OCRPfizer 1 Redacted
OCRPfizer 1 Redacted
OCRPfizer 1 Redacted
BETWEEN
AND
DATED AS OF
30 March 2021
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MANUFACTURING AND SUPPLY AGREEMENT
THIS MANUFACTURING AND SUPPLY AGREEMENT dated as of30 March 2021 (the
"Effective Date") is made by and between PFIZER LABORATORIES (PROPRIETARY)
LIMITED with offices at 85 Bute Lane, Sandton, Johannesburg, South Africa (hereinafter
"Pfizer") and the Government of the Republic of South Africa acting through the National
Depattment of Health of South Africa ("NDOH"), with offices at Dr AB Xuma Building, I 112
Voortrekker Rd, Pretoria Townlands 351-JR, Pretoria, 0187 (hereinafter "Purchaser").
Purchaser and Pfizer may be referred to herein individually as a "Party" or collectively as the
"Parties".
WHEREAS, Pfizer Inc. ("Pfizer US") and BioNTech SE, a company organized and
existing under the laws of Germany ("BioNTech"), are collaborating to develop a vaccine to
address the global COVID-19 pandemic;
WHEREAS, subject to clinical success, Pfizer US and BioNTech shall be responsible for
all requirements of the processes of approval of the clinical trials and the marketing authorization
of the Product;
WHEREAS, Purchaser desires to purchase the Product for use in South Africa (the
"Territory"), and subject to clinical success and regulatory approval, Pfizer desires to
manufacture and supply such Product to Purchaser; and
WHEREAS, the Parties are willing to carry out the foregoing pursuant to the terms and
conditions set fotth in this Agreement.
NOW, THEREFORE, in consideration ofthese premises and the covenants and agreements
set fotth herein, the sufficiency of which is hereby acknowledged and agreed, and intending to be
legally bound thereby, the Parties hereby agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms shall have the meanings set forth below.
I. I "Adjusted Delivery Schedule" shall have the meaning set forth in Section 2.4(e).
1.2 "Advance Payment" shall have the meaning set fo1th in Section Error! Reference source
not found ..
1.3 "Affiliate(s)" means, with respect to each Party or, if applicable, BioNTech, any
corporation, firm, partnership or other entity or Person which directly or indirectly controls
or is controlled by or is under common control with the named Party, including without
limitation Pfizer US, or, if applicable, BioNTech. For purposes of this definition, "control"
(including, with correlative meaning, the terms "controlled by" and " under common
control with") shall be presumed to exist if one of the following conditions is met: (a) in
the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of
the stock or shares having the right to vote for the election of directors of such corporate
entity or any direct or indirect parent of such corporate entity, and (b) in the case ofnon-
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CONFIDENTIAL
corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity
interest with the power to direct the management and policies of such non-corporate
entities.
1.4 "Agreement" means this Manufacturing and Supply Agreement and all Attachments
hereto as the same may be amended, amended and restated, supplemented or otherwise
replaced from time to time.
1.5 "Allocation" shall have the meaning set forth in Section 2.S(a).
1.8 "BioNTech" shall have the meaning set forth in the recitals.
1.9 "Binding Term Sheet" means the binding term sheet entered into by and between the
Parties on 15 January 202 1.
I. 10 "Business Day" means any day other than Saturday, Sunday or a public holiday in New
York, New York or Johannesburg.
1.12 "Conditional Approval" means a conditional marketing authorization for the Product
granted by the South African Health Products Regulatory Authority ("SAHPRA") and
agreed with Pfizer, that permits the supply of the Product in South Africa.
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1.14 "Contracted Doses" shall have the meaning set forth in Section 2.3(a).
1.15 "Covax Facility" means the global procurement mechanism for the procurement and
delivery of doses of approved vaccine for COVID-19.
1.17 "Delivery Price" shall have the meaning set forth in Section 3.2(a).
1.18 "Delivery Specifications" shall have the meaning set forth in Section 2.4(d).
1. 19 "Disclosing Party" means the Party or any of its Affiliates that discloses, or causes to be
disclosed, Confidential Information to the other Party or any of its Affiliates.
1.20 "Effective Date" shall have the meaning set fo1th in the preamble.
1.21 "Exempt Information" means information that: (a) the Recipient or any of its
Representatives lawfully possessed, as demonstrated by competent proof, before the
Disclosing Party disclosed such information under this Agreement; or (b) was already
generally available and in the public domain at the time of disclosure, or becomes public
(other than as a result of breach of this Agreement by the Recipient or its Representatives);
(c) the Recipient or any of its Representatives lawfully obtains from a Person not in breach
of any confidentiality obligation (or other prohibition from disclosing the information) to
the Disclosing Party with respect to such information (and Recipient has made reasonable
enquiry with respect thereto); or (d) the Recipient evidences to the reasonable satisfaction
of the Disclosing Party is independently developed by or on behalf of the Recipient or its
Representatives without the use of, reference to, aid from, or reliance on, the Confidential
Information. In clarification of the foregoing, a general disclosure in the public domain
will not cause more specific (but related) information to be deemed Exempt Information
under one of the above exceptions; similarly, a combination of several pieces of
information, which individually would be deemed Exempt Information, will not be deemed
Exempt Information unless the combination itself is in the public domain, independently
developed by the Recipient or its Representatives or otherwise lawfully in the possession
of the Recipient or any of its Representatives.
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1.22 "Facilities" means Pfizer's manufacturing sites in Kalamazoo (Michigan) and Puurs,
Belgium and BioNTech's two manufacturing sites, in Mainz and Idar Oberstein in
Germany or such other manufacturing site used in connection with the manufacture of the
Product supplied by Pfizer hereunder.
1.23 "Force Majeure Event" shall have the meaning set forth in Section 12.8.
1.24 "Forms" shall have the meaning set forth in Section 12.12.
1.25 "Government" means all levels and subdivisions of government (i.e., local, regional,
national, provincial, federal, administrative, legislative, or executive) of South Africa.
1.26 "ICC" shall have the meaning set forth in Section 12.2.
1.27 "Indemnified Claims" shall have the meaning set fo1th in Section 8.2.
1.28 "lndemnitees" shall have the meaning set forth in Section 8.1.
1.29 "Interim Delivery Schedule" shall have the meaning set forth in Section 2.4(d).
1.30 "Intellectual Property" means (a) any processes, trade secrets, inventions, industrial
models, designs, methodologies, drawings, discoveries, result, materials, formulae,
procedures, techniques, clinical data or technical or other information or data,
manufacturing, engineering and technical drawings, including proprietary rights in any of
the foregoing, and (b) registered trademarks, trade mark applications, unregistered marks,
trade dress, copyrights, know-how, patents, patent applications, and any and all
provisionals, divisions, continuations, continuations in part, extensions, substitutions,
renewals, registrations, revalidations, reissues or additions, including certificates of
supplementary protection, of or to any of the aforesaid patents and patent applications, and
all foreign counterparts of any, or to any, of the aforesaid patents and patent applications.
1.31 "Labelling and Packaging Specifications" shall have the meaning set forth in Section
2.4(e).
1.32 "Latent Defect" means a defect causing the Product to not conform to the applicable
Specifications that Purchaser can show was present at the time of Pfizer's delivery of the
Product to Purchaser and which could not have been detected by Purchaser, its designee,
or their Personnel at delivery through diligent inspection.
1.33 "Lawis" means, collectively, all applicable national and local laws, common laws, statutes,
ordinances, codes, rules, regulations, orders, decrees or other pronouncements of any
government, administrative or judicial authority having the effect of law.
1.34 "Losses" shall have the meaning set forth in Section 8.1.
1.35 "Marketing Authorization" means the marketing authorization or such other permission
having similar effect, in respect of the Product, granted by the South African Health
Products Regulatory Authority, as amended or varied by the South African Health Products
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Regulatory Authority from time to time, and which is acceptable to Pfizer; that allows the
Product to be placed on the market in South Africa according to Law.
1.36 "Non-Complying Product" shall have the meaning set forth in Section 4.4(a).
1.37 "Party" or "Parties" shall have the meaning set forth in the preamble.
1.38 "Person" means any natural person, entity, corporation, general partnership, limited
partnership, limited liability partnership, joint venture or similar entity or organization,
joint stock company, proprietorship, other business organization, trust, union, association
or Government.
1.39 "Personnel" means all Affiliates, subcontractors, or other third parties, and employees and
agents of each of them, used by either Party in the performance of services or obligations
or in connection with this Agreement.
1.40 "Pfizer" shall have the meaning set forth in the preamble.
1.41 "Pfizer US" shall have the meaning set forth in the preamble.
1.42 "Price" shall have the meaning set forth in Section 3.1.
1.43 "Privileges and Imm unities" means any privileges, immunities, or legislation in the
Republic of South Africa, including, without limitation, no-fault vaccine compensation
programs, pandemic insurance programs, immunities from suit or liability, or any
protections, defenses, or limitations-of-liability (whether statutory, regulatory, common
law or otherwise), existing or future, that may separately protect Indemnitees from Losses.
1.45 "Product Materials" means all packaging materials and components needed for delivery
of the Product.
1.46 "Purchase Order" means a written or electronic order form submitted by Purchaser to
Pfizer in accordance with the terms of this Agreement authorizing the manufacture and
supply of the Product, in substantially the form attached as Attachment G (as may be
updated from time to time by Pfizer upon notice to Purchaser).
1.47 "Purchaser" shall have the meaning set forth in the preamble.
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1.48 "Recipient" means the Party who receives Confidential Information from the other Party.
1.49 "Records" means books, documents, and other data, of a ll matters relating to performance
of obligations under this Agreement.
