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2036 Exhibit: Exhibit 2036 Thiboutot et al 2009

Document IPR2019-00207, No. 2036-67 Exhibit - Exhibit 2036 Thiboutot et al 2009 (P.T.A.B. Aug. 9, 2019)

... controlled study of appro priate size; d III Evidence from well designed trials without randomization, single group pre/post, cohort, time series, or matched case controlled studies; d IV Evidence from well designed nonexperimen ...

In addition, very few studies have compared light based treat ments with standard and well validated pharma ceutical treatments and none with the current recommended therapy for most types of acne combination therapy with a topical ...

Nonetheless, it seems that the use of lasers and light therapy alone or with photosensi tizers offer promise.

There are a variety of scars and treatment options that can be used to achieve signiﬁcant cosmetic improvement (Fig 19), but it must be noted that none of the currently available treatments achieve complete resolution of the scar.

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2008 Exhibit: Exhibit 2008 Ahluwalia Intl Publ No WO 2011014627

Document IPR2019-00207, No. 2008-39 Exhibit - Exhibit 2008 Ahluwalia Intl Publ No WO 2011014627 (P.T.A.B. Aug. 9, 2019)

... SEARCH RE PORT Information on patent family members International application No PCT/US20 1 0/04367 1 Publication Patent family date member(s) Patent document cited in search report Publication date I I I us 20071 22435 NONE ...

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2056 Exhibit: Exhibit 2056 Curriculum Vitae of Dr Leon Kircik 2019

Document IPR2019-00207, No. 2056-87 Exhibit - Exhibit 2056 Curriculum Vitae of Dr Leon Kircik 2019 (P.T.A.B. Aug. 9, 2019)

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2027 Exhibit: Exhibit 2027 Mills et al 1986

Document IPR2019-00207, No. 2027-58 Exhibit - Exhibit 2027 Mills et al 1986 (P.T.A.B. Aug. 9, 2019)

8 The intensity of fluorescence was graded on a O to 6 scale with O = none, 1 to 2 = mild fluorescence, 3 to 4 == moderate, and 5 to 6 = heavy fluorescence.

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2042 Exhibit: Exhibit 2042 Aczone 5% Medical Review

Document IPR2019-00207, No. 2042-73 Exhibit - Exhibit 2042 Aczone 5% Medical Review (P.T.A.B. Aug. 9, 2019)

Safety of Drug Product The main issue of discussion with the applicant for labeling was whether patients to be treated with ACZONE Gel, 5%, should have glucose 6-phosphate dehydrogenase (G6PD) and complete blood count evaluations.

In fact, the data provided by the sponsor regarding ACZONE Gel treated patients in their study DAP0I 10 suggest a drop in hematocrit (see graph below).

It will be important to have any further studies conducted to carefully address this by evaluating dapsone levels along with documenting changes in hematocrit, reticulocyte count, and other hematologic parameters.

The applicant did not enroll adequate numbers of subjects with glucose 6-phosphate dehydrogenase (G6PD) deficiency in the clinical studies to be able to make reasonable conclusions about the safety of ACZONE Gel in this population.

3) The applicant stated they had produced at their own risk approximately -... professional sample tubes with labeling prior to Agency evaluation and approval (see graphic below).

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2038 Exhibit: Exhibit 2038 Titus et al 2012

Document IPR2019-00207, No. 2038-69 Exhibit - Exhibit 2038 Titus et al 2012 (P.T.A.B. Aug. 9, 2019)

Selected Topical Retinoids for the Treatment of Acne Vulgaris Agent Adapalene (Differin) Tazarotene (Tazorac) Tretinoin (Retin-A) FDA pregnancy category Adverse effects Available formulations Estimated cost generic (brand)*

Selected Oral Antibiotics for the Treatment of Acne Vulgaris FDA pregnancy category Adverse effects Dosage Agent Doxycycline Erythromycin Minocycline (Minocin) Tetracycline Trimethoprim/ sulfamethoxazole (Bactrim, Septra)

Negative pregnancy 738 American Family Physician www.aafp.org/afp Volume 86, Number 8 ◆ October 15, 2012 Acne systematic review found insufﬁcient evi- dence to recommend the use of spironolac- tone for the treatment of acne.20 Common adverse effects include menstrual irregu- larities and breast tenderness.

The use of isotretinoin has been suggested to worsen depression and increase the risk of suicide, but no causal relationship has been established.5 Required laboratory monitoring during therapy includes a com- plete blood count, fasting lipid panel, and measure- ment of liver transaminase levels.

Thiboutot D, Zaenglein A, Weiss J, Webster G, Calvarese B, Chen D. An aqueous gel ﬁxed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efﬁcacy and safety in 2813 patients.

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