UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 6-K
REPORT OF FOREIGN
PRIVATE ISSUER
PURSUANT TO RULE
13a-16 OR 15d-16
UNDER THE SECURITIES
EXCHANGE ACT OF 1934
For the Month
of July 2024
Commission File
Number: 001-39374
Inventiva S.A.
(Translation
of registrant’s name into English)
50 rue de Dijon
21121 Daix France
+33 3 80 44 75
00
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
x
Form 20-F ¨
Form 40-F
On July 17, 2024, Inventiva
S.A. (the “Registrant”) entered into subscription agreements (the “Royalty Certificate Subscription Agreements”)
with certain investors, pursuant to which the Registrant agreed to issue and sell, and such investors agreed to purchase and acquire,
an aggregate of 201 royalty certificates (the “Royalty Certificates”), in a transaction exempt from registration under
the Securities Act of 1933, as amended (the “Transaction”).
The Royalty Certificates will provide
the holders thereof with the right to an annual payment of royalties (“Royalties”) equal to 3% of the future net sales, if
any, of the Registrant’s product candidate lanifibranor beginning on the fiscal year following the start of the sales of lanifibranor
following the granting of the market authorization for lanifibranor in (i) the United States of America, (ii) the countries
of the European Union or (iii) the United Kingdom, whichever occurs the first, if at all.
The Royalty Certificates will have a
term of 14 years following the date of issue. In the event of a Merger (as defined in the Royalty Certificates), and upon the request
of the Registrant, the holders of Royalty Certificates and the Registrant shall negotiate the terms upon which the Registrant may purchase
all of the then-outstanding Royalty Certificates; provided that neither the Registrant nor the holders of Royalty Certificates will have
any obligation other than to conduct such negotiations in good faith. The Registrant has a preemptive right on any transfer of Royalty
Certificates.
The subscription price of the Royalty
Certificates is €100,000 per certificate. Settlement and delivery of the Royalty Certificates is expected to occur on or about July 22,
2024, subject to the satisfaction of customary closing conditions. In connection with the entry into the Royalty Certificate Subscription
Agreements, the investors party thereto have agreed not to sell, transfer or otherwise dispose of the Royalty Certificates for a period
of six months following the date of closing, subject to certain specified exceptions.
The foregoing description of the Royalty
Certificate Subscription Agreements and the terms and conditions of the Royalty Certificates are qualified in their entirety by reference
to the form of Royalty Certificate Subscription Agreement, a copy of which is filed as Exhibit 99.1 to this report on Form 6-K
and is incorporated by reference herein.
The Registrant expects to receive aggregate
gross proceeds from the Transaction of approximately €20.1 million. The Registrant expects to use approximately 95% of the net
proceeds from the Transaction to support its ongoing NATiV3 Phase III clinical trial of lanifibranor for patients suffering from MASH/NASH,
with the remainder for general corporate purposes.
A copy of the press release issued on
July 18, 2024 in connection with the Transaction is attached hereto as Exhibit 99.2.
Forward-Looking Statements
This report on Form 6-K contains
“forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. All statements, other than statements of historical facts, included in this Form 6-K are forward-looking statements.
These statements include, but are not limited to, the timing and completion of the Transaction, the development and commercialization
of lanifibranor and achievement of any sales related thereto, payment of royalties, the Registrant’s anticipated future performance
and the expected use of proceeds from the Transaction. Certain of these statements, forecasts and estimates can be recognized by the
use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”,
“plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”,
“might”, “should”, and “continue” and similar expressions. Such statements are not historical facts
but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These
statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties
that could cause future results, performance or future events to differ materially from those expressed or implied in such statements.
Actual events are difficult to predict and may depend upon factors that are beyond the Registrant’s control. There can be no guarantees
with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future
clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any
of the anticipated milestones by the Registrant or its partners will be reached on their expected timeline, or at all. Actual results
may turn out to be materially different from the
anticipated future results, performance
or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that the Registrant
cannot provide assurance on the impacts of the previously-announced Suspected Unexpected Serious Adverse Reaction (SUSAR) on enrollment
or the ultimate impact on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that the Registrant is
a clinical-stage company with no approved products and no historical product revenues, the Registrant has incurred significant losses
since inception, the Registrant has a limited operating history and has never generated any revenue from product sales, the Registrant
requires additional capital to finance its operations, in the absence of which, the Registrant may be required to significantly curtail,
delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize
on its business opportunities and may be unable to continue as a going concern, the Registrant’s ability to obtain financing and
to enter into potential transactions, the Registrant’s future success is dependent on the successful clinical development, regulatory
approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials
are not necessarily predictive of future results and the results of the Registrant’s clinical trials may not support the Registrant’s
product candidate claims, the Registrant’s expectations with respect to its clinical trials may prove to be wrong and regulatory
authorities may require holds and/or amendments to the Registrant’s clinical trials, the Registrant’s expectations with respect
to the clinical development plan for lanifibranor for the treatment of MASH/NASH may not be realized and may not support the approval
of a New Drug Application, the Registrant may encounter substantial delays beyond its expectations in its clinical trials or the Registrant
may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of the Registrant to
recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming
process and could be made more difficult or rendered impossible by multiple factors outside the Registrant’s control, the Registrant’s
product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or
limit their commercial potential, the Registrant faces substantial competition and the Registrant’s business, and preclinical studies
and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely
affected by geopolitical events, such as the conflict between Russia and Ukraine, related sanctions and related impacts and potential
impacts on the initiation, enrollment and completion of the Registrant’s clinical trials on anticipated timelines and the state
of war between Israel and Hamas and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including
global inflation, rising interest rates, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties,
no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore,
forward-looking statements, forecasts and estimates only speak as of the date of this report on Form 6-K. Readers are cautioned
not to place undue reliance on any of these forward-looking statements.
Please refer to the Universal Registration
Document for the year ended December 31, 2023 filed with the Autorité des Marchés Financiers on April 3, 2024,
and the Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission on
April 3, 2024 for other risks and uncertainties affecting the Registrant, including those described from time to time under the
caption “Risk Factors”. Other risks and uncertainties of which the Registrant is not currently aware may also affect its
forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.
All information in this report on Form 6-K
is as of the date of the report. Except as required by law, the Registrant has no intention and is under no obligation to update or review
the forward-looking statements referred to above. Consequently, the Registrant accepts no liability for any consequences arising from
the use of any of the above statements.
EXHIBIT INDEX
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
| |
Inventiva S.A. |
| |
|
|
| Date: July 18, 2024 |
By: |
/s/
Frédéric Cren |
| |
|
Name |
Frédéric Cren |
| |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
Royalty Certificate
Subscription Agreement
INVENTIVA
50, rue de Dijon
21121 Daix
France
The undersigned,
[•] (the "Subscriber") hereby confirms its agreement with you as follows:
| 1. | This
Royalty Certificate Subscription Agreement (including the annexes attached hereto, the "Agreement"
or the “Subscription Agreement”) is made as of the date set forth below
between Inventiva S.A., a société anonyme organized under the laws of
the French Republic, with a share capital of €524,771.88, consisting of 52,477,188
ordinary shares of €0.01 nominal value each, and registered with the Commerce and Companies
Registry of Dijon under the number 537 530 255 (the "Company"), and the
Subscriber. |
| 2. | Pursuant
to the decisions adopted by the Board of Directors dated July 16, 2024, the Company
has decided to issue to certain investors only, 201 royalty certificates (the "Royalty
Certificates"), whose Terms and Conditions are attached hereto as Exhibit A
(the "Terms and Conditions of the Royalty Certificates"), for a subscription
price of €100,000 per royalty certificate (the "Subscription Price")
resulting in an offering of 201 Royalty Certificates for an aggregate amount of €20,100,000
to be subscribed by the Subscriber and the Other Subscribers as defined below (the "Transaction"). |
| 3. | The
Company and the Subscriber agree that the Subscriber will subscribe for a number of Royalty
Certificates as set forth below from the Company and, in turn, the Company, promptly upon
receipt of the aggregate amount set forth above, will issue the Royalty Certificates to the
Subscriber. The Royalty Certificates shall be subscribed for pursuant to, and the manner
of settlement shall be as set forth in, the Terms and Conditions for Subscription of Royalty
Certificates attached hereto as Annex I and incorporated herein by reference as if
fully set forth herein. |
| 4. | This
Agreement is signed by the parties electronically, in accordance with the first sentence
of the second paragraph of article 1367 of the French civil code, by means of an electronic
signature creation device provided through www.docusign.com and constitutes an act in electronic
form (écrit électronique) in accordance with article 1366 of the French
civil code. Each party also agrees: |
| - | that
the electronic signature they affix to the Agreement has the same legal value as its handwritten
signature; |
| - | that
the technical means implemented under this signature confer a definite date to each signature; |
| - | that
the necessity for plurality of originals, required by Article 1375 of the French civil
Code, is satisfied for the Agreement, and that the process used to conclude the Agreement
allows each party to have a copy on a durable support or to have access to it; |
| - | and
recognizes the opposability of the electronic signature and its admissibility as evidence
in court. |
| 5. | The
Company and the Subscriber agree that the Subscriber will subscribe, and the Company will
issue to the Subscriber, the Royalty Certificates as follows: |
Number of Royalty Certificates:
________________________
Subscription Price per Royalty
Certificate: €______________________
Aggregate Subscription Price
to be paid by the Subscriber (the “Subscriber Aggregated Subscription Price”): €___________________
Agreed and Accepted
The
Subscriber Aggregated Subscription Price will be paid in euros to the Company's account opened in
the books of Société Générale Securities Services (copied below) as set forth in Section 3.2 of Annex
I.
[*]
We acknowledge
that we received a copy of this Subscription Agreement, including the Annexes and Exhibits hereto.
Please confirm
that the foregoing correctly sets forth the agreement between us by signing in the space provided below for that purpose.
Subscriber:
_________________________
By:
Title:
Agreed and Accepted
this ________ 2024
INVENTIVA S.A.
| By: |
|
|
| Name: Frédéric Cren |
|
| Title: Chief Executive Officer |
|
ANNEX I
TERMS AND CONDITIONS
FOR THE SUBSCRIPTION OF THE ROYALTY CERTIFICATES
| 1. | Authorization
and Issue of the Royalty Certificates |
Subject
to the terms and conditions attached as Annex I to the Agreement (the "Terms and Conditions"),
the Company has duly authorized the issue of the Royalty Certificates (the "Transaction").
| 2. | Agreement
to Issue and Subscribe for the Royalty Certificates |
| 2.1 | At
the Closing Date (defined below), the Company will issue to the Subscriber, and the Subscriber
will subscribe, upon the Terms and Conditions set forth herein and in consideration for the
payment of the Subscriber Aggregated Subscription Price therefor set forth in the Agreement,
the number of Royalty Certificates set forth in the Agreement to which these Terms and Conditions
for Subscription of Royalty Certificates are attached as Annex I. |
| 2.2 | The
Company will enter into this same form of Subscription Agreement with other investors (the
"Other Subscribers") in connection with the Transaction and will complete
the issuance of Royalty Certificates to such Other Subscribers on the terms set forth herein.
The Subscriber and the Other Subscribers are hereinafter sometimes collectively referred
to as the "Subscribers" and this Agreement and the Subscription Agreements
executed by the Other Subscribers are hereinafter sometimes collectively referred to as the
"Agreements". The Company shall not enter into any side letter or otherwise
agree (orally or in writing) to modify or waive any of the terms and provisions of such Subscription
Agreement with any Other Subscriber without the prior written consent of the Subscriber. |
| 3. | Closing
and Transfer of the Royalty Certificates and Funds |
The time
and date of closing shall be no later than 2:00pm (CEST), on the date that is three (3) Business Days following the date of this
Agreement (the “Closing Date”), as agreed by the Company and the Subscriber.