I .SO "Representatives" means, with respect to Recipient, its Affiliates and its and their
respective directors, officers, and employees, agents, contractors, consultants, advisors and
representatives who (a) are subject to an obligation of confidentiality protecting the
Confidential Information on terms no less restrictive than those contained in this
Agreement; and (b) have a need to know the Confidential Information in connection w ith
this Agreement.
l .SI "Specifications" means the material specifications for the manufacture, processing,
packaging, labeling, testing and testing procedures, shipping, storage and supply of the
Product as w ill be set out in Attachment A following the Effective Date (and in any event
before supply in accordance with the agreed Interim Delivery Schedule), and as such
specifications may be amended, supplemented or otherwise modified by Pfizer and
communicated to Purchaser.
l .S2 "Taxes" shall have the meaning set forth in Section 3.4.
l.S3 "Term", with respect to this Agreement, shall have the meaning set forth in Section 6.1.
l .S4 "Third Party Beneficiary" or "Third Party Beneficiaries" shall have the meaning set
forth in Section 12.S(a).
l.SS "USD" means the lawful currency of the United States of America.
l .S6 "Vaccine" shall include (a) a ll vaccines manufactured, in whole or in part, or supplied,
directly or indirectly, by or on behalfof Pfizer or BioNTech or any of their Affiliates that
are intended for the prevention of the human disease COVID-19 or any other human
disease, in each case which is caused by any of the virus SARS-CoV-2, and/or any or all
related strains, mutations, modifications or derivatives of the foregoing that are procured
by Purchaser, its Affiliates or agents by any means (whether pursuant to the Agreement or
by way of any purchase or donation from any third party or otherwise, whether or not
authorized pursuant to Section 2. 1) or that are administered within the Territory, and
whether procured or administered prior to or following execution of this Agreement, (b)
any device, technology, or product used in the administration of or to enhance the use or
effect of, such vaccine, (c) any component or constituent material of (a) or (b), or (d) any
use or application of any product referred to in (a)-(b).
Except where the context expressly requires otherwise, (a) the use of any gender herein
shall be deemed to encompass references to either or both genders, and the use of the
singular shall be deemed to include the plural (and v ice versa), (b) the words " include",
"includes" and " including" shall be deemed to be fo llowed by the phrase "without
limitation", (c) the word "will" shall be construed to have the same meaning and effect as
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the word "shall", (d) any definition of or reference to any agreement, instrument or other
document herein shall be construed as referring to such agreement, instrument or other
document as from time to time amended, supplemented or otherwise modified (subject to
any restrictions on such amendments, supplements or modifications set forth herein), (e)
any reference herein to any person shall be construed to include the person's successors
and assigns, (f) the words "herein", " hereof' and "hereunder", and words of similar import,
shall be construed to refer to this Agreement in its entirety and not to any particular
provision hereof, (g) all references herein to Sections or Attachments shall be construed to
refer to Sections or Attachments of this Agreement, and references to this Agreement
include all Attachments hereto, (h) the word "notice" means notice in writing (whether or
not specifically stated) and shall include notices, consents, approvals and other written
communications contemplated under this Agreement, (i) references to any specific law,
rule or regulation, or article, section or other division thereof, shall be deemed to include
the then-current amendments thereto or any replacement or successor law, rule or
regulation thereof and (j) the term "or" shall be interpreted in the inclusive sense commonly
associated with the term "and/or".
2. SUPPLY OF PRODUCT.
(a) During the Term, Pfizer shall use Commercially Reasonable Efforts to supply or
have supplied the Product to Purchaser, and Purchaser shall purchase the Product,
subject to and in accordance with the terms and conditions of this Agreement.
(b) Purchaser acknowledges and agrees that (i) Pfizer's efforts to develop and
manufacture the Product are aspirational in nature and subject to significant risks
and uncertainties, and (ii) the fact that any other drug or vaccine to prevent, treat or
cure COVID-19 infection is successfully developed or granted authorization earlier
than the granting of Authorization for the Product shall not change the current
situation of urgent needs for prevention of the spread of the COVID-19 infection
that poses serious threats to and harmful effects on the lives and health of the
general public.
(c) Notwithstanding the efforts and any estimated dates set forth in the Interim
Delivery Schedu le, the Parties recognize that the Product has completed Phase 26/3
clinical trials and that, despite the efforts of Pfizer in research, and development
and manufacturing, the Product may not be successful due to technical, clinical,
regulatory, manufacturing, shipping, storage, or other chal lenges or failures.
(d) Accordingly, Pfizer and its Affiliates shall have no liability for any failure by Pfizer
or its Affiliates to develop or obtain Authorization of the Product in accordance
with the estimated dates described in this Agreement. Even if the Product is
successfully developed and obtains Authorization, Pfizer shall have no liability for
any failure to deliver doses in accordance with any estimated delivery dates set
forth herein (other than as expressly set out in this Agreement), nor shall any such
failure give Purchaser any right to cancel orders for any quantities of Product.
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Further, Pfizer shall have no obligation to deliver the Product to Purchaser unless
and until the Indemnification Agreement is executed between the Parties in
accordance with Section 8 (Indemnification).
(e) Pfizer shall keep Purchaser apprised of the progress of the material development of
the Product and shall provide Purchaser with such information regarding that
development as Purchaser reasonably requests.
(t) Purchaser, including any related Person or any agents of Purchaser, covenants to
exclusively obtain all of its supply of any vaccine of Pfizer, BioNTech or their
respective Affiliates intended for the prevention of the human disease COVID-19
(including the Product) either (i) directly from Pfizer or from Pfizer through the
COVAX Facility, or (ii) from a Third Patty, whether by donation, resale or
otherwise, o·nly if Purchaser has obtained Pfizer's prior written consent. Any
breach of this Section 2. 1(f) shall be deemed an uncurable material breach of this
Agreement, and Pfizer may immediately terminate this Agreement pursuant to
Section 6.2. For clarity, nothing in this Section 2. l(f) shall prevent Purchaser from
purchasing competing vaccine products of any Third Patty.
2.2 Capacity.
(a) On the Effective Date, Purchaser shall submit to Pfizer a legally binding and
irrevocable Purchase Order(s) for Twenty million one thousand one hundred fifty
(20,001,150) doses ("Contracted Doses") of the Product. Subject to Section 2.4(c)
of this Agreement, Pfizer shall have the right, at its sole discretion, to update the
Contracted Doses to the nearest possible number that is divisible by the Minimum
Order Quantity.
(b) The Purchase Order shall be provided together with Purchaser's order number,
VAT number, and invoice address. Pfizer shall accept the Purchase Order
conforming to the terms set forth in this Agreement in writing, and the confirmed
Purchase Order shall be binding upon the Parties and subject to the terms and
conditions set out in this Agreement.
(c) The Purchaser may request additional doses during the Tenn of the Agreement
through a legally binding and irrevocable Purchase Order(s), but only upon being
advised that: (i) Pfizer has availability of supply of such additional requested doses
(the "Additional Order") and (ii) Pfizer agrees, in its sole discretion, to allocate
such Additional Order to Purchaser. Each Additional Order will be subject to the
same terms and conditions set forth in the Agreement (and any subsequent
amendments thereto), as applicable; provided such Additional Order must be
placed during the Term of the Agreement. In such event, the doses subject to the
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accepted Additional Order shall be Contracted Doses. After submission to, and
acceptance by, Pfizer of an Additional Order, Purchaser shall pay Pfizer such
additional advance payment within thirty (30) days of the purchase order of such
Additional Order in accordance with the terms of Section 3.2 ("Additional
Advance Payment"). Purchaser shall pay such Additional Advance Payment, and
Pfizer shall provide an updated Attachment B to reflect such Additional Order. Full
payment of the Additional Advance Payment is a condition to supply any doses
subject to the Additional Order. If any failure by Purchaser to pay Pfizer for the
Additional Advance Payment results in a delay in delivery, the undelivered doses
will be at the sole risk of Purchaser, and Pfizer shall have no liability to Purchaser
regarding such delay or further inability to supply by Pfizer.
(a) Pfizer shall deliver the Product Delivery at Place ("DAP") lncoterms 2020.
(b) The Parties shall reasonably agree, in writing, on the location(s) (including number
of locations) for delivery of shipments of Product ("Place(s) of Destination")
within five (5) Business Days from the Effective Date for the first expected
shipment of Product, and for any subsequent delivery, at least eight (8) weeks prior
to shipment of the Product; provided that, in each case: (i) each Place of Destination
meets the requirements set fo1th in Attachment D, and (ii) the Place(s) of
Destination are serviced by a contracted transportation carrier of Pfizer, and (iii)
each Place of Destination is an authorized location to receive the Product, evidence
of which shall be presented to Pfizer on Purchaser's official letterhead and
Purchaser shall provide any additional information, as reasonably requested by
Pfizer in advance of delivery, to verify such authorization ("Shipping Agent").
Pfizer shall have the ability, acting reasonably, to restrict the number of Places of
Destination where shipments of Product shall be delivered. However, the Parties
agree that Purchaser shall have full liability and responsibility for any further
transpo1tation and distribution following delivery to Place of Destination that is not
a point of use of the Product, including but not limited to ensuring compliance with
Attachment D. For the purposes of this Section 2.4(b), Pfizer agrees that it shall
provide the Purchaser with such information as Pfizer considers necessary for the
Purchaser to comply with the provisions of this section, to the extent in Pfizer' s
control and/or possession at the time, including details on the proposed Shipping
Agent as part of Pfizer's logistics planning information.
(d) Pfizer may deliver the Product by separate installments and shall use Commercially
Reasonable Effo1ts to meet the estimated delivery schedule set out in Attachment B
(the "Interim Delivery Schedule"), provided that no Product shall be shipped until
Authorization is received and Purchaser is compliant, in Pfizer's discretion, with
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the terms and conditions of this Agreement. All deliveries shall be accompanied by
the documentation specified in Attachment C (which may be updated from time to
time by Pfizer upon notice to Purchaser), and shall be in accordance with, and
subject to, the delivery specifications to be set forth in Attachment D (as may be
updated from time to time by Pfizer upon notice to Purchaser) ("Delivery
Specifications").
