Advance Purchase Agreement Moderna

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DocuS1gn Envelope ID B52E9FB9-A22B-405B-9473-675OCA6FF0F6 .::,  'I l r.., S.U,1,U/ .)/ U:>'t • .:,1,1,.0.>o:,:,o Sensitive• RELEASABLE TO: Need to know basis Only those Option Doses for which the December Option Increase was not exercised will remain available for the Deferred Option Increase. If the amount of Product doses for which the Commission exercised the December Option Increase is less than eighty million (80,000,000) doses, the remaining doses may be ordered by the Commission on behalf of one or more Participating Member States through the exercise of the Option Increase during the period commencing on January 1, 2021 and ending twenty (20) calendar days after the date of receipt of Marketing Authorisation for the Product ("Deferred Option Increase"). Within five (5) calendar days after the date of receipt of Marketing Authorisation for the Product, the contractor will provide an estimated delivery schedule for the Deferred Option Increase (including the location(s) of the supply and the estimated timelines for delivery of doses of Product from such location(s)) to enable the Commission and the Participating Member States to determine whether or not to exercise the Deferred Option Increase. In the event that the Commission exercises the Deferred Option Increase, then the contractor and each of the Exercising Member States shall mutually agree on a delivery schedule for the Product comprising the Deferred Option Increase, based on the estimated delivery schedule for the Deferred Option Increase and adjusted based on the number of Exercising Member States and the actual number of doses of Product in the Deferred Option Increase. If an agreement on a delivery schedule cannot be agreed between the contractor and an Exercising Member State within 15 calendar days from the date of receipt of the signed Vaccine Order Form by the contractor, the corresponding Vaccine Order Form may be cancelled by that Exercising Member State or the contractor upon written notice to the other. The applicable Vaccine Order Form shall be deemed cancelled unless the relevant Exercising Member State and the contractor confirm in writing the agreement on delivery schedule within 15 calendar days from the date of receipt of the signed Vaccine Order Form by the contractor. Such agreement shall be immediately communicated to the Commission and the other Exercising Member States. The Product doses for which the Deferred Option Increase was exercised shall be paid as follows : (x)          fifty percent (50%) of (i) the number of Option Doses of Product to be delivered to such Exercising Member State multiplied by (ii) a price in euros based on Twenty Two U.S. Dollars and Fifty Cents (US$22.50), payable within thirty (30) day after the return by the contractor of the signed Vaccine Order Form followed by an invoice for the Deferred Option Increase; and (y)          fifty percent (50%) of (i) the number of Option Doses of Product to be delivered to such Exercising Member State multiplied by (ii) a price in euros based on Twenty Two U.S. Dollars and Fifty Cents (US$22.50), payable within thirty (30) days after receipt of the contractor' s invoice for each delivery. In the event that the Commission exercises an Option Increase on behalf of the Exercising Member States, then each Exercising Member State participating in such Option Increase shall deliver to the contractor a separate Vaccine Order Form within 10 calendar days after delivery of notice of the applicable Option Increase by the Commission. If an Exercising Member State does not provide a Vaccine Order Form for its allocated Product doses for the Option Increase on or prior to such date or cancels its order for the Deferred Option increase due to the failure to agree a delivery schedule, the remaining Exercising Member States participating in the Option Increase may, by written notice to the Commission, increase their respective allocation of Option Doses pro 11
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DocuS1gn Envelope ID 852E9F8 9-A228-4058-9473-675OCA6FF0F6 ..., ., 1 c.,~u~u, .>J U;:)'t - ..-,u .o.>o:i-:,o Sensitive• RELEASABL TO: Need to know basis rata or on the basis of any other allocation communicated to the contractor in writing by the Commission. In such case, (i) the Commission shall provide written notification to the contractor of any such increase in allocation of Option Doses for any such Exercising Member States and (ii) such Exercising Member States shall send to the contractor an updated Vaccine Order Form confinning such increased allocation of Option Doses communicated by the Commission to the contractor, in each case ((i)-(ii)), within 20 calendar days after the initial delivery of the notice of the applicable Option Increase by the Commission on behalf of the Exercising Member States. In the event the Commission does not exercise any Option Increase on behalf of one or more of the Participating Member States, the contractor may enter into separate agreements with such Member States for the delivery of Product doses to such Member States after the final delivery of the Initial Doses to the Participating Member States hereunder. 