Advance Purchase Agreement Moderna

EU-Impfvertrag mit Moderna vom 04.12.2020 zurück

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OocuStgn Envelope ID B52E9FB9-A22B-405B-9473-675DCA6FF0F6 .)   'I l C./ ,l, U ,l,U/ .)/ U :J't • .) l ,l,,0.)0:,:,o Sensitive• RELEASABLE TO:  eed to know basis 1.8.3            Payment for Marketing Authorisation and the supply of Product 1. The contractor must send an invoice in paper format or in PDF format by email to the Participating Member States for payment by the Participating Member States under Articles I.4.2 (a), l.4.2(b), l.4.4(b), l.4.4(c), l.4.4(x) and l.4.4(y), as applicable. Invoices shall be established by the contractor for a given order of the Product and for an identified delivery scheduled within the Vaccine Order Form. The contractor must send an invoice in paper format or in PDF format by email for payment due under the Vaccine Order Form accompanied by the following documentation (as applicable): - Proof of delivery of the Products referred to in Article 1.4.2 or 1.4.4 of this APA, to the place of delivery indicated by the Participating Member State concerned in the Vaccine Order Form Each invoice must contain the following information (if applicable): ame of a concerned Member State -    APA and Vaccine Order Form number/reference -    Order reference -    Date of receipt of Marketing Authorisation for the Product -    Product -    Quantity delivered -     Delivery reference and date -     Contractor name and bank account. 2.         The Participating Member States must pay within 30 days from receipt of the invoice. l.8.4           Currency Any payments to be made by the Commission or the Participating Member States under this APA, including under any Vaccine Order Form, shall be made, and any invoices issued pursuant to this APA shall be issued, in euros (EUR). All payments required under this APA (including under any Vaccine Order Form) are based on a unit price set in United States Dollars (USO). As a currency conversion in EUR will be required in connection with such invoices, the amounts payable hereunder shall be expressed in EUR equivalent calculated using the Exchange Rate Methodology (as defined below). The "Exchange Rate Methodology" is calculated as the average of the Euro Foreign Exchange Reference Rates as published by the European Central Bank from the beginning of each calendar year up to the pen-ultimate day of the month preceding the invoice, whereby all days are taken into account on which the Euro Foreign Exchange Rate is published. For the purposes of the Down Payment the conversion between the euro and US$ is calculated by applying the average exchange rate of the uro Foreign Exchange Reference Rates as published by the European Central Bank from l January - 31 October 2020, whereby all days are taken into account on which the Euro Foreign Exchange Rate is published. This rate is US$1 .1304 for 1 euro. 21
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DocuS1gn Envelope ID B52E9FB9-A22B-405S-94 73-675OCA6FF0F6 .:,  'II l l!, /1,U,l,U/ .>/ U:>'t - .:,u..oJo:,:,o Sensitive• RELEASABLE TO: eed to know basis 1.8.S             Refuodability of the Down Payment If this Al'A is automatically terminated pursuant to U.16.1 or terminated by the Commission pursuant to Article II. l 6.2(a) due to the fact that the contractor failed to obtain Marketing Authorisation for the Product, then the Commission will be entitled to a refund of any amounts of the Down Payment in accordance with Article ll.16.5. I.8.6             BANK ACCOUNT Payments must be made to the contractor' s bank account denominated in euro, identified as follows : ame of bank: Bank of America & BAM LI DAC ZURICH Full address of branch: Stockerstrasse 23, 8002 Zurich, Switzerland Exact denomination of account holder: Full account number including bank codes: CH08 0872 6000 0507 7603 3 Swift code: BofACH2X I.9. COMM  ICATIO  DETAILS For the purpose of this APA, communications must be sent to the following addresses: The Commission: European Commission Directorate-General for Health and Food Safety EC-V ACCINES@ec.europa.eu Participating Member States will provide the communication details in the Vaccine Order Forms. Contractor: H.W. Jerome Maddox, Vice President and Associate General Counsel Modema Switzerland GmbH Aeschenvorstadt 48 (c/o Katja Schott, Walder Wyss), 4051 Basel, Switzerland E-mails: lega1@modematx.com and Jerome.Maddox@modematx.com 22
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OocuS1gn Envelope ID B52E9FB9-A22B-405B-9473-675OCA6FF0F6 .:,   , l ~ I.VI.VI -'IU:>'t • O:,l l.,0-'0::1:>0 Sen itive• RELEASABLE TO: eed to know basis By derogation from this Article, different contact details for the Commission, the Participating Member States or the contractor may be provided in Vaccine Order Form. 1.10.        