Advance Purchase Agreement BioNTech Pfizer

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SANTE/2020/C3/043 - 512.838335 SENSITIVE 1.4.4    Renewal of the APA The APA will expire automatically at the end of the Term, unless it is extended in mutual written agreement between the parties. Renewal does not change or postpone any existing obligations. 1.5      IMPLEMENTATION OF THE APA 1.5.1    Period of provision of the supplies The period for the provision of the supplies starts to run as foreseen in Article 1.6.3. 1.5.2    Implementation of the APA The APA shall be implemented following signature between the Commission and the Contractor as follows: In order to guarantee the right of the Participating Member States to acquire Vaccine doses in a given timeframe and at a certain price and conditions, the Commission will pay the Advance Payment. The Contractor shall use Best Reasonable Efforts to build manufacturing capacity or utilise existing capacity to be capable of manufacturing and supplying the Product to the Commission in accordance with the provisions of this APA. The Contractor agrees to supply an initial total number of 200 million Vaccine doses to Participating Member States collectively, upon their order, in accordance with this APA and the respective Vaccine Order Forms. The Participating Member States shall place orders for supplies of 200 million Vaccine doses in total in accordance with the allocation communicated by the Commission to the Contractor pursuant to Article 1.6.3, by sending the Contractor a completed copy of Annex I ("Vaccine Order Form") in paper format or emailed pdf within 10 business days following the Commission communicating the allocation. This Vaccine Order Form shall be signed by an authorised representative of the Participating Member State and the Contractor. Within 10 business days of receipt of the Vaccine Order Form from a Participating Member State, the Contractor must send back to the Participating Member States the duly signed and dated Vaccine Order Form in paper format or emailed pdf. 1.6      SUPPLY OF THE VACCINE 1.6.1    Creation of the Vaccine During the term of this APA, and subject to the successful development and authorisation of the Vaccine as set out in this APA, the Contractor shall use Best Reasonable Efforts to supply or have supplied the Product to the relevant Participating Member States, and the Participating Member States shall purchase the Product, subject to and in accordance with the terms and conditions of this APA. 11
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SANTE/2020/C3/043 - 512.838335 SENSITIVE 1.6.2   Product supply At the Effective Date, the Commission orders 200 million doses ("Contracted Doses") of the Product on behalf of the Participating Member States to be delivered if the Contractor succeeds to develop a safe and effective Vaccine according to the terms laid down in this APA. The parties acknowledge that the Commission may wish to place an additional binding order (the "Additional Order") for a maximum of up to 100 million doses of the Vaccine. The parties also agree that such Additional Order may be placed by the Commission only after (i) being advised by the Contractor that the Contractor has availability of supply of such additional requested doses at the time of the proposed Additional Order (the "Additional Product") (ii) the Contractor agrees, in its sole discretion, to allocate the Additional Product to the Commission (iii) the Contractor confirms how many doses can be delivered and by when (iv) the Commission confirms the required allocation between Participating Member States and (v) the Contractor confirms the delivery schedule based on a pro-rata split of the available doses across the Participating Member States who wish Additional Product. The Additional Order will be placed by way of an additional Vaccine Order Form and, as such, be subject to the same terms and conditions set forth in this APA. The Commission shall communicate to the Contractor the allocation of the Contracted Doses supplied pursuant to the initial order and any Additional Product among the governments of the Participating Member States. Each Participating Member State will have the right to resell or donate them to in need third countries or public institutions, contributing to a global and fair access to the Vaccine across the world. The right to resell or donate excess doses under the preceding sentence shall be subject to the Contractor's consent and be contingent in particular on receipt of (i) written indemnification by the recipient third country or public institution of the Contractor on terms satisfactory to the Contractor, and (ii) written confirmation that the Participating Member States and the receiving third countries or public institutions as the case may be shall, to the extent relevant to their actions in respect of such resale or donation, comply with applicable storage, transport and product acceptance requirements, as well as conditions of further resale or donation, to the satisfaction of the Contractor. Notwithstanding the foregoing, excess doses may be resold or re-allocated by the Participating Member States to other EU Member States or resold to EEA Member States provided, as the case may be, that any receiving EU Member State has executed a Vaccine Order Form and shall agree in writing to be bound by the same terms for such reallocated doses and that any EEA Member State has executed an agreement equivalent to a Vaccine Order Form in case of direct delivery from the Contractor, and shall (i) agree in writing to be bound by the indemnification clause in Article 1.12 and (ii) provide a written confirmation that it shall comply with applicable storage, transport and product acceptance requirements, as well as conditions of further resale or donation, to the satisfaction of the Contractor for such resold doses. Any such resale by a Participating Member State shall be at a price no higher than it paid the Contractor. The parties acknowledge that should resale to any third country take place, the Participating Member State reselling doses has an obligation to reimburse the Commission the Advance Payment per dose paid by the Commission to the Contractor. 