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UNITED STATES
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SECURITIES AND EXCHANGE COMMISSION
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Washington, D.C. 20549
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( Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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or
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from ___ to ___
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Revance Therapeutics, Inc.
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(Exact name of registrant as specified in its charter)
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Delaware
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77-0551645
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State or other jurisdiction of
incorporation or organization
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(I.R.S. Employer
Identification No.)
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Large accelerated filer
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Accelerated filer
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Emerging growth company
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Non-accelerated filer
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Smaller reporting company
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Item 1
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Item 1A
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Item 1B
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Item 2
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Item 3
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Item 4
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Item 5
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Item 6
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Item 7
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Item 7A
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Item 8
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Item 9
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Item 9A
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Item 9B
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Item 10
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Item 11
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Item 12
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Item 13
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Item 14
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Item 15
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Item 16
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our expectations regarding the results, timing, costs and completion of our clinical trials and regulatory submissions needed for the approval of DAXI, including but not limited to, for the treatment of glabellar (frown) lines, forehead lines, lateral canthal lines, upper facial lines (frown lines, forehead lines and lateral canthal lines combined), cervical dystonia, plantar fasciitis, and adult upper limb spasticity in the United States (“U.S.”), Europe and other countries or for the approval of RHA® 1 in the U.S.;
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the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results, or that positive results would assure regulatory approval or commercial success of our product candidates;
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our expectations regarding our future development of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates for other indications, including but not limited to, migraine;
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our ability to effectively and reliably manufacture supplies of DAXI, biosimilar or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process, as well as our ability to acquire supplies of RHA® dermal fillers from Teoxane;
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our plans to research, develop and commercialize our product candidates, including the potential for commercialization by us of DAXI, if approved; our expectations regarding the potential market size, opportunity and growth potential for DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates, if approved for commercial use;
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our belief that DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates can expand overall demand for botulinum toxin;
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that we may not obtain the anticipated financial and other benefits of the distribution agreement (the “Teoxane Agreement”) with Teoxane SA (“Teoxane”), including our ability to realize anticipated synergies and successfully commercialize Teoxane’s Resilient Hyaluronic Acid® dermal fillers (“RHA® dermal fillers”);
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the commercial acceptance and potential of Teoxane’s RHA® dermal fillers, including market size and anticipated adoption rates;
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status of commercial collaborations, including collaboration agreement with Mylan’s continuation decision with respect to our collaboration agreement and the timing thereof;
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our ability to build our own sales and marketing capabilities, or seek collaborative partners including distributors, to commercialize our product candidates, if approved;
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our ability to successfully commercialize our product candidates and the timing of commercialization activities;
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our ability to manufacture in our facility and to scale up our manufacturing capabilities and those of future third-party manufacturers if our product candidates are approved;
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unanticipated costs or delays in research, development and commercialization efforts;
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estimates of our expenses, future revenue, and capital requirements;
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the timing or likelihood of regulatory filings and approvals;
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our ability to obtain and maintain regulatory approval of our product candidates;
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our ability to advance product candidates into, and successfully complete, clinical trials;
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the implementation of our business model, and strategic plans for our business, product candidates and technology;
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our ability to achieve market acceptance of our product candidates;
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the rate and degree of market acceptance of our product candidates;
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the initiation, timing, progress and results of future preclinical studies and clinical trials and our research and development programs;
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unanticipated costs or delays in research;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
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our ability to establish collaborations or obtain funding for our operations;
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our financial performance, including future revenue targets; and
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developments and projections relating to our competitors and our industry.
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Complete DAXI clinical development and obtain marketing approval in glabellar lines in the U.S. We announced positive top-line results for DAXI in alleviating moderate-to-severe glabellar lines in two randomized, double-blind, placebo-controlled pivotal Phase 3 trials that evaluated the safety and efficacy of a single administration of DAXI for the treatment of moderate-to-severe glabellar lines in adults. We submitted the BLA in November 2019. The FDA accepted the BLA on February 5, 2020, and the PDUFA target action date is November 25, 2020. If the BLA is approved on or by the target action date, we plan to initiate commercialization activities for DAXI for the treatment of glabellar lines before year end 2020, pending approval. Furthermore, we completed enrollment of Phase 2 studies for the treatment of forehead lines and lateral canthal lines, and expect to release top-line results from these Phase 2 studies in the first half of 2020. In December 2019, we initiated an additional Phase 2 study for the full upper face (glabellar lines, forehead and crow’s feet). We expect preliminary results from this study in the fourth quarter of 2020.
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Advance DAXI clinical development for therapeutic indications. We have begun developing our commercial organization and have plans to build a specialty sales force upon U.S. Food and Drug Administration (“FDA”) approval for DAXI. Enrollment is complete in our ASPEN-1 Phase 3 pivotal trial for the treatment of isolated cervical dystonia and we expect to report topline results in the second half of 2020. Our Phase 2 placebo-controlled clinical trial of DAXI for the management of plantar fasciitis is also fully enrolled and we expect to announce topline results in the second half of 2020. Our JUNIPER Phase 2 randomized, double-blind, placebo-controlled trial for the treatment of upper limb spasticity in adults continues to enroll patients. We anticipated enrollment should be complete in the second half of 2020, with topline results to follow in the first half of 2021.
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Build our own sales and marketing capabilities in the U.S. In connection with the Teoxane Agreement, we have accelerated the build out of our own, direct medical aesthetics sales organization in the U.S. In anticipation of the launch of Teoxane’s RHA® dermal fillers in the second quarter of 2020, we have begun the process of hiring a field force of approximately 100 people. Specifically, we plan to build a specialty sales force to target key physicians who perform the majority of facial aesthetic injections, including dermatologists, plastic surgeons, facial plastic surgeons, and oculoplastic surgeons. Upon DAXI’s approval, we may further increase the size of U.S. field organization.
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Expand the opportunity for botulinum toxin products. We believe DAXI has the ability to expand the botulinum toxin opportunity beyond the current patient base by appealing to patients who seek a long-lasting effect. We also believe DaxibotulinumtoxinA Topical and other possible formulations can expand the overall botulinum toxin market.
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Establish selective strategic partnerships to maximize the commercial potential of our product candidates. Outside of North America, we plan to evaluate whether to commercialize our product candidates on our own or in collaboration with potential partners and distributors. Specifically, assuming regulatory approval of DAXI outside of the U.S., we will evaluate whether to build in-house commercial capabilities in one or more countries outside of the U.S. or to seek commercialization partners to maximize the profitability of DAXI. As part of this strategy, in December 2018, we entered into a license agreement (the “Fosun License Agreement”) with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun”), whereby we have granted Fosun the exclusive rights to develop and commercialize our proprietary DAXI in mainland China, Hong Kong and Macau (the “Fosun Territory”) and certain sublicense rights. Additionally, the Teoxane Agreement provides Teoxane with a right of first negotiation for DAXI, in aesthetic indications, in select markets where they have a direct affiliate.
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Maximize the value of our botulinum toxin cell line and manufacturing assets. We have developed an integrated manufacturing, analytics, research and development facility that is capable of producing proprietary forms of botulinum toxin for us and for potential future partners. As part of this strategy, in February 2018, we entered into the Mylan Collaboration, pursuant to which we will collaborate with Mylan exclusively, on a world-wide basis (excluding Japan), to develop, manufacture and commercialize the biosimilar to BOTOX®.
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Leverage DAXI’s unique duration profile to build valuable franchises in aesthetics and therapeutics. We will continue to selectively evaluate partnerships, distribution opportunities, joint development agreements and acquisitions as a way to expand our aesthetic and therapeutic franchises while enhancing our competitive position.
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BOTOX® and BOTOX Cosmetic®, marketed by Allergan plc, since its original approval by the FDA in 1989, has been approved for multiple indications, including glabellar lines, forehead lines, crow’s feet, axillary hyperhidrosis, upper and lower limb spasticity, cervical dystonia, strabismus, blepharospasm, chronic migraine, incontinence, and overactive bladder. Allergan is a leading global pharmaceutical company with significant research, discovery, and delivery capabilities. Allergan is also currently in the process of being acquired by AbbVie which may have unknown impacts.
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Dysport®, an injectable botulinum toxin for the treatment of cervical dystonia, glabellar lines and upper and lower limb spasticity, is marketed by Ipsen Ltd., or Ipsen, and Galderma, a Nestle company. Galderma has rights to market the product in the U.S. and Canada. Dysport® was approved by the FDA in 2009. Ipsen received marketing authorization for a cosmetic indication for Dysport® in Germany. Ipsen granted Galderma an exclusive development and marketing license for Dysport® for cosmetic indications in the European Union, Russia, Eastern Europe and the Middle East, and first rights of negotiation for other countries around the world, except the U.S., Canada and Japan. Galderma is Ipsen’s sole distributor for Dysport® in Brazil, Argentina and Paraguay. The health authorities of 15 European Union countries have also approved Dysport® for glabellar lines under the trade name Azzalure®. Ipsen and Syntaxin are engaged in a research collaboration agreement to develop native and engineered formats of botulinum toxin.
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Myobloc® (rimabotulinumtoxinB) is currently marketed by US WorldMeds and approved by the FDA in 2000 for the treatment of cervical dystonia.
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Xeomin®, an injectable botulinum toxin for the treatment of cervical dystonia, glabellar lines, blepharospasm, and upper limb spasticity, is marketed by Merz Pharma, or Merz. Xeomin is approved by the FDA for cervical dystonia and blepharospasm in adults, glabellar lines, and the treatment of upper limb spasticity. Xeomin® is also currently approved for glabellar lines in Korea, Argentina and Mexico, and therapeutic indications in most countries in the European Union as well as Canada and certain countries in Latin America and Asia. Bocouture® (rebranded from Xeomin®), marketed by Merz, has approval for glabellar lines in Germany and the European Union.
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Jeuveau™, an injectable botulinum toxin manufactured by Daewoong Pharmaceutical Co., Ltd. in South Korea, was approved in 2019 by the FDA in the U.S. for the treatment of glabellar lines only. It is marketed in the U.S. by Evolus, Inc. Jeuveau is also known as NABOTA® in South Korea along with other geographic areas and was designated Nuceiva™ in Canada.
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completion of preclinical laboratory tests, animal studies and formulation studies performed in accordance with the FDA’s current good laboratory practices (“GLPs”);
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submission to the FDA of an Investigational New Drug Application (“IND”) which must become effective before human clinical trials in the U.S. may begin;
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approval by an institutional review board, at each clinical trial site before each trial may be initiated;
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performance of adequate and well-controlled human clinical trials in accordance with the FDA’s current good clinical practices (“GCP”) regulations to establish the safety and efficacy of the product candidate for its intended use;
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submission to the FDA of a BLA;
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satisfactory completion of an FDA inspection, if the FDA deems it as a requirement, of the manufacturing facility or facilities where the product is produced to assess compliance with the FDA’s cGMP regulations to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, potency, quality and purity, as well as compliance with applicable Quality System Regulations (“QSR”), for devices;
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potential inspections by the FDA of the nonclinical and clinical trial sites that generated the data in support of the BLA;
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potential review of the BLA by an external advisory committee to the FDA, whose recommendations are not binding on the FDA; and
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FDA review and approval of the BLA prior to any commercial marketing or sale.
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Phase 1. The product candidate is initially introduced into a limited population of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for some diseases, or when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the disease or condition for which the product candidate is intended to gain an early indication of its effectiveness.
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Phase 2. The product candidate is evaluated in a limited patient population, but larger than in Phase 1, to identify possible adverse events and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted indications and to assess dosage tolerance, optimal dosage and dosing schedule.
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Phase 3. Clinical trials are undertaken to further evaluate dosage, and provide substantial evidence of clinical efficacy and safety in an expanded patient population, such as several hundred to several thousand, at geographically dispersed clinical trial sites. Phase 3 clinical trials are typically conducted when Phase 2 clinical trials demonstrate that a dose range of the product candidate is effective and has an acceptable safety profile. These trials typically have at least 2 groups of patients who, in a blinded fashion, receive either the product or a placebo. Phase 3 clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of a BLA.
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timely completion of, or need to conduct additional, clinical trials, including our clinical trials for DAXI, DaxibotulinumtoxinA Topical, biosimilar and any future product candidates, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the number and design of such trials and the accurate and satisfactory performance of third-party contractors;
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our ability to demonstrate the effectiveness and differentiation of our products on a consistent basis as compared to existing or future therapies;
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our ability to demonstrate to the satisfaction of the FDA, the safety and efficacy of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates through clinical trials;
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whether we are required by the FDA or other similar foreign regulatory agencies to conduct additional clinical trials to support the approval of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates;
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our success in educating physicians and patients about the benefits, administration and use of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates, if approved;
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the prevalence and severity of adverse events experienced with our product candidates or future approved products;
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the timely receipt of necessary marketing approvals from the FDA and similar foreign regulatory authorities;
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the ability to raise additional capital on acceptable terms and in the time frames necessary to achieve our goals;
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achieving and maintaining compliance with all regulatory requirements applicable to DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates or approved products;
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the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative treatments;
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the effectiveness of our own or our current and any future potential strategic collaborators’ marketing, sales and distribution strategy and operations;
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our ability to effectively and reliably manufacture clinical trial supplies of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices (“cGMP”);
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our ability to successfully commercialize DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates, if approved for marketing and sale, whether alone or in collaboration with others;
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our ability to enforce our intellectual property rights in and to DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates;
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our ability to avoid third-party patent interference or intellectual property infringement claims;
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acceptance of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates, if approved, as safe and effective by patients and the medical community;
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the willingness of third-party payors to reimburse physicians or patients for DAXI and any future products we may commercialize for therapeutic indications;
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the willingness of patients to pay out of pocket for DAXI and any future products we may commercialize for aesthetic indications; and
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the continued acceptable safety profile of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates following approval.
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develop and execute our sales and marketing strategies for the RHA® dermal fillers;
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develop, maintain and manage the necessary sales, marketing and other capabilities and infrastructure that are required to successfully integrate and commercialize the RHA® dermal fillers, including in connection with our marketing and sale of DAXI;
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achieve, maintain and grow market acceptance of, and demand for, the RHA® dermal fillers;
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establish or demonstrate in the medical community the safety and efficacy of the RHA® dermal fillers and their potential advantages over and side effects compared to existing dermal fillers and products currently in clinical development;
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the relative price of the RHA® dermal fillers as compared to alternative options, and our ability to achieve a suitable profit margin on our sales of the RHA® dermal fillers;
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collaborate with Teoxane to obtain necessary approvals from the FDA and similar regulatory authorities for the RHA® dermal fillers;
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adapt to additional changes to the label for the RHA® dermal fillers, that could place restrictions on how we market and sell the RHA® dermal fillers, including as a result of adverse events observed in these or other studies;
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obtain adequate and timely supply of the RHA® dermal fillers under the Teoxane Agreement;
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comply with the terms of the Teoxane Agreement, including our obligations with respect to purchase quantities and marketing efforts;
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comply with applicable legal and regulatory requirements, including medical device compliance as the RHA® dermal fillers are Class III Premarket Approval (“PMA”) devices under the Food, Drug and Cosmetic Act, as amended (the “FDCA”);
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register as the initial importer of the RHA® dermal fillers with FDA and obtain necessary state prescription medical device distribution permits and hire and operationalize complaint and medical device vigilance services in support of the RHA® dermal fillers; and
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establish agreements with third party logistics providers to distribute the RHA® dermal fillers to customers.
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make it more difficult for us to satisfy obligations with respect to our indebtedness, including the Notes (as defined in Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.”) and any failure to comply with the obligations of any of our debt instruments, including financial and other restrictive covenants, could result in an event of default under the agreements governing such indebtedness;
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require us to dedicate a substantial portion of available cash flow to meet the minimum expenditure requirements, which will reduce the funds available for working capital, capital expenditures, acquisitions and other general corporate purposes;
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limit flexibility in planning for and reacting to changes in our business and in the industry in which we operate;
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limit our ability to engage in strategic transactions or implement our business strategies;
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limit our ability to borrow additional funds; and
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place us at a disadvantage compared to our competitors.
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our inability to demonstrate to the satisfaction of the FDA or an applicable foreign regulatory body that DAXI, DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement or any future product candidates are safe and effective for the requested indication;
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Teoxane’s inability to satisfy FDA approval requirements with respect to the RHA® dermal fillers or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement;
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our inability to demonstrate proof of concept of DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement or other products in future, new indications;
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the FDA’s or an applicable foreign regulatory agency’s disagreement with the trial protocol or the interpretation of data from preclinical studies or clinical trials;
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our inability to demonstrate that clinical and other benefits of DAXI, DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement, or any future product candidates outweigh any safety or other perceived risks;
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the FDA’s or an applicable foreign regulatory agency’s requirement for additional preclinical or clinical studies;
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the FDA’s or an applicable foreign regulatory agency’s non-approval of the formulation, labeling or the specifications of DAXI, DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement or any future product candidates;
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the FDA’s or an applicable foreign regulatory agency’s failure to approve our manufacturing processes or facilities, or the manufacturing processes or facilities of third-party manufacturers with which we contract; or
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the potential for approval policies or regulations of the FDA or an applicable foreign regulatory agency to significantly change in a manner rendering our clinical data insufficient for approval.
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our ability to successfully commercialize the RHA® dermal fillers;
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our ability to establish our marketing, sales, and distribution functions;
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the results of our clinical trials for DAXI and preclinical studies and clinical trials of DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement or any future product candidates;
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the timing of, and the costs involved in, obtaining regulatory approvals for DAXI, or any future product candidates including DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement or any future product candidates;
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the number and characteristics of any additional product candidates we develop or acquire;
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the scope, progress, results and costs of researching and developing and conducting preclinical and clinical trials of DAXI, DaxibotulinumtoxinA Topical, biosimilar, RHA® 1 or any future hyaluronic acid filler products developed pursuant to the Teoxane Agreement or any future product candidates;
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the cost of commercialization activities if DAXI or any future product candidates, including DaxibotulinumtoxinA Topical, biosimilar or any hyaluronic acid filler products developed pursuant to the Teoxane Agreement, are approved for sale, including marketing, sales and distribution costs;
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the cost of manufacturing DAXI, DaxibotulinumtoxinA Topical, biosimilar, any hyaluronic acid filler products developed pursuant to the Teoxane Agreement, or any future product candidates and any products we successfully commercialize and maintaining our related facilities;
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our ability to establish and maintain strategic collaborations, licensing or other arrangements including the Mylan Collaboration, Fosun Licensing Agreement, and the terms of and timing such arrangements;
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the degree and rate of market acceptance of any future approved products;
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the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;
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any product liability or other lawsuits related to our products;
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the expenses needed to attract and retain skilled personnel;
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any litigation, including litigation costs and the outcome of such litigation;
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the costs associated with being a public company;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
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the timing, receipt and amount of sales of, or royalties on, future approved products, if any.
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the effectiveness and duration of effect of our product as compared to existing and future therapies;
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physician willingness to adopt a new therapy to treat glabellar lines, cervical dystonia, plantar fasciitis, adult upper limb spasticity, migraine or other aesthetic or therapeutic indications;
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patient satisfaction with the results and administration of our product and overall treatment experience;
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patient demand for the treatment of glabellar lines, cervical dystonia, plantar fasciitis or other aesthetic or therapeutic indications;
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the willingness of third-party payors to reimburse physicians or patients for DAXI, the RHA® dermal fillers and any future products we may commercialize for therapeutic indications;
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the willingness of patients to pay out of pocket for DAXI, the RHA® dermal fillers and any future products we may commercialize for aesthetic indications; and
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the revenue and profitability that our product will offer a physician as compared to alternative therapies.
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the safety and efficacy and duration of the product as demonstrated in clinical trials;
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the clinical indications for which the product is approved;
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acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment;
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the proper training and administration of our products by physicians and medical staff;
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the potential and perceived advantages of our products over alternative treatments;
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the cost of treatment in relation to alternative treatments and willingness to pay for our products, if approved, on the part of payors and patients;
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the willingness of patients to pay for DAXI, DaxibotulinumtoxinA Topical, any hyaluronic acid filler products developed pursuant to the Teoxane Agreement and other aesthetic treatments in general, relative to other discretionary items, especially during economically challenging times;
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the willingness of third-party payors to reimburse physicians or patients for DAXI and any future products we may commercialize for therapeutic indications;
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the relative convenience and ease of administration;
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the prevalence and severity of adverse events; and
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the effectiveness of our sales and marketing efforts.
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obtain regulatory approval to commence a trial;
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reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtain institutional review board approval at each site;
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recruit suitable subjects to participate in a trial;
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have subjects complete a trial or return for post-treatment follow-up;
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ensure clinical sites observe trial protocol or continue to participate in a trial;
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address any patient safety concerns that arise during the course of a trial;
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address any conflicts with new or existing laws or regulations;
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add a sufficient number of clinical trial sites; or
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manufacture sufficient quantities of product candidate for use in clinical trials.
