REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Files An 8-K Entry into a Material Definitive AgreementITEM 1.01.
REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Files An 8-K Entry into a Material Definitive Agreement
ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.
On March 14, 2017, Revance Therapeutics, Inc. (the “Company”) entered into a Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (the “Services Agreement”) with Ajinomoto Althea, Inc., a contract development and manufacturing organization (“Althea”).
Under the Services Agreement, Althea has agreed, among other things, to provide the Company with a future source of commercial fill/finish services for the Company’s neuromodulator products. The Services Agreement provides the Company expanded capacity and a second source of drug product manufacturing to support a global launch of DaxibotulinumtoxinA for Injection (RT002). The Services Agreement also mitigates supply chain risk by giving the Company a different manufacturing location than its current site and reduces future capital and operating expenditures required in the Company’s primary manufacturing facility by outsourcing to an experienced partner.
The Services Agreement has an initial term that will expire in seven years, unless sooner terminated by either party in accordance with the terms of the Services Agreement. The term of the Services Agreement may be extended by mutual agreement of the parties. Concurrent with the execution of the Services Agreement, the parties also entered into a Statement of Work, which was made part of the Services Agreement and sets forth the particulars of production, components to be supplied and services to be performed under the Services Agreement, including deliverables and pricing information, timelines, milestones, payment schedules, technology transfer plans, and validation protocols, in each case, in support of the Company’s neuromodulator products.
The Services Agreement also contains provisions relating to compliance with current manufacturing practices and applicable laws and regulations, and to intellectual property, indemnification, confidentiality, representations and warranties, dispute resolution and other customary matters for an agreement of this kind.
The foregoing is only a summary description of the material terms of the Services Agreement, does not purport to be a complete description of the terms of the Services Agreement and is qualified in its entirety by reference to the Services Agreement. The Company expects to file the Services Agreement as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2017. Certain terms of the Services Agreement have been omitted from this Form 8-K and will be omitted from the version of the Services Agreement to be filed as an exhibit to the Form 10-Q to a Confidential Treatment Request that the Company plans to submit to the Securities and Exchange Commission at the time of the filing of the Form 10-Q.
About REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC)
Revance Therapeutics, Inc. is a biotechnology company. The Company is focused on the development, manufacturing and commercialization of botulinum toxin products for multiple aesthetic and therapeutic indications. Its TransMTS technology enables delivery of botulinum toxin type A through investigational drug product candidates, including DaxibotulinumtoxinA Topical Gel (RT001), or RT001 topical, and DaxibotulinumtoxinA for Injection (RT002), or RT002 injectable. Its botulinum toxin-peptide complex has over two components that contribute to the performance of RT001 and RT002. Its TransMTS peptide provides the delivery across the skin and restricts the toxin molecule to the target site. Then, the botulinum toxin type A provides the mechanism of pharmacologic action and is responsible for the drug effects demonstrated in its clinical trials. Its TransMTS peptide technology serves various purposes depending on whether it is used in a topical formulation or in an injectable formulation. REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Recent Trading Information
REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) closed its last trading session down -0.40 at 18.30 with 112,946 shares trading hands.
Revance Therapeutics, Inc. is a biotechnology company. The Company is focused on the development, manufacturing and commercialization of botulinum toxin products for multiple aesthetic and therapeutic indications. Its TransMTS technology enables delivery of botulinum toxin type A through investigational drug product candidates, including DaxibotulinumtoxinA Topical Gel (RT001), or RT001 topical, and DaxibotulinumtoxinA for Injection (RT002), or RT002 injectable. Its botulinum toxin-peptide complex has over two components that contribute to the performance of RT001 and RT002. Its TransMTS peptide provides the delivery across the skin and restricts the toxin molecule to the target site. Then, the botulinum toxin type A provides the mechanism of pharmacologic action and is responsible for the drug effects demonstrated in its clinical trials. Its TransMTS peptide technology serves various purposes depending on whether it is used in a topical formulation or in an injectable formulation. REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Recent Trading Information
REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) closed its last trading session down -0.40 at 18.30 with 112,946 shares trading hands.