1.6.3   Supply mechanism Vaccine supply in Europe will primarily come from Pfizer' s manufacturing site in Puurs, Belgium and shall incorporate RNA produced at BioNTech controlled manufacturing sites including sites operated by the following sub-contractors in Germany: 12
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SANTE/2020/C3/043 - 512.838335 SENSITIVE • Polymun Scientific Immunbiologische Forschung GmbH • Dermapharm AG • Rentschler Biopharma SE; however the Contractor may manufacture at and supply from facilities outside Europe, where appropriate to hasten supply, with prior written notice to the Commission, and subject to the Contractor obtaining any necessary regulatory approval. Subject to points (i) to (v) below, it is estimated that the order will be delivered as set out in the table below (the "Interim Delivery Schedule") assuming Authorisation being granted by 15 December 2020. The Interim Delivery Schedule and logistics will be further refined into a monthly schedule by the Contractor after the Commission has communicated how to apportion the 200 million Vaccine doses amongst the Participating Member States pursuant to the provisions of this Article 1.6.3. The Interim Delivery Schedule is as follows (subject to the limitations set forth below): Quarter             Q4 2020  Ql 2021      Q2 2021      Q3 2021 Doses million           25       40            60          75 (i)     No doses will be shipped to the Member States prior to the Contractor receiving Authorisation. (ii)    If Authorisation is received after 15 December 2020 then the Interim Delivery Schedule will shift accordingly and be adjusted to reflect the delay between 15 December 2020 and the date of Authorisation ("Adjusted Delivery Schedule"). (iii)   If Authorisation is not received by 15 August 2021, the Commission and the Contractor will have the right to terminate the APA. (iv)    If Authorisation is received prior to 15 August 2021, and the Contractor is able to manufacture and deliver a certain number of the Contracted Doses, but there is insufficient supply to deliver the full amount of Contracted Doses on the Interim Delivery Schedule or the Adjusted Delivery Schedule, then the Contractor will abide by allocation guidelines based on fair and equitable principles under the then existing circumstances, taking into account, among other things, the contracted volumes and the estimated or adjusted delivery dates across all commitments of the Contractor and its Affiliates. The Contractor will demonstrate its allocation according to the fair and equitable principles mentioned before to the Commission, specifying in particular the available European production capacity in the relevant time-period, the Contractor's and its Affiliates' aggregate dose commitments and estimated delivery dates for doses from such European facilities during the relevant time period and a summary explanation of corresponding delivery timeline adjustments. (v)     If Authorisation is received by 15 August 2021, but by 15 November 2021 the Contractor is unable to deliver any Contracted Doses for technical or other reasons, the Commission and the Contractor will have the right to terminate the APA. 13
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SANTE/2020/C3/043 - 512.838335 SENSITIVE (vi)     In the event the Contractor is unable to deliver the full amount of the Contracted Doses by 31 May 2022, the Commission and the Contractor will have the right to terminate the APA. For the avoidance of doubt, the Participating Member States will not have the right to terminate the Vaccine Order Forms in scenarios (iii), (v) or (vi) above in the event that the Commission has not exercised its right to terminate the APA. If the Vaccine is successfully developed and obtains Authorisation in the foreseen time-line (between 15 December 2020 and 15 August 2021 ), the Contractor shall use Best Reasonable Efforts to ensure that the doses are supplied in accordance with the Interim Delivery Schedule, or if applicable, the Adjusted Delivery Schedule. Allocations shall be made pursuant to Article I.6.3(iv) in case of insufficient supply to deliver the full amount of Contracted Doses. Within 20 days following the Effective Date, the Commission shall communicate to the Contractor a table how to allocate the 200 million Vaccine doses amongst the Participating Member States. Each Participating Member State shall have a commitment to purchase the number of Vaccine doses as set out in the above-mentioned allocation table and to sign a Vaccine Order Form to this effect as set out below. To operationalise the ordering of the Vaccine, each Participating Member State will enter into a Vaccine Order Form. Each Vaccine Order Form will specify in particular the number of doses that the Participating Member State will purchase