<SEC-DOCUMENT>0001193125-23-253804.txt : 20231011
<SEC-HEADER>0001193125-23-253804.hdr.sgml : 20231011
<ACCEPTANCE-DATETIME>20231011060556
ACCESSION NUMBER:		0001193125-23-253804
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		7
CONFORMED PERIOD OF REPORT:	20231011
FILED AS OF DATE:		20231011
DATE AS OF CHANGE:		20231011

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Sanofi
		CENTRAL INDEX KEY:			0001121404
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133529324
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31368
		FILM NUMBER:		231319369

	BUSINESS ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017
		BUSINESS PHONE:		33153774400

	MAIL ADDRESS:	
		STREET 1:		46 AVENUE DE LA GRANDE ARMEE
		CITY:			PARIS
		STATE:			I0
		ZIP:			75017

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI-AVENTIS
		DATE OF NAME CHANGE:	20040826

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SANOFI SYNTHELABO SA
		DATE OF NAME CHANGE:	20010104
</SEC-HEADER>
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<TYPE>6-K
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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">6-K</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT TO RULE <FONT STYLE="white-space:nowrap">13a-16</FONT> OR <FONT STYLE="white-space:nowrap">15d-16</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:20pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">For the month of
October 2023 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Commission File Number: <FONT STYLE="white-space:nowrap">001-31368</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>SANOFI </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Translation of
registrant&#146;s name into English) </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">46, avenue de la Grande Arm&eacute;e, 75017 Paris, FRANCE </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">(Address of principal executive offices) </P> <P STYLE="margin-top:30pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">Indicate
by check mark whether the registrant files or will file annual reports under cover Form <FONT STYLE="white-space:nowrap">20-F</FONT> or Form <FONT STYLE="white-space:nowrap">40-F.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center">Form <FONT STYLE="white-space:nowrap">20-F</FONT> &#9746;&#8195;&#8195;Form <FONT STYLE="white-space:nowrap">40-F</FONT> &#9744; </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">In October 2023, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are
incorporated herein by reference. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit Index </B></P> <P STYLE="font-size:16pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; ">Exhibit&nbsp;No.</P></TD>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:9pt; font-family:Times New Roman; " ALIGN="center">Description</P></TD></TR>