The
Company has designated Société Générale Securities Services as "banque
centralisatrice" (the "Centralizing Bank") to receive the subscriptions and payment of the aggregate amount
equal to the Subscriber Aggregated Subscription Price and the Subscription Price for the Royalty Certificates being subscribed by the
Other Subscribers in accordance with Section 3.3 below.
| (a) | Conditions
to the Company’s Obligations |
At
the Closing Date, the Company’s obligation to issue the Royalty Certificates to the Subscriber will be subject to (i) the
receipt of the documentation necessary for the recording of the Royalty Certificates under registered form (au nominatif) and
for the "know your customer" process, (ii) the receipt in a dedicated account opened at Société
Générale Securities Services, the details of which are set forth in the signature page of the Subscription Agreement
of the aggregate amount equal to the Subscriber Aggregated Subscription Price and the Subscription Price for the Royalty Certificates
being subscribed for by the Other Subscribers in an aggregate amount equal to €20,100,000 and (iii) the representations and
warranties of the Subscriber contained in Section 5.1 being true and correct in all material respects as of the Closing Date.
| (b) | Conditions
to the Subscriber’s Obligations |
At the
Closing Date, the Subscriber’s obligation to subscribe for the Royalty Certificates will be subject to (i) the receipt of
a certified copy of the decisions of the Board of Directors dated July 16, 2024 authorizing the issuance of the Royalty Certificates
and the entry into this Agreement between the Company and the Subscriber and (ii) the accuracy of the representations and warranties
made by the Company as of the date hereof and as of the Closing Date and (iii) the fulfillment of the undertakings of the Company
to be fulfilled prior to the Closing Date.
| (c) | Conditions
to Either Party’s Performance |
The Company’s
and the Subscriber’s obligation to issue and subscribe for, respectively, the Royalty Certificates will be subject to the following
condition precedent: no statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated
or endorsed by any court or governmental authority of competent jurisdiction that prohibits the subscription or issue of the Royalty
Certificates.
| (d) | Company’s
obligation to return funds |
In the
event that the Company has not received an amount equal to (i) the Subscriber Aggregated Subscription Price and (ii) the Subscription
Price for the Royalty Certificates being subscribed for by the Other Subscribers in an aggregate amount equal to €20,100,000 at
the Closing Date, the Subscriber Aggregated Subscription Price shall be returned to the Subscriber within two (2) Business Days
following the Closing Date, unless otherwise agreed by all parties.
No
later than 12.00 pm (CEST) on the Closing Date, the Subscriber shall wire the Subscriber Aggregated
Subscription Price to the account opened in the books of Société Générale Securities Services (the “Centralizing
Bank”).
The account
of the Company to which the Subscriber Aggregated Subscription Price shall be wired is set forth in the signature page of the Subscription
Agreement. By executing this Agreement, the Subscriber irrevocably instructs the Centralizing Bank to accept delivery of, the subscription
monies from its settlement account to the bank account opened at the Centralizing Bank in its book in the name of the Company upon notice
from the Company to the Centralizing Bank, with a copy to the Subscriber, that (i) the conditions to the closing of the Transaction
have been satisfied or waived and (ii) that the entire aggregate subscription price for all the Other Subscribers have been received
by the Centralizing Bank.
On
the Closing Date, the Company shall register, or cause to be registered by Société Générale Securities Services,
under the name of the Subscriber on registered form (au nominatif) the number of Royalty Certificates subscribed by the Subscriber.
The Centralizing Bank will deliver the subscription monies to the Company.
At
the latest one (1) Business Day after each of the Closing Date, a notice confirming the registration
of the Royalty Certificates in the book of the Company held by Société Générale Securities Services shall
be delivered to the Subscriber.
For
purposes of this Agreement, the term “Business Day” shall mean a weekday on which
banks are open for general banking business in the United States and Paris, France.
| 4. | Representations,
Warranties and Undertakings of the Company |
| 4.1 | The Company
represents and warrants to the Subscriber, as of the date hereof and as of the Closing Date,
that: |
| (a) | Organization
and Standing. The Company is a corporation duly organized and validly existing under
the laws of France and has all requisite corporate power and authority to conduct its businesses
in each jurisdiction in which the conduct of its business or its ownership or leasing of
property requires such qualification (except in respect to such conduct of business that
the failure to be so qualified or be in good standing would not have a Material Adverse Effect)
as currently conducted and as currently proposed to be conducted and as described in the
Universal Registration Document, the annual report on the Form 20-F filed with the U.S.
Securities and Exchange Commission on April 3, 2024 (the "Form 20-F"
and together with the Universal Registration Document, the "Annual Report")
and any press releases issued by the Company since the publication of the Annual Report,
(the "Press Releases" and, together with the Annual Report, the "Company
Public Information"). |
In this
Agreement, "Material Adverse Effect" means any event, violation, or circumstance, individually or in the aggregate that
had or could reasonably be expected to have a material adverse effect on the Company’s equity, business, assets, operations, properties,
liabilities or conditions (financial or otherwise), individually or in the aggregate, whether or not arising from transactions in the
ordinary course of business, or on the Company’s ability to consummate the Transaction.
| (b) | Corporate
Power, Authorization. The issuance of the Royalty
Certificates and the entry into this Agreement have been duly authorized by the Company’s
Board of Directors on July 16, 2024. The Company has the legal capacity and power to
enter into this Agreement and to perform its obligations hereunder. This Agreement has been
duly executed by the Company and constitutes a legal, valid and binding obligation of the
Company, enforceable against the Company in accordance with its terms, except as enforceability
may be limited by bankruptcy, insolvency, reorganization, receivership, moratorium or other
similar laws affecting creditors’ rights generally. |
| (c) | No
Insolvency Proceedings. The Company and its Affiliates are not (i) insolvent (en
état de cessation des paiements), (ii) subject to a resolution which has
been passed or meeting convened for its winding-up (dissolution) (iii) subject
to any mandat ad hoc or any safeguard (sauvegarde) (including accelerated safeguard
(sauvegarde accélérée)), bankruptcy, liquidation or equivalent
proceedings under any applicable insolvency law, and no filing has been made (or consent
given) for the opening of any such proceeding in relation to the Company; and no action,
proceedings or other step or action have been taken in relation to any of the above or suspension
or stoppage of payments of the Company or any of its Affiliates or a general moratorium
of any of their indebtedness with its creditors. |
No liquidator,
receiver, administrator, administrative receiver, provisional administrator, compulsory manager or other similar officer, mandataire
ad hoc, in respect of the Company, any of its Affiliates or any of its or their assets has been appointed.
In
this Agreement, "Affiliate" means, with respect to the Company, any other person
that, directly or indirectly, through one or more intermediaries, Controls or is Controlled by or is under common Control with such person,
in each case from time to time. Control shall be construed by reference to the definition set out in Article L. 233-1 of the French
Commercial Code. As of the date hereof, the sole Affiliate of the Company is Inventiva Inc., whose registered office is at 10-34 44 th
Dr, Long Island, 11101 New York, United-States of America.
| (d) | Compliance
with Laws. The Company and its Affiliates are in
compliance in all material respects with the requirements of all applicable laws to which
it is subject and all orders, writs, injunctions and decrees applicable to it or to its properties. |
| (e) | Preferential
subscription right. The issuance of the Royalty Certificate is not subject to any pre-emptive,
preferential subscription right, priority rights (délai de priorité)
or similar rights that have not been validly excluded or waived and no person has any other
right of first refusal, pre-emptive right, right of participation, or any similar right to
participate in the transactions contemplated by the Transaction. |
| (f) | Private
Placement. Neither the Company nor any of its Affiliates, nor any person or entity acting
on its or their behalf, has, directly or indirectly, made any offers or sales of any security
or solicited any offers to buy any security, under any circumstances that would require registration
of the Royalty Certificates under the United States Securities Act of 1933, as amended (the
"Securities Act"). Assuming the accuracy
of the representations and warranties of the Subscriber contained in Section 5.1 hereof,
the Royalty Certificates are being offered in reliance on an exemption from registration
under the Securities Act. |
| (g) | No Conflicts
and No Default. The execution and performance of the Agreement by the Company do not
and will not (i) conflict with or violate any provision of the Company’s articles
of incorporation (statuts), (ii) conflict with, or constitute a default (or an
event that with notice or lapse of time or both would become a default) under, or entitle
third parties to terminate, amend, accelerate or cancel (with or without notice, lapse of
time or both), any material agreement, credit facility, material debt or other material instrument
to which the Company or any of its Affiliates is a party or any of their assets is subject
or (iii) result in a violation of any law, rule, regulation, order, judgment, injunction,
decree or other restriction of any court or governmental authority to which the Company or
any of its Affiliates or of its or their assets is subject, assuming the correctness of the
representations and warranties made by the Subscriber herein. |
| (h) | Issuance
and Delivery of the Royalty Certificates. Upon payment of the aggregate amount of the
Subscription Price by the Subscriber and the Other Subscribers in the manner contemplated
by this Agreement, the Royalty Certificates will be duly and validly issued and fully paid.
Other than restrictions described in the terms and conditions of the Royalty Certificates,
there are no restrictions on transfers of the Royalty Certificates under the laws of France
or the articles of incorporation (statuts) of the Company. |
| (i) | Consents.
Excluding applicable filings and disclosures to be made by the Company pursuant to applicable
laws, and assuming the accuracy of the representations made by the Subscriber in Section 5.1
of this Agreement, no consent, approval, order or authorization of, or registration, qualification,
designation, declaration, prospectus, information notice or filing with any governmental
authority on the part of the Company or any of its Affiliates is required in connection with
the consummation of the Transaction contemplated by this Agreement. |
| (i) | Neither
the Company or its Affiliates and, to the Company's knowledge, any of their respective directors
or officers nor, to the knowledge of the Company, any of their respective employees or agents
has, in the performance of his or her duties on behalf of the Company or any of its Affiliates,
(i) used any corporate funds for any unlawful contribution, gift, entertainment or other
expense relating to political activity; (ii) made any direct or indirect unlawful payment
to any foreign or domestic government official from corporate funds; (iii) violated
or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as
amended, including, without limitation, making use of the mails or any means or instrumentality
of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization
of the payment of money, or other |
| |
|
property, gift, promise to give, or authorization of the
giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political
party or official thereof or any candidate for foreign political office, in contravention of the FCPA, or any other applicable anti-bribery
or anti-corruption laws of the European Union, United Kingdom or France. The Company and its Affiliates have conducted their businesses
on behalf of the Company and its Affiliates in compliance with applicable anti-corruption laws and have instituted and maintained,
and will continue to maintain, policies reasonably designed to promote and achieve compliance with such laws and with the representation
and warranty contained herein. |
| (ii) | The
Company or its Affiliates and, to the knowledge of the Company, their respective directors
or officers, employees and agents have not obtained or induced directly or indirectly through
any person and will not attempt to so obtain or induce the procurement of this Agreement
or any contract, consent, approval, right, interest, privilege or other obligation or benefit
related to this Agreement or a favourable relationship with the Subscriber through any corrupt
or illegal business practice including, have not given or agreed to give and shall not give
or agree to give to any person, either directly or indirectly, any fee, compensation, monetary
benefit or any other benefit, bribe or kickback, with the object of obtaining or inducing
the procurement of this Agreement or any contract, right, interest, privilege or other obligation
or benefit related to this Agreement. For the avoidance of doubt, the representation shall
not apply to any payments that are legitimate in the normal course of business between each
party hereto pursuant to this Agreement or with third parties for the purposes of the implementation
of the Transaction (such as fees for the settlement agent or professional advisers of the
Company) and items, including refreshments, of an inconsequential or immaterial cost or value. |
| (k) | Sanctions.
Neither the Company and its Affiliates, nor, to the Company's knowledge, any of their
respective directors, officers, or employees (i) has been or is currently subject to
any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury
Department ("OFAC") or by any governmental agency of any other applicable
jurisdiction (including the United Nations Security Council, the European Union or the member
state thereof and the United Kingdom (together with the OFAC the "Sanction Authority")),
(ii) has violated or is violating any applicable
sanctions administered by a Sanction Authority or has been subject to any claim, proceeding,
formal notice or investigation with respect to sanctions administered by a Sanction Authority;
and the Company will not directly or indirectly use the proceeds of the Transaction, or lend,
contribute or otherwise make available such proceeds to joint venture partner or other person
or entity, for the purpose of financing the activities of or business with any person, or
in any country or territory, which is currently subject to any sanctions administered by
OFAC or a Sanction Authority. |
| (l) | Other
Subscription Agreements.