1.4.5         Development timeline; Special Commitments On ovember 17, 2020, the contractor announced that the EMA human medicines committee (CHMP) has started a rolling review of the Product following the confirmation of eligibility of the Product for submission on October 14, 2020. The contractor currently anticipates that Marketing Authorisation for the Product may be granted on or before the Expected Approval Date, based on anticipated accelerated EMA timelines. However, the Parties acknowledge that there is a risk that Marketing Authorisation for the Product may not be granted as anticipated. For the avoidance of J uubl, Lhe Expected Approva l Date set forth herein represents the contractor's good-taith expectations and nothing herein shall be construed as an obligation of any kind for the contractor to obtain Marketing Authorisation on or prior to the Expected Approval Date. To produce the Initial Doses, the contractor may not manufacture or have manufactured the Product at manufacturing sites located outside the territory of the European Union, the EEA or Switzerland without the prior consent of the Commission, which consent may not be unreasonably withheld, conditioned or delayed if the manufacturing at such sites is required to accelerate the production of the Initial Doses. The CMO and their manufacturing sites as identified in Annex V are deemed pre-approved for the Initial Doses. 1.4.6        The possibility to re-sell, export and/or distribute Each Participating Member State shall be entitled to re-sell, export and/or distribute the Product doses supplied to them pursuant to this APA to any other EU or EEA Member State, provided however that such re-sale, export and/or distribution may not take place before (i) such Participating Member State has paid the contractor in full for all Product doses subject to such re- sale, export and/or distribution and (ii) the other EU or EEA Member State expressly agrees in writing to assume the indemnity and other relevant rights and obligations hereunder. The contractor and the Indemnified Persons will be express third party beneficiaries under such assumption agreement, and the contractor and the Indemnified Persons will have the right to enforce such obligations and make claims thereunder with such other EU or EEA Member States. The Participating Member State re-selling doses to an EA Member State has an obligation to reimburse the Commission the up-front payment per dose paid by the Commission to the contractor. 12
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DocuSign Envelope ID 852E9FB9-A228-4058-9473-675DCA6FF0F6 .:,ru,  1 £/,J.UI.U/ -'IU;l't • .:, 1,1.,0.lO::f:>O Sensitive* RELEASABLE TO: Need to know basis The Participating Member States shall take appropriate measures to ensure that the Product doses supplied to them pursuant to this APA will only be (i) exported, distributed or donated to another Governmental Authority in a country outside the EU or EEA, either directly or indirectly through NGOs, the World Health Organization or any international public organization, subject to the prior written consent of the contractor (which consent will not be unreasonably withheld, subject to such Participating Member State's and the applicable third country's compliance with the contractor's reasonable requests) (such Governmental Authority, a "Donation Country'') or (ii) re-sold to another Governmental Authority in Europe that is not an EU or EEA Member State, subject to the prior written consent of the contractor (which consent will not be unreasonably withheld, subject to such Participating Member State's and the applicable third country's compliance with the contractor's reasonable requests) (such Governmental Authority, a "Resale Country") and subject to the terms set forth below. For the avoidance of doubt and notwithstanding anything to the contrary herein, (a) it will be reasonable for the contractor to withhold its consent to the exportation, distribution, re-sale or donation to a Donation Country or Resale Country, as applicable, under this Article I.4.6 if the use or administration of the Product doses in such country or jurisdiction would require the contractor to obtain a marketing authorisation in connection with such use or administration in such country or jurisdiction, and (b) the Donation Country or Resale Country, as applicable, will only be permitted to use, deploy and administer any Product doses within its own territory. Each Participating Member State must comply with each of the following obligations in order to provide any Product doses to a Donation Country, and such Participating Member State will provide the contractor with any and all information reasonably requested by the contractor to establish such compliance from time to time until the exportation, distribution or donation is completed. 