Advance Purchase Agreement Moderna

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DocuSign Envelope ID: B52E9FB9-A22B-405B-9473-675DCA6FF0F6 ,:,   , 1 ~ ~u~u, ~.,,v;, .. - .,,~.0.,0::7;;,o Sensitive* RELEASABLE TO:  eed to know basis EUROPEA         COMMISSIO Directorate-General for Health and Food Safety ADY ANCE PURCHASE AGREEME T ("APA") 1 for the production, priority-purchasing options and supply of a successful COVID-19 vaccine for EU Member States NUMBER - SANTE/2020/CJ/054 - S12.838958 1. The European Commission (the 'Commission'), acting on behalf and in the name of the Member States listed in Annex I (hereinafter referred to as "Participating Member States") being represented for the purposes of signature of this APA by Ms Stella Kyriakides, Commissioner for Health and Food Safety: on the one part and 2.        Modema Switzerland GmbH a limited liability company ("Gesellschaft mit beschrlinkter Haftung") organized and existing under the laws of Switzerland Company        umber CHE-344.522.989 Aeschenvorstadt 48 (c/o Katja Schott, Walder Wyss), 4051 Basel, Switzerland CHE-344.522.989 MWST (the 'contractor'), represented for the purposes of the signature of this APA which has the form of a framework contract by Stephane Bancel, Managing Director, on the other part, The Commission, acting on behalf and in the name of the Participating Member States, and the contractor are together referred to as the "Parties" and each individually as a "Party" HAVE AGREED to the special conditions and the general conditions of this APA and the following annexes : Annex I -         List of Participating Member States Annex II -        Model for Vaccine Order Form Annex Ill - Agreement between the Commission and Member States on procuring Covid- 19 vaccines on behalf of the Member States and related procedures, annexed to the Commission Decision C(2020) 4192 final of 18 June 2020 1  This APA is based on the agreement between the Commission and the Member States as approved by Commission Decision C(2020) 4192 final on approving the agreement with Member States on procuring Covid- 19 vaccines on behalf of the Member States and related procedures. 1
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DocuSign Envelope ID: B52E9FB9-A228-4058-9473-675DCA6FF0F6 .:,  , 1 l!J -'U.4U/ \-.J/U;:)'t - .:,u,.O.JO'r.>O Sensitive• RELEASABLE TO: eed to know basis Annex IV -              Description of the contractor' s intended utilization of the Down Payment Annex V -               List of confirmed and planned manufacturing network partners including the location(s) of manufacturing Annex VI -              Preliminary Specifications of the Product which form an integral part of this APA. RECITALS A.            The world is experiencing an emergency healthcare crisis due to the SARS-Co V-2 ( 'COVID-19 ) pandemic (the' CO VJD-19 pandemic') and the global demand for vaccines to prevent CO VID-19 virus infection is expected to be in order of magnitude of billions of doses. B.            The contractor and its affiliates are currently working to develop and manufacture an mRNA-based vaccine to help protect against COVID-19 virus infection in humans. C.            The contractor is currently conducting a Phase 3 study of the Product in the nited tates (the ..COVE Study'). As of 23 ovember 2020, the independent, NIH- appointed Data Safety Monitoring Board (DSMB) has informed the contractor that the COVE Study has met the statistical criteria pre-specified in the study protocol for efficacy. Furthermore, the contractor is currently establishing its manufacturing capacities in Europe through partnership with experienced contract manufacturing organisations ("CMOs") in order to meaningfully contribute to controlling the COVID-19 pandemic. While the contractor has prioritised and accelerated its efforts to develop and manufacture the Product in light of the current COVID-19 pandemic, there is nonetheless substantial uncertainty around these efforts. D.            The Commission intends to create the environment required to support a secure manufacturing network and optimisation for the production of vaccines against COVID-19. To this effect the Commission has concluded an agreement with all Member States of the European Union to conclude, on behalf and in the name of the Member States, Advance Purchase Agreements with vaccine manufacturers with the objective to procure vaccines for the purposes of combatting the COVID- 19 pandemic at Union l.evel. E.            Th.e Commission wishes to secure supply of the Product for human use for the Participating Member States during the COVID-19 pandemic as promptly as possible. F.            The intention of the Commission, on behalf of the Member States, is to ensure that the population in the European Union will be able to access a vaccine in sufficient quantities and at a fair price, but also in safe conditions. The vaccine should only be available to the population once its safety and efficacy will have been cleared by the competent regulatory bodies. 2
