Repros has entered into the sixth amendment to its agreement with the National Institutes of Health (NHI), relating to Proellex.
The company said that the amendment has revised the dates by which development and commercialization benchmarks must be met. It include an extension of date by which the company is required to submit a new drug application, covering a licensed product in the US for a first indication from June 30, 2009 to June 30, 2011.
The company said that under the amendment, it is required to obtain financing, upfront licensing consideration of no less than a combined total of $6 million by September 30, 2009. The amendment also extended the dates by which certain other benchmarks must be met. They are as follows: the filing for approval of a licensed product in Europe and Japan, the filing of an NDA for a licensed product in a second indication in the US, and the application for regulatory approval for a licensed product in a second indication in Europe and Japan.
It also includes benchmarks relating to initiation of phase-III clinical trials in Europe and Japan, for a licensed product in a second indication. Failure to meet these benchmarks could result in modification or termination of the agreement.
The company is obligated to pay NIH an amendment issue royalty of $100,000, in connection with the amendment.