1.         Indemnity. A Participating Member State shall only provide the Product doses to a Donation Country under this Article I.4.6 of this APA if the Donation Country bas agreed to indemnification terms satisfactory to the contractor in writing. 2.          Transportation of Product. Without prejudice to paragraph 6 of this prov1S1on, a Participating Member State that exports, distributes or donates any Product doses to any Donation Country will be responsible for: (i)         seeking, obtaining and maintaining all relevant regulatory authorisations and approvals for the delivery of the Product doses to the applicable Donation Country, including the export of Product doses from the Territory and the import of the Product doses into the country or jurisdiction of the applicable Donation Country; provided, for clarity, that this shall not include seeking marketing authorisation for the Product in the Donation Country, if required; (ii)        packaging, storing and transporting the Product doses to the applicable Donation Country in accordance with the conditions set out in the Specifications, GDP and all applicable laws; and (iii)      delivering to the applicable Donation Country in a timely manner so as to ensure the Product doses have sufficient shelf life remaining following delivery to enable administration of the Product doses prior to the expiry of the Product doses' shelf life as set forth on the label for 13
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OocuSlgn Envelope ID B52E9FB9-A22B-4058-9473-675OCA6FF0F6 .3   ... l t./ -'U-'U/ \.,.>/ \1;:)'t - .3U.OJo::,;,o Sensitive• RELEASABLE TO: eed to know basis such Product doses (which, at the time of delivery to the applicable Donation Country, must be at least thirty (30) days); and 3.           Compliance with Applicable Laws. The Participating Member States shall not provide the Product doses to a Donation Country without that Donation Country having confirmed in writing that such Donation Country will comply with all applicable laws in connection with the packaging, storing, transporting, exporting, importing, insuring or distributing of the Product doses. 4.           Use and Administration of Product Doses. The Participating Member States shall not provide the Product doses to a Donation Country without that Donation Country having confirmed in writing that the Product doses will be used and administered in its own territory in accordance with the label for the Product and applicable laws. 5.           Price. Any Product doses provided by a Participating Member State to any Donation Country will be at no cost to such Donation Country (other than reimbursement of reasonable out- of-pocket costs of such Participating Member State for the provision of such Product doses to such Donation Country). 6.           Documentation. A Participating Member State will comply with the points 1 to 5 above by entering into an agreement in writing that is satisfactory to the contractor with the respective Donation Country to the effect that the Donation Country will take over the obligations and responsibilities as set out in points 1-4 above. The Parties acknowledge that should re-sale to any Resale Country take place, (A) the contractor, the Participating Member State and the applicable Resale Country will enter into a written agreement governing such re-sale, which at a minimum will include the obligations on Participating Member States with respect to Donation Countries set forth in immediately preceding paragraphs 1 through 4 and 6, mutatis mutandis, and (B) the Participating Member State re-selling doses to the applicable Resale Country has an obligation to reimburse the Commission the up- front payment per dose paid by the Commission to the contractor. Any Product doses re-sold by a Participating Member State to any Resale Country will not be at a price higher than the purchase price as set forth in Article I. 7 . l . 1.4. 7          Delivery The contractor shall deliver the Product doses to the Participating Member States in accordance with the allocation and the other terms and conditions of this APA. (a) Initial Delivery Schedule The contractor expects, and shall use Reasonable Best Efforts, to deliver Product doses to the Participating Member States in a non discriminatory manner on the schedule and in the quantities as set out in the following initial delivery schedule ("Initial Delivery Schedule"). 14