EXPLOITATION OF THE RESULTS OF THE APA The Com.mission and the Participating Member States acknowledge and agree that the contractor shall be the sole owner of all intellectual property rights generated during the development, manufacture, and supply of the Product, including all know-how (collectively, the "Vaccine IP Rights"). The contractor shall be entitled to exclusively exploit the results of the APA and any such Vaccine IP Rights. Except as expressly set forth in this APA, the contractor does not grant to the Commission or any of the Participating Member States by implication, estoppel or otherwise, any right, title, license or interest in or to the results of the APA, the Vaccine IP Rights or the contractor's Pre-existing rights. All rights not expressly granted by the contractor hereunder are reserved by the contractor. The Commission and the Participating Member States acknowledge that the Product Marks and all goodwill pertaining thereto are the exclusive property of the contractor or its Affiliates, that nothing in this APA grants the Commission or the Participating Member States or any Person any right, title or interest therein, and that all use of the Product Marks by the Commission or the Participating Member States or any Person acting under its or their authority or instruction will inure to the benefit of the contractor. The Commission and the Participating Member States will discontinue use of any Product Marks to which the contractor objects. The Commission and the Participating Member States will not use any of the Product Marks in a manner that diminishes the value of any of the Product Marks or disparages the contractor or its Affiliates or that the contractor otherwise deems to be inappropriate. The Commission and the Participating Member States will not modify, overprint, distort change, remove or obscure any Product Marks associated with the Product as delivered by the contractor under this APA or the Vaccine Order Forms. 1.11.         APPLI ABLE LAW A D ETTLEME T OF DISP TES I.I 1.1     This APA shall be governed by the laws of Belgium. 1.11.2      Dispute Resolution (a) In the event of a dispute arising under this APA or a Vaccine Order Form between the contractor and the Commission or a Participating Member State, the Parties shall first refer such dispute to informal dispute resolution discussions between their respective representatives. The contractor or the Commission on behalf of itself or of the Participating Member States may initiate such informal dispute resolution by sending written notice of the dispute to the other Party, and, within twenty (20) days of such notice, the representatives shall meet and attempt to resolve the dispute by good faith negotiations. (b) The Commission, the Participating Member States and the contractor irrevocably submit to the exclusive jurisdiction of the courts located in Brussels, Belgium to settle any dispute 23
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DocuSlgn Envelope ID B52E9FB9-A228-4058-9473-675OCA6FFOF6 .:,  " t r-J 1.UI.U/  .:,1u::>'t • .::,u.. o.:,o:,:,o Sensitive• RELEASABLE TO: eed to know basis which may arise under or in connection with this AI'A or the legal relationships established by this APA including under a Vaccine Order Form. 1.12.      OTHER SPECIAL CONDITIONS 1.12.1 Each Participating Member State and the contractor will each maintain records necessary to permit a Recall of any Product delivered to such Participating Member State. 1.12.2 Each Participating Member State and the contractor will notify the other party within 5 working days from notifying the European Medicines Agency of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product in the Participating Member State's territory. I.12.3 Upon receiving this notice or upon this discovery, such Participating Member State and the contractor will stop making any further shipments of any Product in their possession or control in such Participating Member State's territory until a decision has been made whether a Recall or some other corrective action is necessary. I.12.4 The decision to initiate a Recall or to take some other corrective action, if any, with respect to the Product in such Participating Member State's territory will be made by the competent authority concerned, or alternatively by the contractor, in agreement with the competent authority(ies) concerned. 1.12.5        If: (i) any regulatory authority issues a decision, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled in such Participating Member State' s territory; (ii) a court of competent jurisdiction orders a recall in such Participating Member State' s territory; or (iii) the contractor in agreement with the concerned competent authority(ies) determines that any Product should be recalled in such Participating Member State's territory (each a 'Recall'), then the contractor, the Participating Member State(s) and the competent authority(ies) shall assist each other in the Recall process, as appropriate, having regard to all applicable laws, and especially (a) the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Hwnan Use and Veterinary Use - Part 1 - Chapter 8 "Complaints, Quality Defects and Product Recalls" and (b) the compilation of Community procedures on inspections and exchange information in the meaning of article 3 {l) of the Commission Directive 2003/94 C of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. In the event of any Recall, the contractor will bear the costs and expenses for the Recall unless such Recall was carried out due to quality defects in the Product or other groW1ds justifying such recall which were caused by the Gross egligence or Willful Misconduct of a Participating Member State, in which case such Participating Member State will bear the costs and expenses for the Recall. Further, in the event of any Recall that was carried out due to quality defects in the Product or other grounds justifying such recall which in each case were caused by the Gross egligence, Willful Misconduct, Fraud or failure to confonn to GMP of the contractor, the contractor shall, at the election of contractor, either (i) replace such Product doses subject to the Recall within a period of 90 calendar days from the moment of the recall at no additional charge to the Participating 24