(e) The Product shall be labelled and packaged in accordance with the packaging
specifications to be set forth in Attachment E (which shall be populated following
the Effective Date, but in any event before supply in line with the agreed Interim
Delivery Schedule, and as may be updated from time to time by Pfizer upon notice
to Purchaser) ("Labelling and Packaging Specifications").
(a) If Authorization is received but there is insufficient supply to deliver the full
number of Contracted Doses on the Interim Delivery Schedule (including the
Adjusted Delivery Schedule), including to the extent any shortage is due to a
requirement of Pfizer to d ivert available supply of the Product to another market,
Pfizer shall work collaboratively to provide notice (and manage any
communications associated with any Product sho1iages). Following receipt of such
notification, Purchaser shall execute any instructions set out in the notice in a timely
fashion (and in no event longer than 24 hours). Subject to the foregoing, including
any requirement by Pfizer to divert Product to another market, Pfizer shall decide
on necessary adjustments to the number of Contracted Doses and Interim Delivery
Schedule due to the Purchaser to reflect such shortages based on principles to be
determined by Pfizer under the then existing c ircumstances ("Allocation") which
s ha ll be set out in such notice. Purchaser shall be deemed to agree to any revision.
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(b) Purchaser hereby waives all rights and remedies that it may have at Law, in equity
or otherwise, arising from or relating to: (i) any failure by Pfizer to develop or
obtain Authorization of the Product in accordance with the estimated dates
described in this Agreement; or (ii) any failure by Pfizer to deliver the Contracted
Doses in accordance with the Interim Delivery Schedule. In the event of an
inconsistency between the provisions of this Section 2.5 (Product Shortages) and
those of other sections of this Agreement, the provisions of this Section 2.5 (Product
Shotiages) shall control and supersede over those of other sections of this
Agreement to the extent of such inconsistency.
Under no circumstances will Pfizer be subject to or liable for any late delivery penalties.
(a) Pfizer shall use Commercially Reasonable Efforts to assure the Product is
manufactured in accordance with material Specifications and cGMP.
(b) Upon delivery of Product to Purchaser at the Place(s) of Destination and, to the
extent applicable, for any onward distribution and/or transportation to a Place of
Destination that is not a point of use of the Product, Purchaser shall store and handle
the Product in the manner set forth in the Specifications, instructions on Attachment
D and the instructions provided by Pfizer to ensure stability and integrity of the
Product.
(c) For the avoidance of doubt, Purchaser shall bear all expenses for use of the Product
upon delivery by Pfizer at the Place(s) of Destination, including, but not limited to,
those for storage of the Product and distribution and administration of the Product
(if applicable) in South Africa.
(d) Purchaser shall be solely responsible and liable for the proper storage, handling,
distribution, transportation, administration, use and disposal of the Product in South
Africa following delivery of the Product to Purchaser or its designee at the Place(s)
of Destination. Without prejudice to the generality of the foregoing, Purchaser shall
ensure that: (a) recipients of the Product shall follow the return and disposal
instructions in Attachment F (which may be updated from time to time by Pfizer
upon notice to Purchaser) when disposing of open and unused Product and its
packaging components; and (b) such return and disposal complies with Laws
regarding pharmaceutical waste, medical waste, or hazardous waste, as appropriate.
Attachment F provides the ability for Pfizer to charge Purchaser for the cost of such
packaging components, without limiting any other remedies available to Pfizer, in
the event that Purchaser fails to comply with the return requirement set forth in
Attachment F.
(e) Purchaser shall be responsible for and shall ensure that any equipment used to
deliver the Product, for example the shipper(s) and monitoring device(s), are stored
in an appropriate clean and secure location to protect and maintain the functionality
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(f) Pfizer may provide Safety Data Sheets and other information to Purchaser to assist
Purchaser to develop processes and procedures, including training, to handle the
Product a nd Product Materials in a safe manner and in compliance with Laws,
including occupational health and safety Laws. Purchaser represents and warrants
that Purchaser has and shall ensure that all recipients of the Product and Product
Materials have the requisite expertise to develop and impleme,nt appropriate
procedures and training programs to enable proper hand ling of the Product and
Product Materials in a safe and lawful manner.
(a) Title to the Product, and risk of loss or damage shall pass to Purchaser at the
Place(s) of Destination in accordance with Section 2.4(b). Pfizer reserves the right
to change any supply point (being the point from which Pfizer shall supply the
Product) by giving Purchaser adequate notice as acceptable under the Laws. Prices
are quoted on OAP Place(s) of Destination basis in effect at the time and Place(s)
of Destination. For purposes of this Agreement, the terms OAP shall have the
meaning ascribed thereto in INCOTERMS 2020 as published by the ICC, Paris,
France.
(b) Pfizer shall be the importer of the Product in front of the relevant customs
authorities in the Territory ("Importer of Record") and shall be responsible to
obtain, where applicable, any import license or other official authorization and to
carry out all customs formalities for the import of the Product in South Africa.
Pfizer shall also be responsible to pay, where applicable, all duties, taxes and other
charges, as well as the costs of carrying out customs formalities payable upon
import of the Products. G iven the nature of the Product, Purchaser undertakes to
support Pfizer a nd its appointed Shipping Agent to swiftly clear the Product from
the relevant customs authorities within twenty four (24) hours from the arrival of
the Product at the custom s authorities, and to obtain any waivers required; and
Purchaser acknowledges that any delay in such clearance process might affect the
overall shelf-life of the Products. Both Parties confirm that the required documents
for customs clearance of the Product are indicated in Attachment H of this
Agreement. Without prejudice to the generality of the foregoing, Purchaser
undertakes to take appropriate measures and exercise its reasonable efforts to
ensure the smooth and efficient passage of the Product through the port of entry in
accordance with applicable Laws of South Africa.
(c) Purchaser shall be responsible for the unloading of such Product from the
transportation carrier. For the sake of clarity, Purchaser shall be responsible for
unloading the Product from the transp01tat ion carrier and Pfizer's liability shall
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cease, and risk of loss or damage shall transfer, upon carrier's arrival at the Place(s)
of Destination and immediately prior to the unloading of the Product. Without
prejudice to the generality of the foregoing, following delivery of the Product to
Purchaser, Purchaser shall be fully responsible for and liable in relation to any
Product wastage, and for ensuring appropriate disposal in accordance with Sections
2.7(d) and 2.7(e). Pfizer will not be liable for any risks of loss or damage to the
Product after delivering the Product at the Place(s) of Destination, ·including
without limitation, temperature excursions, theft, or damages of any kind to the
Product.
(d) Without prejudice to Section Error! Reference source not found., Purchaser
acknowledges that Pfizer will not, in any circumstances, accept any returns of
Product (or any dose). In particular, following receipt of the Product in accordance
with this Section 2.8, no Product returns may take place under any circumstances
(inclusive of future changes in stock, expired Products, changes in Product
allocation, delivery, demand or new product launch).
3. 1 Purchase Price.
Purchaser shall purchase the Product from Pfizer at the price per dose set out in Attachment
B, excluding VAT (the "Price") and in accordance with the terms of this Agreement. The
Price shall include all of Pfizer's internal costs associated with the manufacturing and
delivery of the Product to the Place(s) of Destination in accordance with this Agreement.
The Price shall be firm for the Term.
(a) In partial consideration of the Contracted Doses, on the Effective Date, Pfizer shall
invoice Purchaser, and Purchaser shall pay, an upfront payment of Forty Million
two thousand three hundred US Dollars (USD 40,002,300) (calculated as two (2)
USD per dose multiplied by the Contracted Doses) (the "Advance Payment").
Purchaser shall pay the Advance Payment within thirty (30) days from the Effective
Date; provided, however, that Pfizer shall have no obligation to deliver any Product
until receipt of the Advance Payment by Pfizer. All amounts due hereunder shall
be converted to South African Rand which shall be determined based on the
exchange rate used by Bloomberg BFIX at the close of business on the day prior to
the invoice date 4:00 pm London time.
(b) Pfizer shall invoice Purchaser for the remainder of the Price for the Contracted
Doses (the "Delivery Price") in advance of each calendar quarter during the Term.
Purchaser shall pay all undisputed (in good faith) amounts on the first ( I st) Business
Day of the first (1st) month of each calendar quarter for the Batch of Contracted
Doses to be delivered in such calendar quarter, or in the case of Batch I, within
five (5) Business Days of the issuance of Conditional Approval. All such amounts
shall be due prior to delivery of the volume of anticipated doses to be delivered in
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such delivery, which Delivery Price shall be equal to the difference of the Price for
the number of the Contracted Doses being delivered in such delivery and an
apportionment of the Advance Payment based on the number of Contracted Doses
in such delivery. Full payment of each prior shipment is a condition to Pfizer's
obligation to supply any future shipment. If any failure by Purchaser to pay Pfizer
for the Contracted Doses results in a delay in delivery, the undelivered doses will
be at the sole risk of Purchaser, and Pfizer shall have no liability to Purchaser
regarding such delay or fu1ther inability to supply by Pfizer.
(c) Invoices shall be provided to the Purchaser at the address set forth in the preamble
of this Agreement. Pfizer shall include the following information on all invoices:
the Purchase Order number and billing address; and shall also include, where
applicable, the type description, part number (if any) and number of Contracted
Doses delivered; the delivery date; the actual date of shipment; the Price; any
applicable taxes or other charges provided for in the Purchase Order; and the shi p-
to destination.
(a) All amounts due under this Agreement shall be paid by the Purchaser to Pfizer in
accordance with the provisions of Section 3.2(a) and 3.2(6). Payment shall be
remitted by wire transfer in immediately available funds to the Pfizer bank account
indicated below. Any payment which falls due on a date which is not a Business
Day may be made on the next succeeding Business Day. Any dispute by Purchaser
of an invoice shall be provided to Pfizer in writing (along with substantiating
documentation and a reasonably detailed description of the dispute) within five (5)
Business Days from the date of such invoice. Purchaser will be deemed to have
accepted all invoices for which Pfizer does not receive timely notification of
disputes, and shall pay all undisputed amounts due under such invoices within the
period set forth in this Section 3.3(a). The Pa1ties shall seek to resolve all such
disputes expeditiously and in good faith.