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DocoSlgn Envelope ID B52E9FB9-A22B-405B-9473-675DCA6FFOF6 .-:)"-1, l CU,UJ.U/  .l/U;J't - .-:)lJ..O.lO:,;;:,o Sensitive• RELEASABLE TO: Need to know basis G.         According to the Agreement between the Commission and the Member States2 and in particular Article 4 thereof, the Commission can conclude an Advance Purchase Agreement that contains a right and an obligation for Participating Member States to acquire vaccine doses. Where the Commission intends to enter into such an agreement, it shall inform the Member States of such intention and the detailed terms. In case a Member State does not agree with the conclusion of an APA containing an obligation to acquire vaccine doses or its terms, it has the right to opt out by explicit notification to the Commission. All Participating Member States not having opted out in accordance with the Agreement between the Commission and the Member States are deemed to have authorised the Commission to negotiate and conclude an Advance Purchase Agreement with the vaccine manufacturer in their name and on their behalf. H.        This APA is such an agreement which the Commission enters into on behalf and in the name of the Participating Member States which have not opted out of the agreement. These Participating Member States will then have an obligation to acquire the Product and a right to be supplied with the respective Product doses. While the APA is legally binding upon those Participating Member States, it will be further implemented by means of the conclusion of contracts between the Participating Member States and the contractor. The present APA will be complemented by a Vaccine Order Form ("Vaccine Order Form") between each of the Participating Member States and the contractor. A model. Vaccine Order Form for the agreement between each of the Participating Member States and the contractor is attached in Annex II. I.        The production, advance sale and supply of the Product as per this APA require significant investments by the contractor to increase the speed of the preparation of the at-scale production capacity along the entire production value chain in the EU required for a rapid deployment of the millions of doses of the Product. The Commission as well as the Participating Member States are willing to contribute to financing of those investments in the form of up-front payments. J.         Pursuant to these terms and conditions, access to Product doses will be allocated to Participating Member States according to a population distribution key, unless a different allocation would be communicated by the Commission to the contractor. The up-front payment<;, paid by the Commission, should be taken into account in equal terms per dose ordered by the Member States. K.         The Parties recognise that the accelerated tirnelines to develop, produce, sell and supply the Product means that the contractor under no circumstance can warrant, or assume any liability, at the time of entry into force of this APA that the Product will be ultimately available or will produce the desired results, i.e. shows sufficient efficacy to prevent a CO VID-19 infection, or be without unacceptable side effects. The Participating Member States are willing to share those risks, which includes an obligation of the Participating Member States to indemnify the contractor and its CMOs in case ofliability incurred, settlements paid and certain costs relating to 2 Such agreement is based on Article 4(5)(b) of Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union, OJ L 70, 16.3.2016, p.l , as amended by Council Regulation (E ) 2020/521 of 14 April 2020 activating the emergency support under Regulation (E ) 2016/369, and amending its provisions taking into account the COVID-19 outbreak, OJ L 117, 15.4.2020, p. 3. The agreement was approved Decision C(2020) 4192 final of 18 June 2020 (sec Annex Ill to this APA). 3
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OocuSign Envelope ID· B52E9FB9-A22B-405B-9473-675OCA6FF0F6 .:,  -, l lU J.VJ.V/ \..,J/V-:1'+ • .:,1J.,G.>OY.:JO Sensitive• RELEASABLE TO:         eed to know basis third party claims with respect to those risks under the conditions set out in this APA. The Commission and Participating Member States acknowledge that the use of Products will happen under epidemic conditions requiring such use, and that the administration of the Product will therefore be conducted under the sole responsibility of the Participating Member States. L.           The Participating Member States acknowledge that, in light of the uncertainties both with respect to the development of the Product and the accelerated establishment of sufficient manufacturing capacities, the delivery dates set out in this APA are the contractor's current best estimates and may be subject to change. Due to possible delays in the authorisation, production and release of the Product, no Product or only reduced volumes of the Product may be available at the estimated delivery dates set out in this APA. In the case of delays to the anticipated availability of the Product, the contractor aims to allocate the doses of the Product fairly across the demand of doses, which the contractor has or will contractually commit to towards its present and future customers, as such doses become available. M.           