from the above-mentioned allocation table, the price of all Vaccine doses pursuant to Article I. 7, and the liability and indemnification undertakings by the Participating Member State (which will be incorporated by reference from the APA into the Vaccine Order Form). Deliveries of doses to each Participating Member State shall be done on a pro-rata basis throughout the delivery period. For the avoidance of doubt, the Contractor shall have no obligation to supply any Vaccine doses to any Participating Member State where there is not a Vaccine Order Form , including provisions related to liability and indemnity (which will be incorporated by reference from the APA into the Vaccine Order Form executed by the Participating Member State and the Contractor). It is agreed that the Contractor may discharge its obligations under the Vaccine Order Form acting with one or more Participating Contractor Affiliates. 1.6.4   Manufacturing The Contractor confirms that it is in possession of all necessary manufacturing authorisations to undertake the manufacturing of the Vaccine. 1.6.5   Legal and regulatory filings and requests The Contractor shall ensure that all Product is properly labelled and packaged in accordance with the provisions of Article I.6.8 and Good Manufacturing Practice and in accordance with the applicable EU legislation on information on packaging (Title V of Directive 2001/83/EC). Notwithstanding the above, prior to delivery, the Contractor shall comply with all conditions (in the relevant timescales) set out in the Authorisation (where applicable), subject to any 14
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SANTE/2020/C3/043 - 512.838335 SENSITIVE exemption, exception or waiver of requirements for the Product granted or permitted by the Participating Member State (including but not limited to serialization). 1.6.6   Clinical trials and licensure The Contractor will use Best Reasonable Efforts to obtain Authorisation. If this is a Conditional Marketing Authorisation, thereafter the Contractor also commits to use Best Reasonable Efforts to seek the Marketing Authorisation once all necessary additional data and other information is available. 1.6.7   Waiver The Commission acknowledges and agrees that the Contractor's efforts to develop and manufacture the Vaccine are aspirational in nature and subject to significant risks and uncertainties. Notwithstanding the efforts and any estimated dates set forth in this APA, the parties recognize that the Vaccine is in Phase 3 clinical trials at the date of signature of this APA and that, despite the diligent efforts of the Contractor in research, and development and manufacturing, the Vaccine may not obtain Authorisation or may not be delivered (despite the Contractor's obligation to use Best Reasonable Efforts pursuant to Articles 1.6.1 and 1.6.6 of this APA) due to technical, clinical, regulatory or manufacturing, shipping, storage or other challenges or failures. Accordingly, the Commission and Participating Member States acknowledge and agree that, in such circumstances, the following remedies: •   obtaining replacement Products pursuant to Articles 1.6.14; •   payment or reimbursement of the costs as provided for in Article 11.6.7; •   the right to terminate given by Article 11.1 7; and •   the right to a refund of the Advanced Payment pursuant to Article 1.8.1 are reasonable and constitute the Commission's and the Participating Member States' remedies for the Contractor's failure to obtain or procure the obtaining of Authorisation or to manufacture, supply or deliver the Products in compliance with this APA or Vaccine Order Forms, for whatever reason. Notwithstanding the foregoing, the parties explicitly agree that the Contractor is liable if found by a court of competent jurisdiction to have breached its obligation to use Best Reasonable Efforts as set out in this APA within the limits of Article 11.6. In addition, the provision on no limitation of liability set out in 11.6.5 prevails. Any failure to deliver doses in accordance with the estimated delivery dates as set out above shall not give the Participating Member States any right to cancel orders for any quantity of Products except as expressly set forth in Article 1.6.3. 1.6.8   Packaging, labelling and shipping At the date of execution of this APA, the Vaccine is expected to be supplied in a thermal shipping box in accordance with Schedule 4 (Labelling and Packaging Specifications) ("Thermal Shipper") containing up to 5 trays of multidose 2ml vials. Each tray will contain 15
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SANTE/2020/C3/043 - 512.838335 SENSITIVE 195 vials. Each vial contains multiple doses of formulated Vaccine. The costs of packaging, packing materials, addressing, labelling, loading and delivery to the agreed Participating Member States' delivery point of the Vaccine shall be borne by the Contractor. All deliveries shall be accompanied by the documentation specified in Attachment 2 (Delivery Documentation) (which may be updated from time to time by the Contractor upon notice to the Commission), and shall be in accordance with, and subject to, the delivery specification set forth in Attachment 3 (Delivery Specification). The Product shall be labelled and packaged in accordance with the packaging specifications set forth in Attachment 4 (Labelling and Packaging Specifications) Final specifications including package size and labels will be communicated to the Commission and to the Participating Member States prior