Document:

Valneva SE 20-F

Exhibit
4.3

 

DESCRIPTION
OF SECURITIES REGISTERED PURSUANT TO

SECTION
12 OF THE SECURITIES EXCHANGE ACT OF 1934

 

The
following description of the ordinary shares, the American Depositary Shares and the articles of association, or bylaws, of Valneva
SE (“Valneva,” the “Company,” “us” or “we”) is a summary and does not purport to be
complete. This summary is subject to, and qualified in its entirety by reference to, the complete text of the Company’s
bylaws, which are incorporated by reference as Exhibit 3.1 of the Company’s Annual Report on Form 20-F to which this
description is also an exhibit. The Company encourages you to read the Company’s bylaws carefully.

 

As
of December 31, 2021, Valneva had the following series of securities registered pursuant to Section 12(b) of the Securities Exchange
Act of 1934, as amended, or the Exchange Act: 

	 	 	 
	Title
    of Each Class	Trading
    Symbol	Name
    of Each Exchange on Which 

Registered
	Ordinary
    Shares, nominal value €0.15 per share*	*	The
    Nasdaq Global Select Market*
	American
    Depositary Shares, each representing two ordinary shares, nominal value €0.15 per share	VALN	The
    Nasdaq Global Select Market

*
Not for trading, but only in connection with the registration of the American Depositary Shares.

 

ORDINARY
SHARES

 

As
of December 31, 2021, our issued share capital consisted of a total of 105,190,223 ordinary shares with a nominal value of €0.15
per share and 48,862 preferred shares convertible into ordinary shares, also with a nominal value of €0.15 per preferred
share. Of these 105,190,223 issued ordinary shares, 105,065,901 shares are outstanding and 124,322 are treasury shares.

 

The
description below reflects the terms of our bylaws and summarizes the material rights of holders of our ordinary shares under
French law. Please note that this is only a summary and is not intended to be exhaustive. For further information, please refer
to the full text of our bylaws, which are incorporated by reference as Exhibit 3.1 of the Company’s Annual Report on Form
20-F to which this description is also an exhibit.

 

Business
Purpose 

 

Our
business purpose, within France and in every country is the following:

 

		•	research
                                         and development within the field of biomedicine and pharmacy;

 

		•	commercial
                                         exploitation of patents and know-how;

 

		•	trading
                                         in products of all kinds, and the provision of services in the field of data processing
                                         and information technology;

 

		•	production,
                                         monitoring and marketing of all products, services and research programs with applications
                                         to human and animal health, using the technologies of molecular and cellular biology
                                         and all of the associated techniques;

 

		•	participation
                                         of the Company by all means, direct or indirect, in all operations which may be associated
                                         with its company object, though the creation of new companies, contributions, subscription
                                         or purchase of securities or company rights, mergers or otherwise, the creation, acquisition,
                                         leasing, lease management of all patents regarding these activities, within France and
                                         abroad;

 

     

     

    

 

and
more generally, all industrial, commercial or financial, securities or property operations, which may be directly or indirectly
associated with its business object or likely to favor its exploitation, realization or development.

 

Management
Board 

 

The
Management Board is responsible for our management and is composed of a minimum of two members and a maximum of seven members
who perform their duties under the supervision of the Supervisory Board.

 

Members
of the Management Board 

 

The
members of the Management Board are appointed or have their appointments renewed by the Supervisory Board. The members of the
Management Board must be individuals. They are not required to be shareholders. They may be French citizens or citizens of other
countries. Members of the Management Board cannot be members of the Supervisory Board.

 

The
maximum age for being a member of the Management Board and the limitations on having such an appointment concurrently with an
appointment in another company are subject to our bylaws and the applicable legal and regulatory provisions. The age limit for
the exercise of duties for a member of the Management Board is seventy years of age. A member of the Management Board is deemed
to have resigned automatically at the end of the financial year during which the member reaches such age.

 

The
term of office for the members of the Management Board is three years and may be renewed. If there is a vacancy, the Supervisory
Board must fill the vacancy within two months. The replacement is appointed for the time remaining until the Management Board
is up for renewal. A member of the Supervisory Board may be appointed by the Supervisory Board to exercise the duties of a member
of the Management Board for the remaining period until the renewal of the Management Board, provided that such period lasts no
more than six months. During this period, the duties of the party in question on the Supervisory Board shall be suspended.

 

The
members of the Management Board may be removed from office, with or without cause, by the Supervisory Board or at any General
Meeting of shareholders, by a simple majority vote.

 

Chairman
of the Management Board 

 

The
Supervisory Board elects a Chairman from among the members of the Management Board to serve for the duration of his appointment
as a member of the Management Board. The Chairman of the Management Board represents us in our relations with third parties.

 

The
Supervisory Board may assign this power of representation to one or more other members of the Management Board. Assignees have
the title of Managing Director.

 

Meetings
and Powers of the Management Board 

 

The
Management Board meets as often as is in the Company’s interest and is required to submit a report to the Supervisory Board at
least once per quarter which summarizes the principal actions or events occurring in the management of the Company. Meetings are
called by the Management Board’s Chairman, its Directeur Général or by at least half of its members.

 

At
least half of the members of the Management Board must be present to constitute a quorum and decisions are made by a majority
of the members of the Management Board present or represented, unless the Management Board has only two members, in which case
decisions must be unanimous.

 

The
Management Board has broad power to act under all circumstances on our behalf. It exercises this power within the limits of our
business purpose and subject to any powers expressly given to the Supervisory Board and Shareholders’ Meetings by law and
according to our bylaws, and abiding by any restrictions on powers decided by the Supervisory Board.

 

     

     

    

Compensation
of the Management Board 

 

The
method and amount of compensation for each member of the Management Board is determined by the Supervisory Board when appointing
such member.

 

Supervisory
Board 

 

Members
of the Supervisory Board 

 

The
Management Board is supervised by a Supervisory Board made up of a minimum of three members and a maximum of eighteen. The members
of the Supervisory Board are appointed for a renewable term of three years at the General Meeting of shareholders, which may revoke
their appointments at any time. The appointees are selected from among the shareholders and may be individuals or companies. Members
of the Supervisory Board cannot be members of the Management Board.

 

The
maximum age for membership on the Supervisory Board is eighty years old.

 

Chairman
of the Supervisory Board 

 

The
Supervisory Board appoints from its members who are individuals a Chairman and a Deputy Chairman, who are in charge of convening
the Supervisory Board and directing its discussions.

 

In
a report to the General Meeting of shareholders attached to the Management Board’s Management Report, the Chairman of the
Supervisory Board reports on the conditions for preparing and organizing the work of the Supervisory Board as well as the internal
control procedures set up by us.

 

Meetings
and Powers of the Supervisory Board 

 

The
Supervisory Board meets as often as is in our interests but least once per quarter. Meetings are called by the Chairman or Vice
Chairman, or by a member of the Management Board, under the circumstances and according to the conditions set forth in the bylaws.

 

Supervisory
Board meetings may also be held (i) by videoconference or any other electronic means of telecommunication or remote transmission,
or (ii) by written decision on the conditions and within the limits provided for by law.

 

At
least half of the members of the Supervisory Board must be present to constitute a quorum and decisions are made by a majority
of the members of the Supervisory Board present or represented. In the case of a tie vote, the Chairman of the Supervisory Board
shall have the deciding vote.

 

The
Supervisory Board exercises permanent control over our management by the Management Board and the powers explicitly conferred
on it by the French laws. It alone has the authority to authorize certain significant transactions.

 

Under
French law, any agreement entered into, directly or through an intermediary, between us and one of the members of the Management
Board or Supervisory Board, or a shareholder that holds over 10% of the voting rights, or, if such shareholder is a company, the
controlling company thereof, must be subject to prior authorization from the Supervisory Board. The interested member cannot vote
on such decision. The same applies to agreements in which a person referred above has an indirect interest. Such prior authorization
also applies to agreements between us and another company if one of the members of our Management Board or Supervisory Board is
the owner, a partner with unlimited liability, manager, director, managing director, member of the Management Board or of the
Supervisory Board, or, in a general manner is in a position of responsibility within the other company. These provisions are not
applicable to agreements concerning ordinary operations entered into under normal conditions.

 

     

     

    

Compensation
of the Supervisory Board 

 

Compensation
for attendance at board meetings is determined at the annual ordinary General Meeting. The General Meeting of shareholders may
allocate an annual fixed sum and our Supervisory Board allocates this sum among its members as it sees fit. In addition, the Supervisory
Board may allocate exceptional compensation (rémunération exceptionnelle) for missions or mandates entrusted
to its members; in this case, this remuneration is subject to the provisions regarding related-parties agreements.

 

Committees

 

The
Supervisory Board may decide to establish committees responsible for reviewing matters which the Supervisory Board or its Chairman
wish to submit to them for examination and advice.

 

Supervisory
Board Observers 

 

The
Supervisory Board may appoint one or more observers

 

The
observers may attend all Supervisory Board meetings, with the right to speak but not to vote. They hold the same information and
communication rights as the Supervisory Board’s members and they are bound to the same confidentiality obligations.

 

Rights
and Obligations Attached to Ordinary Shares 

 

Each
of our ordinary shares gives the right to a share of the profits and assets in proportion to the amount of capital it represents.
It also gives the right to vote and be represented in the General Meeting of shareholders under the conditions set forth by the
law and the bylaws.

 

If
we are liquidated, any assets remaining after payment of the debts, liquidation expenses and all of the remaining obligations
will first be used to repay in full the par value of our ordinary shares. Any surplus will be distributed pro rata among shareholders
in proportion to the number of ordinary shares respectively held by them, taking into account, where applicable, of the rights
attached to ordinary shares of different classes.

 

Shareholders
are liable for corporate liabilities only up to the par value of the ordinary shares they hold; they are not liable to further
capital calls.

 

We
have not issued any ordinary shares giving holders privileged rights compared to those attached to other ordinary shares.

 

Shareholders’
rights may be modified as allowed by French law. Only the extraordinary shareholders’ meeting is authorized to amend any
and all provisions of our bylaws. It may not, however, increase shareholder commitments without the prior approval of each shareholder.

 

Voting
Rights 

 

The
voting rights attached to the ordinary shares are in proportion to the amount of capital they represent and each share gives the
right to one vote. However, ordinary shares fully paid up and evidenced as having been held in registered form in the name of
the same shareholder for at least two years, carry a double voting right in respect to that granted to other ordinary shares,
according to the portion of share capital they represent. The ownership of a share implies, ipso facto, the acceptance of our
bylaws and any decision of our shareholders. However, ADSs are not eligible for double voting rights.

 

Under
French law, treasury shares or ordinary shares held by entities controlled by us are not entitled to voting rights and do not
count for quorum purposes.

 

They
is no limitation on voting rights in our bylaws nor limit the right of non-residents of France or non-French persons to own or,
where applicable, to vote our securities.

 

     

     

    

Under
French law, the holders of warrants of the same class (i.e., warrants that were issued at the same time and with the same rights),
including founders’ warrants, are entitled to vote as a separate class at a general meeting of that class of warrant holders
under certain circumstances, principally in connection with any proposed modification of the terms and conditions of the class
of warrants or any proposed issuance of preferred shares or any modification of the rights of any outstanding class or series
of preferred shares.

 

Dividends

 

We
may only distribute dividends out of our distributable profits, plus any amounts held in our reserves that the shareholders decide
to make available for distribution, other than those reserves that are specifically required by law. The conditions for payment
of dividends in cash shall be set at the shareholders’ meeting.

 

“Distributable
Profits” consist of our statutory net profit in each fiscal year, calculated in accordance with accounting standards applicable
in France, as increased or reduced by any profit or loss carried forward from prior years, less any contributions to the reserve
accounts. Pursuant to French law, we must allocate at least 5% of our statutory net profit for each year to our legal reserve
fund before dividends may be paid with respect to that year. Such allocation is compulsory until the amount in the legal reserve
is equal to 10% of the aggregate par value of our issued and outstanding share capital.

 

Dividends
are distributed to shareholders pro rata according to their respective holdings of ordinary shares. In the case of interim dividends,
distributions are made to shareholders on the date set by our Management Board during the meeting in which the distribution of
interim dividends is approved. The actual dividend payment date is decided by the shareholders at an ordinary general shareholders’
meeting or by our Management Board in the absence of such a decision by the shareholders. Shareholders that own ordinary shares
on the actual payment date are entitled to the dividend.

 

Pursuant
to French law, dividends must be paid within a maximum of nine months after the close of the relevant fiscal year, unless extended
by court order. Dividends not claimed within five years after the payment date shall be deemed to expire and revert to the French
state.

 

Shareholders
may be granted an option to receive dividends in cash or in ordinary shares, in accordance with legal conditions.

 

Change
in Share Capital 

 

Any
change to the capital or the rights attached to the ordinary shares is subject to legal provisions, as our bylaws do not set forth
any particular requirements.

 

Increase
in Share Capital 

 

Pursuant
to French law, our share capital may be increased only with shareholders’ approval at an extraordinary general shareholders’
meeting following the recommendation of our Management Board. The shareholders may delegate to our Management Board either the
authority (délégation de compétence) or the power (délégation de pouvoir) to
carry out any increase in share capital.

 

Increases
in our share capital may be effected by:

 

		•	issuing
                                         additional shares;

 

		•	increasing
                                         the nominal value of existing shares;

 

		•	creating
                                         a new class of equity securities (preference shares); and

 

		•	exercising
                                         the rights attached to securities giving access to the share capital.

 

     

     

    

 

Increases
in share capital by issuing additional securities may be effected through one or a combination of the following issuances:

 

		•	in
                                         consideration for cash;

 

		•	in
                                         consideration for assets contributed in kind;

 

		•	through
                                         an exchange offer or merger;

 

		•	by
                                         conversion of previously issued debt instruments;

 

		•	by
                                         exercise of the rights attached to securities giving access to the share capital;

 

		•	by
                                         capitalization of profits, reserves or share premium; and

 

		•	subject
                                         to certain conditions, by way of offset against debt incurred by us.

 

Decisions
to increase the share capital through the capitalization of reserves, profits and/or share premium require shareholders’
approval at an extraordinary general shareholders’ meeting, acting under the quorum and majority requirements applicable
to ordinary shareholders’ meetings. Increases effected by an increase in the nominal value of shares require unanimous approval
of the shareholders, unless effected by capitalization of reserves, profits or share premium. All other capital increases require
shareholders’ approval at an extraordinary general shareholders’ meeting acting under the regular quorum and majority
requirements for such meetings.

 

Reduction
in Share Capital 

 

Pursuant
to French law, any reduction in our share capital requires shareholders’ approval at an extraordinary general shareholders’
meeting following the recommendation of our Management Board. The share capital may be reduced either by decreasing the nominal
value of the outstanding shares or by reducing the number of outstanding shares. The number of outstanding shares may be reduced
by the repurchase and cancellation of shares. Holders of each class of shares must be treated equally unless each affected shareholder
agrees otherwise, depending on the contemplated operations.

 

Preferential
Subscription Rights 

 

According
to French law, if we issue additional securities for cash, current shareholders will have preferential subscription rights to
these securities on a pro rata basis. Preferential subscription rights entitle the individual or entity that holds them to subscribe
pro rata based on the number of shares held by them to the issuance of any securities increasing, or that may result in an increase
of, our share capital by means of a cash payment or a set-off of cash debts. Pursuant to French law, the preferential subscription
rights are transferable during a period equivalent to the subscription period relating to a particular offering but starting two
days prior to the opening of the subscription period and ending two days prior to the closing of the subscription period.

 

The
preferential subscription rights with respect to any particular offering may be waived at an extraordinary general meeting by
a two-thirds vote of our shareholders or individually by each shareholder.

 

Our
Management Board and our independent auditors are required by French law to present reports to the shareholders’ meeting
that specifically address any proposal to waive the preferential subscription rights.

 

Form,
Holding and Transfer of Shares 

 

Form
of Shares 

 

The
ordinary shares are held under registered or bearer form, if the legislation so permits, according to the shareholder’s
choice.

 

Further,
in accordance with applicable laws, we may request at any time from the central depository responsible for holding our shares,
the information referred to in Article L. 228-2 of the French Commercial Code. Thus, we are, in particular and at any time, entitled
to request the name and year of birth or, in the case of a legal entity, the name and the year of incorporation, nationality and
address of holders of securities conferring immediate or long-term voting rights at its shareholders’ meeting and the amount
of securities owned by each of them and, where applicable, the restrictions that the securities could be affected by.

 

     

     

    

 

Holding
of Shares 

 

In
accordance with French law concerning the “dematerialization” of securities, the ownership rights of shareholders
are represented by book entries instead of share certificates. Shares issued are registered in individual accounts opened by us
or any authorized intermediary, in the name of each shareholder and kept according to the terms and conditions laid down by the
legal and regulatory provisions.

 

Ownership
of ADSs by Non-French Residents 

 

Neither
the French Commercial Code nor our bylaws currently impose any restrictions on the right of non-French residents or non-French
shareholders to own and vote shares. However, non-French residents must file a declaration for statistical purposes with the Bank
of France (Banque de France) within 20 working days following the date of certain direct foreign investments in us, including
any purchase of our ADSs. In particular, such filings are required in connection with investments exceeding €15,000,000 that
lead to the acquisition of at least 10% of our share capital or voting rights or cross such 10% threshold. Violation of this filing
requirement may be sanctioned by five years of imprisonment and a fine of up to twice the amount of the relevant investment. This
amount may be increased fivefold if the violation is made by a legal entity.

 

Further,
any investment:

 

(i)
by (a) any non-French citizen, (b) any French citizen not residing in France, (c) any non-French entity or (d) any
French entity controlled by one of the aforementioned persons or entities;

 

(ii)
that will result in the relevant investor (a) acquiring control of an entity registered in France, (b) acquiring all
or part of a business line of an entity registered in France, or (c) for non-EU or non-EEA investors crossing, directly or
indirectly, alone or in concert, a 25% threshold of voting rights in an entity registered in France; and

 

(iii)
developing activities in certain strategic industries related to (a) activity likely to prejudice national defense interests,
participating in the exercise of official authority or are likely to prejudice public policy and public security (including weapons,
double-use items, IT systems, cryptology, date capturing devices, gambling, toxic agents or storage of data), (b) activities relating
to essential infrastructure, goods or services (including energy, water, transportation, space, telecom, public health, farm products
or media), and (c) research and development activity related to critical technologies (including cybersecurity, artificial
intelligence, robotics, additive manufacturing, semiconductors, quantum technologies, energy storage or biotechnology) or dual-use
items,

 

is
subject to the prior authorization of the French Ministry of Economy, which authorization may be conditioned on certain undertakings.

 

In
the context of the ongoing COVID-19 pandemic, the Decree (décret) n°2020 892 dated July 22, 2020, as amended
(i) on December 28, 2020 by the Decree n° 2020-1729 and (ii) on December 22, 2021 by the Decree n° 2021-1758, has
created until December 31, 2022 a new 10% threshold of the voting rights for the non-European investments made (i) in
an entity with its registered office in France and (ii) whose shares are admitted to trading on a regulated market, in addition
to the 25% above-mentioned threshold. A fast-track procedure shall apply for any non-European investor exceeding this 10% threshold
who will have to notify the Minister of Economy who will then have 10 days to decide whether or not the transaction should be
subject to further examination.

 

In
the absence of such authorization, the relevant investment shall be deemed null and void. The relevant investor may be found criminally
liable and may be sanctioned with a fine not to exceed the greater of the following amounts: (i) twice the amount of the
relevant investment, (ii) 10% of the annual turnover before tax of the target company or (iii) €5 million (for a company)
or €1 million (for a natural person).

 

     

     

    

Foreign
Exchange Controls 

 

Under
current French foreign exchange control regulations there are no limitations on the amount of cash payments that we may remit
to residents of foreign countries. Laws and regulations concerning foreign exchange controls do, however, require that all payments
or transfers of funds made by a French resident to a non-resident such as dividend payments be handled by an accredited intermediary.
All registered banks and substantially all credit institutions in France are accredited intermediaries.

 

Availability
of Preferential Subscription Rights 

 

Under
French law, shareholders have preferential rights to subscribe for cash issues of new ordinary shares or other securities giving
rights to acquire additional ordinary shares on a pro rata basis. Holders of our securities in the United States (which may be
in the form of ordinary shares or ADSs) may not be able to exercise preferential subscription rights for their securities unless
a registration statement under the Securities Act is effective with respect to such rights or an exemption from the registration
requirements imposed by the Securities Act is available. We may, from time to time, issue new ordinary shares or other securities
giving rights to acquire additional ordinary shares (such as warrants) at a time when no registration statement is in effect and
no Securities Act exemption is available. If so, holders of our securities in the United States will be unable to exercise any
preferential subscription rights and their interests will be diluted. We are under no obligation to file any registration statement
in connection with any issuance of new ordinary shares or other securities. We intend to evaluate at the time of any rights offering
the costs and potential liabilities associated with registering the rights, as well as the indirect benefits to us of enabling
the exercise by holders of ADSs in the United States of the subscription rights, and any other factors we consider appropriate
at the time, and then to make a decision as to whether to register the rights. We cannot assure you that we will file a registration
statement.

 

For
holders of our ordinary shares in the form of ADSs, the depositary may make these rights or other distributions available to ADS
holders. If the depositary does not make the rights available to ADS holders and determines that it is impractical to sell the
rights, it may allow these rights to lapse. In that case the holders will receive no value for them. The section herein titled
“American Depositary Shares—Dividends and Other Distributions” explains in detail the depositary’s responsibility
in connection with a rights offering. See also “Risk Factors—Your right as a holder of ADSs to participate in any
future preferential subscription rights or to elect to receive dividends in shares may be limited, which may cause dilution to
your holdings” in the Company’s Annual Report on Form 20-F to which this description is filed as an exhibit.

 

Assignment
and Transfer of Shares 

 

Shares
are freely negotiable, subject to applicable legal and regulatory provisions. French law notably provides for standstill obligations
and prohibition of insider trading.

 

Repurchase
and Redemption of Ordinary Shares 

 

Under
French law, we may acquire our own ordinary shares. Such acquisition may be challenged on the ground of market abuse regulations.
However, Market Abuse Regulation 596/2014 of April 16, 2014 and its delegated regulations, or MAR, provides for safe harbor
exemptions when the acquisition is made (i) under a buy-back program to be authorized by the shareholders in accordance with
the provisions of Article L. 225-209 of the French Commercial Code and with the General Regulations of the French Financial Markets
Authority, or AMF and (ii) for the following purposes:

 

		•	to
                                         decrease our share capital, with the approval of the shareholders at an extraordinary
                                         general meeting; in this case, the ordinary shares repurchased must be cancelled within
                                         one month from the expiry of the purchase offer;

 

		•	to
                                         meet obligations arising from debt securities that are exchangeable into equity instruments;

 

		•	to
                                         provide ordinary shares for distribution to employees or managers under a profit-sharing,
                                         free ordinary share or share option plan; or

 

		•	we
                                         benefit from a simple exemption when the acquisition is made under a liquidity contract
                                         complying with the General Regulations of, and market practices accepted by, the AMF.

