ADVANCE PURCHASE AGREEMENT (“APA”)1 for the development, production, priority-purchasing options and supply of a successful COVID-19 vaccine for EU Member

Article I Subject matter

1. This Vaccine Order Form is submitted by [name of the Participating Member State] to Contractor in accordance with the terms of the APA, and forms an integral part of the APA. The terms and conditions of the APA are incorporated into this Vaccine Order Form by reference. In the event of contradiction between this Vaccine Order Form and the APA, the terms of the APA prevail regardless of any provision to the contrary. Any capitalised terms in this Vaccine Order Form will have the meaning attributed to them in the definitions list included in Article 1.2 of the APA.

2. This Vaccine Order Form relates to the order for the Participating Member State’s full allocated portion of the Contracted Doses or the relevant Additional Order (as applicable) as set out in the allocation provided by the Commission to Contractor pursuant to Article 1.6.2 of the APA. The submission of this signed Vaccine Order Form by the Member State to Contractor constitutes a binding order by the Member State for the purchase of its full allocated portion of the Contracted Doses or the relevant Additional Order (as applicable) as follows

a.    [Name of the Member State] will purchase [insert amount] number of doses of [Contracted Doses] [Additional Order] of the Vaccine, on the basis of the following delivery schedule: [insert details of quarterly allocation],

b.    The Delivery Price of Contracted Doses is [insert price here] euros per dose excl. VAT.

The total amount payable by the Participating Member State for the [Contracted Doses] [Additional Order] is [insert amount], excluding [insert applicable percentage]% VAT.

3. By signature of this Vaccine Order Form, the undersigned Member State warrants to Contractor that:

a it is irrevocably and unconditionally bound by the terms of the APA (as concluded by the Commission on behalf and in the name of the Participating Member States), including the indemnification obligations and the liability, limitation of liability and exclusions terms set out therein;

b the provisions of the APA are enforceable against it in accordance with its terms;

c it shall indemnify the Indemnified Persons in accordance with Article 1.12 (Indemnification) of the APA;

d it has full right, power and authority to enter into this Vaccine Order Form and to perform its respective obligations under it;

e the person executing this Vaccine Order Form is duly authorized to execute and bind the undersigned Participating Member State to the terms set forth herein and incorporated by reference.

4. The Participating Member State acknowledges that the Vaccine and materials related to the Vaccine, and their components and constituent materials are being rapidly developed due to the emergency circumstances of the COVID-19 pandemic and will continue to be studied after provision of the Vaccine to the Participating Member States under the APA. The Participating Member State further acknowledges that the long-

48

term effects and efficacy of the Vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known. Further, to the extent applicable, the Participating Member State acknowledges that the Vaccine shall not be serialized.

5. The Participating Member State represents and warrants that all necessary permissions and approvals have been or will be obtained prior to the time for performance by the Participating Member State, to authorise performance of all of the obligations contained herein.

Article II Delivery, Supply

1.    Delivery Address. The Delivery Address for the Participating Member State is as follows:

[• - Member State to enter location of its distribution hub\

2.    Supply of the Products

The Contractor shall supply the Products as further described in the APA: [Note: Include any additional details concerning the supply here.]

Article III Invoices; Notices

1.    Invoice and Payments. Contractor shall invoice the Participating Member State in accordance with the terms of the APA. All payments to Contractor or its designated Affiliate shall be made in accordance with the terms of the APA.

Payment shall be made in the following currency pursuant to the provisions of Article II. 19.2: [to be completed].

2.    Notice. Any notice given under this Vaccine Order Form must a) be made in writing in English in paper or electronic format; b) bear the APA number and the number of this Vaccine Order Form; c) be made using the relevant communication details set out below with respect to the Member State and Contractor (as applicable); d) be sent by mail and email:

Participating Member State:

[Name of Participating Member State\

[Full official address of Participating Member State\

[Full name of addressee physical person (contact person)]

[Function of addressee physical person (contact person)]

E-mail: [complete email of addressee physical person (contact person)]

Contractor: fAdd detailsl

Article IV.

Entry into Force and Duration

1. This Vaccine Order Form shall enter into force on the date of signature by the Parties and will remain into force until termination of the APA, or if the APA expires, until the last delivery of Product which in any event must take place within 6 months of such expiry.

Article V.

Applicable Law and Settlement of Disputes

1. For the avoidance of doubt, Article 1.13 {Applicable Law and Settlement of Disputes) of the APA shall apply to any dispute arising out of the implementation of or in connection with this Vaccine Order Form and the Participating Member State irrevocably agrees to be bound by the provisions set out therein.

(Signature page follows)

SIGNATURES

For the Participating Member State,

[forename/sumame/position]

Signature:_

Done at [place], [date]

For acceptance of the Vaccine Order Form,

[Contractor],

[forename/sumame/position]

Signature:_

Done at [place], [date]

The invoice will be paid only once the Contractor has returned the signed Vaccine Order Form.