Against this background, the Commission. wishes to enter into, on behalf and in the name of the Participating Member States, an Advance Purchase Agreement with the contractor to secure the availability a total of 80 million doses of the Product, to be allocated among the Participating Member States in accordance with the allocation principles set out in this APA. The Commission, on behalf and in the name of the Participating Member States, shall furthermore have the option to order up to a total of80 million additional doses of the Product, subject to the terms and conditions of this APA . This APA sets out: 1. the procedure and conditions by which the Commission and the Participating Member States shall pay for the Product from the contractor; 2. the provisions that apply to any Vaccine Order Form which the Participating Member States and the contractor conclude under this APA; and 3. the obligations of the Parties during and after the duration of this APA. All documents issued by the contractor (end-user agreements, general terms and conditions, etc.) except its tender and subsequent clarifications are held inapplicable, unless explicitly mentioned in the special conditions of this APA. In all circumstances, in the event of contradiction between this APA and documents issued by the contractor, this APA prevails, regardless of any provision to the contrary in the contractor's documents. 4
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DocuSlgn Envelope ID: B52E9FB9-A22B-4058-9473-675DCA6FF0F6 .:,   "I 11!,/ 1.UI.U/  :JI u:::,'f - ,31.l,.o:,o::,:::,o Sensitive* RELEASABLE TO: Need to know basis TABLE OF CONTENT Recitals ................................................................................................................................ 2 TABLE OF CONTENT .......................................................................................................... 5 I. SPECIAL CONDITIO S ................................................................................................... 7 I.1 .       Order of priority of provisions ........ ........................................................................ 7 I.2.        Subject matter ......................................................................................................... 7 I.3 .       Entry into force and duration of the APA ............................................................... 8 1.4.        Implementation of the APA .................................................................................... 8 1.5.        Acceptance/Rejection of Product.. .. ...................................................................... 17 1.6.        WAR.RANTIES .................................................................................................... 18 1.7.         Prices ..................................................................................................................... 19 1.8.         Payment Arrangements ......................................................................................... 20 1.9.         Communication Details ........................................................................................ 22 1.10.        EXPLOITATION OF THE RESULTS OF THE APA ........................................ 23 1.11 .      Applicable law and settlement of disputes ............................................................ 23 1.12.       OTHER SPECIAL CONDITIONS ....................................................................... 24 1.13.       Defutitions ............................................................................................................. 25 II. GENERAL CONDITIONS FOR THE FRAMEWORK CONTRACT FOR SERVICES ........................................................................................................................ 31 II. I .     Severability ........................................................................................................... 31 II.2.       Provision of Product ............................................................................................. 31 II.3 .      Communication between the parties ..................................................................... 31 ll.4.       Liability ............................ ..... ................................................................................ 32 II.5 .      Indemnification ..................................................................................................... 33 ll.6.       Conflict of interest and professional conflicting interests .................................... 36 II. 7.      Confidentiality ...................................................................................................... 36 11.8.       Processing of personal data ................................................................................... 38 11.9.       