SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
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EMAIL ADDRESS
Maxim.MayerCesiano@Skadden.Com
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Attn:
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Jane Park
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Dorrie Yale
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Jenn Do
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Lynn Dicker
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Division of Corporation Finance
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Office of Life Sciences
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Re:
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Waldencast Acquisition Corp.
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Amendment No. 3 to Registration Statement on Form F-4
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Filed April 27, 2022
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File No. 333-262692
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1. |
We acknowledge your response and revised disclosures to prior comment 4. Please also add disclosure as appropriate, including in a risk factor, to explain the combined aggregate post-transaction
ownership of the Sponsor and its affiliates, including holdings through Beauty FPA Investor.
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2. |
We acknowledge your revised disclosures in response to prior comment 2, which now focuses on Obagi and its beliefs. Please further revise the disclosure to (1) state that you have also not
received any communications from the FDA or similar regulatory authorities, as you indicate in your response letter, (2) explain that if the FDA chooses to pursue an enforcement action, it may choose to pursue one against you in addition to
Obagi, and (3) explain that if the FDA pursues enforcement, you may be required to remove your HQ products from the market until you obtain FDA approval. Please also revise the fourth sentence in this paragraph to clearly explain that although
prescription-strength drug products require FDA approval, you have not sought nor obtained FDA premarket approval or foreign regulatory authorities’ authorization for any of your products, as you make clear on page 49.
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3. |
We note your disclosure on page 287 that Obagi has conducted safety tests in addition to more than thirty studies with leading academic institutions for its Nu-Derm System, Obagi-C Rx System and
CLENZIderm System. We also refer to your disclosure on pages 51 and 284 that the FDA has previously cited evidence that HQ may be related to a skin condition called ochronosis after use of concentrations as low as 1 to 2 percent and recently
describing serious side effects associated with using skin products containing 2% HQ such as skin rashes, facial swelling and skin discoloration. Please expand your disclosure to discuss serious adverse side effects that were observed in the
various safety tests and studies using concentrations of 4% HQ in any of Obagi’s products, if any.
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4. |
It is inappropriate for counsel to limit its opinion to certain documents. Accordingly, please ask Jersey counsel to revise the language in Section 1 to clarify that counsel has examined all
documents that it has deemed necessary to render its opinion. It is inappropriate to include assumptions that are too broad or assume material facts underlying the opinion. The assumptions set forth in paragraphs 2.2, 2.3, 2.4 and 2.8 of your
Jersey counsel’s form of opinion filed as Exhibit 5.1 appear to assume material facts underlying the opinion. Please also ensure that the various assumptions in your U.S. counsel’s opinion relating to matters such as good standing or due
authorization or the lack of requisite approvals are appropriately covered by Jersey counsel, or revise. Please have your counsels file revised versions of the opinions.
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Very truly yours,
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/s/ Maxim O. Mayer-Cesiano
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Maxim O. Mayer-Cesiano
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cc:
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Michel Brousset
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Waldencast Acquisition Corp.
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cc:
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Gregg A. Noel
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Skadden, Arps, Slate, Meagher & Flom LLP
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cc:
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Paul T. Schnell
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Skadden, Arps, Slate, Meagher & Flom LLP
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cc:
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Michael J. Schwartz
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Skadden, Arps, Slate, Meagher & Flom LLP
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cc:
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R. Scott Shean
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Latham & Watkins LLP
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cc:
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B. Shayne Kennedy
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Latham & Watkins LLP
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cc:
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Andrew Clark
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Latham & Watkins LLP
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cc:
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Phillip S. Stoup
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Latham & Watkins LLP
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cc:
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Daniel J. Espinoza
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Goodwin Procter LLP
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cc:
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W. Stuart Ogg
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Goodwin Procter LLP
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