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DocuSign Envelope ID: 852E9FB9-A228-4058·9473•675DCA6FFOF6 .:,1';, J C./J.UJ.U/ .:J/U:)'t - .3 l J.,o.:,o:,,;:>O Sensitive* RELEASABLE TO: Need to know basis Initial delivery schedule For Initial Doses • l Omillion doses for Participating Member States in Ql 2021 • 35 million doses for Participating Member States in Q2 2021 • 35 million doses for Participating Member States in Q3 2021 For Option Doses In the event of the December Option Increase exercise: • up to 25 million Option Doses for exercising Member States as early as Q3 2021 • up to 55 million Option Doses for exercising Member States as early as Q4 2021 In the event of the Deferred Option Increase exercise, the contractor and the Commission, on behalf of the Exercising Member States, will confirm the delivery schedule for the Option Doses at the time of such Deferred Option Increase exercise once all Exercising Member States have agreed or rejected the delivery schedule with the contractor as the case may be in accordance with Article I.4.4. The schedule and quantities set out in the Initial Delivery Schedule are based on the contractor's current expectation that Marketing Authorisation for the Product will be granted or issued on or prior to February 28, 2021 (the "Expected Approval Date"). Under no circumstances will any delivery of Product doses be required under this APA prior to receipt of Marketing Authorisation for the Product unless mutually agreed by the Commission, the relevant Participating Member State(s) and the contractor. For avoidance of doubt, the Expected Approval Date set forth herein represents the contractor' s good-faith expectations and nothing herein shall be construed as an obligation of any kind for the contractor to obtain Marketing Authorisation on or prior to the Expected Approval Date. Nevertheless, the contractor shall use Reasonable Best Efforts as referred to in Article 1.12.7 to obtain Marketing Authorisation for the Product as soon as reasonably possible in order to meet the Expected Approval Date. The contractor shall inform the Commission of any expected change in the initial delivery as per the Initial Delivery Schedule, including any expected change if the Marketing Authorisation for the Product is not granted or issued by the Expected Approval Date. In such case, without prejudice to Articles I.12.7, II.16. l and II.16.2(a), the contractor shall (after prior consultation with the Commission) as soon as reasonably possible propose to the Commission an updated delivery schedule ("Updated Delivery Schedule"). The contractor shall ensure that deliveries of Product doses under the Updated Delivery Schedule are made within a schedule that is as close as reasonably possible to the Initial Delivery Schedule. If the anticipated delivery date of Product doses per an Updated Delivery Schedule is more than 90 calendar days after the corresponding delivery date for such Product doses in the Initial Delivery Schedule, a Participating Member State (or the Commission, acting on its behalf) may cancel its order for the number of Product doses that will be more than 90 calendar days late by providing 15
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DocuS1gn Envelope ID B52E9FB9-A22B-405B-9473-675DCA6FF0F6 _,   'I 11!,/.t.V.t.V/\.,.)/V":J-. - _,,.t.,O.J0:1-:JO Sensitive• RELEASAB E TO: eed to know basis written notice to the contractor within 14 calendar days of the Commission's receipt of such Updated Delivery Schedule. If the Commission or a Participating Member State cancels any Product doses during such 14 calendar day period in accordance with this paragraph, the contractor shall consequently reimburse to the relevant Participating Member State 100% of the payments already made by the relevant Participating Member State to the contractor for such cancelled Product doses. The schedule set out in the Initial Delivery Schedule reflects the calendar quarter in which Product doses are expected to be delivered. The actual delivery dates within the applicable Delivery Schedule for the Product doses will be agreed between the contractor and the Participating Member State, and the contractor will use Reasonable Best Efforts to deliver the first delivery of Initial Doses within fift.een (IS) business days of receipt of Marketing Authorisation for the Product; provided that the contractor shall have no obligation to deliver any Initial Doses to any Participating Member State until such Participating Member State has completed its payment in respect of contractor's receipt of Marketing Authorisation under Article I.4.2(b). The contractor may agree with the Participating Member States to make multiple deliveries over a calendar quarter, in varying quantities, and on a non-discriminatory basis as between all Participating Member States. Deliveries of Product doses will be made in a rolling, non-discriminatory manner between Participating Member States and pro rata to each Participating Member State based on the allocation provided by the Commission pursuant to Article 1.4.3, subject to the contractor's minimum delivery volume and goo<l faith cooperation with the Participating Member States. (b) Form of Delivery The supply of Product doses will be delivered by the contractor to the Participating Member States OAP (Delivered At Place) lncoterms 2020, to one recipient at