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<TD VALIGN="top">Exhibit 99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d866405dex991.htm">Press Release dated October&nbsp;
3, 2023:<B> </B>Sanofi announces agreement for potential <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> vaccine against extraintestinal pathogenic E. coli </A></TD></TR>
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<TD VALIGN="top">Exhibit 99.2</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d866405dex992.htm">Press Release dated October&nbsp;4, 2023: Sanofi and Teva announce exclusive collaboration to deliver inflammatory bowel disease treatment </A></TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:9pt; font-family:Times New Roman">SIGNATURES </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:6%; font-size:9pt; font-family:Times New Roman">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. </P> <P STYLE="font-size:14pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Dated: October&nbsp;11, 2023</TD>
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<TD VALIGN="top" ALIGN="center">SANOFI</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">&#8195;&#8195;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">By&#8195;</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:9pt; font-family:Times New Roman">/s/ Alexandra Roger</P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">&#8195;&#8195;</TD></TR>
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<TD VALIGN="top">Name: Alexandra Roger</TD>
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<TD VALIGN="top">Title: Head of Securities Law and Capital Markets</TD>
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<TYPE>EX-99.1
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<DESCRIPTION>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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</TABLE> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:18pt; font-family:ARIAL"><FONT COLOR="#8925ff"><I>Sanofi announces agreement for potential
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> vaccine against extraintestinal pathogenic E. coli </I></FONT></P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT STYLE="font-family:Times New Roman">&#9744;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify">Extraintestinal pathogenic <I>E. coli</I> (ExPEC) is a leading bacterial cause of sepsis, causing approximately
10&nbsp;million cases of invasive ExPEC disease (IED) annually, worldwide<SUP STYLE="font-size:75%; vertical-align:top">1,2 </SUP> </P></TD>
<TD WIDTH="4%">&nbsp;</TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify">Phase 3 clinical trial of vaccine candidate ongoing. Novel ExPEC vaccine expected to complement existing older adult
vaccine portfolio </P></TD>
<TD WIDTH="4%">&nbsp;</TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, October</B><B></B><B>&nbsp;3, 2023</B>. Sanofi announces today that it has entered into an agreement
with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson&nbsp;&amp; Johnson company, to develop and commercialize the vaccine candidate for extraintestinal pathogenic <I>E. coli</I> <FONT STYLE="white-space:nowrap">(9-valent)</FONT> developed by
Janssen, currently in Phase 3. The agreement brings together Janssen&#146;s robust science behind this potential <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">first-in-class</FONT></FONT> product and Sanofi&#146;s worldwide
manufacturing footprint and recognized world-class expertise in launching innovative vaccines. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:7%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#8925ff"><I>Thomas Triomphe
</I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:7%; font-size:10pt; font-family:ARIAL">Executive Vice President, Vaccines, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:7%; margin-right:4%; font-size:10pt; font-family:Times New Roman" ALIGN="justify">&#147;E. coli<I> is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults,
and the number of cases is rising as the population ages. In line with our commitment to design and deliver first- or <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> medicines and vaccines, this
agreement with Janssen aims to positively impact public health by reducing hospitalization costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives</I>.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Under the terms of the agreement, both parties will <FONT STYLE="white-space:nowrap">co-fund</FONT> current and future research and development costs.
Sanofi will pay USD 175M upfront to Janssen, followed by development and commercial milestones. There will be a profit-share arrangement in the U.S., EU4 (France, Germany, Italy, Spain), and the UK. In the rest of the world (ROW), Janssen will
receive tiered royalties and sales milestones. Closing is subject to customary regulatory clearance. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Extraintestinal pathogenic <I>E. coli</I> is a
leading cause of sepsis, particularly in older adults<SUP STYLE="font-size:75%; vertical-align:top">3</SUP>. Sepsis is a life-threatening bloodstream infection accompanied by severe illness and widespread organ damage, generated by the body&#146;s
self-destructive response to the infection. The main risk factors include age, especially 60+, and chronic illnesses (e.g., diabetes, cancer, or kidney disease). Antimicrobial resistant (AMR) <I>E. coli</I> strains are an ongoing healthcare concern,
with extraintestinal pathogenic <I>E. coli</I> a major driver behind the global AMR crisis<SUP STYLE="font-size:75%; vertical-align:top">4</SUP>. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">The ongoing Phase 3 <I>E.mbrace</I> trial is designed to evaluate the efficacy of the <FONT STYLE="white-space:nowrap">9-valent</FONT> extraintestinal
pathogenic <I>E. coli</I> vaccine (ExPEC9V) compared to placebo in the prevention of invasive <I>E. coli</I> disease (IED) caused by ExPEC9V <FONT STYLE="white-space:nowrap">O-serotypes.</FONT> The study was started in 2021 by Janssen and continues
to enroll patients. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL">Learn more:
<FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#5400b8"><U>https://classic.clinicaltrials.gov/ct2/show/NCT04899336</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:16pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">1</SUP> Russo TA and Johnson JR. Medical and economic impact of extraintestinal infections due to Escherichia coli: focus
on an increasingly important endemic problem. Microbes Infect. 2003;5:449&#150;456. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">2</SUP> Rudd KE, Johnson SC, Agesa
KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. <FONT STYLE="white-space:nowrap">2020;395(10219):200-211.</FONT>
<FONT STYLE="white-space:nowrap">doi:10.1016/S0140-6736(19)32989-7</FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">3</SUP> Rhee C, et al. Prevalence of
Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated with Inadequate and Broad-Spectrum Empiric Antibiotic Use. JAMA Netw Open. 2020;3(4): e202899. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><SUP STYLE="font-size:75%; vertical-align:top">4</SUP> O&#146;Neill J. Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. Review on
Antimicrobial Resistance. Available at: <FONT STYLE="white-space:nowrap">https://amr-review.org/sites/default/files/AMR%20Review%20Pa</FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><FONT
STYLE="white-space:nowrap">per%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf.</FONT> Last accessed: October 2022. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="right"><FONT STYLE="background-color:#e6e6e6; " COLOR="#2b579a">1</FONT>/<FONT STYLE="background-color:#e6e6e6; " COLOR="#2b579a">2</FONT></TD></TR></TABLE>