to delivery. All specifications shall be consistent with any conditions set out in the Authorisation and applicable Law. 1.6.9   Storage, transport and product acceptance Based on current knowledge and subject to updating based on Authorisation, the Vaccine is expected to be a two dose regimen in a concentration liquid formulation that needs to be stored frozen at temperatures between -75 °C (+/- 15 °C).The Vaccine must be thawed on the day of administration and stored at 2-8 °C until administration. The concentrate will need to be diluted at point of use prior to dosing. Vaccinators will need to obtain locally sourced 0.9% Sodium Chloride Injection (Normal Saline) for dilution, syringes and needles, as the Contractor will not be supplying such items with the Vaccine. The non-preserved multidose vial must be discarded after 6 hours of use. To ensure cold chain compliance the Contractor will utilize a GPS enabled temperature monitoring device until the point of delivery. The Participating Member State will switch off the temperature monitoring device when opening the delivery package (which must occur within the timeframe set out in Attachment 3 (Delivery Specification)), and upon request by the Participating Member State prior to the end of such time frame the Contractor will provide conformation of the temperature data from the temperature monitoring device and shall in any event inform the Participating Member State about any temperature non-compliance that occurred prior to delivery. If there has been any temperature non-compliance, the Participating Member State shall reject the Product in accordance with the provisions of Article 1.6.14. Final storage specifications, based on the Authorisation received, will be communicated to the Participating Member State prior to delivery. 1.6.10 Delivery The Contractor will deliver the doses ordered by each of the Participating Member States to one or more locations selected by the Participating Member State in accordance with the procedure set out in this Article I. 6 .10 and the Vaccine Order Form. The Participating Member States can decide whether they wish to have the Vaccine delivered to a reasonable number of sites where the Vaccine will be directly used and administered or to one or several central hubs per Participating Member State from which Participating Member States will ensure themselves the further delivery to the sites of use of the Vaccine. For the avoidance of doubt, the Participating Member States shall bear all costs and expenses for operating these distribution hubs and for use of the Vaccine, including, but not limited to, those for storage and distribution of the Vaccine after delivery, local duties and local QA testing. 16
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SANTE/2020/C3/043 - 512.838335 SENSITIVE The duly authorised representative of the Participating Member State shall sign to confirm receipt of delivery (the current proposed format of which is as set out in Attachment 2 (Delivery Documentation)). The person signing for receipt must ensure the contents of the delivery match the accompanying shipping documentation proof of receipt. The Contractor shall deliver the Product DAP Incoterm 2020 to the location agreed pursuant to this Article I.6.10. The Contractor and the Participating Member State shall agree the location(s) for delivery of shipments of the Product; provided that (i) each location meets the requirements set forth in Attachment 3 (Delivery Specification), and (ii) all locations shall be agreed upon by the Contractor and the Participating Member State at least eight (8) weeks prior to shipment of the Product noting that the Contractor will look to expedite these timescales where it can do so, and, in particular, may be able to shorten the eight (8) week lead time to four (4) weeks or sooner for locations that have been proposed by the relevant Participating Member State in early dialogue with the Contractor hence allowing the Contractor to pre-plan deliveries. The Contractor shall have the ability, acting reasonably, to restrict the number of locations where shipments of Product shall be delivered, provided that it is still agreed to deliver to a reasonable number of sites where the Vaccine will be directly used and administered or to one or several central hubs per Participating Member State from which Participating Member States will ensure themselves the further delivery to the sites of use of the Vaccine. All shipments of Product shall have a minimum volume of 975 doses (one tray). 1.6.11 Product handling Upon delivery of the Product, the Participating Member State shall store and handle the Product in the manner set forth in the Specifications set forth in Attachment 1 (Specifications), instructions in Attachment 3 (Delivery Specification) and the instructions provided by the Contractor to ensure stability and integrity of the Product. The Participating Member States shall be solely responsible and liable for the proper storage, handling, distribution, transportation, administration, use and disposal of the Product in their country following delivery of the Product to the Participating Member State or its designee. Without prejudice to the generality of the foregoing, the Participating Member States ensure that: (a) recipients of the Product shall follow the return and disposal instructions in Attachment 5 (Return and Disposal of Product Materials) (as updated by the Contractor and communicated to the Participating Member State from time to time) when