Annotations
This collaboration agreement (“Agreement DNDi GARDP NIH
When the Agreement was executed, Entasis had already filed an investigational new drug application with the FDA, and completed two phase 1 clinical trials and a phase 2 trial. The Agreement contemplates that the parties will conduct additional studies, beginning with a QT trial in the United States, which measures the drug’s impact on an aspect of the heart’s functioning, that Entasis will conduct (“QT Study Phase III MC Trial CMC
A Joint Steering Committee (“JSC
Each party grants the other an exclusive license in its background technology and foreground technology, which the Agreement calls “collaboration technology
The Agreement includes provisions to prevent antibiotic resistance, including a prohibition on development for “future indications” without both parties’ consent. When negotiating a manufacturing and supply plan, the parties must minimize the number of manufacturing sublicencees in order to ensure continued efficacy and responsible use of the product.
Entasis’ territory includes specified high-income countries. DNDi will commercialize products for the rest of the world. The schedule that defines each party’s exact Territory is redacted, however territory information is available in this GARDP press release .
Provision Language
16. Miscellaneous
16.6 Regulatory Advantages. The Parties acknowledge that both Parties are actively contributing to the Collaboration Programme hereunder. Consequently, in the event that any advantage may be received from any Drug Regulatory Authority resulting from obtaining any Marketing Authorisation hereunder and arising from the classification of the Drug Product on the WHO essential medicines list the Parties shall discuss in good faith to find a way to share the repercussions of such advantage in an equitable manner.
