't zal maar gebeuren schreef op 15 augustus 2016 19:51:
hier nog eens de overeenkomst met santarus ,sijmen heeft alles weg gegeven voor 30 miljoen$ en koopt het nu terug voor 60+65 miljoen.
License Agreement
Under the license agreement, Pharming granted us the non-exclusive rights to develop and manufacture and the
exclusive right to commercialize licensed products in the U.S., Canada and Mexico.
In partial consideration of the licenses granted under the license agreement, we paid Pharming a $15 million
upfront fee and will be required to pay an additional $5 million milestone upon FDA acceptance for review of a
BLA for Rhucin. We may also be required to pay Pharming additional success-based clinical and commercial
milestones totaling up to an aggregate of $30 million, including a $10 million milestone payable on successful
completion of the phase III clinical study, depending upon the achievement of developmental and commercial
objectives. In addition, we will be required to pay certain one-time performance milestones if we achieve certain
aggregate net sales levels of Rhucin. The amount of each such milestone payment varies upon the level of net sales
in a calendar year. The maximum amount of all such payments to Pharming would be $45 million, assuming net
sales exceeded $500 million in a calendar year. As consideration for the licenses and rights granted under the license
agreement, and as compensation for the commercial supply of Rhucin by Pharming pursuant to the supply
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agreement agreement described below, we will pay Pharming a tiered supply price, based on a percentage of net sales of
Rhucin, subject to reduction in certain events.
Under the license agreement, Pharming is responsible for conducting the current phase III clinical study for
Rhucin for the treatment of HAE and all costs of such clinical development. Pharming is also responsible for
preparing and filing the BLA for the treatment of HAE in the U.S. We will be responsible for seeking regulatory
approval for the treatment of HAE for Canada and Mexico.
Either party may propose the development of Rhucin for an additional indication in the U.S., Canada and
Mexico, to which the other party may opt-in to participate in the development.
We have agreed to use commercially reasonable efforts to promote, sell and distribute Rhucin in the U.S.,
Canada and Mexico, including launching Rhucin for the treatment of HAE in the U.S. within 120 days following
receipt of U.S. regulatory approval. During the term of the license agreement, Pharming has agreed not to, and to
insure that its distributors and dealers do not, sell Rhucin to any customer in the U.S., Canada and Mexico. Both
parties have agreed not to manufacture, develop, promote, market or distribute any other forms of C1 inhibitors for
use in the U.S., Canada and Mexico during the term.
The license agreement will continue in effect until we cease to sell Rhucin in the U.S., Canada and Mexico,
unless terminated sooner. Either party may terminate the agreement in the following circumstances: (a) if the other
party breaches any material term of the agreement and fails to cure such breach within a specified time period
following written notice; or (b) upon the insolvency or occurrence of other specified bankruptcy events. We may
also terminate the license agreement at any time subject to 12 months prior written notice.
Following termination by Pharming or by us at will, the rights associated with Rhucin revert to Pharming and the
supply agreement will terminate. Following termination by us for uncured material breach, bankruptcy or
insolvency, the licenses granted to us will survive, we will have a right to reduce the supply price, and the supply
agreement will remain in effect.
Supply Agreement
Under the supply agreement, Pharming will manufacture and exclusively supply to us, and we will exclusively
order from Pharming, Rhucin at the supply price for commercialization activities. Pharming will manufacture and
supply recombinant human C1 inhibitor products to us at cost for development activities.
Pharming will maintain any drug master files and we will have a right to reference any such drug master files for
the purpose of obtaining regulatory approval of Rhucin in the U.S., Canada and Mexico. Pharming will be
responsible for obtaining and maintaining all manufacturing approvals and related costs.
In the event of a supply failure, we have certain step-in rights to cure any payment defaults under Pharming’s
third party manufacturing agreements or to assume sole responsibility for manufacturing and supply. In connection
with the supply agreement, we entered into a deed of usufruct with Pharming Intellectual Property B.V. and
Pharming Technologies B.V., under which we were granted certain supplemental property interests in the form of a
right of usufruct to manufacturing related intellectual property and access to manufacturing materials and knowhow,
in order to assume such manufacturing and supply responsibilities.
The supply agreement is subject to the term and termination provisions of the license agreement.