(b) Any amount required to be paid by a Party hereunder which is not paid on the date
due shall bear interest, to the extent permitted by law, at five percent (5%) above
South African Reserve Bank Repo Rate (or any successor to such rate) effective for
the date such payment was due, as reported in the Wall Street Journal
(https://www.~.com/market-data/bonds). Such interest shall be computed on the
basis of a year of three hundred sixty (360) days for the actual number of days
payment is delinquent. In addition to all other remedies available under this
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Agreement or at Law, if Purchaser fails to pay any undisputed amounts when due
under this Agreement, Pfizer may (i) suspend the delivery of the Product or (ii)
terminate this Agreement.
(c) Purchaser shall not, and acknowledges that it will have no right, under this
Agreement, any Purchase Order, any other agreement, document or Law, to
withhold, offset, recoup or debit any amounts owed ( or to become due and owing)
to Pfizer, whether under this Agreement or otherwise, against any other amount
owed (or to become due and owing) to it by Pfizer or a Pfizer Affil iate.
3.4
It is understood and agreed between the Parties that any payments made and other
consideration provided under this Agreement are exclusive of any VAT or similar tax and
all other taxes which are incurred as a result of manufacturing and supplying the Product
(including, without limitation, custom duties, levies and charges and all local taxes)
("Taxes"), which shall be added thereon as applicable. Where Taxes are properly
chargeable on a payment made or consideration provided under this Agreement, the Party
making the payment or providing the consideration will pay the amount of Taxes in
accordance with the laws and regulations of the country in which the Taxes are chargeable.
In the event any payments made pursuant to this Agreement become subject to withholding
taxes under the laws or regulation of any jurisdiction, the Party making such payment shall
deduct and withhold the amount of such taxes for the account of the payee to the extent
required by Law and such amounts payable to the payee shall be reduced by the amount of
taxes deducted and withheld. Any such w ithholding taxes required under Law to be paid
or withheld shall be an expense of, and borne solely by, the payee.
Pfizer shall manufacture and supply the Product in material accordance with the
Specifications and cGMP. Such Specifications may be revised through written notification
by Pfizer to Purchaser to conform to the Authorization or changes to the manufacturing or
distribution of the Product.
(a) Pfizer shall (a) comply w ith all regulatory or government licenses and permits, and
(b) comply w ith all cGMP with respect to its manufacturing and packaging
processes, the Facilities or otherwise, to permit the performance of its obligations
hereunder.
(b) Pfizer shall ensure that a ll Product is properly labelled and packaged in accordance
with the applicable Authorization, Specifications and material cGMP standards.
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(c) Prior to delivery, Pfizer shall comply with all conditions (in the relevant timescales)
set out in the Authorization; provided, however, that Purchaser sha ll grant, or obtain
on Pfizer's behalf, all exemptions, exceptions, and waivers of country specific
requirements for the Product granted or permitted by the Government authority
(including but not limited to seria lization, applicable laboratory or quality testing
and/or marketing information form submission and approval), which requirements,
absent an exemption, exception or waiver, would prevent Pfizer from supplying
and reJeasing the Product in South Africa upon receipt of the Authorization.
Purchaser acknow ledges the Product will be supplied without
serialization. Purchaser agrees to exercise its best efforts to cause the relevant
Government authorities to facilitate the issuance of appropriate waivers and/or
approvals in case of active serialization, track & trace, and/or 2D coding mandates
within 24 hours. In order to maintain an efficient supply chain for the manufacture,
release and supply of the Product, Pfizer wi ll be sole ly responsible for
determ ination of manufacturing and testing locations and w ill conduct testing in
accordance with the Authorization. The Parties have agreed that Pfizer w ill not be
required to respond to, or provide Product or method transfer in connection with,
requests for local testing, requests for lot release protocols or requests for
registration samples in this Agreement or in subsequent amendments or extensions
of this Agreement.
(d) Due to the c urrent pandemic situation and the fact that any anticipated
A uthorization will be initially under a Conditional Approval in conjunction with
the agreement that Pfizer will only supply the Purchaser directly, the P urchaser
agrees to the be low conditions as a condition precedent to supply of the Product.
Purchaser w ill issue, or make any other Government authority to issue, any
necessary approvals to ensure enforceability of the same:
i. During the Tenn, Pfizer w ill not be required by the Purchaser or any other
Government authority to appoint a local agent or distributor, inc luding
without limitation, for purposes of selling or supplying the Product or
applying for the A uthorization, unless Pfizer, in its discretion during the
Term, appoints a local agent or distributor. For the avoidance of doubt,
Purchaser also agrees that as of the Effective Date (1) Pfizer or any of its
Affiliates wi ll be the ent ity applying and submitting any regulatory fi les
requ ired for issuance of the Conditiona l Approval; and (2) the Conditional
Approval w ill be issued under Pfizer's or any of its Affiliates name.
11. During the Term, Pfizer w ill not be required by the Purchaser or any other
Government authority to submit a price reference certificate for purposes of
applying for the Conditional Approval or otherwise.
iii. In the event that during the Term a third patty is the applicant or holder of
the Authorization, any obligation on Pfizer under this Agreement shall be
taken as a requirement on Pfizer to use Commercially Reasonable Efforts
to procure the compliance of such third party Authorization applicant or
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holder with such obligations to the extent necessary to ensure the relevant
obligation is fully met.
Pfizer shall perform all bulk holding stability, manufacturing trials, validation (including,
but not limited to, method, process and equipment cleaning validation), raw material, in-
process, bulk finished product and stability (chemical or microbial) tests or checks required
to assure the quality of the Product and tests or checks required by the Specifications and
cGMP.
(a) Purchaser may reject any Product that does not materially conform to Specifications
or cGMP ("Non-Complying Product") by providing written notice of rejection to
Pfizer and setting out detai led reasons for such rejection: (i) immediately (and in
no event more than 24 hours) upon delivery of such Non-Complying Product to
Purchaser; or (ii) immediately and in no event more than 24 hours upon its first
knowledge of a Latent Defect. Pfizer shall respond to any rejection and notice of
Non-Complying Product from Purchaser in a timely manner. For clarity, Purchaser
shall not be entitled to reject any Product based on service complaints unless a
Product does not materially conform to Specifications or cGMP.
(b) Pfizer shall conduct an analysis of the causes of any such quality-related complaint,
and shall report to Purchaser on any corrective action taken. If Pfizer's inspection
and testing reveals, to Pfizer's reasonable satisfaction, that such items of the
Product are Non-Complying Product and that any such non-conformity or defect
has not been caused or contributed to by any abuse, misuse, neglect, negligence,
accident, improper testing, improper storage, improper handling, abnormal physical
stress, abnormal environmental conditions or use contrary to any instructions issued
by Pfizer, Pfizer shall use Commercially Reasonable Efforts to replace such Non-
Complying Product as soon as practicable at no additional charge to Purchaser. In
such circumstances, Pfizer will further arrange for reverse logistics for Product
collection and manage the destruction of the Non-Complying Product. Until
collection, Purchaser shall store and maintain the relevant Non-Complying Product
in appropriately secure locations and in accordance with the manufacturers'
specifications. Notwithstanding any other provision ofthis Agreement, this Section
4.4(b) contains Purchaser's sole and exclusive remedy for Non-Complying
Product. The provisions of this Section 4.4 (Rejection of Product; Disposal of
Rejected Shipments) shall survive termination or expiration of this Agreement.
(a) · Each Party shal l maintain detailed Records with respect to its activities under this
Agreement as required by Laws.
(b) Purchaser will maintain a quality system for receipt, inspection, storage,
traceability to further delivery points, and recall activities. If Purchaser does not
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have a quality system for the activities defined, Pfizer may share details of a
proposed quality system for Purchaser's compliance.
All Product delivered to Purchaser shall be: (a) stored securely by Purchaser; and (b)
distributed by Purchaser only in South Africa in a secure manner appropriate to the
transpo1tation route and destination, in each case (a) and (b) to guard against and deter
theft, diversion, tampering, substitution (with, for example, counterfeits) resale or export
out of South Africa, and to protect and preserve the integrity and efficacy of the Product.
Purchaser shall promptly notify Pfizer Quality Department
ProductComplaintsZAF@pfizer.com and Pfizer Adverse Events Reporting by email
ZAF.AEReporting@pfizer.comwithin forty-eight (48) hours (with follow up in writing in
line with the notice provisions of this Agreement) if at any time Purchaser believes that
any of the Product has been stolen, diverted, tampered with, substituted, or otherwise
subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper
storage, improper handling, abnormal physical stress, abnormal environmental conditions
or use contrary to any instructions issued by Pfizer. The notice shall provide all information
relating to the Product diversion, including, but not limited to, detailed information
including the date, time, location, number, batch number(s), expiration
date, circumstances, and contact person(s) information. Purchaser shall cooperate w ith
Pfizer or its designee, upon Pfizer's request, to cooperate in connection with such Product
diversion. Purchaser shall not directly or indirectly resell, export, transfer, donate, or
otherwise distribute Product outside of the Territory without Pfizer's prior written consent.
4.7 Recalls.
Purchaser shall be responsible for all costs of any recall or market withdrawal of the
Product in South Africa, including, without limitation, reasonable costs incurred by or on
behalf of Pfizer and its Affiliates or BioNTech and its Affiliates, except to the extent that
such recall or market withdrawal results from wil lful misconduct (being a wrongful act,
willingly and knowingly committed without legal or factual justification, with the intent to
cause the harmful effects) on the part of, Pfizer or any of its Affiliates or any of their
respective Personnel, in which event Pfizer will be responsible solely for: (a) any
reasonable and documented out of pocket expenses directly incurred by Purchaser to third
parties in implementing such recall or market withdrawal; and (b) replacing, at Pfizer's
expense, the Product which has to be recalled.