one Delivery Address indicated by the Participating Member State concerned in the Vaccine Order Form, which recipient and Delivery Address is authorized, qualified and licensed to receive the Product in accordance with applicable law. (c) Distribution Following delivery of the Product doses, each Participating Member State will solely control and assume all responsibility, at such Participating Member State's own cost and expense for conducting all distribution and related activities relating to the Product doses in the Participating Member State's territory and to countries in the EU or EEA to which the Participating Member State donates or resells Product doses in accordance with Article 1.4.6. ( d) Traceability During the term of this APA and for a period often (10) years thereafter (or longer if required by applicable laws), each Participating Member State will (i) maintain an inventory control system for traceability of the Product supplied to or for the benefit of such Participating Member State, including any Product provided by such Participating Member State to a permitted Donation Country or Resale Country, and (ii) store and promptly make available to the contractor all 16
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DocuS1gn Envelope ID 8 52E9FB9-A228-4058•9473-675OCA6FF0F6 .:,   , t 1!./ ,t,V,t,V/ J / V;)'t • .:11"',0JO:,:,o Sensitive• RELEASABLE TO: Need to know basis traceability records for the Product. The inventory control system is without prejudice to other traceability requirements in accordance with the applicable laws. I.S.      ACCEPTANCE/REJECTION OF PRODUCT I.S.1           Subject to the terms of this Article 1.5, a Participating Member State may claim a remedy (a "Product Claim") for any portion of Product delivered to such Participating Member State by the contractor which at the time of delivery (a) does not comply with the final specifications for the Product as approved in the Marketing Authorisation for the Product or (b) has been affected by a failure to comply with GMP ("Deficient Product"). Such Participating Member State will visually inspect the Product, or review docwnentation provided by or on behalf of the contractor, upon delivery or receipt (as applicable) and will give the contractor written notice of all Product Claims within twenty (20) calendar days after such delivery or receipt (or, in the case of any deficiency at the time of delivery to such Participating Member State that was not reasonably susceptible to discovery upon such delivery or receipt, within twenty (20) calendar days after discovery by such Participating Member State Participating Member State, but not after the expiration date of the Product). If Participating Member State fails to provide a Product Claim within the applicable twenty (20) calendar day period, then the Product will be considered to have been accepted by Participating Member State on the twentieth (20th) day. The contractor will have no liability for any deficiency or claim for which it has not received notice from Participating Member State within the applicable twenty (20) calendar day period. 1.5.2           The contractor will have no obligation for any Product Claims to the extent the Deficient Product was caused by: (a) actions or omissions of such Participating Member State or Third Parties occurring after the time of delivery of the Product by the contractor or its designee; or (b) any breach by such Participating Member State of its obligations under this APA or the applicable Vaccine Order Fonn. 1.5.3           Upon receipt of a Product Claim, the contractor will have twenty (20) days to advise the Participating Member State by notice in writing whether it disagrees with the contents of the Product Claim. If, after joint testing or investigation has been performed, the Parties still cannot agree on whether such Product is Deficient Product, the contractor or the Participating Member State may refer such dispute to a technical expert for resolution in accordance with Article 1.5.4 (a "Technical Di pute '). l.5.4           If any Technical Dispute arises, the contractor and the Participating Member State will first try to resolve it amicably. The contractor or the Participating Member State may send a notice of a Technical Dispute to the other, and each Party will appoint, within ten (10) working days from receipt of the notice, an appropriate single representative having full power and authority to resolve the dispute. The representatives will meet as necessary in order to resolve the Technical Dispute. If the representatives fail to resolve the matter within one month from their appointment, or if a Party fails to appoint a representative as required above, the expert determination procedure below may be started by either Party. Within ten (10) working days after the written request, the contractor and the Participating Member State will appoint a single agreed expert with experience and expertise in the subject matter of the dispute. As a condition of the expert's appointment, the contractor and the Participating Member State will ensure that the expert agrees to disclose any actual or potential conflicts of interest promptly as they arise. The contractor and the Participating Member State do not intend that the expert acts as an arbitrator and therefore any matters requiring 17