 

     

     

    

 

All
other purposes, and especially share buy-backs made for external growth operations in pursuance of Article L. 225-209 of
the French Commercial Code, while not forbidden, must be pursued in strict compliance of market manipulation and insider dealing
rules.

 

Under
MAR and in accordance with the General Regulations of the AMF, a corporation shall report to the competent authority of the trading
value on which the shares have been admitted to trading or are traded, no later than by the end of the seventh daily market session
following the date of the execution of the transaction, all the transactions relating to the buy-back program, in a detailed form
and in an aggregated form.

 

No
such repurchase of ordinary shares may result in us holding, directly or through a person acting on our behalf, more than 10%
of our issued share capital. Ordinary shares repurchased by us continue to be deemed “issued” under French law but
are not entitled to dividends or voting rights so long as we hold them directly or indirectly, and we may not exercise the preemptive
rights attached to them.

 

Sinking
Fund Provisions 

 

Our
bylaws do not provide for any sinking fund provisions.

 

General
Meeting of Shareholders 

 

General
Meetings of shareholders are called by the Management Board, or failing that, by the Supervisory Board. They can also be called
by the auditor(s) or an officer appointed by a court upon request, by any interested party or by the Works Council in an emergency,
by one or more shareholders holding at least five percent of the ordinary shares or by an association of our shareholders. Meetings
are held at our registered offices or at any other location indicated in the convening notice.

 

The
meeting is published in the French Bulletin of Mandatory Legal Notices (Bulletin des Annonces Légales Obligatoires or
BALO) at least 35 days prior to the date of a General Meeting of shareholders. In addition to the information concerning us, the
notice indicates in particular the agenda of the General Meeting of shareholders and the draft resolutions that will be presented.

 

In
the 21 days preceding the meeting, we will publish the information and documents relating to the meeting on our web site.

 

The
General Meeting of shareholders must be announced at least 15 days beforehand, by a notice placed in a journal that publishes
legal announcements in the department where the headquarters are located, and in the BALO. Holders of registered ordinary shares
who have owned them for at least one month as of the date on which the latest notice is published receive individual notices.
When a General Meeting of shareholders is unable to take action because the requisite quorum is not present, a second meeting
is called at least ten days in advance using the same procedure as the first one.

 

The
General Meeting of shareholders may only take action on items on the agenda. However, it may dismiss and replace one or more members
of the Supervisory Boards any time. The General Meeting may also dismiss the members of the Management Board. One or more shareholders
representing at least the percentage of share capital fixed by law, and acting according to the legally required conditions and
deadlines, are allowed to request that items and/or draft resolutions be added to the agenda of the General Meeting of shareholders.

 

Each
shareholder has the right to attend the meetings and take part in deliberation (i) personally; (ii) by granting proxy
to another shareholder, his or her spouse or partner in a civil union or any other natural or legal person of his or her choice;
(iii) by sending a proxy to the company without indication of the beneficiary; (iv) by voting by correspondence; or
(v) by videoconference or another means of telecommunication, including internet, in accordance with applicable laws and
regulations that allow identification; by presenting proof of identity and ownership of ordinary shares, subject to:

 

		•	for
                                         holders of registered ordinary shares, an entry in the shareholder registry at least
                                         two business days before the General Meeting of shareholders; and

 

     

     

    

		•	for
                                         holders of bearer ordinary shares, filing, under the conditions provided by law, of a
                                         certificate of participation issued by an authorized intermediary two days before the
                                         date of the General Meeting of shareholders.

 

The
final date for returning voting ballots by correspondence is set by the Management Board and disclosed in the notice of meeting
published in the BALO. This date cannot be earlier than three days prior to the meeting as provided in the bylaws.

 

A
shareholder who has voted by correspondence will no longer be able to participate directly in the meeting or to be represented.
In the case of returning the proxy form and the voting by correspondence form, the proxy form is taken into account, subject to
the votes cast in the voting by correspondence form.

 

A
shareholder may be represented at meetings by any individual or legal entity by means of a proxy form which we send to such shareholder
either at the shareholder’s request or at our initiative. A shareholder’s request for a proxy form must be received
at the registered office at least five days before the date of the meeting. The proxy is only valid for a single meeting, for
two meetings (an ordinary and an extraordinary meeting convened for the same day or within 15 days) or for successive meetings
convened with the same agenda.

 

A
shareholder may vote by correspondence by means of a voting form, which we send to such shareholder either at the shareholder’s
request or at our initiative, or which we include in an appendix to a proxy voting form under the conditions provided for by current
laws and requirements. A shareholder’s request for a voting form must be received at the registered office at least six
days before the date of the meeting. The voting form is also available on our website at least 21 days before the date of the
meeting. The voting by correspondence form addressed by a shareholder is only valid for a single meeting or for successive meetings
convened with the same agenda.

 

The
above legislation provides that shareholders (and all the persons who may attend the general meeting of shareholders) may participate
in the meeting by means of a teleconference or audio-visual conference call if this conference allows for the identification of
the participants, transmits at least the voice of the participants and allows the continuous and simultaneous retransmission of
the debates.

 

Our
Bylaws and French Corporate Law Contain Provisions that May Delay or Discourage a Takeover Attempt 

 

Provisions
contained in our bylaws and French corporate law could make it more difficult for a third-party to acquire us, even if doing so
might be beneficial to our shareholders. In addition, provisions of our bylaws impose various procedural and other requirements,
which could make it more difficult for shareholders to effect certain corporate actions. These provisions include the following:

 

		•	under
                                         French law, the owner of 90% of the share capital or voting rights of a public company
                                         listed on a regulated market in a Member State of the European Union or in a state party
                                         to the European Economic Area, or EEA, Agreement, including from the main French stock
                                         exchange, has the right to force out minority shareholders following a tender offer made
                                         to all shareholders;

 

		•	under
                                         French law, a non-resident of France as well as any French entity controlled by non-residents
                                         of France may have to file a declaration for statistical purposes with the Bank of France
                                         (Banque de France) within 20 working days following the date of certain direct
                                         foreign investments in us, including any purchase of our ADSs. In particular, such filings
                                         are required in connection with investments exceeding €15,000,000 that lead to the
                                         acquisition of at least 10% of our share capital or voting rights or cross such 10% threshold.
                                         See “Ownership of ADSs by Non-French Residents” herein;

 

		•	under
                                         French law, certain investments in a French company relating to certain strategic industries
                                         (such as research and development in biotechnologies and activities relating to public
                                         health) and activities by individuals or entities not French, not resident in France
                                         of controlled by entities not French or not resident in France are subject to prior authorization
                                         of the Ministry of Economy. See “Ownership of ADSs by Non-French Residents”
                                         herein;

 

     

     

    

		•	a
                                         merger (i.e., in a French law context, a share for share exchange following which our
                                         company would be dissolved into the acquiring entity and our shareholders would become
                                         shareholders of the acquiring entity) of our company into a company incorporated in the
                                         European Union would require the approval of our Management Board as well as a two-thirds
                                         majority of the votes held by the shareholders present, represented by proxy or voting
                                         by mail at the relevant meeting;

 

		•	a
                                         merger of our company into a company incorporated outside of the European Union would
                                         require 100% of our shareholders to approve it;

 

		•	under
                                         French law, a cash merger is treated as a share purchase and would require the consent
                                         of each participating shareholder;

 

		•	our
                                         shareholders may grant in the future our Management Board broad authorizations to increase
                                         our share capital or to issue additional ordinary shares or other securities (for example,
                                         warrants) to our shareholders, the public or qualified investors, including as a possible
                                         defense following the launching of a tender offer for our ordinary shares;

 

		•	our
                                         shareholders have preferential subscription rights on a pro rata basis on the
                                         issuance by us of any additional securities for cash or a set-off of cash debts, which
                                         rights may only be waived by the extraordinary general meeting (by a two-thirds majority
                                         vote) of our shareholders or on an individual basis by each shareholder;

 

		•	our
                                         Supervisory Board appoints the members of the Management Board and shall fill any vacancy
                                         within two months;

 

		•	our
                                         Supervisory Board has the right to appoint members of the Supervisory Board to fill a
                                         vacancy created by the resignation or death of a member of the Supervisory Board for
                                         the remaining duration of such member’s term of office, and subject to the approval
                                         by the shareholders of such appointment at the next shareholders’ meeting, which
                                         prevents shareholders from having the sole right to fill vacancies on our Supervisory
                                         Board;

 

		•	our
                                         Management Board can be convened by the Chairman of the Management Board, its chief executive
                                         officer or at least half of the members of the Management Board;

 

		•	our
                                         Supervisory Board can be convened by the Chairman or the Vice Chairman or one member
                                         of the Supervisory Board. A member of the Management Board or one-third of the members
                                         of the Supervisory Board may send a written request to the Chairman to convene the Supervisory
                                         Board. If the chairman does not convene the Supervisory Board 15 days following the receipt
                                         of such request, the authors of the request may themselves convene the Supervisory Board;

 

		•	our
                                         Supervisory Board meetings can only be regularly held if at least half of its members
                                         attend either physically or by way of videoconference or teleconference enabling the
                                         members’ identification and ensuring their effective participation in the Supervisory
                                         Board’s decisions;

 

		•	approval
                                         of at least a majority of the votes held by shareholders present, represented by a proxy,
                                         or voting by mail at the relevant ordinary shareholders’ general meeting is required
                                         to remove members of the Management Board and/or members of the Supervisory Board with
                                         or without cause;

 

		•	the
                                         crossing of certain ownership thresholds has to be disclosed and can impose certain obligations;
                                         see “Key Provisions of Our Bylaws and French Law Affecting Our Ordinary Shares”
                                         herein;

 

		•	advance
                                         notice is required for nominations to the Supervisory Board or for proposing matters
                                         to be acted upon at a shareholders’ meeting, except that a vote to remove and replace
                                         a member of the Supervisory Board can be proposed at any shareholders’ meeting
                                         without notice;

 

		•	transfers
                                         of shares shall comply with applicable insider trading rules and regulations, and in
                                         particular with the Market Abuse Regulation 596/2014 of April 16, 2014; and

 

		•	pursuant
                                         to French law, our bylaws, including the sections relating to the number of members of
                                         the Management and Supervisory Boards, and election and removal of members of the Management
                                         and Supervisory Boards from office may only be modified by a resolution adopted by two-thirds
                                         of the votes of our shareholders present, represented by a proxy or voting by mail at
                                         the meeting.

 

     

     

    

 

Shareholder
Identification 

 

Ordinary
shares may be registered or bearer ordinary shares, at the option of the shareholder, subject to the applicable legal requirements.

 

To
identify the holders of bearer ordinary shares, we are authorized to ask in accordance with current legal and regulatory requirements,
the central depositary that maintains the records of the issue of these ordinary shares, in exchange for a fee, for the holders’
name or business name, year of birth or year of incorporation, address and nationality, e-mail address, number of securities held
giving immediate or future access to the capital and any restrictions to which the securities are subject.

 

Modification
of the Bylaws 

 

Our
bylaws may only be amended by approval at an extraordinary shareholders’ meeting. Our bylaws may not, however, be amended
to increase shareholder commitments without the approval of each shareholder. Decisions are made by a two-thirds majority of the
votes held by the shareholders present, represented by proxy, or voting by mail.

 

Crossing
the Threshold Set in the Bylaws 

 

Without
prejudice to the legal or regulatory stipulations, any natural person or legal entity who goes above or below, directly or indirectly,
acting alone or in concert (de concert), a percentage of the share capital or voting rights equal to or higher than 2%
or a multiple of this percentage, must inform us of the total number of ordinary shares, voting rights and securities giving access
to capital or voting rights that it, he or she owns immediately or eventually, within five trading days of the date on which such
ownership threshold is crossed.

 

If
shareholders fail to comply with these obligations, shares or voting rights exceeding the fraction that should have been declared
are deprived of voting rights at General Meetings of Shareholders for any meeting that would be held until the expiry of a period
of two years from the date of regularization of the notification in accordance with Article L. 233-14 of the Commercial Code,
if the failure to declare has been determined and one or several shareholders holding at least 5% of the capital make a request
thereof, as recorded in the minutes of the General Meeting.

 

These
requirements are without prejudice to the threshold crossing declarations provided for under French law in Articles L. 233-7,
L. 233-9 and L. 233-10 of the French Commercial Code, which impose a declaration to us and to the French Financial Markets Authority
(AMF) upon crossing of the following thresholds in share capital or voting rights no later than the fourth trading day following
the crossing: 5%, 10%, 15%, 20%, 25%, 30%, 33.33%, 50%, 66.66%, 90% and 95%.

 

Furthermore,
any shareholder crossing, alone or acting in concert, these 10%, 15%, 20% or 25% thresholds shall file a declaration pursuant
to which it shall set out its intention for the following 6 months, including notably whether it intends to continue acquiring
shares of the company or to acquire control over the company and its intended strategy for the company.

 

In
addition, and subject to certain exemptions, any shareholder crossing, alone or acting in concert, the 30% threshold shall file
a mandatory public tender offer. Also, any shareholder holding directly or indirectly a number between 30% and 50% of the capital
or voting rights and who, in less than 12 consecutive months, increases their holding of capital or voting rights by at least
1% of the company’s capital or voting rights, shall file a mandatory public tender offer.

 

     

     

    

 

 

Differences
in Corporate Law 

 

We
are a société européenne à directoire et conseil de surveillance, or S.E., incorporated under
the laws of France. The laws applicable to French S.E. differ from laws applicable to U.S. corporations and their shareholders.
Set forth below is a summary of certain differences between the provisions of the French Commercial Code applicable to us and
the Delaware General Corporation Law, the law under which many public companies in the United States are incorporated. This summary
is not intended to be a complete discussion of the respective rights.

 

	 	 	France	 	Delaware
	Number
    of the members of the Management Board and of the Supervisory Board	 	Under
    French law, a société européenne à directoire et conseil de surveillance must have at least
    three and may have up to eighteen members of the Supervisory Board. The number of members of the Management Board cannot be
    greater than seven. In addition, the composition of the Management Board endeavors to seek a balanced representation of women
    and men. The number of members of the Management Board and of the Supervisory Board is fixed by or in the manner provided
    in the bylaws. The number of members of the Supervisory Board of each gender may not be less than 40%. Any appointment made
    in violation of this limit that is not remedied will be null and void as well as the deliberations taken by the Supervisory
    Board member irregularly appointed. The members of the Supervisory Board are appointed at the shareholders’ general
    meetings.	 	Under
    Delaware law, a corporation must have at least one director and the number of directors shall be fixed by or in the manner
    provided in the bylaws, unless the certificate of incorporation fixes the number of directors.
	 	 	 	 	 
	Members
    of the Management Board and of the Supervisory Board Qualifications	 	Under
    French law, a corporation may prescribe qualifications for the members of the Management Board and of the Supervisory Board
    under its bylaws. In addition, under French law, members of a supervisory board of a corporation may be legal entities (with
    the exception of the chairman of the supervisory board), and such legal entities may designate an individual to represent
    them and to act on their behalf at meetings of the supervisory board.	 	Under
    Delaware law, a corporation may prescribe qualifications for directors under its certificate of incorporation or bylaws.

 

     

     

    

 

	 	 	France	 	Delaware

	Removal
    of members of the Management Board and of the Supervisory Board	 	Under
    French law, the members of the Management Board and of the Supervisory Board may be removed from office, with or without cause
    and without notice, at any shareholders’ meeting, by a simple majority vote of the shareholders present and voting at
    the meeting in person or by proxy. In addition, the members of the Management Board may be removed by the Supervisory Board
    if provided in the bylaws. Our bylaws provide this possibility.	 	Under
    Delaware law, unless otherwise provided in the certificate of incorporation, directors may be removed from office, with or
    without cause, by a majority stockholder vote, though in the case of a corporation whose board is classified, stockholders
    may effect such removal only for cause.
	 	 	 	 	 
	Vacancies
    on the Management Board and on the Supervisory Board	 	Under
    French law, vacancies on the Management Board resulting from death or a resignation have to be filled by the Supervisory Board
    within two months. In case of a vacancy on the Management Board, the Supervisory Board may appoint, for the time remaining
    until the renewal of the member (which may not exceed six months) one of its members to serve as a member of the Management
    Board, resulting in the suspension from his or her duties on the Supervisory Board. Vacancies on the Supervisory Board resulting
    from death or a resignation, may be filled by the remaining members of the Supervisory Board pending ratification by the shareholders
    by the next shareholders’ meeting.	 	Under
    Delaware law, vacancies on a corporation’s board of directors, including those caused by newly created directorships,
    may be filled by a majority of the remaining directors (even though less than a quorum).
	 	 	 	 	 
	Annual
    General Meeting	 	Under
    French law, the annual general meeting of shareholders shall be held at such place, on such date and at such time as decided
    each year by the Management Board and notified to the shareholders in the convening notice of the annual meeting, within six
    months after the close of the relevant fiscal year unless such period is extended by court order.	 	Under
    Delaware law, the annual meeting of stockholders shall be held at such place, on such date and at such time as may be provided
    by the certificate of incorporation or by the bylaws, or by the board of directors if neither the certificate of incorporation
    or the bylaws so provide.

 

     

     

    

 

	 	 	France	 	Delaware

	General
    Meeting	 	Under
    French law, general meetings of the shareholders may be called by the Management Board or, failing that, by the statutory
    auditors, or by a court appointed agent (mandataire ad hoc) or liquidator in certain circumstances, or by the majority
    shareholder in capital or voting rights following a public tender offer or exchange offer or the transfer of a controlling
    block on the date decided by the Management Board or the relevant person. General meetings of the shareholders may also be
    called by the Supervisory Board.	 	Under
    Delaware law, special meetings of the stockholders may be called by the board of directors or by such person or persons as
    may be authorized by the certificate of incorporation or by the bylaws.
	 	 	 	 	 
	Notice
    of General Meetings	 	A
    first convening notice is published in the French Bulletin of Mandatory Legal Notices (BALO) at least 35 days prior to a meeting
    and made available on the website of the company at least 21 days prior to the meeting. Subject to special legal provisions,
    the meeting notice is sent out at least 15 days prior to the date of the meeting, by means of a notice inserted both in a
    legal announcement bulletin (journal d’annonces légales) of the registered office department and in the
    BALO. Further, the holders of registered ordinary shares for at least a month at the time of the latest of the insertions
    of the notice of meeting shall be summoned individually, by regular letter (or by registered letter if they request it and
    include an advance of expenses) sent to their last known address. This notice to registered shareholders may also be transmitted
    by electronic means of telecommunication, in lieu of any such mailing, to any shareholder requesting it beforehand by registered
    letter with acknowledgment of receipt in accordance with legal and regulatory requirements, specifying his e-mail address.
    When the shareholders’ meeting cannot deliberate due to lack of required quorum, the second meeting must be called at
    least ten calendar days in advance in the same manner as used for the first notice. The convening notice shall specify the
    name of the company, its legal form, share capital, registered office address, registration number with the French Registry
    of Commerce and Companies (registre du commerce et des sociétés), the place, date, hour and agenda of
    the meeting and its nature (ordinary and/or extraordinary meeting). The convening notice must also indicate the conditions
    under which the shareholders may vote by correspondence and the places and conditions in which they can obtain voting forms
    by mail.	 	Under
    Delaware law, unless otherwise provided in the certificate of incorporation or bylaws, written notice of any meeting of the
    stockholders must be given to each stockholder entitled to vote at the meeting not less than 10 nor more than 60 days before
    the date of the meeting and shall specify the place, date, hour, means of remote communication, if any, by which stockholders
    and proxy holders may be deemed to be present in person and vote, the record date for voting if it is different from the record
    date determining notice and, in the case of a special meeting, purpose or purposes for which the meeting is called.

 

     

     

    

	 	 	France	 	Delaware

	Proxy	 	Each
    shareholder has the right to attend the meetings and participate in the discussions (i) personally, or (ii) by granting
    proxy to another shareholder, his/her spouse, his/her partner with whom he/she has entered into a civil union or to any natural
    or legal person of his/her choice; or (iii) by sending a proxy to the company without indication of the beneficiary (in
    which case, such proxy shall be cast in favor of the resolutions supported by the Management Board), or (iv) by voting
    by correspondence, or (v) by video conference or another means of telecommunication in accordance with applicable laws
    that allow identification. The proxy is only valid for a single meeting, for two meetings (an ordinary
    and an extraordinary meeting convened for the same day or within 15 days) or for successive meetings convened with the same
    agenda.	 	Under
    Delaware law, at any meeting of stockholders, a stockholder may designate another person to act for such stockholder by proxy,
    but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period.
    A director of a Delaware corporation may not issue a proxy representing the director’s voting rights as a director.
	 	 		 	 
	 	 	 	 	 

     

     

    

 

	 	 	France	 	Delaware

	Shareholder
    action by written consent	 	Under
    French law, shareholders’ action by written consent is not permitted in a société européenne.	 	Under
    Delaware law, a corporation’s certificate of incorporation (1) may permit stockholders to act by written consent
    if such action is signed by all stockholders, (2) may permit stockholders to act by written consent signed by stockholders
    having the minimum number of votes that would be necessary to take such action at a meeting or (3) may prohibit actions
    by written consent.
	 	 	 	 	 
	Preemptive
    Rights	 	Under
    French law, in case of issuance of additional ordinary shares or other securities for cash or set-off against cash debts,
    the existing shareholders have preferential subscription rights to these securities on a pro rata basis unless such
    rights are waived by a two-thirds majority of the votes held by the shareholders present at the extraordinary meeting deciding
    or authorizing the capital increase, voting in person or represented by proxy or voting by mail. The votes cast do not include
    votes attached to shares held by shareholders who did not take part in the vote, abstained or whose votes were blank or null.
    In case such rights are not waived by the extraordinary general meeting, each shareholder may individually either exercise,
    assign or not exercise its preferential subscription rights. Preferential subscription rights may only be exercised during
    the subscription period. In accordance with French law, the exercise period shall not be less than five trading days. Preferential
    subscription rights are transferable during a period equivalent to the subscription period but starting two business days
    prior to the opening of the subscription period and ending two business days prior to the closing of the subscription period.	 	Under
    Delaware law, unless otherwise provided in a corporation’s certificate of incorporation, a stockholder does not, by
    operation of law, possess preemptive rights to subscribe to additional issuances of the corporation’s stock or to any
    security convertible into such stock.

 

     

     

    

 

	 	 	France	 	Delaware

	Sources of Dividends	 	Under
        French law, dividends may only be paid by a French société européenne out of “distributable
        profits,” plus any distributable reserves and “distributable premium” that the shareholders decide to
        make available for distribution, other than those reserves that are specifically required by law. “Distributable
        profits” consist of the unconsolidated net profits of the relevant corporation for each fiscal year, as increased
        or reduced by any profit or loss carried forward from prior years.