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identify recruit, train, integrate, incentivize and retain adequate numbers of effective sales and marketing personnel;
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generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team;
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achieve, maintain and grow market, physician, patient and healthcare payor acceptance of, and demand for our products;
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manage our clinical trials and manufacturing operations effectively;
|
•
|
manage our internal development efforts effectively while carrying out our contractual obligations to Teoxane under the Teoxane Agreement and to other third parties; and
|
•
|
continue to improve our operational, financial and management controls, reporting systems and procedures.
|
•
|
the indication for which the product is approved and its approved labeling;
|
•
|
the presence of other competing approved treatments and therapies;
|
•
|
the potential advantages of the product over existing and future treatment products;
|
•
|
the relative convenience and ease of administration of the product;
|
•
|
the strength of our sales, marketing and distribution support;
|
•
|
the willingness of third-party payors to provide adequate reimbursement for our approved products, and the willingness of payments to pay for our approved products in the absence of third-party reimbursement; and
|
•
|
the price and cost-effectiveness of the product.
|
•
|
the success of any sales and marketing programs that we, or any third parties we engage, undertake, and as to which we have limited experience;
|
•
|
the extent to which physicians recommend the RHA® dermal fillers or DAXI to their patients;
|
•
|
the extent to which the RHA® dermal fillers or DAXI satisfies patient expectations;
|
•
|
our ability to properly train physicians in the use of the RHA® dermal fillers and DAXI or such that their patients do not experience excessive discomfort during treatment or adverse side effects;
|
•
|
the cost, safety and effectiveness of the RHA® dermal fillers and DAXI versus other treatments;
|
•
|
consumer sentiment about the benefits and risks of aesthetic procedures generally and the RHA® dermal fillers and DAXI in particular;
|
•
|
the success of any direct-to-consumer marketing efforts we may initiate; and
|
•
|
general consumer confidence, which may be impacted by general economic and political conditions.
|
•
|
decreased demand for the RHA® dermal fillers, DAXI or any future product candidates or products we develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants or cancellation of clinical trials;
|
•
|
costs to defend the related litigation;
|
•
|
a diversion of management’s time and our resources;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
•
|
loss of revenue;
|
•
|
an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage; and
|
•
|
the inability to commercialize the RHA® dermal fillers, DAXI or any other products we develop.
|
•
|
the research methodology used may not be successful in identifying potential product candidates;
|
•
|
competitors may develop alternatives that render our product candidates obsolete or less attractive;
|
•
|
product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
|
•
|
a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
|
•
|
a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
|
•
|
a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable; and
|
•
|
intellectual property rights of third parties may potentially block our entry into certain geographies or make such entry economically impracticable.
|
•
|
the scope of rights granted under the Teoxane Agreement and other interpretation-related issues;
|
•
|
the extent to which our technology and processes infringe on intellectual property of Teoxane that is not subject to the Teoxane Agreement;
|
•
|
the sublicensing of patent and other rights under our collaborative development relationships; and
|
•
|
the ownership of inventions and know-how resulting from the development of intellectual property under the Teoxane Agreement.
|
•
|
warning letters;
|
•
|
civil and criminal penalties;
|
•
|
injunctions;
|
•
|
withdrawal of approved products;
|
•
|
product seizure or detention;
|
•
|
product recalls;
|
•
|
total or partial suspension of production; and
|
•
|
refusal to approve pending BLAs or supplements to approved BLAs.
|
•
|
a product candidate may not be deemed safe, effective, or of required quality;
|
•
|
FDA officials may not find the data from preclinical studies and clinical trials sufficient;
|
•
|
the FDA might not approve our third-party manufacturers’ processes or facilities; or
|
•
|
the FDA may change its approval policies or adopt new regulations.
|
•
|
If DAXI, the RHA® dermal fillers or any future product candidates fail to demonstrate safety and efficacy in clinical trials or do not gain approval, our business and results of operations will be materially and adversely harmed.
|
•
|
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
|
•
|
fines, warning letters or holds on clinical trials;
|
•
|
refusal by the FDA to approve pending applications or supplements to approved applications submitted by us or our strategic collaborators, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; and
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
changes to manufacturing methods;
|
•
|
recall, replacement, or discontinuance of one or more of our products; and
|
•
|
additional recordkeeping.
|
•
|
regulatory or legal developments in the U.S. and foreign countries;
|
•
|
our success or lack of success in commercializing the RHA® dermal fillers;
|
•
|
results from or delays in clinical trials of our product candidates, including our ongoing ASPEN Phase 3 clinical program in cervical dystonia and our Phase 2 programs in plantar fasciitis, adult upper limb spasticity, forehead lines, and lateral canthal lines all with DAXI;
|
•
|
announcements of regulatory approval or disapproval of DAXI, the RHA® dermal fillers or any future product candidates;
|
•
|
FDA or other U.S. or foreign regulatory actions or guidance affecting us or our industry;
|
•
|
introductions and announcements of new products by us, any commercialization partners or our competitors, and the timing of these introductions and announcements;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
announcements by us or our competitors of significant acquisitions, licenses, strategic partnerships, joint ventures or capital commitments;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of securities analysts’ reports or recommendations;
|
•
|
quarterly variations in our results of operations or those of our future competitors;
|
•
|
changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance;
|
•
|
sales of substantial amounts of our stock by insiders and large stockholders, or the expectation that such sales might occur;
|
•
|
general economic, industry and market conditions;
|
•
|
additions or departures of key personnel;
|
•
|
intellectual property, product liability or other litigation against us;
|
•
|
expiration or termination of our potential relationships with customers and strategic partners;
|
•
|
the occurrence of trade wars or barriers, or the perception that trade wars or barriers will occur; and
|
•
|
other factors described in this “Risk Factors” section.
|
•
|
only one of our three classes of directors will be elected each year;
|
•
|
no cumulative voting in the election of directors;
|
•
|
the ability of our board of directors to issues shares of preferred stock and determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval;
|
•
|
the exclusive right of our board of directors to elect a director to fill a vacancy or newly created directorship;
|
•
|
stockholders will not be permitted to take actions by written consent;
|
•
|
stockholders cannot call a special meeting of stockholders;
|
•
|
stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings;
|
•
|
the ability of our board of directors, by a majority vote, to amend the bylaws; and
|
•
|
the requirement for the affirmative vote of at least 66 2/3 percent or more of the outstanding common stock to amend many of the provisions described above.
|
•
|
We will indemnify our directors and officers for serving us in those capacities, or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
|
•
|
We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.
|
•
|
We are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
|
•
|
We will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification.
|
•
|
The rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
|
•
|
We may not retroactively amend our amended and restated bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
|
Company/Index
|
|
12/31/2014
|
|
|
12/31/2015
|
|
|
12/31/2016
|
|
|
12/31/2017
|
|
|
12/31/2018
|
|
|
12/31/2019
|
|
||||||
Revance Therapeutics, Inc.
|
|
$
|
100.00
|
|
|
$
|
201.65
|
|
|
$
|
122.20
|
|
|
$
|
211.04
|
|
|
$
|
118.83
|
|
|
$
|
95.81
|
|
Nasdaq Biotechnology Index
|
|
$
|
100.00
|
|
|
$
|
111.77
|
|
|
$
|
87.91
|
|
|
$
|
106.92
|
|
|
$
|
97.45
|
|
|
$
|
121.91
|
|
Nasdaq Composite Index
|
|
$
|
100.00
|
|
|
$
|
106.96
|
|
|
$
|
116.45
|
|
|
$
|
150.96
|
|
|
$
|
146.67
|
|
|
$
|
200.49
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
Consolidated Statements of Operations Data:
|
(In thousands, except share and per share data)
|
||||||||||||||||||
Revenue
|
$
|
413
|
|
|
$
|
3,729
|
|
|
$
|
262
|
|
|
$
|
300
|
|
|
$
|
300
|
|
Total operating expenses
|
$
|
164,872
|
|
|
$
|
146,363
|
|
|
$
|
120,686
|
|
|
$
|
88,515
|
|
|
$
|
72,617
|
|
Loss from operations
|
$
|
(164,459
|
)
|
|
$
|
(142,634
|
)
|
|
$
|
(120,424
|
)
|
|
$
|
(88,215
|
)
|
|
$
|
(72,317
|
)
|
Loss before income taxes
|
$
|
(159,429
|
)
|
|
$
|
(139,568
|
)
|
|
$
|
(120,587
|
)
|
|
$
|
(89,270
|
)
|
|
$
|
(73,476
|
)
|
Basic and diluted net loss
|
$
|
(159,429
|
)
|
|
$
|
(142,568
|
)
|
|
$
|
(120,587
|
)
|
|
$
|
(89,270
|
)
|
|
$
|
(73,476
|
)
|
Basic and diluted net loss per share
|
$
|
(3.67
|
)
|
|
$
|
(3.94
|
)
|
|
$
|
(4.01
|
)
|
|
$
|
(3.18
|
)
|
|
$
|
(3.02
|
)
|
|
As of December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
Consolidated Balance Sheet Data:
|
(In thousands)
|
||||||||||||||||||
Cash and cash equivalents
|
$
|
171,160
|
|
|
$
|
73,256
|
|
|
$
|
282,896
|
|
|
$
|
63,502
|
|
|
$
|
201,615
|
|
Short-term investments
|
$
|
118,955
|
|
|
$
|
102,556
|
|
|
$
|
—
|
|
|
$
|
122,026
|
|
|
$
|
52,439
|
|
Working capital
|
$
|
255,623
|
|
|
$
|
175,952
|
|
|
$
|
264,309
|
|
|
$
|
173,048
|
|
|
$
|
241,926
|
|
Total Assets
|
$
|
340,287
|
|
|
$
|
226,348
|
|
|
$
|
295,699
|
|
|
$
|
204,360
|
|
|
$
|
275,822
|
|
Financing obligation, net of current portion
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,872
|
|
|
$
|
5,346
|
|
Accumulated deficit
|
$
|
(844,204
|
)
|
|
$
|
(684,775
|
)
|
|
$
|
(542,167
|
)
|
|
$
|
(421,543
|
)
|
|
$
|
(332,273
|
)
|
|
Year Ended December 31,
|
|
2019 vs. 2018
|
|||||||||||
(in thousands, except percentages)
|
2019
|
|
2018
|
|
2017
|
|
%
|
|||||||
Milestone
|
$
|
413
|
|
|
$
|
3,729
|
|
|
$
|
—
|
|
|
(89
|
)%
|
Relastin Royalty
|
—
|
|
|
—
|
|
|
262
|
|
|
—
|
%
|
|||
Total revenue
|
$
|
413
|
|
|
$
|
3,729
|
|
|
$
|
262
|
|
|
(89
|
)%
|
•
|
salaries and related expenses for personnel in research and development functions, including stock-based compensation;
|
•
|
expenses related to the initiation and completion of clinical trials and studies for DAXI, DaxibotulinumtoxinA Topical and our biosimilar candidate, including expenses related to production of clinical supplies;
|
•
|
fees paid to clinical consultants, contract research organizations (“CROs”) and other vendors, including all related fees for investigator grants, patient screening fees, laboratory work and statistical compilation and analysis;
|
•
|
other consulting fees paid to third parties;
|
•
|
expenses related to establishment and maintenance of our own manufacturing facilities;
|
•
|
expenses related to the manufacture of drug substance and drug product supplies for ongoing and future preclinical and clinical trials and other pre-commercial supplies;
|
•
|
expenses to support our product development and establish manufacturing capabilities to support potential future commercialization of any products for which we may obtain regulatory approval;
|
•
|
expenses related to license fees and milestone payments under in-licensing agreements;
|
•
|
expenses related to compliance with drug development regulatory requirements in the U.S., the European Union and other foreign jurisdictions; and
|
•
|
depreciation and other allocated expenses.
|
|
Year Ended December 31,
|
|
2019 vs. 2018
|
|||||||
(in thousands, except percentages)
|
2019
|
|
2018
|
|
%
|
|||||
Clinical and regulatory
|
$
|
52,191
|
|
|
$
|
47,777
|
|
|
9
|
%
|
Manufacturing and quality
|
32,226
|
|
|
25,857
|
|
|
25
|
%
|
||
Other research and development expenses
|
9,932
|
|
|
11,386
|
|
|
(13
|
)%
|
||
Stock-based compensation
|
8,512
|
|
|
7,480
|
|
|
14
|
%
|
||
Total research and development expenses
|
$
|
102,861
|
|
|
$
|
92,500
|
|
|
11
|
%
|
•
|
pre-activities including market research, public relations, promotion and advertising;
|
•
|
personnel and service costs in our finance, information technology, commercial, investor relations, legal, human resources, and other administrative functions, including stock-based compensation; and
|
•
|
professional fees for accounting and legal services, including legal services associated with obtaining and maintaining patents and litigation.
|
|
Year Ended December 31,
|
|
2019 vs. 2018
|
|||||||
(in thousands, except percentages)
|
2019
|
|
2018
|
|
%
|
|||||
General and administrative expenses before stock-based compensation
|
$
|
52,601
|
|
|
$
|
45,070
|
|
|
17
|
%
|
Stock-based compensation
|
9,410
|
|
|
8,793
|
|
|
7
|
%
|
||
Total general and administrative expenses
|
$
|
62,011
|
|
|
$
|
53,863
|
|
|
15
|
%
|
|
Year Ended December 31,
|
|
2019 vs. 2018
|
|||||||
(in thousands, except percentages)
|
2019
|
|
2018
|
|
%
|
|||||
Interest income
|
$
|
5,532
|
|
|
$
|
4,023
|
|
|
38
|
%
|
Interest expense
|
—
|
|
|
(44
|
)
|
|
(100
|
)%
|
||
Changes in fair value of derivative liability
|
(199
|
)
|
|
(140
|
)
|
|
42
|
%
|
||
Other expense, net
|
(303
|
)
|
|
(773
|
)
|
|
(61
|
)%
|
||
Total net non-operating income
|
$
|
5,030
|
|
|
$
|
3,066
|
|
|
64
|
%
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||
(in thousands)
|
2019
|
|
2018
|
|
|||||||
Cash, cash equivalents, and short-term investments
|
$
|
290,115
|
|
|
$
|
175,812
|
|
|
$
|
114,303
|
|
Working Capital
|
$
|
255,623
|
|
|
$
|
175,952
|
|
|
$
|
79,671
|
|
Stockholders’ Equity
|
$
|
225,490
|
|
|
$
|
145,622
|
|
|
$
|
79,868
|
|
|
Year Ended December 31,
|
||||||
(in thousands)
|
2019
|
|
2018
|
||||
Net cash provided by (used in):
|
|
|
|
||||
Operating activities
|
$
|
(106,161
|
)
|
|
$
|
(104,246
|
)
|
Investing activities
|
$
|
(17,592
|
)
|
|
$
|
(107,026
|
)
|
Financing activities
|
$
|
221,657
|
|
|
$
|
1,782
|
|
•
|
the results of our clinical trials for DAXI and preclinical trials of DaxibotulinumtoxinA Topical, biosimilar or any future product candidates;
|
•
|
the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results, or that positive results would assure regulatory approval or commercial success of our product candidates;
|
•
|
the timing of, and the costs involved in, obtaining regulatory approvals for DAXI, or any future product candidates including DaxibotulinumtoxinA Topical or biosimilar;
|
•
|
the number and characteristics of any additional product candidates we develop or acquire;
|
•
|
the scope, progress, results and costs of researching and developing and conducting preclinical and clinical trials of DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates;
|
•
|
our plans to research, develop and commercialize the RHA® dermal fillers and our other product candidates, including the potential for commercialization by us of DAXI, if approved;
|
•
|
the cost of commercialization activities for the RHA® dermal fillers and, if approved for sale, DAXI or any future product candidates including DaxibotulinumtoxinA Topical or biosimilar, including marketing, sales and distribution costs;
|
•
|
the cost of manufacturing DAXI, DaxibotulinumtoxinA Topical, biosimilar or any future product candidates and any products we successfully commercialize and maintaining our related facilities;
|
•
|
our ability to successfully commercialize the RHA® dermal fillers and our other product candidates and the timing of commercialization activities;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements, including the Mylan collaboration, and the terms of and timing such arrangements;
|
•
|
that we may not obtain the anticipated financial and other benefits of the Teoxane Agreement, including our ability to realize anticipated synergies and successfully commercialize the RHA® dermal fillers
|
•
|
the commercial acceptance and potential of the RHA® dermal fillers, including market size and anticipated adoption rates;
|
•
|
the degree and rate of market acceptance of any future approved products;
|
•
|
the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products or treatments;
|
•
|
our ability to establish our marketing, sales, and distribution functions if we receive regulatory approval for our product candidates;
|
•
|
our ability to effectively and reliably manufacture supplies of DAXI, biosimilar or any future product candidates and to develop, validate and maintain a commercially viable manufacturing processes, as well as our ability to acquire supplies of RHA® dermal fillers from Teoxane;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
any litigation, including litigation costs and the outcome of such litigation;
|
•
|
the costs associated with being a public company;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
|
•
|
the timing, receipt and amount of sales of, or royalties on, future approved products, if any.
|
|
Year Ended
|
|
|
December 31, 2019
|
|
Expected term (in years)
|
6.0
|
|
Expected volatility
|
60.2
|
%
|
Risk-free interest rate
|
2.1
|
%
|
Expected dividend rate
|
—
|
%
|
|
Year Ended
|
|
|
December 31, 2018
|
|
Expected term (in years)
|
6.0
|
|
Expected volatility
|
60.2
|
%
|
Risk-free interest rate
|
2.7
|
%
|
Expected dividend rate
|
—
|
%
|
•
|
Expected Term. For stock options, the expected term is based on the simplified method, as our stock options have the following characteristics: (i) granted at-the-money; (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable, or “plain vanilla” options, and we have limited history of exercise data. For stock options granted to non-employees before adoption of ASU 2018-07 on July 1, 2018, the expected term is based on the remaining contractual term. For ESPP, the expected term is based on the term of the purchase period under the 2014 ESPP.
|
•
|
Expected Volatility. The expected volatility is based on the historical volatilities of a group of similar entities combined with the historical volatility of us. In evaluating similarity, we considered factors such as industry, stage of life cycle, capital structure, and company size.
|
•
|
Risk-Free Interest Rate. The risk-free interest rate is based on U.S. Treasury constant maturity rates with remaining terms similar to the expected term of the stock options.
|
•
|
Expected Dividend Rate. We use an expected dividend rate of zero because we have never paid any dividends and do not plan to pay dividends in the foreseeable future.
|
|
|
|
|
Year Ended
|
|
|
December 31, 2019
|
|
Expected term (in years) (1)
|
10.0
|
|
Expected volatility (2)
|
60.0
|
%
|
Risk-free interest rate
|
1.8
|
%
|
Expected dividend rate
|
—
|
%
|
(1)
|
Expected term was based on the expiration period of the performance stock awards in the award agreement.
|
(2)
|
Expected volatility was based on the historical volatilities of a group of similar entities combined with our historical volatility.
|
|
As of December 31,
|
|||||||||||
|
2019
|
|
2018
|
|||||||||
|
Unrecognized Compensation Cost
|
|
Weighted Average Expected Recognize Period
|
|
Unrecognized Compensation Cost
|
|
Weighted Average Expected Recognize Period
|
|||||
|
(in thousands)
|
|
(in years)
|
|
(in thousands)
|
|
(in years)
|
|||||
Stock options
|
$
|
18,487
|
|
|
2.9
|
|
$
|
20,202
|
|
|
2.7
|
|
Restricted stock awards
|
11,891
|
|
|
2.3
|
|
10,591
|
|
|
2.4
|
|
||
Performance stock awards
|
8,839
|
|
|
2.4
|
|
—
|
|
|
—
|
|
||
Total unrecognized compensation cost
|
$
|
39,217
|
|
|
2.6
|
|
$
|
30,793
|
|
|
2.6
|
|
|
|
Payment due by period
|
||||||||||||||||||
Contractual Obligations
|
|
Total
|
|
Less than 1 year
|
|
1-3 years
|
|
3-5 years
|
|
More than 5 years
|
||||||||||
|
|
( In thousands)
|
||||||||||||||||||
Operating lease obligations
|
|
$
|
42,657
|
|
|
$
|
6,735
|
|
|
$
|
12,406
|
|
|
$
|
11,290
|
|
|
$
|
12,226
|
|
•
|
We are obligated to pay milestone and royalties to List Laboratories on future sales of botulinum toxin products.
|
•
|
We also have one future milestone payment of $4.0 million due to certain settlement agreement in 2012 upon the achievement of regulatory approval for DAXI or DaxibotulinumtoxinA Topical.
|
•
|
In June 2016, we entered into BTRX Purchase Agreement in which we agreed to pay up to an additional $16.0 million in aggregate upon the satisfaction of specified milestones relating to our sales revenue, intellectual property, and clinical and regulatory events. In exchange, we acquired all rights, title and interest in a portfolio of botulinum toxin-related patents and patent applications from BTRX and were granted the right of first negotiation and first refusal with respect to other botulinum toxin-related patents owned or controlled by BTRX.
|
•
|
In April 2016, we entered into an agreement with BioSentinel, Inc. to in-license their technology and expertise for research and development and manufacturing purposes. In addition to minimum quarterly use fees, we are obligated to make a one-time future milestone payment of $0.3 million payable to BioSentinel, Inc. upon the achievement of regulatory approval.
|
•
|
In March 2017, we entered into the Althea Services Agreement, under which Althea has agreed to provide us with a future source of commercial fill/finish services for our neuromodulator products. The Althea Services Agreement has an initial term that will expire in 2024, unless terminated sooner by either party. In accordance with the Althea Services Agreement, and we have minimum purchase obligations based on our production forecasts.
|
•
|
In January 2020, we entered into the Teoxane Agreement. Pursuant to the Teoxane Agreement. If Teoxane pursues regulatory approval for the RHA® dermal fillers for certain new indications or filler technologies, including innovations with respect to existing products in the U.S., we will be subject to certain specified cost-sharing arrangements for third party expenses incurred in achieving regulatory approval for such products. We are required to meet certain minimum purchase obligations during each year of the term. We are also required to meet certain minimum expenditure requirements in connection with commercialization efforts.
|
(a)
|
The following documents are filed as part of this Annual Report on Form 10-K:
|
(1)
|
Financial Statements. The financial statements required by this item are set forth beginning at F-1 in this Annual Report on Form 10-K and are incorporated herein by reference.
|
(2)
|
Financial Statement Schedules. None. Financial statement schedules have been omitted because they are not applicable.
|
(3)
|
Exhibits: See Item 15(b) below.