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DocuSign Envelope ID· 852E9FB9-A228-405B-9473-675DCA6FF0F6 .:,  ~ l C.I ~U~U/\.,.;>/ 1}:,.. - .:).l~.o.;,o::,:,o Sensitive* RELEASABL TO: eed to know basis legal interpretation or adjudication including disputes relating to the conduct of the Technical Dispute are solely reserved for the dispute resolution procedure wtder Article I.11.2. For the avoidance of doubt, any technical determination by the expert under a Technical Dispute may be used as evidence under Article I. l 1.2. The contractor and the Participating Member State will require the expert to provide an opinion on each referred issue (with reasonably detailed reasoning) within fifteen (15) working days (or as agreed by the contractor and the Participating Member State with the ex.pert). The contractor and the Participating Member State will give to the ex.pert all the evidence and infonnation within their respective possession or control as the expert may reasonably request, which they will disclose promptly and in any event within five (5) working days of a written request from the expert to do so. At all times the contractor and the Participating Member State will co-operate and seek to narrow and limit the issues to be determined. The technical determination of the expert will, except for fraud or manifest error or where an unapproved conflict of interest is discovered, be final and binding upon the contractor and the Participating Member State with respect to the referred Technical Dispute. Each of the contractor and the Participating Member will bear its own costs for any matter referred to an expert under this Article 1.5.4 and, in the absence of express agreement to the contrary, the costs and expenses of the expert will be shared equally by the contractor and the Participating Member. 1.5.S         If a Participating Member State makes a Product Claim pursuant to this Article I.5 and (a) the contractor and the Participating Member State agree the Product that is the subject of such Product Claim is Deficient Product (such agreement not to be unreasonably withheld, conditioned or delayed) or (b) any previously delivered Product is determined to be Deficient Product, the contractor will replace such Deficient Product as soon as reasonably practicable after the time of such agreement or determination (and in no event later than 90 days after the time of such agreement or determination). If such replacement products are not delivered within this time limit, the contractor shall reimburse the purchase price for the Deficient Product to the Participating Member States in question in so far as that purchase price was already paid. 1.5.6         A Participating Member State will not dispose of any Product for which it intends to assert a Product Claim against the contractor without the contractor's prior written authorization to do so. The contractor may instruct Participating Member State to return the Product to the contractor to a location identified by the contractor. The contractor will bear the cost of return and disposition of any Deficient Product. In all other circumstances, the Participating Member State will bear the cost of return and disposition, including all applicable fees for manufacturing of the Product. 1.5. 7        Except as and to the extent required by applicable law, and without prejudice to Articles ll.4.6 and 11.5, this Article 1.5 sets out the only contractual liability of the contractor and the Participating Member States' sole and exclusive remedy for Deficient Products that are unsold or unused and returned, destroyed or otherwise disposed of by the Participating Member States in accordance with this APA l.6. WARRANTlES 1.6.1         The Commission and each of the Participating Member States warrant to the contractor that as of the date hereof, this APA has been duly executed and is a legal, valid and binding obligation on it, enforceable against it in accordance with its terms. 18