disposing of open and unused Product and its packaging components; and (b) such return and disposal complies with Laws regarding pharmaceutical waste, medical waste, or hazardous waste, as appropriate. Participating Member States shall be responsible for and shall ensure that any equipment used to deliver the Product, for example the Thermal Shipper(s) and monitoring device(s), are stored in an appropriate clean and secure location to protect and maintain the functionality of such equipment (in controlled conditions, with no exposure to weather or pests, etc). Within 20 business days ofreceipt of the Product, subject to Article I.6.14, the Participating Member State shall take the necessary measures to enable the collection by the Contractor of all such equipment, including the Thermal Shipper and temperature monitoring device, in accordance with the Contractor's instructions, consistent with the provisions of Attachment 5 (Return and Disposal of Product Materials). 17
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SANTE/2020/C3/043 - 512.838335 SENSITIVE The Contractor may provide Safety Data Sheets and other agreed information to Participating Member States to assist them to develop processes and procedures, including training, to handle the Product and Product Materials in a safe manner and in compliance with Laws, including occupational health and safety Laws. While the Contractor is responsible for the content of such training materials and proposals for handling procedures, Participating Member States acknowledge that it is their responsibility to implement such training programs and procedures to enable proper handling of the Product and Product Materials in a safe and lawful manner. 1.6.12 Title to Product and risk of loss Title to the Product and risk of loss or damage shall pass to the Participating Member State on delivery pursuant to Article 1.6.10 and Participating Member States shall be responsible for the unloading of such Product from the transportation carrier. For the sake of clarity, the Contractor's liability shall cease, and risk ofloss or damage shall transfer, upon carrier's arrival at the point of delivery and immediately prior to the unloading of the Product. Without prejudice to the generality of the foregoing, following delivery of the Product to Participating Member States, the latter shall be fully responsible for and liable in relation to any Product wastage, and for ensuring appropriate disposal in accordance with the relevant provisions of this APA. The Participating Member States acknowledge that the Contractor or the Participating Contractor Affiliate will not, other than as provided in Article 1.6.14, accept any returns of Product (or any dose). In particular, following receipt of the Product in accordance with this paragraph, no Product returns may take place other than as provided in Article 1.6.14 (inclusive of future changes in stock, changes in Product allocation, delivery, demand or new product launch). 1.6.13 Quality tests and checks The Contractor shall perform all bulk holding stability, manufacturing trials, validation (including, but not limited to, method, process and equipment cleaning validation), raw material, in-process, bulk finished product and stability (chemical or microbial) tests or checks required to assure the quality of the Product and tests or checks required by the Specifications and Good Manufacturing Practice. 1.6.14 Rejection of Product; Disposal of rejected shipments A Participating Member State must visually inspect the Product within 24 hours of delivery following the instructions set out in Attachment 3 (Delivery Specification) and may reject any specific delivery of the Product or doses therein that does not conform to Specifications or Good Manufacturing Practice ("Non-Complying Product") by providing notice to Pfizer Customer Service following an agreed protocol: (i) within 48 hours after delivery of such Non- Complying Product to the Participating Member State for any issues which would be apparent on visual inspection of the Product; or (ii) within 5 business days after its first knowledge of a Latent Defect. The Contractor shall respond to any rejection and notice of such Non-Complying Product from the Participating Member State in a timely manner. For clarity, the Participating Member State shall not be entitled to notify rejection of any Product based on service complaints unless a Product in its view does not conform to Specifications or Good Manufacturing Practice. 18
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SANTE/2020/C3/043 - 512.838335 SENSITIVE The Contractor shall conduct an analysis of the causes of any such quality-related complaint, and shall report to the Participating Member State on any corrective action taken. If the Contractor's inspection and testing reveals, to the Contractor's reasonable satisfaction, that such items of the Product are Non-Complying Product and that any such non-conformity or defect has not been caused or contributed to by any abuse, misuse, neglect, negligence, accident, improper testing, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions or use by the Participating Member State contrary to any instructions issued by the Contractor in accordance with this APA, the Contractor shall replace such Non-Complying Product as soon as practicable at no additional charge to the Participating Member State. In such circumstances, the Contractor will further arrange for reverse logistics for Product collection and manage the destruction