         

        “Distributable
        premium” refers to the contribution paid by the shareholders in addition to the par value of their ordinary shares
        for their subscription that the shareholders decide to make available for distribution.

         

        Except
in case of a share capital reduction, no distribution can be made to the shareholders when the net equity is, or would become,
lower than the amount of the share capital plus the reserves which cannot be distributed in accordance with the law or the bylaws. 
	 	Under
    Delaware law, dividends may be paid by a Delaware corporation either out of (1) surplus as defined in and computed in
    accordance with Delaware law or (2) in case there is no such surplus, out of its net profits for the fiscal year in which
    the dividend is declared and/or the preceding fiscal year, except when the capital is diminished by depreciation in the value
    of its property, or by losses, or otherwise, to an amount less than the aggregate amount of capital represented by issued
    and outstanding stock having a preference on the distribution of assets.
	 	 	 	 	 

 

     

     

    

 

	 	 	France	 	Delaware

	Repurchase
    of Ordinary Shares	 	Under
    French law, a corporation may acquire its own ordinary shares. Such acquisition may be challenged on the ground of market
    abuse regulations. However, Market Abuse Regulation 596/2014 of April 16, 2014 provides for safe harbor exemptions when
    the acquisition is made for the following purposes:

 

•     to
decrease its share capital, with the approval of the shareholders at the extraordinary general meeting;

 

•     to
meet obligations arising from debt securities that are exchangeable into equity instruments; or

 

•     with
a view to distributing the relevant shares to employees or managers under a profit-sharing, restricted free ordinary share or
share option plan.

 

All
other purposes, and especially share buy-backs made for external growth operations in pursuance of Article L. 225-209 of the French
Commercial Code, while not forbidden, must be pursued in strict compliance of market manipulation and insider dealing rules.

 

Under
the Market Abuse Regulation 596/2014 of April 16, 2014 (MAR) and in accordance with the General Regulations of the AMF, a
corporation shall report to the competent authority of the trading venue on which the shares have been admitted to trading or
are traded, no later than by the end of the seventh daily market session following the date of the execution of the transaction,
all the transactions relating to the buy-back program, in a detailed form and in an aggregated form.

 

No
such repurchase of ordinary shares may result in the company holding, directly or through a person acting on its behalf, more
than 10% of its issued share capital.

	 	Under
    Delaware law, a corporation may generally redeem or repurchase shares of its stock unless the capital of the corporation is
    impaired or such redemption or repurchase would impair the capital of the corporation.
	 	 	

         
	 	
	 	 		 	 

     

     

    

 

	 	 	France	 	Delaware

	Liability of members of the Management Board
    and of the Supervisory Board	 	Under French law,
    the bylaws may not include any provisions limiting the liability of members of the Management Board. Civil liabilities of
    the members of the Management Board and of the Supervisory Board may be sought for (1) an infringement of laws and regulations
    applicable to a company, (2) breach of the bylaws and (3) management failure. Civil liabilities of the members of
    the Supervisory Board may be sought for the infractions committed by the members of the Management Board if, by knowing it,
    they did not reveal it to the shareholders’ meeting.	 	Under
        Delaware law, a corporation’s certificate of incorporation may include a provision eliminating or limiting the personal
        liability of a director to the corporation or its stockholders for damages arising from a breach of fiduciary duty as
        a director. However, no provision can limit the liability of a director for:

         

        •     any
        breach of the director’s duty of loyalty to the corporation or its stockholders;

         

        •     acts
        or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;

         

        •      intentional
        or negligent payment of unlawful dividends or stock purchases or redemptions; or

         

        •     any
        transaction from which the director derives an improper personal benefit.

        

	 	 	 	 	 
	Voting Rights	 	French law provides
    that, unless otherwise provided in the bylaws, each shareholder is entitled to one vote for each share of capital stock held
    by such shareholder. As from April 2016, double voting rights are automatically granted to the shares held in registered form
    for more than two years, unless provided otherwise in the bylaws. Our bylaws do not provide otherwise.	 	Delaware law provides
    that, unless otherwise provided in the certificate of incorporation, each stockholder is entitled to one vote for each share
    of capital stock held by such stockholder.

 

     

     

    

 

	 	 	France	 	Delaware

	Shareholder Vote on Certain Transactions	 	Generally,
        under French law, completion of merger, dissolution, sale, lease or exchange of all or substantially all of a corporation’s
        assets requires:

         

        •     the
        approval of the Management Board; and

         

        •     approval
        by a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the
        relevant meeting or, in the case of a merger with a non-European Union company, approval of all shareholders of the corporation
        (by exception, the extraordinary general meeting of the acquiring company may delegate to the Management Board authority
        to decide a merger-absorption or to determine the terms and conditions of the merger plan).

        
	 	Generally,
        under Delaware law, unless the certificate of incorporation provides for the vote of a larger portion of the stock, completion
        of a merger, consolidation, sale, lease or exchange of all or substantially all of a corporation’s assets or dissolution
        requires:

         

        •     the
        approval of the board of directors; and

         

        •     approval
by the vote of the holders of a majority of the outstanding stock or, if the certificate of incorporation provides for more or
less than one vote per share, a majority of the votes of the outstanding stock of a corporation entitled to vote on the matter.

	 	 	 	 	 
	Dissent or Dissenters’ Appraisal Rights	 	French law does
    not provide for any such right but provides that a merger is subject to shareholders’ approval by a two-thirds majority
    vote as stated above.	 	Under
        Delaware law, a holder of shares of any class or series has the right, in specified circumstances, to dissent from a merger
        or consolidation by demanding payment in cash for the stockholder’s shares equal to the fair value of those shares,
        as determined by the Delaware Chancery Court in an action timely brought by the corporation or a dissenting stockholder.
        Delaware law grants these appraisal rights only in the case of mergers or consolidations and not in the case of a sale
        or transfer of assets or a purchase of assets for stock.

         

        

         

 

     

     

    

 

	 	 	France	 	Delaware

	 	 	 	 	

        

        Further,
        no appraisal rights are available for shares of any class or series that is listed on a national securities exchange or
        held of record by more than 2,000 stockholders, unless the agreement of a merger or consolidation requires the holders
        to accept for their shares anything other than:

         

        •     shares
        of stock of the surviving corporation;

         

        •     shares
        of stock of another corporation that are either listed on a national securities exchange or held of record by more than
        2,000 stockholders;

         

        •     cash
        in lieu of fractional shares of the stock described in the two preceding bullet points; or

         

        •     any
        combination of the above.

         

        •     In
        addition, appraisal rights are not available to holders of shares of the surviving corporation in specified mergers that
        do not require the vote of the stockholders of the surviving corporation.

        

	 	 	 	 	 
	Standard
    of Conduct for members of the Management Board and of the Supervisory Board	 	French
    law does not contain specific provisions setting forth the standard of conduct of a member of the Management Board and of
    the Supervisory Board. However, members of the Management Board and of the Supervisory Board have a duty to act without self-interest,
    on a well-informed basis and they cannot make any decision against a corporation’s corporate interest (intérêt
    social). In addition, members of the Management Board shall take into account social and environmental issues arising
    out of the Company’s activity.	 	Delaware
    law does not contain specific provisions setting forth the standard of conduct of a director. The scope of the fiduciary duties
    of directors is generally determined by the courts of the State of Delaware. In general, directors have a duty to act without
    self-interest, on a well-informed basis and in a manner they reasonably believe to be in the best interest of the stockholders.

 

     

     

    

 

	 	 	France	 	Delaware

	Shareholder
    Suits	 	French
                                                                     law provides that a shareholder, or a group of shareholders, may initiate a legal action to seek indemnification from the
                                                                     Management Board (but not from the Supervisory Board) of a corporation in the corporation’s interest if it fails to
                                                                     bring such legal action itself. If so, any damages awarded by the court are paid to the corporation and any legal fees
                                                                     relating to such action are borne by the relevant shareholder or the group of shareholders. The plaintiff must remain
                                                                     a shareholder through the duration of the legal action. There is no other case where shareholders may initiate a derivative
                                                                     action to enforce a right of a corporation.

         

        A
        shareholder may alternatively or cumulatively bring individual legal action against the members of the Management Board
        only, provided he has suffered distinct damages from those suffered by the corporation. In this case, any damages awarded
        by the court are paid to the relevant shareholder.

        
	 	Under
                                         Delaware law, a stockholder may initiate a derivative action to enforce a right of a
                                         corporation if the corporation fails to enforce the right itself. The complaint must:

         

        •     state
        that the plaintiff was a stockholder at the time of the transaction of which the plaintiff complains or that the plaintiff’s
        shares thereafter devolved on the plaintiff by operation of law; and allege with particularity the efforts made by the
        plaintiff to obtain the action the plaintiff desires from the directors and the reasons for the plaintiff’s failure
        to obtain the action; or

         

        •     state
        the reasons for not making the effort.

         

        Additionally,
        the plaintiff must remain a stockholder through the duration of the derivative suit. The action will not be dismissed
        or compromised without the approval of the Delaware Court of Chancery.

        

	 	 	 	 	 
	Amendment
    of Certificate of Incorporation	 	Under
    French law, corporations are not required to file a certificate of incorporation with the French Registry of Commerce and
    Companies (registre du commerce et des sociétés) and only have bylaws (statuts) as organizational
    documents.	 	Under
                                         Delaware law, generally a corporation may amend its certificate of incorporation if:

         

        •      its
        board of directors has adopted a resolution setting forth the amendment proposed and declared its advisability; and

         

        •     the
        amendment is adopted by the affirmative votes of a majority (or greater percentage as may be specified by the corporation)
        of the outstanding shares entitled to vote on the amendment and a majority (or greater percentage as may be specified
        by the corporation) of the outstanding shares of each class or series of stock, if any, entitled to vote on the amendment
        as a class or series.

         

 

     

     

    

 

	 	 	France	 	Delaware

	Amendment of Bylaws	 	Under French law,
    only the extraordinary shareholders’ meeting is authorized to adopt or amend the bylaws. The extraordinary shareholders’
    meeting may authorize the Supervisory Board to amend the by-laws to comply with legal provisions, subject to the ratification
    of such amendments by the next extraordinary shareholders’ meeting.	 	Under Delaware
    law, the stockholders entitled to vote have the power to adopt, amend or repeal bylaws. A corporation may also confer, in
    its certificate of incorporation, that power upon the board of directors.

 

AMERICAN
DEPOSITARY SHARES

 

Citibank
is the depositary for the ADSs representing our ordinary shares. Citibank’s depositary offices are located at 388 Greenwich
Street, New York, New York 10013. ADSs represent ownership interests in securities that are on deposit with the depositary. ADSs
may be represented by certificates that are commonly known as American Depositary Receipts, or ADRs. The depositary typically
appoints a custodian to safekeep the securities on deposit. In this case, the custodian is Citibank Europe plc, located at 1 North
Wall Quay, Dublin 1 Ireland.

 

We
have appointed Citibank as depositary pursuant to a deposit agreement. The form of the deposit agreement is on file with the SEC
under cover of a registration statement on Form F-6. You may obtain a copy of the deposit agreement from the SEC’s website
(www.sec.gov). Please refer to registration number 333-255301 when retrieving such copy. The portions of this summary description
that are italicized describe matters that may be relevant to the ownership of ADSs but that may not be contained in the deposit
agreement.

 

We
are providing you with a summary description of the material terms of the ADSs and of your material rights as an owner of ADSs.
Please remember that summaries by their nature lack the precision of the information summarized and that the rights and obligations
of an owner of ADSs will be determined by reference to the terms of the deposit agreement and not by this summary. We urge you
to review the deposit agreement in its entirety.

 

Each
ADS represents the right to receive, and to exercise the beneficial ownership interests in, two ordinary shares that are on deposit
with the depositary and/or custodian. An ADS also represents the right to receive, and to exercise the beneficial interests in,
any other property received by the depositary or the custodian on behalf of the owner of the ADS but that has not been distributed
to the owners of ADSs because of legal restrictions or practical considerations. We and the depositary may agree to change the
ADS-to-Share ratio by amending the deposit agreement. This amendment may give rise to, or change, the depositary fees payable
by ADS owners. The custodian, the depositary and their respective nominees will hold all deposited property for the benefit of
the holders and beneficial owners of ADSs. The deposited property does not constitute the proprietary assets of the depositary,
the custodian or their nominees. Beneficial ownership in the deposited property will under the terms of the deposit agreement
be vested in the beneficial owners of the ADSs. The depositary, the custodian and their respective nominees will be the record
holders of the deposited property represented by the ADSs for the benefit of the holders and beneficial owners of the corresponding
ADSs. A beneficial owner of ADSs may or may not be the holder of ADSs. Beneficial owners of ADSs will be able to receive, and
to exercise beneficial ownership interests in, the deposited property only through the registered holders of the ADSs, the registered
holders of the ADSs (on behalf of the applicable ADS owners) only through the depositary, and the depositary (on behalf of the
owners of the corresponding ADSs) directly, or indirectly, through the custodian or their respective nominees, in each case upon
the terms of the deposit agreement.

 

     

     

    

 

If
you become an owner of ADSs, you will become a party to the deposit agreement and therefore will be bound to its terms and to
the terms of any ADR that represents your ADSs. The deposit agreement and the ADR specify our rights and obligations as well as
your rights and obligations as an owner of ADSs and those of the depositary. As an ADS holder you appoint the depositary to act
on your behalf in certain circumstances. The deposit agreement and the ADRs are governed by New York law. However, our obligations
to the holders of ordinary shares will continue to be governed by the laws of France, which may be different from the laws in
the United States.

 

In
addition, applicable laws and regulations may require you to satisfy reporting requirements and obtain regulatory approvals in
certain circumstances. You are solely responsible for complying with such reporting requirements and obtaining such approvals.
Neither the depositary, the custodian, us or any of their or our respective agents or affiliates shall be required to take any
actions whatsoever on your behalf to satisfy such reporting requirements or obtain such regulatory approvals under applicable
laws and regulations.

 

The
manner in which you own the ADSs (e.g., in a brokerage account vs. as registered holder, or as holder of certificated vs. uncertificated
ADSs) may affect your rights and obligations, and the manner in which, and extent to which, the depositary’s services are
made available to you.

 

As
an owner of ADSs, we will not treat you as one of our shareholders and you will not have direct shareholder rights. The depositary
will hold on your behalf the shareholder rights attached to the ordinary shares underlying your ADSs. As an owner of ADSs, you
will be able to exercise the shareholders rights for the ordinary shares represented by your ADSs through the depositary only
to the extent contemplated in the deposit agreement. To exercise any shareholder rights not contemplated in the deposit agreement
you will, as an ADS owner, need to arrange for the cancellation of your ADSs and become a direct shareholder. 

 

As
an owner of ADSs, you may hold your ADSs either by means of an ADR registered in your name, through a brokerage or safekeeping
account, or through an account established by the depositary in your name reflecting the registration of uncertificated ADSs directly
on the books of the depositary (commonly referred to as the “direct registration system” or “DRS”). The
direct registration system reflects the uncertificated (book-entry) registration of ownership of ADSs by the depositary. Under
the direct registration system, ownership of ADSs is evidenced by periodic statements issued by the depositary to the holders
of the ADSs. The direct registration system includes automated transfers between the depositary and The Depository Trust Company,
or DTC, the central book-entry clearing and settlement system for equity securities in the United States. If you decide to hold
your ADSs through your brokerage or safekeeping account, you must rely on the procedures of your broker or bank to assert your
rights as ADS owner. Banks and brokers typically hold securities such as the ADSs through clearing and settlement systems such
as DTC. The procedures of such clearing and settlement systems may limit your ability to exercise your rights as an owner of ADSs.
Please consult with your broker or bank if you have any questions concerning these limitations and procedures. All ADSs held through
DTC will be registered in the name of a nominee of DTC, which nominee will be the only “holder” of such ADSs for purposes
of the deposit agreement and any applicable ADR. This summary description assumes you have opted to own the ADSs directly by means
of an ADS registered in your name and, as such, we will refer to you as the “holder.” When we refer to “you,”
we assume the reader owns ADSs and will own ADSs at the relevant time.

 

The
registration of the ordinary shares in the name of the depositary or the custodian shall, to the maximum extent permitted by applicable
law, vest in the depositary or the custodian the record ownership in the applicable ordinary shares with the beneficial ownership
rights and interests in such ordinary shares being at all times vested with the beneficial owners of the ADSs representing the
ordinary shares. The depositary or the custodian shall at all times be entitled to exercise the beneficial ownership rights in
all deposited property, in each case only on behalf of the holders and beneficial owners of the ADSs representing the deposited
property.

 

Dividends
and Distributions 

 

As
a holder of ADSs, you generally have the right to receive the distributions we make on the securities deposited with the custodian.
Your receipt of these distributions may be limited, however, by practical considerations and legal limitations. Holders of ADSs
will receive such distributions under the terms of the deposit agreement in proportion to the number of ADSs held as of the specified
record date, after deduction of the applicable fees, taxes and expenses.

 

     

     

    

 

Distributions
of Cash 

 

Whenever
we make a cash distribution for the securities on deposit with the custodian, we will deposit the funds with the custodian. Upon
receipt of confirmation of the deposit of the requisite funds, the depositary will arrange for the funds received in a currency
other than U.S. dollars to be converted into U.S. dollars and for the distribution of the U.S. dollars to the holders, subject
to the laws and regulations of France.

 

The
conversion into U.S. dollars will take place only if practicable and if the U.S. dollars are transferable to the United States.
The depositary will apply the same method for distributing the proceeds of the sale of any property (such as undistributed rights)
held by the custodian in respect of securities on deposit.

 

The
distribution of cash will be made net of the fees, expenses, taxes and governmental charges payable by holders under the terms
of the deposit agreement. The depositary will hold any cash amounts it is unable to distribute in a non-interest bearing account
for the benefit of the applicable holders and beneficial owners of ADSs until the distribution can be effected or the funds that
the depositary holds must be escheated as unclaimed property in accordance with the laws of the relevant states of the United
States.

 

Distributions
of Shares 

 

Whenever
we make a free distribution of ordinary shares for the securities on deposit with the custodian, we will deposit the applicable
number of ordinary shares with the custodian. Upon receipt of confirmation of such deposit, the depositary will either
distribute to holders new ADSs representing the ordinary shares deposited or modify the ADS-to-ordinary shares ratio, in
which case each ADS you hold will represent rights and interests in the additional ordinary shares so deposited. Only whole new
ADSs will be distributed. Fractional entitlements will be sold and the proceeds of such sale will be distributed as in the case
of a cash distribution.

 

The
distribution of new ADSs or the modification of the ADS-to-ordinary shares ratio upon a distribution of ordinary shares will be
made net of the fees, expenses, taxes and governmental charges payable by holders under the terms of the deposit agreement. In
order to pay such taxes or governmental charges, the depositary may sell all or a portion of the new ordinary shares so distributed.

 

No
such distribution of new ADSs will be made if it would violate a law (e.g., the U.S. securities laws) or if it is not operationally
practicable. If the depositary does not distribute new ADSs as described above, it may sell the ordinary shares received upon
the terms described in the deposit agreement and will distribute the proceeds of the sale as in the case of a distribution of
cash.

 

Distributions
of Rights 

 

Whenever
we intend to distribute rights to subscribe for additional ordinary shares, we will give prior notice to the depositary and we
will assist the depositary in determining whether it is lawful and reasonably practicable to distribute rights to subscribe for
additional ADSs to holders.

 

The
depositary will establish procedures to distribute rights to subscribe for additional ADSs to holders and to enable such holders
to exercise such rights if it is lawful and reasonably practicable to make the rights available to holders of ADSs, and if we
provide all of the documentation contemplated in the deposit agreement (such as opinions to address the lawfulness of the transaction).
You may have to pay fees, expenses, taxes and other governmental charges to subscribe for the new ADSs upon the exercise of your
rights. The depositary is not obligated to establish procedures to facilitate the distribution and exercise by holders of rights
to subscribe for new ordinary shares other than in the form of ADSs.

 

The
depositary will not distribute the rights to you if:

 

		•	We
                                         do not timely request that the rights be distributed to you or we request that the rights
                                         not be distributed to you; or

 

		•	We
                                         fail to deliver satisfactory documents to the depositary; or

 

		•	It
                                         is not reasonably practicable to distribute the rights.

 

 

     

     

    

The
depositary will sell the rights that are not exercised or not distributed if such sale is lawful and reasonably practicable. The
proceeds of such sale will be distributed to holders as in the case of a cash distribution. If the depositary is unable to sell
the rights, it will allow the rights to lapse.

 

Elective
Distributions 

 

Whenever
we intend to distribute a dividend payable at the election of shareholders either in cash or in additional shares, we will give
prior notice thereof to the depositary and will indicate whether we wish the elective distribution to be made available to you.
In such case, we will assist the depositary in determining whether such distribution is lawful and reasonably practicable.

 

The
depositary will make the election available to you only if it is reasonably practicable and if we have provided all of the documentation
contemplated in the deposit agreement. In such case, the depositary will establish procedures to enable you to elect to receive
either cash or additional ADSs, in each case as described in the deposit agreement.

 

If
the election is not made available to you, you will receive either cash or additional ADSs, depending on what a shareholder in
France would receive upon failing to make an election, as more fully described in the deposit agreement.

 

Other
Distributions 

 

Whenever
we intend to distribute property other than cash, ordinary shares or rights to subscribe for additional ordinary shares, we will
notify the depositary in advance and will indicate whether we wish such distribution to be made to you. If so, we will assist
the depositary in determining whether such distribution to holders is lawful and reasonably practicable.

 

If
it is reasonably practicable to distribute such property to you and if we provide to the depositary all of the documentation contemplated
in the deposit agreement, the depositary will distribute the property to the holders in a manner it deems practicable.

 

The
distribution will be made net of fees, expenses, taxes and governmental charges payable by holders under the terms of the deposit
agreement. In order to pay such taxes and governmental charges, the depositary may sell all or a portion of the property received.

 

The
depositary will not distribute the property to you and will sell the property if:

 

		•	We
                                         do not request that the property be distributed to you or if we request that the property
                                         not be distributed to you; or

 

		•	We
                                         do not deliver satisfactory documents to the depositary; or

 

		•	The
                                         depositary determines that all or a portion of the distribution to you is not reasonably
                                         practicable.

 

The
proceeds of such a sale will be distributed to holders as in the case of a cash distribution.

 

Redemption

 

Whenever
we decide to redeem any of the securities on deposit with the custodian, we will notify the depositary in advance. If it is practicable
and if we provide all of the documentation contemplated in the deposit agreement, the depositary will provide notice of the redemption
to the holders.

