol 7 of the Treaty on the Functioning of the European Union on the privileges and immunities of the European Union.

It is understood and agreed between the parties that any prices stated under this APA and Vaccine Order Form are exclusive of any VAT or similar tax and all other taxes which are incurred as a result of manufacturing and supplying the Product (including custom duties, levies and charges and all local taxes) (“Taxes”), which shall be added thereon as applicable. Where Taxes are properly chargeable on any amounts payable under this APA or Vaccine Order Form, the party making the payment will pay the amount of Taxes, as specified on the invoice, in accordance with the laws and regulations of the country in which the Taxes are chargeable.

In the event any payments made pursuant to this APA become subject to withholding taxes under the laws or regulation of any jurisdiction, the party making such payment shall deduct and withhold the amount of such taxes for the account of the payee to the extent required by applicable laws or regulations and such amounts payable to the payee shall be reduced by the amount of taxes deducted and withheld. Any such withholding taxes required under applicable laws or regulations to be paid or withheld shall be an expense of, and borne solely by, the payee.

11.19 Payments and guarantees

II.19.1 Date of payment

The date of payment is deemed to be the date on which the Commission’s account or the account of the Participating Member State in question is debited.

II. 19.2 Currency

Payments are made in euros or, for non-Eurozone countries, the local functional currency of the Participating Member State. For non-Eurozone countries, the Vaccine Order Form shall set forth the Delivery Price in the local functional currency converted from euro at the exchange rate existing one (1) day prior to the Effective Date of the APA as of 4:00pm London time published in Bloomberg FX Fixings (BFIX), such rates being found via Bloomberg or the website www.bloomberg.com/markets/currencies/fx-fixings.

II. 19.3 Costs of transfer

The costs of the transfer are borne as follows:

(a) the Commission or the Participating Member State in question bears the costs of dispatch charged by its bank;

(b) the Contractor or the Participating Contractor Affiliate bears the costs of receipt charged by its bank;

II. 19.4 Suspension of the time allowed for payment

The Commission or the Participating Member State in question may suspend the payment periods specified in Article 1.8 at any time by notifying the Contractor or the Participating Contractor Affiliate (or leader in the case of a joint tender) that its invoice cannot be processed. The reasons the Commission or the Participating Member State in question may cite for not being able to process an invoice are:

(a) because it does not comply with the APA or Vaccine Order Form;

(b) because the Contractor or the Participating Contractor Affiliate has not produced the appropriate documents or deliverables; as required by the APA or a Vaccine Order Form; or

(c) because the Commission or the Participating Member State in question has reasonable observations on the documents or deliverables submitted with the invoice as not complying with the APA or Vaccine Order Form.

The Commission or the Participating Member State in question must notify the Contractor or the Participating Contractor Affiliate (or leader in the case of joint tender) as soon as possible of any such suspension, giving the reasons for it. In cases b) and c) referred above, the Commission or the Participating Member State in question shall notify the Contractor or the Participating Contractor Affiliate (or leader in case of a joint tender) the time limits to submit additional information or corrections or a new version of the documents or deliverables.

Suspension takes effect on the date the Commission or the Participating Member State in question sends the notification. The remaining payment period resumes from the date on which the requested information or revised documents are received or the necessary further verification, including on-the-spot checks, is carried out. Where the suspension period exceeds two months, the Contractor or the Participating Contractor Affiliate (or leader in the case of a joint tender) may request the Commission or the Participating Member State in question to justify the continued suspension.

II.19.5 Interest on late payment

On expiry of the payment periods specified in Article 1.8, the Contractor or the Participating Contractor Affiliate (or leader in the case of a joint tender) is entitled to interest on late payment at the higher of (a) the rate applied by the European Central Bank for its main refinancing operations in euros (the reference rate) plus five points (or such centralized bank reference rate set forth in the Vaccine Order Form) and (b) 2%. 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.

Suspension of the payment period as provided for in Article II. 19.4 is not considered as giving rise to late payment.

Interest on late payment covers the period running from the day following the due date for payment up to and including the date of payment as defined in Article II. 19.1.

11.20 Recovery

II.20.1 Recovery procedure

In all cases where the recovery procedure as described in the Financial Regulation applies, the parties shall follow the procedure set out in this Article.

Before recovery, the Commission or the Participating Member State in question must formally notify the Contractor of its intention to recover the amount it claims, specifying the amount due and the reasons for recovery and inviting the Contractor to make any observations within thirty (30) days of receipt.

If no observations have been submitted or if, despite the observations submitted, the Commission or the Participating Member State in question decides to pursue the recovery procedure, it must confirm recovery by formally notifying a debit note to the Contractor, specifying the date of payment. The Contractor must pay in accordance with the provisions specified in the debit note.

If the Contractor does not pay by the due date, the Commission or the Participating Member State in question may, after informing the Contractor in writing, recover the amounts due:

(a) by offsetting them against any amounts owed to the Contractor by the Commission or the Participating Member State in question; by taking legal action.