ANNEX TT: AnttEEMENT BETWEEN THE COMMISSION AND MEMBEK STATES ON PROrURTNC COVTD-19 VACCINES ON BEHALF OF THE MEMBER STATES AND RELATED PROCEDURES. ANNEXED

to the Commission Decision CI202014192 final of 18 June 2020

Agreement

Preamble

Having regard to Article 4(5)(b) of Council regulation (EU) 2016/369 on the provision of emergency support within the Unionlas amended by Council regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak (hereinafter “ESI” or “ESI regulation”);

The European Commission (“the Commission”) and

The following Member States: (XXX), hereinafter referred to as “the Participating Member States” Together referred to as “the Parties”

Agree on the Following:

Article 1: Objective and mandate of the Commission

On the basis of the present agreement, the Commission is mandated to conclude, on behalf of the Participating Member States, Advance Purchase Agreements (“APA”) with vaccine manufacturers with the objective to procure vaccines for the purposes of combatting the COVID 19 pandemic at Union level.

The Annex to this agreement sets out the negotiating directives for this purpose.

Article 2: Acquisition of vaccine doses

It is the Participating Member States, and not the Commission, that shall acquire vaccine doses from the manufacturers on the basis of the APAs unless otherwise agreed. All relevant vaccination policies shall therefore remain matters for the Participating Member States.

Article 3: APAs containing a right to acquire vaccine doses

Where the Commission concludes an APA in conformity with the present agreement that provides the right for the Participating Member States to acquire vaccine doses, the use of such a right shall take place by means of the conclusion of contracts between the Participating Member States and the vaccine manufacturers. There shall be no obligation for any Participating Member State to conclude such a contract on the basis of the APA. The APA shall contain a clause to this end.

Article 4: APAs containing an obligation to acquire vaccine doses

Where the Commission intends to conclude, in conformity with the present agreement, an APA containing an obligation to acquire vaccine doses, it shall inform the Participating Member

States of such intention and the detailed terms. In case a Participating 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 within 5 working days after the Commission has communicated its intention to conclude the APA. All Participating Member States not having opted out within the period of 5 working days are deemed to have authorised the Commission to negotiate and conclude the APA with the vaccine manufacturer in their name and on their behalf.

Article 5: The legally binding nature of APAs

Once concluded, the terms of the APA shall be legally binding on the Participating Member States, except for those who have exercised their right to opt out.

Article 6: Responsibility and liability

The present Agreement regulates only the division of potential liability and indemnification between the Commission and the Participating Member States. It does not regulate the extent to or the conditions under which potential liability of the vaccine manufacturer may be taken over or indemnified under the APAs.

The Commission shall be exclusively responsible for the procurement process and the conclusion of APAs including any liability arising out of the conduct of the negotiations.

Participating Member States acquiring a vaccine shall be responsible for the deployment and use of the vaccines under their national vaccination strategies, and shall bear any liability associated with such use and deployment. This shall extend to and include any indemnification of vaccine manufacturers under the terms and conditions of the relevant APA for liability related to the use and deployment of vaccines normally borne by such manufacturer.

Article 7: Obligation not to negotiate separately

By signing the present Agreement, the Participating Member States confirm their participation in the procedure and agree not to launch their own procedures for advance purchase of that vaccine with the same manufacturers.

In case an APA containing an obligation to acquire vaccine doses has been concluded with a specific manufacturer, the Member States having made use of the opt-out provided under the present Agreement can enter into separate negotiations with the same manufacturer after the APA under the present Agreement has been signed.

Annex

Initial considerations

A permanent solution to the COVID-19 crisis is most likely to be brought about by the development and deployment of a safe and effective vaccine against the virus. Every month gained in the deployment of a vaccine will save many lives, many jobs and billions of euros.

Therefore, it is the objective of the present Agreement that the EU takes steps to secure sufficient supplies of a safe and effective vaccine for Member States.

Structure and purpose of the procurement

Work on a COVID-19 vaccine is challenging for many reasons: the shortened development timeframe, the large upfront costs for manufacturers, the high failure rate during clinical trials. If vaccine producers follow their usual practice of making investments in production capacity only when they are sure of a viable product, this will result in considerably longer waiting times for a vaccine. Investments need to be made now in order to ensure that vaccines are being produced at the scale required as early as possible.

Under the present agreement, this challenge will be addressed through concluding EU-level Advance Purchase Agreements (“APA”) with vaccine manufacturers when necessary, to secure access to vaccine candidates where they are successful, including up-front EU financing to de-risk essential investments to increase the speed and scale of manufacturing successftd vaccines. Funding for the up-front payments will come from the Emergency Support Instrument (ESI).

The Parties understand that developing a safe and effective vaccine is a highly complex process and the risk of failure in any such venture is very high. Therefore, the aim is to put in place APAs with a number of manufacturers of leading vaccine candidates, to maximise the chances of having access to at least one successful vaccine.

The Commission will invite all vaccine manufacturers to manifest interest. In general, the Commission will give priority to negotiating specific APAs with those manufacturers that (a) have entered or have firm plans to enter clinical trials still in 2020, (b) have the capacity to develop a successful vaccine and (c) have a proven capacity to produce at scale already in 2021.

