Revance Therapeutics, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, D.C. 20590 DEC 11 2009 Mr. Philip Perotti QA Sr. Manager Revance Therapeutics, Inc. 7555 Gateway Blvd Newark, CA 94560 Ref. No. 09-0259 Dear Mr. Perotti: This responds to your letter requesting clarification of the packaging requirements for toxic substances under the Hazardous Materials Regulations (HMR; 49 CPR Parts 171-180). Specifically, you ask whether any regulatory exceptions apply to shipments of Botulinum Toxin A, a Division 6.1 Packing Group I hazardous material, in quantities of 0.5 mg per shipment. Your questions are paraphrased and answered as follows: Q1. Do the HMR provide any packaging exceptions for hazardous materials described as "UN3462, Toxins, extracted from living sources, solid, n.o.s., 6.1, PG I'~? AI. No. Packaging exceptions for a hazardous material are specified, if any, in a section or sections identified in Column (8A) of the § 172.101 Hazardous Materials Table (HMT). There is no section referenced in Column (8A) of the HMT entry for "UN3462, Toxins, extracted from living sources, solid, n.o.s., 6.1, PG I." Q2. Special provision 141 is referenced in Column (7) of the HMT entry for UN3462. How does this special provision impact the proper description or packaging of Botulinum Toxin A? AZ. Under § 172.102(c)(1) Special provision 141, if your material also meets the criteria for a Division 6.2 infectious substance, it must be described as UN2900 or UN2814, as appropriate, and packaged in accordance with requirements in § 173.196.#

Page 203. If Botulinum Toxin A does not meet the definition of an infectious substance, is it eligible for the small quantity exceptions under § 173.4? A3. Yes, if all the conditions specified in § 173.4 are met. I trust this satisfies your inquiry. Please contact us if we can be of further assistance. Si~ ~ Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 3S+evms ~ It.3. I~3 E-x. e.ep~ 0 nS l)'1-oz..5q 7555 Gateway Blvd. Newark, CA 94560 p 510.742.3400 f510.742.3401 www.revance.com Thursday, October 22, 2009 U.S. Department of Transportation PHMSA Office of Hazardous Materials Standards ATTN-PHH-1O East Building 1200 New Jersey Avenue, SE Washington, DC 20590-0001 Dear Sir or Madam, Revance intends to manufacture Botulinum Toxin A for commercial sale as a medicine in the future much like commercial Botox ® is today; I wish to understand how I can alleviate our current DOT shipping requirement for ID# UN3462; Hazard Class 6.1; Packaging Group I; Provision 141 - we will be shipping commercial scale quantities of our product in the 2011 timeframe and wish to understand what our options are per DOT regulations. We do not intend to ship anymore at one time than the 0.5mg quantities regulated by the CDC APHIS form 2 and the paint-can style packaging is not feasible. I am referring to CFR 173.153(c)(2) but I do not understand the text in the General section 173.153(a) that states the material is only eligible if it is referenced in the 172.101 Table ofthe subchapter...... I cannot locate anything to this affect. Can you please help? What is the process of exemption for UN3462 per l73.153? The DOT operators I get on the phone when I call a DOT helpline are not knowledgeable whatsoever in this regard and do not know where to direct me. I get no response from any email address I have attempted to contact from the website. I have spoken to Mr. William Clark, an FAA Security and Hazardous Materials Special Agent out of the Burlingame, California office on the phone and he has directed me to write this letter and follow-up by phone. I intend to attempt to contact someone at 1-800-467-4922 after sufficient time has been given to receive and read this letter. If you wish, you can contact me directly by phone or by email. Regards, Philip Perotti IQA Sr. Manager Revance Therapeutics, Inc. 7555 Gateway Blvd I Newark, CA 94560 T 510-742-34481 F 510-742-3401 pperotti@revance.com Iwww.revance.com#