 

The
custodian will be instructed to surrender the shares being redeemed against payment of the applicable redemption price. The depositary
will convert into U.S. dollars upon the terms of the deposit agreement the redemption funds received in a currency other than
U.S. dollars and will establish procedures to enable holders to receive the net proceeds from the redemption upon surrender of
their ADSs to the depositary. You may have to pay fees, expenses, taxes and other governmental charges upon the redemption of
your ADSs. If less than all ADSs are being redeemed, the ADSs to be retired will be selected by lot or on a pro rata basis,
as the depositary may determine.

 

     

     

    

 

 

Changes
Affecting Ordinary Shares 

 

The
ordinary shares held on deposit for your ADSs may change from time to time. For example, there may be a change in nominal or par
value, split-up, cancellation, consolidation or any other reclassification of such ordinary shares or a recapitalization, reorganization,
merger, consolidation or sale of assets of the Company.

 

If
any such change were to occur, your ADSs would, to the extent permitted by law and the deposit agreement, represent the right
to receive the property received or exchanged in respect of the ordinary shares held on deposit. The depositary may in such circumstances
deliver new ADSs to you, amend the deposit agreement, the ADRs and the applicable Registration Statement(s) on Form F-6, call
for the exchange of your existing ADSs for new ADSs and take any other actions that are appropriate to reflect as to the ADSs
the change affecting the Shares. If the depositary may not lawfully distribute such property to you, the depositary may sell such
property and distribute the net proceeds to you as in the case of a cash distribution.

 

Issuance
of ADSs upon Deposit of Ordinary Shares 

 

The
depositary may create ADSs on your behalf if you or your broker deposit ordinary shares with the custodian. The depositary will
deliver these ADSs to the person you indicate only after you pay any applicable issuance fees and any charges and taxes payable
for the transfer of the ordinary shares to the custodian. Your ability to deposit ordinary shares and receive ADSs may be limited
by U.S. and French legal considerations applicable at the time of deposit.

 

The
issuance of ADSs may be delayed until the depositary or the custodian receives confirmation that all required approvals have been
given and that the ordinary shares have been duly transferred to the custodian. The depositary will only issue ADSs in whole numbers.

 

When
you make a deposit of ordinary shares, you will be responsible for transferring good and valid title to the depositary. As such,
you will be deemed to represent and warrant that:

 

		•	The
                                         ordinary shares are duly authorized, validly issued, fully paid, non-assessable and legally
                                         obtained.

 

		•	All
                                         preemptive (and similar) rights, if any, with respect to such ordinary shares have been
                                         validly waived or exercised.

 

		•	You
                                         are duly authorized to deposit the ordinary shares.

 

		•	The
                                         ordinary shares presented for deposit are free and clear of any lien, encumbrance, security
                                         interest, charge, mortgage or adverse claim, and are not, and the ADSs issuable upon
                                         such deposit will not be, “restricted securities” (as defined in the deposit
                                         agreement).

 

		•	The
                                         ordinary shares presented for deposit have not been stripped of any rights or entitlements.

 

If
any of the representations or warranties are incorrect in any way, we and the depositary may, at your cost and expense, take any
and all actions necessary to correct the consequences of the misrepresentations.

 

Transfer,
Combination, and Split Up of ADRs 

 

As
an ADR holder, you will be entitled to transfer, combine or split up your ADRs and the ADSs evidenced thereby. For transfers of
ADRs, you will have to surrender the ADRs to be transferred to the depositary and also must:

 

		•	ensure
                                         that the surrendered ADR is properly endorsed or otherwise in proper form for transfer;

 

		•	provide
                                         such proof of identity and genuineness of signatures as the depositary deems appropriate;

 

		•	provide
                                         any transfer stamps required by the State of New York or the United States; and

 

 

     

     

    

 

		•	pay
                                         all applicable fees, charges, expenses, taxes and other government charges payable by
                                         ADR holders pursuant to the terms of the deposit agreement, upon the transfer of ADRs.

 

To
have your ADRs either combined or split up, you must surrender the ADRs in question to the depositary with your request to have
them combined or split up, and you must pay all applicable fees, charges and expenses payable by ADR holders, pursuant to the
terms of the deposit agreement, upon a combination or split up of ADRs.

 

Withdrawal
of Ordinary Shares Upon Cancellation of ADSs 

 

As
a holder, you will be entitled to present your ADSs to the depositary for cancellation and then receive the corresponding number
of underlying ordinary shares at the custodian’s offices. Your ability to withdraw the ordinary shares held in respect of
the ADSs may be limited by U.S. and French legal considerations applicable at the time of withdrawal. In order to withdraw the
ordinary shares represented by your ADSs, you will be required to pay to the depositary the fees for cancellation of ADSs and
any charges and taxes payable upon the transfer of the ordinary shares. You assume the risk for delivery of all funds and securities
upon withdrawal. Once canceled, the ADSs will not have any rights under the deposit agreement.

 

If
you hold ADSs registered in your name, the depositary may ask you to provide proof of identity and genuineness of any signature
and such other documents as the depositary may deem appropriate before it will cancel your ADSs. The withdrawal of the ordinary
shares represented by your ADSs may be delayed until the depositary receives satisfactory evidence of compliance with all applicable
laws and regulations. Please keep in mind that the depositary will only accept ADSs for cancellation that represent a whole number
of securities on deposit.

 

You
will have the right to withdraw the securities represented by your ADSs at any time except for:

 

		•	Temporary
                                         delays that may arise because (i) the transfer books for the ordinary shares or
                                         ADSs are closed, or (ii) ordinary shares are immobilized on account of a shareholders’
                                         meeting or a payment of dividends.

 

		•	Obligations
                                         to pay fees, taxes and similar charges.

 

		•	Restrictions
                                         imposed because of laws or regulations applicable to ADSs or the withdrawal of securities
                                         on deposit.

 

The
deposit agreement may not be modified to impair your right to withdraw the securities represented by your ADSs except to comply
with mandatory provisions of law.

 

Voting
Rights 

 

As
a holder, you generally have the right under the deposit agreement to instruct the depositary to exercise the voting rights for
the ordinary shares represented by your ADSs.

 

At
our request, the depositary will distribute to you any notice of shareholders’ meeting received from us together with information
explaining how to instruct the depositary to exercise the voting rights of the securities represented by ADSs. In lieu of distributing
such materials, the depositary may distribute to holders of ADSs instructions on how to retrieve such materials upon request.

 

If
the depositary timely receives voting instructions from a holder of ADSs, it will endeavor to vote the securities (in person or
by proxy) represented by the holder’s ADSs in accordance with such voting instructions.

 

Securities
for which no voting instructions have been received will not be voted (except as otherwise contemplated in the deposit agreement).
Please note that the ability of the depositary to carry out voting instructions may be limited by practical and legal limitations
and the terms of the securities on deposit. We cannot assure you that you will receive voting materials in time to enable you
to return voting instructions to the depositary in a timely manner.

 

     

     

    

 

Fees
and Charges 

 

As
an ADS holder, you will be required to pay the following fees under the terms of the deposit agreement:

 

	 	 
	Service	Fees
	Issuance
    of ADSs (e.g., an issuance of ADS upon a deposit of ordinary shares, upon a change in the ADS(s)-to-ordinary share ratio,
    or for any other reason), excluding ADS issuances as a result of distributions of ordinary shares	Up to U.S. 5¢
    per ADS issued
	 	 
	Cancellation
    of ADSs (e.g., a cancellation of ADSs for delivery of deposited property, upon a change in the ADS(s)-to ordinary share ratio,
    or for any other reason)	Up to U.S. 5¢
    per ADS cancelled
	 	 
	Distribution
    of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements)	Up to U.S. 5¢
    per ADS held
	 	 
	Distribution
    of ADSs pursuant to (i) stock dividends or other free stock distributions, or (ii) exercise of rights to purchase
    additional ADSs	Up to U.S. 5¢
    per ADS held
	 	 
	Distribution
    of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off)	Up to U.S. 5¢
    per ADS held
	 	 
	ADS
    Services	Up to U.S. 5¢
    per ADS held on the applicable record date(s) established by the depositary
	 	 
	Registration
    of ADS transfers (e.g., upon a registration of the transfer of registered ownership of ADSs, upon a transfer of ADSs into
    DTC and vice versa, or for any other reason)	Up to U.S. 5¢
    per ADS (or fraction thereof) transferred
	 	 
	Conversion
    of ADSs of one series for ADSs of another series (e.g., upon conversion of Partial Entitlement ADSs for Full Entitlement ADSs,
    or upon conversion of Restricted ADSs (each as defined in the Deposit Agreement) into freely transferable ADSs, and vice
    versa).	Up
    to U.S. 5¢ per ADS (or fraction thereof) converted

 

As
an ADS holder, you will also be responsible to pay certain charges such as:

 

		•	taxes
                                         (including applicable interest and penalties) and other governmental charges;

 

		•	the
                                         registration fees as may from time to time be in effect for the registration of ordinary
                                         shares on the share register and applicable to transfers of ordinary shares to or from
                                         the name of the custodian, the depositary or any nominees upon the making of deposits
                                         and withdrawals, respectively;

 

		•	certain
                                         cable, telex and facsimile transmission and delivery expenses;

 

		•	the
                                         fees, expenses, spreads, taxes and other charges of the depositary and/or service providers
                                         (which may be a division, branch or affiliate of the depositary) in the conversion of
                                         foreign currency;

 

		•	the
                                         reasonable and customary out-of-pocket expenses incurred by the depositary in connection
                                         with compliance with exchange control regulations and other regulatory requirements applicable
                                         to ordinary shares, ADSs and ADRs; and

 

		•	the
                                         fees, charges, costs and expenses incurred by the depositary, the custodian, or any nominee
                                         in connection with the ADR program.

  

ADS
fees and charges for (i) the issuance of ADSs, and (ii) the cancellation of ADSs are charged to the person for whom
the ADSs are issued (in the case of ADS issuances) and to the person for whom ADSs are cancelled (in the case of ADS cancellations).
In the case of ADSs issued by the depositary into DTC, the ADS issuance and cancellation fees and charges may be deducted from
distributions made through DTC, and may be charged to the DTC participant(s) receiving the ADSs being issued or the DTC participant(s)
holding the ADSs being cancelled, as the case may be, on behalf of the beneficial owner(s) and will be charged by the DTC participant(s)
to the account of the applicable beneficial owner(s) in accordance with the procedures and practices of the DTC participants as
in effect at the time. ADS fees and charges in respect of distributions and the ADS service fee are charged to the holders as
of the applicable ADS record date. In the case of distributions of cash, the amount of the applicable ADS fees and charges is
deducted from the funds being distributed. In the case of (i) distributions other than cash and (ii) the ADS service
fee, holders as of the ADS record date will be invoiced for the amount of the ADS fees and charges and such ADS fees and charges
may be deducted from distributions made to holders of ADSs. For ADSs held through DTC, the ADS fees and charges for distributions
other than cash and the ADS service fee may be deducted from distributions made through DTC, and may be charged to the DTC participants
in accordance with the procedures and practices prescribed by DTC and the DTC participants in turn charge the amount of such ADS
fees and charges to the beneficial owners for whom they hold ADSs. In the case of (i) registration of ADS transfers, the
ADS transfer fee will be payable by the ADS holder whose ADSs are being transferred or by the person to whom the ADSs are transferred,
and (ii) conversion of ADSs of one series for ADSs of another series, the ADS conversion fee will be payable by the Holder
whose ADSs are converted or by the person to whom the converted ADSs are delivered.

 

     

     

    

 

 

In
the event of refusal to pay the depositary fees, the depositary may, under the terms of the deposit agreement, refuse the requested
service until payment is received or may set off the amount of the depositary fees from any distribution to be made to the ADS
holder. Note that the fees and charges you may be required to pay may vary over time and may be changed by us and by the depositary.
You will receive prior notice of such changes. The depositary may reimburse us for certain expenses incurred by us in respect
of the ADR program, by making available a portion of the ADS fees charged in respect of the ADR program or otherwise, upon such
terms and conditions as we and the depositary agree from time to time.

 

Amendments
and Termination 

 

We
may agree with the depositary to modify the deposit agreement at any time without your consent. We undertake to give holders of
ADSs 30 days’ prior notice of any modifications that would materially prejudice any of their substantial rights under the
deposit agreement. We will not consider to be materially prejudicial to your substantial rights any modifications or supplements
that are reasonably necessary for the ADSs to be registered under the Securities Act or to be eligible for book-entry settlement,
in each case without imposing or increasing the fees and charges you are required to pay. In addition, we may not be able to provide
you with prior notice of any modifications or supplements that are required to accommodate compliance with applicable provisions
of law.

 

You
will be bound by the modifications to the deposit agreement if you continue to hold your ADSs after the modifications to the deposit
agreement become effective. The deposit agreement cannot be amended to prevent you from withdrawing the ordinary shares represented
by your ADSs (except as permitted by law).

 

We
have the right to direct the depositary to terminate the deposit agreement. Similarly, the depositary may in certain circumstances
on its own initiative terminate the deposit agreement. In either case, the depositary must give notice to the holders at least
30 days before termination. Until termination, your rights under the deposit agreement will be unaffected.

 

After
termination, the depositary will continue to collect distributions received (but will not distribute any such property until you
request the cancellation of your ADSs) and may sell the securities held on deposit. After the sale, the depositary will hold the
proceeds from such sale and any other funds then held for the holders of ADSs in a non-interest bearing account. At that point,
the depositary will have no further obligations to holders other than to account for the funds then held for the holders of ADSs
still outstanding (after deduction of applicable fees, taxes and expenses).

 

In
connection with any termination of the deposit agreement, the depositary may make available to owners of ADSs a means to withdraw
the ordinary shares represented by ADSs and to direct the depositary of such ordinary shares into an unsponsored American depositary
share program established by the depositary. The ability to receive unsponsored American depositary shares upon termination of
the deposit agreement would be subject to satisfaction of certain U.S. regulatory requirements applicable to the creation of unsponsored
American depositary shares and the payment of applicable depositary fees.

 

     

     

    

 

Books
of Depositary 

 

The
depositary will maintain ADS holder records at its depositary office. You may inspect such records at such office during regular
business hours but solely for the purpose of communicating with other holders in the interest of business matters relating to
the ADSs and the deposit agreement.

 

The
depositary will maintain in New York facilities to record and process the issuance, cancellation, combination, split-up and transfer
of ADSs. These facilities may be closed from time to time, to the extent not prohibited by law.

 

Transmission
of Notices, Reports and Proxy Soliciting Material 

 

The
depositary will make available for your inspection at its office all communications that it receives from us as a holder of deposited
securities that we make generally available to holders of deposited securities. Subject to the terms of the deposit agreement,
the depositary will send you copies of those communications or otherwise make those communications available to you if we ask
it to.

 

Limitations
on Obligations and Liabilities 

 

The
deposit agreement limits our obligations and the depositary’s obligations to you. Please note the following:

 

		•	We
                                         and the depositary are obligated only to take the actions specifically stated in the
                                         deposit agreement without negligence or bad faith.

 

		•	The
                                         depositary disclaims any liability for any failure to carry out voting instructions,
                                         for any manner in which a vote is cast or for the effect of any vote, provided it acts
                                         in good faith and in accordance with the terms of the deposit agreement.

 

		•	The
                                         depositary disclaims any liability for any failure to accurately determine the lawfulness
                                         or practicality of any action, for the content of any document forwarded to you on our
                                         behalf or for the accuracy of any translation of such a document, for the investment
                                         risks associated with investing in ordinary shares, for the validity or worth of the
                                         ordinary shares, for any tax consequences that result from the ownership of ADSs or other
                                         deposited property, for the credit-worthiness of any third party, for allowing any rights
                                         to lapse under the terms of the deposit agreement, for the timeliness of any of our notices
                                         or for our failure to give notice or for any act or omission of or information provided
                                         by DTC or any DTC participant.

 

		•	The
                                         depositary shall not be liable for acts or omissions of any successor depositary in connection
                                         with any matter arising wholly after the resignation or removal of the depositary.

 

		•	We
                                         and the depositary will not be obligated to perform any act that is inconsistent with
                                         the terms of the deposit agreement.

 

		•	We
                                         and the depositary disclaim any liability if we or the depositary are prevented or forbidden
                                         from or subject to any civil or criminal penalty or restraint on account of, or delayed
                                         in, doing or performing any act or thing required by the terms of the deposit agreement,
                                         by reason of any provision, present or future of any law or regulation including regulations
                                         of any stock exchange, or by reason of present or future provision of any provision of
                                         our Articles of Incorporation, or any provision of or governing the securities on deposit,
                                         or by reason of any act of God or war or other circumstances beyond our control.

 

		•	We
                                         and the depositary disclaim any liability by reason of any exercise of, or failure to
                                         exercise, any discretion provided for in the deposit agreement or in our Articles of
                                         Incorporation or in any provisions of or governing the securities on deposit.

 

		•	We
                                         and the depositary further disclaim any liability for any action or inaction in reliance
                                         on the advice or information received from legal counsel, accountants, any person presenting
                                         Shares for deposit, any holder of ADSs or authorized representatives thereof, or any
                                         other person believed by either of us in good faith to be competent to give such advice
                                         or information.

  

     

     

    

		•	We
                                         and the depositary also disclaim liability for the inability by a holder or beneficial
                                         holder to benefit from any distribution, offering, right or other benefit that is made
                                         available to holders of ordinary shares but is not, under the terms of the deposit agreement,
                                         made available to you.

 

		•	We
                                         and the depositary may rely without any liability upon any written notice, request or
                                         other document believed to be genuine and to have been signed or presented by the proper
                                         parties.

 

		•	We
                                         and the depositary also disclaim liability for any consequential or punitive damages
                                         for any breach of the terms of the deposit agreement.

 

		•	We
                                         and the depositary disclaim liability arising out of losses, liabilities, taxes, charges
                                         or expenses resulting from the manner in which a holder or beneficial owner of ADSs holds
                                         ADSs, including resulting from holding ADSs through a brokerage account.

 

		•	No
                                         disclaimer of any Securities Act liability is intended by any provision of the deposit
                                         agreement.

 

Nothing
in the deposit agreement gives rise to a partnership or joint venture, or establishes a fiduciary relationship, among us, the
depositary and you as ADS holder.

 

Nothing
in the deposit agreement precludes Citibank (or its affiliates) from engaging in transactions in which parties adverse to us or
the ADS owners have interests, and nothing in the deposit agreement obligates Citibank to disclose those transactions, or any
information obtained in the course of those transactions, to us or to the ADS owners, or to account for any payment received as
part of those transactions.

 

As
the above limitations relate to our obligations and the depositary’s obligations to you under the deposit agreement, we
believe that, as a matter of construction of the clause, such limitations would likely to continue to apply to ADS holders who
withdraw the ordinary shares from the ADS facility with respect to obligations or liabilities incurred under the deposit agreement
before the cancellation of the ADSs and the withdrawal of the ordinary shares, and such limitations would most likely not apply
to ADS holders who withdraw the ordinary shares from the ADS facility with respect to obligations or liabilities incurred after
the cancellation of the ADSs and the withdrawal of the ordinary shares and not under the deposit agreement. 

 

In
any event, you will not be deemed, by agreeing to the terms of the deposit agreement, to have waived our or the depositary’s
compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder. In fact, you cannot waive our
or the depositary’s compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder.

 

Taxes

 

You
will be responsible for the taxes and other governmental charges payable on the ADSs and the securities represented by the ADSs.
We, the depositary and the custodian may deduct from any distribution the taxes and governmental charges payable by holders and
may sell any and all property on deposit to pay the taxes and governmental charges payable by holders. You will be liable for
any deficiency if the sale proceeds do not cover the taxes that are due.

 

The
depositary may refuse to issue ADSs, to deliver, transfer, split and combine ADRs or to release securities on deposit until all
taxes and charges are paid by the applicable holder. The depositary and the custodian may take reasonable administrative actions
to obtain tax refunds and reduced tax withholding for any distributions on your behalf. However, you may be required to provide
to the depositary and to the custodian proof of taxpayer status and residence and such other information as the depositary and
the custodian may require to fulfill legal obligations. You are required to indemnify us, the depositary and the custodian for
any claims with respect to taxes based on any tax benefit obtained for you.

 

Foreign
Currency Conversion 

 

The
depositary will arrange for the conversion of all foreign currency received into U.S. dollars if such conversion is practical,
and it will distribute the U.S. dollars in accordance with the terms of the deposit agreement. You may have to pay fees and expenses
incurred in converting foreign currency, such as fees and expenses incurred in complying with currency exchange controls and other
governmental requirements.

 

     

     

    

 

If
the conversion of foreign currency is not practical or lawful, or if any required approvals are denied or not obtainable at a
reasonable cost or within a reasonable period, the depositary may take the following actions in its discretion:

 

		•	Convert
                                         the foreign currency to the extent practical and lawful and distribute the U.S. dollars
                                         to the holders for whom the conversion and distribution is lawful and practical.

 

		•	Distribute
                                         the foreign currency to holders for whom the distribution is lawful and practical.

 

		•	Hold
                                         the foreign currency (without liability for interest) for the applicable holders.

 

Governing
Law/Waiver of Jury Trial 

 

The
deposit agreement, the ADRs and the ADSs will be interpreted in accordance with the laws of the State of New York. The rights
of holders of ordinary shares (including ordinary shares represented by ADSs) are governed by the laws of France.

 

AS
A PARTY TO THE DEPOSIT AGREEMENT, YOU IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, YOUR RIGHT TO TRIAL
BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF THE DEPOSIT AGREEMENT OR THE ADRs AGAINST US AND/OR THE DEPOSITARY. 

 

The
deposit agreement provides that, to the extent permitted by law, ADS holders waive the right to a jury trial of any claim they
may have against us or the depositary arising out of or relating to our ordinary shares, the ADSs or the deposit agreement, including
any claim under U.S. federal securities laws. If we or the depositary opposed a jury trial demand based on the waiver, the
court would determine whether the waiver was enforceable in the facts and circumstances of that case in accordance with applicable
case law. However, you will not be deemed, by agreeing to the terms of the deposit agreement, to have waived our or the depositary’s
compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder.Valneva SE 20-F

 

Exhibit
10.3

 

 

SENSITIVE

 

[***]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL
AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL.