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DocuSlgn Envelope 10. B52E9FB9-A228-4058-9473-675DCA6FF0F6 .:)al"" 1 I!./ l.Ul.U/ .J/U:,'f • .:'tl-',O.Jo:,:,o Sensitive"' RELEASABLE TO: Need to know basis Member State(s) or (ii) refund the Participating Member State(s) the applicable price paid by the Participating Member State(s) to the contractor for the Product doses subject to a Recall. Except as and to the extent required by applicable law, this Article 1.12.5 sets out the only liability of the contractor and the sole and exclusive remedy for Participating Member States for a Recall in accordance with this APA. 1.12.6          The contractor shall keep the Commission and the Participating Member States informed about any signal detected during the pharmacovigilance or Product monitoring programmes in relation to the Products which are the object of this APA within 5 working days from notifying the European Medicines Agency in accordance with the European Medicines Agency's guidelines on good pharmacovigilance practices. 1.12.7          The contractor shall use Reasonable Best Efforts to obtain Marketing Authorisation for the Product. To that end, the contractor has submitted a rolling submission for application for Marketing Authorisation for the Product as soon as reasonably practicable after successful clinical development of the Product. If the contractor first obtains a conditional Marketing Authorisation for Product, the contractor shall use Reasonable Best Efforts to obtain full Marketing Authorisation as soon as possible upon completion of the dataset necessary to obtain such full Marketing Authorisation. (. 12.8         The contractor shall provide to the Commission and the Participating Member States, via the Commission, the following information as part of and until its submission for Marketing Authorisation and full production: (a) summarised key updates on progress made in the clinical development of the Product; final reports of clinical studies and safety evaluations submitted to the European Medicines Agency, promptly after submission to the European Medicines Agency; (b) key updates on (i) challenges on establishment of the supply chain and (ii) the purchasing of materials necessary for the manufacture of the Product doses, which, in each case, materially affects the delivery schedule set forth in Article I.4. 7; (c) the use of the Down Payment by the Commission and the Participating Member States, linked to points (a) to (b ), in general terms every two months after the signature of this APA based on Annex rv; and (d) scientific publications and public announcements, after such publications and announcements have been published. 1.13. DEFI ITIONS For the purpose of this APA, the following definitions (indicated in italics in the text) apply: 'Affiliate': with respect to the contractor, any Person that controls, is controlled by, or is under common control with the contractor. For purposes of this APA, such Person will be deemed to control another Person if it owns or controls, directly or indirectly, more than fifty percent (50%) of the equity securities of such Person entitled to vote in the election of directors (or, in the case that such Person is not a corporation, for the election of the corresponding managing authority), or 25
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OocuSign Envelope ID 852E9FB9-A228-405B-9473-675OCA6FF0F6 .::, , l r.,, .v.u1\...>1u ;,<i • .::,u.. o.>o:r;,o Sensitive* RELEASABLE TO: Need to know basis otherwise has the power to direct the management and policies of such Person. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage will be substituted in the preceding sentence; provided, that such foreign investor has the power to direct the management and policies of such entity; 'APA': has the meaning set forth in the preamble; 'Breach of obligations' : failure by the contractor to fulfil one or more of its contractual obligations under this APA; 'Claim': has the meaning set forth in Article 115.2; 'CMOs': has the meaning set forth in the Recitals; 'Commission': has the meaning set forth in the preamble; 'contractor': has the meaning set forth in the preamble; 'Confidential information or document': any information or document received by either party from the other or accessed by either party in the context of the implementation of the APA, that any of the parties has identified in writing as confidential, or, if not so identified, that would be reasonably understood in the biophannaceutical industry to be confidential. It may not include infonnation that is publicly available; 'Conflict of interest': a situation where the impartial and objective implementation ofthe APA by the contractor is compromised for reasons involving family, emotional life, political or national affinity, economic interest, any