พรรคก้าวไกล ได้เผยแพร่หนังสือสัญญาต่างๆ ที่เกี่ยวข้องกับการดำเนินนโยบายวัคซีนแอสตร้าเซนเนก้า (AstraZeneca) ของรัฐบาลไทย รวมถึง หนังสือแสดงเจตจำนง (Letter of Intent) ระหว่างกระทรวงสาธารณสุข-สยามไบโอไซเอนซ์-เอสซีจี และแอสตร้าเซนเนก้า และ สัญญาจัดซื้อวัคซีนแอสตร้าเซนเนก้า ซึ่งเป็นเอกสารที่ได้รับจากสถาบันวัคซีนแห่งชาติ ตามที่ นายวิโรจน์ ลักขณาอดิศร ส.ส.พรรคก้าวไกล ได้ยื่นหนังสือขอข้อมูลไป
ทั้งหนังสือแสดงเจตจำนงฯ และสัญญาจัดซื้อวัคซีนแอสตร้าเซนเนก้า โดยเอกสารทั้ง 2 ฉบับนี้ เผยแพร่ในรูปแบบไฟล์ PDF ที่เป็นรูปภาพ ทีมงาน iTAX จึงปรับเอกสารดังกล่าวให้เป็นข้อความ (Text) ที่สามารถค้นหาได้ เพื่อประโยชน์สำหรับประชาชนที่สนใจต่อไป
หนังสือแสดงเจตจำนง (Letter of Intent) ระหว่างกระทรวงสาธารณสุข-สยามไบโอไซเอนซ์-เอสซีจี และแอสตร้าเซนเนก้า
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Letter of Intent
broad, equitable and timely access to the University of Oxford’s potential COVID-19 vaccine in Thailand and beyond
The Ministry of Public Health (“MOPH”), The Siam Cement Plc, Ltd. (“SCG”), Siam Bioscience Co. Ltd. (“SBS”), and AstraZeneca UK Limited (“AstraZeneca”) (hereafter collectively referred to as the “Parties”);
- Recognising the importance of broad and equitable access to the University of Oxford’s potential vaccine against COVID-19 (hereafter referred to as the “vaccine”) for global public health;
- Recognising that the vaccine is still under clinical development and that, despite the risk of failure, governments and industry have a shared duty to create access to the vaccine without delay;
- Acknowledging MOPH’s effective response to COVID-19 and its leadership role in the global health community; and
- Acknowledging that SCG has been at the forefront of promoting swift, coordinated action between public and private partners in Thailand and beyond; and
- Acknowledging that SBS’ vaccine manufacturing capability is of critical significance to supplying the vaccine at global scale at an unprecedented pace; and
- Acknowledging AstraZeneca’s role in leading the global development, manufacturing and distribution of the vaccine at no profit/no loss for the duration of the pandemic;
hereby express their mutual intention to collaborate, inter-alia, on:
- Broad, equitable and international access to the vaccine, by:
- setting up the required manufacturing capacity at SBS at pace, recognising the risks and working together to mitigate them as much as possible;
- facilitating requests that support Thai and foreign regulatory approval of the supply chain;
- agreeing to the export of the vaccine without limitations, based on the constructive discussion between MOPH and AstraZeneca.
- Protection of Thai public health, by;
- facilitating the conclusion of an agreement between the Government of Thailand and AstraZeneca before 31 October 2020 to financially support the required arrangements for the timely provision of 26 million doses of the vaccine destined for use in Thailand;
- agreeing on the indemnification of AstraZeneca as Marketing Authorisation Holder, in line with international practice and national legal framework to accelerate countermeasures to the pandemic.
After signing this Letter of Intent, as soon as possible, the Parties shall cooperate to determine the necessary steps in order to explore, encourage and promote cooperation in the abovementioned areas. All of the aforementioned cooperation activities shall be conducted in accordance with Thai laws and regulations, and shall be subject to the availability of appropriate resources and the respective internal approval of the Parties.
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Letter of Intent
broad, equitable and timely access to the University of Oxford’s potential COVID-19 vaccine in Thailand and beyond
This Letter of Intent serves only as a record of the intention of the Parties, and shall not constitute or create a legally binding commitment or obligation between the Parties with respect to any of the cooperation contemplated in this Letter of Intent.
This Letter of Intent shall not be interpreted as granting any incentive or reward for any prescription, payment, reimbursement or authorization of any product or service of SCG, SBS or AstraZeneca, nor any business opportunity or advantage for, or a form of sponsorship to, SCG, SBS or AstraZeneca.
This Letter of Intent may be terminated by any of the Parties with prior written notice to the other Parties.
This Letter of Intent is signed by and between the Parties in Bangkok, Thailand and London, United Kingdom, on 12 October 2020, in four original copies in English.