Process and governance

In order to run the procurement centrally and efficiently, the European Commission will set up a steering board for the process subject to Article 6 of the present Agreement. It will be co-chaired by the European Commission and a Participating Member State with experience in the negotiations and production capacities for vaccines. The steering board will include senior officials from all Participating Member States to assist and provide guidance throughout the evaluation process.

The co-chairs of the steering board will propose a team of a limited number of experts with relevant experience for the ongoing negotiations from six Participating Member States with production capacities for vaccines. These experts will join with the European Commission in a negotiation team (“joint negotiation team”), which will work on a continuous basis as one unit. That joint negotiation team will start work immediately building on previous contacts with individual companies by the European Commission and Participating Member States. In order to launch negotiations with a specific manufacturer, there needs to be support from at least four Participating Member States. The joint negotiation team will make its best effort to take the advice of the steering board into account in the negotiations and will report back to the steering board on a regular basis on the progress made in negotiating with individual companies.

For compliance with the applicable rules, all members of the steering board and the joint negotiation team will obtain the status of experts associated to the procurement process as provided in the Financial Regulation. Given their access to highly sensitive business information, all those members will be required to sign strict confidentiality and no-conflict-of-interest agreements.

Assisted by the steering board, the European Commission will then decide which of the resulting APAs should be concluded, in particular if financing under ESI is insufficient to finance all relevant packages. The Commission will only consider those APAs for financing where at least four Participation Member States have expressed agreement. Before making any final decisions, the Commission will seek independent scientific advice on the state of progress and the available data on quality, safety and efficacy for the vaccine candidate in question.

Should financing under ESI be insufficient, Participating Member States can decide to top up ESI funding to make up the gap to finance all packages. In such a case where there are opportunities to conclude further APAs but money from ESI is no longer sufficient, Participating Member States will have the opportunity to express their interest in such opportunities. If at least four Participating Member States express interest, those Participating Member States will make use of the possibility of a voluntary contribution to ESI to the required amount allowing the Commission to proceed with signing the APA only on behalf of those Member States that have expressed interest and contributed the funds to ESI.

For full transparency, the European Commission will report to the IPCR at least once every two weeks on overall progress more generally.

Advanced Purchase Agreements and conditions

To conclude APAs, the joint negotiating team will negotiate funding packages with individual vaccine producers in return for die right to buy a specific number of vaccine doses in a given timeframe and at a certain price.

As outlined in the present Agreement, the European Commission also has the possibility to conclude APAs including an obligation to procure the vaccine if it becomes available, where the conditions (notably the pricing) of those APAs make this worthwhile and in line with the conditions in the present Agreement. If in such a case the distinction between upfront payments and purchase price is difficult to draw, the Commission will share the total cost related to the vaccine purchase but will in any case contribute no more than 50% of the total cost.

Funding provided up front will be considered as an advance payment for any eventual purchase by Member States, thus reducing the amount that Member States will have to pay when eventually purchasing that vaccine.

The up-front payments under the APAs shall be used by manufacturers to de-risk the necessary investments related to both vaccine development and clinical trials, and the preparation of the at-scale production capacity along the entire vaccine production value chain in the EU required for a rapid deployment of millions of doses of an eventual vaccine. The relevant payments should be structured according to the need of the manufacturer, but subject to the state of the vaccine development, in particular relying on transparency of the associated clinical data and its assessment, at the time of payment. This is in order to avoid obligations to pay in situations where the development work has shown a vaccine candidate likely to be unsuccessful.

The purchase price of the vaccine, as well as the amount of funding provided up front will take into account a transparent estimation of production costs (supported by independent audits where available), as well as the resources already granted from other public sources. Under the APA, the manufacturer can be asked to provide ex post proof supported by independent audits concerning the activities financed by these payments.

The aim of the negotiation is to conclude APAs with individual companies under the best possible conditions. These APAs should specify details with respect to:

a) Payments to be made, such as payment amounts, payment schedules, type of payments requested and the use of those payments related to de-risk investment, financing clinical trials, providing working capital and scaling-up production capacity;

b)    Delivery details of the vaccine if successful, such as price per person immunised (or alternatively, number of doses required per person immunised and price per dose), quantity of doses to be delivered and delivery timeline following approval;

and

c)    Any other relevant conditions, such as production capacity built or used in the EU or liability arrangements.

For liability arrangements, the joint negotiation team will make its best effort to limit what is required by individual companies for the purpose of indemnification to be included in the terms and conditions of the APA.

The APAs will contain provisions to clarify the law applicable to both the APA and resulting purchase orders as well as the competent courts. The Participating Member States agree that each APA negotiated by the Commission on their behalf with a vaccine manufacturer will have the same applicable law for all Participating Member States, and that the courts corresponding to that applicable law will be competent to hear disputes arising from that APA.

