Collaborations

In May 2017, DURECT and Sandoz AG entered into an agreement granting Sandoz an exclusive license to develop and commercialize in the United States POSIMIR®, DURECT’s investigational non-opioid analgesic for the treatment of post-surgical pain. DURECT will remain responsible for completion of the ongoing PERSIST Phase 3 clinical trial for POSIMIR and for all FDA interactions through approval.

In connection with the Sandoz agreement, Sandoz made an upfront payment to DURECT of $20 million, with the potential for up to an additional $43 million in development and regulatory milestones, up to an additional $230 million in sales-based milestones, as well as a tiered double-digit royalty on product sales in the United States.

There are various termination provisions in the agreement.

In December 2002, DURECT entered into an agreement granting Pain Therapeutics the exclusive worldwide right to develop and commercialize four oral sustained-release, abuse-deterrent opioid analgesic products based on ORADUR® technology. These products were REMOXY® (ORADUR-oxycodone) ER capsules, ORADUR-hydromorphone, ORADUR-oxymorphone, and ORADUR-hydrocodone. Pain Therapeutics subsequently returned to DURECT all of its rights and was relieved of its obligations under the license agreement with respect to ORADUR-hydromorphone, ORADUR-oxymorphone, and ORADUR-hydrocodone. The rights and obligations related to REMOXY ER were unaffected.

Under the terms of the agreement, Pain Therapeutics paid DURECT an upfront license fee of $1.0 million, with the potential for an additional $3.0 million in performance milestone payments based on the successful development and approval of REMOXY ER. Of these potential milestones, $1.5 million has been paid to DURECT. DURECT will also receive royalties for REMOXY ER, if commercialized, of 6.0% to 11.5% of net sales of the product, depending on sales volume.

There are various termination provisions in this agreement.

In December 2014, DURECT and Santen entered into an agreement (the Santen Agreement) granting Santen an exclusive worldwide license to develop and commercialize a sustained-release injectable ophthalmology product utilizing DURECT’s proprietary SABER® technology and other intellectual property. Santen will control and fund the development and commercialization program for this product. The parties will establish a joint management committee to oversee, review, and coordinate development activities.

In accordance with the Santen agreement, Santen paid DURECT an upfront fee of $2.0 million and agreed to make contingent cash payments to DURECT of up to $76.0 million upon the achievement of certain milestones—of which $13.0 million are development-based and $63.0 million are commercialization-based—including requirements for the achievement of certain product sales targets. Santen will pay for a certain portion of DURECT’s costs incurred in the development of the licensed product, and if the product is commercialized, DURECT will also receive a tiered single-digit to low-double-digit royalty on annual net product sales, determined on a country-by-country basis.

There are various termination provisions in this agreement.