Ministry of Public Health
Name: H.E. Anutin Charnvirakul
Title: Deputy Prime Minister and Minister of Public Health
The Siam Cement Plc, Ltd.
Name: Roongrote Rangsiyopash
Title: President and CEO
Siam Bioscience Co. Ltd.
Name: Air Chief Marshal Satitpong Sukvimol
AstraZeneca UK Limited
Name: James Teague
Title: Country President, Thailand
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[PRIVILEGED AND CONFIDENTIAL]
Advance Market Commitment Agreement
for the supply of a potential COVID-19 Vaccine in Thailand
This Advance Market Commitment Agreement for the supply of a potential COVID-19 Vaccine in Thailand (“Agreement”) is made at the National Vaccine Institute, Building <1, Sth floor, Bamrasnaradura Infectious Diseases Institute, No. 38 Soi Tiwaron 14, Tambon Talad Kwan, Amphioc Muang, Nonthaburi Province, on …………………………… 2020 between the National Vaccine Institute, ***ถูกเซ็นเซอร์***, hereinafter referred to as “NVI”;
AstraZeneca (Thailand) Ltd., registered as a juristic person at the Bangkok Partnerships and Companies Registration Office (Department of Business Development), with its principal office located at No. 173/20 Asia Center Building, South Sathorn Road, Khwaeng Thungmahamek, Khet Sathorn, Bangkok ***ถูกเซ็นเซอร์*** hereinafter referred to as “AZ”; and
AstraZeneca UK Limited, a juristic person incorporated under the laws of England and Wales with the registration No. 3671842, whose registered office is at | Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, England CB2 0AA, hereinafter referred to as “AZUK”.
WHEREAS, the World Health Organization (WHO) declared the Coronavirus disease 2019 a Public Health Emergency of International Concern (PHEIC), and subsequently a global pandemic. Countries around the world have issued various measures to stop virus transmission, reduce losses of lives, and ease the socioeconomic impacts.
WHEREAS, the Thai Government declared an Emergency about the Coronavirus disease outbreak situation in all areas of the Kingdom as from 26 March B.E. 2563 (2020) and issued the Regulation in accordance with the Emergency Decree on Public Administration in Emergency Situations,
WHEREAS, according to the National Vaccine Security Act B.E. 2561 (2018) (the “Act”) and the Notification of the Ministry of Public Healili re: Sourcing of Coronavirus Discase 2019 or COVID-19 Vaccines in Emergency Situations or as a Necessity, BE. 2363 (2020) (the “Notification”), section 18 (4) of the Act, in the case of emergency or necessary cause for public interest, be responsible for prevention, control, treatment for abatement of disease severity, or act for security of the country, NVI shall establish a memorandum of understanding or agreement with private or state agencies concerning COVID:19 Vaccine development which may contain Advance Market Commitment (AMC) for COVID-19 Vaccine,
WHEREAS, to combat the current COVID-19 global pandemic, on 17 May 2020 AZUK entered into an agreement and partnered with Oxford University to rapidly clinically evaluate and scale up global manufacturing of the Vaccine.
WHEREAS, AZ, in collaboration with relevant institutions and authorities involved with prevention of COVID-19, has a role in leading the global development, manufacturing and distribution of the potential COVID-19 vaccine AZDI222 (the “Vaccine”), at no profit and no loss for the duration of the COVID-19 pandemic.
WHEREAS, under the Notification, DDC shall be responsible for procuring the Vaccine. As such, NVI wishes to designate Department of Disease Control (“DDC”) to procure the Vaccine from AZ in accordance with the terms of the Pureliase Agreement (defined below).
Both parties hereby agree as follows:
1. Scope of the Agreement
Upon the successful development of the Vaccine and upon receipt of the requisite approvals from the Thai Food and Drug Administration (“FDA”) by AZ for the Vaccine, AZ agrees, subject to terms of Agreement and the Purchase Agreement (defined below), to supply ***ถูกเซ็นเซอร์จำนวนโดส*** doses of the Vaccine to DDC, for ***ถูกเซ็นเซอร์ราคา*** (the “Purchase Price”)). Prior to the Purchase Agreement becoming elective, AZ shall use its Best Reasonable Efforts (as defined in the Purchase Agreement) to implement the development of thic Vaccine in accordance with the proposal attached to Appendix A of this Agreement (the “Proposal”). The parties agree that in no circumstances shall AZ be requested or required to manufacture or supply the Vaccine at a loss or to supply the Vaccine without regard to the commercial interests of AZ.
2. Documents that form an integral part of the Agreement
The following attachments to this Agreement shall be deemed an integral part of the Agreement:
Appendix A Proposal 3 pages
Appendix B Purchase Agreement (including Annex 1) 24 pages
In the event of a conflict in the terms and conditions of the attachments and/or this Agreement, conflicts among the documents shall be resolved in the following order of precedence: (1) Purchase Agreement (defined below), (2) this Agreement, and (3) the Proposal.