When taking a decision to finance individual APAs, the European Commission, in consultation with the steering board, will take into account the following elements: any available data on quality, safety and efficacy of the vaccine at time of negotiation of the contract, speed of delivery at scale, cost, risk-sharing, diversification of technologies, capacity to supply through development of production capacity within the EU, possible flexible future use of any capacity funded, engagement at an early stage with EU regulators with the intention to apply for an EU marketing authorisation for the candidate vaccine(s), commitment to supply vulnerable countries.

The procedure outlined above complies with the ESI Regulation and the Financial Regulation. The latter is aligned to the European procurement Directives, which also provide the basis for national procurement rules. Participating Member States may rely on the procedure run by the European Commission to directly purchase vaccines from the manufacturers as and when any of the vaccines becomes available based on the conditions laid down in the APA. Access to vaccine doses will be allocated to Participating Member States according to the population distribution key.

In the negotiations with the pharmaceutical industry under the present Agreement, the Commission will promote a Covid-19 vaccine as a global public good. This promotion will include access for low and middle income countries to these vaccines in sufficient quantity and at low prices. The Commission will seek to promote related questions with the pharmaceutical industry regarding intellectual property sharing, especially when such IP has been developed with public support, in order to these objectives. Any vaccines available for purchase under the APAs concluded but not needed and purchased by Participating Member States can be made available to the global solidarity effort.

Annex V - PARTICIPATING CONTRACTOR AFFILIATES

Attachment 1: SPECIFICATIONS

Biotherapeutics Pharmaceutical Sciences Specification Review Team INX100421728, Version 4

To:    David Cirelli

From:    JeffRyczek

Date:    I4-Aug-2020

Subject: Specification Report for PF-07305885 COVID-19 Vaccine BNTl62b2 mRNA Drug Substance

CC:    Margaret Rucsch, Justin Sperry, Amy St Charles, Susan John, Mary Denton,

Specification Review Team

1.0 Notification of Changes

This report has been updated lo add process performance qualification (PPQ) drug substance specifications. Table 2-1 has been amended to add the LIMS Product Name for the PPQ drug substance. Initial drug substance specifications are retained in Section 3.0 and remain unchanged versus version 3 of this document. PPQ drug substance specifications are added as Section 4.0. Minor changes to text and table headers were made in order to differentiate the initial and PPQ drug substance specification sections.

A summary of changes between the initial and the PPQ specifications is captured in Tabic 1-1.

specification Report Template

Page 2 of 6

2.0 PRODUCT INFORMATION

A brief description oftbe product and other information relevant to establishing ihe specification are provided in Table 2-1.

specification Report Template

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3.0 INITIAL SPECIFICATIONS FOR DRUG SUBSTANCE

Analytical test methods contained in this section were chosen to ensure the quality, identity, and purity of the PF-07305885 drug substance throughout the manufacturing process and during long tcrni storage under recommended storage conditions. The initial release specifications for PF-07305885 drug substance (LIMS Product Name DS-001426) are provided in Table 3-l. These arc the analytical requirements Tor batch release listed in LIMS as the Drug Substance Specification. Analytical procedures and acceptance criteria applicable to the PF-07305885 drug substance stability program arc noted in the table.

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Additional analytical tests as listed in Table 3-2 are performed for each drug substance batch to gain further information about the normal range ol’drug substance manufacturing process variation, to evaluate new methods, or to monitor the significance of the attributc(s) measured by these tests.

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4.0 I’PQ SPECIFICATIONS FOR DRUG SUBSTANCE

Analytical test methods contained in this section were chosen to ensure the quality, identity, and purity of the PF-07305885 drug substance throughout the manufacturing process and during long term storage under recommended storage conditions. The process performance qualification (PPQ) release specifications for PF-07305885 drug substance (LIMS Product Name DS-001477) are provided in Table 4-1. These arc the analytical requirements for batch release listed in LIMS as the Drug Substance Specification. Analytical procedures and acceptance criteria applicable to the PF-07305885 drug substance stability program are noted in the table.

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Additional analytical tests as listed in Table 4-2 are performed for each clinical drug substance batch to gain further information about the normal range of drug substance manufacturing process variation, to evaluate new methods, or to monitor the significance of the ailribuie(s) measured by these tests.

Biotherapeutics Pharmaceutical Sciences

Specification Review Team INX100422573, Version 1

To:    David Cirelli

From:    Rcbokah Ward

Date:    07-Aug-2020

Subject: Specification Report for BNTl62b2 (PF-07302048) COVID-19 Vaccine Lipid Nanoparlicle (I.NP) Drug Product to support Emergency Use Authorization

CC:    Lavinia Lewis, Mary Denton, Justin Sperry, Fanyu Meng

1.0 Notification of Changes

A summary of changes reflected throughout the document with associated rationale.

specification Report Template

Page 2 of 5

2.0 PRODUCT INFORMATION

A brief description of the product and other information relevant to establishing the specification arc provided in Table 2-1.