The Subscription Agreements of the Other Subscribers for the subscription of the Royalty
Certificates do not include terms or conditions that are more advantageous than the terms
and conditions of this Agreement other than provisions relating to the specific regulations
or status applicable to such Other Subscriber. The Company (directly or indirectly) has not
entered and shall not enter into any side letter or otherwise agree (orally or in writing)
to modify or waive any of the terms and provisions of such Subscription Agreement with any
Other Subscriber without the prior written consent of the Subscriber. |
| (m) | Acknowledgment
regarding Subscriber’s Subscription of Royalty Certificates. The Company acknowledges
and agrees that the Subscriber is acting solely in the capacity of an arm’s length
subscriber with respect to this Agreement and the transactions contemplated hereby. The Company
further acknowledges that the Subscriber is not acting as a financial advisor or fiduciary
of the Company (or in any similar capacity with respect to the Company) |
| |
|
or any Other Subscriber with respect to this Agreement and the transactions
contemplated hereby and any advice given by the Subscriber or any of its respective representatives or agents to the Company in connection
with this Agreement and the transactions contemplated hereby is merely incidental to the Subscriber’s subscription of the Royalty
Certificates. The Company further represents to the Subscriber that the Company’s decision to enter into this Agreement has
been based on the independent evaluation of the transactions contemplated hereby by the Company and its representatives. |
| (n) | Other
than the information disclosed in the Company Public Information or pursuant to a written
employment agreement in force as of the date hereof or as required by applicable laws or
collective bargaining agreements, none of the employees, officers or managers, regardless
of their status, of the Company or its Affiliates benefit from any severance, separation
or termination pay, retention bonus, golden parachute or any similar-type benefit or payment. |
| (o) | The
Company has not made available to the Subscriber information that could be qualified as inside
information within the meaning of Regulation No. 596/2014 of 16 April 2014 on market
abuse which is required to be disclosed in accordance with applicable law. |
| 4.2 | The Company
undertakes the following: |
| (a) | Interim
Covenants. During the period from the date of this Agreement and continuing until the
earlier of the termination of this Agreement and the Closing Date, the Company and its Affiliates
shall conduct their business in the usual, regular and ordinary course of business consistent
with past practice. |
| (b) | Royalty
Certificate Issuance. The Company shall take all action necessary to cause the Royalty
Certificates to be issued to the Subscriber on, or, as soon as possible following, the Closing
Date in accordance with the terms and conditions of this Agreement. |
Upon
payment of the Subscriber Aggregated Subscription Price by the Subscriber in the manner contemplated by this Agreement, the Company shall
register these Royalty Certificates upon records to be maintained by the Company or any other entity appointed as registrar by the Company
(as set forth in Terms and Conditions of the Royalty Certificates attached as Exhibit A) for that purpose in the name of the record
holder of such Royalty Certificate. No physical documents evidencing the title to the Royalty Certificates will be issued.
(i) PFIC.
The Company will (a) promptly notify the Subscriber (and in no event later than 30 Business Days following the end of each calendar
year) whether the Company has determined that it or any of its subsidiaries was a PFIC (as each such term is defined above) for such
calendar year and (b) provide the Subscriber with sufficient information, on a timely basis, to determine whether the Company is
a PFIC and allow its investors to make and maintain a Qualified Electing Fund election under Section 1295 of the U.S. Internal Revenue
Code of 1986, as amended with respect to the Company in the event the Company for any year in which the Company is treated as a PFIC.
(ii) Corporate
Status. The Company will not take any action inconsistent with the treatment of the Company as a corporation for U.S. federal income
tax purposes and will not elect to be treated as an entity other than a corporation for U.S. federal income tax purposes.
| (d) | Use
of Proceeds. The Company undertakes to use the proceeds from the subscription of the
Royalty Certificates to pursue lanifribanor phase III clinical study as disclosed in the
press release relating to the issue of the Royalty Certificates. |
| (e) | Employees.
For a period of 8 weeks from the date hereof, the Company shall not (and shall cause
its Affiliates not to), whether by way of an agreement, unilateral commitment, promise or
otherwise, (A) entitle, grant or pay to any of the employees, officers or managers,
regardless of their status, of the Company or of its Affiliates (i) any direct or indirect
increase in salary, compensation, pension, welfare or fringe benefits, (ii) any bonus,
commission or incentive (including share option, share purchase, restricted share, equity
or equity-based), (iii) any severance, separation or termination pay, retention bonus,
golden parachute or any similar-type benefit or payment, and (iv) more generally, any
specific benefits (avantages particuliers) or conditions more favourable than those
provided in the agreements in force as of the date hereof, applicable laws or collective
bargaining agreements in the event of termination, resignation, retirement, illness, disability
or death (in particular with respect to career progression, notice, severance, wages, and
benefits), in each of the cases referred to in (i) to (iv) regardless of their
due date or date of payment (including if they are deferred or conditional) and in
cash or otherwise or (B) accelerate the time of payment or vesting of any of the items
referred in (A), except, in each case, pursuant to a written employment agreement in force
as of the date hereof or as required by applicable laws or collective bargaining agreements
or (C) loan or advance any amount to any of their employees, officers and managers,
regardless of their status. |
| 4.3 | The Company
acknowledges and agrees that notwithstanding any provision of this Agreement otherwise requiring
the Subscriber to provide any information or documents to the Company or any third party,
the Subscriber shall be entitled to withhold, edit, redact and/or otherwise limit disclosure
of any such information or documents on the grounds of national security and/or financial
or economic sensitivity and the Subscriber shall have no liability whatsoever and shall be
free and harmless from any claims whatsoever for exercising its rights pursuant to this clause. |
| 4.4 | For the avoidance
of doubt, the Subscriber is solely liable for its obligations set forth in or arising under
this Agreement, and no direct or indirect legal or beneficial owner of the Subscriber shall
have any liability in respect of this Agreement. |
| 4.5 | The rights of
the Subscriber under or in connection with this Agreement are separate and independent rights
and any debt arising under this Agreement to the Subscriber from the Company is a separate
and independent debt in respect of which the Subscriber shall be entitled to enforce its
rights in accordance with the last sentence of this paragraph. The Subscriber may, except
as specifically provided in the Terms and Conditions, separately enforce its rights under
or in connection with this Agreement. |
| 4.6 | The Company
will sign and execute and deliver such documents and take such actions as are necessary for
the consummation of the subscription of the Royalty Certificates to the Subscriber hereunder;
provided, that nothing herein shall require the Company to sign, execute and deliver any
document or take any action that, in the good faith determination of the Company, could reasonably
be expected to result in (i) harm or prejudice to the Company, (ii) the disclosure
of any confidential or proprietary information of the Company or (iii) the breach of
any applicable law, regulation or judicial, administrative or regulatory process. |
| 5. | Representations
and Warranties and Covenants of the Subscriber |
| 5.1 | The
Subscriber represents and warrants to the Company that: |
| (a) | Organization.
The Subscriber is duly organized and is validly existing under the laws of its state
of incorporation. |
| (b) | Power;
Authorization. The execution and performance by the Subscriber of the Agreement has been
duly authorized by all necessary corporate bodies, or, if the Subscriber is not a corporation,
such partnership, limited liability company or other applicable bodies, on the part of the
Subscriber. As such (i) the Subscriber has all requisite corporate or other power and
capacity and has taken all requisite corporate or other action to execute and deliver this
Agreement, to subscribe the Royalty Certificates to pay the Subscriber Aggregated Subscription
Price, and to carry out and perform all of its obligations under this Agreement; and (ii) this
Agreement has been duly executed by the Subscriber, and when delivered by the Subscriber
in accordance with terms hereof, will constitute the valid and legally binding obligation
of the Subscriber, enforceable against it in accordance with its terms, except as limited
by applicable bankruptcy, insolvency, reorganization, or similar laws relating to or affecting
the enforcement of creditors’ rights generally. |
| (c) | Information.
The Subscriber has had an opportunity to discuss the Company’s business, management,
financial affairs and the terms and conditions of the offering of the Royalty Certificates
with the Company’s management. The foregoing, however, does not limit or modify the
representations and warranties of the Company in Section 4.1 of this Agreement or the
right of the Subscribers to rely thereon. |
| (d) | Investment
Intent. The Subscriber is subscribing the Royalty Certificates for its own account as
principal, for investment purposes only, and not with the intent or for the purpose of the
resale distribution thereof, in whole or in part, within the meaning of the Securities Act
or the other applicable securities laws of any other jurisdiction to the extent applicable.
The Subscriber understands that its subscription of the Royalty Certificates has not and
will not have been registered under the Securities Act in reliance on specific exemptions
therefrom, which exemptions may depend upon, among other things, the bona fide nature of
such Subscriber’s investment intent as expressed herein. Except as contemplated by
this Agreement, the Subscriber has not entered into any agreement, undertaking, arrangement,
obligation or commitment providing for the disposition of the Royalty Certificates. The Subscriber
represents that it has not been organized, reorganized or recapitalized specifically for
the purpose of investing in the Royalty Certificates. |
| (e) | No Insolvency
Proceedings. To the knowledge of the Subscriber, no bankruptcy, insolvency or other proceedings
of general application affecting creditors’ rights have been proposed, commenced or
threatened against the Subscriber, and no judgment has been made or is pending declaring
the Subscriber insolvent. |
| (f) | No
Violation. Neither the execution of this Agreement by the Subscriber nor the subscription
of the Royalty Certificates by the Subscriber violates or will violate (i) any provision
of the articles of association (or equivalent constituent documents) of the Subscriber, (ii) any
material applicable law or material regulation binding upon the Subscriber or its assets,
(iii) any judgment, order or decree of any governmental body, agency or court having
jurisdiction over the Subscriber or any of its assets, (iv) the rules of any stock
exchange as they apply to the Subscriber (but excluding the rules of any stock exchange
as they apply to the Company only), and (v), any other material agreements to which the Subscriber
is a party, in each case, with respect to clauses (i) – (v) of this Section 5.1(e),
except to the extent that such violation would not reasonably
be expected to materially impair or delay the Subscriber’s ability to perform its obligations
under this Agreement. |
| (g) | Category
of Subscriber. The Subscriber is a "qualified investor" within the meaning
of Article 2(e) of Regulation (UE) 2017/1129, as amended. The Subscriber is subscribing
for the number of Royalty Certificates set forth hereto in the ordinary course of its business
for investment only and with no present intention of distributing any of such Royalty Certificates
or any arrangement or understanding with any other persons regarding the distribution of |
| |
|
such Royalty Certificates. The Subscriber will subscribe for at least
an amount equal to EUR 100,000. |
| (h) | Lock-up.
The Subscriber agrees that it will not, during the period beginning on the Closing Date
and ending 6 months after the Closing Date (such period, the "Restricted Period"),
(1) offer, pledge, sell, contract to sell, sell any option or contract to purchase,
purchase any option or contract to sell, grant any option, right or warrant to purchase,
or otherwise transfer or dispose of, directly or indirectly of any of the Royalty Certificates
it owns, or publicly disclose the intention to make any offer, sale, pledge or disposition
of the Royalty Certificates, (2) enter into any swap or other agreement that transfers,
in whole or in part, any of the economic consequences of ownership of the Royalty Certificates,
in each case other than to any Affiliates. |
| (i) | Restricted
Securities.
The Subscriber understands that the Royalty Certificates have not been, and will not be,
registered under the Securities Act, by reason of a specific exemption from the registration
provisions of the Securities Act which depends upon, among other things, the bona fide nature
of the investment intent and the accuracy of the Subscriber’s representations as expressed
herein. The Subscriber understands that, in addition to the restrictions applicable to the
Royalty Certificates under this Agreement, the Royalty Certificates may be deemed “restricted
securities” under applicable U.S. federal and state securities laws and that, pursuant
to these laws, the Subscriber must hold the Royalty Certificates indefinitely unless they
are registered with the Securities and Exchange Commission and qualified by state authorities,
or an exemption from such registration and qualification requirements is available. The Subscriber
acknowledges that the Company has no obligation to register or qualify the Royalty Certificates
for resale. The Subscriber further acknowledges that if an exemption from registration or
qualification is available, it may be conditioned on various requirements including, but
not limited to, the time and manner of sale, the holding period for the Royalty Certificates,
and on requirements relating to the Company which are outside of the Subscriber’s control,
and which the Company is under no obligation and may not be able to satisfy. The Subscriber
understands that no United States federal or state agency or any other government or governmental
agency has passed upon or made any recommendation or endorsement of the Royalty Certificates. |
| (j) | Accredited
Investor. The Subscriber is an accredited investor as defined in Rule 501(a) of
Regulation D promulgated under the Securities Act. |
| (k) | No
General Solicitation. The Subscriber is not purchasing or subscribing for the Royalty
Certificates as a result of any advertisement, article, notice or other communication regarding
the Royalty Certificates published in any newspaper, magazine or similar media or broadcast
over television or radio or presented at any seminar or, to such Subscriber's knowledge,
any other general solicitation or general advertisement (within the meaning of Rule 502(c) under
the Securities Act). |
| (l) | Residence.