Subcontracting ...................................................................................................... 38 11.10. Amendments ......................................................................................................... 39 ll.11. Assignment ........................................................................................................... 39 11.12. Intellectual property rights .................................................................................... 39 II. I 3. Force majeure ........................................................................................................ 40 ll.14. Consequences of Delay ......................................................................................... 40 11.15. Suspension of the implementation of the APA ..................................................... 41 11.16. Termination of the APA ........................................................................................ 41 U.17. Invoices, Taxes, value added tax and e-invoicing ............................................... .45 5
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DocuSign Envelope 10: B52E9FB9-A22B"4058-9473-675DCA6FF0F6 '3   ~, r.t ..t.V.t.V/'-..,J/V:>'+ - '31.t..o.,o~;,o Sensitive• RELEASABLE TO: eed to know basis Il.18. Pa)'lllents and guarantees ...................................................................................... 46 11.19. Recovery ............................................................................................................... 47 ll.20. Checks and audits ................................... ...................................................... ........ 48 Annex I - List of Participating Member States ..................................................... 50 Annex ll - Model for Vaccine Order Form ........................................... .. ............ 51 Annex Ill - Agreement between the Commission and Member States on procuring Covid-19 vaccines on behalf of the Member States and related procedures, annexed to the Commission Decision C(2020) 4192 fmal of 18 June 2020 ........................................... .......... 56 Annex IV - Description of the contractor's intended utilization of the Down Pa)'lllent.. ... 62 Annex V - List of confirmed and planned manufacturing network partners including the location(s) of manufacturing ...... ....... ............................................................ 67 Annex VI - Preliminary Specifications of the Product.. .......................... . ............. 68 6
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DocuSign Envelope ID B52E9FB9-A22B-4058-9473-675DCA6FF0F6 -,   , 1 r.u.u~u, .,,u:>'t - .,,~.o.,o:,::,o Sensitive• RELEASABL TO: Need to know basis I.      SPECI AL C ONDITIONS 1.1.      O RDER OF PRIORITY OF PROVISIO S If there is any conflict between different provisions in this APA, the following rules must be applied: (a) The provisions set out in the special conditions take precedence over those in the other parts of the APA. (b) The provisions set out in the general conditions take precedence over those in the Vaccine Order Form (Annex Il). 1.2.   S BJECT MATTER The subject of this APA is the advance purchase of 80 million doses of the Product, as described below in Article l.4.2, to be allocated among the Participating Member States by the Commission in accordance with the allocation principles set out below in Article I.4.3. Additionally, this APA gives the Commission the option to order, on behalf and in the name of the Participating Member States, up to 80 million additional doses of the Product in accordance with Article 1.4.4 such Optional Increase to be allocated between the Participating Member States by the Commission as set out below in Article l.4.4. On the basis of this APA, the contractor commits to use Reasonable Best Efforts (i) to obtain Marketing Authorisation for the Product and (ii) to establish sufficient manufacturing capacities to enable the manufacturing and supply of the contractually agreed volumes of the Product to the Participating Member States in accordance with the delivery schedule set out below in Article I.4.7. Each Participating Member State shall issue a Vaccine Order Form as regards its allocation of the Initial Doses, through which the contractor shall supply to the Participating Member States the Product doses in accordance with the terms of this APA. If the Commission acting on behalf and in the name of the Participating Member States decides to exercise the Optional Increase under Article I.4.4, Vaccine Order Forms shall also be concluded with regard to such Optional Increase. The delivery of the Product to the individual Participating Member States shall be carried out in accordance with the tenns and conditions of this APA and in particular in accordance with the allocation notified by the Commission, as well as the additional delivery details set out in the Vaccine Order Forms to be concluded between the contractor and the Participating Member States using the model Vaccine Order Form provided as Annex II to this APA. The