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3.0 SPECIFICATIONS FOR DRUG PRODUCT

Analytical test methods contained in this section were chosen to ensure the quality, identity, purity, and potency of the BNT162b2 ( PF-07302048) drug product throughout the manufacturing process and during long term storage under recommended storage conditions. The release specification for BNT162b2 drug product EUA is provided in Table 3-1, These are the batch release analytical requirements listed in LIMS as the Drug Product Specification. Analytical procedures and acceptance criteria applicable to the BNT162b2 drug product stability program are noted in the table. Drug product lots are additionally required to undergo 100% and acceptable quality limit visua l inspections as part of product release.

Table 3-1: Drug Product Specification

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Additional analytical tests listed in Table 3-2 arc perfonned for each clinical drug product lot to gain further information about the normal range of drug product manufacturing process variation or to monitor the significance ofthe attribute(s) measured by this test.

Routine in-process tests are listed in Table 3-3 and arc performed for each clinical drug product lot. These methods may be performed at a variety of stages in the process.

Table 3-4 lists the analytical mcthod(s) that will be performed for characterization purposes.

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Document Approval Record

INX100422573

Specification Report for BNT162b2 (PF-07302048) COVID-19 Vaccine Lipid Nanoparticle (LIMP) Drug Product

Date(GMT)    Signing Capacity

O7-Aug-202O 22:37:18    Author Approval

ATTACHMENT 2: DELIVERY DOCUMENTATION Documentation and Delivery Notes Thermal Shipper Documentation

It is currently envisaged that the following will be provided with each shipment of the Products:

1.    Authorisation Fact Sheets/Leaflets - Five (5) fact sheets folded 3x2” in a plastic bag

2.    Pfizer Brochure - One (1) per Thermal Shipper container containing product storage and handling information including:

Dry Ice Handling Insert

Safety Data Sheet (SDS) for Dry Ice

Return instructions for GPS loggers and thermal shipping system A stand-alone SDS for Dry Ice

Blank label - purpose of the blank label: for carriers to mark out the dry ice label to indicate that the Thermal Shipper containers are empty (not containing dry ice)

3.    Return Shipping Label - One (1)

4.    Outbound Shipping Label - One (1), standard label on Thermal Shipper

5.    Contents Label - One (1) label on inside flap, picking label details how many carton trays are in Thermal Shipper

Proof of Delivery Documentation

Currently, the Contractor intends to use the carrier delivery signal as proof of delivery.

Proof of delivery document that can be accessed online based on track and trace number. See UPS example³ below:

9 Location³    0 Untied Slates - English v    i Scott Wo

1Z86958Y2460508262 Delivered Q Proof of Delivery n Alternate Tracking Number: (?> S1G ON FILE

CORONA SPECIALTY PHARMACY 1280 CORONA POINTE CT CORONA, CA, US 92879 08/27/2020, 11:24 AM Inside Delivery

ATTAfHMTNT V. DFIIVFRY SlPFUIFir ATION

Product Delivery. Storage & Handling Specifications

Product delivery, storage and handling specifications are captured below specific to the distribution model: direct shipping from the Contractor manufacturing sites direct to point of use (POU) locations or shipping to one or several central hubs per Participating Member State from which Participating Member States will ensure themselves the further delivery to the sites of use of the Vaccine.

Shipments will arrive in a long distance Thermal Shipper as provided by the Contractor in accordance with Attachment 4 (Labelling and Packaging Specifications). At this time, the minimum order quantity in any shipment shall be one (1) tray with 195 vials or 975 doses of Product. The Contractor is investigating the viability of fewer than 195 vial count SKUs and expects to determine feasibility of an alternative shipping configuration by 1H2021. The Contractor will determine order quantities for future pack sizes.

The Participating Member State shall ensure that at the expected time of arrival a dedicated person will be available to receive the Product, sign acceptance for delivery, and immediately, no later than 24 hours of delivery, switch off the temperature logger located in the Thermal Shipper, and:

1.    immediately transfer the Product to:

1.    a -75 °C (+/-15 °C) ultra-low temperature (“ULT”) freezer; or

2.    a 2-8 °C refrigerator; or

2.    maintain the Product in accordance with product storage and handling guideline captured in Pfizer’s brochure and website (e.g. unpacking, storage, re-icing).

The Participating Member State acknowledges the following storage guidelines:

•    As at the Effective Date, the Product has a shelf-life of up to 6 months when stored at a constant -75°C(±15°C)

•    Provided the re-icing protocols are followed and re-icing occurs within 24 hours of delivery and every 5 days thereafter, the Product may be stored in the Thermal Shipper for up to 15 days

•    The Product has an effective life of up to 5 days when stored at refrigerator temperatures 2-8°C

•    Once the Product is defrosted and reconstituted it can be retained for up to 6 hours at standard ambient room temperatures (19-25°C)

All costs associated with receiving, handling, storing and further delivery of the Product shall be the responsibility of the Participating Member State, and the Participating Member State shall ensure that all locations where any Product is delivered shall comply with the product storage and handling specifications set forth in this Attachment 3 and shall meet the standards set forth herein.