If the Subscriber is an individual, then the Subscriber resides in the state identified
in the address of the Subscriber set forth in Section 7; if the Subscriber is a partnership,
corporation, limited liability company or other entity, then the office or offices of the
Subscriber in which its principal place of business is conducted is identified in the address
or addresses of the Subscriber set forth in Section 7. |
| (m) | Exculpation
among Subscribers. The Subscriber acknowledges that it is not relying on any other individual
or entity (including any Other Subscriber), other than the Company and its officers and directors,
in making its investment or decision to invest in the Company. |
| (n) | No
rights in the Company's Securities. The Subscriber understands that by subscribing to
the Royalty Certificates, it shall not be entitled to vote or be deemed the holder of any
other securities of the Company, nor shall anything contained herein be construed to confer
upon |
| |
|
the Subscriber, as such, the rights of a stockholder of the Company
or the right to vote for the election of directors or upon any matter submitted to stockholders at any meeting thereof, or give or
withhold consent to any corporate action or to receive notice of meetings or other actions affecting stockholders or to receive dividends
or subscription rights or otherwise. |
| 5.2 | The
Subscriber undertakes that: |
| (a) | It will
comply with any notification requirements which may be required to be made under any applicable
law and the Company's by-laws. |
| (b) | It will
sign and execute and deliver such documents and take such actions as are necessary for the
consummation of the subscription of the Royalty Certificates to the Subscriber hereunder;
provided, that nothing herein shall require the Subscriber to sign, execute and deliver any
document or take any action that, in the good faith determination of the Subscriber, could
reasonably be expected to result in (i) harm or prejudice to the Subscriber, (ii) the
disclosure of any confidential or proprietary information of the Subscriber or (iii) the
breach of any applicable law, regulation or judicial, administrative or regulatory process. |
| 6. | Survival
of Representations, Warranties and Agreements |
Notwithstanding
any investigation made by any party to this Agreement, all covenants, agreements, representations and warranties made by the Company
and the Subscriber herein will survive the execution of this Agreement, the transfer to the Subscriber of the Royalty Certificates being
subscribed and the payment therefor.
All notices,
requests, consents and other communications required or permitted hereby shall be in writing will be sent by email, or mailed, and will
be deemed given if delivered by email, upon electronic confirmation of receipt and addressed to the relevant recipient in the manner
provided below, and shall be deemed to have been duly and sufficiently given only if (a) delivered either personally by hand, or
by an international courier service, and, in each case, (b) confirmed by email to the relevant recipient. Notices shall
be deemed effective if given on a Business Day, in the manners prescribed in the immediately preceding sentence, by 13:30 (CEST) in the
place of receipt or on the following Business Day if completed after 13:30 (CEST).
All notices
will be delivered as addressed as follows:
| (a) | if to the
Company, to: |
Inventiva
S.A.
50, rue
de Dijon
21121 Daix
France
Attention: Frédéric
Cren
Phone:
Email:
| (b) | if to the
Subscriber, to: |
[•]
This
Agreement may not be modified or amended except by written agreement signed by the Company and the Subscriber.
In case
any provision contained in this Agreement should be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability
of the remaining provisions contained herein will not in any way be affected or impaired thereby.
Legal
and financial advisors’ reasonable and duly documented costs, fees and expenses pertaining to the Subscriber, for which invoices
and receipts are furnished to the Subscriber, in relation to the negotiation, subscription and implementation of the Royalty Certificates
shall be paid by the Company up to an amount of €100,000, regardless of whether the closing occurs. This provision will survive
the execution of this Agreement, the transfer to the Subscriber of the Royalty Certificates being subscribed and the payment therefor.
| 11. | Governing
Law and Jurisdiction |
This
Agreement will be governed by, and construed in accordance with, the laws of France. Any dispute or suit relating to the interpretation,
validity and performance of this Agreement, or arising out of or as a consequence hereof, shall be subject to the exclusive jurisdiction
of the Tribunal de commerce of Paris.
Each
party to this Agreement acknowledges that Cooley LLP, U.S. counsel for the Company, has in the past performed and may continue to perform
legal services for the Subscriber and/or Other Subscriber in matters unrelated to the transactions described in this Agreement. Accordingly,
each party to this Agreement hereby (a) acknowledges that they have had an opportunity to ask for information relevant to this disclosure;
and (b) gives its informed consent to Cooley LLP’s representation of the Subscriber and/or Other Subscriber in such unrelated
matters and to Cooley LLP’s representation of the Company in connection with this Agreement and the transactions contemplated hereby.
Exhibit A
Terms and Conditions
of the 2024 Royalty Certificates
Terms and
Conditions of the 2024 Royalty Certificates
The
terms and conditions of the 2024 Royalty Certificates (the "Conditions") are as follows:
The
issue by Inventiva S.A., a limited liability company (société anonyme)
incorporated and organized under the laws of France, whose registered office is at 50, rue de Dijon, 21121 Daix, France, registered with
the Trade and Companies Register of Dijon under number 537 530 255 ("Inventiva" or the "Company"),
of its two hundred and one (201) royalty certificates (the "2024 Royalty Certificates") for an amount of €100,000
each, as decided by the board of directors (conseil d’administration) of the Company on July 16, 2024.
An aggregate of
two hundred and one (201) 2024 Royalty Certificates (the "Total Number of 2024 Royalty Certificates") have been issued
pursuant to Subscription Agreements entered into by the Company and each investor in consideration for the Subscription Price paid by
each investor as set forth in Appendix A.
All capitalized
terms used in these Conditions shall have the following meaning:
“Affiliate”
when used with reference to a specified Person, means any Person that, directly or indirectly through one or more intermediaries, controls,
is controlled by or is under common control with such specified Person, in each case from time to time; for such purposes, the term “control”
(including the terms “controlling”, “controlled by” and “under common control with”) shall mean the
possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether
through the ownership of voting securities, by contract or otherwise and shall include the notion of control within the meaning of Article L.
233-3, paragraphs I and II, of the French Commercial Code (Code de commerce). For the avoidance of doubt, (i) Affiliates
of a Fund shall include (x) any Fund Manager and (y) any other Fund that is managed or advised by such Fund’s Fund Manager
or by any Affiliate of that Fund Manager, and (ii) Affiliates of a Fund Manager shall include any Fund managed or advised by it
or by any of its Affiliates. For the purposes of this definition and these Conditions, no holder of Inventiva Shares shall be considered
an Affiliate unless such holder of Inventiva Shares exercises 50% or more of the voting rights in Inventiva. As of the date hereof, the
sole Affiliate of Inventiva is Inventiva Inc., whose registered office is at 10-34 44 th Dr, Long Island, 11101 New York, United-States
of America
“Agent”
has the meaning ascribed to this term under Condition 8.1 (Representative).
“Business
Day” means any day except (i) a Saturday, a Sunday, (ii) a day that is not a trading day on the regulated market
of Euronext Paris, (iii) a day on which banks in Paris and the United States are authorized or required by Law to remain closed
or (iv) a day on which T2 (Trans-European Automated Real-time Gross Settlement Express Transfer System) is not open (or any combination
of the above).
“Certificate
Payment Date” means fifteen (15) Business Days after the publication of the Company's audited financial statements for the
prior fiscal year in which the relevant Net Sales (or in respect of any Commercialization Agreement, any amounts received under the Commercialization
Agreement in respect of the Product or resulting from Net Sales of the Product) were recorded by the Company or any of its Affiliates.
"Collective
Decisions" has the meaning ascribed to this term under Condition 8.2 (Collective decisions).
“Commercialize”
means commercial manufacture, marketing, promotion, sale or distribution.
"Commercialization
Agreement” means any agreement under which the Company or any of its Affiliates grants or has (directly or indirectly, including
through sublicenses) granted or authorized the grant of a license to a third party (including, without limitation, third party agents,
distributors and wholesalers) to Commercialize any Product (such third party, a “Commercialization Partner”).
“Commercialization
Partners” has the meaning given in the definition of Commercialization Agreement.
“Conditions”
means these terms and conditions.
“Disposal
Transaction” means any transaction (or series of related transactions) as a result of
which the Company (or any of its Affiliates) or any Third Party Acquirer (or any of its Affiliates) directly or indirectly disposes of
or grants any rights to or under any assets or rights (including intellectual property rights) relating to Lanifibranor or any Product
be it through an asset or share sale, transfer or swap of assets, merger, reorganization, joint venture, lease or any other transaction
or arrangement having a similar result or effect.
“Entity”
means any entity, company, corporation, group, de facto company, association, partnership, joint venture, whether governmental
or private, or whether or not having a separate legal personality.
“€”
and “Euro” means the currency introduced at the start of the third stage of European economic and monetary union
pursuant to the Treaty establishing the European Community (signed in Rome on 25 March 1957), as amended.
“FTT”
has the meaning ascribed to this term under Condition 6 (Taxation)
“Fund”
means any Entity in the form of trusts or investment funds, or other investment vehicles, in any form, that (a) has been established
to pool the resources of multiple underlying investors or utilize the resources of the one underlying investor, (b) is managed or
advised by a Fund Manager and (c) has been established to invest in a class of assets or investments, rather than in a single asset
or investment.
“Fund
Manager” means a general partner, trustee, nominee, investment manager or advisor or other person appointed by a Fund to manage
or advise directly or indirectly that Fund on a day-to-day basis in relation to all or part of its assets.
“General
Meeting” has the meaning ascribed to this term under Condition 8.2 (Collective decisions).
“Governmental
Entity” means any domestic or foreign court or other judicial authority or governmental, administrative or regulatory body,
department, agency, commission or authority.
“Independent
Expert” has the meaning ascribed to this term under Condition 7.3 (Independent Expert - Audits)
“Inventiva
Shares” means ordinary shares of Inventiva, each with a par value of €0.01 (ISIN Code: FR0013233012).
“Issue
Date” means the closing date of the subscription of the Royalty Certificates by the investors under the Subscription Agreements
which is expected to be on or about July 22, 2024.
“Lanifibranor”
means an orally-available small molecule in development for the treatment of NASH that acts to induce anti-fibrotic, anti-inflammatory
and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptors, or PPAR,
isoforms, and including any deuterated derivatives or analogs, racemates, salts, metabolites, esters, diastereomers, tautomers, enantiomers,
prodrug forms, hydrates, solvates, intermediates, polymorphs and degradants thereof, in each case, that have a similar pharmacological
effect, in crystal, powder or other form. PPARs are well-
characterized nuclear
receptor proteins that regulate gene expression, and their relevance for the fibrotic, inflammatory, vascular and metabolic processes
that characterize NASH is well-established.
“Law”
means any domestic, EU, foreign, federal, local or municipal laws, rules, judgments orders, regulations, statutes, ordinances, codes,
decisions, injunctions, orders, decrees or requirements of any Governmental Entity.
“Lock-up
Period” means the period beginning on the Issue Date and ending on the date that is six months following the Issue Date.