 

EN

 

ANNEX

 

to
the

 

COMMISSION
DECISION

 

approving
an Advance Purchase Agreement on COVID-19 vaccines

 

     

     

    

 

Contract
No: SANTE/2020/C3/089 – Confidential

 

	

        

	EUROPEAN
        COMMISSION 

        Directorate-General
        for Health and Food Safety

 

		Sensitive*
	 	RELEASABLE
               TO: Need to know basis

 

ADVANCE
PURCHASE AGREEMENT (“APA”)1 for the development, production,

purchasing
and supply of a successful COVID-19 vaccine for EU Member States

 

NUMBER
— [complete]

 

1.
The European Commission (the ‘Commission’), acting on behalf and in the name of the Member States listed in
Annex I (hereinafter referred to as “Participating Member States”) being represented for the purposes of signature
of this APA by Ms Stella Kyriakides, Commissioner for Health and Food Safety:

 

on
the one part and

 

2.
Valneva Austria GmbH, a limited liability company (“Gesellschaft mit beschränkter Haftung”) incorporated
under company number [***], whose registered office is at Campus Vienna Biocenter 3, 1030 Vienna, Austria

 

VAT
registration number: [***]

 

(the
‘contractor’), represented for the purposes of the signature of this APA which has the form of a framework
contract by [***]

 

on
the other part,

 

The
Commission, acting on behalf and in the name of the Participating Member States, and the contractor are together referred to as
the “Parties” and each individually as a “Party”

 

HAVE
AGREED

 

to
the special conditions and the general conditions of this APA and the following annexes:

 

Annex
I –             List of Participating Member States and
allocated volumes

 

 

 1 This APA is based on the agreement between the Commission and the Member States as approved by Commission Decision C(2020) 4192 final on approving the agreement with Member States on procuring Covid- 19 vaccines on behalf of the Member States and related procedures.

 

     2

     

    

 

Annex
II –          Model for Vaccine Order Form

 

Annex
III –        Agreement between the Commission and Member States on
procuring Covid-19 vaccines on behalf of the Member States and related procedures, annexed to the Commission Decision C(2020)
4192 final of 18 June 2020

 

Annex
IV –        List of confirmed and planned manufacturing network partners
including the location(s) of manufacturing

 

Annex
V –          Target Product profile

 

Annex
VI –          Contractor's insurance

 

Annex
VII –         Details of the utilisation of the Down Payment

 

which
form an integral part of this APA.

 

Recitals 

 

		A.	The
                                         world is experiencing an emergency healthcare crisis due to the SARS-CoV-2 (“COVID-19”)
                                         pandemic (the “COVID-19 pandemic”) and the global demand for vaccines
                                         to prevent COVID-19 virus infection is expected to be in order of magnitude of billions
                                         of doses.

 

		B.	The
                                         contractor is currently working to develop and manufacture a highly purified, inactivated
                                         and adjuvanted vaccine candidate against the SARS-CoV-2 virus, consisting in an inactivated
                                         whole virus of SARS-CoV-2 [***], to help protect against COVID-19 virus infection in
                                         humans.

 

		C.	The
                                         Commission intends to create the environment required to support a secure manufacturing
                                         network and optimisation for the production of vaccines against COVID-19. To this effect
                                         the Commission has concluded an Agreement with all Member States of the European Union
                                         to conclude, on behalf and in the name of the Member States, Advance Purchase Agreements
                                         with vaccine manufacturers with the objective to procure vaccines for the purposes of
                                         combatting the COVID-19 pandemic at Union level.

 

		D.	The
                                         Commission wishes to secure the supply of the Product for human use for the Participating
                                         Member States during the COVID-19 pandemic as promptly as possible.

 

		E.	The
                                         intention of the Commission, on behalf of the Member States, is to ensure that the population
                                         in the European Union will be able to access a vaccine in sufficient quantities and at
                                         a fair price, but also in safe conditions. The vaccine should only be available to the
                                         population once its safety and efficacy will have been cleared by the competent regulatory
                                         bodies.

 

     3

     

    

 

		F.	According
                                         to the Agreement between the Commission and the Member States2 and in particular
                                         Article 4 thereof, the Commission can conclude an Advance Purchase Agreement that contains
                                         a right and an obligation for Participating Member States to acquire vaccine doses. Where
                                         the Commission intends to enter into such an agreement, it shall inform the Member States
                                         of such intention and the detailed terms. In case a Member State does not agree with
                                         the conclusion of an APA containing an obligation to acquire vaccine doses or its terms,
                                         it has the right to opt out by explicit notification to the Commission. All Participating
                                         Member States not having opted out in accordance with the Agreement between the Commission
                                         and the Member States are deemed to have authorised the Commission to negotiate and conclude
                                         an Advance Purchase Agreement with the vaccine manufacturer in their name and on their
                                         behalf.

 

		G.	This
                                         APA is such an agreement which the Commission enters into on behalf and in the name of
                                         the Participating Member States which have not opted out of the agreement. These Participating
                                         Member States will then have an obligation to acquire the Product and a right to be supplied
                                         with the respective Product doses. While the APA is legally binding upon those Participating
                                         Member States, it will be further implemented by means of the conclusion of contracts
                                         between the Participating Member States and the contractor. The present APA is complemented
                                         by a Vaccine Order Form (“Vaccine Order Form”) between each of the
                                         Participating Member States and the contractor. A model Vaccine Order Form is attached
                                         in Annex II.

 

		H.	The
                                         development, production, advance sale and supply of the Product as per this APA require
                                         significant investments by the contractor to increase the speed of clinical development,
                                         and the preparation of the at-scale production capacity along the entire production value
                                         chain in the EU required for a rapid deployment of the millions of doses of the Product.
                                         The Participating Member States are willing to contribute to financing of those investments
                                         in the form of up-front payments.

 

		I.	Pursuant
                                         to these terms and conditions, access to Product doses will be allocated to Participating
                                         Member States as provided in Annex I. The up-front payments, paid by the Participating
                                         Member States, should be taken into account in equal terms per dose ordered by
                                         the Participating Member States.

 

		J.	The
Parties recognise that the timelines to develop, produce, sell and supply the Product are accelerated and that the Participating Member
States are willing to share risks arising from this accelerated timetable, [***]

 

 

 

2 Such agreement is based on Article 4(5)(b) of Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union, OJ L 70, 16.3.2016, p.1, as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak, OJ L 117, 15.4.2020, p. 3. The agreement was approved Decision C(2020) 4192 final of 18 June 2020 (see Annex III to this APA).

 

     4

     

    

 

		K.	Against
                                         this background, the Commission wishes to enter into, on behalf and in the name of the
                                         Participating Member States, an Advance Purchase Agreement with the contractor to secure
                                         the availability of a total of 24.341.449 doses of the Product and 35.658.551 optional
                                         doses of the Product, to be allocated among the Participating Member States in accordance
                                         with the allocation principles set out in this APA.

 

This
APA sets out:

 

		1.	the
                                         procedure and conditions by which the Participating Member States shall pay for the Product
                                         from the contractor;

		2.	the
                                         provisions that apply to any Vaccine Order Form which the Participating Member States
                                         and the contractor shall conclude under this APA; and

		3.	the
                                         obligations of the Parties during and after the duration of this APA.

 

All
terms and conditions issued by the contractor (end-user agreements, general terms and conditions, etc.) are held inapplicable,
unless explicitly mentioned in the special conditions of this APA. In all circumstances, in the event of contradiction between
this APA and documents issued by the contractor, this APA prevails, regardless of any provision to the contrary in the contractor’s
documents.

 

     5

     

    

 

TABLE
OF CONTENT

 

	TABLE
    OF CONTENT	6
	I.	SPECIAL
    CONDITIONS	8
	 	I.1	Order
    of priority of provisions	8
	 	I.2	Subject
    matter	8
	 	I.3	Entry
    into force and duration of the APA	8
	 	I.4	Implementation
    of the APA	9
	 	I.5	Acceptance/Rejection
    of Product	16
	 	I.6	Warranties
    and release	18
	 	I.7	Prices	18
	 	I.8	Payment
    Arrangements	19
	 	I.9	Exploitation
    of the results of the APA	21
	 	I.10	Applicable
    law and settlement of disputes	21
	 	I.11	Other
    special conditions	22
	 	I.12	Definitions	23
	II.	GENERAL
    CONDITIONS FOR THE FRAMEWORK CONTRACT	28
	 	II.1	Severability	28
	 	II.2	Provision
    of Product	28
	 	II.3	Communication
    between the Parties	28
	 	II.4	Liability	29
	 	II.5	Indemnification	30
	 	II.6	Conflict
    of interest and Professional conflicting interests	32
	 	II.7	Confidentiality	33
	 	II.8	Processing
    of personal data	34
	 	II.9	Subcontracting	34
	 	II.10	Amendments	35
	 	II.11	Assignment	35
	 	II.12	Intellectual
    property rights	35
	 	II.13	Force
    majeure	36
	 	II.14	Liquidated
    damages	37
	 	II.15	Suspension
    of the Implementation of the APA	37
	 	II.16	Termination
    of the APA	38
	 	II.17	Invoices,
    Taxes, value added tax and e-invoicing	41
	 	II.18	Payments	41
	 	II.19	Recovery	42

 

     6

     

    

 

	 	II.20
    	Checks
    and audits	42
	 	Annex
    I: Participating Member States and allocated volumes	45
	 	Annex
    II: Model for Vaccine Order Forms	46
	 	Annex
    III: Agreement between the Commission and Member States on procuring Covid-19 vaccines on behalf of the Member States and
    related procedures, annexed to the Commission Decision C(2020) 4192 final of 18 June 2020	51
	 	Annex
    IV: List of confirmed and planned manufacturing network partners including the location(s) of manufacturing	57
	 	Annex
    V: Target Product profile	58
	 	Annex
    VI: Contractor's insurance	59
	 	Annex
    VII: Details of the Utilisation of the Down Payment	60

 

     7

     

    

 

		I.	SPECIAL
                                         CONDITIONS

 

I.1       Order
of priority of provisions

 

If
there is any conflict between different provisions in this APA, the following rules must be applied:

 

		(a)	The
                                         provisions set out in the special conditions take precedence over those in the other
                                         parts of the APA, including its annexes.

		(b)	The
                                         provisions set out in the general conditions take precedence over those in the Vaccine
                                         Order Forms signed by the Participating Members States.

		(c)	All
                                         terms and conditions issued by the contractor (such as end-user agreements, general terms
                                         and conditions, etc.) are held inapplicable, unless they are issued under or in accordance
                                         with this APA (such as the final specifications, (Formal) Notifications, etc.). In all
                                         circumstances, in the event of contradiction between this APA and documents issued by
                                         the contractor, this APA prevails, regardless of any provision to the contrary in the
                                         contractor’s documents.

 

I.2       Subject
matter

 

The
subject of this APA is the advance purchase of (i) 24.341.449 doses of the Product, as described below in Article I.4.2, to be
allocated among the Participating Member States by the Commission in accordance with the allocation principles set out below in
Article I.4.3, and (ii) the optional and additional purchase of up to 35.658.551 Option Doses, according to the conditions laid
down in Article I.4.4.

 

On
the basis of this APA, the contractor (i) commits to use Best Reasonable Efforts to obtain a Marketing Authorisation for the Product;
and, (ii) if a Marketing Authorisation for the Product is obtained, [***] supply the contractually agreed volumes of the Product
to the Participating Member States in accordance with said Marketing Authorisation and the Delivery Schedule set out below in
Article I.4.7.

 

Each
Participating Member State shall issue a Vaccine Order Form as regards its allocation of the Doses, through which the contractor
shall supply to the Participating Member States the Product doses in accordance with the terms of this APA.

 

The
delivery of the Product to the individual Participating Member States shall be carried out in accordance with the terms and conditions
of this APA and in particular in accordance with the allocation set out in Annex I, as well as the additional delivery details
set out in the Vaccine Order Forms concluded between the contractor and each Participating Member State using the model Vaccine
Order Form provided as Annex II to this APA.

 

I.3       Entry
into force and duration of the APA

 

I.3.1    The
APA enters into force on the date on which the contractor and the Commission have signed it.

 

     8

     

    

 

I.3.2    Unless
earlier terminated in accordance with Article II.16 or expired in accordance with Article I.3.5, the APA is concluded for a period
of [***] with effect from the date of its entry into force.

 

I.3.3
  Its duration may be extended upon mutual agreement if at the end of the term of [***] not all of the Doses, and, as
the case may be, doses of Product purchased under the 2023 Option (as defined below) have been supplied. [***] The Participating
Member States and the contractor may not sign any Vaccine Order Form after the APA expires.

 

I.3.4    The
APA continues to apply to signed Vaccine Order Forms after its expiry.

 

I.3.5    The
APA shall automatically expire on the date on which all the Doses and, as the case may be, all doses of Product purchased under
the 2023 Option, have been delivered and paid in full.

 

I.3.6    Articles
I.4.6, I.4.7.3(d), I.4.7.4(5), I.4.7.6, I,8, I.10, I.11.1, I.11.2, I.11.3, I.11.4, I.11.5, II.4, II.5, II.7, II.16.5, II.18, II.19,
II.20 and any other clause which produces legal effects after the termination or expiry of this APA according to its wording,
shall survive the termination or expiry of this APA.

 

I.4       Implementation
of the APA

 

I.4.1
General principles and Variant Switch

 

I.4.1.1
General principles

 

The
APA shall be implemented following signature between the Commission on behalf and in the name of the Participating Member States
and the contractor as follows:

 

(1)
Following entry into force of this APA, this APA is binding upon the contractor, the Commission and all Participating Member States
on behalf and in the name of which the Commission has concluded this APA, as identified in Annex I.

 

(2)
Within 10 days after the signature of the APA by the Commission, each Participating Member State shall place an order for its
allocated portion of the Doses by sending the contractor the duly completed and signed Vaccine Order Form (the format for which
is set out in Annex II) in PDF format and by email, to the contractor’s address specified in the Vaccine Order Form.

 

(3)
Within 10 days of receipt of the Vaccine Order Form from a Participating Member State, the contractor must send back to the Participating
Member State the Vaccine Order Form duly signed and dated in PDF format and by email, to the Participating Member State’s
address specified in the Vaccine Order Form.

 

(4)
The Parties acknowledge that any delivery is dependent on the date on which the Marketing Authorisation for the Product is obtained.

 

     9

     

    

 

(5)
Wherever this APA provides that:

 

		a)	certain
                                         rights enjoyed by the Participating Member States under the APA shall be exercised by
                                         the Commission, the Commission alone shall be entitled to (Formally) Notify the contractor
                                         of the exercise of such rights. Such (Formal) Notification shall be binding upon all
                                         Participating Member States, or, in situations where this APA provides that the Commission
                                         can exercise certain rights on behalf of some but not necessarily all Participating Member
                                         States, upon the Participating Member States concerned by such notification;

 

		b)	certain
                                         Notifications of the contractor shall be issued to the Commission, such Notification
                                         to the Commission shall bind all Participating Member States. The Commission is acting
                                         on behalf and in the name of the Participating Member States in such cases.

 

The
foregoing sub-sections a) and b) shall not apply to the Vaccine Order Forms, unless provided otherwise in the APA or the relevant
Vaccine Order Form. The Vaccine Order Forms shall only be implemented, performed and consummated by the contractor and the relevant
Participating Member State (but not the Commission).

 

I.4.1.2
Variant Switch

 

The
contractor will keep the Commission informed of the availability of any new strains which contractor may use as basis to manufacture
COVID-19 vaccines and the impact on production of contractor's arrangements to address any new strains. The Participating Member
States can then elect to request contractor to switch the strain used as basis for the Doses to such a new strain (“Variant
Switch”). The following conditions shall apply to any such Variant Switch:

 

[***]

 

I.4.2       Doses

 

The
contractor commits to supply 24.341.449 doses in the aggregate of the Product (the “Doses”) to all Participating
Member States in accordance with the terms of this APA and the applicable Vaccine Order Forms. Annex V provides the target Product
profile, as at the date of signature of the APA, which contractor may vary as the Product is being developed. [***]

 

Each
Participating Member State shall, in proportion to the Doses allocated to such Participating Member State in accordance with Article
I.4.3, contribute to the relevant costs for the Doses in the form of an up-front payment of [***] of the total price of the Doses
as laid down in Article I.7.1 (the “Down Payment”). This amount shall be invoiced upon signature of the APA
and paid as provided in Article I.8.1.

 

[***]
of the price of the Doses actually delivered to such Participating Member State is invoiced upon delivery and paid as provided
in Article I.8.3.

 

     10

     

    

 

I.4.3       Allocation
between Participating Member States; Vaccine Order Forms

 

a)
The volumes of Doses shall be allocated between Participating Member States in accordance with Annex I.

 

b)
Each Participating Member State and the contractor will conclude a Vaccine Order Form, using the model Vaccine Order Form attached
as Annex II to this APA, setting out the details of the delivery of the doses of the Product allocated to the respective Participating
Member State. For the avoidance of doubt, each Participating Member State is obligated to conclude a Vaccine Order Form for the
Doses contractually allocated to it in Annex I, unless such Member State has opted out of this APA pursuant to the Agreement between
the Commission and the Member States.

 

I.4.4       Increase
of Doses

 

I.4.4.1
General principle

 

If
the Commission, acting on behalf of one or more of the Participating Member States, wishes to purchase doses of Product in addition
to the Doses, it may elect to purchase such doses in accordance with the provisions of this APA.

 

I.4.4.2
Option for deliveries in 2023

 

The
contractor will keep the Commission informed of its manufacturing capacity for 2023. The Participating Member States may then,
to the extent permitted by such capacity and [***] from the contractor's informing the Commission of such capacity, elect to purchase
doses of Product in addition to the Doses for delivery in 2023 up to 35.658.551 doses in the aggregate (the "2023 Option").
The following conditions shall apply to any 2023 Option: 

 

		-	[***]

 

		-	the
                                         request for the 2023 Option shall be notified to the contractor by the Commission, acting
                                         in the name and on behalf of the relevant Participating Members States and shall specify
                                         the Participating Member States participating in such 2023 Option (the “Exercising
                                         Member States”) and the allocation of doses of Product to be purchased by and
                                         delivered to each such Exercising Member State (the “Option Doses”);

 

		-	the
                                         contractor shall confirm the available supplies of the Product for the order for Option
                                         Doses to the Commission [***];

 

		-	the
                                         order for the Option Doses shall be formalized through the conclusion of Vaccine Order
                                         Forms by the Exercising Member States;

 

		-	each
                                         Exercising Member State shall, in proportion to the Option Doses allocated to such Exercising
                                         Member State, contribute to the relevant costs for the Option Doses in the form of an
                                         up-front payment of [***] of the total price of the Option Doses (the “Down
                                         Payment for Option Doses”), payable [***] after the receipt of an invoice issued
                                         by contractor following the receipt of a Vaccine Order Form signed by the Exercising
                                         Member State. The balance of payments for the supply of Option Doses will be paid by
                                         each Participating Member State upon delivery as provided under the APA.

 

     11

     

    

		-	subject
                                         to the above provisions, the other terms of this APA applicable to the Doses shall apply
                                         mutatis mutandis to the Option Doses.

 

I.4.5       Development
timeline; Special Commitments

 

The
contractor’s current assumptions on development timelines in support of an EU Marketing Authorisation for a Vaccine based
on the Wuhan Strain are: 

-[***].

 

To
produce the Doses, the contractor shall not manufacture or have manufactured the Product at manufacturing sites located outside
the territory of the European Union or the European Economic Area without the prior consent of the Commission, which consent may
not be unreasonably withheld, conditioned or delayed if the manufacturing at such sites is required to accelerate the production
of the Doses for delivery to Participating Member States. However, consent may be refused if the sites located outside the territory
of the European Union or the European Economic Area (EEA) [***].

 

I.4.6       Right
of the Participating Member State to re-sell, export, donate and/or distribute

 

The
Participating Member States shall be entitled to re-sell, export, distribute and/or donate for free any of the Products supplied
to them pursuant to this APA to any other EU Member State, EEA Member State and/or Switzerland, [***]. 

[***] 

[***]
For the avoidance of doubt, any re-sale, export, distribution or donation activities shall be carried out under the sole cost
and responsibility of the relevant Participating Member State, unless the Parties agree otherwise in writing.

 

I.4.7       Delivery

 

The
contractor shall deliver the Product doses to the Participating Member States in accordance with the allocation provided in Annex
I and the other terms and conditions of this APA. The Parties acknowledge and agree that the allocation provided in Annex I, as
well as the numbers in the Delivery Schedule in accordance with Article I.4.7.2, can be amended by an exchange of letters between
the Commission, represented for this purpose by the Deputy Director-General for Health of the European Commission’s Directorate-General
for Health and Food Safety, and the contractor.

 

I.4.7.1       Delivery
Schedule

 

The
contractor commits to deliver Product doses to the Participating Member [***] and [***] supply such doses on the schedule and
in the quantities as set out in the initial delivery schedule provided below (“Delivery Schedule”).

 

     12

     

    

 

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***] 
	[***] 

 

The
schedule and quantities set out in the Delivery Schedule are based on the contractor’s current expectation that the Marketing
Authorisation for the Product based on the Wuhan Strain will be granted [***] (the “Expected Approval Date”).
[***]

 

The
contractor shall use Best Reasonable Efforts to obtain Marketing Authorisation for the Product as soon as reasonably possible
in order to meet the Expected Approval Date. [***] Under no circumstances will any delivery of Product doses be required under
this APA prior to receipt of a Marketing Authorisation for the Product.

 

I.4.7.2
Performance under the Delivery Schedule 

 

a)
The Delivery Schedule may only be updated in the following circumstances:

 

-
the Marketing Authorisation for the Product is received after the Expected Approval Date. In such situation, the delivery dates
in the Delivery Schedule will be delayed with the same amount of time as the Marketing Authorisation is delayed beyond the Expected
Approval Date;

 

-
to account for a Variant Switch as foreseen in Article I.4.1.2; or

 

-
if required due to occurrence of a Force majeure event affecting the Delivery Schedule.

 

The
contractor shall henceforth comply with such updated Delivery Schedule.

 

In
case any updated Delivery Schedule proposed by the contractor pursuant to this Article proposes the delivery of the Doses with
a delay of more than [***] compared to the initial Delivery Schedule (the "Delayed Doses"), then any concerned
Participating Member State may cancel its purchase [***]. Any cancellation shall be notified by the Commission to the contractor
in writing and shall indicate the amount of cancelled Delayed Doses, as well as the Participating Member States involved. In case
of cancellation of Delayed Doses, the contractor shall reimburse to the Participating Member States [***].

 

     13

     

    

 

b)
The schedule set out in the Delivery Schedule reflects the [***] delivery rate in which Product doses are expected to be delivered.
The actual delivery dates within the applicable Delivery Schedule for the Product doses will be agreed between the contractor
and the Participating Member States in line with the Delivery Schedule which may not be derogated from, [***]. Once the Marketing
Authorisation for the Product is obtained, the contractor shall make the first delivery of Doses within the later of [***] after
receipt of the Marketing Authorisation for the Product if the Marketing Authorisation is granted on or after the Expected Approval
Date and subject to the labelling and packaging material being approved by the EMA [***] before the Expected Approval Date, or
[***].

 

Save
in exceptional circumstances and as mutually agreed between the contractor and the relevant Participating Member State(s), deliveries
of Product doses shall be made in a [***] manner between Participating Member States with a minimum of one delivery per
month per Participating Member State and pro rata to each Participating Member State based on the allocation provided in Annex
I, subject to the contractor’s [***]. To the extent a Participating Member State considers that deliveries of Products are
carried out in [***], the Commission, on behalf of the Participating Member States, shall be exclusively in charge of resolving
any disagreements in this respect with the contractor, and no payment of contractor's invoices shall be delayed on such grounds.