Protocols for Unpacking Product and Re-icing: See Exhibits 1 and 2 of Attachment 3

Requirements of Delivery Location:

1.    Vaccination points with -75°C (+/-15 °C) ULT freezer

2.    Vaccination points with sufficient access and supply of dry-ice

3.    Vaccination points with 2-8°C refrigerator

Vaccine Preparation & Administration Instructions Removing the Vials to Thaw

•    From storage, remove 1 vial for every 5 recipients according to planned vaccinations schedule.

•    Vials may be stored in the refrigerator for 5 days (120 hours).

Diluting the Vaccine

•    Obtain 0.9% Sodium Chloride Injection, for use as a diluent. Do not use any alternate diluents.

•    Dilute the thawed vial by adding 1.8 mL of 0.9% Sodium Chloride Injection into the vial.

•    Ensure vial pressure is equalized by withdrawing 1.8 mL air into the empty diluent syringe before removing the needle from the vial.

Preparing the Dose

•    Draw up 0.3 mL of the diluted dosing solution into a new sterile dosing syringe with a needle appropriate for intramuscular injection.

•    For each additional dose, use a new sterile syringe and needle and ensure the vial stopper is cleansed with antiseptic before each withdrawal.

Vaccine Administration

•    Diluted vials must be used within 6 hours from the time of dilution and stored between 2-25 °C (35-77°F).

•    A single 30 mcg/0.3 mL dose is followed by a second dose 21 days later.

1.    Purpose

Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper with version control.

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Appendix A: Instructions (11 Pages)

2020TA022 v2.0

Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

1.    Purpose

The purpose of this controlled document is to provide unpackaging and re-icing requirements on the AeroSafe 47L7 Parcel Shipper with Dry Ice.

CAUTION: Use of dry ice in confined spaces (small rooms or walk-in coolers) and/or poorly ventilated areas can result in depletion of oxygen resulting in asphyxiation. Exposed skin should be protected from contact with dry ice. Eye protection is recommended (for example, safety glasses).

Appropriate training to be been conducted for personnel handling dry ice and documented within their relevant training system as required.

2.    Scope

This controlled document is applicable to unpackaging and re-icing requirements using the AeroSafe 47L7 ULT Parcel Shipper with Dry Ice.

2020TA022 v2.0

Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

4.2. Recommendations

Recommendations (Using Thermal Shipping Container as Temporary Storage)

•    The thermal shipping container is a passive (non-compressor) device that contains dry ice as the energy source to maintain the required temperatures when maintained properly as defined by Pfizer instructions. The dry ice in the thermal shipper will deplete over a number of days (duration will vary depending on use and care), which will impact how long the shipper holds the temperatures. This differs from an ultra-low-temperature freezer, an active (electronically powered, compressor-driven) device, which when plugged in, is designed to maintain ultra-low temperatures indefinitely. The longer the thermal shipping container remains closed, the longer it will take for the dry ice to deplete.

•    The thermal shipping container should be stored at 15° to 25° Celsius, which is 59° to 77° Fahrenheit.

•    The thermal shipping container is qualified with a minimum of 22 kgs of dry ice pellets (10 mm -16 mm pellets). Upon receipt and after opening, the box should be replenished/inspected with dry ice within 24 hours by adding dry ice to the maximum within the payload insert areas and dry ice pod.

•    The thermal shipping container should be re-iced every 5 days.

• This can help maintain the level of dry ice and the temperature of the vaccine product. It is recommended that the thermal shipping container not be opened more than 2 times a day, and shouldn't be opened for more than 1 minute at a time. If that is followed, the thermal shipping container should then be re-iced every 5 days.

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2020TA022 v2.0

Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

Recommendations (Using Thermal Shipping Container as Temporary Storage)

•    Local dry ice suppliers should be used for re-icing the thermal shipping container.

•    Temperature monitoring devices to be used if thermal shipping container is used as temporary storage. Sites are responsible for obtaining their own temperature monitoring devices to monitor temperatures when using the thermal shipping container as temporary storage. Temperature monitoring devices (probe or probeless) capable of being in a dry ice environment to be used and placed in the location of the vial tray payload area within the thermal shipping container.

•    The thermal shipping container should be returned within 20 business days of delivery, including temperature data logger.

•    If you receive a Controlant Real-Time Temperature Monitor, it must be returned with the thermal shipping container.

•    If you receive a Sensitech Temperature Monitor, it does not need to be returned.

3, Procedure

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Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

Responsible Action Step Role

3. Remove the VIP Lid carefully as the temperature monitor probe is connected to the Payload Box. Care should be taken to not disconnect the probe from the Payload Box.

4. While wearing insulated (thermal) gloves, take out the Dry Ice Tray.

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Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

Responsible Action Step Role

5. Remove the Payload Box from the thermal shipper by carefully pulling directly upwards. Care should be taken to not disconnect the probe from the Payload Box.

6. Open the Payload Box and remove the vial tray.

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Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

5.2. Re-Icing

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Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

Responsible Role Action Step

3. Remove the VIP lid, Item A.

4.    While wearing insulated (thermal) gloves, take out the Dry Ice Tray, Item B as required to get better access to the Scaffolding to begin re-icing.