“Net
Sales” means the gross amount billed or invoiced or otherwise recognized as revenue by the Company, its Commercialization Partners
or any of their respective Affiliates for sales or other dispositions of the Product in or in relation to the Territory to third parties,
in bona fide, arms-length transactions, less the total of the following items, as specifically allocated to such Products, actually
allowed and taken by such third parties and not otherwise recovered by or reimbursed to the Company, its Commercialization Partners or
any of their respective Affiliates and not previously deducted from the amount invoiced:
| (i) | trade,
cash and/or quantity discounts, credits or allowances actually allowed (provided that such
discounts are applied in a normal and customary manner with respect to other similarly situated
products of the selling party, and not in a manner which is unreasonably disproportionate
to one or more Products when compared to other products of the selling party); |
| (ii) | charge
back payments, price reductions and rebates allowed or granted to managed care organizations,
government agencies or trade customers, including wholesalers and chain and pharmacy buying
groups (provided that such discounts are applied in a normal and customary manner with respect
to other similarly situated products of the selling party, and not in a manner which is unreasonably
disproportionate to one or more Products when compared to other products of the selling party); |
| (iii) | credits
actually allowed for claims, allowances for damaged goods, retroactive price reductions or
rejected or returned goods; |
| (iv) | prepaid
freight, distribution, postage, shipping, customs duties and insurance charges to the extent
added to the sale price (whether or not specifically identified as such in the invoice to
the third party); and |
| (v) | sales
taxes, value added taxes, duties and other governmental charges to the extent added to the
sale price (whether or not specifically identified as such in the invoice to the third party). |
For purposes of
determining Net Sales, “sale” will not include transfers or dispositions for charitable, promotional, pre-clinical, clinical,
regulatory or governmental purposes (in each case, for no consideration). Net Sales shall include the amount or fair market value of
all other consideration received by the Company, its Commercialization Partners or any of their respective Affiliates, in respect of
the Product, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between
or among the Company, its Commercialization Partners (on the basis that it is the sale or disposal of the Product by the Commercialization
Partner or its Affiliate that constitutes the Net Sale for purposes of these Conditions) or their respective Affiliates.
"Offered
Certificates" has the meaning ascribed to this term under Condition 3.2 (Transfer and Company's pre-emptive right).
“Outstanding
2024 Royalty Certificates” means, as of the date of determination, all 2024 Royalty Certificates issued under these Conditions,
except for the 2024 Royalty Certificates purchased by the Company and/or cancelled in accordance with these Conditions.
“Person”
means a natural person, an Entity or a Governmental Entities.
"Preemption
Right" has the meaning ascribed to this term under Condition 3.2 (Transfer and Company's
pre-emptive right).
“Product”
means any product containing Lanifibranor, in any and all finished forms, presentations, delivery systems, strength, dosages, formulations
and routes of administration.
"Public
Disclosure" means with respect to the Company (i) its universal registration document (document
d'enregistrement universel) as amended from time to time, (ii) its annual report on the Form of 20-F filed with the U.S.
Securities and Exchange Commission, (iii) its half year financial report and (iv) any press release issued by the Company on
its websites.
"QIB"
means a qualified institutional buyer as defined in Rule 144A under the U.S. Securities Act of 1933, as amended.
"Qualified
Investor" means persons or entities which enter into the definition provided in point e), Article 2 of Regulation (EU)
2017/1129 of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on
a regulated market.
"Registrar"
has the meaning ascribed to this term under Condition 2 (Form, denomination and title)
“Reports”
has the meaning ascribed to this term under Condition 7.2 (Reporting obligations).
“Representative”
has the meaning ascribed to this term under Condition 8.1 (Representative).
“Royalty”
means, with respect to each Royalty Certificate and each Certificate Payment Date, the product of (i) the Royalty Rate and (ii) a
fraction, the numerator of which is the amount of Net Sales of the Product during the fiscal year preceding the Certificate Payment Date
and the denominator of which is the Total Number of 2024 Royalty Certificates (rounded up to the nearest multiple of euro 0.0001).
“Royalty
Certificate” or "Certificate" means the 2024 Royalty Certificates issued by the Company and whose terms and
conditions are described herein.
“Royalty
Certificate Holder” means the holder of a Royalty Certificate.
“2024
Royalty Certificates Expiration Date” means July 22 2038 i.e. the date that is 14 years following the Issue Date.
“Royalty
Rate” means three per cent (3%), exclusive of any value added tax, if applicable.
"Selling
Holder" has the meaning ascribed to this term under Condition 3.2 (Transfer and Company's pre-emptive right).
“Subscription
Agreements” means the subscription agreements pursuant to which the Royalty Certificates are issued by the Company and subscribed
by the initial Royalty Certificates Holders.
“Subscription
Price” means, with respect to each investor, the aggregate amount corresponding to €100,000 euros per 2024 Royalty Certificate,
paid by such investor for its Royalty Certificate(s) upon their issuance.
“Tax”
means any federal, state, local or foreign income, profits, gross receipts, license, payroll, employment, severance, stamp, occupation,
premium, windfall profits, environmental, customs duty, capital stock, franchise, sales, social security, unemployment, disability, use,
property, withholding, excise, transfer, registration, production, value added, alternative minimum, occupancy, estimated or any other
tax of any kind whatsoever, together with any interest, penalty or addition thereto, imposed by any Governmental Entity responsible for
the imposition of any such tax, whether disputed or not.
“Territory”
means the United States of America and each country of the European Union (including any additional member states as may become members
of the European Union prior to the 2024 Royalty Certificates Expiration Date) and the United Kingdom.
“Third
Party Acquirer” has the meaning ascribed to this term under Condition 7.4 (Disposal).
"Written
Decision" has the meaning ascribed to this term under Condition 8.2 (Collective decisions).
| 2. | Form,
denomination and title |
The
Certificates will be issued in dematerialised registered form. Title to the Certificates will be evidenced by book-entries (inscription
en compte), in accordance with Articles L. 211-3 et seq. of the French Monetary and Financial Code.
The
Certificates holders' rights shall be evidenced by a book entry on a securities account open in their name in the books of the Company
or any other entity appointed as registrar by the Company (the "Registrar") which expression shall, where the context
so admits, include any successor for the time being as Registrar.
On
the Issue Date, the Registrar appointed by the Company is Société Générale Securities Services.
No
physical document of title will be issued in respect of the Certificates.
The 2024 Royalty
Certificates are sui generis debt instruments referred to in Article L. 228-36-A of the French Commercial Code (Code de
commerce) that represent the right of the Royalty Certificate Holders to receive payment of Royalties (if any) on each Certificate
Payment Date.
The rights of the
2024 Royalty Certificates Holders are limited to the rights expressed in these Conditions. Without prejudice to Condition 8 (Representation
of the Royalty Certificate Holders), no Royalty Certificate Holder, as such, shall be entitled to vote or be deemed the holder of
any other securities of the Company, nor shall anything contained herein be construed to confer upon the Royalty Certificate Holder,
as such, the rights of a shareholder of the Company or the right to vote upon any matter submitted to the shareholders at any meeting
thereof, or give or withhold consent to any corporate action or to receive notice of meetings or other actions affecting shareholders
(except as provided herein), or to receive dividends or subscription rights or otherwise.
The 2024 Royalty
Certificates constitute direct, unconditional, unsubordinated and unsecured financial instruments of the
Company and ranking equally between themselves. Other than as set out in these Conditions, holders of 2024 Royalty Certificates
have no rights to receive any sums (including any right of redemption of the Subscription Price) from the Company at any time in regard
to such 2024 Royalty Certificates.
| 3.2 | Transfer and Company's pre-emptive
right |
The Royalty Certificates
cannot be sold, transferred or otherwise disposed of during the Lock-Up Period to any person. Notwithstanding the foregoing, a Royalty
Certificate Holder may at any time during the Lock-Up Period transfer all or part of its 2024 Royalty Certificates(provided that a partial
transfer shall only be made for a minimum number of 10 (ten) 2024 Royalty Certificates) to its Affiliate (subject to any applicable Laws).
In the event that,
after the Lock-Up Period, any Royalty Certificate Holder (the "Selling Holder") intends to sell, transfer, or otherwise
dispose of all or part of its 2024 Royalty Certificates (provided that a partial transfer shall only be made for a minimum number of
10 (ten) 2024 Royalty Certificates) (the "Offered Certificates"), the Company shall have a preemption right to purchase
all (but not less than all of) the Offered Certificate on the same terms and conditions as offered by the prospective third-party purchaser
(the "Preemption Right").
The Selling Holder
shall provide written notice in accordance with Condition 9 (Notices) to the Company specifying (i) the postal and email
addresses of the third-party purchaser, (ii) (a) the exemption from the registration requirements of the Securities Act of
1933, as amended, pursuant to which the Selling Holder sold the Securities and confirming that all conditions for the use of such exemption
are complied with, or (b) confirming that the new Royalty Certificate Holder is a Qualified Investor and/or a QIB and (iii) the
price, terms, and conditions of the proposed sale. The Company shall have five (5) Business Days from the receipt of such notice
to inform the Selling Holder in accordance with Condition 9 (Notices) that it may exercise its Preemption Right. The Company shall
have fifteen (15) additional Business Days following the receipt of the notice by the Selling Holder to exercise its Preemption Right.
Any Royalty Certificate so purchased will automatically be cancelled and may not be re issued or re sold.
If the Company
does not exercise its Preemption Right within the specified timeframe, the Selling Holder shall be free to sell the Offered Certificate
to the third-party purchaser on the terms specified in the notice and shall provide written notice in accordance with Condition 9 (Notices)
of the account details of the new Royalty Certificate Holder for the purpose of receiving Royalty payments hereunder as well as written
notice of the notice details of the new Royalty Certificate Holder .
Any transfer not
complying with the present Condition shall be deemed null and void, and the Company or the Registrar shall not be bound to recognize
such transfer and shall forthwith inform the Royalty Certificate Holder. Notwithstanding the foregoing, a Royalty Certificate Holder
may transfer all or part of its 2024 Royalty Certificates (provided that a partial transfer shall only be made for a minimum number of
10 (ten) 2024 Royalty Certificates) to its Affiliate (subject to any applicable Laws) or to other Royalty Certificate Holders which transfer(s) will
not be subject to the Preemption Right.
In accordance with
Articles L. 211-15 and L. 211-17 of the French Monetary and Financial Code (Code monétaire et financier), transfers of
the 2024 Royalty Certificates will be made by transfer from account to account and the transfer of ownership of the 2024 Royalty Certificates
will occur once they are recorded as book entries in the acquirer’s securities account.
| 4. | PURCHASE
AND CANCELLATION |
| 4.1 | Purchase of the 2024 Royalty Certificates
by the Company |
The Company, subject
to a thirty (30) calendar days prior written notice to the relevant Royalty Certificate Holders, will have the right at any time to purchase
in cash all or part of the 2024 Royalty Certificate(s) of one or more Royalty Certificate Holder(s) at the price per 2024 Royalty
Certificate to be agreed with the relevant Royalty Certificate Holder. 2024 Royalty Certificates so purchased by the Company or any of
its Affiliates will be automatically cancelled and may not be re issued or re sold.
In the event that
the Company exercises its rights provided in the preceding paragraph or otherwise agrees to enter into a transaction with a 2024 Royalty
Certificate Holder that would result in the direct or indirect transfer (in any way whatsoever) of all or part of that Royalty Certificate
Holder's Certificates to the Company under this Condition 4.1, each other Royalty Certificate Holder will have the right to sell for
cash up to the same pro-rata portion of its 2024 Royalty Certificates to the Company on the same terms and conditions and on the same
date as agreed among the Company and the transferring Royalty Certificate Holder.
At least fifteen
(15) Business Days prior to the completion of the transaction between the transferring Royalty Certificate Holder and the Company, the
Company shall provide written notice in accordance with Condition 9 (Notices) to the other Royalty Certificate Holders
specifying the identity of the transferring Royalty Certificate Holder and the price, terms, and conditions of the proposed acquisition.
Each other Royalty Certificate Holder shall have five (5) Business Days from the receipt of such notice to inform the Company in
accordance with Condition 9 (Notices) that it may exercise its tag along right.
For the avoidance
of doubt, the initial Royalty Certificate Holders shall, for the purpose of this Condition, be deemed not to be an Affiliate of the Company.
| 4.2 | Full Purchase of the 2024 Royalty
Certificates and Cancellation |
In the event of
(i) a change of control of the Company (the term control being as defined as provided in the definition of “Affiliate”)
or if a Person takes control of the Company, or (ii) in case of a merger, spin-off or reorganization involving the Company entailing
a transfer of all or substantially all of the assets of the Company ((i) and (ii), collectively, the “Merger”),
so long as, in each case, the Company’s shareholders of record immediately prior to such Merger will, immediately after such Merger,
hold less than fifty percent (50%) of the voting power of the Company or the surviving entity, the Royalty Certificate Holders, shall,
upon request of the Company negotiate with the Company, the Royalty Certificate Holders and the Company both acting in good faith, the
terms upon which the Company may purchase in cash all, and no less than all of the Outstanding 2024 Royalty Certificates; provided that
neither the Company nor the Royalty Certificate Holders will have any obligation other than to conduct such negotiations in good faith.
