Hyperion, Clal In Interim Deal To Attempt To Resolve Disputes Between Them

(RTTNews) - Hyperion Therapeutics, Inc. (HPTX) and Clal Biotechnology Industries Ltd. or CBI Tuesday said they have entered into an interim agreement to attempt to resolve the disputes between them.

The agreement also allows CBI to evaluate whether there is any clinical efficacy to, and whether there is a potential regulatory path forward for, DiaPep277 that a party other than Hyperion may wish to pursue.

Under the terms of the interim agreement, and consistent with Hyperion's statement of September 8, Hyperion will complete the current DIA-AID 2 study of DiaPep277, at its expense.

An independent party or parties will be appointed by CBI, at CBI's expense, and will be permitted to have access to relevant non-privileged documentary materials including, the statistical analysis plans, the study dataset after unblinding, and any correspondence with the FDA and other medical/clinical regulatory entities.

The independent party is expected to assess, for CBI's benefit, the ongoing conduct of the DIA-AID 2 study, the conduct of the completed DIA-AID 1 study, the integrity of the studies' readouts, and any potential regulatory path forward for DiaPep277.

The assessment shall be conducted during the DIA-AID 2 study and thereafter for as long as reasonably required to complete the review.

Hyperion will not be obligated to take any action in response to the independent party's observations.

During the interim period, Hyperion and CBI have agreed to not take any additional steps to prosecute any lawsuit, claim, or other litigation against the other party relating to the development of DiaPep277 or the Share Purchase Agreement regarding Andromeda Biotech, Ltd., which Hyperion acquired from CBI in June.

Hyperion and CBI have further agreed that by virtue of the interim agreement, neither party has waived any right, claim or defense relating to the Share Purchase Agreement.

The interim period is until October 31, which may be extended by either party for an additional period of 3 weeks