|
(b)
|
Exhibits. The following exhibits are included herein or incorporated herein by reference:
|
|
|
|
|
Incorporated by Reference
|
|
|
||||||
Exhibit Number
|
|
Exhibit Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
10.9*
|
|
|
S-1/A
|
|
333-193154
|
|
10.7
|
|
January 27, 2014
|
|
|
|
10.10*
|
|
|
S-1/A
|
|
333-193154
|
|
10.8
|
|
January 27, 2014
|
|
|
|
10.11*
|
|
|
8-K
|
|
001-36297
|
|
99.1
|
|
December 14, 2015
|
|
|
|
10.12*
|
|
|
10-Q
|
|
001-36297
|
|
10.5
|
|
November 10, 2015
|
|
|
|
10.13*
|
|
|
10-K
|
|
001-36297
|
|
10.31
|
|
March 4, 2016
|
|
|
|
10.14
|
|
|
S-1
|
|
333-193154
|
|
10.9
|
|
December 31, 2013
|
|
|
|
10.15
|
|
|
S-1
|
|
333-193154
|
|
10.10
|
|
December 31, 2013
|
|
|
|
10.16
|
|
|
S-1
|
|
333-193154
|
|
10.11
|
|
December 31, 2013
|
|
|
|
10.17
|
|
|
8-K
|
|
001-36297
|
|
10.35
|
|
March 4, 2014
|
|
|
|
10.18
|
|
|
8-K
|
|
001-36297
|
|
10.1
|
|
May 11, 2018
|
|
|
|
10.19+
|
|
|
S-1
|
|
333-193154
|
|
10.15
|
|
December 31, 2013
|
|
|
|
10.20+
|
|
|
S-1
|
|
333-193154
|
|
10.16
|
|
December 31, 2013
|
|
|
|
10.21+
|
|
|
S-1
|
|
333-193154
|
|
10.18
|
|
December 31, 2013
|
|
|
|
10.22+
|
|
|
S-1
|
|
333-193154
|
|
10.20
|
|
December 31, 2013
|
|
|
|
10.23+
|
|
|
10-Q
|
|
001-36297
|
|
10.1
|
|
November 10, 2015
|
|
|
|
10.24+
|
|
|
S-1
|
|
333-193154
|
|
10.19
|
|
December 31, 2013
|
|
|
|
10.25
|
|
|
10-Q
|
|
001-36297
|
|
10.3
|
|
August 3, 2018
|
|
|
|
|
|
|
Incorporated by Reference
|
|
|
||||||
Exhibit Number
|
|
Exhibit Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
10.26*
|
|
|
10-Q
|
|
001-36297
|
|
10.3
|
|
November 4, 2019
|
|
|
|
10.27*
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
10.28*
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
10.29*
|
|
|
S-1/A
|
|
333-193154
|
|
10.25
|
|
January 27, 2014
|
|
|
|
10.30*
|
|
|
10-K
|
|
001-36297
|
|
10.34
|
|
March 4, 2016
|
|
|
|
10.31*
|
|
|
10-Q
|
|
001-36297
|
|
10.1
|
|
August 3, 2018
|
|
|
|
10.32*
|
|
|
10-K
|
|
001-36291
|
|
10.37
|
|
February 28, 2019
|
|
|
|
10.33
|
|
|
10-Q
|
|
001-36297
|
|
10.4
|
|
May 9, 2017
|
|
|
|
10.34
|
|
|
8-K
|
|
001-36297
|
|
99.1
|
|
March 13, 2018
|
|
|
|
10.35+
|
|
|
10-Q
|
|
001-36297
|
|
10.1
|
|
May 9, 2018
|
|
|
|
10.36++
|
|
|
10-Q
|
|
001-36297
|
|
10.1
|
|
November 4, 2019
|
|
|
|
10.37+
|
|
|
10-K
|
|
001-36291
|
|
10.42
|
|
February 28, 2019
|
|
|
|
10.38*
|
|
|
10-Q
|
|
001-36297
|
|
10.2
|
|
November 4, 2019
|
|
|
|
10.39*
|
|
|
10-Q
|
|
001-36297
|
|
10.4
|
|
November 4, 2019
|
|
|
|
10.40*
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
10.41*
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
10.42*
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
|
|
|
Incorporated by Reference
|
|
|
||||||
Exhibit Number
|
|
Exhibit Description
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
10.43++
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
21.1
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
24.1
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
31.1
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
31.2
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
32.1†
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
32.2†
|
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
|
101.INS
|
|
XBRL Instance Document
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
104
|
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
X
|
*
|
Indicates a management contract or compensatory plan or arrangement.
|
+
|
Confidential treatment has been granted for portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
++
|
Portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the registrant if publicly disclosed.
|
†
|
The certifications attached as Exhibit 32.1 and 32.2 that accompany this Annual Report on Form 10-K are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Revance Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-K, irrespective of any general incorporation language contained in such filing.
|
Consolidated Financial Statements:
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Revenue
|
$
|
413
|
|
|
$
|
3,729
|
|
|
$
|
262
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
102,861
|
|
|
92,500
|
|
|
80,361
|
|
|||
General and administrative
|
62,011
|
|
|
53,863
|
|
|
37,398
|
|
|||
Loss on impairment
|
—
|
|
|
—
|
|
|
2,927
|
|
|||
Total operating expenses
|
164,872
|
|
|
146,363
|
|
|
120,686
|
|
|||
Loss from operations
|
(164,459
|
)
|
|
(142,634
|
)
|
|
(120,424
|
)
|
|||
Interest income
|
5,532
|
|
|
4,023
|
|
|
1,410
|
|
|||
Interest expense
|
—
|
|
|
(44
|
)
|
|
(457
|
)
|
|||
Changes in fair value of derivative liability
|
(199
|
)
|
|
(140
|
)
|
|
(591
|
)
|
|||
Other expense, net
|
(303
|
)
|
|
(773
|
)
|
|
(525
|
)
|
|||
Loss before income taxes
|
(159,429
|
)
|
|
(139,568
|
)
|
|
(120,587
|
)
|
|||
Income tax provision
|
—
|
|
|
(3,000
|
)
|
|
—
|
|
|||
Net loss
|
(159,429
|
)
|
|
(142,568
|
)
|
|
(120,587
|
)
|
|||
Unrealized gain (loss) and adjustment on securities included in net loss
|
11
|
|
|
(8
|
)
|
|
45
|
|
|||
Comprehensive loss
|
$
|
(159,418
|
)
|
|
$
|
(142,576
|
)
|
|
$
|
(120,542
|
)
|
Basic and diluted net loss
|
$
|
(159,429
|
)
|
|
$
|
(142,568
|
)
|
|
$
|
(120,587
|
)
|
Basic and diluted net loss per share
|
$
|
(3.67
|
)
|
|
$
|
(3.94
|
)
|
|
$
|
(4.01
|
)
|
Basic and diluted weighted-average number of shares used in computing net loss per share
|
43,460,804
|
|
|
36,171,582
|
|
|
30,101,125
|
|
|
|
|
Additional Paid-In Capital
|
|
Other Accumulated Comprehensive Gain (Loss)
|
|
Accumulated Deficit
|
|
Total Stockholders’ Equity
|
|||||||||||||
|
Common Stock
|
|
||||||||||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance — December 31, 2016
|
28,648,954
|
|
|
$
|
29
|
|
|
$
|
598,630
|
|
|
$
|
(45
|
)
|
|
$
|
(421,543
|
)
|
|
$
|
177,071
|
|
Cumulative-effect adjustment from adoption of ASU 2016-09
|
—
|
|
|
—
|
|
|
37
|
|
|
|
|
(37
|
)
|
|
—
|
|
||||||
Issuance of common stock relating to employee stock purchase plan
|
28,135
|
|
|
—
|
|
|
583
|
|
|
—
|
|
|
—
|
|
|
583
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
13,230
|
|
|
—
|
|
|
—
|
|
|
13,230
|
|
|||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs of $603
|
1,802,651
|
|
|
2
|
|
|
38,155
|
|
|
—
|
|
|
—
|
|
|
38,157
|
|
|||||
Issuance of common stock in connection with the 2017 offering, net of issuance costs of $535
|
5,389,515
|
|
|
5
|
|
|
156,928
|
|
|
—
|
|
|
—
|
|
|
156,933
|
|
|||||
Issuance of common stock upon net exercise of warrants
|
9,878
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of stock options
|
309,341
|
|
|
1
|
|
|
3,985
|
|
|
—
|
|
|
—
|
|
|
3,986
|
|
|||||
Issuance of restricted stock awards, net of cancellation
|
353,620
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net settlement of restricted stock awards for employee taxes
|
(26,019
|
)
|
|
—
|
|
|
(573
|
)
|
|
—
|
|
|
—
|
|
|
(573
|
)
|
|||||
Unrealized gain and adjustment on securities included in net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
45
|
|
|
—
|
|
|
45
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(120,587
|
)
|
|
(120,587
|
)
|
|||||
Balance — December 31, 2017
|
36,516,075
|
|
|
37
|
|
|
810,975
|
|
|
—
|
|
|
(542,167
|
)
|
|
268,845
|
|
|||||
Cumulative-effect adjustment from adoption of ASU 2018-07
|
—
|
|
|
—
|
|
|
40
|
|
|
—
|
|
|
(40
|
)
|
|
—
|
|
|||||
Issuance of common stock relating to employee stock purchase plan
|
37,894
|
|
|
—
|
|
|
765
|
|
|
—
|
|
|
—
|
|
|
765
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
16,273
|
|
|
—
|
|
|
—
|
|
|
16,273
|
|
|||||
Issuance of common stock upon exercise of stock options
|
293,100
|
|
|
—
|
|
|
4,527
|
|
|
—
|
|
|
—
|
|
|
4,527
|
|
|||||
Issuance of restricted stock awards, net of cancellation
|
201,032
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net settlement of restricted stock awards for employee taxes
|
(72,898
|
)
|
|
—
|
|
|
(2,212
|
)
|
|
—
|
|
|
—
|
|
|
(2,212
|
)
|
|||||
Unrealized loss and adjustment on securities included in net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(8
|
)
|
|
—
|
|
|
(8
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(142,568
|
)
|
|
(142,568
|
)
|
|||||
Balance — December 31, 2018
|
36,975,203
|
|
|
37
|
|
|
830,368
|
|
|
(8
|
)
|
|
(684,775
|
)
|
|
145,622
|
|
|||||
Issuance of common stock relating to employee stock purchase plan
|
74,935
|
|
|
—
|
|
|
818
|
|
|
—
|
|
|
—
|
|
|
818
|
|
|||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
17,922
|
|
|
—
|
|
|
—
|
|
|
17,922
|
|
|||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs of $265
|
687,189
|
|
|
1
|
|
|
10,604
|
|
|
—
|
|
|
—
|
|
|
10,605
|
|
|||||
Issuance of common stock in connection with the 2019 offerings, net of issuance costs of $770
|
13,264,705
|
|
|
13
|
|
|
211,187
|
|
|
—
|
|
|
—
|
|
|
211,200
|
|
|||||
Issuance of common stock upon exercise of stock options
|
10,135
|
|
|
—
|
|
|
119
|
|
|
—
|
|
|
—
|
|
|
119
|
|
|||||
Issuance of restricted stock awards, net of cancellation
|
1,447,544
|
|
|
1
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net settlement of restricted stock awards for employee taxes
|
(84,976
|
)
|
|
—
|
|
|
(1,378
|
)
|
|
—
|
|
|
—
|
|
|
(1,378
|
)
|
|||||
Unrealized loss and adjustment on securities included in net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
11
|
|
|
—
|
|
|
11
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(159,429
|
)
|
|
(159,429
|
)
|
|||||
Balance — December 31, 2019
|
52,374,735
|
|
|
$
|
52
|
|
|
$
|
1,069,639
|
|
|
$
|
3
|
|
|
$
|
(844,204
|
)
|
|
$
|
225,490
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
||||||
Net loss
|
$
|
(159,429
|
)
|
|
$
|
(142,568
|
)
|
|
$
|
(120,587
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation
|
2,909
|
|
|
1,726
|
|
|
1,468
|
|
|||
Amortization of premium (discount) on investments
|
(2,637
|
)
|
|
(1,103
|
)
|
|
410
|
|
|||
Stock-based compensation expense
|
17,922
|
|
|
16,273
|
|
|
13,230
|
|
|||
Gain on disposal of property and equipment
|
(8
|
)
|
|
(1,466
|
)
|
|
—
|
|
|||
Impairment of property and equipment
|
—
|
|
|
—
|
|
|
2,927
|
|
|||
Other non-cash operating activities
|
810
|
|
|
175
|
|
|
767
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
27,000
|
|
|
(26,952
|
)
|
|
80
|
|
|||
Prepaid expenses and other current assets
|
(1,377
|
)
|
|
(2,911
|
)
|
|
4,849
|
|
|||
Operating lease right of use assets
|
(1,868
|
)
|
|
—
|
|
|
—
|
|
|||
Other non-current assets
|
1,578
|
|
|
(1,871
|
)
|
|
(403
|
)
|
|||
Accounts payable
|
(360
|
)
|
|
1,691
|
|
|
2,607
|
|
|||
Accruals and other liabilities
|
3,565
|
|
|
1,488
|
|
|
(690
|
)
|
|||
Deferred revenue
|
4,587
|
|
|
51,272
|
|
|
—
|
|
|||
Operating lease liabilities
|
1,147
|
|
|
—
|
|
|
—
|
|
|||
Net cash used in operating activities
|
(106,161
|
)
|
|
(104,246
|
)
|
|
(95,342
|
)
|
|||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
||||||
Purchases of investments
|
(331,362
|
)
|
|
(314,911
|
)
|
|
(36,028
|
)
|
|||
Purchases of property and equipment
|
(3,238
|
)
|
|
(6,991
|
)
|
|
(2,525
|
)
|
|||
Proceeds from maturities of investments
|
317,000
|
|
|
146,000
|
|
|
157,445
|
|
|||
Proceeds from sale of property and equipment
|
8
|
|
|
1,541
|
|
|
—
|
|
|||
Proceeds from sale of investments
|
—
|
|
|
67,435
|
|
|
—
|
|
|||
Payment for acquisition of in-process research and development
|
—
|
|
|
(100
|
)
|
|
(100
|
)
|
|||
Net cash provided by (used in) investing activities
|
(17,592
|
)
|
|
(107,026
|
)
|
|
118,792
|
|
|||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock in connection with offerings, net of commissions and discount
|
211,970
|
|
|
—
|
|
|
157,468
|
|
|||
Proceeds from issuance of common stock in connection with at-the-market offerings, net of commissions
|
10,870
|
|
|
—
|
|
|
38,760
|
|
|||
Proceeds from the exercise of stock options and common stock warrants, and purchases under the employee stock purchase plan
|
937
|
|
|
5,292
|
|
|
4,569
|
|
|||
Net settlement of restricted stock awards for employee taxes
|
(1,378
|
)
|
|
(2,212
|
)
|
|
(573
|
)
|
|||
Payment of offering costs
|
(742
|
)
|
|
(366
|
)
|
|
(644
|
)
|
|||
Principal payments made on financing obligations
|
—
|
|
|
(932
|
)
|
|
(3,636
|
)
|
|||
Net cash provided by financing activities
|
221,657
|
|
|
1,782
|
|
|
195,944
|
|
|||
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH
|
97,904
|
|
|
(209,490
|
)
|
|
219,394
|
|
|||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — Beginning of period
|
73,986
|
|
|
283,476
|
|
|
64,082
|
|
|||
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH — End of period
|
$
|
171,890
|
|
|
$
|
73,986
|
|
|
$
|
283,476
|
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
|
|
|
|
|
|
||||||
Cash paid for income taxes
|
$
|
3,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
16
|
|
|
$
|
299
|
|
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION:
|
|
|
|
|
|
||||||
Property and equipment purchases included in accounts payable and accruals
|
$
|
619
|
|
|
$
|
642
|
|
|
$
|
718
|
|
Accrued offering costs
|
$
|
293
|
|
|
$
|
354
|
|
|
$
|
251
|
|
•
|
Level 1 — Observable inputs, such as quoted prices in active markets for identical assets or liabilities;
|
•
|
Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
|
•
|
Level 3 — Valuations based on unobservable inputs to the valuation methodology and including data about assumptions market participants would use in pricing the asset or liability based on the best information available under the circumstances.
|
|
As of December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Outstanding common stock options
|
4,734,616
|
|
|
3,605,333
|
|
|
3,210,400
|
|
Outstanding common stock warrants
|
34,113
|
|
|
34,113
|
|
|
34,113
|
|
Unvested restricted stock awards
|
1,808,518
|
|
|
605,012
|
|
|
639,287
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||||||||||
|
Cost
|
|
Unrealized
|
|
Fair Value
|
|
Cost
|
|
Unrealized
|
|
Fair Value
|
||||||||||||||||||||
(in thousands)
|
|
Gains
|
|
Losses
|
|
|
|
Gains
|
|
Losses
|
|
||||||||||||||||||||
Money market funds
|
$
|
136,258
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
136,258
|
|
|
$
|
38,354
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
38,354
|
|
U.S. treasury securities
|
48,349
|
|
|
6
|
|
|
—
|
|
|
48,355
|
|
|
80,844
|
|
|
5
|
|
|
(5
|
)
|
|
80,844
|
|
||||||||
U.S. government agency obligations
|
5,993
|
|
|
2
|
|
|
(5
|
)
|
|
5,990
|
|
|
52,586
|
|
|
—
|
|
|
(8
|
)
|
|
52,578
|
|
||||||||
Commercial paper
|
77,082
|
|
|
—
|
|
|
—
|
|
|
77,082
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Overnight repurchase agreements
|
15,001
|
|
|
—
|
|
|
—
|
|
|
15,001
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Total cash equivalents and available-for-sale securities
|
$
|
282,683
|
|
|
$
|
8
|
|
|
$
|
(5
|
)
|
|
$
|
282,686
|
|
|
$
|
171,784
|
|
|
$
|
5
|
|
|
$
|
(13
|
)
|
|
$
|
171,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
$
|
163,731
|
|
|
|
|
|
|
|
|
$
|
69,220
|
|
||||||||||||
Short-term investments
|
|
|
|
|
|
|
118,955
|
|
|
|
|
|
|
|
|
102,556
|
|
||||||||||||||
Total cash equivalents and available-for-sale securities
|
|
|
|
|
|
|
$
|
282,686
|
|
|
|
|
|
|
|
|
$
|
171,776
|
|
|
As of December 31, 2019
|
||||||||||||||
(in thousands)
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
136,258
|
|
|
$
|
136,258
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. treasury securities
|
48,355
|
|
|
48,355
|
|
|
—
|
|
|
—
|
|
||||
Commercial paper
|
77,082
|
|
|
—
|
|
|
77,082
|
|
|
—
|
|
||||
Overnight repurchase agreements
|
15,001
|
|
|
—
|
|
|
15,001
|
|
|
—
|
|
||||
U.S. government agency obligations
|
5,990
|
|
|
—
|
|
|
5,990
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
282,686
|
|
|
$
|
184,613
|
|
|
$
|
98,073
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liability
|
$
|
2,952
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,952
|
|
Total liabilities measured at fair value
|
$
|
2,952
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,952
|
|
|
|
|
|
|
|
|
|
||||||||
|
As of December 31, 2018
|
||||||||||||||
(in thousands)
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
38,354
|
|
|
$
|
38,354
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S. treasury securities
|
80,844
|
|
|
80,844
|
|
|
—
|
|
|
—
|
|
||||
U.S. government agency obligations
|
52,578
|
|
|
—
|
|
|
52,578
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
171,776
|
|
|
$
|
119,198
|
|
|
$
|
52,578
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Derivative liability
|
$
|
2,753
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,753
|
|
Total liabilities measured at fair value
|
$
|
2,753
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,753
|
|
(in thousands)
|
|
Derivative liability
|
||
Fair value as of December 31, 2018
|
|
$
|
2,753
|
|
Change in fair value
|
|
199
|
|
|
Fair value as of December 31, 2019
|
|
$
|
2,952
|
|
|
As of December 31,
|
||||||
(in thousands)
|
2019
|
|
2018
|
||||
Manufacturing equipment
|
$
|
19,113
|
|
|
$
|
11,307
|
|
Leasehold improvements
|
5,374
|
|
|
4,752
|
|
||
Construction in progress
|
2,386
|
|
|
8,925
|
|
||
Computer software
|
2,040
|
|
|
1,299
|
|
||
Computer equipment
|
1,505
|
|
|
1,351
|
|
||
Furniture and fixtures
|
1,203
|
|
|
787
|
|
||
Total property and equipment
|
31,621
|
|
|
28,421
|
|
||
Less: Accumulated depreciation
|
(16,866
|
)
|
|
(13,972
|
)
|
||
Property and equipment, net
|
$
|
14,755
|
|
|
$
|
14,449
|
|
|
As of December 31,
|
||||||
(in thousands)
|
2019
|
|
2018
|
||||
Accruals related to:
|
|
|
|
||||
Compensation
|
$
|
7,933
|
|
|
$
|
6,743
|
|
Clinical trials
|
4,746
|
|
|
4,021
|
|
||
Professional service
|
2,732
|
|
|
2,272
|
|
||
Nonrecurring milestone payment
|
1,000
|
|
|
1,000
|
|
||
Manufacturing and quality control
|
1,798
|
|
|
260
|
|
||
Property and equipment (including construction in progress)
|
221
|
|
|
111
|
|
||
Other current liabilities
|
206
|
|
|
541
|
|
||
Total accruals and other current liabilities
|
$
|
18,636
|
|
|
$
|
14,948
|
|
(1)
|
We recorded $5.5 million and $5.3 million for bonus accruals as of December 31, 2019 and 2018, respectively.
|
|
Year Ended
|
||
(in thousands)
|
December 31, 2019
|
||
Operating lease cost
|
$
|
5,618
|
|
Variable lease cost (1)
|
1,184
|
|
|
Total operating lease costs
|
$
|
6,802
|
|
(1)
|
Variable lease cost includes management fees, common area maintenance, property taxes, and insurance, which are not included in the lease liabilities and are expensed as incurred.
|
Year Ending December 31,
|
(in thousands)
|
||
2020
|
$
|
6,735
|
|
2021
|
6,942
|
|
|
2022
|
5,464
|
|
|
2023
|
5,557
|
|
|
2024
|
5,733
|
|
|
2025 and thereafter
|
12,226
|
|
|
Total operating lease payments
|
42,657
|
|
|
Less imputed interest (1)
|
(13,317
|
)
|
|
Present value of operating lease payments
|
$
|
29,340
|
|
(1)
|
Our lease contracts do not provide a readily determinable implicit rate. The imputed interest was based on a weighted average discount rate of 12.0%, which represents the estimated incremental borrowing based on the information available at the adoption or commencement dates.
|
Year Ending December 31,
|
(in thousands)
|
||
2019
|
$
|
5,826
|
|
2020
|
6,011
|
|
|
2021
|
6,196
|
|
|
2022
|
4,696
|
|
|
2023 and thereafter
|
20,173
|
|
|
Total payments
|
$
|
42,902
|
|
|
Year Ended
|
||
(in thousands)
|
December 31, 2019
|
||
Cash paid for amounts included in the measurement of operating lease liabilities
|
$
|
6,339
|
|
Right-of-use assets obtained in exchange for operating lease liabilities
|
$
|
3,890
|
|
|
Shares
|
|
Weighted Average Exercise Price Per Share
|
|
Weighted Average Remaining Contractual Term (in Years)
|
|
Weighted-Average Grant-Date Fair Value Per Share
|
|
Aggregate Intrinsic Value(1)
(in thousands)
|
|||||||
Balance as of December 31, 2016
|
2,790,646
|
|
|
$
|
19.31
|
|
|
|
|
|
|
|
||||
Granted
|
960,525
|
|
|
$
|
21.75
|
|
|
|
|
$
|
13.59
|
|
|
|
||
Exercised
|
(309,341
|
)
|
|
$
|
12.88
|
|
|
|
|
|
|
$
|
7,073
|
|
||
Forfeited
|
(231,430
|
)
|
|
$
|
22.76
|
|
|
|
|
|
|
|
||||
Balance as of December 31, 2017
|
3,210,400
|
|
|
$
|
20.41
|
|
|
|
|
|
|
|
||||
Granted
|
1,136,650
|
|
|
$
|
28.30
|
|
|
|
|
$
|
16.35
|
|
|
|
||
Exercised
|
(293,100
|
)
|
|
$
|
15.45
|
|
|
|
|
|
|
$
|
1,519
|
|
||
Forfeited
|
(448,617
|
)
|
|
$
|
25.59
|
|
|
|
|
|
|
|
||||
Balance as of December 31, 2018
|
3,605,333
|
|
|
$
|
22.66
|
|
|
|
|
|
|
|
||||
Granted
|
1,976,750
|
|
|
$
|
14.53
|
|
|
|
|
$
|
8.29
|
|
|
|
||
Exercised
|
(10,135
|
)
|
|
$
|
11.76
|
|
|
|
|
|
|
$
|
45
|
|
||
Forfeited
|
(837,332
|
)
|
|
$
|
22.40
|
|
|
|
|
|
|
|
||||
Balance as of December 31, 2019
|
4,734,616
|
|
|
$
|
19.34
|
|
|
6.2
|
|
|
|
$
|
7,762
|
|
||
Exercisable as of December 31, 2019
|
2,659,741
|
|
|
$
|
21.31
|
|
|
3.9
|
|
|
|
$
|
3,433
|
|
(1)
|
The total intrinsic values of options exercised as of December 31, 2019, 2018 and 2017 were determined by multiplying the number of shares by the difference between exercise price of the stock options and the fair value of the common stock as of December 31, 2019, 2018 and 2017 of $16.23, $20.13 and $35.75 per share, respectively. The intrinsic values of outstanding and exercisable options were determined by multiplying the number of shares by the difference in exercise price of the options and the fair value of the common stock as of December 31, 2019.
