Remarkably, the license agreement (filed on Edgar) between Novartis and CELG has not been elided - all the numbers are present. (This is the first time I've ever seen this).
Here are the milestone figures:
(a) On the Effective Date, a payment of U.S.$10,000,000
plus interest accrued at the rate of 8% per annum from the date of execution of
this Agreement to the Effective Date; provided, however, that if antitrust
clearance from the FTC and the Antitrust Division of the Department of Justice
is not received by the parties with respect to this Agreement and
notwithstanding any termination of this Agreement pursuant to Section 11.3(f)
hereof, Novartis shall pay Celgene a payment of U.S. $5,000,000 plus interest
accrued at the rate of 8% per annum from the date of execution of this Agreement
to the Termination Date.
(b) Upon the acceptance by the FDA of an NDA for d-MPH IR,
a payment of U.S.$5,000,000.
(c) Upon FDA Approval of d-MPH IR, a payment of
U.S.$12,500,000.
(d) Upon the submission to FDA of an NDA for the d-MPH PR,
a payment of U.S.$7,500,000.
(e) Upon FDA Approval of the d-MPH PR, a payment of
U.S.$20,000,000.
(f) If either of the d-MPH Products is transferred from
its current status of C-II under the Controlled Substances Act of 1970 (the
"Act") to a status of either C-IV or C-V under the Act, or if either of the
d-MPH Products is determined not to be a controlled substance under the Act,
Novartis will pay to Celgene, upon the happening of either event, a payment of
U.S.$15,000,000 (said milestone payable only once).
(g) Upon the submission of regulatory dossier in Europe
for d-MPH IR:
(i) Centralized (EMEA), US$5,000,000; or
(ii) Mutual Recognition for each of France, Germany,
Italy, Spain and the United Kingdom (collectively, the "Five Major Markets"),
US$1,000,000 per market.
h) Upon approval in Europe for d-MPH IR:
(i) Centralized (EMEA), US$10,000,000; or
(ii) Mutual Recognition for each of the Five Major
Markets, US$2,000,000 per market.
(i) Upon the submission of regulatory dossier in Europe
for d-MPH PR:
(i) Centralized (EMEA), US$5,000,000; or
(ii) Mutual Recognition for each of the Five Major
Markets, US$1,000,000 per market.
(j) Upon approval in Europe for d-MPH PR:
(i) Centralized (EMEA), US$10,000,000; or
(ii) Mutual Recognition for each of the Five Major
Markets, US$2,000,000 per market.
Interestingly, the milestones for the pulse release version are higher than for the straight version, even though presumably the FDA risk is much higher for the first filing. That confirms that they think they need the PR version to compete effectively.
From a quick scan of the agreement, CELG manufactures the drug and bills for 35% of the eventual selling price. (All subject to a bunch of adjustments under various circumstances).
Miljenko, any guess as to the cost of manufacture as a percentage of the eventual sales price of the drug?
Peter |