 

I.4.7.3
Late Deliveries

 

a)
In the event that doses of Product are not delivered [***] for which their delivery is foreseen in the Delivery Schedule [***],
such doses (“Missing Doses”) shall be considered as being delivered late (“Late Delivery”)
and Participating Member States which have not been fully delivered their share of the Product Doses due [***] pursuant to the
allocation provided in Annex I shall be entitled to apply the measures foreseen in Article II.14 to the contractor [***]. Any
Participating Member State wishing to apply the measures foreseen in Article II.14 to the contractor shall notify the contractor
of that intention [***].

 

b)
In the event that the contractor [***], the concerned Participating Member States may cancel the purchase of such Missing Doses
provided that such right to cancellation is exercised [***].

 

c)
For the avoidance of doubt, the measures foreseen in Article II.14 and the cancellation rights referred to in Articles I.4.7.2(a)
and I.4.7.3(b) shall not apply if the contractor is unable to respect the Delivery Schedule due to a situation of Force majeure,
[***] or because the Marketing Authorisation is delayed for reasons not imputable to the contractor.

 

Following
any cancellation under Articles I.4.7.2(a) or I.4.7.3(b), the contractor shall consequently reimburse to each relevant Participating
Member States:

 

		-	[***].

 

     14

     

    

 

d)
[***].

 

e)
For the avoidance of doubt, no Doses that had actually been delivered before the receipt by the contractor of notification of
cancellation can be subject to a cancellation.

 

Nothing
in this Article shall affect the Delivery Schedule of Doses not subject to a Late Delivery.

 

I.4.7.4
Marketing Authorisation for sub-groups of the population

 

In
case the contractor receives a Marketing Authorisation which does not cover the entire adult population but is limited to sub-groups
of that population, the following provisions shall apply: 

 

		1)	[***];

 

		2)	[***];

 

		3)	in
                                         case the contractor does not manage to receive a Marketing Authorisation for the entire
                                         adult population by 30 June 2022 [***], the Participating Member States shall have the
                                         right to cancel the [***] Doses. [***];

 

[***].
 

 

		4)	in
                                         case of cancellation of Doses under the above subparagraph I.4.7.4 3), the contractor
                                         shall be obliged to reimburse 100% of the Down Payment, prorated with respect to its
                                         number of cancelled Doses.

 

		5)	[***].

 

		6)	Table:

 

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

	[***]

         
	[***]

         

[***].

 

     15

     

    

I.4.7.5
Form of Delivery and transfer of title

 

The
Product doses will be delivered by the contractor to the Participating Member States [***]. Title on the Product will transfer
upon full payment of the corresponding invoice by the relevant Participating Member State, such retention of title not preventing,
however, the administration of the Product to the patients as and when deemed necessary by the relevant treating healthcare professionals.

 

I.4.7.6
Distribution

 

Following
delivery of the Product doses, each Participating Member State will solely control and assume all responsibility, at such Participating
Member State’s own cost and expense, for conducting all distribution and related activities relating to the Product doses
in the Participating Member State’s territory and to countries in the EU, EEA or Switzerland, or other countries/entities,
to which the Participating Member State re-sells, exports, distributes and/or donates Product doses in accordance with Article
I.4.6. If a Participating Member State re-sells, exports, distributes and/or donates Product doses in accordance with Article
I.4.6, contractor may agree to deliver directly such doses to the recipient country provided the relevant parties agree reasonable
terms for such delivery and contractor does not incur additional costs.

 

I.4.7.7
Traceability

 

During
the term of this APA and for a period of ten (10) years thereafter (or longer if required by applicable laws), each Participating
Member State will maintain an inventory control system for traceability of the Product supplied to or for the benefit of such
Participating Member State, including any Product provided by such Participating Member State to a Donation Country or Resale
Country. The inventory control system is without prejudice to other traceability requirements in accordance with the applicable
laws.

 

I.5       Acceptance/Rejection
of Product

 

I.5.1    Contractor
warrants that the Product (1) shall comply with the final specifications for the Product as approved in the Marketing Authorisation
for the Product and (2) shall be manufactured in all material respects in accordance with the Good Manufacturing Practices in
effect at the time of manufacture in the place of manufacture. Subject to the terms of this Article I.5 and Article I.6.2, a Participating
Member State may claim a remedy (a “Product Claim”) for any portion of Product delivered to such Participating
Member State by the contractor which at the time of delivery (a) does not comply with the final specifications for the Product
as approved in the Marketing Authorisation for the Product or (b) has not been manufactured in accordance with the said Good Manufacturing
Practices (“Deficient Product”). Such Participating Member State will visually inspect the Product, or review
documentation provided by or on behalf of the contractor, upon delivery or receipt (as applicable) and will give the contractor
written notice of the Product Claims:

 

		-	immediately
                                         in case of visible damages resulting from transportation; or

 

		-	[***]
                                         for other apparent damage after such delivery or receipt; or

 

     16

     

    

		-	in
                                         the case of any deficiency at the time of delivery to such Participating Member State
                                         that was not reasonably susceptible to discovery upon such delivery or receipt, [***].

 

In
the absence of notice, the Product is deemed to be accepted by the Participating Member State.

 

I.5.2    The
contractor will have no obligation for any Product Claims to the extent the Deficient Product was caused exclusively by actions
or omissions of such Participating Member State or Third Parties occurring after the time of delivery of the Product by the contractor
or its designee.

 

I.5.3    Upon
receipt of a Product Claim, the contractor will have [***] to advise the Participating Member State by notice in writing whether
it disagrees with the content of the Product Claim. If, after joint testing or investigation has been performed, the Parties still
cannot agree on whether such Product is a Deficient Product, the contractor or the Participating Member State may refer such dispute
to a technical expert for resolution in accordance with Article I.5.4 (a “Technical Dispute”).

 

I.5.4    If
any Technical Dispute arises, the contractor and the Participating Member State will first try to resolve it amicably. The contractor
or the Participating Member State may send a notice of a Technical Dispute to the other, and each Party will appoint, [***], an
appropriate single representative having full power and authority to resolve the dispute. The representatives will meet as necessary
in order to resolve the Technical Dispute. If the representatives fail to resolve the matter [***], or if a Party fails to appoint
a representative as required above, the expert determination procedure below may be started by either Party. [***], the contractor
and the Participating Member State will appoint a single agreed expert with experience and expertise in the subject matter of
the dispute. As a condition of the expert’s appointment, the contractor and the Participating Member State will ensure that
the expert agrees to disclose any actual or potential conflicts of interest promptly as they arise. The contractor and the Participating
Member State do not intend that the expert acts as an arbitrator and therefore any matters requiring legal interpretation or adjudication
including disputes relating to the conduct of the Technical Dispute are solely reserved for the dispute resolution procedure under
Article I.10.2. For the avoidance of doubt, any technical determination by the expert under a Technical Dispute may be used as
evidence under Article I.10.2. The contractor and the Participating Member State will require the expert to provide an opinion
on each referred issue (with reasonably detailed reasoning) [***]. The contractor and the Participating Member State will give
to the expert all the evidence and information within their respective possession or control as the expert may reasonably request,
which they will disclose promptly [***]. At all times the contractor and the Participating Member State will co-operate and seek
to narrow and limit the issues to be determined. The technical determination of the expert will, except for fraud or manifest
error or where an unapproved conflict of interest is discovered, be final and binding upon the contractor and the Participating
Member State with respect to the referred Technical Dispute. Each of the contractor and the Participating Member State will bear
its own costs for any matter referred to an expert under this Article I.5.4 and, in the absence of express agreement to the contrary,
the costs and expenses of the expert will be shared equally by the contractor and the Participating Member State.

 

I.5.5    If
a Participating Member State makes a Product Claim pursuant to this Article I.5 and (a) the contractor and this Participating
Member State agrees the Product that is the subject of such Product Claim is a Deficient Product (such agreement not to be unreasonably
withheld, conditioned or delayed) or (b) any previously delivered Product is determined to be a Deficient Product, the contractor
will replace such Deficient Product [***] after the time of such agreement or determination, any other remedy under this APA being
excluded in case of Deficient Product unless the concerned Participating Member State and contractor agree otherwise.

 

     17

     

    

I.5.6    In
the cases referred to in Article I.5.5, the contractor may instruct the concerned Participating Member State to place the Product
at the contractor’s disposal. The contractor will bear the cost of [***] disposal of any Deficient Product.

 

I.6       Warranties
and release

 

I.6.1.   The
contractor warrants to the Commission and the Participating Member States that:

 

(a)       as
of the date hereof, this APA has been duly executed and is a legal, valid and binding obligation on it, enforceable against it
in accordance with its terms;

 

(b)       as
of the date hereof, it is not under any obligation, contractual or otherwise, to any third party in respect of the delivery of
the Doses that conflicts with or is inconsistent with the terms of this APA or that would impede the complete fulfilment of its
obligations under this APA;

 

(c)
      it will not undertake any contractual obligations, including any settlements, that would
conflict with, hinder or impede the fulfilment of its obligations under this APA; and

 

(d)       [***].

 

I.6.2.   The
Commission and each of the Participating Member States each within their respective competencies, on behalf of itself, waive and
release any claim against the contractor arising out of or relating to:

 

 (a)
lack of safety or efficacy of the Vaccine, [***]; 

 (b)
use or administration of the Vaccine under pandemic conditions, except to the extent such claim arises from contractor's breach
of this APA which classifies as Willful Misconduct or Gross Negligence; or 

 (c)
delays in delivery of the Vaccine doses under this APA, the only remedies available in case of delays being, if applicable, [***].

 

I.7       Prices

 

I.7.1    Price
per Dose of Product

 

The
price per single dose of Product purchased hereunder, [***], shall be [***].

 

For
clarity, the price for the total Product volume shall be obtained by multiplying the price of a single Product dose by the total
number of Product doses covered by this APA.

 

The
total price of the Doses shall be [***] doses, equalling [***].

 

     18

     

    

I.7.2    Down
payment and payment schedule under the APA 

 

The
Down Payment for the Doses is [***] of the total price of the Doses as laid down in Article I.7.1, equalling [***].

 

The
payment schedule for purchases of Doses by or on behalf of Participating Member States is addressed in Article I.4.2.

 

I.8       Payment
Arrangements

 

I.8.1    Payment
of the Down Payment

 

The
invoices for the Down Payment shall be issued by contractor upon signature of the APA.

 

The
contractor must send the invoice for the Down Payment to each Participating Member State in PDF format by email.

 

Each
invoice for the Down Payment shall be paid in a single instalment.

 

The
invoice for the Down Payment must contain the following information:

		-	Name
                                         of the addressee

		-	APA
                                         number

		-	Contractor
                                         name and bank account.

 

The
invoice must indicate the place of taxation of the contractor for value added tax (VAT) purposes and must specify separately amounts
not including VAT and amounts including VAT (where VAT is applicable).

 

Provided
that the invoice includes the above information, each Participating Member State shall pay the invoice [***] after receipt of
the invoice.

 

I.8.2    Utilisation
of the Down Payment

 

The
Parties acknowledge and agree that the Down Payment is intended to cover costs incurred by the contractor for [***].

 

The
contractor intends to use the Down Payment as further specified in Annex VII.

 

I.8.3    Payment
for the supply of Product

 

The
contractor must send an invoice in PDF format by email to the Participating Member States for payment by the Participating Member
States under Article I.4.2.

 

Invoices
shall be established by the contractor for a given order of Product doses and for an identified delivery scheduled in accordance
with the APA.

 

     19

     

    

 

Each
invoice shall be accompanied by the following documentation (as applicable):

 

- Proof of delivery of the Products referred to in Article I.4.2 of this APA, to the place of
delivery indicated by the Participating Member State concerned in the Vaccine Order Form (or offer of such delivery if the Participating
Member State illegitimately refuses acceptance of delivery).

 

Each
invoice must contain the following information:

 

		-	Name
                                         of the concerned Participating Member State

		-	APA
                                         and Vaccine Order Form number/reference

		-	Order
                                         reference

		-	Date
                                         of receipt of the Marketing Authorisation for the Product

		-	Product
                                         name

		-	Quantity
                                         delivered (or offered to be delivered if the Participating Member State illegitimately
                                         refuses acceptance of delivery),

		-	Delivery
                                         reference and date

		-	Contractor
                                         name and bank account.

 

The
Participating Member States must pay these invoices [***] from their respective date of issuance.

 

I.8.4    Currency

 

Any
payments to be made by the Participating Member States under this APA, including under any Vaccine Order Form, shall be made,
and any invoices issued pursuant to this APA shall be issued, in euros (EUR).

 

I.8.5    Refundability
of Unspent Amounts

 

If
this APA is terminated pursuant to Article II.16.1, then the Participating Member States will be entitled to a refund of Unspent
Amounts in accordance with Article II.16.5.

 

I.8.6    Bank
account

 

Payments
must be made to the contractor’s bank account denominated in euro, identified as follows:

 

 [***]

 

I.8.7    Communication
Details

 

For
the purpose of this APA, communications must be sent to the following addresses:

 

The
Commission:

 

European
Commission

 

Directorate-General
for Health and Food Safety

 

E-mail:
SANTE-PROCUREMENT@ec.europa.eu

 

     20

     

    

Participating
Member States will provide their respective communication details in the Vaccine Order Forms.

 

Contractor:

 

[***]

 

By
derogation from this Article, different contact details for the Commission, the Participating Member States or the contractor
may be provided in Vaccine Order Forms.

 

I.8.8    Suspension
if no payment

 

Timely
payment by all the Participating Member States of amounts under this APA is of essence. If any Participating Member State fails
to pay any amounts when due, contractor shall have the right to suspend performance of the APA in relation to that Participating
Member State until full payment. In particular, the Parties acknowledge and agree that (i) compliance by contractor with delivery
schedules is conditional on timely payments, (ii) any such suspension of manufacturing and deliveries may cause subsequent delay
in supply, and that (iii) related quantities of Products may be redirected by contractor to other entities.

 

I.9       Exploitation
of the results of the APA

 

The
Commission and the Participating Member States acknowledge and agree that the contractor shall be the sole owner of all intellectual
property rights generated during the development, manufacture, and supply of the Product, including all know-how (collectively,
the “Vaccine IP Rights”). The contractor shall be entitled to exclusively exploit any such Vaccine IP Rights.
Except as expressly set forth in this APA, the contractor does not grant to the Commission or any of the Participating Member
States by implication, estoppel or otherwise, any right, title, license or interest in the Vaccine IP Rights. All rights not expressly
granted by the contractor hereunder are reserved by the contractor.

 

I.10     Applicable
law and settlement of disputes

 

I.10.1  This
APA is based on Article 4(5)(b) of Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the
Union (ESI Regulation, as amended by Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under
Regulation (EU) 2016/369.

 

This
APA shall be governed by the laws of [***].

 

I.10.2  Dispute
Resolution

 

(a)
In the event of a dispute arising under this APA or a Vaccine Order Form between the contractor and the Commission or a Participating
Member State, the Parties shall first refer such dispute to informal dispute resolution discussions between their respective representatives.
The contractor or the Commission on behalf of itself or of the Participating Member States may initiate such informal dispute
resolution by sending written notice of the dispute to the other Party, and, [***], the representatives shall meet and attempt
to resolve the dispute by good faith negotiations.

 

     21

     

    

(b)
The Commission, the Participating Member States and the contractor irrevocably submit to the exclusive jurisdiction of the courts
located in [***] to settle any dispute which may arise under or in connection with this APA or the legal relationships
established by this APA including under a Vaccine Order Form.

 

I.11     Other
special conditions

 

I.11.1  Each
Participating Member State and the contractor will each maintain records necessary to permit a Recall of any Product delivered
to such Participating Member State.

 

I.11.2  Each
Participating Member State and the contractor will Notify the other Party [***] from notifying the European Medicines Agency of
any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall
or seizure of the Product in the Participating Member State’s territory.

 

I.11.3  Upon
receiving this notice or upon this discovery, and save where contractor challenges any decision regarding a Recall, such Participating
Member State and the contractor will stop making any further shipments of any Product in their possession or control in such Participating
Member State’s territory until a decision has been made whether a Recall or some other corrective action is necessary.

 

I.11.4  The
decision to initiate a Recall or to take some other corrective action, if any, with respect to the Product in such Participating
Member State’s territory will be made by the competent authority concerned, or by the contractor (after having consulted
with the competent authority(ies) concerned).

 

I.11.5  If:
(i) any regulatory authority issues a decision, order or, following the issuance of a safety warning or alert about a Product,
a written request that any Product be recalled in such Participating Member State’s territory; (ii) a court of competent
jurisdiction orders a recall in such Participating Member State’s territory; or (iii) the contractor (after having consulted
the concerned competent authority(ies)) determines that any Product should be recalled in such Participating Member State’s
territory (each a ‘Recall’), then the contractor, the Participating Member State(s) and the competent authority(ies)
shall assist each other in the Recall process, as appropriate, having regard to all applicable laws, and especially (a) the EU
Guidelines for Good Manufacturing Practice for Medicinal Products for Human Use and Veterinary Use – Part 1 – Chapter
8 “Complaints, Quality Defects and Product Recalls” and (b) the compilation of Community procedures on inspections
and exchange information in the meaning of Article 3 (1) of the Commission Directive 2003/94/EC of 8 October 2003 laying down
the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational
medicinal products for human use.

 

In
the event of any Recall, [***].

 

[***].

 

I.11.6  The
contractor shall use Best Reasonable Efforts to obtain Marketing Authorisation for the Product. [***].

 

     22

     

    

I.11.7  The
contractor shall provide to the Commission and the Participating Member States, via the Commission, the following information
as part of and until its submission for Marketing Authorisation and full production:

 

		(a)	summarised
                                         key updates on progress made in the clinical development of the Product; final reports
                                         of clinical studies and safety evaluations submitted to the European Medicines Agency,
                                         promptly after submission to the European Medicines Agency;

 

		(b)	key
                                         updates on [***].

 

		(c)	the
                                         use of the Down Payment, linked to points (a) to (b), in general terms [***];
                                         and

 

		(d)	scientific
                                         publications and public announcements, after such publications and announcements have
                                         been published.

 

I.12     Definitions

 

For
the purpose of this APA, the following definitions apply:

 

[***]:
has the meaning set forth in Article I.4.4.2;

 

‘Affiliate’: with respect to a Party, any other individual,
partnership, corporation, limited liability company, association, a joint stock company, trust, joint venture, unincorporated
organization, or a governmental entity (or any department, agency, or political subdivision thereof) (“Person”)
that controls, is controlled by, or is under common control with such Person. For the purpose of this definition only, “control”
(including, with correlative meaning, the terms “controlled by” and “under the common control”) means
the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management
and policies of any Person, whether by the ownership of more than 50% of the voting security of such Person, by contract or otherwise;

 

‘APA’:
has the meaning set forth in the preamble;

 

‘Best
Reasonable Efforts’ shall mean with respect to the diligence to be expected by the contractor, [***];

 

‘Breach
of obligations’: failure by a Party to fulfil one or more of its contractual obligations under this APA;

 

‘CMOs’:
has the meaning set forth in the Recitals;

 

‘Commission’:
has the meaning set forth in the preamble;

 

‘contractor’:
has the meaning set forth in the preamble;

 

‘Confidential
information or document’: any information or document, in any format, disclosed in writing or orally, received by either
Party from the other or accessed by either Party in the context of the Implementation of the APA, that any of the Parties has
identified in writing as confidential or which, due to the context in which it is disclosed, should be considered as confidential.
It may not include information that is publicly available; 

 

     23

     

    

‘Conflict
of interest’: a situation where the impartial and objective Implementation of the APA by the contractor is compromised
for reasons involving family, emotional life, political or national affinity, economic interest, any other direct or indirect
personal interest, or any other shared interest with the Commission, the Participating Member State or any third party related
to the subject matter of the APA;

 

‘COVID-19’:
has the meaning set forth in the Recitals;

 

‘COVID-19
pandemic’: has the meaning set forth in the Recitals;

 

‘Deficient
Product’: has the meaning set forth in Article I.5.1;

 

‘Delayed
Doses’: has the meaning set forth in Article I.4.7.2;

 

[***];

 

‘Delivery
Schedule’: has the meaning set forth in Article I.4.7.1;

 

‘Donation
Country’: means a country to which Product is donated in accordance with Article I.4.6;

 

‘Doses’:
has the meaning set forth in Article I.4.2;

 

‘Down
Payment’: has the meaning set forth in Article I.4.2;

 

‘Down
Payment for Option Doses’: has the meaning set forth in Article I.4.4.2;

 

'EMA':
means the European Medicines Agency;

 

[***];

 

‘European
Institutions’: has the meaning set forth in Article II.7.6;

 

‘Exercising
Member State’: has the meaning set forth in Article I.4.4.2;

 

‘Expected
Approval Date’: has the meaning set forth in Article I.4.7.1;

 

‘Financial
Statement’: has the meaning set forth in Article II.16.5;

 

‘Force
majeure’: any unforeseeable, exceptional situation or event beyond the control of the Parties that prevents either of
them from fulfilling any of their obligations under the APA; the situation or event must not be attributable to error or negligence
on the part of the Parties or on the part of the subcontractors and must prove to be inevitable despite their exercising reasonable
due diligence. The situation or event must not be attributable to a Breach of obligations of the APA on the part of the Parties
or on the part of the subcontractors. [***];

 

‘Formal
notification’ (or ‘Formally notify’): form of communication between the Parties made in writing by
mail, which provides the sender with compelling evidence that the message was delivered to the specified recipient;

 

     24

     

    

‘Fraud’:
an act or omission committed in order to make an unlawful gain for the perpetrator or another by causing a loss to the European
Union’s financial interests, and relating to: i) the use or presentation of false, incorrect or incomplete statements or
documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget, ii) the
non-disclosure of information in violation of a specific obligation, with the same effect or iii) the misapplication of such funds
or assets for purposes other than those for which they were originally granted, which damages the European Union’s financial
interests;

 

‘Good
Manufacturing Practices’ or ‘GMP’: means the current practices for manufacture required by the standards,
rules, principles and guidelines set out in Directive 2001/83/EC (as last amended), Directive 2003/94/EC, Directive 2017/1572
and EudraLex - Volume 4 of the Rules Governing Medicinal Products in the EU entitled “EU Guidelines to Good Manufacturing
Practice Medicinal Products for Human and Veterinary Use”;

 

[***];

 

‘Implementation
of the APA’: the purchase of the Product envisaged in the APA through the signature and Performance of Vaccine Order
Forms;

 

‘Indemnified
Persons’: has the meaning set forth in Article II.5.1;

 

‘Irregularity’:
any infringement of a provision of European Union law resulting from an act or omission by an economic operator, which has, or
would have, the effect of prejudicing the European Union’s budget;

 

[***];

 