3. Project Management
3.1 Project Manager. Promptly alter the date of this Agreement, cach party shall appoint, and provide details to the other party of, a project manager (“Project Manager”) who shall lic responsible for and represent the applicable party as liaison between the parties concerning personnance and progress under this Agreement. The Project Managers shall work together to manage and facilitate communications between NVI And AZ under this Agreement, and shall meet ***ถูกเซ็นเซอร์*** to perform their responsibilities in accordance with the terms of this Agreement. The Project Managers shall not have final decision-making authority with respect to any matter under this Agreement. Each of NVI and AZ may replace its Project Manager at any time by ***ถูกเซ็นเซอร์*** prior notice in writing to the oiler party. NVI and AZ shall each bear the costs of its Project Manager.
4. Purchase Agreement ***ถูกเซ็นเซอร์***
4.1 The parties acknowledge that, on the date of this Agreement, AZ, AZUK and DDC lave entered into the purchase agreement attached to Appendix B of this Agreement (the “Purchase Agreement”) for the procurement of the Vaccine. The parties further acknowledge that, the purchase Agreement shall become effective upon the successful development of the Vaccine and upon receipt of the requisite approvals from the FDA by AZ for the Vaccine.
4.7 Unless otherwise agreed by the parties, all payments to AZ under this Agreement shall be made by deposit of US Dollars by wire transfer of immediately available funds in the requisite amount to such bank account as AZ may from time to time designate by written notice to NVI.
5. Change to the Project
5.1 Any change in relation to the Agreement, shall be proposed by AZ to NVI for consideration and approval in writing before such change can be effected.
5.2 In the case that AZ must take any action in addition to that specified in the Proposal due to an event beyond the control of AZ and that could not have been foreseen by AZ, or in the case that the parties agree to amend or revise the Proposal and/or the Agreement as a result of AZ’s request, AZ will receive additional compensation, including reimbursable expenses (if any), as shall be negotiated and agreed by the parties in good faith.
6. Termination of the Agreement
6.1 ln the event that AZ abandons the development of the Vaccine and other elloris under the Proposal (whether as a result of its determination (at the Vaccine cannot be safely or efficaciously developed, manufactured, distributed, or administered or the determination that regulatory approvals from the Regulatory Authority (as defined in the Purchase Agreement) for the Vaccine cannot or will not be obtained in a timely manner), AZ shall notify NVI of such abandonment and the reasons justifying it and either party will have the right to terminate this Agreement upon ***ถูกเซ็นเซอร์*** prior written notice to the other party.
6.2 Either party may terminate this Agreement if the other party is in material breach of its obligations (considered as a whole) of this Agreement following notice and opportunity to cure as set forth in this clause 6.2. Prior to any termination under this clause 6.2, if either party is in material breach of its obligations of this Agreement, the non-defaulting party shall notify the defaulting party in writing of its intention to terminate the Agreement and the grounds for termination. The defaulting party shall have a reasonable period of not less than ***ถูกเซ็นเซอร์*** following the receipt of the written notification to rectify the non-compliance or dispute the existence of such underlying breach by submitting observations, including the measures it has taken or will take to continue fulfilling its contractual obligations. If the non-defaulting party confirms the measures the defaulting party has taken or will take to rectify the non-compliance, the notice of termination submitted by the non-defaulting party shall become null and void. In the event of a dispute of the existence or cure status of any material breach, such dispute shall be subject to clause 14.2 of this Agreement prior to any termination of this Agreement.
6.3 Upon termination of the Agreement pursuant to clause 61 or 6.2, AZ, shall prepare a report of the work done, together with all information or data of the work done, and submit the same t0 NVI within ***ถูกเซ็นเซอร์*** from the date of receipt of the notice.
6.4 Upon termination of the Agreement pursuant to clause 6.1 or 6.2 or 7.4, AZ shall ***ถูกเซ็นเซอร์*** relating to its obligations under this Agreement, within ***ถูกเซ็นเซอร์*** from the date of termination.
6.5 Upon termination of the Agreement, AZ shall discuss with NVI in good faith to determine the activities set out in the Proposal that can reasonably still be undertaken in view of the goals expressed in the Proposal, including the contribution to the technical capability and expertise of the Thai biopharmaceutical industry.
7. Force majeure
7.1 force majeure shall mean any of the force majeure events provided in Section 18.6 of the Purchase Agreement.
7.2 If either party cannot perform the Agreement due to a force majeure, such party shall notify the other party within ***ถูกเซ็นเซอร์*** from the date of the occurrence of the event, and the other person who receives such notice shall consider whether the event constitutes a force majeure and notify the notifying party within a reasonable time.
