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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): May 9, 2006
IMMUNOMEDICS, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-12104 61-1009366
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
300 American Road, Morris Plains, New Jersey 07950
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(Address of Principal Executive Offices) (Zip Code)
(973) 605-8200
(Registrant's telephone number, including area code)
Not applicable
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[ ] Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425).
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12).
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)).
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)).
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ITEM 1.01. ENTRY INTO MATERIAL DEFINITIVE AGREEMENT.
On May 9, 2006 (the "Effective Date") Immunomedics, Inc., a Delaware
corporation (the "Company"), entered into a Development, Collaboration and
License Agreement (the "Agreement") with UCB, S.A. ("UCB") providing UCB an
exclusive worldwide license to develop, manufacture, market and sell
epratuzumab, the Company's humanized CD22 antibody ("Epratuzumab"), for the
treatment of all autoimmune disease indications. Under the terms of the
Agreement, the Company retains the rights to develop Epratuzumab in the field of
oncology, and UCB has the right to acquire development and commercialization
rights to Epratuzumab with respect to cancer indications at anytime prior to the
first commercial sales thereof. If UCB exercises its buy-in right with respect
to Epratuzumab in the field of oncology, UCB will reimburse the Company for the
development cost actually incurred, plus a buy-in fee.
Under the terms of the Agreement, the Company will receive in cash from
UCB initial payments totaling, before fees, $38 million (which includes a $25
million upfront payment, plus a $13 million reimbursement for development costs
of Epratuzumab related to the clinical development of Epratuzumab in patients
with systemic lupus erythematosus (SLE) and Sjogren's syndrome), within ten
business days of the Effective Date. In addition, the Company is entitled to
receive regulatory milestone payments, which could aggregate to a maximum of up
to $145 million in cash payments and $20 million in equity investments. These
milestone payments are dependent upon specific achievements in the regulatory
approval process under the Agreement. The Company will also receive product
royalties based upon a percentage of aggregate annual net sales under the
Agreement during the product royalty term, which percentage is subject to
reduction under certain circumstances. In addition, the Company will be entitled
to receive sales bonuses of up to $135 million upon annual net sales reaching
certain target levels.
The Agreement calls for the creation of a global autoimmune guidance
committee, with equal representation by the Company and UCB, to plan and oversee
the conduct and progress of the development and commercialization of
Epratuzumab. UCB has the deciding vote on the committee. UCB will be solely
responsible for the development, manufacturing and commercialization of
Epratuzumab for the treatment of all autoimmune indications and for the
continuation of ongoing clinical trials in SLE, with the Company responsible for
supplying Epratuzumab for the completion of clinical trials relating to SLE. The
Company is also obligated to manufacture and supply Epratuzumab, if needed and
at UCB's request, for the initial commercial launch of Epratuzumab for the
treatment of SLE and for future clinical trials relating to the treatment of
Sjogren's syndrome, if necessary. UCB will have sole responsibility for all
clinical development, regulatory filings and related submissions, as well as all
commercialization activities with respect to Epratuzumab in all autoimmune
indications.
The Agreement commences on the Effective Date and shall terminate in
accordance with the terms thereof or by mutual written consent, unless UCB
decides to cease all development and commercialization of Epratuzumab pursuant
to the Agreement. Either the Company or UCB has the right to terminate the
Agreement by notice in writing to the other party upon or after any material
breach of the Agreement by the other party, if the other party has not cured the
breach within 60 days after written notice to cure has been given, with certain
exceptions.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits.
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Exhibit No. Description
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99.1 Press Release of Immunomedics, Inc. dated May 10, 2006.
SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
IMMUNOMEDICS, INC.
By: /s/ Cynthia Sullivan
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Name: Cynthia Sullivan
Title: President and Chief Executive Officer
Date: May 10, 2006