‘Losses’:
has the meaning set forth in Article II.5.4;

 

[***];

 

‘Marketing
Authorisation’: the approval under the relevant provisions of Regulation (EC) 726/2004 of the European Parliament and
of the Council of 31 March 2004 laying down European Union procedures for the authorisation and supervisions of medicinal products
for human and veterinary use and establishing a European Medicines Agency, by the European Commission necessary for the placing
on the market of the Vaccine in the territory of the European Union, including conditional marketing authorisation in accordance
with Article 14-a of Regulation 726/2004;

 

[***];

 

‘Notification’
(or ‘Notify’): form of communication between the Parties made in writing including by electronic means
(except for Formal notifications which must be sent by mail);

 

‘Option
Doses’: has the meaning set forth in Article I.4.4.2;

 

‘Participating
Member State(s): has the meaning set forth in the preamble;

 

     25

     

    

‘Party’
and ‘Parties’: have the meaning set forth in the preamble;

 

‘Performance
of a Vaccine Order Form’: the execution of tasks and delivery of the Product by the contractor to the Participating
Member States;

 

‘Potential
Termination Event’: has the meaning set forth in Article II.16.1;

 

‘Pre-existing
material’: any material, document, technology or know-how which exists prior to the contractor using it for the production
of a Result in the Implementation of the APA;

 

‘Pre-existing
right’: any industrial and intellectual property right on Pre-existing material; it may consist in a right of ownership,
a licence right and/or right of use belonging to the contractor, the creator, the Commission as well as to any other third
parties;

 

‘Product’
or 'Vaccine': the finished and packaged form of the contractor’s vaccine against COVID-19 based on the Wuhan Strain
or any other strain agreed by the Parties. The Product will be delivered in a 10-dose vial;

 

‘Product
Claim’: has the meaning set forth in Article I.5.1;

 

‘Professional
conflicting interest’: a situation in which the contractor’s previous or ongoing professional activities affect
its capacity to implement the APA or to perform a Vaccine Order Form to an appropriate quality standard;

 

‘Recall’:
has the meaning set forth in Article I.11.5;

 

‘Refundable
Items’: has the meaning set forth in Article II.16.5;

 

‘Related
person’: any natural or legal person who is a member of the administrative, management or supervisory body of the contractor,
or who has powers of representation, decision or control with regard to the contractor;

 

‘Resale
Country’: means a country to which Product is re-sold, exported or distributed in accordance with Article I.4.6;

 

‘Result’:
any intended outcome of the Implementation of the APA, whatever its form or nature. A Result may be further defined in this APA
as a deliverable. A Result may, in addition to newly created materials produced specifically for the Participating Member States
by the contractor or at its request, also include Pre-existing materials;

 

[***];

 

‘Technical
Dispute’: has the meaning set forth in Article I.5.3;

 

‘Termination
Intent Notice’: has the meaning set forth in Article II.16.1;

 

‘Third
Party’: any Person other than (a) the Commission or any of the Participating Member States or (b) the contractor or
its Affiliates;

 

     26

     

    

‘Third
Party Claim’: has the meaning set forth in Article II.5.9;

 

‘Unspent
Amounts’: has the meaning set forth in Article II.16.5;

 

‘Vaccine
IP Rights’: has the meaning set forth in Article I.9;

 

‘Vaccine
Order Form’: has the meaning set forth in the Recitals;

 

‘Variant
Product’: has the meaning set forth in Article I.4.1.2;

 

‘Variant
Switch’: has the meaning set forth in Article I.4.1.2;

 

[***];

 

'Wuhan
Strain' means the strain BetaCoV/Italy/SPL1/2020/EPI ISL 412974/2020-01-29 originating from Wuhan/NC 045512.2.

 

SIGNATURES

 

	For
                           the contractor,

         

        [***]

         

        Signature:_______________________________________

         

        Done
        at [***]

         

        AND

         

        [***]

         

        Signature: 

         

        Done
        at [***]

         

        In
        duplicate in English.

         

	For
                           the Commission, on behalf and in the name of the Participating Member States,

         

        [***]

         

         

        Signature:_______________________________________

         

        Done
        at [***]

         

     27

     

    

 

		II.	GENERAL
                                         CONDITIONS FOR THE FRAMEWORK CONTRACT

 

II.1      Severability

 

Each
provision of this APA is severable and distinct from the others. If a provision is or becomes illegal, invalid or unenforceable
to any extent, it must be severed from the remainder of the APA. This does not affect the legality, validity or enforceability
of any other provisions of the APA, which continue in full force and effect. The illegal, invalid or unenforceable provision must
be replaced by a legal, valid and enforceable substitute provision which corresponds as closely as possible with the actual intent
of the Parties under the illegal, invalid or unenforceable provision. The replacement of such a provision must be made in accordance
with Article II.10. The APA must be interpreted as if it had contained the substitute provision as from its entry into force.

 

II.2      Provision
of Product

 

II.2.1   The
contractor must supply the Product in accordance with the provisions of this APA.

 

II.2.2   The
contractor must comply with the requirements provided for in this APA.

 

II.2.3   All
periods specified in the APA are calculated in calendar days, unless otherwise specified.

 

II.2.4   The
contractor must immediately inform the Commission of any changes in the exclusion situations as declared, according to Article
137 (1) of Regulation (EU) 2018/1046.

 

II.3      Communication
between the Parties

 

II.3.1   Form
and means of communication

 

Any
communication of information, notices or documents under the APA must: 

 

		(a)	be
                                         made in writing in paper or electronic format in the language of the contract;

		(b)	bear
                                         the APA number and, if applicable, the Vaccine Order Form number;

		(c)	be
                                         made using the relevant communication details set out in Article I.8.7; and

		(d)	be
                                         sent by mail or email (except for Formal notifications which must be sent by mail).

 

If
a Party requests written confirmation of an e-mail within a reasonable time, the other Party must provide an original signed paper
version of the communication as soon as possible.

 

The
Parties agree that any communication made by email has full legal effect and is admissible as evidence in judicial proceedings,
except for Formal notifications which must be sent by mail.

 

II.3.2   Date
of communications by mail and email

 

Any
                                         communication is deemed to have been made when the receiving Party receives it, unless
                                         this APA refers to the date when the communication was sent.

 

     28

     

    

E-mail
is deemed to have been received by the receiving Party on the day of dispatch of that e-mail, provided that it is sent to the
e-mail address indicated in Article I.8.7. The sending Party must be able to prove the date of dispatch. In the event that the
sending Party receives a non-delivery report, it must make every effort to ensure that the other Party actually receives the communication
by email or mail. In such a case, the sending Party is not held in Breach of obligation to send such communication within a specified
deadline.

 

Mail
sent to the Commission or a Participating Member State is deemed to have been received on the date on which the department responsible
referred to in Article I.8.7 or in the relevant Vaccine Order form registers it.

 

Formal
notifications are considered to have been received by the receiving Party on the date of receipt indicated in the proof received
by the sending Party that the message was delivered to the specified recipient.

 

II.4      Liability

 

II.4.1   Without prejudice to Article II.5, the Commission and the Participating Member States are
                                      not liable for any damage or loss caused by the contractor, including any damage or loss
                                      to Third Parties during or as a consequence of the Implementation of the APA.

 

II.4.2   Annex
VI sets out a summary of contractor's insurance coverage. Contractor shall maintain such policy during the term of this APA. Upon
request, the contractor must provide evidence of such insurance coverage to the Commission.

 

II.4.3   [***]
The Commission and the Participating Member State shall, upon request, cooperate with the contractor and its legal representatives
in connection with the investigation and defense against such action, including by providing or otherwise making available information
in their possession with respect thereto. The Commission and the Participating Member State shall only be allowed to settle a
Third Party Claim with the prior consent of the contractor, such consent not to be unreasonably withheld, conditioned or delayed.

 

II.4.4   [***]
This liability cap shall not apply in case of liability for loss or damages caused by the contractor’s Breach of obligations
classified as Willful Misconduct or Gross Negligence, in which case the contractor’s liability shall be uncapped.

 

[***]

 

II.4.5   The
Parties acknowledge that they are not relying on any understanding, arrangement, statement, representation (including, any negligent
misrepresentation but excluding any fraudulent misrepresentation), warranty, condition, term, customary practice, course of dealing
or provision except for the warranties set out in this APA. All statements, representations, warranties, terms, conditions and
provisions (including, any implied by statute or equivalent, case law or otherwise and any implied warranties and/or conditions
as to merchantability, satisfactory quality, fitness for purpose and skill and care), other than fraudulent misrepresentations
and the provisions set out in this APA, are hereby excluded to the maximum extent permissible by law.

 

     29

     

    

II.5       Indemnification

 

II.5.1
Due to the exceptional circumstances of the COVID-19 pandemic and the request to develop new vaccines at an unprecedented
speed, the Commission, on behalf of the Participating Member States, declares that the use of the Vaccine supplied under this
APA will happen under pandemic conditions requiring such use, in a context where it is impossible for the contractor to detect
all possible defects of the Vaccine despite its observance of all Good Manufacturing Practices and obligations under the EMA pharmacovigilance
regulations, and that the administration of doses of the Vaccine will therefore be conducted under the sole risk and responsibility
of the Participating Member States. 

 

Hence,
each Participating Member State shall indemnify for and hold harmless the contractor and/or its Affiliates, as well as their respective
sub-contractors and sub-licensees, officers, directors, employees, other agents and representatives (together, the “Indemnified
Persons”) against:

 

(a)
liability incurred by an Indemnified Person in relation to Losses (defined in Article II.5.4) caused by doses of Vaccine administered
in the jurisdiction of the Participating Member State in question;

 

(b)
the consequences of any settlements to which the concerned Participating Member State(s) has/have consented to as per Article
II.5.11; and

 

(c)
reasonable and necessary direct external legal fees (including attorneys’ and courts fees) and experts’ fees, which
an Indemnified Person incurs in relation to (i) claims connected to liability under sub-paragraph (a) above, and/or (ii) the circumstances
referred to in sub-paragraph (b) above. Each Participating Member State agrees that any Indemnified Person has the right to select
an attorney who is experienced and reputable in relation to the subject matter and in the Participating Member State concerned
to defend itself in case of a Third Party Claim. For the avoidance of doubt, (1) the indemnification of legal and experts’
fees subject to the conditions of this clause shall not be dependent on the success of a Third Party Claim; and (2) legal and
experts’ fees recovered from the claimant by an Indemnified Person following a court order, and legal and experts’
fees covered by insurance, shall not be subject to indemnification under this clause.

 

     30

     

    

Such
indemnification shall be available regardless of whether the properties of the Vaccine causing the Losses originate from the testing,
development, manufacture, delivery, export, import, distribution, sale, offer for sale, administration, use or deployment of the
Vaccine.

 

II.5.2
[***].

 

II.5.3
[***].

 

II.5.4
[***].

 

II.5.5
Specifically and only for the purposes of this Article II.5:

 

“Best
Reasonable Efforts” [***].

 

II.5.6.
[***].

 

II.5.7.
In case an Indemnified Person requests indemnification pursuant to Article II.5.1, the contractor shall give the Participating
Member State(s) in question, or an independent expert as referred to in Article II.5.8, access to reasonable information necessary
for the Participating Member State(s) to indemnify the Indemnified Persons and to verify whether the conditions pursuant to Articles
II.5.1 to II.5.4 are fulfilled. [***]

 

II.5.8
A Participating Member State shall be allowed to access the information as referred to in Article II.5.7 through an independent
expert in the field of the Losses, in particular in the field of public health. In that case, this Participating Member State
shall Notify the contractor in advance of its intention to use an expert to conduct the verification pursuant to Article II.5.7
above, and shall specify the identity of such expert. The contractor shall be allowed to object to the use of and/or access to
the information referred to in Article II.5.7 by such expert [***] counted from the date of receipt of such Notification. [***]
In such case, the Participating Member State shall designate another independent expert and observe the same Notification process
as the one described herein until the designated expert is approved by the contractor. The expert shall complete its assessment
[***] of its appointment, and shall share its assessment report with the Parties. The expert's assessment shall not be binding
on any Indemnified Person.

 

II.5.9
The contractor shall promptly inform the relevant Participating Member State(s) of any claim for a Loss which is brought against
any of the Indemnified Persons and which an Indemnified Person considers asking for indemnification under this Article II.5 (“Third
Party Claim”), stating the nature and basis of such claim and the maximum amount of damages, external legal fees, experts’
fees and related disbursements estimated by the contractor, which could be payable by all Indemnified Persons as a result of such
claim. The contractor shall keep the Participating Member State informed of any developments relating to such Third Party Claim,
including updates in this estimated maximum amount of damages, fees and disbursements. The contractor's assessment of said maximum
amount shall have no consequences on any indemnification unless the contractor has estimated such amount in bad faith.

 

     31

     

    

II.5.10
[***].

 

[***]

 

II.5.11
[***] The Indemnified Persons shall only be allowed to settle a Third Party Claim with the prior consent of the relevant Participating
Member State(s) in question, such consent not to be unreasonably withheld, conditioned or delayed. The relevant Participating
Member States shall have the right to assume and control the defense of the Indemnified Persons against Third Party Claims, in
which case the Indemnified Persons shall nevertheless have the right to retain and be advised by independent counsel and experts.
[***]

 

II.6      Conflict
of interest and Professional conflicting interests

 

II.6.1   The
                                      contractor must take all the necessary measures to prevent any situation of Conflict of
                                      interest or Professional conflicting interest.

 

II.6.2   The
contractor must Notify the Commission as soon as possible of any situation that could constitute a Conflict of interest or a Professional
conflicting interest during the Implementation of the APA. The contractor must immediately take action to rectify the situation.

 

The
Commission may do any of the following:

 

(a)          verify
that the contractor’s action is appropriate; 

(b)          require
the contractor to take further action within a specified deadline which shall be reasonable taking into account the context of
the situation; 

(c)          decide, in the name and on behalf of a Participating Member State, not to award a Vaccine Order Form to the contractor.

 

The
Commission cannot implement the action referred to in (c) above before having given to contractor the possibility to complete
the rectification of the situation [***] or a shorter period if the urgency of the situation requires such shorter period.

 

II.6.3      The
contractor must pass on all the relevant obligations in writing to:

 

		(a)	its
                                         personnel;

		(b)	any
                                         natural person with the power to represent it or take decisions on its behalf;

		(c)	third
                                         parties involved in the Implementation of the APA, including subcontractors.

 

The
contractor must also ensure that the persons referred to above are not placed in a situation which could give rise to conflicts
of interest.

 

     32

     

    

II.7      Confidentiality

 

II.7.1   The
Commission, the Participating Member State and the contractor must treat with confidentiality any Confidential Information. Contractor's
Confidential Information includes, in particular, any and all know-how, software, algorithms, designs, plans, forecasts, analyses,
evaluations, research, business information, financial information, business plans, strategies, customer lists, marketing plans,
or other information whether oral, in writing, in electronic form, or in any other form; and any physical items, compounds, components,
samples or other materials; disclosed by or on behalf of contractor to the Commission or to the Participating Member States or
any of their Affiliates before, on or after the effective date of this APA.

 

II.7.2   The
Commission, the Participating Member State and the contractor shall:

 

(a)       not
use Confidential information or documents of another Party for any purpose other than to perform its obligations under the APA
or a Vaccine Order Form without the prior written agreement of such other Party;

 

(b)       ensure
the protection of such Confidential information or documents with the same level of protection as its own Confidential information
or documents and in any case with due diligence;

 

(c)       not
disclose, directly or indirectly, Confidential information or documents to third parties unless such third parties agree to comply
with this Article or are subject to substantially similar confidentiality obligations as provided in this Article.

 

II.7.3   The
confidentiality obligations set out in this Article are binding on the Commission, the Participating Member States and the contractor
during the Implementation of the APA and for as long as the information or documents remain confidential unless:

 

(a)       the
disclosing Party agrees to release the receiving Party from the confidentiality obligation earlier;

 

(b)       the
Confidential information or documents become public through other means than a breach of the confidentiality obligation;

 

(c)       the
applicable law requires the disclosure of the Confidential information or documents

 

II.7.4   The
contractor must obtain from any natural person with the power to represent it or take decisions on its behalf, as well as from
third parties involved in the Implementation of the APA a commitment that they will comply with this Article or ensure that such
person is subject to substantially similar confidentiality obligations. At the request of the Commission, the contractor must
provide a document providing evidence of this commitment.

 

II.7.5   Notwithstanding
the other provisions of this Article, the Commission, the Participating Member States and the contractor may issue a press release
and/or other public statement. The Parties shall consult together on the timing, contents and manner of any press release relating
to this APA. A Party may subsequently publicly disclose any information previously contained in any public announcement made in
accordance with this Article.

 

     33

     

    

II.7.6   The
contractor acknowledges that the Commission, along with other agencies and offices of the European Union (collectively, the “European
Institutions”), are subject to requirements under Regulation (EC) 1049/20013, which may require the European
Institutions to disclose information to Third Parties on request.

 

II.8       Processing
of personal data

 

Both
Parties agree each act as data controllers with regards to the processing of personal data they each undertake.

 

II.8.1   Processing
of personal data by the Commission

 

Any
personal data included in or relating to the APA, including its implementation, shall be processed in accordance with Regulation
(EU) 2018/1725. Such data shall be processed solely for the purposes of the implementation, management and monitoring of the APA
by the data controller. For the purpose of this provision, the data controller for the Commission shall be the Deputy Director-General
for Health of the European Commission’s Directorate-General for Health and Food Safety. The data protection notice is available
at https://ec.europa.eu/info/data-protection- public-procurement-procedures_en.

 

The
contractor or any other person whose personal data is processed by the data controller in relation to this APA has specific rights
as a data subject under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, rectify
or erase their personal data and the right to restrict or, where applicable, the right to object to processing or the right to
data portability.

 

Should
the contractor or any other person whose personal data is processed in relation to this APA have any queries concerning the processing
of its personal data, it shall address itself to the data controller. They may also address themselves to the Data Protection
Officer of the data controller. They have the right to lodge a complaint at any time to the European Data Protection Supervisor.

 

II.8.2   Processing
of personal data by the contractor

 

The
processing of personal data by the contractor shall meet the requirements of Regulation (EU) 2018/1725 and be processed solely
for the purposes set out by the controller.

 

II.9      Subcontracting

 

II.9.1   [***]

 

II.9.2   [***]

 

II.9.3   [***].

 

 

 3 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p. 43.

 

     34

     

    

 

II.9.4   [***]4.

 

II.10    Amendments

 

II.10.1  Any
amendment to the APA (including a Vaccine Order Form) must be made in writing before all contractual obligations have been fulfilled.

 

II.10.2  No
amendment can make changes to the APA (including a Vaccine Order Form) that might alter the initial conditions of the procurement
procedure or result in unequal treatment of tenderers or contractors.

 

II.11    Assignment

 

II.11.1  The
contractor cannot assign any of the rights and obligations arising from the APA without prior written authorisation from the Commission,
which shall not be unreasonably withheld, conditioned or delayed. In such cases, the contractor must provide the Commission with
the identity of the intended assignee.

 

II.11.2  Any
right or obligation assigned by the contractor without authorisation is not enforceable against the Commission or the Participating
Member States.

 

II.11.3  As
an exception to Articles II.11.1 and II.11.2, contractor can assign, without the Commission's or the Participating Member States'
authorization:

 

		-	any
                                         receivables under this APA to Third Parties, such as financial institutions, for the
                                         purposes of obtaining and maintaining funding, and/or providing such receivables as security
                                         to its creditors;

		-	this
                                         APA to:

		o	a
                                         person that succeeds to all or substantially all of contractor's business or assets or
                                         all or substantially all of contractors' business or assets relating to this APA, whether
                                         by sale, merger, operation of law or otherwise;

		o	a
                                         person that acquires all rights to the Product; or

		o	an
                                         Affiliate of contractor;

 

and
contractor shall provide notice of such assignment to the Commission and the Participating Member State.

 

II.12    Intellectual
property rights

 

II.12.1 Identification
of Pre-existing rights

 

When
delivering the Results, the contractor must warrant that, for any use that the Commission or the Participating Member States may
envisage within the limits set in this APA, the newly created parts and the Pre-existing material incorporated in the Results
are free of claims from creators or from any Third Parties and all the necessary Pre-existing rights have been obtained or licensed.

 

 

4
[***]

     35

     

    

[***]

 

II.12.2   Evidence
of granting of Pre-existing rights

 

Upon
request by the Commission, the contractor must, in addition to the list mentioned under Article II.12.1, provide evidence that
it has the ownership or the right to use all the listed Pre-existing rights, except for the rights owned or licensed by the European
Union. [***]

 

This
evidence must include, as appropriate:

 

[***]

 

II.12.3   Copyright
notice for Pre-existing rights

 

When
the contractor retains Pre-existing rights on parts of the Results, reference must be inserted to that effect when the Result
is used as set out in Article I.12.1, with the following disclaimer: ‘© — year — European Union. All
rights reserved. Certain parts are licensed under conditions to the EU’, or with any other equivalent disclaimer as the
Commission may consider best appropriate, or as the Parties may agree on a case-by-case basis. This does not apply where inserting
such reference would be impossible, notably for practical reasons.

 

II.12.4   Visibility
of Union funding and disclaimer

 

When
making use of the Results, the contractor must declare that they have been produced under a contract with the European Union and
that the opinions expressed are those of the contractor only and do not represent the Commission’s official position. The
Commission may waive this obligation in writing or provide the text of the disclaimer.

 

II.13      Force
majeure

 

II.13.1   If
a Party is affected by Force majeure, it must Notify the other Party without undue delay, stating the nature of the circumstances,
their likely duration and foreseeable effects.

 

II.13.2   A
Party is not liable for any delay or failure to perform its obligations under the APA if that delay or failure is a result of
Force majeure. The obligations affected by a Force majeure event shall be suspended and the time for performance shall be extended
for a period equal to the time lost by reason of such event. If the contractor is unable to fulfil its contractual obligations
owing to Force majeure, it has the right to remuneration only for the services and doses of Product actually provided.

 

II.13.3   The
Parties must take all necessary measures to limit any damage due to Force majeure, it being specified that nothing herein shall
require a Party to settle on terms unsatisfactory to such Party any strike or dispute.

 

     36

     

    

II.13.4.
To the extent that an event of Force majeure continues for a period [***], the Parties agree (i) to negotiate in good faith
[***] of the end of that period either to (ia) resolve the event of Force majeure, if possible, or (ib) to extend the time period
to resolve, eliminate or overcome such event, or (ii) to terminate the APA if such negotiations are unsuccessful. If the Force
majeure event affects only one or more Vaccine Order Forms, but not the APA in its whole, then such termination shall apply only
to those affected Vaccine Order Form(s). [***]

 

II.14      Liquidated
damages

 

II.14.1       In
accordance with Article I.4.7.3, and the conditions provided for therein, if the contractor fails to deliver doses in accordance
with the Delivery Schedule, the Participating Member State which delivery is subject to Late Delivery may claim liquidated damages.
[***]

 

II.14.2   [***]

 

[***]

 

II.14.3   [***]

 

[***]

 

II.15      Suspension
of the Implementation of the APA

 

II.15.1   Suspension
by the contractor

 

If
the contractor is affected by Force majeure, it may suspend the provision of the services and Product under a Vaccine Order Form,
as provided under Article II.13.