|
|
Shares
|
|
Weighted-Average Grant-Date Fair Value Per Share
|
|||
Unvested balance as of December 31, 2016
|
416,229
|
|
|
$
|
20.02
|
|
Granted
|
435,525
|
|
|
$
|
22.08
|
|
Vested
|
(130,562
|
)
|
|
$
|
23.25
|
|
Forfeited
|
(81,905
|
)
|
|
$
|
19.32
|
|
Unvested balance as of December 31, 2017
|
639,287
|
|
|
$
|
20.86
|
|
Granted
|
373,500
|
|
|
$
|
28.37
|
|
Vested
|
(235,307
|
)
|
|
$
|
20.25
|
|
Forfeited
|
(172,468
|
)
|
|
$
|
24.83
|
|
Unvested balance as of December 31, 2018
|
605,012
|
|
|
$
|
24.61
|
|
Granted
|
1,640,275
|
|
|
$
|
12.78
|
|
Vested
|
(244,038
|
)
|
|
$
|
23.80
|
|
Forfeited
|
(192,731
|
)
|
|
$
|
21.47
|
|
Unvested balance as of December 31, 2019
|
1,808,518
|
|
|
$
|
14.32
|
|
•
|
Fair Value of Common Stock. The fair value of the common stock shares is based on our stock price as quoted by the Nasdaq.
|
•
|
Expected Term. For stock options, the expected term is based on the simplified method, as our stock options have the following characteristics: (i) granted at-the-money; (ii) exercisability is conditioned upon service through the vesting date; (iii) termination of service prior to vesting results in forfeiture; (iv) limited exercise period following termination of service; and (v) options are non-transferable and non-hedgeable, or “plain vanilla” options, and we have limited history of exercise data. For stock options granted to non-employees before adoption of ASU 2018-07 on July 1, 2018 (Note 2), the expected term is based on the remaining contractual term. For ESPP, the expected term is based on the term of the purchase period under the 2014 ESPP.
|
•
|
Expected Volatility. The expected volatility is based on the historical volatilities of a group of similar entities combined with the historical volatility of us. In evaluating similarity, we considered factors such as industry, stage of life cycle, capital structure, and company size.
|
•
|
Risk-Free Interest Rate. The risk-free interest rate is based on U.S. Treasury constant maturity rates with remaining terms similar to the expected term of the stock options.
|
•
|
Expected Dividend Rate. We use an expected dividend rate of zero because we have never paid any dividends and do not plan to pay dividends in the foreseeable future.
|
•
|
Forfeitures. We account for forfeitures as they occur.
|
|
Year Ended
|
|
|
December 31, 2019
|
|
Expected term (in years)
|
6.03
|
|
Expected volatility
|
60.2
|
%
|
Risk-free interest rate
|
2.1
|
%
|
Expected dividend rate
|
—
|
%
|
|
Year Ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Expected term (in years)
|
0.5
|
|
|
0.5
|
|
|
0.5
|
|
Expected volatility
|
43.4
|
%
|
|
50.9
|
%
|
|
59.2
|
%
|
Risk-free interest rate
|
2.3
|
%
|
|
1.9
|
%
|
|
0.9
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Year Ended December 31,
|
||||
|
2018
|
|
2017
|
||
Expected term (in years)
|
5.5
|
|
|
8.9
|
|
Expected volatility
|
59.4
|
%
|
|
67.9
|
%
|
Risk-free interest rate
|
2.8
|
%
|
|
2.3
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
Year Ended December 31,
|
||||
|
2018
|
|
2017
|
||
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
Expected volatility
|
60.2
|
%
|
|
67.7
|
%
|
Risk-free interest rate
|
2.7
|
%
|
|
2.1
|
%
|
Expected dividend rate
|
—
|
%
|
|
—
|
%
|
|
Year Ended
|
|
|
December 31, 2019
|
|
Expected term (in years) (1)
|
10.0
|
|
Expected volatility (2)
|
60.0
|
%
|
Risk-free interest rate
|
1.8
|
%
|
Expected dividend rate
|
—
|
%
|
(1)
|
Expected term was based on the expiration period of the performance stock awards in the award agreement.
|
(2)
|
Expected volatility was based on the historical volatilities of a group of similar entities combined with our historical volatility.
|
(in thousands)
|
Year Ended December 31,
|
||||||||||
2019
|
|
2018
|
|
2017
|
|||||||
Research and development
|
$
|
8,512
|
|
|
$
|
7,480
|
|
|
$
|
5,902
|
|
General and administrative
|
9,410
|
|
|
8,793
|
|
|
7,328
|
|
|||
Total stock-based compensation expense
|
$
|
17,922
|
|
|
$
|
16,273
|
|
|
$
|
13,230
|
|
|
As of December 31,
|
|||||||||||
|
2019
|
|
2018
|
|||||||||
|
Unrecognized Compensation Cost
|
|
Weighted Average Expected Recognize Period
|
|
Unrecognized Compensation Cost
|
|
Weighted Average Expected Recognize Period
|
|||||
|
(in thousands)
|
|
(in years)
|
|
(in thousands)
|
|
(in years)
|
|||||
Stock options
|
$
|
18,487
|
|
|
2.9
|
|
$
|
20,202
|
|
|
2.7
|
|
Restricted stock awards
|
11,891
|
|
|
2.3
|
|
10,591
|
|
|
2.4
|
|
||
Performance stock awards
|
8,839
|
|
|
2.4
|
|
—
|
|
|
—
|
|
||
Total unrecognized compensation cost
|
$
|
39,217
|
|
|
2.6
|
|
$
|
30,793
|
|
|
2.6
|
|
|
Year Ended December 31,
|
||||||||||
(in thousands)
|
2019
|
|
2018
|
|
2017
|
||||||
Domestic
|
$
|
(159,429
|
)
|
|
$
|
(139,568
|
)
|
|
$
|
(118,331
|
)
|
Foreign
|
—
|
|
|
—
|
|
|
(2,256
|
)
|
|||
Loss before income taxes
|
$
|
(159,429
|
)
|
|
$
|
(139,568
|
)
|
|
$
|
(120,587
|
)
|
|
Year Ended December 31,
|
||||||||||
(in thousands)
|
2019
|
|
2018
|
|
2017
|
||||||
Tax benefit at statutory federal rate (1)
|
$
|
(33,480
|
)
|
|
$
|
(29,309
|
)
|
|
$
|
(40,999
|
)
|
Research and development credits
|
(4,723
|
)
|
|
(4,064
|
)
|
|
(1,858
|
)
|
|||
Other changes in valuation allowance
|
36,379
|
|
|
42,902
|
|
|
(35,783
|
)
|
|||
Nondeductible/nontaxable items
|
1,429
|
|
|
108
|
|
|
738
|
|
|||
Other
|
395
|
|
|
(153
|
)
|
|
224
|
|
|||
Sale of intellectual property (2)
|
—
|
|
|
(14,008
|
)
|
|
14,008
|
|
|||
Foreign rate differential and withholding taxes
|
—
|
|
|
2,370
|
|
|
767
|
|
|||
Impact of the Tax Reform Act
|
—
|
|
|
5,154
|
|
|
62,903
|
|
|||
Income tax provision
|
$
|
—
|
|
|
$
|
3,000
|
|
|
$
|
—
|
|
(1)
|
U.S. federal statutory rate was 21%, for the years ended December 31, 2019 and 2018, and 35% for the year ended December 31, 2017.
|
(2)
|
This represents the tax effect of an intra-entity sale between us and our wholly owned subsidiary, Revance International Limited, which was eliminated for financial reporting purposes (discussed below).
|
|
Year Ended December 31,
|
||||||
(in thousands)
|
2019
|
|
2018
|
||||
Deferred tax assets
|
|
|
|
||||
Net operating loss carryforward
|
$
|
184,879
|
|
|
$
|
146,618
|
|
Accruals and reserves
|
1,537
|
|
|
2,191
|
|
||
Stock-based compensation
|
6,241
|
|
|
5,173
|
|
||
Tax credits
|
17,449
|
|
|
12,230
|
|
||
Fixed and intangible assets
|
2,803
|
|
|
3,328
|
|
||
Deferred revenue
|
10,703
|
|
|
—
|
|
||
Operating lease liabilities
|
6,174
|
|
|
—
|
|
||
Other
|
19
|
|
|
—
|
|
||
Total deferred tax assets
|
229,805
|
|
|
169,540
|
|
||
Less: valuation allowance (1)
|
(224,222
|
)
|
|
(169,540
|
)
|
||
Deferred tax assets, gross
|
5,583
|
|
|
—
|
|
||
Deferred tax liabilities
|
|
|
|
||||
Operating lease right of use assets
|
(5,583
|
)
|
|
—
|
|
||
Deferred tax assets, net
|
$
|
—
|
|
|
$
|
—
|
|
(1)
|
The valuation allowance for the year ended December 31, 2019 increased by $54.7 million, compared to the same period in 2018, primarily due to net operating losses and credits generated in those years.
|
|
Year Ended December 31,
|
||||||||||
(in thousands)
|
2019
|
|
2018
|
|
2017
|
||||||
Balance at the beginning of the period
|
$
|
4,200
|
|
|
$
|
2,577
|
|
|
$
|
1,819
|
|
Additions for prior years
|
—
|
|
|
333
|
|
|
—
|
|
|||
Additions for current year
|
1,498
|
|
|
1,290
|
|
|
758
|
|
|||
Balance at the end of the period
|
$
|
5,698
|
|
|
$
|
4,200
|
|
|
$
|
2,577
|
|
|
Three Months Ended
|
||||||||||||||||||||||||||||||
|
2019
|
|
2018
|
||||||||||||||||||||||||||||
|
December 31,
|
|
September 30,
|
|
June 30,
|
|
March 31,
|
|
December 31,
|
|
September 30,
|
|
June 30,
|
|
March 31,
|
||||||||||||||||
|
(in thousands, except per share amounts)
|
||||||||||||||||||||||||||||||
Revenue
|
$
|
89
|
|
|
$
|
46
|
|
|
$
|
—
|
|
|
$
|
278
|
|
|
$
|
487
|
|
|
$
|
2,362
|
|
|
$
|
686
|
|
|
$
|
193
|
|
Loss from operations
|
$
|
(46,170
|
)
|
|
$
|
(42,540
|
)
|
|
$
|
(39,122
|
)
|
|
$
|
(36,627
|
)
|
|
$
|
(38,412
|
)
|
|
$
|
(33,641
|
)
|
|
$
|
(34,919
|
)
|
|
$
|
(35,662
|
)
|
Net loss
|
$
|
(45,326
|
)
|
|
$
|
(41,409
|
)
|
|
$
|
(37,390
|
)
|
|
$
|
(35,304
|
)
|
|
$
|
(40,616
|
)
|
|
$
|
(32,834
|
)
|
|
$
|
(34,080
|
)
|
|
$
|
(35,037
|
)
|
Basic and diluted net loss
|
$
|
(45,326
|
)
|
|
$
|
(41,409
|
)
|
|
$
|
(37,390
|
)
|
|
$
|
(35,304
|
)
|
|
$
|
(40,616
|
)
|
|
$
|
(32,834
|
)
|
|
$
|
(34,080
|
)
|
|
$
|
(35,037
|
)
|
Basic and diluted net loss per share(1)
|
$
|
(0.99
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(0.86
|
)
|
|
$
|
(0.85
|
)
|
|
$
|
(1.12
|
)
|
|
$
|
(0.91
|
)
|
|
$
|
(0.94
|
)
|
|
$
|
(0.97
|
)
|
|
REVANCE THERAPEUTICS, INC.
|
|
|
|
|
|
By:
|
/s/ Mark J. Foley
|
|
|
Mark J. Foley
|
|
|
President and Chief Executive Officer
|
|
|
(Duly Authorized Principal Executive Officer)
|
|
|
|
|
By:
|
/s/ Tobin C. Schilke
|
|
|
Tobin C. Schilke
|
|
|
Chief Financial Officer
|
|
|
(Duly Authorized Principal Financial Officer and Principal Accounting Officer)
|
Signatures
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Mark J. Foley
|
|
President, Chief Executive Officer and Director
|
|
February 26, 2020
|
Mark J. Foley
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Tobin C. Schilke
|
|
Chief Financial Officer
|
|
February 26, 2020
|
Tobin C. Schilke
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Angus C. Russell
|
|
Director, Chairman
|
|
February 26, 2020
|
Angus C. Russell
|
|
|
|
|
|
|
|
|
|
/s/ Jill Beraud
|
|
Director
|
|
February 26, 2020
|
Jill Beraud
|
|
|
|
|
|
|
|
|
|
/s/ Robert Byrnes
|
|
Director
|
|
February 26, 2020
|
Robert Byrnes
|
|
|
|
|
|
|
|
|
|
/s/ Julian S. Gangolli
|
|
Director
|
|
February 26, 2020
|
Julian S. Gangolli
|
|
|
|
|
|
|
|
|
|
/s/ Phyllis Gardner
|
|
Director
|
|
February 26, 2020
|
Phyllis Gardner, M.D.
|
|
|
|
|
|
|
|
|
|
/s/ Chris Nolet
|
|
Director
|
|
February 26, 2020
|
Chris Nolet
|
|
|
|
|
|
|
|
|
|
/s/ Philip J. Vickers
|
|
Director
|
|
February 26, 2020
|
Philip J. Vickers, Ph.D.
|
|
|
|
|
•
|
before such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
|
•
|
upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
|
•
|
on or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least 66-2/3% of the outstanding voting stock that is not owned by the interested stockholder.
|
•
|
any merger or consolidation involving the corporation and the interested stockholder;
|
•
|
any sale, lease, transfer, pledge or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder;
|
•
|
subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
|
•
|
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; or
|
•
|
the receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits by or through the corporation.
|
a.
|
All Eligible Directors: $42,000
|
b.
|
Chairman of the Board Service Retainer (including Eligible Director Service Retainer): $78,000
|
a.
|
Member of the Audit Committee: $10,000
|
b.
|
Member of the Compensation Committee: $7,500
|
c.
|
Member of the Nominating & Governance Committee: $5,000
|
d.
|
Member of the Science & Technology Committee: $6,000
|
e.
|
Member of the Brand Strategy Committee: $6,000
|
a.
|
Chairman of the Audit Committee: $20,000
|
b.
|
Chairman of the Compensation Committee: $15,000
|
c.
|
Chairman of the Nominating & Governance Committee: $10,000
|
d.
|
Chairman of the Science & Technology Committee: $12,500
|
e.
|
Chairman of the Brand Strategy Committee: $12,500
|
1.
|
Initial Option Grant: On the date of the Eligible Director’s initial election to the Board, for each Eligible Director who is first elected to the Board following the Effective Date (or, if such date is not a market trading day, the first market trading day thereafter), the Eligible Director will be automatically, and without further action by the Board or Compensation Committee of the Board, granted a stock option for 20,000 shares (an “Initial Option Grant”). The shares subject to each Initial Option Grant will vest on the one year anniversary of the date of grant, subject to the Eligible Director’s Continuous Service (as defined in the Plan) through each such vesting date.
|
2.
|
Initial Restricted Stock Award: On the date of the Eligible Director’s initial election to the Board, for each Eligible Director who is first elected to the Board following the Effective Date (or, if such date is not a market trading day, the first market trading day thereafter), the Eligible Director will be automatically, and without further action by the Board or Compensation Committee of the Board, granted a restricted stock award for 10,000 shares (an “Initial RSA”). The shares underlying the Initial RSA will vest on the one year anniversary of the date of grant, subject to the Eligible Director’s Continuous Service (as defined in the Plan) through such vesting date.
|
3.
|
Annual Option Grant: On the date of each Company’s annual stockholder meeting held after the Effective Date, each Eligible Director who continues to serve as a non-employee member of the Board will be automatically, and without further action by the Board or Compensation Committee of the Board, granted a stock option for 12,000 shares (an “Annual Option Grant”). The shares subject to the Annual Option Grant will vest on the one year anniversary of the date of grant, subject to the Eligible Director’s Continuous Service (as defined in the Plan) through such vesting date.
|
4.
|
Annual Restricted Stock Award: On the date of each Company’s annual stockholder meeting held after the Effective Date, each Eligible Director who continues to serve as a non-employee member of the Board will be automatically, and without further action by the Board or Compensation Committee of the Board, granted a restricted stock award for 6,000 shares (an “Annual RSA”). The shares underlying the Annual RSA will vest on the one year anniversary of the date of grant, subject to the Eligible Director’s Continuous Service (as defined in the Plan) through such vesting date.
|
|
|
REVANCE THERAPEUTICS, INC.
|
||
|
|
|
|
|
|
|
|
By:
|
/s/ Mark J. Foley
|
|
|
|
|
Mark J. Foley
|
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
|
|
EXECUTIVE
|
||
|
|
|
|
|
|
|
|
By:
|
/s/ Dustin Sjuts
|
|
|
|
|
Dustin Sjuts
|
|
|
|
|
Chief Commercial Officer, Aesthetics & Therapeutics
|
January 8, 2020
|
|
|
|
Via Hand Delivery
|
(b)
|
Health Care Continuation Coverage.
|
12.
|
RELEASE OF CLAIMS.
|
(b)
|
Scope of Release. The Released Claims include, but are not limited to:
|
REVANCE THERAPEUTICS, INC.
|
|
|
|
|
|
|
|
By:
|
/s/ Mark J. Foley
|
|
|
|
Mark J. Foley
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
|
ACCEPTED AND AGREED:
|
|
|
|
|
|
|
|
By:
|
/s/ Caryn G. McDowell
|
|
|
|
Caryn G. McDowell
|
|
|
|
|
|
|
|
January 8, 2020
|
|
|
|
Date
|
|
|
|
|
|
|
|
Caryn G. McDowell
|
|
|
|
|
|
|
|
|
|
|
|
Date
|
|
|
|
|
REVANCE THERAPEUTICS, INC.
|
||
|
|
|
|
|
|
|
|
By:
|
/s/ Mark J. Foley
|
|
|
|
|
Mark J. Foley
|
|
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
|
EXECUTIVE
|
||
|
|
|
|
|
|
|
|
By:
|
/s/ Dwight Moxie
|
|
|
|
|
Dwight Moxie
|
|
|
|
|
|
|
|
|
|
January 20, 2020
|
|
|
|
|
Date
|
Exclusive Distribution Agreement
|
|
|
|
Dated January 10, 2020
|
|
|
|
between
|
|
|
|
Teoxane SA
|
(the Supplier)
|
Rue de Lyon 105, CH-1203 Geneva, Switzerland
|
|
|
|
and
|
|
|
|
Revance Therapeutics Inc.
|
(the Distributor)
|
7555 Gateway Boulevard Newark, California, USA
|
|
|
|
(the Supplier and the Distributor, together the Parties, and each a Party)
|
|
7
|
|
||||
|
|
|
|||
20
|
|
||||
|
20
|
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|
20
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21
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22
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22
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23
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25
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|
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26
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26
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27
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28
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28
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28
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29
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29
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30
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30
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30
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31
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|
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31
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|
||||
|
31
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|
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|
34
|
|
|||
|
35
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|
|||
|
|
35
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|
||
|
|
36
|
|
|
|
57
|
|
||
|
|
|
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|
|
58
|
|
||||
|
|
|
|||
58
|
|
||||
|
|
|
|||
60
|
|
||||
|
|
|
|||
64
|
|
||||
|
|
|
|||
66
|
|
||||
|
66
|
|
|||
|
66
|
|
|||
|
67
|
|
|||
|
68
|
|
|||
|
68
|
|
|||
|
|
68
|
|
||
|
|
68
|
|
||
|
69
|
|
|||
|
|
69
|
|
||
|
|
71
|
|
||
|
|
71
|
|
||
|
|
|
|
|
|
71
|
|
||||
|
|
|
|||
72
|
|
||||
|
72
|
|
|||
|
72
|
|
|||
|
73
|
|
|||
|
|
|
|
|
|
74
|
|
||||
|
74
|
|
|||
|
75
|
|
|||
|
75
|
|
|||
|
76
|
|
|||
|
76
|
|
|||
|
76
|
|
|||
|
77
|
|
A.
|
The Supplier is a Swiss share corporation having its registered office at rue de Lyon 105, 1203 Geneva, Switzerland.
|
B.
|
The Supplier is a company specialised in the development, manufacturing and distribution of sterile injectable products based on crosslinked or non-cross-linked hyaluronic acid, in particular intended for filling depressions, wrinkles and fine lines. It holds intellectual property rights as well as specific and recognised know-how in the medical, clinical and biophysical fields and in the development and manufacturing of wrinkle filling products based on hyaluronic acid that qualify as medical devices or cosmetics.
|
C.
|
The Distributor is a biotechnology company with its headquarters located in Newark, California, USA.
|
D.
|
The Distributor is a company currently in the process of developing DaxibotulinumtoxinA, a product intended for injection, combining a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components and is indicated for aesthetics (the DAXI Product).
|
E.
|
The Supplier intends to appoint the Distributor as exclusive Distributor for certain products in the Territory according to the terms and conditions of this Agreement (as defined below), and the Distributor intends to accept such appointment.
|
(a)
|
Affiliate shall mean with respect to a Party, any person or entity that is directly or indirectly controlled by, under common control with, or that controls such Party. For the avoidance of doubt, any such person or entity shall cease to be an "Affiliate" of such Party under this Agreement when such person or entity (as the case
|
(b)
|
Agreed New Fillers shall mean for the following products for which the Supplier at its discretion intends to obtain Regulatory Approval:
|
(i)
|
the hyaluronic acid-based dermal filler RHA 1 containing lidocaine or mepivacaine and that is indicated for injection in the dermis and superficial dermis of the face for correction of moderate to severe perioral rhytids in adults aged 22 years or older, and
|
(ii)
|
the hyaluronic acid-based dermal fillers (a) RHA 2, (b) RHA 3 and (c) RHA 4 containing mepivacaine and that are indicated for injection in the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds (such as nasolabial folds) in adults aged 22 years or older, and
|
(iii)
|
any Possible New Fillers qualifying as Agreed New Fillers according to Clause 2.5(a).