of the Non-Complying Product. Until collection, the Participating Member State shall store and maintain the relevant Non- Complying Product in appropriately secure locations and in accordance with the manufacturers' specifications. If the Participating Member State disputes the Contractor's finding and this cannot be resolved with the Contractor, upon the Participating Member State's request, a sample of the rejected Product will be sent to a third party lab (which will be selected by mutual agreement between the Contractor and the Participating Member State) for analysis and the parties agree that they will use reasonable efforts to discuss an appropriate resolution on the basis of the third party lab's analysis. For the avoidance of doubt, the foregoing is without prejudice to either party's right to refer to the dispute resolution procedure set out in Article I.13.2 in order to establish whether any of the delivered Product constitutes Non-Complying Product. Without prejudice to the right to refer the matter to the dispute resolution procedure set out in Article I.13 .2 and the provision on no limitations on liability under Article II.6.5, replacement of Non-Complying Product shall be the Participating Member State's sole and exclusive remedy for Non-Complying Product (as defined in this Article I.6.14). The provisions of this Article I.6.14 shall survive termination or expiration of this APA. 1.6.15 Maintenance and retention of Records Each party shall maintain detailed Records with respect to its activities under this APA as required by Laws. The Participating Member State will maintain a quality system for receipt, inspection, storage, traceability to further delivery points, and recall activities. If the Participating Member State does not have a quality system for the activities defined, the Contractor may share details of a proposed quality system for the Participating Member State's compliance. 1.6.16 Diversion issues All Product delivered to a Participating Member State shall be: (a) stored securely by the Participating Member State; and (b) without prejudice to Article I.6.2, distributed by the Participating Member State in a secure manner appropriate to the transportation route and destination, in each case (a) and (b) to guard against and deter theft, diversion, tampering, substitution (with, for example, counterfeits) or unauthorised resale or export out of the Participating Member State, and to protect and preserve the integrity and efficacy of the Product. The Participating Member State shall promptly notify the Contractor in writing (and in any event within 5 business days) if at any time the Participating Member State believes or 19
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SANTE/2020/C3/043 - 512.838335 SENSITIVE becomes aware that any of the Product has been stolen, diverted, tampered with, substituted, or otherwise subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions or use contrary to any instructions issued by the Contractor. The notice shall provide all information relating to the Product diversion, including, but not limited to, detailed information including the date, time, location, number, batch number(s), expiration date, circumstances, and contact person( s) information. 1.7     PRICES The price of the Vaccine to the Commission and the Participating Member States for the 200 million Contracted Doses will be €15,50 per dose excluding VAT. The unit price for each dose of the Vaccine is volume-based as set out in the following table: Volume tier (doses)                      1-100 million                  101-200 million Total price per dose within                  €17,50                         €13,50 each volume tier, excluding VAT To the extent that, contrary to the commitments set out in Article 1.6.2 and in the table set out in Article 1.6.3, fewer than 200 million doses are ordered under this APA, then the price per dose of the Vaccine will be adjusted accordingly. For example, if the APA is for 150 million doses, the average price will be: ((100 million x €17.50) + (50 million x €13.50)) / 150 million = €16.17 per dose. As another example, if the APA is for 70 million doses, the average price will be: (70 million x €17.50)/70 million= €17.50 per dose. In addition, if an Additional Order is requested by the Commission and agreed to by the Contractor, the price of the Additional Product will be: 1.   €15,50 per dose for any Additional Order placed and agreed by the Contractor within three (3) months of the date that the Contractor first obtains Authorisation; 11.   €17,50 per dose for any Additional Order placed and agreed by the Contractor thereafter but prior to termination of the APA. 1.8     PAYMENT ARRANGEMENTS 1.8.1   Advance Payment The Commission agrees to pay an upfront payment of €700 million (calculated as €3.50 per dose multiplied by 200 million doses) to the Contractor (the "Advance Payment"). The Advance Payment shall be a down payment to secure the volume ordered as per Article 1.5.2, and shall be counted as a payment towards the Delivery Price as defined below. The Commission shall pay to Contractor the Advance Payment, on behalf of the Participating Member States, within 20 business days after the date of Contractor's invoice in respect thereof. The parties agree that, as a sole and exclusive remedy for the Commission and all Participating Member States, one-hundred percent (100%) of the Advance Payment will be refunded to the 20
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