SC TO-T/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE TO

Tender Offer Statement under Section 14(d)(1) or 13(e)(1)

of the Securities Exchange Act of 1934

(Amendment No. 1)

Provention Bio, Inc.

(Name of Subject Company (Issuer))

ZEST ACQUISITION SUB, INC.

AVENTIS INC.

SANOFI

(Names of Filing Persons — Offerors)

Common Stock, Par Value $0.0001 Per Share

(Title of Class of Securities)

74374N102

(Cusip Number of Class of Securities)

Roy Papatheodorou

Executive Vice President, General Counsel, Head of Legal, Ethics & Business Integrity

Sanofi

46, avenue de la Grande Armée, 75017

Paris, France

Telephone: 011 + 33 1 53 77 40 00

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)

Copies to:

Michael J. Aiello, Esq.

Sachin Kohli, Esq.

Weil, Gotshal & Manges LLP

767 Fifth Avenue

New York, New York 10153

(212) 310-8000

☒ Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number, or the form or schedule and the date of its filing.

Amount Previously Paid: $332,495.24	Filing Party: Sanofi, Aventis Inc. and Zest Acquisition Sub, Inc.
Form or Registration No.: Schedule TO-T (File No. 005-90545)	Date Filed: March 24, 2023

☐ Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

Check the appropriate boxes below to designate any transactions to which the statement relates:

☒ Third-party tender offer subject to Rule 14d-1.

☐ Issuer tender offer subject to Rule 13e-4.

☐ Going-private transaction subject to Rule 13e-3.

☐ Amendment to Schedule 13D under Rule 13d-2.

Check the following box if the filing is a final amendment reporting the results of the tender offer: ☐

If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:

☐ Rule 13e-4(i) (Cross-Border Issuer Tender Offer)

☐ Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)

This Amendment No. 1 (this “Amendment”) amends and supplements the Tender Offer Statement on Schedule TO filed by (i) Zest Acquisition Sub, Inc., a Delaware corporation (“Purchaser”) and an indirect wholly owned subsidiary of Sanofi, a French société anonyme (“Parent”), (ii) Parent, and (iii) Aventis Inc., a Delaware corporation and a direct wholly owned subsidiary of Parent and direct parent of Purchaser (“Aventis”) on March 24, 2023 (together with any subsequent amendments or supplements thereto, including this Amendment, the “Schedule TO”), relating to the offer by Purchaser to purchase all of the outstanding shares of common stock, par value, $0.0001 per share (the “Shares”), of Provention Bio, Inc., a Delaware corporation (the “Company”), at a purchase price of $25.00 per Share (the “Offer Price”) to the seller in cash, without interest and subject to any withholding of taxes required by applicable legal requirements, on the terms and subject to the conditions set forth in the Offer to Purchase, as it may be amended or supplemented from time to time, and in the related Letter of Transmittal, as it may be amended or supplemented from time to time, copies of which are attached to the Schedule TO as Exhibits (a)(1)(A) and (a)(1)(B), respectively.

All information set forth in the Offer to Purchase, including Schedule I thereto, is incorporated by reference herein in response to Items 1 through 9 and Item 11 of this Schedule TO and is supplemented by the information specifically provided in this Amendment, except as otherwise set forth below. This Amendment should be read together with the Schedule TO. Capitalized terms used and not otherwise defined in this Amendment have the meanings given to such terms in the Offer to Purchase.

Items 1 through 9 and Item 11.

The Offer to Purchase and Items 1 through 9 and Item 11 of the Schedule TO, to the extent such Items incorporate by reference the information contained in the Offer to Purchase, are hereby amended and supplemented as follows:

1. The second paragraph of the subsection entitled “Antitrust Compliance” in Section 16 “Certain Legal Matters; Regulatory Approvals” is amended and supplemented by replacing the second sentence of the paragraph with the following sentences:

“Each of Parent and the Company filed a Premerger Notification and Report Form under the HSR Act with respect to the Offer and the Merger with the Antitrust Division and the FTC on March 24, 2023. On April 10, 2023, following informal discussions with the staff of the FTC, Parent voluntarily withdrew and refiled the Premerger Notification and Report Form under the HSR Act relating to the Purchaser’s proposed acquisition of the Company, in order to provide the FTC with additional time to review the proposed acquisition and information recently provided to them. As a result, the waiting period will expire at 11:59 P.M., Eastern Time, on April 25, 2023, unless (i) earlier terminated by the FTC and the Antitrust Division, (ii) Parent receives a request for additional information or documentary material prior to that time or (iii) Parent or the Company pulls and refiles its notification so as to provide the FTC and the Antitrust Division an additional 15 days to review the transaction. Withdrawing and refiling pre-merger notifications is a standard procedure in order to provide additional time for antitrust review of certain transactions. Parent and the Company continue to work cooperatively with the FTC in its review of the proposed transaction, and continue to expect to complete the transaction subject to the satisfaction or permitted waiver of the conditions to closing.”