|
(c)
|
Agreed New Indications shall mean for the following products for which the Supplier at its discretion intends to obtain Regulatory Approval:
|
(i)
|
RHA 1 containing lidocaine or mepivacaine indicated for the
|
(ii)
|
RHA 3 containing lidocaine or mepivacaine indicated for injections into lips for lip augmentation in adults aged 22 years or older; and
|
(iii)
|
RHA 4 containing lidocaine or mepivacaine indicated for injections into the mid- to deep-dermis for cheek augmentation and correction of age-related mid-face contour deficiencies in adults aged 22 years or older.
|
(d)
|
Agreement shall mean this exclusive distribution agreement including all of its Annexes.
|
(e)
|
[*]
|
(f)
|
[*]
|
(g)
|
AMLA shall have the meaning set forth in Clause 14(a)(iii).
|
(h)
|
Annex shall mean an annex to this Agreement.
|
(i)
|
Approved Dermal Fillers shall mean the products RHA 2, RHA 3 and RHA 4, all containing lidocaine, which have the necessary Regulatory Approvals, and whose approved indications are as follows:
|
(i)
|
RHA 2 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older;
|
(j)
|
Binding Purchase Commitments shall have the meaning set forth in Clause 9.2(c).
|
(k)
|
Business Day shall mean a day (other than a Saturday or Sunday) on which banks are open for general business in Geneva (Switzerland) and New-York (United States of America).
|
(l)
|
Business Forecast shall mean the Initial Business Forecast or the New Business Forecast (as applicable). The Initial Business Forecast is attached as Annex 8.1(a) to the Agreement.
|
(m)
|
[*] Option shall mean the right to [*], subject to the conditions set forth at Clause 2.6(d) of the Agreement and in exchange for the payment of [*], the distribution right for the Territory of a Possible New Filler where [*] within [*] calendar days from the receipt of the Written Proposal for such Possible New Filler.
|
(n)
|
Change of Control shall mean, with respect to the Distributor, the acquisition (directly or indirectly, whether by merger, consolidation, purchase and sale, share exchange or otherwise, and whether effected by one (1) or a series of transactions occurring prior to or after the Effective Date) by a Competitor of a beneficial interest in the securities of the Distributor representing more than [*] of the combined voting power of the Distributor’s then outstanding securities.
|
(o)
|
CHF shall mean Swiss francs, being the lawful currency of Switzerland.
|
(p)
|
Clause shall mean any clause of this Agreement.
|
(q)
|
Clinical Trial Costs shall mean all [*] costs [*] arising out of the clinical trial activities [*].
|
(r)
|
CO shall mean the Swiss Code of Obligations (OR).
|
(s)
|
Commercialisation Expenses shall mean the costs related to the advertisement and promotion of the Filler Products to customers and consumers, as accounted for and recorded in accordance with the Distributor’s standard accounting practice as well as US GAAP. [*]:
|
(i)
|
[*];
|
(ii)
|
[*];
|
(iii)
|
[*].
|
(t)
|
Committee shall have the meaning given on Clause 4.1(a).
|
(u)
|
Confidential Information shall mean any and all non-public information, regardless of its form and the type of disclosure (whether written, oral or electronic, and including, without limitation, documents, data files, charts, sketches, plans, e-mails, trade secrets, know-how, technical and scientific information, business forecasts and strategies, marketing plans, customer and supplier lists, product information, research and development
|
(i)
|
a Party makes directly or indirectly available to the other Party in connection with this Agreement or has already made available prior to the conclusion of the Agreement; and
|
(ii)
|
has been identified in writing or marked as "confidential" or which should reasonably be known by the receiving Party to be confidential by nature (in particular financial data, sales figures, know-how, customer lists), provided that oral disclosures shall be reduced to writing and designated as confidential within thirty days following disclosure.
|
(1)
|
it has become publicly available without the receiving Party being involved in breach of its obligations or otherwise being responsible for it;
|
(2)
|
a Party has created or obtained the information itself independently of the disclosure by the other Party, provided that such Party may assume in good faith that no confidentiality obligations have been breached thereby and that such Party may use and/or disclose this information; or
|
(3)
|
a Party has explicitly excluded from the confidentiality obligations in written form beforehand.
|
(v)
|
Contract Year shall mean a twelve-month period ending on 31 December of each calendar year, with the exception of the first Contract Year which shall be deemed to begin on the Launch Date and end on the expiration of that Contract Year in which it falls.
|
(w)
|
Core Terms shall have the meaning set forth in Clause 11.1.
|
(x)
|
Cosmeceutical Core Terms shall have the meaning set forth in Clause 2.6(a).
|
(y)
|
Cosmeceutical Distribution Agreement shall have the meaning set forth in Clause 2.6(d).
|
(z)
|
Cosmeceutical Distribution Proposal shall have the meaning set forth in Clause 2.6(a).
|
(aa)
|
Cosmeceutical Exercise Notice Period shall have the meaning set forth in Clause 2.6(b).
|
(bb)
|
Cosmeceutical ROFN shall have the meaning set forth in Clause 2.6(a).
|
(cc)
|
Cosmeceutical(s) shall mean cosmeceutical product(s) manufactured by the Supplier and that do not require any Regulatory Approval.
|
(dd)
|
DAXI Product shall have the meaning as set forth in Preamble D.
|
(ee)
|
Delivery Date shall have the meaning set forth in Clause 9.3(b).
|
(ff)
|
Distribution Proposal shall have the meaning set forth in Clause 11.1(b).
|
(gg)
|
Distributor shall have the meaning set forth in cover page of this Agreement.
|
(hh)
|
Distributor IPR shall have the meaning set forth in Clause 7.2(a).
|
(ii)
|
Distributor Marks means the trademark(s) and tradename(s) of Distributor listed in Annex 7.2(a) and such other trademarks as the Distributor notifies to the Supplier in writing from time to time
|
(jj)
|
Distributor Non-Compete Undertaking shall have the meaning set forth in Clause 12.
|
(kk)
|
Effective Date shall mean the date of the execution of this Agreement or the date of execution of the Share Purchase Agreement, whichever is later, by the Parties.
|
(ll)
|
Exercise Notice Period shall have the meaning set forth in Clause 11.1(c).
|
(mm)
|
Expenditure Report shall have the meaning set forth in Clause 8.2.4(b).
|
(nn)
|
FDA shall mean the United States Food and Drug Administration, and any successor agency thereto.
|
(oo)
|
Filler Products shall mean all together the Approved Dermal Fillers, the Agreed New Fillers, the Agreed New Indications and the Possible New Fillers.
|
(pp)
|
GAAP shall mean United States generally accepted accounting practices.
|
(qq)
|
Good Manufacturing Practices shall mean the good manufacturing practices, as established by FDA and applicable law, including all applicable U.S, federal, state, foreign and local environmental, health and safety laws, in effect at the time and place of manufacture.
|
(rr)
|
Healthcare Technologies shall mean software and hardware technology services which are associated with point of sale, subscription services, EMR, patient education, patient marketing, loyalty programs designed to increase retention, conversion and outreach for aesthetic practices.
|
(ss)
|
Indemnified Party shall have the meaning set forth in Clause 13(c).
|
(tt)
|
Indemnifying Party shall have the meaning set forth in Clause 13(c).
|
(uu)
|
Initial Minimum Purchase Commitment shall have the meaning set forth in Clause 9.13.1(a).
|
(vv)
|
Initial Business Forecast shall have the meaning set forth in Clause 8.1(a).
|
(ww)
|
Initial Products shall mean (i) the Approved Dermal Fillers and (ii) Cosmeceuticals.
|
(xx)
|
Initial Purchase Order shall have the meaning set forth in Clause 9.2(b).
|
(yy)
|
Innovation Plan shall have the meaning set forth in Clause 5.1.
|
(zz)
|
Intellectual Property Right or IPR shall mean patents, rights to inventions, copyright and related rights, moral rights, trademarks, service marks, logos, symbols, signs, business, company and trade names, get-up and trade dress, domain names, and social media usernames, goodwill and the right to sue for passing off or unfair competition, rights in designs, rights in computer software, database rights, rights to use, trade secrets and other confidential and proprietary know-how, and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.
|
(aaa)
|
Launch Date shall mean the date of the first commercialisation of
|
(bbb)
|
Minimum Commercialisation Effort shall have the meaning set forth in Clause 8.2.4(a).
|
(ccc)
|
Minimum Purchase Commitment shall mean Initial Minimum Purchase Commitment and Subsequent Minimum Purchase Commitment.
|
(ddd)
|
Net Sales shall mean the consolidated net sales of the Products in the Territory, as such net sales are reported in the publicly filed audited consolidated financial statements of the Distributor determined in accordance with the accounting principles and practices used by the Distributor to calculate net sales for purposes of the preparation of its annual audited consolidated financial statements, for the applicable Contract Year.
|
(eee)
|
Neutral Accounting Firm shall have the meaning set forth in Clause 8.2.4(d).
|
(fff)
|
New Business Forecast shall have the meaning set forth in Clause 8.1(b).
|
(ggg)
|
New Product(s) shall mean the Agreed New Fillers and the Agreed New Indications; all intended to receive Regulatory Approval (if applicable).
|
(hhh)
|
New Filler Option Period shall have the meaning set forth in Clause 2.5(c).
|
(iii)
|
Non-Achieved Commitment Amount shall have the meaning set forth in Clause 9.13.1(a).
|
(jjj)
|
Not-For-Sale Products shall mean the Products that are
|
(i)
|
for free; or
|
(ii)
|
on a rebated and/or discounted basis wherein the rebate or discount is [*] of the Products sold in the Territory, being clarified that rebates [*] shall [*] Not-For-Sale Products.
|
(kkk)
|
Party/Parties shall have the meaning set forth in cover page of this Agreement.
|
(lll)
|
Person shall mean any natural person, corporation, company, partnership, limited liability company, proprietorship, trust or estate, joint venture, association or other legal entity.
|
(mmm)
|
Possible New Filler(s) shall mean any hyaluronic acid dermal fillers developed and manufactured by the Supplier other than (i) the Approved Dermal Fillers, (ii) the Agreed New Fillers, (iii) any Possible New Filler(s) that is not included as an Agreed New Filler pursuant to Clause 2.5, or (iv) the Agreed New Indications that shall obtain Regulatory Approval at the Supplier’s discretion.
|
(nnn)
|
Products shall mean the Initial Products and the New Products.
|
(ooo)
|
Projected Net Sales shall mean the amounts set out in the Business Forecasts as estimated Net Sales (as defined under Clause 1(ddd)) for the relevant Contract Year (which, for future Business Forecasts shall be based on good faith estimates taken from the Distributor’s actual Net Sales in accordance with Clause 8.1(b) or, if the Parties do not agree on a New Business Forecast, according to the default mechanism to determine New Business Forecast as defined in Annex 8.1(b)).
|
(ppp)
|
Purchase Order shall have the meaning set forth in Clause 9.3.
|
(qqq)
|
Purchase Price shall have the meaning set forth in Clause 9.9(a).
|
(rrr)
|
Purpose shall have the meaning set forth in Clause 18.2(b)
|
(sss)
|
Quality Agreement shall mean the quality agreement set forth in Annex 6.3.
|
(ttt)
|
Recall shall have the meaning set forth in Clause 9.12(a).
|
(uuu)
|
Recall Costs shall have the meaning set forth in Clause 9.12(e).
|
(vvv)
|
Regulatory Approvals shall mean all governmental authorisations, clearance, registrations and approvals as required for the distribution of the relevant products in the Territory.
|
(www)
|
Regulatory Authority shall mean the FDA and any other applicable U.S., federal, state, foreign and local authority.
|
(xxx)
|
Right of First Negotiation shall have the meaning set forth in Clause 11.1(a).
|
(yyy)
|
Sanctioned Country shall have the meaning set forth in Clause 14(a)(iv)(2).
|
(zzz)
|
Sanctioned Person shall have the meaning set forth in Clause 14(a)(iv)(1).
|
(aaaa)
|
Sanctions Laws shall have the meaning set forth in Clause 14(a)(iv)(1).
|
(bbbb)
|
Share Purchase Agreement shall have the meaning set forth in Clause 3(b).
|
(cccc)
|
Subsequent Minimum Purchase Commitment shall have the meaning set forth in Clause 9.13.2.
|
(dddd)
|
Supplier IPR shall have the meaning set forth in Clause 7.1(b).
|
(eeee)
|
Supplier Marks means the trademark(s) and tradename(s) of Supplier listed in Annex 7.1 and such other trademarks as the Supplier notifies to the Distributor in writing from time to time after the Effective Date of this Agreement.
|
(ffff)
|
Supplier New IPR shall have the meaning set forth in Clause 7.1(b).
|
(gggg)
|
Supplier Prior IPR shall have the meaning set forth in Clause 7.1.
|
(hhhh)
|
Supported Percentage shall have the meaning set forth in Clause 10.1(b).
|
(iiii)
|
Term shall mean the term of the Agreement until termination or expiration of the Agreement.
|
(jjjj)
|
Third Party shall mean any Person other than the Parties or their respective Affiliates.
|
(kkkk)
|
Territory shall mean the United States of America, including the District of Columbia, Puerto Rico and all states, territories, possessions and protectorates thereof.
|
(llll)
|
Unit shall mean with respect to each relevant product, one (1) box consisting of two (2) syringes.
|
(mmmm)
|
USD shall mean United States Dollar, being the lawful currency of the United States of America.
|
(nnnn)
|
Warranty shall have the meaning set forth in Clause 9.6(a).
|
(oooo)
|
Written Proposal shall have the meaning set forth in Clause 2.6(a).
|
2.
|
Appointment and Exclusivity
|
2.1.
|
Appointment
|
(a)
|
The Supplier appoints the Distributor as the exclusive distributor for the Filler Products in the Territory for the Term, and the Distributor accepts such appointment for the Term, subject to the terms and conditions of this Agreement.
|
(b)
|
For clarity, except as set forth in Clause 2.6, unless otherwise agreed upon between the Parties by way of an amendment to this Agreement no exclusivity whatsoever is granted by the Supplier to the Distributor with respect to the Cosmeceuticals in the Territory.
|
(a)
|
Subject to the terms and conditions of this Agreement, the Supplier grants the Distributor a non-transferable (except for permitted assignments under Clause 19.8 or permitted sub-contracting under Clause 2.4) exclusive rights to import, market, promote, sell and distribute the Filler Products in and within the Territory for the Term provided and to the extent that the respective Filler Product has Regulatory Approval and/or can be lawfully distributed in compliance with the applicable laws.
|
(b)
|
In this context, for the Term, the Supplier agrees:
|
(i)
|
not to appoint any other distributor or third party distributor for the Filler Products for the Territory; and
|
(ii)
|
not to carry out any active, direct marketing, promotion and/or sales or import of the Filler Products in the Territory.
|
(c)
|
For the avoidance of doubt, any rights of the Supplier not expressly granted to the Distributor under this Agreement shall be retained by the
|
(i)
|
appointing any distributor or third party distributor of the Filler Products and/or any other dermal fillers outside of the Territory;
|
(ii)
|
importing, marketing, promoting, selling and distributing the Filler Products and/or any other dermal fillers outside of the Territory.
|
(d)
|
The Distributor shall not actively export, sell or distribute the Products outside the Territory. In addition, the Distributor shall further not sell or distribute the Products outside the Territory without the government or regulatory approvals required for the sale of the Products in the territory(ies) concerned.
|
(a)
|
The relationship between the Distributor and the Supplier shall be that of independent contractors. Nothing contained in this Agreement shall be construed to imply a joint venture or principal-agent relationship between the Parties.
|
(b)
|
The Distributor shall act in its own name and for its own account. All financial obligations associated with the business of the Distributor are the sole responsibility of the Distributor.
|
(c)
|
Neither Party shall have, nor shall they hold themselves out as having any right, power or authority to create any contract or obligation, either expressed or implied on behalf of, in the name of, or binding upon the other Party.
|
(a)
|
The Distributor [*] the Supplier.
|
(b)
|
The Distributor may appoint [*]. The Distributor may also delegate the execution or performance of any of its obligations under this Agreement through one or several of its Affiliates, subject to (i) prior written notice by the Distributor of such delegation to the Supplier (identifying the obligations delegated and the Affiliates to whom such obligations shall be delegated) and (ii) the Distributor remaining always fully and jointly liable to the Supplier for the compliance of such Affiliates with the terms of this Agreement, and for any liability arising from the performance by such Affiliates.
|
2.5.
|
Development of Possible New Fillers by the Supplier
|
(a)
|
In the event the Supplier intends to pursue the necessary Regulatory Approvals for a new Possible New Filler in the Territory, any clinical trial design and protocol related thereto shall be provided to the Committee, provided that all such information and materials shall be deemed confidential Supplier IPR. The Committee shall then provide its comments and suggestions, if any, to the Supplier. The Supplier shall then submit to the Distributor a written proposal containing (i) the description of the project related to the Possible New Filler, and (ii) an estimate of the relevant Clinical Trial Costs (the Written Proposal).
|
(b)
|
Should the Distributor agree to pursue the distribution of such Possible New Filler in the Territory, such Possible New Filler shall qualify as an Agreed New Filler under the Agreement and all the provisions of the Agreement shall apply with respect to this Possible New Filler as an Agreed New Filler including the cost sharing with regard to the Clinical Trial Costs for Agreed New Fillers.
|
(c)
|
Should the Distributor not accept in writing to pursue the distribution of such Possible New Filler within [*] calendar days of receipt of the Written Proposal (the New Filler Option Period), the Supplier shall have the right to distribute such Possible New Filler, whether directly or indirectly (notably through the appointment of a Third Party distributor), in the Territory, and Distributor shall have no liability for any Clinical Trial Costs associated with such Possible New Filler.
|
(d)
|
Without limiting Clause 2.5(c), the Distributor may, at any time during the [*] period after the expiration of the New Filler Option Period, elect by written notice to the Supplier to exercise the [*]. If the Distributor gives such notice, the Supplier shall confirm to the Distributor [*] following expiration of the New Filler Option Period), and provide within [*] Business Days an invoice for [*]. If the Supplier provides such confirmation, the Distributor shall [*], and effective as of the date of the Supplier’s confirmation notice, such Possible New Filler will become an Agreed New Filler and subject to all provisions of this Agreement in relation thereto.
|
2.6.
|
Distributor’s Right of Negotiation for Cosmeceuticals
|
(a)
|
In the event the Supplier intends to appoint a distributor in the Territory for Cosmeceuticals the Supplier hereby grants the Distributor in first priority the exclusive right to negotiate an exclusive distribution agreement for the distribution of such Cosmeceuticals at any time after the Supplier files for the relevant regulatory approval (if and to the extent necessary) for such Cosmeceutical in the Territory (the Cosmeceutical ROFN). The Supplier shall notify and provide relevant information to the Distributor with regard to such Cosmeceuticals, including a list of the Cosmeceuticals the Supplier proposes to launch, and a written distribution proposal (a Cosmeceutical Distribution Proposal). Each Cosmeceutical Distribution Proposal shall contain at a minimum the following terms: [*] (the Cosmeceutical Core Terms). Notwithstanding the foregoing, the Supplier agrees that it (1) will not provide any Cosmeceutical Distribution Proposal to the Distributor before the date that is [*], and (2) will not enter into any agreement (including any amendment of any existing agreement) with a Third Party with respect to granting exclusive rights to distribute Cosmeceuticals in the Territory until [*].
|
(b)
|
If the Distributor wishes to exercise the Cosmeceutical ROFN, it shall notify the Supplier or any of its Affiliates thereof within a period of [*] of the receipt of the Cosmeceutical Distribution Proposal (the Cosmeceutical Exercise Notice Period). If the Distributor is not provided with the Cosmeceutical Core Terms in the Cosmeceutical Distribution
|
(c)
|
If the Distributor does not exercise its Cosmeceutical ROFN within the Cosmeceutical Exercise Notice Period the Supplier or any of its Affiliates shall be free to enter into negotiation with any other Party on the distribution of the applicable Cosmeceuticals and/or to distribute itself the Cosmeceuticals in the Territory. The non-exercise of the Cosmeceutical Right of First Negotiation shall in no case be construed as a waiver of the Supplier’s rights under this Agreement, except with respect to the applicable Cosmeceutical(s) that were the subject of such Cosmeceutical ROFN.
|
(d)
|
If the Distributor exercises its Cosmeceutical ROFN within the Cosmeceutical Exercise Notice Period, the Supplier and the Distributor or any of its Affiliates shall enter in good faith into exclusive negotiation for a period of [*] from the date of the Distributor’s exercise, in respect of the distribution of the applicable Cosmeceutical(s) in the Territory, and endeavour to reach an agreement on the purchase price for such Cosmeceuticals and any other terms and conditions of such distribution, and incorporate such terms into an amendment to this Agreement (the Cosmeceutical Distribution Amendment).
|
(e)
|
The negotiation shall be deemed as terminated upon the earlier of:
|
(i)
|
the Cosmeceutical Distribution Amendment has validly been signed by both Parties and/or its Affiliates; or
|
(ii)
|
the Parties and/or its Affiliates jointly agree in writing on the termination of the negotiation; or
|
(iii)
|
the Cosmeceutical Distribution Amendment is not signed within [*] after commencement of the negotiation.
|
(f)
|
Upon agreement between the Parties on an amendment for any Cosmeceutical, it shall qualify as a Cosmeceutical under the Agreement and all the provisions of the Agreement shall apply with respect to this New Cosmeceutical.
|
(g)
|
The Distributor understands and acknowledges it is at the Supplier’s discretion if any Cosmeceutical shall be distributed in the Territory and that the Distributor and/or its Affiliates have no claim that any Cosmeceutical will ever reach market maturity.
|
3.
|
Down Payment
|
(a)
|
As consideration for the granting of the exclusive distribution rights pursuant to this Agreement, the Distributor shall irrevocably and unconditionally deliver to the Supplier on the Effective Date 2,500,000 common stock shares of the Distributor (the Shares). After [*] lock-up period (as described in the Share Purchase Agreement), the Shares may be freely sold by the Supplier in accordance with applicable securities laws.
|
(b)
|
In respect of Clause 3(a) the Parties shall enter into a separate share purchase agreement in the form attached hereto as Annex 3(b) (the Share Purchase Agreement):
|
(c)
|
The Shares delivered or due under this Clause 3 shall not be refundable by the Supplier to the Distributor for whatever reason.
|
4.
|
Governance and Committee Structure
|
4.1.