II.20.2 Interest on late payment

If the Contractor does not honour the obligation to pay the amount due by the date set by the Commission or the Participating Member State in question, the amount due bears interest at the rate indicated in Article II. 19.5. Interest on late payments will cover the period starting on the day after the due date for payment and ending on the date when the Commission or the Participating Member State in question receives the full amount owed.

Any partial payment is first entered against charges and interest on late payment and then against the principal amount.

11.21 Checks and audits

11.21.1 The Commission and the European Anti-Fraud Office may check or require an audit on the Implementation of the APA. This may be carried out either by OLAF’s own staff or by any outside body authorised to do so on its behalf, provided that the auditor may not be a competitor of the Contractor.

Such checks and audits may be initiated at any moment during business hours during the provision of the services and up to five years starting from the payment of the balance of the last specific contract issued under this APA.

The audit procedure is initiated on the date of receipt of the relevant letter sent by the Commission. Audits are carried out on a confidential basis.

11.21.2 The Contractor must keep all original documents stored on any appropriate medium, including digitised originals if authorised under national law, for a period of five years starting from the payment of the balance of the last specific contract issued under this APA.

11.21.3 The Contractor must grant the appropriate right of access to sites and premises where the APA is implemented, and to all information, including information in electronic format, needed to conduct such checks and audits. The Contractor must ensure that the information is readily available at the moment of the check or audit and, if so requested, that information is handed over in an appropriate format. The auditor must, insofar possible, comply with all applicable and reasonable security measures notified to Commission by the Contractor subject to this not creating any material obstacles for the performance of the auditor’s tasks.

11.21.4 On the basis of the findings made during the audit, a provisional report is drawn up. The Commission or its authorised representative must send it to the Contractor, who has 30 days following the date of receipt to submit observations. The Contractor must receive the final report within 60 days following the expiry of the deadline to submit observations.

On the basis of the final audit findings, the Commission or the Participating Member State in question may recover all or part of the payments made in accordance with Article 11.20 and may take any other measures which it considers necessary.

11.21.5 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 provision of the services and up to five years starting from the payment of the balance of the last specific contract issued under this APA.

11.21.6 The Court of Auditors and the European Public Prosecutor’s Office established by Council Regulation (EU) 2017/19398 (‘the EPPO’) have the same rights as the Commission, particularly right of access, for the purpose of checks, audits and investigations.

11.22 Relationship of the parties

The relationship hereby established between the Contractor and the Commission is solely that of independent contractors. Neither party has authority to act or make any agreements or representations on behalf of the other party. This APA is not intended to create, and shall not be construed as creating, between the parties, the relationship of principal and agent, employer and employee, joint venturers, co-partners, or any other such relationship, the existence of which is expressly denied.

11.23 Waiver

A waiver by any party of any term or condition of this APA in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach thereof. All remedies specified in this APA shall be cumulative and in addition to any other remedies provided at Law or in equity, except where expressly otherwise agreed.

11.24 Further documents

Each party hereto agrees to execute such further documents and take such further steps as may be reasonably necessary or desirable to effectuate the purposes of this APA.

11.25 Headings

Headings of Articles or other parts of this APA are included herein for convenience of reference only and shall not constitute a part of this APA or change the meaning of this APA.

11.26 Electronic Delivery and Storage

Delivery of a signed APA by reliable electronic means, including facsimile or email (with receipt electronically confirmed), shall be an effective method of delivery of the executed APA.

This APA may be stored by electronic means and either an original or an electronically stored copy of this APA can be used for all purposes, including in any proceeding to enforce the rights or obligations of the parties to this APA.

11.27 Entire Agreement

This APA, together with any Annexes and Attachments, which are hereby incorporated by reference, constitute the entire agreement of the parties with respect to its subject matter and merges and supersedes all prior discussions and writings with respect to thereto.

11.28 Costs

Each party will bear its own legal costs in preparing and concluding this APA.

Annex T: VAfinNE Ordek Form

This Vaccine Order Form is submitted by:

[The Government of [•]] (the “Participating Member State”), represented for the purposes of signing this Vaccine Order Form by [ forename, surname, function, department of authorising officer],

to:

[Add details for Contractor]

The Participating Member State and Contractor are together referred to as the “Parties” and each individually as a “Party”.

WHEREAS

— Contractor and the European Commission, acting on behalf of and in the name of the Participating Member States, entered into an Advance Purchase Agreement for the purchase and supply of Contractor’s Vaccine for EU Member States dated [•] 2020 (the “APA”), the terms of which are binding on the Participating Member States and must be read in conjunction with this Vaccine Order Form.

— The APA provides that each Participating Member State will submit to Contractor a Vaccine Order Form through which Contractor shall make available and deliver to the relevant Participating Member State a proportion of the Contracted Doses or Additional Order as applicable, in accordance with the allocation provided by the Commission pursuant to Article 1.6.3 of the APA and at the price and conditions as set out in the APA.

— In accordance with Article 1.5.2 of the APA, the [name of Participating Member State] hereby places its order for its full allocated portion of the Contracted Doses or Additional Order (as applicable).