5.    Fill the Scaffolding, Item D of the shipper with dry ice to the top of the scaffolding.

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Responsible Action Step Role

6. Reinsert the Dry Ice Tray, Item B on top of the Payload Box, Item C. Fill the Dry Ice Tray, Item B with dry ice to the top.

7. Add the VIP Shipper Lid, Item A back on top.

8. Fold the outer corrugated flaps and reseal shipper with tape.

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Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

6. History of changes

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Unpackaging and Re-Icing Instructions of the AeroSafe 47L7 ULT Parcel Shipper

7. Appendix

7.1 Appendix 1: AeroSafe 47L7 ULT Parcel Shipper

Note: Approximate weights are based on maximum configuration of dry ice.

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Exhibit 2 of Attachment 3 - Unpacking and Re-icing: Thermal Shipper B

1.    Purpose

Unpackaging and Re-Icing Instructions of the Softbox Medium ULT Parcel Shipper with version control.

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Appendix A: Instructions (12 Pages)

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Unpackaging and Re-Icing Instructions of the Softbox Medium ULT Parcel Shipper Table    Of Content

1.    Purpose.,............................. 2

2.    Scope............................................................................................................................................2

3.    Reference Documents..................................................................................................................3

4.    General Requirements..................................................................................................................3

4.1,    Materials....,,...............................................„.,........................................................................3

4.2.    Recommendations........................................................................................................................3

5.    Procedure.....................................................................................................................................4

5.1.    Unpackaging............................................................ 4

5.2.    Re-Icing.........................................................................................................................................7

6.    History of changes......................................................................................................................11

7.    Appendix.....................................................................................................................................12

7.1    Appendix 1; Softbox    Medium ULT Parcel Shipper......................................................................12

1.    Purpose

The purpose of this controlled document is to provide unpackaging and re-icing requirements on the Softbox Medium ULT Parcel Shipper with Dry Ice.

CAUTION: Use of dry ice in confined spaces (small rooms or walk-in coolers) and/or poorly ventilated areas can result in depletion of oxygen resulting in asphyxiation. Exposed skin should be protected from contact with dry ice. Eye protection is recommended (for example, safety glasses).

Appropriate training to be been conducted for personnel handling dry ice and documented within their relevant training system as required.

2.    Scope

This controlled document is applicable to unpackaging and re-icing requirements using the Softbox Medium ULT Parcel Shipper with Dry Ice.

•    The thermal shipping container is a passive (non-compressor) device that contains dry ice as the energy source to maintain the required temperatures when maintained properly as defined by Pfizer instructions. The dry ice in the thermal shipper will deplete over a number of days (duration will vary depending on use and care), which will impact how long the shipper holds the temperatures. This differs from an ultra-low-temperature freezer, an active (electronically powered, compressor-driven) device, which when plugged in, is designed to maintain ultra-low temperatures indefinitely. The longer the thermal shipping container remains closed, the longer it will take for the dry ice to deplete.

•    The thermal shipping container should be stored at 15° to 25° Celsius, which is 59° to 77° Fahrenheit.

•    The thermal shipping container is qualified with a minimum of 23 kgs of dry ice pellets (10 mm -16 mm pellets). Upon receipt and after opening, the box should be replenlshed/inspected with dry ice within 24 hours by adding dry ice to the maximum within the payload insert areas and dry ice pod.

•    The thermal shipping container should be re-iced every 5 days.

• This can help maintain the level of dry ice and the temperature of the vaccine product. It is recommended that the thermal shipping container not be opened more than 2 times a day, and shouldn't be opened for more than 1 minute at a time. If that is followed, the thermal shipping container should then be re-iced every 5 days.

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Recommendations (Using Thermal Shipping Container as Temporary Storage)

•    Local dry ice suppliers should be used for re-icing the thermal shipping container.

•    Temperature monitoring devices to be used if thermal shipping container is used as temporary storage. Sites are responsible for obtaining their own temperature monitoring devices to monitor temperatures when using the thermal shipping container as temporary storage. Temperature monitoring devices (probe or probeless) capable of being in a dry ice environment to be used and placed in the location of the vial tray payload area within the thermal shipping container.

•    The thermal shipping container should be returned within 20 business days of delivery, including temperature data logger.

•    If you receive a Controlant Real-Time Temperature Monitor, it must be returned with the thermal shipping container.

•    If you receive a Sensitech Temperature Monitor, it does not need to be returned.

5. Procedure

Once the lid is opened the dry ice pod will be seen as illustrated below.

4. While wearing insulated (thermal) gloves, take out the Dry Ice Pod.

Responsible Action Step Role

5. Access the payload sleeve, which is on top of a thin layer of dry ice and open it.

Note: The payload sleeve does not have a bottom, so do not pull it out of the thermal shipping container.

6. Take out the product for inspection and immediately (within one minute of opening) store in an ultra-low temperature freezer or prepare for use. If shipper will be used as temporary storage for remaining vial trays, immediately reinsert the trays within one minute of opening and follow the re-icing instructions.