2. The subsection entitled “Antitrust Compliance” in Section 16 “Certain Legal Matters; Regulatory Approvals” is amended and supplemented by adding the following after the second paragraph of such subsection:

“On April 10, 2023, in connection with Parent’s voluntary withdrawal and refile of the Premerger Notification and Report Form under the HSR Act, Parent extended the expiration of the Offer. The Offer was previously scheduled to expire at one minute after 11:59 P.M., Eastern Time, on April 20, 2023. The expiration date of the Offer is extended to one minute after 11:59 P.M., Eastern Time, on April 26, 2023, unless further extended.

On April 10, 2023, Parent issued a press release relating to the voluntary withdrawal and refile of the Premerger Notification and Report Form and announcing the extension of the Offer. The full text of the press release is attached as Exhibit (a)(5)(C) to the Schedule TO and is incorporated herein by reference.”

3. All references to “one minute after 11:59 P.M., Eastern Time, on April 20, 2023” set forth in the Offer to Purchase (Exhibit (a)(1)(A)), Letter of Transmittal (Exhibit (a)(1)(B)), Letter to Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees (Exhibit (a)(1)(C)) and Letter to Clients for use by Brokers, Dealers, Commercial Banks, Trust Companies and Other Nominees (Exhibit (a)(1)(D)) are hereby amended and replaced with “one minute after 11:59 P.M., Eastern Time, on April 26, 2023”.

4. Section 16 — “Certain Legal Matters; Regulatory Approvals” is hereby amended and supplemented by adding the following to the end of such Section after the subsection captioned “State Takeover Laws”:

“Legal Proceedings Relating to the Tender Offer. Between March 27, 2023 and April 10, 2023, eight complaints were filed in the United States District Courts for the Southern District of New York (“S.D.N.Y.”), the District of Delaware (“D. Del.”), and the District of New Jersey (“D.N.J.”) by purported stockholders of the Company: O’Dell v. Provention Bio, Inc., et al., 1:23-cv-2582 (S.D.N.Y. Mar. 27, 2023); Walker v. Provention Bio, Inc., et al., 1:23-cv-2574 (S.D.N.Y. Mar. 27, 2023); Wang v. Provention Bio, Inc., et al., 1:23-cv-2599 (S.D.N.Y. Mar. 28, 2023); Coffman v. Provention Bio, Inc., et al., 1:23-cv-2628 (S.D.N.Y. Mar. 29, 2023); Finger v. Provention Bio, Inc., et al., 1:23-cv-356 (D. Del. Mar. 29, 2023); Zain v. Provention Bio, Inc., et al., 1:23-cv-2638 (S.D.N.Y. Mar. 29, 2023); Jenkins v. Provention Bio, Inc. et al., 1:23-cv-2731 (S.D.N.Y. Mar. 31, 2023); and Israel v. Provention Bio, Inc., et al., 3:23-cv-1861 (D.N.J. Apr. 3, 2023) (collectively, the “Actions”). The Actions name the Company and the members of the board of directors of the Company as defendants. The Actions assert claims under Sections 14(d), 14(e), and 20(a) of the Exchange Act and allege, among other things, that defendants omitted material information related to the Tender Offer from the Solicitation/Recommendation Statement on Schedule 14D-9 that was filed by Provention Bio on March 24, 2023. The Actions seek, among other things, to enjoin or rescind the proposed transaction contemplated by the merger agreement and request an award of attorneys’ and experts’ fees and damages in unspecified amounts. If additional similar complaints are filed, absent new or different allegations that are material, the Company will not necessarily announce such filings.”