If the Company
and all Royalty Certificate Holders, pursuant to the first paragraph of this Condition 4.2, have agreed to the terms and conditions of
the purchase of all, but not less than all, the Outstanding Royalty Certificates by the Company, all the 2024 Royalty Certificates so
purchased by the Company will be immediately cancelled upon their purchase by the Company and may not be re issued or re sold.
Any purchase by
(or transfer to) the Company of any Royalty Certificate not complying with Conditions 4.1 or 4.2 shall be deemed null and void, and the
Company and the Registrar may not recognize such transfer and shall forthwith inform the Royalty Certificate Holders.
| 4.3 | Cancellation
of the 2024 Royalty Certificates upon the 2024 Royalty Certificates Expiration Date |
Any Outstanding
2024 Royalty Certificates on the 2024 Royalty Certificates Expiration Date will be cancelled, provided that all Royalties, if any, that
are due in accordance with these Conditions have been paid as at such date. Upon cancellation of such 2024 Royalty Certificates, no further
amounts shall be due and payable.
| 4.4 | Conditions to remain in force |
For the sake of
clarity, other than in the event of cancellation of a Royalty Certificate pursuant to Conditions 3.2, 4.1, 4.2 or 4.3, the obligations
and undertakings of the Company pursuant to the Conditions shall remain in full force and effect notwithstanding any cancellation or
disappearance (for any reason
whatsoever) of
the Royalty Certificates or a change of control (“control” having the meaning set forth in article L. 233-3 I and II of the
French commercial code) affecting the Company. The Conditions shall inure to the benefit of, and be binding upon, the Company and its
respective successors and permitted assigns (including, for the avoidance of doubt, a merger, spin-off or other reorganization).
The right of the
Royalty Certificate Holders to receive payment of Royalties shall be contingent upon commercial sales or other dispositions of the Product
or otherwise the receipt of any damages pursuant to Condition 5.5 (Infringement Actions) that are treated as Net Sales. Payment
of Royalties in respect of Net Sales in respect to such commercial sales or other dispositions shall occur on the Certificate Payment
Date immediately following the fiscal year in which such commercial sales occur. In the event that no commercial sales or other dispositions
occur in a fiscal year, no payment of Royalties shall be due in respect of that fiscal year.
Royalties shall
become irrevocably due by the Company upon the occurrence of commercial sales or other dispositions with respect to which such Royalties
are calculated in accordance with these Conditions.
When commercial
sales or other dispositions of the Product occur during a fiscal year, the Company shall, on or prior to the related Certificate Payment
Date immediately following the fiscal year in which such commercial sales occur, pay, or cause to be paid in respect of the Royalty Certificate(s) owned
by a Royalty Certificate Holder by wire transfer to the account designated by each of the Royalty Certificate Holders, an amount equal
to the product of (i) the Royalty and (ii) the number of 2024 Royalty Certificates owned by such Royalty Certificate Holder.
All payments in
respect of the 2024 Royalty Certificates, including payments of Royalties, will be made in Euros by the Company by credit or transfer
to a Euro-denominated account (or any other account to which euros may be credited or transferred). All payment of the Royalties validly
made to the Royalty Certificate Holders will be an effective discharge of the Company, as the case may be, in respect of such payment.
The Company shall not be responsible or account for any wire or other fees charged to the accounts of such Royalty Certificate Holders.
The Company’s
obligations to pay Royalties in respect of any 2024 Royalty Certificate shall terminate automatically upon the purchase in full of the
2024 Royalty Certificates and/or cancellation in accordance with Condition 4 (Purchase and Cancellation).
| 5.2 | Payment on Business Days |
If the due date
for payment of any Royalties is not a Business Day, payment shall be made on the next following Business Day, and the Royalty Certificate
Holders shall not be entitled to any interest or other sums in respect of thereof.
If any amounts
payable by the Company shall be overdue for ten (10) Business Days, the Company shall additionally pay to the Royalty Certificate
Holders to whom such payment is owed simple interest on the sum outstanding at the rate per annum equal to six (6) months EURIBOR
plus 4%. The payment of such interest shall not prevent the Royalty Certificate Holders from exercising any other rights it may have
as a consequence of the lateness of any payment.
Payments made to
Royalty Certificate Holders in respect of the 2024 Royalty Certificates will not be subject to any clawback.
As from the Issue
Date and as long as there are Outstanding 2024 Royalty Certificates, if the Company, its Commercialization Partners or any of their respective
Affiliates recovers any monetary damages from any third party in any action for infringement of any intellectual property rights relating
to Lanifibranor or any Product (but only in circumstances where the infringing product competes with the Product in a manner that has
had a detrimental effect on Net Sales of the Product), where such definitive damages (whether in the form of an irrevocable judgment
(décision de justice irrévocable) or settlement) are awarded for such infringement of such intellectual property
rights relating to Lanifibranor or any Product, (i) such damages will be allocated first to the reimbursement of any expenses incurred
by the Company in bringing such action (including reasonable attorney’s fees) not already reimbursed from other damages awarded
under the same action, then (ii) any residual amount of such damages will be treated as Net Sales (and for purposes of these Conditions,
such amount shall be deemed commercial sales of the Product) of the Product for purposes of Royalties.
| 6. | Taxation
UNDER FRENCH LAW |
This Condition
does not purport to be a comprehensive description of all the tax considerations that may arise in respect of the 2024 Royalty Certificates
or that may be relevant to any Royalty Certificate Holders.
This Condition
is not intended to be, nor should it be construed to be, legal or tax advice.
Royalty Certificate
Holders should therefore consult their own professional advisers as to the effects of state, local or foreign laws, including French
tax law, to which they may be subject.
Withholding
taxes in respect of the 2024 Royalty Certificates
All payments by
or on behalf of the Company in respect of the 2024 Royalty Certificates shall be made free and clear of, and without withholding or deduction
for, any taxes, unless such withholding or deduction is required by law.
No additional amount
will be paid to the Royalty Certificate Holder if a withholding or deduction in respect of any present or future taxes is applicable
on payments made in respect of the 2024 Royalty Certificates.
French financial
transaction tax
Pursuant to Article 235
ter ZD of the French Tax Code (Code général des impôts) as in force and applicable on the date hereof,
a financial transaction tax (the “FTT”) applies, subject to certain exceptions, to acquisitions for consideration
resulting in a transfer of ownership of equity securities (titres de capital) within the meaning of Article L. 212-1 A of
the French Monetary and Financial Code (Code monétaire et financier) or assimilated equity securities (titres de capital
assimilés) within the meaning of Article L. 211-41 of the French Monetary and Financial Code (Code monétaire
et financier) admitted to trading on a regulated market, which are issued by a company having its head office in France and whose
market capitalization exceeds €1 billion on 1st December of the year preceding the year of imposition.
The list of the
companies meeting the above-mentioned criteria for each upcoming year is published each year by the French tax authorities in their administrative
guidelines (Bulletin Officiel des Finances Publiques-Impôts BOI-ANNX-000467 published on 20 December 2023).
Since the 2024
Royalty Certificates do not qualify as equity securities and given that the market capitalization of the Company did not exceed €1
billion on 1st December 2023, the acquisition of these 2024 Royalty Certificates should not be subject to the FTT.
Registration
duties
Pursuant to Article 726
of the French Tax Code (Code général des impôts) as in force and applicable on the date hereof, registration
duties apply to the transfer for consideration of equity securities (droits sociaux) issued by a listed French company are subject
to uncapped registration duties at the rate of 0.1% if the transfer is evidenced by a written statement (acte) executed either
in France or outside France.
Although there
is no case law or official guidelines published by the French tax authorities on this point, transfers of 2024 Royalty Certificates should
remain outside of the scope of the aforementioned 0.1% registration duties since the 2024 Royalty Certificates do not qualify as equity
securities (droits sociaux).
| 7. | UNDERTAKINGS
FROM THE COMPANY |
| 7.1 | Commercialization Partners |
Company shall ensure
that all of its Commercialization Agreements include reporting obligations and audit rights that are sufficient to ensure that the Company
can fulfil its reporting obligations and audit rights provided for in Condition 7.2 and 7.3, including such obligations on its Commercialization
Partners and their respective Affiliates to report Net Sales as are necessary to ensure that Royalty Certificate Holders (and/or the
Independent Expert, where applicable, as provided in Condition 7.3) can obtain satisfactory confirmation and reasonable evidence of the
Net Sales of the Product by the Company, its Commercialization Partners and their respective Affiliates for purposes of the Royalty.
If
the Company ceases at any time prior to the 2024 Royalty Certificates Expiration Date to be a publicly-listed
Company, the Company will provide the Royalty Certificate Holders with such information and updates as it would otherwise have provided
had it remained a publicly-listed Company, including a copy of Commercialization Agreements (including any related amendments, modification,
supplement or waivers that may exist from time to time) on request of the Royalty Certificate Holders, provided that the Company shall
be entitled to redact commercially sensitive information from the copy of the Commercialization Agreement provided to the Royalty Certificate
Holders in a manner consistent with its redactions in its public filings of such agreements as a publicly-listed Company.
As from the issuance
of 2024 Royalty Certificates and as long as there are Outstanding 2024 Royalty Certificates,
| (i) | the
Company shall keep the Royalty Certificate Holders (as the case may be through the Representative)
informed in writing or through Public Disclosure once a year, no later than April 30
of each year, of the status, in reasonable detail, of the development of the Product as it
is being developed, and, if applicable, if the Company or any of its Affiliates becomes aware
of any fact or event which could reasonably result in the commercialization of the Product
being delayed or not occurring, provided that for the avoidance of doubt this obligation
will be deemed to be satisfied if equivalent information is included in the Public Disclosure.
The above notwithstanding, the Company shall be under no obligation to disclose any inside
information (information privilégiée) to the Royalty Certificate Holders
prior to the public disclosure of such information to the market; and |
| (ii) | concurrently
with each payment of Royalties on the Certificate Payment Date, the Company shall deliver
to Royalty Certificate Holders a written report setting forth in reasonable detail, the calculation
of the Royalty payable to the Royalty Certificate Holder for the prior fiscal year identifying,
on a country-by-country basis, gross sales generated by or on behalf of the Company or any
of its Affiliates, licensees or sublicensees (including any Commercialization Partners),
foreign currency exchange rates used (which shall be rates of exchange determined in a manner
consistent with the Company’s method for calculating rates of exchange in the preparation
of the Company’s annual financial statements in accordance with generally accepted
accounting principles), and a detailed break-down of all permitted deductions from gross
sales used to determine Net Sales (including the available information of any items falling
within subparagraphs (iv) or (v) of the definition of Net Sales to the extent those
have been added to the sales price) and the Royalty due to the Royalty Certificate Holder
– Inventiva shall use best efforts to obtain from licensees or sublicensees (including
any Commercialization Partners) the authorization to provide the relevant section needed
to justify the Net Sales calculation from copies of any royalty reports or similar communications
received by the Company or its Affiliates from its Commercialization Partners or their respective
Affiliates. |
(collectively, the “Reports”).
| 7.3 | Independent Expert - Audits |
(a) Determination
of the Royalty
In the case of
a dispute as to the calculation(s) of the Royalty, the Company shall submit the disputed calculation, by any written means in accordance
with Condition 9 (Notices), within ten (10) Business Days of receipt of a written notice from the Representative giving rise
to such dispute to the Royalty Certificate Holder(s).
If all Royalty
Certificate Holders and the Company are unable to agree upon such calculation(s) of the Royalty within ten (10) Business Days
of such disputed calculation(s), then the Company shall provide, within twenty (20) Business Days of receipt of such notice, an independent
expert (the "Independent Expert") designated by common agreement between the Representative and the Company (or failing
such agreement, by the President of the Commercial Court of Paris, France upon request of the Company or of the Representative) with
access during normal business hours to any document which are reasonably required to enable the Independent Expert to verify the accuracy
of the calculation of the Royalties by the Company (including, for avoidance of doubt, to verify the accuracy of the calculation of Net
Sales to which the Royalty relates, which may include reviewing the reporting from Commercialization Partners to the Company of the Net
Sales of those Commercialization Partners and reviewing all deductions from gross sales used to determine Net Sales).