contractor shall receive from the Commission a down payment, subject to the terms of the APA, to enable the contractor to (i) establish, expand and accelerate its manufacturing capacity in Europe in relation to the manufacturing of the Initial Doses of the Product, (ii) purchase (and make financial commitments for the purchase of) raw materials, supplies, components and equipment necessary for the manufacture of the Initial Doses of the Product, (iii) commence and continue the at-risk production of the Initial Doses of the Product, and (iv) establish regulatory and pharmacovigilance capabilities in relation to the Product in Europe. Such down payment shall be fully deductible from the price of the Initial Doses of the Product. In addition, the Participating 7
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DocuS1gn Envelope ID 852E9FB9-A22B-4058-9473-675OCA6FF0F6 .:)  , l r./ .I.U.I.IJ/ 1...:J/ U7''t • 0:,1..1,.0,;JO:,::,o Sensitive• REL ASABLE TO: eed to know basis Member States shall pay the balance of the payments for the supply of the Initial Doses of the Product in accordance with Article I.4.2. 1.3.         E TRY I TO FORCE A D D RATIO OF THE APA 1.3.1         The APA enters into force on the date on which the contractor and the Commission have signed it. 1.3.2          Unless earlier tenninated in accordance with Article ll.16 or expired in accordance with Article I.3 .3, the APA is concluded for a period of 24 months with effect from the date of its entry into force. Its duration may be extended if at the end of the term of24 months not all of the Initial Doses or Option Doses, as the case may be, have been supplied. In such case, its duration will be extended until the delivery of, and payment in full for, all of the Initial Doses or all of the Option Doses, as the case may be. The Participating Member States and the contractor may not sign any Vaccine Order Form after the APA expires. The APA continues to apply to signed Vaccine Order Forms after its expiry. The obligations relating to such Vaccine Order Forms must be performed no later than six months after the expiry of the APA. L3.3           The APA shall automatically expire on (i) the date on which all the Initial Doses have been delivered and paid in full, in the event the Commission has not elected an Option Increase in accordance with Article 1.4.4, or (ii) the date on which all of the Initial Doses and the Option Doses have been delivered and paid in full, in the event the Commission has elected an Option Increase in accordance with Article 1.4.4. 1.3.4          Articles 1.1, 1.4.6, l.4.7(c), 1.4.?(d), 1.5, I.6.5, 1.7, 1.8, 1.11 , 1.12, 1.13, Ill, 11.3, ll.4, II.5, ll.7, II.8, 11.12.2, Il.16.5, Il.17, 11.18.4, 11.19 and Il.20 shall survive the tennination or expiry of this APA. 1.4.    lMPLEME TATIO OF THE   APA 1.4.1          Implementation of the APA The APA shall be implemented following signature between the Commission on behalf and in the name of the Participating Member States and the contractor as follows: Following entry into force of this APA, this APA is binding upon the contractor, the Commission and all Participating Member States on behalf and in the name of which the Commission has concluded this APA, as identified in Annex I. Following entry into force of this APA, the Commission will determine the allocation of the contractually agreed doses of the Product between the Participating Member States in accordance with the procedure set out below in Article l.4.3 and will formally notify this allocation to the contractor. The allocation notified to the contractor by the Commission on behalf and in the name of the Participating Member States is binding upon all Participating Member States. Each Participating Member State and the contractor will conclude a Vaccine Order Form, using the model Vaccine Order Form attached as Annex II to this APA, setting out the details of the delivery of the doses of the Product allocated to the respective Participating Member State. For the avoidance of doubt, and unless otherwise laid down in this APA, each Participating Member State 8
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DocuSlgn Envelope ID 852E9FB9-A22 B-4058 -9473-675OCA6FFOF6 '31-\J.' a r..,1,u1.u1 J1u;,.. - .:,11,.oJo:,;,o Sensitive• RELEASABLE TO: Need to know basis is obligated to purchase and pay for the doses contractually allocated to it as notified by the Commission regardless of whether such Vaccine Order Form is concluded or not. 1.4.2            Initial Doses Without prejudice to the Option Increase (see Article 1.4.4), the contractor agrees to supply an initial number of eighty million (80,000,000) doses of the Product (the Initial Doses") to all Participating Member States in accordance with the terms of this APA and the applicable Vaccine Order Forms. Each dose will be one hundred (100)-microgram equivalent of Product in a multi- dose vial, and the Product is administered as a two-dose vaccination regimen according to a drug label for the commercial supply in English, as determined by the contractor and which is not