5.1 Mutual Representations and Warranties. Pfizer and Purchaser each represents and warrants
to each other the following:
(a) Organization and Authority. It has full right, power and authority to enter into this
Agreement and to perform its respective obligations under this Agreement,
including, in the case of Purchaser, that all necessary authorizations and approvals
have been obtained by Purchaser to authorize its performance of all of its
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obligations contained herein, that Purchaser has the authority to bind the Republic
of South Africa and that Purchaser has exercised that authority to bind the Republic
of South Africa as to each of the provisions and terms and conditions set forth in
this Agreement;
(b) No Conflicts or Violations. The execution and delivery of this Agreement"by such
Party and the performance of such Party's obligations hereunder (i) do not conflict
with or v iolate any Laws existing as of the Effective Date and applicable to such
Party and (ii) do not conflict with, violate, breach or constitute a default under, and
are not prohibited or materially restricted by, any contractual obligations of such
Party existing as of the Effective Date; and
(c) Valid Execution. Such Party is duly authorized to execute and deliver this
Agreement, and the Person executing this Agreement on behalf of such Party is
duly authorized to execute and bind such Party to the terms set f01th herein.
(a) At the time of delivery, the Product (except for any non-compliance or failure to
meet the relevant standard or requirement that cou ld not be reasonably discovered
given the state of medical, scientific or technical knowledge at the time when Pfizer
delivered the Product):
(i) complies in a material manner with the relevant Specifications; and
(ii) has been manufactured in material accordance with current Good
Manufacturing Practices.
(b) Subject to Pfizer's disclaimer ofnon-infringement ofintellectual Prope1ty rights of
a third party (at Section 5.4(a) and (b) below), it has good title to the Product
delivered to Purchaser pursuant to this Agreement and shall pass such title to
Purchaser free and clear of any security interests, liens, or other encumbrances.
(c) The execution, delivery and performance of this Agreement by Pfizer will not
violate any agreement or instrument to which Pfizer is a party.
(a) The Parties represent and warrant that,.beyond the mutual consideration set forth in
this Agreement, neither they nor their agents have provided or requested, or will
provide or request, any additional incentive or benefit to or from the other Party or
its agents to induce either Party to enter this Agreement or perform any part of this
Agreement. ·
(b) Pfizer has not made, and will not make, in the performance of this Agreement
directly or indirectly any payment, offer, promise, or authorization of payment of
money or anything of value to a Government official, political party, candidate for
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political office, or any other Person, and has not sought and will not seek
improperly or corruptly to influence any Government official, political paity,
candidate for political office, or any other Person, in order to gain an improper
business advantage.
(c) The Parties will comply with applicable economic sanctions, import, and expo1t
control laws, regulations, and orders in the performance of this Agreement.
(d) Activities performed under this Agreement will not involve Restricted Parties
(defined as the list of sanctioned parties maintained by the United Nations; the
Specially Designated Nationals List and the Sectoral Sanctions Identifications List,
as administered by the U.S. Department of the Treasury Office of Foreign Assets
Control; the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified
List, all administered by the U.S. Department of Commerce; the entities subject to
restrictive measures and the Consolidated List of Persons, Groups and Entities
Subject to E.U. Financial Sanctions, as implemented by the E.U. Common Foreign
& Security Policy; and similar lists of restricted patties maintained by relevant
governmental entities).
(e) Notwithstanding any other provision of this Agreement, Pfizer shall not be required
to take or refrain from taking any action prohibited or penalized under the laws of
the United States or any applicable non-United States jurisdiction, including,
without limitation, the antiboycott laws administered by the U.S. Commerce and
Treasury Depattments.
Except to the extent set out expressly in this Agreement, all conditions, warranties or other
terms which might have effect between the Patties or be implied or incorporated into this
Agreement (whether by statute, common law or otherwise) are hereby excluded to the
fullest extent permitted by Laws. Without prejudice to the general nature of the previous
sentence, unless this Agreement specifically states otherwise and to the maximum extent
permitted by Law, Pfizer expressly disclaims any representations or warranties with respect
to the Product, including, but not limited to, any representation, warranties or undertaking
as to (a) non-infringement of Intellectual Property rights of any third patty, (b) that there
is no requirement to obtain a license of third party Intellectual Property rights to enable the
use or receipt of the Product, (c) merchantability, or (d) fitness for a particular purpose.
Purchaser 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 Purchaser under this Agreement. Purchaser further acknowledges that
the long-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, Purchaser acknowledges that the Product shall not be serialized.
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6. TERM; TERMINATION.
This Agreement shall commence on the Effective Date and shall continue until the later of
(a) delivery of the Contracted Doses of the Product under the accepted Purchase Order
submitted on the Effective Date, and (b) twenty-four (24) months from the Effective Date,
unless extended or terminated pursuant to this Section 6 (Term; Termination) or the mutual
written agreement of the Parties ("Term").
Either Party may terminate this Agreement immediately upon written notice to the other
Party in the event of a material breach by the other Party of any term of this Agreement,
which breach remains uncured for thirty (30) days following written notice to the other
Party of such material breach. Notwithstanding the foregoing, if such material breach, by
its nature, cannot be cured, the terminating Party may terminate this Agreement
immediately upon written notice to the other Party. In the event that this Agreement is
terminated by Pfizer under this Section 6.2, Purchaser shall pay within thirty (30) days of
the date of notice of termination of this Agreement the full Price for all Contracted Doses
less amounts already paid to Pfizer as of such date.
(a) In the event: (i) the Authorization has not been obtained in the Territory by
30 September 2021 (except in a case where such event is mainly or solely
attributable to Purchaser or any ministry or secretary of the Government of the
Republic of South Africa) Pfizer has supplied to Purchaser no doses of Product by
30 September 2021, subject to the extensions set forth in Section 2.4 (Delivery
Schedule), or (ii) Pfizer is unable to supply all of the Contracted Doses by
December 3 1, 2022, then either Party may terminate this Agreement upon written
notice to the other Party. Purchaser may invoice Pfizer for a refund of fifty percent
(50%) of the Advance Payment for the Contracted Doses not delivered (as
determined ratably for the doses not delivered) except for cases where the cause of
the termination is mainly or solely attributable to Purchaser. In the event this
Agreement is terminated pursuant to this Section 6.3, the return of fifty percent
(50%) Advance Payment shall be Purchaser's sole and exclusive remedy for the
fai lure to deliver any Contracted Doses.
In the event that Pfizer: (a) becomes insolvent, or institutes or has instituted against it a
petition for bankruptcy or is adjudicated bankrupt; or (b) executes a bill of sale, deed of
trust, or a general assignment for the benefit of creditors; or (c) is dissolved or transfers a
substantial portion of its assets to a third party (excluding any of Pfizer's Affiliates); or (d)
has a receiver appointed for the benefit of its creditors, or has a receiver appointed on
account of insolvency; then Pfizer shall immediately notify Purchaser of such event and
Purchaser shall be entitled to terminate this Agreement.
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(i) Purchaser shall pay any sums owed to Pfizer pursuant to this Agreement
within thirty (30) days of the date of invoice for the same; and
(ii) each Party shall use Commercially Reasonable Effo1ts to mitigate both (l)
the damages that would otherwise be recoverable from the other pursuant
to this Agreement, and (2) any costs, fees, expenses or losses that may be
incurred by a Party, or for which a Patty may be responsible, under this
Agreement, by taking appropriate and reasonable actions to reduce or limit
the amount of such damages, costs, fees, expenses or losses.
(b) The termination or expiration of this Agreement shall not affect the survival and
continuing validity of Sections I, 2.1 (b)-(d), 2.5(b), 2.6, 2.7(b)-(e), 2.8, 3.1, 3.3,
3.4, 4.4, 4.5, 4.6, 4.7, 5.4, 5.5, 6.2 (final sentence), 6.5, 7, 8, 9.2, 9.3, 9.4, 9.5, 9.6,
I0, 11 , 12 or of any other provision which is expressly or by implication intended
to continue in force after such termination or expiration.
(c) Expiry or termination of this Agreement for any reason shall be without prejudice
to either Party's other rig hts and remedies or to any accrued rights and liabilities as
the date of such expiry or termination; provided that (i) Pfizer shall have no liability
for any failure by Pfizer to develop or obtain Authorization of the Product in
accordance with the estimated dates described in this Agreement and (ii) even if the
Product is successfully developed and Pfizer obtains Authorization, Pfizer shall
have no liability for any failure to deliver Contracted Doses in accordance with any
estimated delivery dates set forth herein.
7. INTELLECTUAL PROPERTY.
Pfizer US will be the sole owner of all Intellectual Property it generates during the
development, manufacture, and supply of the Product or otherwise related to the Product.
Neither Party will gain any rights of ownership to or use of any property or Intellectual
Property owned by the other (whether by virtue of this Agreement, by implication or
otherwise).
8. INDEMNIFICATION.
8.1 Indemnification by Purchaser. Purchaser hereby agrees to indemnify, defend and hold
harmless Pfizer, BioNTech, each of their Affiliates, contractors, sub-contractors, licensors,
licensees, sub-licensees, distributors, contract manufacturers, services providers, clinical
trial researchers, third parties to whom Pfizer or BioNTech or any of their respective
Affiliates may directly or indirectly owe an indemnity based on the research, development,
manufacture, distribution, commercialization or use of the Vaccine, and each of the
officers, directors, employees and other agents and representatives, and the respective
predecessors, successors and assigns of any of the foregoing ("Indernnitees"), from and
against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements,
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penalties, fines, costs and expenses (including, without limitation, reasonable attorneys'
and other counsels' fees and other expenses of an investigation or litigation), whether
sounding in contract, tort (delict), intellectual property, or any other theory, and whether
legal, statutory, equitable or otherwise by any natural or legal person (collectively,
"Losses") caused by, arising out of, relating to, or resulting from the Vaccine, including
but not limited to any stage of design, development, investigation, formulation, testing,
clinical testing, manufacture, labeling, packaging, transport, storage, distribution,
marketing, promotion, sale, purchase, · licensing, donation, dispensing, prescribing,
administration, provision, or use of the Vaccine, any information, instructions, advice or
guidance provided by Pfizer, or BioNTech or any of their respective Affiliates and relating
to the use of the Vaccine, or any processing or transfer of anyone's personal information
processed and transferred by Purchaser to the Indemnitees ("Covered Activities").