|
Committee Establishment
|
(a)
|
The Parties shall establish a committee (the Committee) which shall facilitate the exchange of information and communication between the Parties with respect to this Agreement.
|
(b)
|
Within thirty (30) calendar days of the Effective Date, the Parties shall appoint their representatives to the Committee, in accordance with the principles set forth below.
|
(c)
|
The Committee shall be composed of at least three (3) representatives of the Supplier and of the Distributor, but in any case an equal number of representatives of each Party. Each Party may replace its representatives at any time upon written notice to the other Party. The Supplier shall elect the secretary of the Committee, who shall be responsible for calling the meetings (at its own option or at the request of another member of the Committee), preparing and circulating an agenda and preparing and issuing minutes of the meetings, to be reviewed and commented by the other members of the Committee.
|
(d)
|
The Committee shall hold meetings at such times and in such places as it elects to do so, but in no event shall such meetings be held less frequently than once a quarter. Meetings of the Committee may be held by audio or video teleconference. A meeting of the Committee will not be validly held unless at least one (1) representative of each Party attends such meeting.
|
(e)
|
Each Party shall be responsible for all its own expenses in connection with its participation in the Committee.
|
4.2.
|
Responsibilities
|
(a)
|
At the Committee, the representatives of the Supplier shall inform the representatives of the Distributor on the progress of the implementation of the Innovation Plan.
|
(b)
|
The Committee:
|
(i)
|
shall discuss any present and future sales of the Products, market conditions in the Territory, marketing plan, the market’s response to the Products and customers’ feedbacks, any competition in the Territory, the implementation of new marketing policies and progress of the implementation of the Innovation Plan;
|
(ii)
|
shall serve as platform for discussion with respect to the rights and obligations of each Party set forth in the Agreement; and
|
(iii)
|
shall fulfil its duties in accordance with the Agreement.
|
(c)
|
The Committee has no authority, implicit or otherwise, to take any decision with respect to or amend the Agreement or to act in any way on behalf of a Party.
|
(d)
|
The Parties shall discuss in good faith the setting-up of any measures that prove necessary to protect their respective Confidential Information such as trade secrets and confidential Intellectual Property Rights.
|
(e)
|
The representatives of the Distributor shall keep the representatives of the Supplier reasonably informed about the activities of the Distributor with respect to the distribution and the sales of the Products and about market conditions in the Territory. The representatives of the Distributor shall provide reasonable additional information in response to any reasonable request for information of the Supplier’s representatives on the Committee in connection with the Distributor’s activities under this Agreement.
|
5.
|
Innovation Plan for the New Products
|
5.1.
|
Innovation Plan for New Products
|
(a)
|
The innovation plan for the New Products for the Territory covering the first [*] Contract Years (the Innovation Plan) is attached as Annex 5.1 hereto.
|
(b)
|
The Distributor understands and acknowledges that it has no claim that any of the New Products will ever reach market maturity and/or receive Regulatory Approval (if applicable).
|
5.2.
|
Implementation of the Innovation Plan
|
(a)
|
The Supplier shall be solely responsible for conducting all researches and development activities in connection with the New Products for the Territory, and it shall use commercially reasonable efforts to implement the Innovation Plan.
|
(b)
|
The Parties acknowledge and agree that the research on and development and launch of the New Products may deviate from the Innovation Plan, provided that such deviations shall have no impact whatsoever on the obligations of the Parties under this Agreement. Without prejudice to the foregoing, the Supplier will provide any updates to the Innovation Plan (including any changes to expected timelines) for discussion at regular meetings of the Committee, in any case no less frequently than quarterly, provided that the Supplier shall use its commercially reasonable efforts to notify the Distributor promptly of any material deviations from the Innovation Plan, and the Parties shall discuss any impacts of such deviations through the Committee.
|
(c)
|
The Distributor may request the Supplier to inform the Committee on the actual implementation of the Innovation Plan once in each calendar quarter of each Contract Year.
|
5.3.
|
Clinical Trial Costs
|
(a)
|
The Supplier shall inform the Distributor in the last quarter of each Contract Year of the forecasted Clinical Trial Costs for which the Distributor is obligated to pay a share for the following Contract Year with the exception of the first Contract Year where the forecasted Clinical Trial Costs are set forth as Annex 5.3 to this Agreement.
|
(b)
|
Irrespective of whether the relevant products obtain FDA approval or not, [*] of the Supplier’s Clinical Trial Costs. The Supplier shall provide the Distributor each calendar quarter with a rolling update of Clinical Trial Costs actually incurred, and an estimate of Clinical Trial Costs to be incurred in the following calendar quarter.
|
(c)
|
The Supplier shall pay the Clinical Trial Costs when due, and report to the Distributor at least once every calendar quarter) with regard to the
|
(d)
|
The Clinical Trial Costs to be borne by the Distributor shall be paid by the Distributor to the Supplier by wire transfer to the bank account notified by the Supplier within [*] calendar days of the Distributor’s receipt of the invoice; provided however that Supplier shall not submit such an invoice more frequently than once in any [*] period.
|
(e)
|
Any disputes related to the Clinical Trial Costs shall be settled in accordance with Clauses 8.2.4(c) and 8.2.4(d) by analogy.
|
5.4.
|
Revision of the Innovation Plan
|
(a)
|
The Parties agree to include in the Innovation Plan any Possible New Fillers developed by the Supplier and accepted by the Distributor according to Clause 2.5 and not already included in the Innovation Plan.
|
(b)
|
In such event, (i) the Possible New Filler shall qualify as an Agreed New Filler under the Agreement and (ii) Clause 5.3 regarding the Clinical Trial Costs shall apply.
|
6.
|
Regulatory Approval and Compliance
|
6.1.
|
Regulatory Approval
|
(a)
|
The Supplier shall be responsible for obtaining and maintaining all Regulatory Approvals for the Products, if and to the extent necessary, during the Term, and only the Supplier shall act as authorisation holder of all such Regulatory Approvals.
|
(b)
|
Subject to Clause 5.3 of the Agreement with respect to Clinical Trial Costs, the Supplier shall bear all other costs and expenses for obtaining
|
(c)
|
If and when requested by the Supplier, the Distributor shall provide, [*], all reasonable assistance to the Supplier in obtaining and maintaining the Regulatory Approvals, in particular but not limited to assistance in [*].
|
6.2.
|
Compliance with all Applicable Laws and Reporting
|
(a)
|
The Distributor undertakes that during the Term it shall commercialize (including but not limited to any marketing endeavours), distribute and sell the Products and the Not-For-Sale Products, and perform under this Agreement, in the Territory in compliance with and subject to all applicable laws and regulations as well as the Marketing Authorizations where applicable.
|
(b)
|
Upon the Distributor’s reasonable request, the Supplier shall provide, directly to the FDA or such other competent Regulatory Authority, with the information and documents mandatorily requested by applicable laws to fully enable the Distributor to perform its obligations under the Agreement; it being specified that the Distributor shall under no circumstance be provided with nor granted access to any information pertaining to the Supplier’s manufacturing know-how.
|
(c)
|
The Distributor shall use its reasonable efforts to notify promptly the Supplier of any breach or alleged breach it would become aware of, including but not limited to correspondence from a Regulatory Authority alleging any breach, of any applicable law and/or the Regulatory Approvals in connection with the performance of this Agreement.
|
(d)
|
The Distributor shall be the primary importer of the Products and Not-For-Sale Products, and shall comply with and assume all obligations under all laws and regulations applicable in this capacity.
|
(e)
|
The Distributor undertakes that during the Term and thereafter, as long as required by law, it must comply with all documentation and reporting requirements according to applicable laws and support and grant the
|
(f)
|
The Distributor undertakes that during the Term and thereafter it shall comply with its obligation set forth in Annex 6.2(f).
|
6.3.
|
Quality Agreement
|
7.
|
Intellectual Property Rights
|
(a)
|
All Intellectual Property Rights in or related to the Products that is owned or controlled by the Supplier and/or its Affiliates as of the date of this Agreement and the Supplier Marks (the Supplier Prior IPR), shall remain the property of the Supplier and/or its Affiliates, and the Distributor and/or its Affiliates shall not acquire any right, title or interest relating thereto, except for the licence as provided under Clause 7.1(c). The Supplier Prior IPR includes the patents and patent applications and the Supplier Marks listed in Annex 7.1.
|
(b)
|
All (i) materials, documents, research, development, manufacture, drawings, patterns, software, data, specifications, concepts, analyses, studies, reports, graphic designs, three dimensional designs, photographs, names and/or logos developed solely by the Supplier and/or its Affiliates after the Effective Date in connection with the labelling, packaging, distribution, marketing and/or promotion of the Products and all Intellectual Property Rights therein, (ii) all Intellectual Property Rights in or related to the Products which are developed after the date of this Agreement and that are owned or controlled by the
|
(c)
|
The Supplier hereby grants the Distributor during the Term or the term of protection of the Supplier IPR, whichever is shorter, a non-exclusive, non-transferable (except for permitted assignments under Clause 19.8), revocable, fully paid-up and personal non-sublicensable license and right to use the Supplier IPR to distribute, sell, market and promote the Products in the Territory and otherwise perform its obligations under this Agreement, provided that all such use is (i) in accordance with the terms and conditions of this Agreement, and (ii) only made in connection with, and as necessary for, the distribution, sale, marketing and/or promotion of the Products as expressly permitted under this Agreement. The Distributor acknowledges and agrees (and shall cause its Affiliates to acknowledge and agree) that it has no right to use, and will not use, any Supplier IPR other than as expressly licensed to do so in the Agreement and in the form approved in writing in advance by the Supplier. In particular, the Distributor undertakes not the register (and shall cause its Affiliates not to register), and represents (and shall cause its Affiliates to represent) that it has not registered, any Intellectual Property Rights identical, substantially or confusingly similar to those of the Supplier
|
(d)
|
The Distributor and its Affiliates agree neither to register nor to register through Third Parties, all or any part of the Supplier IPR, in the Territory or elsewhere. They furthermore agree not to include all or any part of the Supplier IPR in their own trade, company name or domain name(s), save if and to the extent provided otherwise in this Agreement.
|
(e)
|
For the avoidance of doubt, except as expressly set forth in this Agreement, nothing in the Agreement shall oblige the Supplier to disclose any particular information to the Distributor. The Supplier shall decide at its own discretion whether it wishes to disclose information that it considers confidential or not. It is of utmost importance that the Supplier remains free to decide which information it provides the Distributor with and to determine solely whether any non-public information included in such information is to be considered as confidential. The disclosure of any information under this Agreement shall not be construed as granting either a license under or right of ownership in such information or any other right such as, but not limited to, patents, trademarks, trade names or know-how, to the Distributor and/or its Affiliates.
|
7.2.
|
Distributor IPR
|
(a)
|
All Intellectual Property Rights owned or controlled by the Distributor and/or its Affiliates as of the date of this Agreement and the Distributor Marks (the Distributor IPR), shall remain the property of the Distributor and/or its Affiliates, and the Supplier and its Affiliates shall not acquire any right, title or interest relating thereto, except as provided under
|
(b)
|
The Distributor hereby grants the Supplier and its Affiliates during the Term a non-exclusive, non-transferable (except for permitted assignments under Clause 18.9), royalty-free, sublicenseable (through multiple tiers) license and right to use the Distributor Marks solely to the extent necessary for the Supplier to perform its obligations under this Agreement, provided that all such use is in accordance with the terms and conditions of this Agreement.
|
(c)
|
The Supplier and its Affiliates agree neither to register nor to register through Third Parties, all or any part of the Distributor IPR, in the Territory or elsewhere. They furthermore agree not to include all or any part of the Distributor IPR in their own trade, company name or domain name, save if and to the extent otherwise provided in this Agreement.
|
7.3.
|
Infringements
|
7.3.1.
|
Infringements of Supplier IPR
|
(a)
|
The Distributor shall use its reasonable efforts to immediately notify the Supplier upon becoming aware of any possible infringement of the Supplier IPR in the Territory that comes to the Distributor’s or its Affiliates’ attention. The Distributor shall reasonably assist the Supplier in any action in respect of such infringements. The Supplier (i) shall have the first right, at its sole discretion, to take action against any possible infringement of the Supplier’s patents or patent applications included within the Supplier IPR, and (ii) shall have the right, at its sole discretion, to take action against any possible misappropriation or misuse of the other Supplier IPR.
|
(b)
|
All costs and expenses in connection with any action taken by the Supplier against any such infringement, misappropriation or misuse of the Supplier IPR shall be borne solely by the Supplier including any costs and expenses related to the assistance of the Distributor and/or its Affiliates as requested by the Supplier, unless otherwise agreed in
|
(c)
|
In the event the Supplier decides not to take any action in respect of any infringement, misappropriation or misuse of the Supplier IPR that would have been reported to the Supplier by the Distributor, the Supplier shall notify this decision to the Distributor and/or its Affiliates. [*] the Distributor and/or its Affiliates may elect to initiate action against such possible infringement of the Supplier IPR in the Territory, at the Distributor’s costs and expenses. The Supplier shall provide the Distributor with reasonable assistance in such action (including making documents and records available for review and copying, and making persons within its control available for pertinent testimony), and such assistance shall be at the Distributor’s expense. Any damages awarded to the Distributor and/or its Affiliates shall be [*].
|
7.3.2.
|
Infringement of Distributor IPR
|
7.3.3.
|
Infringements of Third Party Intellectual Property Rights by the Products
|
(a)
|
The Distributor shall immediately notify the Supplier of any infringement or alleged infringement of Third Party Intellectual Property Rights by the Products or the Supplier IPR in the Territory (a Supplier Infringement Claim) that comes to the Distributor’s and/or its Affiliates’ attention and shall fully cooperate at the Supplier’s first request in any steps undertaken by the Supplier towards defence of the Products or the Supplier IPR in the Territory.
|
(b)
|
In such case, the Supplier, at its sole discretion:
|
(i)
|
may conduct negotiations with Third Party;
|
(ii)
|
shall assume, conduct and control the defence of any Supplier Infringement Claim; and
|
(iii)
|
may issue binding instructions to the Distributor regarding the Products or the Supplier IPR affected by such claims, provided that Supplier may not enter into any settlement of any such infringement action that requires the payment of any damages by the Distributor, or admits any liability on the part of the Distributor, without the prior written consent of the Distributor.
|
(c)
|
Supplier shall keep the Distributor reasonably informed of the progress and status of any such infringement action. If the Supplier elects not to defend such claim, the Distributor and/or its Affiliates may assume the defence thereof; provided that, however, the Distributor will not enter into any settlement without the prior written consent of the Supplier.
|
8.
|
Business Forecast, Commercialisation and Packaging
|
8.1.
|
Business Forecast
|
(a)
|
The Parties have agreed upon an initial business forecast in respect of the commercialisation of the Products in the Territory covering the period from the Launch Date through the end of the [*] Contract Year from the Launch Date (the Initial Business Forecast). The Initial Business Forecast is attached in Annex 8.1(a).
|
(b)
|
No later than [*] prior to the expiration of the [*] Contract Year and on each subsequent anniversary date thereof, the Parties shall agree on a new business forecast (the New Business Forecast) covering the subsequent Contract Years.
|
(c)
|
If the Parties do not agree on a New Business Forecast pursuant to Clause 8.1(b), the applicable Business Forecast of each subsequent Contract Year shall be determined according to the mechanism described in Annex 8.1(b).
|
8.2.
|
Commercialisation
|
8.2.1.
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Launch Date
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(a)
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The Distributor shall launch the Initial Products on the Launch Date, provided that all necessary Regulatory Approvals have been obtained. If the Supplier is unable to supply sufficient Product suitable for sale on or before the Launch Date, the Parties will discuss in good faith and agree upon reasonable adjustments to the Minimum Commercialization Efforts and the Minimum Purchase Commitments to take account of any such shortfall in supply.
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(b)
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The Distributor shall launch each New Product on the earlier of (i) [*] after all Regulatory Approvals have been obtained for the relevant Development Product in the Territory or (ii) [*] after the relevant New Product has been made available ([*]) to the Distributor; but in any case no later than [*] after the relevant New Product has been made available to the Distributor, provided that, however, such relevant New Product has been made available to the Distributor at least [*] before expiry of this [*] term.
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8.2.2.
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Commercialisation Activities
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(a)
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The Distributor shall use its commercially reasonable efforts to promote the distribution of and sell the Products in the Territory, and shall comply with Distributor’s obligations under this Agreement, including as set forth in Clause 8.2.4.
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(b)
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The Distributor shall have in the Territory the responsibility to (i) receive, accept, and fill orders for Products, including the right to set pricing in relation thereto, (ii) control invoicing, order processing, and collection of accounts receivable for sales of the Products, (iii) record sales of the Products in the Territory in its books of account, and (iv) receive returns of Products.
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(c)
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In all its marketing and communication, the Distributor shall clearly demonstrate that it acts as an independent the Distributor of the Products and does not act on behalf of the Supplier.
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(d)
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The Distributor shall adhere to and comply with all Supplier’s copyrights and brand guidelines. The Distributor shall also comply with the Supplier’s master brand (as notified in writing from time to time by the Supplier to the Distributor during the term of this Agreement).
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8.2.3.
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Commercialisation Costs
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8.2.4.
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Minimum Commercialisation Effort
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(a)
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The Distributor shall [*] (the Minimum Commercialisation Effort), calculated in accordance with Annex 8.2.4(a):
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(i)
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in the Contract Years [*]: [*] set forth in the Business Forecast;
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(ii)
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in the Contract Year [*]: [*] in the Business Forecast;
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(iii)
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in the Contract Year [*]: [*] in the Business Forecast;
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(iv)
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in the Contract Year [*]: [*] in the Business Forecast; and
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(v)
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in any subsequent Contract Year thereafter: [*] in the New Business Forecast.
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(b)
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Within [*] calendar days of the end of each Contract Year, the Distributor shall provide a report to the Supplier summarising its activities and expenditure efforts for the Filler Products under the Business Forecast regarding the prior Contract Year. Such report shall include a confirmation that the Minimum Commercial Efforts have been met and a report of the [*], and the calculation made by Distributor to determine the Minimum Commercialisation Effort (the Expenditure Report).
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(c)
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The Expenditure Report shall become binding upon the Parties, unless the Supplier delivers a statement of objections to the Distributor within [*] calendar days of the Supplier’s receipt from the Distributor of the Expenditure Report, specifying the positions the Supplier objects to and
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(d)
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For [*] calendar days following the Distributor’s receipt of the Supplier’s statement of objections, the Parties shall negotiate in good faith in order to resolve the positions on which the Supplier objected. If and to the extent that they fail to reach an agreement on the objected matters within such [*]-calendar day period, either Party may submit the objected matters to an independent accountant or accounting team within an internationally recognized public accounting firm (e.g. Deloitte, KPMG, E&Y and PwC, subject to any conflict of interest) (the Neutral Accounting Firm) for determination, who shall hereby act as arbitral expert in the sense of article 189 of the Swiss Civil Procedure Code (CPC/ZPO) (and not as an arbitrator). The Parties shall procure that the Neutral Accounting Firm will be provided with all documents and information necessary for its determination of the Commercialisation Expenses and the Minimum Commercial Effort, as it may reasonably request. The Parties shall cause the Neutral Accounting Firm to use its best efforts to determine the objected matters within [*] calendar days of the receipt of all the relevant documentation by the Neutral Accounting Firm (i.e. whether the Minimum Commercial Effort has been met) and shall set out the reason of its decision in writing. The Neutral Accounting Firm’s determination shall be final and binding upon the Parties (other than in case of calculation errors or other obvious mistakes of the Neutral Accounting Firm, in which case the matter shall be referred back to the Neutral Accounting Firm for correction). The costs and expenses relating to the Neutral Accounting Firm’s engagement shall be borne by [*]. In case the Minimum Commercialisation Effort has not been met by the Distributor, Clause 16.2(b)(xi) shall apply.
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8.3.
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Packaging and Labelling
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(a)
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It is at the Supplier’s sole discretion to ultimately decide on Products packaging and labelling and the Distributor shall comply with such decision.
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(b)
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The Distributor shall not make any modification or alteration to the Products as delivered by the Supplier, including their packaging, their labelling or any product description. The Distributor shall not remove any labelling (e.g. stickers) on any packaging (e.g. packaging of Not-For-Sale Products) and/or any markings necessary [*].
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(c)
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As an exception, and subject to the Supplier’s prior written approval, the Distributor may change the products labelling into "Not-For-Sale Products". The relevant Purchase Price would then be amended accordingly through a credit note issued by the Supplier to the Distributor.
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8.4.
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Training
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(a)
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The Supplier shall provide education regarding the Products and/or training to the Distributor’s training and marketing teams in accordance with a training plan and schedule to be mutually agreed between the Parties within the first Quarter of each Contract Year or at such other time as the Parties may mutually agree. The costs and expenses related to [*] shall be [*].
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(b)
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The Supplier shall also grant to the relevant KOL as selected and hired by the Distributor access to the Supplier’s "Teoxane Academy" in Geneva [*] for a full immersion day program. [*] of each KOL and of the Distributor’s representatives shall be [*]. The [*] costs shall be [*]. Any additional education required by the Distributor shall be subject to the Supplier’s prior approval and availability and all the costs thereof, including educational costs, shall be [*]. In any case, education and training of the Distributor’s KOL and representatives shall not exceed [*].
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(c)
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If a Supplier’s representative is requested to travel for any training and/or any other education or full immersion program outside of the "Teoxane Academy" in Geneva, all costs and expenses related to such training and/or any other education or full immersion program shall be [*].
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(d)
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Any and all trainings and/or any educational program organised by the Distributor, will use the tools and documentation provided by the Supplier as the foundation for the creation of training materials and comply with the Supplier’s copyrights and brand guidelines, in particular but without limitation the Supplier’s master brand (as notified in writing from time to time by the Supplier to the Distributor during the term of this Agreement), and shall ensure compliance with applicable laws and regulations at all times.
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8.5.
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Product bundling
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(a)
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[*];
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(b)
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[*];
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(c)
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[*];
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(d)
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[*];
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(e)
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[*]; and
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(f)
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[*].
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9.1.
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Manufacture
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9.2.
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Forecasting
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(a)
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No later than the [*] day of each month subsequent to the Launch Date of the Agreement, the Distributor shall provide the Supplier in the form set out in Annex 9.2(a) hereto with an estimate of quantities of the Products, determined on a product-by-product basis, it foresees to order during the following [*] months on a per-month basis (the Forecasting Form). The first Forecasting Form shall be provided to the Supplier within [*] days from the Effective Date.
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(b)
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The Distributor shall place an initial purchase order [*] calendar days prior to the Launch Date (the Initial Purchase Order). Clause 9.3 of the Agreement shall apply by analogy to the Initial Purchase Order with respect to the order process.
