Excellent information regarding DEPO and the "out clauses." Thank you for providing that to the board. That is clarity with regards to the recent events by ABT with DM-1796.
Message in reply to:
DEPO - so here are the out clauses: I SEE NONE THAT APPLY.
“Termination Event” means any
(a) withdrawal of the Product in the Field from the market in the Territory,
(b) material medical or scientific concerns as to toxicity, safety and/or efficacy of Product in the Field,
(c) written request of any Governmental Authority or the applicable institutional review board or data safety monitoring board to stop clinical trials of the Product in the Field,
(d) failure of the Product to meet all primary endpoints in clinical trials conducted prior to Regulatory Approval of Product in the Field,
(e) a Patent Right controlled by a Third Party is identified that is not included in the Depomed Patents and that is not otherwise licensed to Solvay, which Patent Right (i) claims inventions reasonably necessary for the manufacture, use, sale, offer for sale or import of the Product in the Field in the Territory and (ii) is not available for licensing or otherwise transferable to Solvay on terms reasonably acceptable to Solvay, or
(f) any of the following events: (i) a determination that the Product is not approvable by FDA, as evidenced by a written communication from FDA to Solvay, its Affiliate or sublicensee;(ii); or (iii) managed care providers, comprising at least a majority of the managed care environment in the United States, blocking, materially restricting (including, without limitation, imposition of step edits or prior authorizations) or declining coverage and/or reimbursement for the Product.
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