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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #b7b7b7">&nbsp;</P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#8925ff"><I>About Sanofi </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science
to improve people&#146;s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving
vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">Sanofi is listed on
EURONEXT: SAN and NASDAQ: SNY </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#8925ff"><I>Media Relations </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sandrine Guendoul</B><B></B>&nbsp;|&nbsp;+ 33 6 25 09 14 25 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Evan Berland</B> | +1 215 432 0234 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>evan.berland@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Victor
Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#8925ff"><I>Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eva
Schaefer-Jansen</B><B></B>&nbsp;|&nbsp;+ 33 7 86 80 56 39 |&nbsp;<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Arnaud Del&eacute;pine</B><B></B>&nbsp;|&nbsp;+ 33 6 73 69 36 93 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>arnaud.delepine@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine
Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>corentine.driancourt@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Felix Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Tarik Elgoutni|</B>
+ 1 617 710 3587 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#8925ff"><U>nathalie.pham@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:16pt; margin-bottom:0pt; font-size:7.5pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7.5pt; font-family:ARIAL" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;,
&#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data
and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as
their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and
commercial success of therapeutic alternatives, Sanofi&#146;s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related
pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact
that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and
uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under &#147;Risk Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking
Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise
any forward-looking information or statements. </P>
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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="justify"><FONT COLOR="#7a00e6"><I>Sanofi and Teva announce exclusive collaboration to deliver inflammatory bowel
disease treatment </I></FONT></P> <P STYLE="font-size:16pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify"><FONT STYLE="white-space:nowrap">TEV-574,</FONT> a novel anti-TL1A therapy, is being developed to treat ulcerative
colitis and Crohn&#146;s disease </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify">Collaboration supports Sanofi&#146;s immunology strategy of exploring novel mechanisms of action for chronic
inflammatory diseases </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:ARIAL; " ALIGN="justify">Collaboration leverages the innovative R&amp;D and commercial expertise of both companies </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify"><B>Paris, France and Parsippany, New Jersey, October</B><B></B><B>&nbsp;4, 2023</B>. Sanofi (EURONEXT: SAN and NASDAQ: SNY) and Teva Pharmaceuticals, a
U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announce today a collaboration to <FONT STYLE="white-space:nowrap">co-develop</FONT> and <FONT STYLE="white-space:nowrap">co-commercialize</FONT> asset <FONT
STYLE="white-space:nowrap">TEV-574,</FONT> currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn&#146;s Disease, two types of inflammatory bowel disease. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Paul Hudson </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">Chief Executive Officer, Sanofi </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:7%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;Anti-TL1As are a promising class of therapies, and we believe that
<FONT STYLE="white-space:nowrap">TEV-574</FONT> could emerge as a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">best-in-class</FONT></FONT> option for people living with serious gastrointestinal diseases. This collaboration
strengthens our commitment to advancing innovative treatment options for inflammatory conditions with a high unmet need and bolsters our goal to be an industry leader in immunology.&#148; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><B><I>Richard Francis </I></B></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:ARIAL" ALIGN="justify">President and Chief Executive Officer, Teva </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; margin-right:7%; font-size:10pt; font-family:Times New Roman" ALIGN="justify"><I>&#147;This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth
strategy. This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A</I>. We <I>are honored to partner with Sanofi to bring their proven capabilities, leadership, and success in the
immunology and gastroenterology space together with our capabilities to optimize development and global launches.&#148;</I> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Under the terms of the
new collaboration agreement, Teva will receive an upfront payment of <FONT STYLE="font-family:Times New Roman">&#128;</FONT>469&nbsp;million ($500 million) and up to <FONT STYLE="font-family:Times New Roman">&#128;</FONT>940&nbsp;million ($1
billion) in development and launch milestones. Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement and Sanofi will lead the development of
the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. The transaction will
become effective after customary closing conditions are met. Initial program results are expected to be available in 2024. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Inflammatory bowel
disease (IBD) is the term for two conditions -- Crohn&#146;s disease and ulcerative colitis &#150; characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. The common
symptoms for both conditions are persistent diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. An estimated ~10&nbsp;million people worldwide live with IBD. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right">1/3 </P>