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(c)
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The estimates of quantities of Products for the first [*] months set out in each Forecasting Form shall be considered as the Distributor’s binding commitment to purchase such quantities of Products (the Binding Purchase Commitments). The estimates of quantities of Products for the last [*] months set out in each Forecasting Form shall only be considered as non-binding estimates.
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(d)
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In any case a monthly Binding Purchase Commitment shall not exceed [*] of the total rolling [*]-month forecasts volumes indicated in the Forecasting Form.
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(e)
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The Distributor shall include the relevant New Product, if any, in each Forecasting Form starting on the first month following the obtainment of the Regulatory Approval for the relevant New Product.
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9.3.
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Order Process
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(a)
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No later than [*] calendar days prior to the requested Delivery Date (as defined below), the Distributor shall place with the Supplier an order for the Products by using the purchase order form as attached in Annex 9.3 (the Purchase Order). Unless otherwise agreed between the Parties, the Distributor shall [*].
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(b)
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All Purchase Orders shall include (i) the name of the ordered products, (ii) the quantities, (iii) the requested delivery date from Supplier’s premises, which shall be not earlier than [*] calendar days after receipt of the Purchase Order by the Supplier (the Delivery Date), and (iv) any other information dictated by the circumstances of the order.
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(c)
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Except in case of Clause 9.3(e) below, an order shall be binding upon the Distributor as soon as placed with the Supplier.
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(d)
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The Purchase Orders which are made by the Distributor within the quantities forecasted in the monthly Binding Purchase Commitment shall be accepted by the Supplier. Delivery Dates are only binding if they have been expressly agreed by the Supplier. The Supplier shall use commercially reasonable efforts to accept Purchase Orders for amounts in excess of the quantities forecasted in the monthly Binding Purchase Commitment but has no obligation to so.
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(e)
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The Supplier may reject a Purchase Order if (i) the requested Delivery Date is less than [*] calendar days after receipt of the Purchase Order, it being specified that without prejudice to its rejection right the Supplier undertakes to use commercially reasonable efforts to comply with the requested Delivery Date before rejecting the Purchase Order, or (ii) a Purchase Order for a given month exceeds [*] of the total rolling [*] forecasts indicated in the Forecasting Form, or (iii) the Distributor has not complied with Clause 9.2(d) or its payment obligation in accordance with Clauses 9.9 to 9.11 and 10.1. In case the quantities ordered by the Distributor are lower than the quantities forecasted in the Binding Purchase Commitment for a given month, the Supplier shall be entitled to deliver the quantities forecasted in the Binding Purchase Commitment in lieu of the ordered quantities.
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(f)
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The Distributor shall immediately notify the Supplier in writing in case of a delivery of a confirmed Purchase Order later than twenty (20) calendar days after the Delivery Date, failing that the Distributor shall be deemed to have waived any and all of its rights under this Agreement in particular those rights set forth under Clause 9.3 of this Agreement.
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9.4.
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Delivery
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9.5.
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Receipt of the Deliveries
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(a)
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The Distributor shall be obliged to take delivery of the ordered Products even in case of partial deliveries or late deliveries.
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(b)
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The Distributor shall upon delivery inspect the delivered Products within [*] to ensure the absence of any discrepancies with the order in quantities.
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(c)
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If the delivery was made by a carrier, the Distributor shall not accept a visibly damaged delivery from the carrier without reservation.
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(d)
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The Distributor shall notify the Supplier within [*] after the delivery and in writing about any defects of the delivered products.
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(e)
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In case of any discrepancies with the order in quantity, the Distributor shall notify the Supplier within [*] upon delivery and in writing. Failing such notice, the delivery shall be deemed to have been correctly performed and the Supplier shall have no duty to correct any discrepancy in quantity.
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(f)
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In the event of a notice of discrepancies with the Purchase Order in quantity and provided such discrepancy in quantity has not been cured by any subsequent delivery, the Supplier shall bear all cost and expense (including shipment costs) relating to the delivery to the Distributor within [*] calendar days upon receipt of the notice of discrepancies of the relevant quantity of Products in accordance with the initial Purchase Order.
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9.6.
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Warranty
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(a)
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The Supplier warrants to the Distributor that the Products shall be free from defects at the time of delivery (the Warranty).
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(b)
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In particular, the Warranty does not apply:
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(i)
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to minor defects, such as cosmetic damages or scratches;
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(ii)
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to Products which have been modified after delivery (for the avoidance of doubt, any agreed bundling of products will not be a modification of the products), it being understood that also the removal of any serial number qualifies as modification in the sense of this paragraph;
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(iii)
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to defects not existing at the time of delivery, such as defects caused by normal wear and tear or otherwise due to the normal aging of the Products;
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(iv)
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to deviations from any description of the Products in order documents, offers, catalogue, on websites or in any documentation of the Supplier.
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(c)
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In case of breach of this Warranty, the Supplier shall, at its option, replace or repair the defective Product or reimburse the purchase price for the defective Product, provided that, however, if the defect is limited to altered packaging the Supplier shall not replace the Product itself. All other rights for defects are excluded, including the right to claim damages, to reduce the purchase price or to rescind the respective order.
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(d)
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Any warranty claim of the Distributor shall be precluded if:
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(i)
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with regard to a visible defect, such defect is not notified to the Supplier according to Clause 9.5(d), or
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(ii)
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with regard to a hidden defect, such defect is not notified to the Supplier immediately after the detection of this defect.
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(e)
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In any case, an action for breach of this Warranty becomes time-barred [*] after the delivery of the affected Product to the Distributor, even if the Distributor does not discover the defects until later.
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(f)
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Except for this Warranty and the representations and warranties provided in Clause 14, no representation or warranty, express or implied, whatsoever is made by or on behalf of the Supplier, and all other representations and warranties are hereby expressly excluded.
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(g)
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This Clause 9.6 as well as Clause 7.3 shall apply by analogy to defects of title in the Products ("Rechtsgewährleistung" / "garantie en cas d’éviction").
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9.7.
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Manufacturer Warranty
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9.8.
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Buffer Stock
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(a)
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The Distributor shall be responsible for creating and maintaining a sufficient stock of Products in order to limit any short term interruption, discontinuance or limitation of supply of any kind in the Territory (the Buffer Stock), it being understood that the Distributor’s Buffer Stock shall correspond to at least [*] of the forecasted sales set forth in the relevant [*] Forecasting Form but not more than [*] of the forecasted sales set forth in the relevant [*] Forecasting Form.
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(b)
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The Buffer Stock shall at any time contain as minimum quantities at least of [*] but not exceeding [*] in average of the forecasted sales in the Forecasting form for the relevant year.
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(a)
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The Supplier agrees to sell to the Distributor, and the Distributor agrees to buy from the Supplier, the Products at the following purchase prices (the Purchase Price):
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(i)
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for the Approved Dermal Fillers
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(1)
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For the years [*] (i) a Purchase Price of USD [*] per Unit and (ii) an additional price adjustment sum of USD [*] per sold Unit in each Contract Year between [*] and [*], in which [*] set forth in [*] to be payable in [*]. For clarity, (A) if [*], no such additional price adjustment must be paid, and (B) no additional amount shall be payable for any Contract Year for which [*]
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(2)
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As from [*], a price of USD [*] per Unit shall be paid;
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(ii)
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For the Agreed New Fillers a price of USD [*] per Unit shall be paid as from [*].
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(iii)
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The Purchase Price of Possible New Fillers and New Indications shall be agreed upon between the Parties in writing before the Launch Date of such.
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(b)
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For the avoidance of doubt,
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(i)
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the Purchase Price does not comprise any [*] herein. Such [*].
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(ii)
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nothing in the Agreement restrains the Distributor’s freedom to set the selling prices of the Products in the Territory. The non-binding recommended resale price of the Supplier to physicians is not below USD [*] per syringe.
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9.10.
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Not-For-Sale Products
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(a)
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The Distributor shall not purchase more than the following amounts of Not-For-Sale Products of the Approved Dermal Fillers from the Supplier (each amount being for a full financial year; to be adjusted on a pro rata temporis basis depending on the actual Launch Date):
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(i)
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in [*]: [*] syringes;
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(ii)
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in [*]: [*] syringes;
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(iii)
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in [*]: [*] syringes;
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(iv)
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in [*]: [*] syringes;
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(v)
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in [*]: [*] syringes;
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(vi)
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in each and every Contract Year thereafter: [*] syringes or [*] of sales, whichever is greater.
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(b)
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The Supplier agrees to sell to the Distributor, and the Distributor agrees to buy from the Supplier, the Not-For-Sale Products at the following purchase prices (the Sample Purchase Price):
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(i)
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Each Unit sold as Not-For-Sale Products shall cost:
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(1)
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USD [*] per Unit of the Approved Dermal Fillers (i.e. USD [*] per syringe), the New Indications and the New Agreed Filler containing lidocaine;
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(2)
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USD [*] per Unit (i.e. USD [*] per syringe) for New Agreed Fillers and New Indications containing mepivacaine.
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(c)
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The Distributor shall specify the orders of the Products purchased as Not-For-Sale Products in the Purchase Orders and shall allocate such orders proportionally on each month over each Contract Year.
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(d)
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The Parties expressly agree upon the following:
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(i)
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no indemnity amounts shall be owed by the Supplier to the Distributor in case of failure to deliver in time the Units purchased as Not-For-Sale Products;
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(ii)
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in case of any [*] in accordance with Clause 10.1(b) of the Agreement.
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9.11.
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Payments
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9.12.
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Recall
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(a)
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In the event that either Party believes that any Product poses an actual or potential product hazard or substantial risk of injury or may otherwise require a correction or removal, as those terms are defined in 21 C.F.R. § 806.2, or a recall, as defined by other equivalent laws in the Territory, withdrawal or field correction of any Product (collectively a Recall), it shall immediately inform the other Party of such suggestion to proceed to a Recall. If the Distributor becomes aware of any Product defect or any action by a governmental authority requiring a Recall, then it shall also notify the Supplier within [*] of becoming aware of such event.
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(b)
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Supplier shall retain full authority and responsibility for making Recall decisions, which shall all be made promptly and in compliance with all Applicable Laws and United States regulatory requirements.
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(c)
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Supplier shall keep the Distributor reasonably informed in connection with any possible Recall, and shall consider in good faith and take into account Distributor’s reasonable comments in connection with any Recall. If the Supplier decides that a Recall is warranted, the Supplier will provide written notice to the Distributor within [*] of such decision, and a summary of the reason for and implementation of such action. The Supplier shall provide such information as the Distributor may reasonably require to assist with the implementation of the Recall and to prepare any additional customer notification of such Recall, which notification shall be issued by the Distributor upon the request of the Supplier.
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(d)
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Any such Recall shall be handled in accordance with the policies and procedures maintained by the Supplier. The Supplier shall submit to the applicable Regulatory Authority, such as the FDA, any necessary reports, as required under the Applicable Laws, including 21 C.F.R. Part 806, and shall be responsible for drafting any recall notifications with respect to the Product(s). [*] all costs associated with a Recall, subject to [*] in accordance with Clause 9.12(e).
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(e)
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Recall Costs:
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(i)
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The Party responsible for the event(s) causing the Recall shall bear all costs, whether internal or external, relating to a Recall (including,
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(ii)
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If any such Recall is the result of negligence or wilful misconduct or violation of applicable laws by both Parties and/or the breach by both Parties of any representation, warranty, covenant or agreement under this Agreement and/or the Quality Agreement, then the Recall Costs will be equitably apportioned between the Parties in proportion to their respective fault.
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(iii)
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If the cause of a given Recall cannot be determined, [*] the Recall costs.
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(f)
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To adequately administer a Recall, the Distributor shall keep the records relating to product shipment, traceability and storage conditions up to date and make these documents available to the Supplier, for a minimum of [*] years. Product traceability is the ability to determine which customer received which product (including the lot number and UDI of that product). These documents must be available to be sent to the Supplier upon simple request, at any time and within [*].
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9.13.
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Minimum Purchase Commitment
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9.13.1.
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Minimum purchase commitment [*]
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(a)
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For the years [*] the Distributor shall purchase (delivered and invoiced Products), in each Contract Year, such total value as defined under Annex 9.13.1 (the Initial Minimum Purchase Commitment).
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(b)
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For clarity, [*] for the purpose of determining the Initial Minimum Purchase Commitment.
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9.13.2.
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Minimum purchase commitment after [*]
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(a)
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As from the year [*], as the case may be, the Distributor shall purchase (delivered and invoiced products), in each Contract Year, of a total value corresponding to at least [*] of the purchases under the New Business Forecast (the Subsequent Minimum Purchase Commitment).
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(b)
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For clarity, [*] for the purpose of determining the Subsequent Minimum Purchase Commitment.
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10.
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[*]
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10.1.
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[*]
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(a)
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The Distributor acknowledges that the Supplier has entered into the [*].
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(b)
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The Distributor shall bear [*] payable by the Supplier [*]. The Distributor shall pay [*].
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(c)
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Should there be any dispute with [*] between the Parties, solely to the extent applicable to sales of Products under this Agreement. Notwithstanding the foregoing, prior to agreeing to an [*], the Supplier shall discuss in good faith with the Distributor the response to any claim and the approach to be taken in connection therewith, being agreed that [*] in this respect, including in relation to [*] of the license related to the Licensed Products (as this term is defined in [*], the Distributor shall continue, to pay to the Supplier [*].
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(d)
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The Distributor shall comply with its obligations under [*].
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10.2.
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Accounting and Records
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(a)
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The Supplier shall perform its obligations as [*].
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(b)
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The Distributor shall perform its obligations [*] as the exclusive distributor of the Products hereunder and agrees to be [*] to such
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(i)
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within [*] days after the Quarterly Period [*] in respect of which [*], the Distributor shall prepare and send to the Supplier all information and supporting documents requested by Supplier (if any) that is required [*].
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(ii)
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Specifically, the Distributor shall provide Supplier with a report setting forth, for the applicable Quarterly Period (A) the amount of gross sales in the Territory of the Products, and (B) the units of Not-For-Sale Products [*] distributed in the Territory, and (C) the units of Products (other than those designated as Not-For-Sale Products) purchased from Supplier during the Quarterly Period, and [*] sales to the Distributor and the [*] the Distributor to the Supplier.
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(iii)
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Simultaneously with the submission of each report pursuant to Clauses 10.2(b)(i) and 10.2(b)(vii), the Distributor shall, in a commercially reasonable manner, [*] for the period covered by the reports. In the event any payments are made later than the dates set forth herein, the Distributor shall also pay interest on such late payments, at the prime rate as reported in the Wall Street Journal on the last date of the applicable quarter (or the highest rate allowed by law, if lower), compounded monthly, from the date on which the payment was due until it was made.
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(iv)
|
All payments by the Distributor to the Supplier required under this Clause 10 shall be made by wire transfer to the name or account of the Supplier as specified below or to another account designated by the Supplier in writing:
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(v)
|
Any and/or all of such payments shall be subject to such withholding tax laws, rules and regulations as may be applicable and, if such
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(vi)
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The Distributor shall keep accurate records in respect of all sales of the Products by the Distributor in the Territory and shall maintain such records for a period of not less than [*] years from the date of its report to the Supplier for such sales. The Supplier shall have the right, at its sole cost and expense, not more than [*], to have the Distributor’s records reviewed in respect of sale of the Products [*] at times that are reasonably convenient to the Distributor, using an independent certified public accountant designated by the Supplier and reasonably acceptable to the Distributor provided the independent accountant signs a confidentiality agreement with the Distributor providing that such records, books of account, information and data shall be treated as confidential information which may be disclosed only to the Supplier [*]. If the independent accountant’s review determines that [*] reported by the Distributor for such Quarterly Period, then the Distributor shall bear the costs and expense of such review. Any deficiencies in payment shall be payable with interest from the date the initial payment was due at the rate specified in Clause 10.2(b)(iii). The identification of a deficiency under this Clause shall not be considered a breach of the Agreement so long as the Distributor pays the Supplier any amount owed within [*] of receiving the report of the independent accountant. Any overage in payment shall be payable by the Supplier to the Distributor within [*] of receiving the report of the independent accountant. For clarity, in the case of [*], the Parties shall discuss in good faith and upon Supplier’s request, Distributor will also make available to Supplier [*] Distributor’s sales under this Agreement.
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(vii)
|
At the [*], the Distributor shall render a final report to the Supplier within [*] after the end of the Quarterly Period in which such
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(viii)
|
The Distributor understands and acknowledges that any reports under this Clause 10 [*].
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(ix)
|
The Distributor warrants and agrees that the distribution of Not-For-Sale Products [*], shall not [*]. Otherwise, the [*] according to the terms of this Clause 10.
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11.
|
Distribution of the DAXI Product by Supplier
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11.1.
|
Right of First Negotiation
|
(a)
|
For the Term, the Distributor and/or any of its Affiliates hereby grant the Supplier in first priority the exclusive right to negotiate an exclusive distribution agreement for the distribution of the DAXI Product in countries where Supplier has an Affiliate (except for the [*]) at any time after Distributor files for the relevant regulatory approval (if and to the extent necessary) for the respective DAXI Product is granted (the Right of First Negotiation).
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(b)
|
If during the Term, the Distributor or any of its Affiliates files for regulatory approval for the DAXI Product in any country pursuant to Clause 11.1(a), the Distributor or any of its Affiliates shall submit in priority to the Supplier a written distribution proposal (the Distribution Proposal) and the Supplier and the Distributor or any of its Affiliates shall enter into a mutually agreeable dedicated non-disclosure and confidentiality agreement for this purpose. The Distribution Proposal shall contain at a minimum the following terms: [*] (the Core Terms).
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(c)
|
If the Supplier wishes to exercise its Right of First Negotiation, it shall notify the Distributor or any of its Affiliates thereof within a period of [*] calendar days of the receipt of the Distribution Proposal (the Exercise Notice Period). If the Supplier is not provided with [*]. The Supplier may
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11.2.
|
No Exercise of the Right of First Negotiation
|
(a)
|
If the Supplier does not exercise its Right of First Negotiation within the Exercise Notice Period the Distributor or any of its Affiliates shall be free to enter into negotiation with any other Party on the distribution of the DAXI Product, and these activities shall not qualify as a breach of Clause 12 (Non-Compete).
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(b)
|
The non-exercise of the Right of First Negotiation shall in no case be construed as a waiver of the Supplier’s rights under this Agreement, except with respect to the DAXI Product and country that was the subject of such Right of First Negotiation.
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11.3.
|
Exercise of the Right of First Negotiation
|
(a)
|
If the Supplier exercises its Right of First Negotiation within the Exercise Notice Period, the Supplier and the Distributor or any of its Affiliates shall enter in good faith into exclusive negotiation for a period of [*] from the date of Supplier’s exercise, in respect of the distribution of the DAXI Product in the applicable country or countries, and endeavour to reach an agreement on the terms and conditions of such distribution (including term, responsibilities, and costs) (the DAXI Distribution Agreement).
|
(b)
|
The negotiation shall be deemed as terminated upon the earlier of:
|
(i)
|
the DAXI Distribution Agreement has validly been signed by both Parties and/or its Affiliates, in which case the DAXI Distribution Agreement shall prevail;
|
(ii)
|
the Parties and/or its Affiliates jointly agree in writing on the termination of the negotiation; and
|
(iii)
|
the DAXI Distribution Agreement is not signed within [*] after commencement of the negotiation.
|
12.
|
Non-Compete
|
(a)
|
research on, develop, manufacture, market, sell, commercialise, distribute and/or promote any [*] in the Territory; and/or
|
(b)
|
enter into [*] activity (including [*]) or business related to, or Person which activity relates to, any [*]; and/or
|
(c)
|
market, sell, commercialise, distribute and/or promote any [*] within the Territory.
|
13.
|
Indemnification and Third Party Claims
|
(a)
|
The Distributor shall hold harmless and indemnify the Supplier from Third Party claims against the Supplier, including claims for reasonable legal expenses, resulting from:
|
(i)
|
the Distributor’s acts or omissions and based on a final judgment or settlement agreement attributing liability for such claim to Distributor;
|
(ii)
|
the Distributor’s breach of this Agreement;
|
(iii)
|
any breach of applicable law or misrepresentation or negligent or wilful act by the Distributor in connection with the sale of Products or the provision of services in connection with such sales;
|
(iv)
|
any Third Party claim or threat thereof that the Distributor’s services activities infringe, misappropriate or violate any patent, copyright,
|
(v)
|
any unauthorized use of the Supplier’s Intellectual Property Rights by the Distributor,
|
(b)
|
The Supplier shall hold harmless and indemnify the Distributor from all Third Party claims against the Distributor, including claims for reasonable legal expenses arising from (i) any Third Party claim or threat thereof that the Supplier’s IPR or activities infringe, misappropriate or violate any patent, copyright, trademark, trade secret, or other rights of any third party except if such claim or threat is related to the Distributor IPR, (ii) Supplier’s material breach of this Agreement, (iii) personal injury arising from the manufacture, use or sale of the Products, including any products liability claims, except in each case of (i) through (iii) to the extent Distributor is required to indemnify Supplier for such claims.
|
(c)
|
Indemnifications according to this Clause 13 are only due if the Party having received a Third Party claim has complied with all obligations under this Clause 13(c). The Party receiving any third party claim (the Indemnified Party) shall promptly inform the other Party (the Indemnifying Party) of such third party claim that comes to the Indemnified Party’s attention; provided that failure of the indemnified Party to give prompt notice of any third party claim shall not release, waive or otherwise affect the indemnifying Party’s obligations with respect thereto except to the extent that the indemnifying Party can demonstrate actual loss and prejudice as a result of such failure. In such case, the Indemnifying Party may conduct negotiations with the third party and shall assume, conduct and control the defence of any suit or action for infringement against the Indemnified Party provided, however, that the Indemnifying Party shall not consent to any settlement agreement without the prior written consent of the Indemnified Party, not to be unreasonably withheld, conditioned or delayed.
|
(d)
|
Where Supplier is responsible for indemnifying the Distributor, the Supplier may issue binding instructions to the Distributor regarding the Products affected by such Third Party claims.
|
14.