8.2 Assumption of Defense by Purchaser. The Indemnitee(s) shall notify Purchaser of Losses
for which it is seeking indemnification pursuant hereto ("Indemnified Claims"). Upon
such notification, the lndemnitee(s) shall have the option to conduct and control the defense
or to require Purchaser to promptly assume conduct and control of the defense of such
Indemnified Claims with counsel acceptable to lndemnitee(s), whether or not the
Indemnified Claim is rightfully brought; provided, however, that Purchaser shall provide
advance notice in writing of any proposed compromise or settlement of any Indemnified
Claim and in no event may Purchaser compromise or settle any Indemnified Claim without
Indemnitee(s)'s prior written consent, such consent not to be unreasonably withheld.
Indemnitee(s) shall reasonably cooperate with Purchaser in the defense of any Indemnified
Claims conducted and controlled by Purchaser.
8.3 Participation Rights. Each Indemnitee shall have the right to retain its own counsel and to
participate in Purchaser's defense of any Indemnified Claim, at its own cost and expense
except as set forth below. A failure by the Indemnitee(s) to give notice of Indemnified
Claims or to offer to tender the defense of the action or suit pursuant to this Section 8.3
(Participation Rights) shall not limit the obligation of Purchaser under this Section 8
(Indemnification), except and only to the extent Purchaser is actually prejudiced thereby.
8.4 Assumption of Defense. Notwithstanding the foregoing and without prejudice to Section
12.5, Pfizer, directly or through any of its Affiliates or through BioNTech, may elect to
assume control of the defense of an Indemnified Claim (a) within thirty (30) days of
lndemnitee's notice to Purchaser of the Indemnified Claim or (b) at any time if, in Pfizer's
sole discretion: (i) Purchaser fai ls to timely assume the defense of or reasonably defend
such Indemnified Claim(s) in good faith to the satisfaction of Pfizer (or Pfizer's Affiliates
and BioNTech); or (ii) Pfizer believes (or any of Pfizer's Affiliates or BioNTech believe)
in good faith that a bona fide conflict exists between Indemnitee(s) and Purchaser with
respect to an Indemnified Claim hereunder. Upon written notice of such election, Pfizer
shall have the right to assume control of such defense (directly or through either one of its
Affiliates or BioNTech), and Purchaser shall pay (as incurred and on demand), all Losses,
including, without limitation, the reasonable attorneys' fees and other expenses incurred
by Indemnitee(s), in connection with the Indemnified Claim. In all events, Purchaser shall
cooperate with Indemnitee(s) in the defense, settlement or compromise of the Indemnified
Claim.
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8.5 Privileges and Immunities. Purchaser acknowledges that its indemnification obligations
under this Agreement are (a) expressly in addition to, and not limited by, any Privileges
and Immunities, and (b) do not waive or relinquish Indemnitees' rights to any Privileges
and Immunities.
8.6 Costs. Costs and expenses, including, without limitation, fees and disbursements of
counsel, incurred by the Indemnitee(s) in connection with any Indemnified Claim shall be
reimbursed on a qua,terly basis by Purchaser, without prejudice to Purchaser's right to
refund in the event that Purchaser is ultimately held in a final, non-appealable judgment or
award to be not obligated to indemnify the Indemnitee(s).
9.1 Insurance.
During the Term, Pfizer or its Affiliates shall self-insure or procure and maintain such types
and amounts of general liability insurance to cover liabilities related to its activities under
this Agreement as is normal and customary in the pharmaceutical industry generally for
companies that are similarly situated and providing similar manufacturing and supply
services. For absolute clarity, this shall not include, nor constitute, product liability
insurance to cover any third party/patients claims and such general liability insurance shall
be without prejudice to Purchaser's indemnification obligation as set out in this Agreement.
(a) Subject to the exclusions set forth in Section 9.3, in no circumstances shall (i) either
Party be liable to the other Party or its Affiliates, whether arising in tort (including,
without limitation, negligence), contract or otherwise, for any indirect, special,
consequential, incidental or punitive damages, whether in contract, warranty, tort,
negligence, strict liability or otherwise arising out of or relating to this Agreement,
the transactions contemplated therein or any breach thereof (whether or not
reasonably foreseeable and even if the first Party had been advised of the possibility
of the other Party incurring such loss or type of loss), and (ii) in the case of Pfizer
and its Affiliates, in no event shall Pfizer be liable to Purchaser for any direct
damages except to the extent such direct damages were a result of a material breach
of a representation or warranty by Pfizer under this Agreement that directly and
solely caused the damage. In no instance shall Pfizer and its Affiliates be liable to
Purchaser (whether arising in warranty, tort (including, without limitation,
negligence), contract, strict liability or otherwise) for any liabilities of Purchaser to
any third party, including, without limitation, through contribution, indemnity, or
for any claim for which Purchaser would have to indemnify Pfizer if that claim
were brought directly against Pfizer.
(b) The aggregate liability of Pfizer and its Affiliates (whether arising in warranty, tort
(including, without limitation, negligence, contract, strict liability or otherwise)
arising out of, under or in connection with this Agreement shall not exceed a sum
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equivalent to one hundred percent (I 00%) of the total Price actually received by
Pfizer under this Agreement for the Contracted Doses.
Nothing in this Agreement excludes or limits the liability of either Patty for:
(iv) in the case of Purchaser, failure to pay the Price for the Product or any other
sums properly owing to Pfizer under this Agreement.
9.4 Waiver of Sovereign Immunity. Purchaser, on behalf of itself and the Republic of South
Africa, expressly and irrevocably waives any right of immunity which either it or its assets
may have or acquire in the future (whether characterized as sovereign immunity or any
other type of immunity), including any assets controlled by any agency, instrumentality,
central bank, or monetary authority of the Republic of South Africa as specified by 28
U.S.C. § 1611 in respect of any arbitration pursuant to Section 12.2 (Arbitration) or any
other legal procedure init iated to confirm or enforce any arbitral decision, order or award,
or any settlement in connection with any arbitration pursuant to Section 12.2 (Arbitration),
whether in the Republic of South Africa or any other foreign jurisdiction, including but not
limited to immunity against service of process, immunity of jurisdiction, immunity against
any judgment rendered by a court or tribunal (including any interim award or decision),
immunity against any order to enforce the judgment, and immunity against precautionary
seizure of any of its assets. Purchaser, on behalfof itself and the Republic of South Africa,
further covenants and agrees not to assert any such immunity in any proceeding in
connection with this Agreement. Purchaser, on behalf of itself and the Republic of South
Africa expressly and irrevocably submits to the jurisdiction of the courts of New York, or
any other cou1t of competent jurisdiction, for the purposes of enforcing any arbitral
decision, order or award, or any settlement in connection with any arbitration pursuant to
Section 12.2 and represents and warrants that the person signing this Agreement on its
behalf has actual authority to submit to such jurisdiction. Purchaser also expressly and
irrevocably waives the application of any Law in any jurisdiction that may otherwise limit
or cap its obligation to pay damages arising from or in connection with any Indemnified
Claims. Purchaser represents and warrants that the person signing this Agreement on its
behalf has actual authority to waive such immunity and bind Purchaser and the Republic
of South Africa to the limitations of liability and liability waivers set forth herein.
9.5 Vaccine Compensation Program. Purchaser covenants and agrees that Purchaser shall, by
no later than April 30, 2021, create, dedicate, and maintain a no-fault compensation fund
sufficient to undertake and completely fulfil the indemnification obligations in the
Definitive Agreement (the "Dedicated Fund"). Purchaser shall provide that any claim for
damage, inj ury, or harm arising out of, relating to, or resulting from the development,
Page 26 of 46
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administration, or use of the Vaccine in the Territory or supplied under this Definitive
Agreement - whether occurring before or after the creation of the Dedicated Fund - shall
be within the scope of, and eligible for compensation under, the Dedicated Fund.
(a) Purchaser represents that it has and will continue to have adequate statutory or
regulatory authority and adequate funding appropriation to undertake and
completely fulfil the indemnification obligations and provide adequate protection
to Pfizer and all Indemnitees from liability for claims and all Losses arising out of
or in connection with the Vaccine or its use.
(b) Purchaser hereby covenants, acknowledges, and agrees that the following are
conditions precedent to supply of the Vaccine:
(ii) Purchaser shall implement and maintain the Dedicated Fund pursuant to
Section 9.5 of this Agreement; and
(c) Purchaser acknowledges that (a) Pfizer's supply of Product hereunder is in reliance
(without any duty of investigation or confirmatio n by or on behalf of Pfizer or its
Affiliates), inter alia, on Purchaser's representations and covenants under this
Section 9.6, Purchaser implementing and maintaining in effect the requirements
and funding appropriation described in this Section 9.6 and the other
representations and warranties made by Purchaser under this Agreement, and (b) in
assessi ng the cost and pricing of the Vaccine pursuant to this Agreement, Pfizer
took into account the above-mentioned indemnity and liability protections and
accordingly consider such indemnity and liability protection as fundamental
elements of this Agreement.
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(d) For the avoidance of doubt, each of the requirements under this Section 9.6 must
be satisfied before supply or continued supply of the Vaccine. The satisfaction of
all such conditions precedent shall be determined by Pfizer, at its sole discretion.
If any condition precedent is not satisfied, Pfizer may nonetheless elect to supply
doses, at its sole discretion. Pfizer's paitial performance under this Agreement,
including any elective supply under this Section 9.6(d) shall not constitute waiver.