7.3 During the occurrence of a force majeure, preventing AZ from completing its obligations under the Proposal, as specified in this Agreement, AZ is entitled to suspend the performance of its obligations under the Proposal, and to an extension of the term equivalent to the period lost due to the force majeure. AZ shall notify NVI in writing within ***ถูกเซ็นเซอร์*** from the date on which the force majeure ends.
7.4 In the case that either party cannot perform the work or consent to the performance of this Agreement in whole or in part, due to a force majeure event occurring longer than ***ถูกเซ็นเซอร์*** from the date of the notification of the force majeure in accordance with clause 7.2, if either party deems that the performance of this Agreement is rendered impossible, such party is entitled to terminate the Agreement by written notice to the other party.
8. Rights of the parties upon suspension of work
8.1 Upon suspension of the Agreement pursuant to clause 7, NVI will pay expenses to AZ as necessary in accordance with the amount to be agreed between the parties.
9. Obligations of AZ
9.2 Subject to clause 11 hereof, AZ shall from time to time provide progress reports to NVI of the actions taken for the areas of work under clause 3.6 of the Proposal.
10. Intellectual property
The parties agree that, AZUK shall be the sole owner of all intellectual property rights created in connection with the Vaccine (collectively, the “JP Rights”), and AZUK shall be entitled to exclusively exploit any such IP Rights.
11. Disclosure of information or performance outcome
The parties shall keep confidential all data that it receives under this Agreement, without disclosing the data, in whole or in part, to the public or third parties, except if consent in writing is obtained from the disclosing party in advance. Either party may utilize the data for any other purpose, provided that a prior written consent is obtained from the other party.
12. Obligations of NVI
12.1 NVI shall share information in relation to the development of the Vaccine in the possession of NVI with AZ at the request of AZ, provided that NYI is not required to share with AZ any information which is subject to confidentiality obligations under a non-disclosure agreement between NVI and any third party.
12.2 If AZ requests for assistance, NVI will provide assistance or facilitation as appropriate, to ensure the smooth and effective performance of AZ’s development of the Vaccine in accordance with the Proposal under this Agreement.
12.3 NVI shall support AZ in respect of the following matters:
(a) complying with all legal requirements of approval processes of the clinical trials and the market authorization of the Vaccine.
(b)providing accelerated quality and current Good Manufacturing Practices (as defined under the Purchase Agreement) facility approvals if the requirements of safety, quality and efficacy of the Vaccine allow it to do so and are fully met.
(c) achieving the Vaccine fast access to the population in Thailand and other countries in the south east region through access mechanisms in Thailand, including accelerated regulatory approval processes.
13.1 Each party represents that it has the power and authority to execute and deliver this Agreement and the attachments, it has the power and authority to perform cach of its obligations hereunder, and it has complied with the Applicable Laws (as defined in the Purchase Agreement), including the Notification, and constitutional documents to enable it to undertake the foregoing actions. Each party further represents that this Agreement has been duly executed and is a legal, valid and binding obligation on it, enforceable against it in accordance with its terms.
14. Governing Law and Dispute Resolution
14.1 This Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with the laws of Thailand.
14.2 Any dispute arising out of or in connection with this Agreement, including any question regarding iis existence, validity or termination and including any dispute relating to a non-contractual obligation, between NVI on the one hand and AZ on the other hand, shall be referred to and finally resolved by arbitration conducted in accordance with the Arbitration Rules of the Thai Arbitration Institute, as then in force (the “Rules”), which Rules are deemed to be incorporated by reference in his clause 14.2. The seat of arbitration shall be Thailand. The language to be used in any arbitration proceedings shall be English.
Notices or consent or approval given under this Agreement shall be made in writing and shall be deemed duly sent it delivered by any of the following method:
1) delivered to tie authorized representative of each party;
2) by registered mail;
3) by facsimile or electronic mail, followed by a hardcopy sent to the name or address of each Party, as follows;
NVI: National Vaccine Institute, No. 38 Building 4, 5th floor, Bamrasnaradura Infectious Diseases Institute, Soi Tiwanon 14, Tambon Talad Kwan, Amphoe Muang, Nonthaburi Province 11000, ***ถูกเซ็นเซอร์***
AZ: AstraZeneca (Thailand) Lid., No. 173/20 Asia Center Building, South Sathorn Road, Khwaeng Thungmahamek, Khet Sathorn, Bangkok Tel. +6627397400, Facsimile +6627397497, ***ถูกเซ็นเซอร์***
AZUK: AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, England CB2 0AA, ***ถูกเซ็นเซอร์***
This Agreement is made in duplicate with identical and correct wording. Ilaving thoroughly read and understood the content of the Agreement, the parties hereby affix their names before the witnesses. Each party retains one copy.
12 JANUARY 2021