5. “Schedule I” is amended and supplemented by replacing “Carole Huntsman” and her related information in the third row of the table titled “Directors and Executive Officers of Purchaser and Parent—2. Aventis Inc.” starting on pg. 51 of the Offer to Purchase with the following:

Brian Foard Director Brian Foard currently serves as the Head of North America for Sanofi Specialty Care and Country Lead at Sanofi. In his role as Country Lead, Brian leads the coordination of Sanofi’s presence in the U.S., spanning all Global Business Units and Functions. Prior to this role he was the global franchise head for Immunology at Sanofi.   Brian Foard is a citizen of the United States of America.

Item 12.

Item 12 of the Schedule TO is hereby amended and supplemented by adding the following exhibits:

(a)(5)(C)	Press Release issued by Sanofi, dated April 10, 2023.*
*Filed herewith

SIGNATURES

After due inquiry and to the best knowledge and belief of the undersigned, each of the undersigned certifies that the information set forth in this statement is true, complete and correct.

Date: April 10, 2023

	Zest Acquisition Sub, Inc.
By:	/s/ Michael J. Tolpa
	Name: Michael J. Tolpa
	Title: President
	Sanofi
By:	/s/ Roy Papatheodorou
	Name: Roy Papatheodorou
	Title: Executive Vice President, General Counsel, Head of Legal, Ethics & Business Integrity
	Aventis Inc.
By:	/s/ Jamie Haney
	Name: Jamie Haney
	Title: Vice President

EX-99.A5C

Exhibit (a)(5)(C)

Press Release

Sanofi announces withdrawal and refiling of Premerger Notification and Report Form under the HSR Act and extension of tender offer to acquire Provention Bio, Inc.

Paris, France – April 10, 2023 – Sanofi announced today that it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), in connection with Sanofi’s pending acquisition of Provention Bio, Inc. As previously announced on March 24, 2023, Sanofi commenced a cash tender offer to purchase all outstanding shares of common stock of Provention Bio, Inc. (the “Shares”), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law.

Sanofi has elected to withdraw and refile its Premerger Notification and Report Form, which was initially filed on March 24, 2023, to provide the Federal Trade Commission (the “FTC”) with additional time for review. Following such refiling, the waiting period under the HSR Act will expire at 11:59 P.M., Eastern Time, on April 25, 2023. The acquisition is expected to close in the second quarter of 2023.

Consummation of the tender offer remains subject to, among other conditions, the expiration or termination of the applicable waiting period under the HSR Act. As a result, Sanofi is extending the tender offer, which was previously scheduled to expire at one minute after 11:59 P.M., Eastern Time, on April 20, 2023, until one minute after 11:59 P.M., Eastern Time, on April 26, 2023. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). All other terms and conditions of the tender offer will remain unchanged during the extended period.

Innisfree M&A Incorporated is acting as information agent for the tender offer. Requests for documents and questions regarding the tender offer may be directed to Innisfree M&A Incorporated by telephone, toll-free at (877) 800-5195 for shareholders, or collect at (212) 750-5833 for Banks and Brokers.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’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.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations

Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com

Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com

Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com

Investor Relations

Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com

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Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com

Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com

Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com

Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com

Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Sanofi Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product, 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 “expects”, “anticipates”, “believes”, “will be”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful and risks related to Sanofi’s ability to complete the acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, as well as other risks related Sanofi’s business, including the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will 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 “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 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.

Additional Information for US Shareholders and Where to Find It

This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Provention Bio, Inc. Sanofi and its acquisition subsidiary have filed with the U.S. Securities and Exchange Commission (the “SEC”) a tender offer statement on Schedule TO, and Provention Bio, Inc. has filed a Solicitation/Recommendation Statement on Schedule 14D-9, all with respect to the Offer (as defined in those documents). HOLDERS OF SHARES OF PROVENTION BIO, INC. ARE URGED TO READ THE RELEVANT TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, THE RELATED LETTER OF TRANSMITTAL AND THE OTHER TENDER OFFER DOCUMENTS) AND THE SOLICIATION/RECOMMENDATION STATEMENT BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT PROVENTION BIO, INC. STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING SHARES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, are available to holders of shares of Provention Bio, Inc. at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Sanofi’s Investor Relations Department at ir@sanofi.com or on Sanofi’s website at https://en.sanofi.com/investors or by contacting Kristen Kelleher, Investor Relations, at investorrelations@proventionbio.com, or on Provention Bio, Inc.’s website, www.proventionbio.com.

In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Sanofi files annual and special reports and other information with the SEC and Provention Bio., Inc. files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Sanofi and Provention Bio., Inc. at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Sanofi’s and Provention Bio., Inc.’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov

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