If Pfizer determines in its sole discretion that fulfilment of any condition under this
Section 9.6 lapses or otherwise becomes unsatisfactory, then Pfizer shall not be
obligated to supply any further Vaccine
Each Recipient shall, and shall cause its Representatives which have access to the
Disclosing Party's Confidential Information to, maintain in strict confidence, and shall not
disclose to any third party, all Confidential Information observed by or disclosed to it by
or on behalf of the Disclosing Party pursuant to this Agreement. Each Recipient shall not
use or disclose such Confidential Information except as permitted by this Agreement. Each
Recipient shall safeguard the confidential and proprietary nature of the Disclosing Party's
Confidential Information w ith at least the same degree of care as it holds its own
confidential or proprietary information oflike kind, which shall be no less than a reasonable
degree of care. The Recipient and its Representatives may use, copy, and make extracts of
the Disclosing Party's Confidential Information only in connection with fulfilling its
obligations under this Agreement and, without limiting the foregoing, shall not use the
Confidential Information for the benefit of the Recipient or any of its Representatives, or
for the benefit of any other Person. In the event that Recipient becomes aware of any
breach of the obligations contained in this Section IO (Confidential Information) by it or
its Representatives, Recipient shall promptly notify the Disclosing Party in writing of such
breach and all facts known to Recipient regarding same. In addition, if Recipient is
required to disclose the Disclosing Party's Confidential Information in connection with any
court order, statute or Government directive or requirement under any Law, Recipient shall
give the Disclosing Party notice of such request, as soon as practicable, before such
Confidential Information is disclosed so that the Disclosing Party may seek an appropriate
protective order or other remedy, or waive compliance with the relevant provisions of this
Agreement. If the Disclosing Party seeks a protective order or other remedy, Recipient
shall promptly cooperate with and reasonably assist the Disclosing Party (at the Disclosing
Party's cost) in such efforts. If the Disclosing Party fails to obtain a protective order or
waives compliance with the relevant provisions of this Agreement, Recipient shall disclose
only that portion of Confidential Information which its legal counsel determines it is
required to disclose. Neither this Agreement nor the performance by either Party hereunder
shall transfer to the Recipient any proprietary right, title, interest or claim in or to any of
the Disclosing Party's Confidential Information (including, but not limited to, any
Intellectual Property rights subsisting therein) or be construed as granting a license in its
Confidential Information. Notwithstanding the foregoing, in all cases, (a) Purchaser may
not disclose any of the financial or indemnification provisions contained in this Agreement,
including, without limitation, the price per dose of Product or refundability of the Advance
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Payment or any information that could reasonably ascertain the price per dose of Product,
without the prior written consent of Pfizer, and (b) Pfizer may disclose (i) Confidential
Information to its Affiliates and BioNTech without prior written consent of Purchaser, and
(ii) upon foreign government request, financial information relating to this Agreement,
including cost per dose.
Upon the written request of the Disclosing Party, Recipient shall promptly return or, at the
Recipient's option, delete or destroy all Confidential Information of the Disclosing Party
(including, without limitation, all copies in whatever medium provided to, or made by,
such recipient); provided, however, that, subject to the terms of this Agreement, (i)
Recipient shall be entitled to retain one archival copy of such Confidential Information for
purposes of determining its obligations under this Agreement; and (ii) Recipient shall not
be required to destroy any computer files stored securely by the Recipients or its Affiliates
that are created during automatic system back up, or retained for legal purposes by the legal
division of the Recipient and its Affiliates, provided that such retained Confidential
Information shall remain subject to the terms of this Agreement. Notwithstanding
Recipient's return or destruction of Confidential Information, Recipient shall continue to
be bound by its obligation of confidentiality and non-use under this Agreement.
I 0.4 Survival.
The provisions of this Section 10 (Confidential Information) shall survive the termination
or expiration of the this Agreement for a period of ten (I 0) years, except with respect to
any information that constitutes a trade secret (as defined under Law), in which case the
recipient of such information will continue to be bound by its obligations under this Section
10 (Confidential Information) for so long as such information continues to constitute a
trade secret, but in no event for a period of less than the ten ( 10)-year period specified
above.
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11 . NOTICES.
Any notice required to be given hereunder shall be in writing and deemed to have been sufficiently
given, (a) when delivered in person, (b) on the next Business Day after mailing by overnight
courier service, or, where overnight courier service is unavailable, by other expedited delivery
provided by a recognized express courier, or (c) when delivered via e-mail, provided the original
is delivered via one of the preceding methods on or prior to the fifth (5th) Business Day after
transmission of the e-mail, to the addresses specified below. Each notice shall specify the name
and date of and parties to this Agreement.
Redacted by HJI
4 Sept 2023
If to Pfizer: With a copy (which shall not constitute
notice) to:
Pfizer Laboratories (Pty) Ltd
85 Bute Lane Pfizer Laboratories (Pty) Ltd
Sandton 85 Bute Lane
Johannesburg Sandton
South Africa Johannesburg
2196 South Africa
Attention: Country Manager 2 196
Attention: Legal Director
Either Party may, by notice to the other Party, change the addresses and names given above.
12. MISCELLANEOUS.
Prior to commencing any arbitration with respect to any controversy, claim, counterclaim,
dispute, difference or misunderstanding arising out of or relating to the interpretation or
application of any term or provisions of this Agreement, a Party shall provide written notice
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to the other Party of the existence of such dispute. The Parties shall for a period of thirty
(30) days following such notice enter into good faith discussions and negotiations in an
attempt to resolve such dispute. If, by the end of such thirty (30) day period, unless such
period is extended by mutual written agreement of the Parties, the Parties have been unable
to resolve such dispute, either Party may initiate arbitration in accordance with the
procedures set fotth in Section I 2.2 (Arbitration). The procedures specified in this Section
12.1 (Negotiations of Dispute) are a precondition to the initiation of arbitration by a Party,
in connection with disputes between the Parties arising from or related to this Agreement
or a Purchase Order; provided, however, that a Party may seek a preliminary injunction or
other preliminary judicial relief, without attempting to resolve such dispute as provided in
this Section 12.1 (Negotiations of Dispute), if in its judgment such action is necessary to
avoid irreparable harm. The Patties expressly and irrevocably submit to the jurisdiction of
the courts of New York, New York, U.S.A· for any such injunctive relief. Further, the
requirement to attempt to resolve a dispute in accordance with this Section I 2.1
(Negotiations of Dispute) does not affect a Party's right to terminate this Agreement as
provided in Section 6 hereof, and neither Party shall be required to follow these procedures
prior to terminating the Agreement. The failure of either Party to participate in good faith
discussions and negotiations in an attempt to resolve such dispute shall not delay the date
by which the other Party may initiate arbitration under this Section I 2. I (Negotiations of
Dispute).
12.2 Arbitration.
Any dispute, controversy, or claim arising out of, relating to, or in connection with this
Agreement, including with respect to the formation, applicability, breach, termination,
validity or enforceability thereof, or relating to arbitrability or the scope and application of
this Section 12.2 (Arbitration), shall be finally resolved by arbitration. The arbitration shall
be conducted by three arbitrators, in accordance with the Rules of Arbitration of the
International Chamber of Commerce ("ICC"). The claimant shall nominate an arbitrator
in its request for arbitration. The respondent shall nominate an arbitrator within thirty (30)
days of the receipt of the request for arbitration. The two (2) arbitrators nominated by the
Parties shall nominate a third arbitrator, in consultation with the Parties, within thirty (30)
days after the confirmation of the later-nominated arbitrator. The third arbitrator shall act
as chair of the tribunal. If any of the three (3) arbitrators are not nominated within the time
prescribed above, then the ICC shall appoint the arbitrator(s). The seat of the arbitration
shall be New York, New York, U.S.A. and it shall be conducted in the English language.
The Parties undertake to maintain confidentiality as to all aspects of the arbitration,
including its existence, content and result, and as to all submissions, correspondence and
evidence relating to the arbitration proceedings. The foregoing sentence shall survive the
termination of the arbitral proceedings. Notwithstanding the foregoing, a Party may
disclose information relating to the arbitration proceedings to the extent that disclosure is
required to protect or pursue a legal right related to the arbitration; enforce or challenge an
award in bona fide legal proceedings; respond to a bona fide compulsory order or request
for information of a governmental or regulatory body; make a disclosure required by
securities laws, rules of a securities exchange, or other similar laws, regulations, or rules;
or seek legal, accounting, or other professional services. The costs of the arbitration,
including, without limitation, the Parties' reasonable legal fees, shall be borne by the
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unsuccessful Party or Parties. However, the arbitral tribunal may appo1tion such costs
between the Parties if it determines that appo1tionment is reasonable, taking into account
the circumstances of the case. The arbitration award shall be final and binding on the
Paities, and the parties unde1take to carry out any award without delay. Judgment upon
the award may be entered by any court having jurisdiction of the award or having
jurisdiction over the relevant party or its assets.
12.3 Publicity.
A Party shall not use the name, trade name, service marks, trademarks, trade dress or logos
of the other Party in publicity releases, advertising or any other publication, without the
other Party's prior written consent in each instance.
All disputes shall be governed by the Laws of the State ofNew York, USA, without regard
,,-, to conflict of Law principles other than Section 5-1401 of the New York General
Obligations Law, except that any dispute regarding the arbitrability or the scope and
application of this Section shall be governed by the Federal Arbitration Act of the United
States.
(a) Purchaser agrees the applicable rights granted or provided to Pfizer under this
Agreement are also granted or provided to Pfizer' s Affiliates or to BioNTech to the
extent that those rights relate to such Affiliates or BioNTech, including but not
limited to the indemnification in Section 8(a) (each a "Third Party Beneficiary"
and together the "Third Party Beneficiaries"). Each Third Party Beneficiary shall
be entitled to enforce the terms of this Agreement; provided that, to the extent
permissible by Law and where reasonably practicable, any claims, demands or
actions from any Third Party Beneficiary shall be brought by Pfizer itself on behalf
of the relevant Third Party Beneficiary.