5.2. Re-Icing

Once the lid is opened the dry ice pod will be seen as illustrated below.

4. While wearing insulated (thermal) gloves, take out the Dry Ice Pod.

5. Fill the sides of the payload sleeve with dry ice until it's equal with the corrugated structure.

7. Close the Dry Ice Pod.

6. History of changes

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Unpackaging and Re-Icing Instructions of the Softbox Medium ULT Parcel Shipper 7. Appendix

7.1 Appendix 1: Softbox Medium ULT Parcel Shipper

Note: Approximate weights are based on maximum configuration of dry Ice.

ITEM
	PAYLOAD SLEEVE (Takes 1 to 5 vial trays) MEDIUM ULT THERMAL SHIPPER

ATTACHMENT 4 : LABELLING AND PACKAGING SPECIFICATIONS Product Labelling Specifications

Product labels for primary, secondary and tertiary packaging will be shared closer to regulatory filings.

It is currently envisaged that the following will be part of the initial product artwork:

Primary Packaging (Vial):

•    Linear barcode: Scans as the Global Trade Item Number (GTIN) that includes the human-readable National Drug Code (NDC) number.

Secondary Packaging (Carton Tray):

•    Linear barcode: Scans as the GTIN number that includes the human-readable NDC number.

•    QR code: When scanned, this code links to a landing page where a copy of the Fact Sheets for the Healthcare Provider, patient/recipient, and Emergency Use Authorization Product Insert (i.e. e-leaflet) will be available.

•    2D GS1 DataMatrix: Scan of the 2D code will include the GTIN number, lot and expiry information.

Product Packaging Specifications Primary Packaging

•    2 mL type 1 glass preservative free multi-dose vial (MDV)

•    MDV has 0.45 mL frozen liquid drug product

•    5 doses per vial

Secondary Packaging “Single Tray”

•    Single tray holds 195 vials

•    975 doses per tray

•    Tray (white box) dimensions: 229 X 229 x 40 mm

Tertiary Container: Thermal Shipper (Softbox)

•    Minimum 1 tray (975 doses) or up to 5 trays (max 4875) stacked in a payload area of the

shipper

•    Payload carton submerged in 23 Kg of dry ice pellets (9 mm - 16 mm pellets)

•    Thermal shipper dimensions:

o Internal Dimensions: 245mm X 245mm X 241mm o External Dimensions: 400mm X 400mm X 560mm

ATTACHMENT 5: RETURN AND DISPOSAL OF PRODUCT MATERIALS A. Return

“Logistics Delivery Equipment” refers to the long-distance thermal shipping container (“Thermal Shipper”) used for shipping and the temperature data logger/monitoring device attached to such Thermal Shipper.

Once dry ice is no longer needed, open the Logistics Delivery Equipment and leave it at room temperature in a well-ventilated area. The dry ice will readily sublime from a solid to a gas. DO NOT leave dry ice unattended.

Store the empty Logistics Delivery Equipment until return in an appropriate clean and secure location to protect and maintain the functionality of the equipment (e.g., do not store outside under uncontrolled conditions, exposed to weather, exposed to pests, etc.).

Return of the Logistics Delivery Equipment to be undertaken within 20 business days following delivery of the Product to the Participating Member State’s recipient, which will be effected by collection by the Contractor within that time. Instructions and logistics for return will be provided on the interior of the Thermal Shipper and will also be available on Pfizer’s website. In the event that either: (a) the Logistics Delivery Equipment (or any part thereof), is not made available for collection within such 20 business days; or (b) the Logistics Delivery Equipment (or any part thereof), is damaged in any way (determined in the Contractor’s sole discretion), the Contractor shall be entitled to charge the Participating Member State $450 (exclusive of VAT) per Thermal Shipper and logger; which the Participating Member State shall pay within 30 days of the date of any invoice for such amount(s). Participating Member State acknowledges that such amount represents a reasonable pre-estimate of replacement cost for such Logistics Delivery Equipment as a result of the Participating Member State’s default, act or omission.

B. Disposal

“Primary Container Units” refers to the vials that contain the Product.

Destruction of the Primary Container Units that have been opened or are unused must take place at a facility appropriately licensed to handle and destroy pharmaceutical waste, medical waste, and/or hazardous waste, and destruction must be by means of grinding or incineration.

“Secondary Cartons” refers to the immediate boxes that contain the vials of Product.

Secondary Cartons must be defaced and destroyed in accordance with local clinical dosing facility waste management services, and Secondary Cartons may not be disposed of in routine household waste collection or recycling centres.

104

1

   the provisions that apply to any Vaccine Order Form which the Participating Member States and the Contractor may conclude under this APA; and

2

   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 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.

3

The above proof of delivery image is an example only. Please note that the transport carrier selection will be based on the detail agreed in the Vaccine Order Form between the Contractor and the relevant Participating Member State.

4

Refer to Recommendations section of this procedure for further details on using the thermal shipping container as temporary storage.

8.    If not using the thermal shipping container as temporary storage, insert all components back into the thermal shipping container for return.