ITEM 1.01 ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On December 18, 2020, Revance Therapeutics, Inc. (the “Company”) and Ajinomoto Althea, Inc. dba Aji Bio-Pharma Services, a contract development and manufacturing organization (“ABPS”), entered into Amendment No. 1 to the Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (the “Amendment”) in connection with the supply of DaxibotulinumtoxinA for Injection. ABPS will serve as a dual supply source and provide drug product manufacturing services for the Company at its aseptic manufacturing facility in San Diego, California. As previously disclosed on a Current Report on Form 8-K filed on March 15, 2017, the Company entered into the Technology Transfer, Validation and Commercial Fill/Finish Services Agreement with ABPS on March 14, 2017 (the “Services Agreement”). Under the Services Agreement, ABPS agreed, among other things, to provide the Company with expanded capacity and a second source of drug product manufacturing and commercial fill/finish services for the Company’s neuromodulator products. The Services Agreement has an initial term that will expire in March 2024, unless sooner terminated by either party in accordance with the terms of the Services Agreement. 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.
The Amendment modified ABPS’s dedicated manufacturing capacity and buyback obligations and the Company’s related payment obligations for the Company’s neuromodulator products, as well as provisions relating to the cancellation of product batches and the termination of the Services Agreement.
Concurrent with the execution of the Amendment, 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 drug product manufacturing, shipping, materials, product maintenance, pricing, payment obligations, and capacity buyback, in each case, in support of the Company’s neuromodulator products. This Statement of Work expires on December 31, 2021, except for the capacity and related payment obligations, which survive the termination of the Statement of Work.
The foregoing summary of the terms of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2020, portions of which may be subject to confidential treatment.