(b) Any Losses suffered by a Third Party Beneficiary will not be treated as being
indirect solely because it has been suffered by a Third Party Beneficiary and not by
Pfizer directly.
The relationship hereby established between Purchaser and Pfizer is solely that of
independent contractors. Neither Party has authority to act or make any agreements or
representations on behalf of the other Party. This Agreement is not intended to create, and
shall not be construed as creating, between Pfizer and Purchaser, the relationship of
principal and agent, employer and employee, joint venture rs, co-partners, or any other such
relationship, the existence of which is expressly denied.
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CONFIDENTIAL
Neither Purchaser nor Pfizer shall assign any of its rights or delegate or subcontract any of
its duties and obligations under this Agreement without the prior written consent of the
other Pa,ty, which may be withheld at such Party's discretion, provided that Pfizer, without
Purchaser's consent, may assign, delegate or subcontract any of its duties and obligations
under this Agreement to an Affiliate of Pfizer, BioNTech or an Affiliate of BioNTech. Any
such attempted assignment of rights or delegation or subcontracting of duties without the
required prior written consent of the other Party shall be void and ineffective. Any such
assignment, delegation or subcontracting consented to by a Party in writing shall not relieve
the other Party of its responsibilities and liabilities hereunder and such assigning Party shall
remain liable to other Party for the conduct and performance of each permitted assignee,
delegate and subcontractor hereunder. This Agreement shall apply to, inure to the benefit
of and be binding upon the Parties hereto and their respective successors and permitted
assigns. The Parties agree that this Agreement is not intended by either Party to give any
benefits, rights, privileges, actions or remedies to any Person or entity, partnership, firm or
corporation as a third party beneficiary or otherwise under any theory of Law.
Neither Party shall be liable for any failure to perform or any delays in performance, and
neither Party shall be deemed to be in breach or default of its obligations set forth in this
Agreement, if, to the extent and for so long as, such failure or delay is due to any causes
that are beyond its reasonable control and not to its acts or omissions, including, without
limitation, such causes as acts of God, natural disasters, flood, severe storm, earthquake,
civil disturbance, lockout, riot, order of any court or administrative body, embargo, acts of
Government (other than Purchaser), war (whether or not declared), acts of terrorism, the
impact on a Party of an outbreak of any disease or an epidemic or pandemic or other similar
causes ("Force Majeure Event"). Failure or inability to pay shall not be a basis for a Force
Majeure Event under this Agreement. In the event of a Force Majeure Event, the Party
prevented from or delayed in performing shall promptly give notice to the other Party and
shall use Commercially Reasonable Efforts to avoid or minimize the delay.
12.9 Severability.
If and solely to the extent that any court or tribunal of competent jurisdiction holds any
provision of this Agreement to be unenforceable in a final non-appealable order, such
unenforceable provision shall be stricken and the remainder of this Agreement shall not be
affected thereby. In such event, the Parties shall in good faith attempt to replace any
unenforceable provision of this Agreement with a provision that is enforceable and that
comes as close as possible to expressing the intention of the original provision.
A waiver by any Party of any term or condition of this Agreement in any instance shall not
be deemed or construed to be a waiver of such term or condition for the future, or of any
subsequent breach thereof. All remedies specified in this Agreement shall be cumulative
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CONFIDENTIAL
Each Party hereto agrees to execute such further documents and take such further steps as
may be reasonably necessary or desirable to effectuate the purposes of this Agreement.
12.12 Forms.
The Parties recognize that, during the Term, a Purchase Order acknowledgment form or
similar routine document (collectively, "Forms") may be used to implement or administer
provisions of this Agreement. The Parties agree that the terms of this Agreement shall
prevail in the event of any conflict between terms of this Agreement and the terms of such
Forms, and any additional or different terms contained in such Forms shall not apply to
this Agreement.
12.13 Headings.
Headings of Sections or other parts of this Agreement are included herein for convenience
of reference only and shall not constitute a part of this Agreement or change the meaning
of this Agreement.
12.14 Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall
constitute an original and all of which together shall constitute one and the same agreement,
and shall become effective when signed by each of the Parties hereto and delivered to the
other Party in accordance with the means set forth in Section 11 (Notices) or by reliable
electronic means (with receipt electronically confirmed).
This Agreement, together with any attachments and amendments (and as such attachments
may be amended, amended and restated or replaced from time to time), which are hereby
incorporated by reference, constitute the entire agreement of the Patties with respect to its
subject matter and merges and supersedes all prior discussions and writings with respect to
thereto, including the Binding Term Sheet. Except as otherwise set out herein; no
modification or alteration of this Agreement shall be binding upon the Patties unless
contained in a writing signed by a duly authorized agent for each respective Paity and
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The Patties have pa1ticipated jointly in the negotiation and drafting of this Agreement. In
the event that an ambiguity or question of intent or interpretation arises, this Agreement
shall be construed as if drafted jointly by the Parties and no presumption or burden of proof
shall arise favoring or disfavoring any Party by virtue of the authorship of any of the
provisions of this Agreement.
This Agreement shall be written and executed in, and all other communications under or
in connection with this Agreement shall be in, the English language. Any translation into
any other language shall not be an official version thereof, and in the event of any conflict
in interpretation between the English version and such translation, the English version shall
control.
Each Party will bear its own legal costs in preparing and concluding this Agreement.
Page 35 of 46
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed and
delivered as of the date first written above.
01-04-2021
Title: Cluster Lead: SSA and Country Title: Director General of Health
Manager: South Africa
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Attachment A - Specifications
Page 37 of 46
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Attachment C - Delivery Documentation
[tis currently envisaged that the following will be provided with each shipment of the Products:
1. Fact Sheets/Leaflets - Five (5) fact sheets folded 3x2" in a plastic bag
2. Pfizer Brochure - One (I) 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 SOS for Dry lee
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)
5. Contents Label - One (1) label on inside flap, picking label details how many carton trays are in
thermal shipper
Currently, Pfizer 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 example* below:
1Z8'K..8YJ'1(.o"i08JG1
.D..t..loos!.cl0~'C)"I
Alltmott Ind1ln11.ll.Mmlm.l.0
SICONflLE
~.i
,c,~
~if:t~t~ltffi:tfl~i~ii,:!iill~H¼!
wqi;t,r-~t.•t f_lo'ffe:l."1tS,!,Jl'-,-.r,. 1 U J ;.o H:."'f
i! ~~~~R~~;E!!~~~
CLJRON,.SP((.'tAllY PlwtMACY ~io=-ordoll\ll'!Kd
ueo COO,OflA r'OIH1'£ CT . , , . ~ , . 0, tolMIDGKtod c.o.o.
&.,~
~~CA.U';, ~'.m..!:!.a~'t
08/21/20!0. U :21 A.M
Tt1ticM;OtMl'V
Page 39 of 46
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sss
Attachment D - Delivery Specification
Purchaser ensures that at the expected time of arrival at the Place(s) of Destination 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:
• The Product has a shelf-life ofup to 6 months when stored at a constant-75 °C (+/- 15 °C)
• The Thermal Shipper can be used as temporary storage for up to 30 days, as long as dry
ice is replenished upon receipt and at least every five (5) days per Pfizer's guidelines.
• The Product has an effective life ofup 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 (2-25°C)
Any further shipment or distribution of the Product by Purchaser from the Place(s) of Destination
shall be through a certified shipping service, or use of its own logistics system, that will ensure
next day delivery from the Place(s) of Destination to point of use of the Product; and Purchaser
shall be liable for ensuring continual compliance with the Good Distribution Practices ("GDP")
including cold chain requirements for any further distribution following delivery to a Place of
Destination that is not a point of use of the Product. In all cases, Purchaser shall ensure that all
Product is transported via a GDP qualified shipping system. Purchaser acknowledges that the
Thermal Shipper (including Pfizer temperature monitoring devices) shall not be utilized for any
in-market transportation and/or distribution by the Purchaser and shall be returned to Pfizer in
accordance with Attachment F - Return and Disposal of Product Materials of this Agreement.
Subj ect to the terms of the Agreement, all costs associated with receiving, handling, storing and
further delivery of the Product shall be the responsibility of Purchaser, and Purchaser shall ensure
that all locations where any Product is delivered by, or on behalf of Purchaser, shall comply with
the requirements set forth in this Attachment D and shall meet the standards set forth herein.
Page 40 of 46
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CONFIDENTIAL
Protocols for Unpacking Product and Re-icing: See Exhibits I and 2 of Attachment D
-
~
Shipper Apdf
-
~
Shipper B.pdf
• From storage, remove I vial for every 6 recipients according to planned vaccinations schedule.
• Vials may be stored in the refrigerator for 5 days (120 hours).
• 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 of0.9% 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.
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• 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.
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Attachment E - Labelling and Packaging Specifications
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 (NOC) number.
• Linear barcode: Scans as the GTIN number that includes the human-readable NOC 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 Product Insert (i.e. e-leaflet) will be available.
• 2D GS 1 DataMatrix: Scan of the 2D code will include the GTIN number, lot and expiry
information.
Page43 of 46
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Attachment F - 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.).
B. Disposal
"Primary Container Units" refers to the v ials 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 centers.
Page 44 of 46
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Attachment G - Form of Purchase Order
• Purchase details
• PONumber
• Currency
• Creation Date
• Requested Date
• Incoterm
• Ship-To location details
• Item Description
• Quantity
• Price and Total Value
• Payment terms
,.,........
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• Any other documents not included in the above-mentioned list of documents, including
but not limited to imp01t permits, will be waived by the Purchaser or any other
Government authority.
• Any required analysis to release any of the shipments upon arrival at the port of entry
and/or Place(s) of Destination will be waived by the Purchaser or any other Government
authority.
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