DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Entry into a Material Definitive AgreementItem 1.01 Entry into a Material Definitive Agreement.
Effective May 4, 2018, DURECT Corporation (“DURECT” or the “Company”) and Sandoz AG (“Sandoz”) entered into an amendment (the “Amendment”) to the license agreement dated May 5, 2017, regarding POSIMIR® (SABER®-bupivacaine) in the United States. to the original license agreement, DURECT received an upfront payment of $20 million and was initially eligible for up to an additional $43 million in milestone payments based on successful development and regulatory milestones (of which $30 million is feasible following the results of the PERSIST Phase 3 clinical trial), and up to an additional $230 million in sales-based milestones.Sandoz received exclusive commercialization rights for POSIMIR in the U.S. upon regulatory approval with sole funding responsibility for commercialization activities.Sandoz will pay the Company a tiered double-digit royalty on product sales for a defined period, after which the license granted to Sandoz shall convert to a non-exclusive, fully paid, royalty-free, irrevocable and perpetual license.
to the Amendment, DURECT is eligible for up to $30 million in milestone payments based on NDA approval, and remains eligible for up to an additional $230 million in sales-based milestones. to the Amendment, each party is also permitted to develop or commercialize competing products.The Amendment also includes modifications to DURECT’s development obligations and to both parties’ termination provisions, including a right for DURECT to terminate for convenience prior to NDA approval, and a new termination fee payable to DURECT in the event that Sandoz terminates the agreement for convenience.Except as expressly set forth in the Amendment, the license agreement remains in full force and effect.
About DURECT CORPORATION (NASDAQ:DRRX)
Durect Corporation is a biopharmaceutical company with research and development programs. The Company’s products candidates include DUR-928, oral for metabolic/lipid disorders, and DUR-928, injectable for acute organ injuries. Its other product candidates include POSIMIR (controlled release injection of bupivacaine), REMOXY (oral controlled release oxycodone), ORADUR-ADHD, ELADUR (controlled release injection of bupivicane), Relday (risperidone), ORADUR-based opioid (hydromorphone) and SABER-based ophthalmic. The Company’s ALZET product line consists of miniature, implantable osmotic pumps and accessories used for experimental research in mice, rats and other laboratory animals. The Company also manufactures and sells osmotic pumps used in laboratory research and design; and develops and manufactures a range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products.