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DocuSlgn Envelope ID 852E9F89-A228-4058-9473-675DCA6FF0F6 '3   'I l l!,/ 1.VJ.VI .J/ U::>6t - '31/..0.J0:,:,o Sensitive• RELEASABLE TO: Need to know basis 1.6.2           Each Participating Member State warrants to the contractor that at the time of its delivery to the contractor, each Vaccine Order Form from such Participating Member State has been duly executed and is a legal, valid and binding obligation on it, enforceable against it in accordance with its terms. 1.6.3           The contractor warrants to the Commission and the Participating Member States that (a) as of the date hereof, this APA has been duly executed and is a legal, valid and binding obligation on it, enforceable against it in accordance with its terms; and (b) as of the date hereof, it is not under any obligation, contractual or otherwise, to any third party in respect of the delivery of the Initial Doses or that conflicts with or is inconsistent in any material respect with the terms of this APA or that would impede the complete fulfillment of its obligations under this APA. 1.6.4          The contractor warrants to the Commission and the Participating Member States that (a) all Product doses supplied to the Participating Member States shall at the time of delivery conform with the final specifications for the Product as approved in the Marketing Authorisation for the Product; (b) all Product doses supplied to the Participating Member States shall at the time of delivery have been manufactured in conformance with GMP and all applicable laws; and (c) at the time of delivery, it has good title to the Product doses delivered to the Participating Member States pursuant to this APA and it shall pass such title to the Participating Member States free and clear of any security interests, liens, or other encumbrances, including, to the knowledge of the contractor, having obtained any necessary IP rights. The Parties agree that the sole and exclusive remedy for a breach of the product warranties set forth in this Article I.6.4 (a) and (b) will be the remedies set forth in Article I.S. 1.6.S           Except as expressly set forth in this APA, the contractor and its Affiliates make no other warranties of any kind, express or implied, including any implied warranties of merchantability or fitness for a particular purpose, or non-infringement, or regarding results obtained through the use of the Product. 1.7.         PRICES 1.7.1           Price per Dose of Product The price per single dose of Product purchased hereunder shall be the equivalent in euros based on Twenty Two U.S. Dollars and Fifty Cents (US$22.S0). For clarity, the price for the total Product volume shall be obtained by multiplying the price of a single Product dose by the total number of Product doses covered by this APA. Payments are made in euros by taking into account the Exchange Rate Methodology set out under Article 1.8.4. 19
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OocuS1gn Envelope ID 852E9FB9-A22B-4058-947J.675DCA6FF0F6 .:,l'\.1-, 1 CJ"-V"-V/ .JtV:><t - .:,u.o.>o:,:,o Sensitive• RELEASABLE TO: Need to know basis 1.7.2           Down payment under the APA The Down Payment for the Initial Doses is 318,471,338.00 euros based on Three Hundred Sixty Million U.S. Dollars (US$360,000,000.00) calculated using the Exchange Rate Methodology set out under Article l.8.4. The Down payment shall be fully deductible from the price of each dose of the Initial Doses at a rate of Four U.S. Dollars and Fifty Cents US$ 4.50 per single dose. The price for each dose for the Initial Doses remaining for the Participating Member States after deduction of the Down payment is consequently the equivalent in euros based on Eighteen U.S. Dollars (US$18 .00). The payment schedule for purchases of Initial Doses by or on behalf of Participating Member States is addressed in Article 1.4.2. The payment schedule for purchases of Option Doses by or on behalf of Participating Member States is addressed in Article I.4.4. 1.8. PAYME TARRA GEME TS 1.8.1            Pre-financing (Payment of the Down Payment) Within ten (10) days following signature of the APA, the contractor shall send to the Commission an invoice for the payment of the Down Payment in paper format or in PDF format by email. The invoice shall indicate the reference number of the APA and comply with the terms of the APA. The Down Payment shall be paid in a single instalment. The invoice for the Down Payment must contain the following information: ame of the addressee -        APAnumber -        name and bank account. The Commission must pay the Down Payment within 15 days after receipt of the invoice as referred to in the first subparagraph. 1.8.2           Utilisation of the Down Payment The parties acknowledge and agree that the Down Payment is intended to cover costs incurred by the contractor for (i) the establishment, expansion, and acceleration of manufacturing capacities necessary for the manufacture of the Initial Doses, (ii) the purchase (and financial commitments to purchase) raw materials, supplies, components and equipment necessary for the manufacture of the Initial Doses covered by this APA. (iii) the commencement and continuation of at-risk production of the Initial Doses covered by this APA. and (iv) the establishment of regulatory and phannacovigilance capabilities in relation to the Product doses covered by this APA, in each case prior to the execution of this APA. The Down Payment is used as further specified in Annex IV. 20
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