other direct or indirect personal interest, or any other shared interest with the Commission, the Participating Member State or any third party related to the subject matter of the APA; 'COVE Study': has the meaning set forth in the Recitals; 'COVID-19': has the meaning et forth in the Recitals; 'COVID-19 Pandemic' : has the meaning set forth in the Recitals; 'December Option Increase': has the meaning set forth in Article 1.4.4; 'Deferred Option Increase': has the meaning set forth in Article l.4.4; Deficient Product': has the meaning set forth in Article 1.5. l; 'Donation Country': has the meaning set forth in Article l.4 .6; 'Down Payment': has the meaning set forth in Article 1.4.2; 'European Institu tions': has the meaning set forth in Article II.7.6; 'Exchange Rate Methodology' : has the meaning set forth in Article 1.8.4; 'Exercising Member State': has the meaning set forth in Article I.4.4; 26
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OocuSlgn Envelope ID 852E9FB9-A22B-405B-9473-675DCA6FF0F6 .:,ru'II 11!.I 1.U-',V/ .,,v:>'t • .:,u.o.,o:,,:,o Sensitive• RELEASABLE TO: Need to know basis 'Expected Approval Date': has the meaning set forth in Article l.4.7(a); 'Financial Statement': has the meaning set forth in Article Il.16.S(a); 'Force majeure': any unforeseeable, exceptional situation or event beyond the control of the Parties that prevents either of them from fulfilling any of their obligations under the APA. The situation or event must not be attributable to error or negligence on the part of the parties or on the part of the subcontractors and must prove to be inevitable despite their exercising due diligence. Defaults of service, defects in equipment or material or delays in making them available, labour disputes, strikes and financial difficulties, as well as the Covid- 19 Pandemic, may not be invoked as force majeure; 'Formal notification' (or ' formally notify' ): form of communication between the parties made in writing by mail or email, which provides the sender with compelling evidence that the message was delivered to the specified recipient; 'Fraud': an act or omission committed in order to make an unlawful gain for the perpetrator or another by causing a loss to the Union's financial interests, and relating to : i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget, ii) the non- disclosure of information in violation of a specific obligation, with the same effect or iii) the misapplication of such funds or assets for purposes other than those for which they were originally granted, which damages the Union ' s financial interests; 'Good Manufacturing Practices' or 'GMP': means the then-current good manufacturing practices for manufacture required by the standards, regulations and guidelines set out in Directive 2003/94/EC, Directive 2017/1572 and EudraLex - Volume 4 of the Rules Governing Medicinal Products in the EU entitled ' EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, as based on the relevant provisions of Directive 2001/83/EC"; 'Governmental Authority': any applicable government authority, court, cowicil, tribunal, arbitrator, agency, department, bureau, branch, office, legislative body, commission or other instrumentality of (i) any government of any cowitry, (ii) any nation, state, province, county, city, or other political subdivision thereof, or (iii) any supranational body; 'Gross Negligence' means "faute lourde" under Belgian law; 'Implementation of the APA' : the purchase of the Product envisaged in the APA through the signature and performance o/Vaccine Order Forms; 'Indemnified Persons' : has the meaning set forth in Article 11.5. l ; 'Initial Doses' : has the meaning set forth in Article 1.4.2; 'Initial Delivery Schedule' : has the meaning set forth in Article l.4.7(a); 'Irregularity': any infringement of a provision of Union law resulting from an act or omission by an economic operator, which has, or would have, the effect of prejudicing the Union ' s budget; 'Losses': has the meaning set forth in Article 11.5.1; 27
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OocuS1gn Envelope ID 8 52E9F89-A22B-4058-9473-675DCA6FF0F6 .:, ., 1 r.1',u,1,,v1 .,, v:,.. - .:,u.,o.>o::,::,o Sensitive* RELEASABLE TO: eed to know basis 'Marketing Authorisation': the approval under the relevant provisions of Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervisions of medicinal products for human and veterinary use and establishing a European Medicines Agency, by the European Commission necessary for the placing on the market of the Vaccine in the territory of the European Union, including conditional marketing authorisation in accordance with Article 14-a of Regulation 726/2004; 'Notification' (or 'notify' ): fonn of com munication between the parties made in writing including by electronic means; 'Option Doses': has the meaning set forth in Article I.4.4; 'Option Increase': has the meaning set forth in Article l.4.4; 'Party' and 'Parties': have the meaning set forth in the preamble; 'Performance of a Vaccine Order Form': the execution of tasks and delivery of the Product by the contractor to the Participating Member State; 'Person': means an individual, partnership, corporation, limited liability company, joint stock company, unincorporated organization or association, trust or joint venture, or a Governmental