The fees charged
by such Independent Expert shall be paid (i) by the Company in the event the Independent Expert were to identify an error leading
to a difference of more than 5% in the Company’s calculation of the Royalty, and (ii) in all other cases by the 2024 Royalty
Certificates Holders who have not agreed with the Company upon such calculation(s) of the Royalty, provided that, in such case,
the fees of the Independent Expert will be deducted from the next payment of Royalties to each such Royalty Certificate Holder pro
rata the number of Outstanding 2024 Royalty Certificates such Royalty Certificate Holder holds. The Independent Expert shall disclose
to the Representative and to the Company any matters directly related to its findings.
The Independent
Expert shall provide the Company with a copy of all disclosures, reports or findings made or delivered to the Representative.
If the Independent
Expert concludes that any Royalty should have been paid but was not paid when due, the Company shall pay the relevant Royalties, and
any applicable interests pursuant to Condition 5.3 (Late Payment), to the Royalty Certificate Holders within thirty (30) Business
Days of the date on which the Representative delivers to the Company the Independent Expert’s written report concluding that Net
Sales have been received by the Company.
The procedure conducted
by the Independent Expert shall be adversarial (contradictoire), shall give each of the Representative and the Company a reasonable
opportunity to make written and oral representations to it and require that each of them provide the others with a copy of any written
representations at the same time as they are made to the Independent Expert.
The decision of
the Independent Expert shall be final, conclusive and binding on the Company and the Royalty Certificate Holders, save in case of manifest
error.
In
any case of any Disposal Transaction (other than in connection with the entry into and performance
of a Commercialization Agreement or for the avoidance of doubt, any change of control (as defined in the definition of “Affiliate”)
of the Company):
| (i) | all
provisions of these Conditions shall remain fully applicable to the Company, including the
obligation to pay the Royalties (if any and regardless of whether the Third Party Acquirer
complies with sub-paragraph (ii)(b) below) (the name of the beneficiary of the Disposal
Transaction (the “Third Party Acquirer”) shall be substituted for the
term “Company” in all Conditions of this Agreement solely for the purpose of
determining the Royalties payable by the Company in relation to any Net Sales attributable
to the Third Party Acquirer or any of its Affiliates or their respective Commercialization
Partners); |
| (ii) | as
a condition of executing the Disposal Transaction, the Company shall (x) cause the Third
Party Acquirer by way of a written agreement (a) to comply with these Conditions vis-à-vis
the Company and vis-à-vis the Royalty Certificate Holders as if, where applicable,
the Third Party Acquirer were in place of the Company under these Conditions, mutatis
mutandis (including in particular Condition 7 (Undertakings from the Company)
and the corresponding definitions), (b) to pay to the Company or any of its Affiliates
an amount equivalent to the Royalty due under these Conditions in relation to Net Sales attributable
to such Third Party Acquirer or any of its Affiliates (or their respective Commercialization
Partners) (such amount, the “Third Party Acquirer Pro Rata Royalty”),
and (c) to impose the same obligations as provided for in this Condition 7.4 on any
further third party acquirer(s) in case of any subsequent Disposal Transaction(s) by
the Third Party Acquirer, and (y) upon a request from the Representative and following
a Collective Decision, assign by way of a security interest (cession de créance
à titre de garantie), pursuant to Article 2373 et seq. of the Code
civil, the claims the Company may have against any Third Party Acquirer under paragraph (ii)(x)(b) above
to secure the rights of the Royalty Certificate Holders under paragraph (i) up to the
amount to be paid by the Third Party Acquirer to the Company pursuant to paragraph (ii)(x)(b) only,
within the limits of such claims; |
| (iii) | the
Company shall, at its own initiative or upon request of the Representative, for the benefit
of the Company and/or Royalty Certificate Holders enforce these Conditions against the Third
Party |
Acquirer
in case the Third Party Acquirer fails to comply with its applicable obligations under these Conditions, and shall pass through (after
first allocating the proceeds and/or damages to the reimbursement of any expenses incurred by the Company in bringing such action (including
reasonable attorney’s fees) not already reimbursed from other damages awarded under the same action) to the Royalty Certificate
Holders the proceeds and/or damages of any such enforcement or claim attributable to the breach (including non-payment of amounts due
to the Company) of the Third Party Acquirer of these Conditions. For avoidance of doubt, amounts recovered and paid to Royalty Certificate
Holders under this sub-paragraph shall not result in double-counting with payments of Royalties.
| (iv) | the
Company shall promptly (and in any event within fifteen (15) Business Days) after signing
of the relevant agreement provide to the Representative and/or Royalty Certificate Holders
a copy of the written agreement (which may be redacted in respect of commercially sensitive
information) between the Company (or any of its Affiliates) and the Third Party Acquirer
(or any of its Affiliates) relating to the Disposal Transaction that fulfils the requirements
in subparagraph (ii) above together with notice details of the Third Party Acquirer. |
In all cases, the
Company shall ensure that (a) its Affiliates (from time to time, including future Affiliates) comply with these Conditions including
any provisions of these Conditions stated to be applicable to the Company’s Affiliates and (b) the Third Party Acquirer shall
be an entity of financial standing at least equivalent to that of the Company.
For
clarity, (a) this Condition 7.4 is without prejudice to the Company’s rights under Condition 4.2 (Full Purchase of the
2024 Royalty Certificates and Cancellation) and (b) in the event of the entry into and performance
of a Commercialization Agreement or of a change of control (as defined in the definition of “Affiliate”) of the Company,
all provisions of these Conditions shall remain fully applicable to the Company, including the obligation to pay the Royalties (if any).
| 8. | Representation
of the Royalty Certificate Holders |
Christian Richard
has been appointed by the Royalty Certificate Holders as their representative (the “Representative”) and shall have
the powers set out in this Condition 8.
The Representative
shall, subject to applicable law, have the power to:
| (i) | represent
the Royalty Certificate Holders vis-à-vis the Company and any of the Company’s
Affiliates; |
| (ii) | designate
an Independent Expert as provided for under Condition 7.3 (Independent Expert - Audits); |
| (iii) | undertake
any conservatory measures in the exclusive interest of the Royalty Certificate Holders; |
| (iv) | undertake,
in connection with the 2024 Royalty Certificates and/or these Conditions, any legal proceedings
against the Company and any of the Company’s Affiliates; |
| (v) | designate
a third-party professional firm as an agent or representative of the Royalty Certificate
Holders (the “Agent”) to undertake any of the above activities set out
in (i-iv) above on behalf of and/or at the direction of the Representative. The fees and
expenses of the Agent will be borne by the Royalty Certificate Holders. |
The Representative
may not interfere in the management of the affairs of the Company.
The Representative
may be replaced at any time by a decision of the Royalty Certificate Holders holding no less than 60% of the total number of the Outstanding
2024 Royalty Certificates.
In circumstances
where a member of the Representative is a Royalty Certificate Holder, in case of transfer by such member of all its 2024 Royalty Certificates
to a given transferee, the transferee of such 2024 Royalty Certificates shall be automatically appointed as the new Representative (unless
decided otherwise by a decision of the Royalty Certificate Holders holding no less than 60% of the total number of the Outstanding 2024
Royalty Certificates).
The following persons
may not be appointed as the Representative or Agent:
| (i) | the
Company, the members of the Company’s board of directors, the Company’s executive
officers, the Company’s statutory auditors or the Company’s employees, as well
as the Affiliates, ascendants, descendants or spouses of any such persons; or |
| (ii) | companies
guaranteeing all or part of the obligations of the Company, their respective managers, executive
officers, members of their management body, executive board or supervisory board, their statutory
auditors or their employees, as well as the Affiliates, ascendants, descendants or spouses
of any such persons; or |
| (iii) | companies
holding one third (33 1/3 %) or more of the share capital of the Company, or companies in
which the Company holds one third (33 1/3 %) or more of the share capital; |
| (iv) | the
legal and financial advisors of the aforementioned persons. |
Except in the event
of willful misconduct, fraud or gross negligence by the Representative, the Representative shall not bear any liability whatsoever in
its capacity as Representative for the Royalty Certificate Holders.
Except as set forth
above with respect to the fees and expenses of the Agent designated by the Representative, the Company shall reimburse the Representative
for any reasonable costs and expenses incurred by the Representative in the performance of its role and duties as representative for
the Royalty Certificate Holders, upon submission of a written invoice. In the event that the costs or expenses of the Representative
are advanced or incurred by any Royalty Certificate Holder (whether in the capacity of the Representative or otherwise), the Company
shall reimburse such Royalty Certificate Holder through adding the amount of such costs or expenses to be reimbursed to the Royalty payable
to such Royalty Certificate Holder on the Certificate Payment Date.
Collective
decisions (the "Collective Decisions") of the 2024 Royalty Certificates Holders are adopted either (i) in a general
meeting of 2024 Royalty Certificates Holders (the "General Meeting") or (ii) by consent following a written consultation
(the "Written Decision"), and will be binding on all Royalty Certificate Holders.
The
Company shall hold a register of the Collective Decisions and shall make it available, upon request, to any subsequent holder of any
of the 2024 Royalty Certificates Holder.
The
rights of each Royalty Certificate Holder to participate in the Collective Decisions will be evidenced by entries in the books of the
Company or the Registrar, as the case may be, in the name of such Royalty Certificate Holder at midnight (Paris time) on the Business
Day preceding the date of the General Meeting.
The
General Meeting may be held at any time on convocation either by the Company or by the Representative.
One
or more Royalty Certificate Holders, holding together at least one-third (1/3rd) of the Outstanding 2024 Royalty Certificates,
may address to the Company and the Representative a demand for convocation of the General Meeting, together with the proposed agenda
for such General Meeting. If such General Meeting has not been convened within one (1) month after such demand, the Royalty Certificate
Holders may commission one of their members to petition the competent court in Paris to appoint an agent (mandataire) who will
call the General Meeting.
Notice of date,
hour, place and agenda of any General Meeting will be given by way of a notice in accordance with Condition 9 (Notices) not less
than five (5) calendar days prior to the date of such general meeting on first notice, and five (5) calendar days on second
notice. The Board of Directors or the Representative may decide that any votes cast during a General Meeting may be expressed by videoconference
or by any means of telecommunications that enable the identification of 2024 Royalty Certificates Holders, and such under the conditions
provided for by applicable regulations for shareholders meetings.
Except
as otherwise stated in the Conditions, the General Meeting can only validly deliberate based on the first call if the Royalty Certificate
Holders present or represented hold at least one-third (1/3) of the total number of the Outstanding 2024 Royalty Certificates. On second
notice, no quorum will be required. Decisions of the General Meeting shall be taken with a majority of 60% of the votes (for avoidance
of doubt, on the basis of one vote per Outstanding Royalty Certificate) held by the Royalty Certificate Holders present or represented.
At
the initiative of the Company or the Representative, Collective Decisions may also be taken by Written Decision made by Royalty
Certificate Holders holding no less than 60% of the total number of
Outstanding 2024 Royalty Certificates. Any Written Decision shall, for all intents and purposes, have the same effect as a resolution
adopted at a General Meeting. Such a decision may be embodied in a single document or in several documents, signed by or on behalf of
one or more Royalty Certificate Holders. The Representative shall promptly (and in any event within five (5) Business Days after
their adoption) circulate a copy of any adopted Written Decisions to all Royalty Certificate Holders.
For the avoidance
of doubt, the provisions of Articles L. 228-46 et seq. of the French Commercial Code (Code de commerce) shall not apply
to the 2024 Royalty Certificates.
All notices and
other communications required or permitted to be given or made pursuant to these Conditions shall be in writing in the English language
and shall be: (i) delivered by hand against an acknowledgement of delivery dated and signed by the recipient; (ii) sent by
an overnight international courier service of recognized international standing (all charges paid); or (iii) sent by e-mail transmission
and confirmed by return of e-mail, in each case at the address set forth below:
INVENTIVA
S.A.