 

In
accordance with Article II.13, the contractor must Notify the Commission and the Participating Member States of the suspension.
The Notification must include a description of the Force majeure and state when the contractor expects to resume the provision
of the Product.

 

The
contractor must Notify the Commission and the Participating Member States as soon as it is able to resume Performance of the Vaccine
Order Form, unless the Commission has already terminated the APA or the Vaccine Order Form in accordance with Article II.13.

 

II.15.2   Suspension
by the Commission or the Participating Member State

 

The
Commission or the Participating Member State in question may suspend the Implementation of the APA or Performance of a Vaccine
Order Form (of such Participating Member State) or any part of it if the procedure for awarding the APA or a Vaccine Order Form
or the Implementation of the APA proves to have been subject to Irregularities or Fraud by the contractor.

 

The
Commission or the Participating Member State in question must Formally notify the contractor of the suspension and the reasons
for it. Suspension takes effect on the date of Formal notification, or at a later date if the Formal notification so provides.

 

     37

     

    

The
Commission or the Participating Member State in question must Notify the contractor as soon as the verification is completed whether: 

 

		(a)	it
                                         is lifting the suspension; or

		(b)	it
                                         intends to terminate the APA or its Vaccine Order Form under Article II.16.2(d).

 

[***]

 

II.16      Termination
of the APA

 

II.16.1   Termination
due to failure to meet long stop dates

 

If: 

		-	the
                                         contractor fails to receive a Marketing Authorisation for the Product on or before 30
                                         April 2022, or any other later date mutually agreed upon by the Commission and the contractor
                                         in writing. [***]; or

		-	delivery
                                         of all the Doses does not occur by 31 December 2022 or any other later date mutually
                                         agreed upon by the Commission and the contractor in writing;

 

(each
a "Potential Termination Event"), then the Commission and the Participating Member States shall Notify to contractor,
within 15 days of the Potential Termination Event, whether they consider terminating this APA and the Vaccine Order Forms due
to the Potential Termination Event ("Termination Intent Notice"). If contractor fails to remedy the situation
within 30 days and the Commission and the Participating Member States do not find contractor's remedial plan acceptable, the Commission
and the Participating Member States shall have the right to terminate this APA [***].

 

[***]

 

II.16.2       Other
grounds for termination by the Commission and a Participating Member State

 

The
Commission may terminate the APA or a Participating Member State may terminate its on-going Vaccine Order Form in the following
circumstances:

 

		(a)	if
                                         the contractor is in material Breach of obligations [***];

 

[***]

 

		(b)	if
                                         the contractor or any person that assumes unlimited liability for the debts of the contractor
                                         is in one of the situations provided for in points (a) and (b) of Article 136(1) of the
                                         Financial Regulation5;

 

 

5
Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules
applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU)
No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing
Regulation (EU, Euratom) No 966/2012, OJ L 193 of 30.7.2018, p.1 https://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1544791836334&uri=CELEX:32018R1046

 

     38

     

    

		(c)	if
                                         the contractor or any Related person is in one of the situations provided for in points
                                         (c) to (h) of Article 136(1) or to Article 136(2) of the Financial Regulation;

 

		(d)	if
                                         the procedure for awarding the APA or the Implementation of the APA prove to have been
                                         subject to Irregularities, Fraud or Breach of obligations;

 

		(e)	if
                                         the contractor is in a situation that constitutes a Conflict of interest or a Professional
                                         conflicting interest and the situation is not resolved in accordance with Article II.6.2;

 

		(f)	a
                                         change regarding the exclusion situations listed in Article 136 of Regulation (EU) 2018/1046
                                         that calls into question the decision to award the contract;

 

		(g)	in
                                         the event of Force majeure, as provided under Article II.13.4.

 

II.16.3   Grounds
for termination by the contractor

 

The
contractor may terminate the APA in the following circumstances:

 

		(a)	If
                                         the Commission materially fails to comply with its respective obligations

 

		(b)	In
                                         the event of Force majeure, as provided under Article II.13.4.

 

The
contractor may terminate the Vaccine Order Form of a Participating Member State in the following circumstances:

 

		(a)	If
                                         the Participating Member State in question materially fails to comply with its respective
                                         obligations

 

		(b)	In
the event of Force majeure, as provided under Article II.13.4.

 

II.16.4   Procedure
for termination under Articles II.16.2 and II.16.3

 

A
Party must Formally notify the other Party of its intention to terminate the APA or a Vaccine Order Form and the grounds for termination.

 

If
a Party Formally notifies its intention to terminate under Articles II.16.2(a) to (f), or II.16.3(a), the other Party has [***]
to cure the relevant issue or dispute the existence of such issue by submitting observations, including the measures it has taken
or will take to continue fulfilling its contractual obligations.

 

If
the terminating Party confirms that the measures the other Party has taken, or will take, cure such issue [***], the notice of
termination submitted by the terminating Party shall become null and void. If the terminating Party does not provide such confirmation,
and the other Party fails to cure the issue [***], the Party intending to terminate must Formally notify such Party’s decision
to terminate this APA or a Vaccine Order Form and the grounds for termination. [***] in the event of a dispute of the existence
or cure status of the relevant issue, such dispute shall be subject to Article I.10.2 prior to any termination of this APA or
of a Vaccine Order Form.

 

     39

     

    

II.16.5   Effects
of termination

 

In
case of termination pursuant to Article II.16.1:

 

		(a)	No
                                         liability is incurred by any Party;

 

		(b)	The
                                         Down Payment paid to the contractor shall be refundable according to the following procedure:

 

		(i)	The
                                         contractor shall send to the Commission [***] from Notifying the Commission about the
                                         termination of the APA, a financial statement (the “Financial Statement”),
                                         detailing for which expenses the Down Payment has been used in relation to the purposes
                                         as set out in the APA. Expenses to be taken into account include the full amount of internal
                                         and/or external expenses which have been, or will be, incurred as well as such which
                                         have been committed by, or relate to commitments made by, the contractor at the time
                                         when the contractor Notified the Commission, [***].

 

		(ii)	In
                                         the Financial Statement, the contractor will set out such amounts as well as those amounts
                                         of the Down Payment that have neither been incurred nor committed (“Unspent
                                         Amounts”). Such Unspent Amounts will be reimbursed by the contractor to the
                                         Participating Member States [***] from the receipt of the Financial Statement by the
                                         Commission, it being understood that the Financial Statement and the Unspent Amounts
                                         shall be final and binding upon all Parties to the extent the Commission has not provided
                                         to the contractor a written statement of objections, specifying in reasonable detail
                                         the grounds of objections, [***] from the receipt of the Financial Statement by the Commission.
                                         The reimbursement of the Unspent Amounts shall be distributed between the Participating
                                         Member States in proportion of each Participating Member State's allocation of Doses
                                         under the APA.

 

		(c)	In
                                         addition, the contractor will transfer, upon the Commission's request to be provided
                                         [***] after the receipt of Notification about the termination, to the Commission, or
                                         a Third Party named by the Commission, any raw materials and primary components paid
                                         for with the Down Payment and not used (the “Refundable Items”). The
                                         contractor will also use its Best Reasonable Efforts to facilitate the discussion of
                                         a transfer of reserved capacity with CMOs paid for with the Down Payment to a Third Party
                                         selected by the Commission. Any such transfer is subject to the CMOs express agreement
                                         and any discussions about financial terms of such transfer will take place between such
                                         selected Third Party and the CMO.

 

[***]

 

The
Parties must take all appropriate measures to minimise costs, prevent damage and cancel or reduce their commitments.

 

[***],
the contractor must submit any report and any invoice for Product doses that were already delivered or in delivery in compliance
with the APA at the time of termination.

 

     40

     

    

II.17      Invoices,
Taxes, value added tax and e-invoicing

 

II.17.1   Payment
Requests, Invoices and value added tax

 

Payment
requests and invoices shall contain the information set out in Articles I.8.1 and I.8.3.

 

II.18      Payments

 

II.18.1   Date
of payment

 

The
date of payment is deemed to be the date on which contractor receives the relevant sums on its bank account.

 

II.18.2   Costs
of transfer

 

The
costs of the transfer are borne as follows: 

 

		(a)	the
                                         Commission or the Participating Member State in question bears the costs of dispatch
                                         charged by its bank;

		(b)	the
                                         contractor bears the costs of receipt charged by its bank;

		(c)	the
                                         Party causing repetition of the transfer bears the costs for repeated transfer.

 

II.18.3   Suspension
of the time allowed for payment

 

The
Commission or the Participating Member State in question may suspend the payment periods specified in Articles I.8.1 and I.8.3
at any time by Notifying the contractor that its invoice cannot be processed. The only reason the Commission or the Participating
Member State in question may cite for not being able to process an invoice is because it does not substantially comply with the
invoicing process in the APA.

 

The
Commission or the Participating Member State in question must Notify the contractor as soon as possible of any such suspension,
giving the reasons for it. The Commission or the Participating Member State in question shall Notify the contractor the time limits
to submit additional information or corrections or a new version of the documents.

 

Suspension
takes effect on the date the Commission or the Participating Member State in question sends the Notification. The remaining payment
period resumes from the date on which the requested information or revised documents are received. The contractor may request
the Commission or the Participating Member State in question to justify the continued suspension.

 

II.18.4   Interest
on late payment

 

On
expiry of the payment periods specified in Article I.8, the contractor is entitled to interest [***]. The reference rate is the
rate in force, as published in the C series of the Official Journal of the European Union, on the first day of the month
in which the payment period ends.

 

Suspension
of the payment period as provided for in Article II.18.3 is not considered as giving rise to late payment.

 

     41

     

    

Interest
on late payment covers the period running from the day following the due date for payment up to and including the date of payment
as defined in Article II.18.1.

 

II.19      Recovery

 

II.19.1   Recovery
procedure

 

Before
recovery, the Commission or the Participating Member State in question must Formally notify the contractor of its intention to
recover the amount it claims, specifying the amount due and the reasons for recovery and inviting the contractor to make any observations
within 30 days of receipt.

 

If
no observations have been submitted or if, despite the observations submitted, the Commission or the Participating Member State
in question decides to pursue the recovery procedure, it must confirm recovery by Formally notifying a debit note to the contractor,
specifying the date of payment. The contractor must pay in accordance with the provisions specified in the debit note unless contractor
disputes such payment.

 

If
the contractor does not pay by the due date, the Commission or the Participating Member State in question may, after informing
the contractor in writing, recover the amounts due: 

 

		(a)	by
                                         offsetting them against any amounts owed to the contractor by the Commission or the Participating
                                         Member State in question, provided that legal conditions for such offsetting are met;

		(b)	by
                                         taking legal action.

 

The
contractor will be liable for any losses or damages caused by its late payment.

 

II.19.2   Interest
on late payment

 

If
the contractor does not honour the obligation to pay the amount due by the date set by the Commission or the Participating Member
State in question, the amount due bears interest at the rate indicated in Article II.18.4. Interest on late payments will cover
the period starting on the day after the due date for payment and ending on the date when the Commission or the Participating
Member State in question receives the full amount owed.

 

Any
partial payment is first entered against charges and interest on late payment and then against the principal amount.

 

II.20      Checks
and audits

 

II.20.1
The Commission and the European Anti-Fraud
Office (OLAF) may check or require an audit on the Implementation of the APA. This may be carried out either by OLAF’s own
staff or by any outside body authorised to do so on its behalf, provided that the auditor may not be a competitor of the contractor.

 

     42

     

    

Such
checks and audits may be initiated at any moment during business hours during the provision of the Product doses and up to five
years starting from the payment of the balance of the last Vaccine Order Form issued under this APA.

 

The
audit procedure is initiated on the date of receipt of the relevant letter sent by the Commission. Audits are carried out on a
confidential basis.

 

Audit
missions scope applies to the contractor's compliance with applicable regulatory standards insofar as relevant for the Implementation
of the APA. Audit missions may not be extended to a broader audit of the contractor's activities or the contractors' contractual
relations, which do not involve the Commission or the Participating Member States regarding the purpose of this APA or the Vaccines
Order Forms.

 

II.20.2
  The contractor must keep all original documents
stored on any appropriate medium, including digitised originals if allowed under national law, for a period of five years starting
from the payment of the balance of the last Vaccine Order Form issued under this APA.

 

II.20.3
  The contractor must grant the appropriate
right of access to sites and premises where the APA is implemented, and to all information, including information in electronic
format, needed to conduct such checks and audits. The contractor must ensure that the information is readily available at the
moment of the check or audit and, if so requested, that information is handed over in an appropriate format. The auditor must,
insofar possible, comply with all applicable and reasonable security measures Notified to Commission by the contractor, and minimize
disruption in contractor's operations, subject to this not creating any material obstacles for the performance of the auditor’s
tasks.

 

II.20.4   On
the basis of the findings made during the audit, a provisional report is drawn up. The Commission or its authorised representative
must send it to the contractor, who has 30 days following the date of receipt to submit observations. The contractor must receive
the final report within 60 days following the expiry of the deadline to submit observations.

 

If,
on the basis of the final audit findings, the Commission or a Participating Member State wishes to challenge all or part of the
payments made under the APA, and the Parties cannot reach an agreement, any dispute between the Parties in this respect shall
be settled under Article I.10.2.

 

II.20.5   In
accordance with Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspection carried
out by the Commission in order to protect the European Communities’ financial interests against Fraud and other Irregularities
and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations
conducted by the European Anti-Fraud Office, the European Anti- Fraud Office may carry out investigations, including on the spot
checks and inspections, to establish whether there has been Fraud, corruption or any other illegal activity under the APA affecting
the financial interests of the European Union. Findings arising from an investigation may lead to criminal prosecution under national
law.

 

     43

     

    

The
investigations may be carried out at any moment during the provision of the Product doses and up to [***].

 

II.20.6       The
Court of Auditors and the European Public Prosecutor’s Office established by Council Regulation (EU) 2017/19396
(‘the EPPO’) have the same rights as the Commission, particularly right of access, for the purpose of checks,
audits and investigations.

 

 

6
                                         Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation
                                         on the establishment of the European Public Prosecutor’s Office 

     44

     

    

 

Annex
I: Participating Member States and allocated volumes

 

[***]

     45

     

    

Annex
II: Model for Vaccine Order Forms

 

	EXPLANATORY
NOTE  

        ✓ 
  Who shall send a Vaccine Order Form? 

        -      Each
        Part icipating Member State shall send to the contractor one duly completed and signed Vaccine Order in electronic
        format (PDF by e-mail) for its relevant allocated Doses as set out in Annex I (of this APA). 

         
By when (deadline)? Within 10 days of the date of signature of the APA. 

         

        ✓ 
  To Whom and how shall the Vaccine Order Form be sent? 

        -      To the contractor by email at the following email address: [***], with a copy to [***]. Please always send the duly completed
and signed Vaccine Order Form as a PDF attachment to the email. 

         

        ✓ 
  How to complete this Vaccine Order Form? 

        -      The relevant information in square brackets must be completed by each Participating Member State.  

        -      Other than completing such information in square brackets, no changes or amendments are permitted to this model
Vaccine Order Form unless explicitly agreed by the contractor and the Commission. If any such change or amendment is made, the
Vaccine Order Form will be deemed invalid and not conform to the APA requirements. 

         

        ✓ 
  Whom to contact in case of questions re. how to complete this Vaccine Order Form? 

        -       Commission representatives:  

        o   
 Commission will confirm the name after signature. Please copy all communications to EC-VACCINES@ec.europa.eu 

        -       Contractor’s representatives:  

        [***]

         

	 

     46

     

    

 

[Letterhead
of Government if available]

 

This
Vaccine Order Form is submitted by:

 

[The
Government of [•]] (the “Member State”), represented for the purposes of signing this specific order
form by [forename, surname, function, department of authorising officer],

 

to:

 

Valneva
Austria GmbH, a limited liability company (“Gesellschaft mit beschränkter Haftung”) incorporated under company
number [***], whose registered office is at [***] (hereinafter referred to as the “contractor”)

 

The
Member State and the contractor are together referred to as the “Parties” and each individually as a “Party”.

 

WHEREAS

 

		—	The
                                         contractor and the European Commission, acting on behalf of and in the name of the Participating
                                         Member States, entered into an Advance Purchase Agreement for the purchase and supply
                                         of the contractor’s COVID-19 vaccine for EU Member States SANTE/2020/C3/054
                                         (the “APA”), the terms of which are binding on the Participating
                                         Member States.

 

The
APA provides that each Participating Member State will submit to the contractor a Vaccine Order Form through which the contractor
shall (subject to the terms and conditions of the APA) deliver to the relevant Participating Member State a proportion of the
Doses at the price and conditions as set out in the APA.

 

		—	In
                                         accordance with Article I.4, the Member State hereby places its order for its allocation
                                         of Doses.

 

Article
I

 

Definitions

 

Capitalized
terms used but not defined in this Vaccine Order Form shall have the meaning given in the APA.

 

     47

     

    

Article
II

 

Subject
matter

 

		1.	This
                                         Vaccine Order Form is submitted by the Member State to the contractor in accordance with
                                         the terms of the APA, and forms an integral part of the APA. The terms and conditions
                                         of the APA are incorporated into this Vaccine Order Form by reference. In the event of
                                         contradiction between this Vaccine Order Form and the APA, the terms of the APA prevail
                                         regardless of any provision to the contrary.

 

		2.	This
                                         Vaccine Order Form relates to the order for the Member State’s full allocated Doses
                                         as set out in Annex I of the APA. The provision of this Vaccine Order Form by the Member
                                         State to the contractor constitutes a binding order by the Member State for the purchase
                                         of its full allocated Doses at the Price.

 

Article
III

 

Delivery;
Quality

 

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

 

[•
- Member State to enter location ]

 

		2.	Quality.
                                         The roles and responsibilities between the contractor and the Member States in relation
                                         to acceptance/rejection matters related to the Product doses are set out in Article I.5
                                         of the APA.

 

Article
IV

 

Invoices;
Notices

 

		1.	Invoice
                                         and Payments. The contractor shall invoice the Member State in accordance with the
                                         terms of the APA. All payments to the contractor shall be made in accordance with the
                                         terms of the APA.

 

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

 

Member
State:

 

[Name
of Member State] 

[Full
official address of Member State] 

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

[Function
of addressee physical person (contact person)] 

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

 

     48

     

    

Contractor:

 

 

Valneva
                                         Austria GmbH

 

To
the attention of: [***]

 

Mail
address: [***]

 

Email
address: [***]

 

with
a copy sent, in any case, by email to: [***]

 

 

Article
V. 

 

Entry
into Force and Duration

 

		1.	This
                                         Vaccine Order Form shall become effective upon execution and delivery by the Member State
                                         to the contractor in accordance with the APA.

 

		2.	This
                                         Vaccine Order Form shall automatically expire upon delivery of the Member State’s
                                         full allocated Doses as set out in the APA.

 

		3.	Expiry
                                         of the Vaccine Order Form shall be without prejudice to Article I.3.4 of the APA (Surviving
                                         Provisions).

 

Article
VI. 

Applicable
Law and Settlement of Disputes

 

Article
I.10 (Applicable Law and Settlement of Disputes) of the APA shall apply mutatis mutandis to this Vaccine Order Form.

 

(Signature
page follows)

 

     49

     

    

SIGNATURES

 

	For
                                         the Member State,

         

        [forename/surname/position]

         

        Signature:_________________________________

         

        Done
        at [place], [date]

         

	For
                                         acceptance of the Vaccine Order Form,

         

        [forename/surname/position]

         

        Signature:
        _________________________________

         

        Done
        at [place], [date]

         

	

 

     50

     

    

Annex
III: Agreement between the Commission and Member States on procuring Covid-19 vaccines on behalf of the Member States and related
procedures, annexed to the Commission Decision C(2020) 4192 final of 18 June 2020

 

Agreement

 

Preamble

 

Having
regard to Article 4(5)(b) of Council regulation (EU) 2016/369 on the provision of emergency support within the Union1as amended
by Council regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under regulation (EU) 2016/369, and amending
its provisions taking into account the COVID-19 outbreak (hereinafter “ESI” or “ESI regulation”);

 

***

 

The
European Commission (“the Commission”)

 

and

 

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

 

Together
referred to as “the Parties”

 

Agree
on the Following:

 

Article
1: Objective and mandate of the Commission

 

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

 

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

 

Article
2: Acquisition of vaccine doses

 

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

 

Article
3: APAs containing a right to acquire vaccine doses

 

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

 

     51

     

    

Article
4: APAs containing an obligation to acquire vaccine doses

 

Where
the Commission intends to conclude, in conformity with the present agreement, an APA containing an obligation to acquire vaccine
doses, it shall inform the Participating Member States of such intention and the detailed terms. In case a Participating Member
State does not agree with the conclusion of an APA containing an obligation to acquire vaccine doses or its terms, it has the
right to opt out by explicit notification to the Commission within 5 working days after the Commission has communicated its intention
to conclude the APA. All Participating Member States not having opted out within the period of 5 working days are deemed to have
authorised the Commission to negotiate and conclude the APA with the vaccine manufacturer in their name and on their behalf.

 

Article
5: The legally binding nature of APAs

 

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

 

Article
6: Responsibility and liability

 

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

 

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

 

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

 

Article
7: Obligation not to negotiate separately

 

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

 

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

 

     52

     

    

Annex

 

Initial
considerations

 

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

 

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

 

Structure
and purpose of the procurement

 

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

 

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

 

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

 

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

 

Process
and governance

 

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

 

     53

     

    

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

 

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

 

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

 

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

 

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

 

     54

     

    

Advanced
Purchase Agreements and conditions

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

and

 

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

 

     55

     

    

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

 

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

 

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

 

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

 

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

 

     56

     

    

 

Annex
IV: List of confirmed and planned manufacturing network partners including the location(s) of manufacturing

 

[***]

 

     57

     

    

Annex
V: Target Product profile

 

At
the date of signature of the APA, the current target Product profile is set out below, and can be varied by contractor during
the APA as and when the Product is being developed in accordance with Article I.4.2 of the APA. For the avoidance of doubt, the
final Product and related Marketing Authorisation (and notably the Product indication) will depend on the clinical trial data
and acceptability of the Marketing Authorisation application by the EMA.

 

	 	Vaccine
    Properties
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]
	[***]	+     
    [***]

 

     58

     

    

Annex
VI: Contractor’s Insurance

 

[***]

 

     59

     

    

 

Annex
VII: Details of the Utilisation of the Down Payment

 

[***]

 

     60

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