specific to the territory. The Commission and the Participating Member States hereby confirm that such drug label for the commercial supply in English is permissible under applicable law of each Participating Member State. In order for the contractor to (i) establish, expand and accelerate its manufacturing capacity for the Initial Doses, (ii) purchase (and make financial commitments for the purchase oO raw materials, supplies, components and equipment necessary for the manufacture of the Initial Doses, (iii) commence and continue the at-risk production of the Initial Doses, (iv) establish regulatory and pharmacovigilance capabilities in relation to the Product in the European Union, and (v) guarantee that the Participating Member States are able to acquire the Initial Doses in a given timefrarne and at a certain price and conditions, the Commission will contribute to the relevant costs for the Initial Doses in the form of an up-front payment as follows : twenty percent (20%) of (i) eighty million (80,000,000) Initial Doses of Product multiplied by (ii) a price in euros based on Twenty Two U.S. Dollars and Fifty Cents (US$22.50), payable within fifteen (15) days after the receipt of an invoice following signature of this APA (the "Down Payment"). The balance of payments for the supply of Initial Doses will be paid by each Participating Member State according to the following schedule: (a)           forty percent (40%) of (i) the number of Initial Doses ordered by such Participating 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 the date of receipt of Marketing Authorisation for the Product; and (b)           forty percent (40%) of (i) the number of Initial Doses delivered to such Participating 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. 1.4.3          Allocation between Participating Member States; Vaccine Order Forms The Conunission shall coordinate with the Participating Member States to agree to the allocation of the Initial Doses to be purchased from the contractor. The Commission shall provide to the contractor in writing the allocation for distribution of the Initial Doses among the Participating Member States within 15 calendar days after signature of the APA. Such allocation shall indicate 9
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DocuS1gn Envelope ID· B52E9F89-A228-405B-9473-67SDCA6FF0F6 ~    ~ 1.1!,/ '-U'-Ul\...J/ U::,.. - ~l'-,O.Jo :,:,o Sensitive• RELEASABLE TO: Need to know basis for each Participating Member State the precise volume of Initial Doses to be delivered to each Participating Member State. Within 10 calendar days after the notification by the Commission of the allocation for distribution of the Initial Doses among the Participating Member States, each Participating Member State shall place an order for its full allocated portion of the Initial Doses by sending the contractor the duly completed and signed Vaccin.e Order Form (the fonnat for which is set out in Annex II) in paper format and in PDF format by email to contractor' s address specified in the Vaccine Order Fonn. Within 10 calendar days of receipt of the Vaccine Order Form from a Participating Member State, the contractor must send back to the Participating Member State the Vaccine Order Form duly signed and dated in paper format or in PDF format by email to the Participating Member State' s address specified in the Vaccine Order Form. If the contractor refuses to sign the Vaccine Order Form at the conditions laid down in the APA and in Annex II or fails to supply the Product doses to the Participating Member States on time, the contractor may be considered in breach of its obligations under thls APA as set out in Article Il.16.2(c). 1.4.4          Option Increase Subject to the terms of this Article I.4.4, the Commission, acting on behalf of one or more of the Participating Member States, may elect to increase the number of doses of Product by up to an additional eighty million (80,000,000) doses in the aggregate (the "Option Increase") at the times set forth below. An Option Increase will be made by written notice from the Commission to the contractor, which notice shall specify the Participating Member States participating in such Option Increase (the "Exercising Member States' ) and the allocation of doses of Product to be purchased by and delivered to each such Exercising Member State (the "Option Doses' ). The Option Increase will be paid by the Exercising Member State according to the following schedule: If the Option Increase is exercised by the Commission on behalf of one or more exercising Member States on or prior to December 31 , 2020 ("December Option Increase"): (a)         twenty percent (20%) 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 the return by the contractor of the Vaccine Order Form; (b)         forty percent (40%) 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 the date of receipt of Marketing Authorisation for the Product; and (c)         forty percent (40%) 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. 10
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