Authority or political subdivision thereof; 'Pre-existing material' : any material, docwnent, technology or know-how which exists prior to the contractor using it for the production of a result in the implementation of the APA; ' Pre-existing right': any industrial and intellectual property right on pre-existing material; it may consist in a right of ownership, a licence right and/or right of use belonging to the contractor, the creator, the Commission as well as to any other third parties; 'Product': the finished and packaged form of the contractor's proprietary mRNA- 1273 vaccine against COVID-19; 'Product Claim ': has the meaning set forth in Article 1.5. l; 'Product Marks': MODERNA, MODERNATX, any Trademark incorporating either term, any Trademark that is used by the contractor in association with the Product, including any Trademarks that accompany the Product when delivered by the contractor to the Participating Member States, and any Trademark for which the contractor has applied for registration in the European Union. The contractor may provide the Commission and the Participating Member States with a list of such Product Marks from time to time; 'Professional conOicting interest': a situation in which the contractor' s previous or ongoing professional activities affect its capacity to implement the APA or to perform a Vaccine Order Fonn to an appropriate quality standard; 'Rea onable Best Efforts': a reasonable degree of diligent efforts to accomplish a given task, acknowledging that such things as the complex and highly regulated nature of the Product; the timely availability of raw materials and inventories; the success of necessary clinical trials 28
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DocuSign Envelope ID. B52E9FB9-A228-4058-9473-675DCA6FF0F6 '3   'I l I!,/ I.UI.UI .3/U:>'t - '3U,.o.,o:,:,o Sensitive• RELEASABLE TO: Need to know basis programs to support safety and immunogenicity data for the Product; contractor's commitments to other purchasers of the Product; other reasons relating to the uncertainties of producing a new Product for a new disease with an mRNA platform for which Products have not yet been registered by regulatory authorities; and any other currently unknown factors which may delay or render impossible, contractor's successful completion of the particular task, including developing a suitable production process as may be required for a new strain of virus, ramping up capacity at contract manufacturing partners, meeting delivery schedules and obtaining Marketing Authorisation may be beyond the complete control of the contractor, provided, however, that the contractor shall not be required to take any actions inconsistent with past practice, ordinary course of business, prudent and reasonable business behaviour; 'Recall' : has the meaning set forth in Article 1.12.5; 'Refundable Items' : has the meaning set forth in Article Il.16.S{a); 'Related person' : any natural or legal person who is a member of the administrative, management or supervisory body of the contractor, or who has powers of representation, decision or control with regard to the contractor; 'Resale Country': has the meaning set forth in Article I.4.6; 'Result': any intended outcome of the implementation of the APA, whatever its form or nature. A result may be further defined in this APA as a deliverable. A result may, in addition to newly created materials produced specifically for the Participating Member States by the contractor or at its request, also include pre-existing materials; 'Vaccine IP Rights' : has the meaning set forth in Article 1.10; 'Vaccine Order Form' : has the meaning set forth in the Recitals; 'Technical Dispute' : has the meaning set forth in Article l.5 .3; 'Third Party': any Person other than (a) the Commission or any of the Participating Member States or (b) the contractor or its Affiliates; 'Trademark': trademarks, service marks, certification marks, trade dress, intemet domain names, trade names, identifying symbols, designs, product names, company names, slogans, logos or insignia, whether registered or unregistered, and all common law rights, applications and registrations therefor, and all goodwill associated therewith; 'Unspent Amounts' : has the meaning set forth in Article ll.16.S(a); 'Updated Delivery Schedule': has the meaning set forth in Article l.4.7(a); 'Willful Misconduct' means conduct which (i) constitutes an intentional act aimed at achieving a wrongful purpose, (ii) occurs in the absence of a legal or factual justification, and (iii) occurs in disregard of a known or obvious risk of causing harm. (Signature page follows) 29
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DocuS1gn Envelope ID 852E9FB9-A228-4058-9473-675OCA6FF0F6 .:,  , I I!,/ .t.Ul.Uf'--'/ U:,<t - .:,u..o.:,o:,;,o Sensitive• RELEASABLE TO: Need to kn.o w basis SIGNATURES For the contractor,                                     For the Commission, on behalf and in the name of the Participating Member States, Modema Switzerland GmbH                                 Ms Stella Kyriakides, Commissioner for Stephane Bancel, Managing Director                      Health and Food Safety Cambridge, MA, USA Done at ....... ........ .. . , . .... . ... ..... . In duplicate in English. 30
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