|
Representations and Warranties
|
(a)
|
The Supplier represents and warrants that:
|
(i)
|
it is the legal owner of the Supplier IPR with the exception of [*], free from encumbrances or liens;
|
(ii)
|
it has the full right, power and title to grant all rights, title and interest under this Agreement, including all licenses and exclusive distribution rights set forth herein to the Distributor, without conflict with or breach of the terms of any agreement with any Third Party;
|
(iii)
|
it shall comply with all laws applicable to its commercial activities, including but not limited to the Swiss Federal Act on Combating Money Laundering and Terrorist Financing in the Financial Sector (AMLA) and it agrees not to pay, promise to pay or authorize the payment of any money or anything of value, directly or indirectly, to any person for the purpose of illegally or improperly inducing a decision or obtaining or retaining business, or securing any improper advantage in connection with this Agreement;
|
(iv)
|
neither the Supplier nor to the best of its knowledge any of its Affiliates, shareholders, nor any officer, assigned to perform the obligations of this Agreement:
|
(1)
|
now and throughout the Term, is a Person that is, or is owned or controlled by a Person that is, currently the target of any sanctions administered or enforced by the U.S. Government (including, without limitation, the Office of Foreign Assets Control of the U.S. Department of Treasury (OFAC), the U.S. Department of Commerce or the U.S. Department of State and including, without limitation, designation as a "specially designated national" or "blocked person"), the United Nations
|
(2)
|
now and throughout the Term, is located, organized or resident in Cuba, Iran, North Korea, Crimea Region of Ukraine, Syria or any other country or territory that is the target of Sanctions Laws, except to the extent permitted under those laws (each, a Sanctioned Country);
|
(3)
|
has knowingly engaged in or is now knowingly engaging in any dealings or transactions that resulted in or will result in a violation of Sanctions Laws in connection with the performance of this Agreement; or
|
(4)
|
will knowingly engage directly or indirectly in any dealings or transactions with Sanctioned Persons or that violate any of the prohibitions set forth in any Sanctions Laws in connection with the performance of this Agreement.
|
(v)
|
it has obtained and holds as of the Effective Date hereof for the Initial Products, all Regulatory Approvals, if and to the extent necessary.
|
(b)
|
The Distributor represents and warrants that:
|
(i)
|
as of the Effective Date neither the Distributor nor any of its Affiliates research on, develop, manufacture, market, sell,
|
(ii)
|
it has and will maintain at all times during the Term, an adequate insurance coverage for the purpose of its activities and notably, to perform its obligations under the Agreement;
|
(iii)
|
it shall comply with all laws in the Territory dealing with improper or illegal payments, gifts and gratuities, such as the U.S. Foreign Corrupt Practices Act of 1977 and the International Anti-Bribery and Fair Competition Act of 1998, and it agrees not to pay, promise to pay or authorize the payment of any money or anything of value, directly or indirectly, to any person for the purpose of illegally or improperly inducing a decision or obtaining or retaining business, or securing any improper advantage in connection with this Agreement;
|
(iv)
|
neither the Distributor nor to the best of its knowledge any of its Affiliates, shareholders, nor any officer assigned to perform the obligations of this Agreement:
|
(1)
|
now and throughout the Term, is a Person that is, or is owned or controlled by a Sanctioned Person under Sanctions Laws.
|
(2)
|
now and throughout the Term, is located, organized or resident in a Sanctioned Country;
|
(3)
|
has knowingly engaged in or is now knowingly engaging in any dealings or transactions that resulted in or will result in a violation of Sanctions Laws in connection with the performance of this Agreement; or
|
(4)
|
will knowingly engage directly or indirectly in any dealings or transactions with Sanctioned Persons or that violate any of the prohibitions set forth in any Sanctions Laws in connection with the performance of this Agreement;
|
(v)
|
it has obtained and holds or shall endeavour to obtain and hold in good standing during the Term all Regulatory Approvals, including permits and licenses, if and to the extent necessary, to permit the Distributor to comply with its obligations in connection with the Products in the Territory (as relevant for the purpose of this Agreement). It complies or will comply during the Term of the Agreement, with applicable regulatory obligations, without limitation, FDA post-marketing and IDE requirements, including but not limited to maintaining documentation, supplementing as necessary, and fulfilling all reporting and complaint handling requirements in accordance with all applicable requirements;
|
(vi)
|
it shall comply with all laws applicable to its commercial activities, including but not limited to the AMLA or any such laws applicable in the Territory which are, by essence, substantially similar in their nature and extent, and it agrees not to pay, promise to pay or authorize the payment of any money or anything of value, directly or indirectly, to any person for the purpose of illegally or improperly inducing a decision or obtaining or retaining business, or securing any improper advantage in connection with this Agreement;
|
(vii)
|
it and/or its affiliates complies and will continue to comply during [*];
|
(viii)
|
it will comply with any packaging and labelling obligations according to Clause 8.3.
|
(c)
|
Each Party represents and warrants to the other Party, as follows:
|
(i)
|
Duly Organized. Such Party is a corporation duly organized, validly existing and, if applicable, in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification and failure to have such would prevent such Party from performing its obligations under this Agreement.
|
(ii)
|
Due Authorization; Binding Agreement. The execution, delivery and performance of this Agreement by such Party have been duly authorized by all necessary corporate action. This Agreement is a legal and valid obligation binding on such Party and enforceable in accordance with its terms and does not: (i) violate any law, rule, regulation, order, writ, judgment, decree, determination or award of any court, governmental body or administrative or other agency having jurisdiction over such Party; nor (ii) conflict with, or constitute a default under, any law or agreement, instrument or understanding, oral or written, to which such Party is a party or by which it is bound.
|
(iii)
|
Consents. In respect of the Initial Products, such Party has obtained at the latest 60 calendar days prior to the Launch Date, or is not required to obtain, the consent, approval or authorization of any third party, or has completed, or is not required to complete any registration, qualification, designation, declaration, or filing with, any Regulatory Authority, in connection with the execution and delivery of this Agreement and the performance by such Party of its obligations under this Agreement.
|
(iv)
|
No Conflicting Grant of Rights. Each Party has the right to grant the licenses and rights as contemplated under this Agreement and has not, and will not during the Term, grant any right to any Third Party which would conflict with the licenses and rights granted to the other Party hereunder.
|
15.
|
Liability
|
(a)
|
Each Party shall be liable to the other Party for all direct damages incurred or suffered by the other Party as a result of the damaging Party’s failure to perform its obligations in accordance with this Agreement or a breach of representations and warranties as set out in Clause 14 and subject to the limitations set forth in Clause 15(b), except to the extent that the damaging Party can prove that no fault is attributable to it, it being understood that any liability arising out of or in connection with any breach of a representation or warranty does not
|
(b)
|
Any liability limitation shall not apply to claims and/or losses based on gross negligence and/or wilful misconduct and amounts owed for Products supplied. The Supplier’s liability for associates (“Hilfspersonenhaftung”/”Responsabilité pour des auxiliaires”) is excluded if the Supplier is able to prove that it took all due care to avoid a loss or damage of the type that occurred or that the loss or damage would have occurred even if all such due care had been taken by the Supplier, provided that the foregoing exclusion shall not apply to employees of Supplier.
|
(c)
|
Notwithstanding the limitation of liability set forth in Clause 15(a), [*] shall be liable toward the other Party for [*]. In addition, the Parties agree that in such case of [*], the Party who [*], provided that such [*].
|
16.
|
Entry into force, Term and Termination
|
16.1.
|
Entry into force and Term
|
16.2.
|
Early Termination for Breach
|
(a)
|
Without prejudice to any other rights or remedies provided under this Agreement, either Party has the right, but not the obligation, to terminate this Agreement immediately upon written notice served to the other Party in writing if the other Party (the Breaching Party) has materially breached its obligations under this Agreement, and the Breaching Party has not cured such material breach within (i) [*] calendar days of receipt of a written notice of such breach by the non-breaching Party to remedy such breach or (ii) in the case of any non-payment due under this Agreement, [*] calendar days of receipt of a written notice requesting payment of such due amount.
|
(b)
|
In particular, but without limitation, the uncured (within the period set forth above) violation of any of the following Clauses or the following events shall be considered a material breach of the Agreement:
|
(i)
|
[*];
|
(ii)
|
[*];
|
(iii)
|
[*];
|
(iv)
|
[*];
|
(v)
|
[*];
|
(vi)
|
[*];
|
(vii)
|
[*];
|
(viii)
|
[*];
|
(ix)
|
[*];
|
(x)
|
[*];
|
(xi)
|
[*];
|
(xii)
|
[*];
|
(xiii)
|
[*].
|
16.3.
|
Termination for Insolvency
|
(a)
|
Either Party may terminate the Agreement, at any time with immediate effect upon written notice to the other Party in case of bankruptcy, moratorium, receivership or liquidation proceeding with regard to the other Party.
|
(b)
|
Notwithstanding the above, the Distributor hereby agrees that it shall be obliged to pay and perform all of the Distributor’s obligations hereunder in case of any bankruptcy, moratorium, receivership, liquidation proceeding involving the Distributor, and to take as the case may be the best effort to transfer the Agreement and assign and assume and any and all rights and obligations under this Agreement. The Distributor understands and acknowledges that, by virtue of this Clause, it has specifically assumed any and all risks of any such proceedings with respect to the Distributor. Without in any way limiting the generality of the foregoing, any subsequent modification of the obligations of the Distributor under the Agreement in any reorganisation case concerning the Distributor shall not affect the obligation of the Distributor to pay and perform the Distributor’s obligations under the Agreement in accordance with the original terms thereof.
|
16.4.
|
Termination in case of a Change of Control
|
16.5.
|
Effects of the Notice of Termination
|
16.5.1.
|
Exclusivity
|
16.5.2.
|
Delivery of Products
|
16.6.
|
Effects of Termination
|
16.6.1.
|
Termination Date
|
(a)
|
all rights and licenses granted by the Supplier to the Distributor under this Agreement shall terminate and subject to Clause 16.6.1(b), the Distributor shall immediately cease all marketing, promotion, distribution and sales of the Products and the Not-For-Sale Products (including on its website) and the Distributor shall not accept or agree to the sale of any Products and the Not-For-Sale Products following the Termination Date;
|
(b)
|
the Supplier shall have an exclusive option, by delivery of written notice to the Distributor no later than [*] before the Termination Date to elect to purchase, and, if such option is exercised, the Distributor will sell to the Supplier, all or part of its stock of Products and the Samples Products (except Products or Not-For-Sale Products for which the Distributor has firm customer orders at the time of termination that have been validly accepted by the Supplier) within [*] of its receipt of such election notice (subject to such products being in commercially saleable condition), at their original effective selling price (paid by the Distributor to the Supplier) or their then current value (whichever is the lower). In the event that the termination is caused by a breach, default, act or omission of a given Party, such Party shall [*]. If the Supplier elects not to exercise this option, or only purchases part of the Distributor’s stock of products, the Distributor shall be authorised to sell its remaining stock of Products and Not-For-Sale Products in accordance with the terms of this Agreement during a period of [*] after the Termination Date provided that such products being in commercially saleable condition, in compliance with any regulatory obligations and not infringing upon any third party’s Intellectual Property Rights (including but not limited to any rights and obligations [*]);
|
(c)
|
all outstanding Purchase Orders shall be automatically cancelled as of the Termination Date, except for the outstanding accepted Purchase Orders to the extent that the Distributor has firm customer orders (the exception shall not apply if the termination is caused by a breach, default, act or omission of the Distributor or if the Supplier is no longer able to fulfil the Purchase Orders);
|
(d)
|
all amounts under this Agreement shall become immediately due and payable;
|
(e)
|
the Distributor shall return all information, documents and material received from the Supplier upon the Supplier’s request; conversely and as applicable, the Supplier shall return all information, documents and material received from the Distributor upon the Distributor’s request, all subject to the exceptions set out in Clause 16.6.1(f);
|
(f)
|
the Distributor shall as promptly as commercially practicable transfer to the Supplier all records and materials in the Distributor’s possession or control containing Confidential Information of the Supplier, or, pursuant to the written consent of the Supplier, destroy, such records and materials and provide a written certificate as to such destruction signed by a senior executive, with the exception of documents required to be kept as a matter of law or order/judgment;
|
(g)
|
promptly to the extent permitted by applicable law, the Distributor shall assign to the Supplier or its designee all authorizations, documentations, licenses, permits and registration obtained by the Distributor which are necessary to perform the distribution of the Products and the Not-For-Sale Products within the Territory. In the event such assignment is not permitted by applicable laws, the Distributor shall cooperate with the Supplier in good faith and provide assistance, support, documentation for an uninterrupted, transfer and migration of the activities defined in the Agreement to the Supplier or a designee. All costs occurred in relation with this Clause 16.6.1(g) shall be borne equally between the Supplier and the Distributor;
|
(h)
|
the Distributor shall terminate or cause to be terminated any and all rights previously granted by the Distributor or any of its Affiliates to any Third Party under this Agreement;
|
(i)
|
the Distributor shall execute all documents and take all such further actions as may be reasonably requested by the Supplier in order to give effect to the foregoing.
|
16.6.2.
|
[*]
|
16.6.3.
|
Surviving Obligations
|
17.
|
Information and Audit
|
(a)
|
Distributor shall keep, and shall cause its Affiliates to keep if applicable, complete and accurate books and records pertaining to Products in sufficient detail to (i) calculate all amounts payable hereunder, and its obligations to Supplier with respect to Minimum Commercialization Efforts and the Commercialisation Expenses, and (ii) to reflect in reasonable detail and in accordance with industry standard practice, Distributor’s activities in connection with Products under this Agreement. At the reasonable request of Supplier, and no more frequently than [*], Distributor will respond to inquiries by Supplier in connection with Distributor’s activities, which may include providing reasonable documentation and information in order to confirm the Distributor’s compliance with its obligations under this Agreement.
|
(b)
|
At the request and expense of the Supplier, Distributor shall permit a Neutral Accounting Firm, at reasonable times during normal business hours and upon [*] prior written notice, to audit the books and records maintained pursuant to this Clause 17 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not (a) be conducted for any Contract Year more than [*] years after the end of such Contract Year determined on the basis of the audit notification, (b) be conducted more than [*] or (c) be repeated for any Calendar Year. The accounting firm shall disclose to the Supplier only whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared with the Supplier.
|
18.
|
Confidentiality
|
18.1.
|
General Rule
|
18.2.
|
Handling of the Confidential Information by the Parties
|
(a)
|
keep the Confidential Information confidential, not make it available to Third Parties and protect it from unauthorised access;
|
(b)
|
use the Confidential Information for the performance of each Party’s obligations under the Agreement (the Purpose) only;
|
(c)
|
only make available the Confidential Information to its own employees and consultants as well as to the employees and consultants of its Affiliates and to its Affiliates themselves, provided that they
|
(i)
|
require such Confidential Information for the Purpose;
|
(ii)
|
were informed about the confidentiality of the Confidential Information; and
|
(iii)
|
have undertaken in writing to keep the Confidential Information confidential or are subject to a statutory obligation of professional secrecy, it being specified that the disclosing Party shall be responsible and liable for any breach of confidentiality by its Affiliates, employees and consultants.
|
(d)
|
inform the disclosing party upon request as to whom the Confidential Information has been made available;
|
(e)
|
inform the disclosing party if the Confidential Information becomes known without authorisation or is inappropriately used by Third Parties or if there are any indications thereof and take measures in order to prevent further distribution or use of the Confidential Information;
|
(f)
|
upon request and at the choice of the disclosing party, but prior to expiry of the Agreement at the latest, return the Confidential Information to the disclosing party, destroy or delete it and confirm this in writing to the disclosing party. The following shall be excluded from these obligations: The retention of copies, provided that such retention is required by law, according to guidelines from professional or self-regulating organisations or by an order of a court, an authority or a regulator (including self-regulating organisations).
|
18.3.
|
Exceptions
|
(a)
|
If a Party is obliged to disclose Confidential Information by law or by order of a court, an authority or a regulator (including any securities exchange in any jurisdiction, and self-regulating organisations), the following shall apply:
|
(i)
|
The disclosure shall be limited to the necessary extent.
|
(ii)
|
The Party obliged to disclose Confidential Information shall inform the disclosing party to the extent permitted and reasonably prior to the disclosure and shall use commercially reasonable efforts to coordinate the next steps with the disclosing party.
|
(iii)
|
The Party obliged to disclose Confidential Information shall take reasonably appropriate legal measures to seek to cause Confidential Information to be kept confidential to the extent reasonably possible.
|
(b)
|
If a Party is obliged to disclose Confidential Information to internal or external auditors due to compliance regulations, such disclosure is to be limited to the necessary extent and the provisions of Clause 18.2(c) shall apply by analogy.
|
19.
|
Miscellaneous
|
19.1.
|
Publicity
|
19.2.
|
Entire Agreement and Annexes
|
19.3.
|
Written Notices
|
(a)
|
Any written notice with regard to this Agreement shall be delivered by in writing, by fax or courier (e.g., post, FedEx, UPS) to the following addresses:
|
If to Supplier:
|
Teoxane SA
Rue de Lyon 105 CH-1203 Geneva, Switzerland Attention: Head of Legal Fax: +41 22 340 29 33 |
If to Distributor:
|
Revance Therapeutics Inc.
7555 Gateway Boulevard Newark, California, USA |
(b)
|
Each change of address shall be communicated to the other Party in the same way.
|
19.5.
|
Waiver
|
19.6.
|
Additional remedies
|
19.7.
|
Amendments
|
19.8.
|
Assignment
|
(a)
|
Unless otherwise provided herein, this Agreement, or the assets, rights and obligations related to this Agreement, may not be assigned or transferred, in whole or in part, by the Distributor to any Third Party without the prior written consent of the Supplier.
|
(b)
|
Notwithstanding Clause 19.8(a), the Distributor may assign this Agreement without consent of the Supplier to an Affiliate of the Distributor, provided however that cumulatively (i) the Distributor remains jointly liable for the performance of all obligations under this Agreement following, (ii) such assignment would not modify the obligations of the Distributor under this Agreement, including with respect to Minimum Commercialization Effort and Minimum Purchase Commitments, and (iii) such assignment would not trigger any decrease of the existing level of sales force promoting, marketing and distributing both the DAXI Product and the Filler Products in the Territory.
|
(c)
|
For the avoidance of doubts, this Clause 19.8 shall not apply to, and no consent shall be required from the Supplier in case of, an internal reorganization, a merger, an acquisition or a sale of the Distributor or a sale of all or substantially all the assets of the Distributor [*], provided that any such transaction shall be subject to Clause 16.4 (Termination in case of a Change of Control).
|
19.9.
|
Costs
|
19.10.
|
Applicable Law and Dispute Resolution
|
(a)
|
This Agreement shall for all purposes be governed by and interpreted in accordance with the laws of [*], without giving effect to conflicts of laws principles. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods is specifically excluded from application to this Agreement.
|
(b)
|
Disputes shall be submitted to final and binding arbitration before the International Chamber of Commerce (ICC) under the rules of the ICC. The seat, or legal place, of arbitration shall be [*] and the arbitration shall be conducted in English. The arbitration tribunal shall be composed of three members.
|
(c)
|
Any dispute arising out of or in relation to this Agreement, including its existence and substance as well as any decision or award (whether partial or final) shall remain strictly confidential and the Parties acknowledge and agree to instruct the ICC and any arbitrator appointed pursuant to Clause 19.10(b) above accordingly, including among others to prevent the publication of any decision or award (whether partial or final). The arbitrators shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.
|
(d)
|
The Parties and the arbitrators shall use all reasonable efforts to complete any such arbitration within [*] following the appointment of the arbitrators pursuant to Clause 19.10(b) above.
|
(e)
|
Notwithstanding anything to the contrary in this Clause 19.10, either Party may seek a temporary injunction or other interim equitable relief under Article 28(1) (Conservatory and Interim Measures) of the ICC Rules of Arbitrations, subject to the application by either Party to a judicial authority as provided under Article 28(2) of the ICC Rules of Arbitrations. Such judicial authority shall have no jurisdiction or ability to resolve disputes beyond the specific issue of temporary injunction or other interim equitable relief as provided under Article 28(2) of the ICC Rules of Arbitrations.
|
19.11.
|
Third Party Beneficiaries
|
19.12.
|
Nature of Parties’ Rights and Obligations
|
19.13.
|
Counterparts
|
Signatures
|
|
|
|
The Supplier
|
Teoxane SA
|
January 9, 2020
|
/s/ Valérie Taupin
|
Place, date
|
By: Valérie Taupin
|
|
Title: Founder, CEO and Chairwoman of the
|
|
Board of directors
|
|
|
The Distributor
|
Revance Therapeutics Inc.
|
January 10, 2020
|
/s/ Mark Foley
|
Place, date
|
By: Mark Foley
|
|
Title: Chief Executive Office
|
|
|
January 10, 2020
|
/s/ Tobin Schilke
|
Place, date
|
By: Tobin Schilke
|
|
Title: Chief Financial Officer
|
KUSD
|
|
2020
|
2021
|
2022
|
2023
|
2024
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
TOTAL
|
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
•
|
Patents related to RHA mépivacaïne:
|
•
|
Patents related to TEOSYAL RHA 1, 2, 3 and 4: [*]:
|
-
|
[*]
|
-
|
License patents include any U.S. patents issued or issuing from any continuing applications thereof (including continuations, continuations-in-part, divisionals), reexaminations, or reissues thereof of any of the foregoing.
|
•
|
Trademarks:
|
Trademarks
|
Status
|
Classes
|
Filing date
|
Registration date
|
Registration n°
|
Renewals date
|
RHA
|
registered
|
3, 5
|
26 July 2013
|
26 July 2013
|
1176843
|
26 July 2023
|
TEOSYAL
|
renewed
|
3, 10
|
23 March 2005
|
23 March 2005
|
851523
|
23 March 2025
|
RHA resilient hyaluronic acid
|
registered
|
3, 5
|
18 Oct. 2011
|
18 Oct. 2011
|
1104083
|
18 Oct. 2021
|
TEOXANE
|
registered
|
3, 5, 10
|
20 Sept. 2006
|
20 Sept. 2006
|
904036
|
20 Sept. 2026
|
TEOXANE + logo goutte (fig)
|
registered
|
3, 5, 10
|
22 Dec. 2016
|
22 Dec. 2016
|
1353858
|
22 Dec. 2026
|
TEOXANE the excellence of swiss science (fig)
|
registered
|
3, 5, 10
|
22 Dec. 2016
|
22 Dec. 2016
|
1353859
|
22 Dec. 2026
|
Annex 9.2(a) – Forecasting Form
|
Annex 9.3 – Purchase Order
|
Annex 10.1(a)– [*]
|
|
/s/ Mark J. Foley
|
|
Mark J. Foley
|
|
President and Chief Executive Officer
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(Principal Executive Officer)
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/s/ Tobin C. Schilke
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Tobin C. Schilke
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Chief Financial Officer
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(Principal Financial Officer and Principal Accounting Officer)
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1.
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The Company’s Annual Report on Form 10-K for the period ended December 31, 2019 (the “Annual Report”), to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
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2.
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The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Mark J. Foley
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Mark J. Foley
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President and Chief Executive Officer
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(Principal Executive Officer)
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1.
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The Company’s Annual Report on Form 10-K for the period ended December 31, 2019 (the “Annual Report”), to which this Certification is attached as Exhibit 32.2, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
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2.
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The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Tobin C. Schilke
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Tobin C. Schilke
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Chief Financial Officer
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(Principal Financial Officer and Principal Accounting Officer)
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