UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 10, 2010
SANTARUS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware (State or Other Jurisdiction of Incorporation or Organization) |
0-50651 (Commission File Number) |
33-0734433 (I.R.S. Employer Identification No.) |
3721 Valley Centre Drive, Suite 400, San Diego, California 92130
(Address of Principal Executive Offices) (Zip Code)
(Address of Principal Executive Offices) (Zip Code)
(858) 314-5700
(Registrants Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions:
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01. | Entry into a Material Definitive Agreement. |
On September 10, 2010, Santarus, Inc. (Santarus) entered into a License Agreement (the
License Agreement) and a Supply Agreement (the Supply Agreement) with Pharming Group N.V., on
behalf of itself and each of its affiliates, including Pharming Intellectual Property B.V. and
Pharming Technologies B.V. (Pharming), under which Santarus was granted certain non-exclusive
rights to develop and manufacture, and certain exclusive rights to commercialize Rhucin®
(recombinant human C1 inhibitor) in the United States, Canada and Mexico (the Territory) for the
treatment of acute attacks of hereditary angioedema (the Initial Indication) and other future
indications, as further described below.
License Agreement
Under the License Agreement, Pharming granted Santarus the non-exclusive right to develop and
manufacture and the exclusive right to commercialize licensed products in the Territory.
In partial consideration of the licenses granted under the License Agreement, Santarus will
pay Pharming a $15 million upfront fee and an additional $5 million milestone upon U.S. Food and
Drug Administration (FDA) acceptance of a Biologic License Application (BLA) for Rhucin.
Santarus may also pay Pharming additional success-based clinical and commercial milestones,
including upon achievement of certain aggregate net sales levels of Rhucin. 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 Agreement described below, Santarus 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 clinical development of
Rhucin for the Initial Indication and all costs of such clinical development. Pharming will also be
responsible for preparing and filing the BLA for the Initial Indication in the U.S. Santarus will
be responsible for seeking regulatory approval for the Initial Indication for each other country in
the Territory.
Santarus and Pharming will share responsibility for conducting clinical development of Rhucin
for the treatment or prevention of renal transplantation rejection in humans (the Transplant
Indication), and will equally share the costs of such clinical development. Santarus will be
responsible for preparing and filing the drug approval application for the Transplant Indication
throughout the Territory and for seeking regulatory approval to market and sell Rhucin for such
indication.
Either party may propose the development of Rhucin for an additional indication in the
Territory, to which the other party may opt-in.
Santarus has agreed to use commercially reasonable efforts to promote, sell and distribute
Rhucin in the Territory, including launching Rhucin for the Initial Indication 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 Territory. Both parties have agreed not to manufacture, develop, promote,
market or distribute any other forms of C1 inhibitors for use in the Territory during the term.
The License Agreement will continue in effect until Santarus ceases to sell Rhucin in the
Territory, 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. Santarus may also terminate the License Agreement at any time subject to 12
months prior written notice.
Following termination by Pharming or by Santarus at will, the rights associated with Rhucin
revert to Pharming and the Supply Agreement will terminate. Following termination by Santarus for
uncured material breach, bankruptcy or insolvency, the licenses granted to Santarus will survive,
Santarus 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 Santarus, and
Santarus will exclusively order from Pharming, Rhucin at the supply price for commercialization
activities. Pharming will manufacture and supply recombinant human C1 inhibitor products to
Santarus at cost for development activities.
Pharming will maintain any drug master files and Santarus will have a right to reference any
such drug master files for the purpose of obtaining regulatory approval of Rhucin in the Territory.
Pharming will be responsible for obtaining and maintaining all manufacturing approvals and related
costs.
In the event of a supply failure, Santarus has certain step-in rights to cure any payment
defaults under Pharmings third party manufacturing agreements or to assume sole responsibility for
manufacturing and supply. In connection with the Supply Agreement, Santarus entered into a Deed of
Usufruct with Pharming Intellectual Property B.V. and Pharming Technologies B.V., under which
Santarus was granted a right of usufruct to manufacturing related intellectual property and access
to manufacturing materials and know-how, in order to assume such manufacturing and supply
responsibilities.
The Supply Agreement is subject to the term and termination provisions of the License
Agreement.
The foregoing description of the terms of the License Agreement and Supply Agreement is
qualified in its entirety by reference to the provisions of the License Agreement and Supply
Agreement, which will be filed as exhibits to Santarus Quarterly Report on Form 10-Q for the
quarter ending September 30, 2010.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SANTARUS, INC. |
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Date: September 13, 2010 | By: | /s/ Gerald T. Proehl | ||
Name: | Gerald T. Proehl | |||
Title: | President and Chief Executive Officer | |||