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<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL"><B>Teva Investor Call </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Teva will hold an investor call and live webcast today (Wednesday, October&nbsp;4, 2023) at 8:00 a.m. ET to discuss this collaboration. To participate,
please register in advance <FONT STYLE="font-family:ARIAL" COLOR="#7a00e6"><B><U>here</U></B></FONT><FONT STYLE="font-family:ARIAL"> to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will be available on
Teva&#146;s website at: </FONT><FONT STYLE="font-family:ARIAL; font-size:10pt" COLOR="#7a00e6"><U><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">https://ir.tevapharm.com/Events-and-Presentations</FONT></FONT></U></FONT><FONT
STYLE="font-family:ARIAL">. </FONT></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Sanofi </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people&#146;s lives. Our team, across
some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally,
while putting sustainability and social responsibility at the center of our ambitions. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL">Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>About Teva </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="justify">Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people&#146;s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over
3,500 products in nearly every therapeutic area. Around 200&nbsp;million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our
established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Sanofi Media Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sally Bain
</B>| + 1 617 834 6026 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sally.bain@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sandrine Guendoul </B>| + 33 6 25 09 14 25 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>sandrine.guendoul@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Victor Rouault</B><B></B>&nbsp;|&nbsp;+ 33 6 70 93 71 40 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>victor.rouault@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Sanofi Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eva Schaefer-Jansen</B><B></B>&nbsp;|&nbsp;+ 33 7 86 80 56 39 |&nbsp;<FONT
STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>eva.schaefer-jansen@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Arnaud
Del&eacute;pine</B><B></B>&nbsp;|&nbsp;+ 33 6 73 69 36 93 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>arnaud.delepine@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Corentine Driancourt</B><B></B>&nbsp;|&nbsp;+ 33 6 40 56 92 21 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>corentine.driancourt@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Felix
Lauscher</B><B></B>&nbsp;|&nbsp;+ 1&nbsp;908&nbsp;612 7239 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>felix.lauscher@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Tarik Elgoutni&nbsp;|</B>&nbsp;+ 1 617 710 3587 | <FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>tarik.elgoutni@sanofi.com</U></FONT><FONT
STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Nathalie Pham</B><B></B>&nbsp;|&nbsp;+ 33 7 85 93 30 17 |
<FONT STYLE="font-family:ARIAL; font-size:8pt" COLOR="#7a00e6"><U>nathalie.pham@sanofi.com</U></FONT><FONT STYLE="font-family:ARIAL"> </FONT></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
 COLOR="#7a00e6"><I>Teva Investor Relations </I></FONT></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Ran Meir </B>| (267) <FONT STYLE="white-space:nowrap">468-4475</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Yael Ashman </B>| +972 (3) 914 8262 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Sanjeev Sharma </B>| (973) <FONT
STYLE="white-space:nowrap">524-1908</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT COLOR="#7a00e6"><I>Teva Corporate Affairs </I></FONT></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Kelley Dougherty </B>| (973) <FONT STYLE="white-space:nowrap">658-0237</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:ARIAL"><B>Eden Klein </B>| +972 (3) 906 2645 </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:4.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #cccccc">&nbsp;</P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL"><B>Sanofi Forward-Looking Statements </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words &#147;expects&#148;, &#147;anticipates&#148;,
&#147;believes&#148;, &#147;intends&#148;, &#147;estimates&#148;, &#147;plans&#148; and similar expressions. Although Sanofi&#146;s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data
and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as
their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and
commercial success of therapeutic alternatives, Sanofi&#146;s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and
</P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right">2/3 </P>

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any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost
containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as
on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under &#147;Risk
Factors&#148; and &#147;Cautionary Statement Regarding Forward-Looking Statements&#148; in Sanofi&#146;s annual report on Form <FONT STYLE="white-space:nowrap">20-F</FONT> for the year ended December&nbsp;31, 2022. Other than as required by
applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify"><B>Teva Forward-Looking
Statements </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:7pt; font-family:ARIAL" ALIGN="justify">This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,
which are based on management&#146;s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that
expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as &#147;should,&#148; &#147;expect,&#148; &#147;anticipate,&#148; &#147;estimate,&#148; &#147;target,&#148;
&#147;may,&#148; &#147;project,&#148; &#147;guidance,&#148; &#147;intend,&#148; &#147;plan,&#148; &#147;believe&#148; and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial
performance. Important factors that could cause or contribute to such differences include: risks relating to our exclusive collaboration with Sanofi, including uncertainties around the effective date of the collaboration and our ability to satisfy
the closing conditions related thereto; risks related to the timing of and our ability to achieve expected results for <FONT STYLE="white-space:nowrap">TEV-48574</FONT> (anti-TL1A), including our ability to commercialize <FONT
STYLE="white-space:nowrap">TEV-48574</FONT> (anti-TL1A); the extent to which we will realize the anticipated financial and other benefits of the Sanofi collaboration; our ability to satisfy the conditions to receiving milestone cash payments under
the Sanofi collaboration agreement; the risk that we will incur significant costs in connection with the development of <FONT STYLE="white-space:nowrap">TEV-48574</FONT> (anti-TL1A), which may exceed any revenue generated by <FONT
STYLE="white-space:nowrap">TEV-48574</FONT> (anti-TL1A); risks that regulatory approvals and other requirements may delay the development and commercialization of <FONT STYLE="white-space:nowrap">TEV-48574</FONT> (anti-TL1A); our ability to
successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, AJOVY<SUP
STYLE="font-size:75%; vertical-align:top">&reg;</SUP> and COPAXONE<SUP STYLE="font-size:75%; vertical-align:top">&reg;</SUP>, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize
additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our
innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; our
substantial indebtedness which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow
funds in amounts or on terms that are favorable to us; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs
and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks;
and other factors discussed in our Quarterly Report on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the second quarter of 2023 and in our Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended
December&nbsp;31, 2022, including in the section captioned &#147;Risk Factors.&#148; Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other
information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:ARIAL" ALIGN="right">3/3 </P>

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