50,
rue de Dijon
21121
Daix
France
Email:
[•]
Attention:
[•]
| - | if
to the Royalty Certificate Holders, to the addresses set forth in Appendix A hereto;
or to such other persons or at such other addresses as hereafter may be furnished by the
Company or any of the Royalty Certificate Holders by like notice to the Company and the (other)
Royalty Certificate Holders, as applicable. Any Third Party Acquirer shall promptly notify
all Royalty Certificate Holders of its address for notices under these Conditions. |
Any such notice
will be deemed to have been received:
| (i) | if
personally received by hand delivery or by courier service, on the date of delivery as evidenced
by an acknowledgement of receipt from the addressee; |
| (ii) | if
sent by e-mail, on the date of the acknowledgment by the recipient of such e-mail transmission; |
provided that any
delivery after 13:30 (local time at the place of receipt) is deemed to be delivered on the next following Business Day.
| 10. | GOVERNING
LAW and JURISDICTION |
These Conditions
and the 2024 Royalty Certificates shall be governed by, and construed in accordance with, French Law.
Any claim in connection
with these Conditions and the 2024 Royalty Certificates shall be brought before the competent court of the jurisdiction of the Paris
Court of Appeal.
All
claims against the Company for payment of any amounts under the 2024 Royalty Certificates shall, unless the Royalty Certificate Holder
or any of its Affiliates notifies the Company, any successor or any of their respective Affiliates of its entitlement to the overdue
amounts in accordance with applicable law, lapse after five (5) years from the due date for payment thereof.
Appendix A
| Investors |
Number
of Certificates |
Aggregate
Subscription Price
per Investor (in Euros)
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
TOTAL
|
|
|
Exhibit 99.2
Inventiva announces a €20.1
million issuance of royalty certificates
| ► | Royalty certificates subscribed by Samsara BioCapital and existing shareholders (BVF Partners, NEA, Sofinnova and Yiheng). |
| ► | Royalty of 3% on future net sales of lanifibranor in the United States of America, the European Union
and the United Kingdom over a 14-year term. |
| ► | Cash runway extended through September 2024
and evaluation of strategic and financing options pursued1. |
Daix
(France), Long Island City (New York, United States), July 18, 2024 – Inventiva (Euronext Paris and Nasdaq:
IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development
of oral small molecule therapies for the treatment of patients with metabolic dysfunction-associated steatohepatitis (“MASH”),
also known as non-alcoholic steatohepatitis (“NASH”), and other diseases with significant unmet medical needs, today
announced the issuance of royalty certificates (the “Royalty Certificates”) subscribed by Samsara BioCapital, BVF Partners,
NEA, Sofinnova, and Yiheng, for an amount of approximately €20.1 million (the “Transaction”).
Frederic
Cren, Chairman, Chief Executive Officer, and cofounder of Inventiva stated: “Besides extending our cash runway,
this agreement demonstrates the commitment from our key shareholders to continue the development of lanifibranor. We are also pleased
to have gained the interest and support of Samsara BioCapital, a leading U.S. specialized fund. With this transaction completed, we continue
to focus on advancing the development of lanifibranor, one of the most promising drugs in MASH/NASH, and we are pursuing our evaluation
of strategic and financing options to fully support its development.”
Reasons for the issuance and
use of the proceeds of the Transaction
The Company intends to use approximately 95% of
the net proceeds from the Transaction to continue the NATiV3 Phase III trial of lanifibranor in MASH/ NASH (“NATiV3”)
and the remainder for general corporate purposes.
Before
giving effect to the Transaction and the cash preservation measures implemented by the Company with its creditors, considering the Company’s
cost structure and forecasted expenditures, the Company estimated that its cash, cash equivalents and deposits allowed the Company to
fund its operations as planned until the beginning of the third quarter of 2024. As of June 30, 2024, the
Company’s cash and cash equivalents are estimated (non-audited) to be €10.1
million, compared with €9.6 million, €0.1 million2 of short-term deposits and €10 million3 of
long-term deposits as of May 31, 2024.
1
This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company
and any additional expenditures related to the potential continued development of the odiparcil program or resulting from the potential
in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The
Company may have based this estimate on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
2
Short-term deposits are classified as "other current assets" in the consolidated statement of financial position under IFRS
and are considered by the Company to be liquid and readily available.
3
The two-year long-term deposit has a two-year term, is accessible prior to the expiration of the term with 31 days notice and is considered
liquid by the Company.
Considering its current cost structure and forecasted
expenditures and including the proceeds of approximately €20.1 million from the issuance of the Royalty Certificates and the cash
preservation measures in the short term set up by the Company with its creditors, the Company estimates that its cash, cash equivalents
and deposits should allow the Company to fund its operations through September 2024. These factors raise substantial doubt regarding
the Company’s ability to continue as a going concern beyond the end of September 2024.
The Company explored a variety of options, including
the issuance of debt, equity and other instruments, prior to deciding to enter into the Transaction. In order to finance its activities
beyond the end of September 2024, the Company will need to raise additional funds, and it is continuing to actively review potential
financing (including debt, equity and equity-linked or other instruments) and strategic options.
Main characteristics of the
Transaction
The Royalty Certificates are being issued pursuant
to a decision of Board of Directors on July 16, 2024, in accordance with the provisions of Article L. 228-36-A of the French
Commercial Code (Code de commerce) to one new investor and existing shareholders.
The Royalty Certificates give the holders thereto
the right to an annual payment of royalties (the "Royalties") equal to 3% of the future net sales of lanifibranor (the
"Product"), if any, beginning on the fiscal year following the start of the sales of the Product following the potential
granting of the market authorization (Autorisation de mise sur le marché) for the Product in (i) the United States
of America or (ii) the countries of the European Union or (iii) the United Kingdom, whichever occurs the first.
The Royalty Certificates do not have any additional
financial rights besides the right to payment of Royalties referred to above. Specifically, the Royalty Certificates do not grant any
financial rights on any other products that may be developed by the Company beyond lanifibranor.
The subscription price for the Royalty Certificates
is €20.1 million and has been calculated taking into account the net present value (“NPV”) of expected cash flows
related to the Royalty Certificates and the current financial position of the Company. The NPV calculation depends strongly on assumptions
made by the Company with regards to the chances of success of its studies, the commercialization calendar of lanifibranor, the market
size addressed for lanifibranor, the market share of the product and the discount rate. In the process of setting the discount rate, the
Company analyzed the expected cash flow derived from its business plan as regards to its market capitalization.
The Royalty Certificates have a term of 14 years
following their issuance and do not provide for an accelerated repayment in case of change of control. The Company may at any time repurchase
in full the Royalty Certificates by paying a price to be agreed between the Company and the holders of the Royalty Certificates. The Company
may also redeem the Royalty Certificates from each holder, subject to offering such redemption to every holders. Lastly, the Company has
a pre-emptive right in the event of the sale of Royalty Certificates by a holder.
The holders of Royalty Certificates are subject
to a 6-month lock-up period after which the Royalty Certificates will become freely transferable (in whole or in part, provided that the
transfer involves a minimum number of 10 Royalty Certificates) only pursuant to an exemption from the registration requirements of the
U.S. Securities Act of 1933, as amended, (the “Securities Act”)and to qualified investors pursuant to Article 2(e) of
Regulation (EU) 2017/1129. The Company will have a preemptive right on any transfer of Royalty Certificates.
Settlement and delivery of the Royalty Certificates
is expected to occur on July 22, 2024. The Royalty Certificates will not be listed on any stock exchange and will not be assigned
an ISIN. The closing of the Transaction is subject to the satisfaction of customary closing conditions.
It is reminded that these Royalty Certificates
are independent from the royalty certificates issued in August 2023, and do not have the same characteristics (see the Company's
press release published on August 31, 2023) (the “2023 Royalty Certificates”).
The Royalty Certificates will be issued in a private
placement exempt from registration under the Securities Act and have not been, and will not be, registered under the Securities Act, and
may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
The issue and subscription of the Royalty Certificates
will not result in any change in the shareholder structure (for a description of the share capital, please refer to section 6.1.1 of the
Company's 2023 Universal Registration Document dated April 3, 2024).
Important notice
The Transaction has not been the subject of a
prospectus submitted to the Autorité des Marchés Financiers for its approval.
The payment of Royalties for the Royalty Certificates
and of royalties for the 2023 Royalty Certificates in the event of the commercialization of the Product (respectively, 3% and 5% of sales
of the Product in the United States, in European Union countries and in the United Kingdom), if approved, would result in a decrease in
cash flow generated by sales of the Product, which will have an unfavorable effect on the Company's financial position, particularly at
the beginning of the commercialization phase.
Please
refer to the Universal Registration Document for the year ended December 31, 2023, filed with the Autorité des Marchés
Financiers on April 3, 2024, and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the
Securities and Exchange Commission (the “SEC”) on April 3, 2024 for other risks and uncertainties affecting Inventiva,
including those described under the caption “Risk Factors”, and in our future filings with the SEC. Other risks and uncertainties
of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of
events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as
required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred
to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
Financial Calendar
The Company intends to publish the cash position
and revenue as of June 30, 2024 as planned on July 31, 2024.
About Inventiva
Inventiva
is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment
of patients with MASH/NASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience
in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing
one clinical candidate, has a pipeline of two preclinical programs and continues
to explore other development opportunities to add to its pipeline.
Inventiva’s lead product candidate, lanifibranor,
is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH/NASH, a common and progressive
chronic liver disease.
Inventiva’s pipeline also includes odiparcil,
a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva’s decision to focus clinical efforts on the development
of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential
further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately
90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and
clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of
which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment
B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States
(ticker: IVA). www.inventivapharma.com
Contacts
|
Inventiva
Pascaline Clerc, PhD
EVP, Strategy and Corporate
Affairs
media@inventivapharma.com
+1 202 499
8937 |
Brunswick Group
Tristan Roquet Montegon /
Aude Lepreux /
Julia Cailleteau
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83
83 |
Westwicke, an ICR Company
Patricia L. Bank
Investor relations
patti.bank@westwicke.com
+1 415 513-1284 |
Important Notice
This press release contains certain “forward-looking
statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but
are not limited to, statements with respect to the Transaction, including statements regarding the anticipated proceeds, completion and
timing of the Transaction, Inventiva’s expected use of proceeds from the Transaction, Inventiva’s estimated cash
position prior to and following the Transaction and implementation of cash preservation measures, including its estimated cash runway, Inventiva’s
ability to execute potential financing and strategic options, their outcome and likelihood of success, as well as statements regarding
, potential regulatory submissions and approvals, and Inventiva’s pipeline and preclinical and clinical development plans, business
and regulatory strategy, the commercialization of lanifibranor and achievement of any sales related thereto, payment of royalties and
anticipated future performance. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without
limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”,
“estimates”, “may”, “will”, “would”, “could”, “might”, “should”,
“designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”,
“aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements
of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views
and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future
results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult
to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product
candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated
as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by
Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different
from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due
to a number of factors, including that Inventiva cannot provide assurance on the impacts of the SUSAR on enrollment
or the ultimate impact on the results or timing
of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and
no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating
history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations,
in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or
development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to
continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva's
future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and
any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the
results of Inventiva's and its partners’ clinical trials may not support Inventiva's and its partners’ product candidate claims, Inventiva's
expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require holds and/or amendments
to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor
for the treatment of MASH/NASH may not be realized and may not support the approval of a New Drug Application, Inventiva and its
partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the
satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical
studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult
or rendered impossible by multiple factors outside Inventiva's and its partners’ control, Inventiva's product candidates may
cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial
potential, Inventiva faces substantial competition and Inventiva’s and its partners' business, and preclinical studies and
clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected
by geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, impacts and potential impacts on the initiation,
enrollment and completion of Inventiva’s and its partners’ clinical trials on anticipated timelines and the state of war between
Israel and Hamas and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including global inflation,
rising interest rates, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations
are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these
forward-looking statements.
Disclaimers
This press release does not constitute an offer
to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale
in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities
laws of that jurisdiction.
The distribution of this document may, in certain
jurisdictions, be restricted by local legislations. Persons into whose possession this document comes are required to inform themselves
about and to observe any such potential local restrictions.
United States of America
This press release shall not constitute an
offer to sell or a solicitation of an offer to buy Royalty Certificates in the United States of America, nor shall there be any sale of
Royalty Certificates in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration
or qualification under the securities laws of any such state or other jurisdiction.
The Royalty Certificates have not been registered
under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration
statement or an applicable exemption from the registration requirements.
Inventiva (PK) (USOTC:IVEVF)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Inventiva (PK) (USOTC:IVEVF)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024
