Immunomedics,Inc. (NASDAQ:IMMU) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
Development and License Agreement
On February10, 2017 (the Execution Date),Immunomedics,Inc., a
Delaware corporation (the Company), entered into a Development
and License Agreement (the License Agreement) with Seattle
Genetics,Inc., a Delaware corporation (SGEN), granting SGEN a
worldwide, exclusive license, including the right to sublicense
subject to the terms and conditions of the License Agreement, to
develop, manufacture and commercialize sacituzumab govitecan
(IMMU-132), an antibody-drug conjugate comprising hRS7, SN-38 and
the proprietary linker CL-2A, and any second generation
antibody-drug conjugates binding to Trop-2 for all human
therapeutic uses in all indications.
Under the terms of the License Agreement, SGEN will be
responsible for, and bear the future costs of, worldwide
development and commercialization of licensed products, subject
to specified exceptions. SGEN will also assume control over
manufacturing of all licensed products under the License
Agreement, subject to assistance from the Company. SGEN will use
commercially reasonable efforts to develop IMMU-132 in multiple
indications and will use commercially reasonable efforts to
market, promote and commercialize IMMU-132 in any indication for
which regulatory approval is obtained in a major market country
(as specified in the License Agreement). The Company and SGEN
will form a Joint Steering Committee (the JSC) to oversee
development, commercialization, manufacturing and intellectual
property, which committee will be chaired by a representative of
SGEN. The Company has the right to elect to co-promote IMMU-132
in the United States by participating in 50% of the sales effort,
subject to certain parameters set forth in the License Agreement.
Closing of the License Agreement is subject to specified closing
conditions, including clearance under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (HSR). Following closing and
subject to the terms of the License Agreement, the Company will
receive an initial cash payment of $250 million, and could
receive an additional $50 million (or negotiated economic splits)
relating to rights outside the United States, Canada and the EU,
and other potential cash milestone payments totaling up to
approximately $1.7 billion in the aggregate, which are contingent
upon achieving certain milestones relating to the development and
regulatory approval of IMMU-132 for TNBC and other indications in
the United States and other territories, as well as certain
sales-related milestones. The Company is also entitled to receive
an escalating double digit royalty starting in the teens and
escalating to twenty percent based on global net sales of
licensed products by SGEN, its affiliates or sublicensees during
the royalty term specified in the License Agreement.
The License Agreement is not effective until closing after the
expiration or termination of the applicable HSR waiting period
and the satisfaction or waiver of other specified conditions (the
Effective Date). Either the Company or SGEN can terminate the
License Agreement in the event of an uncured material breach by
the other party, subject to the dispute resolution procedures
described in the License Agreement. For fundamental material
breaches satisfying specific criteria described in the License
Agreement, SGEN also has the right to terminate specified rights
and obligations of the Company (not including SGENs milestone,
royalty and upfront payment obligations in accordance with the
License Agreement) as an alternative to termination of the
License Agreement in its entirety. In addition, the License
Agreement may be terminated by SGEN for any reason upon written
notice to the Company, which will be effective 270 days from the
date of receipt of such notice. The License Agreement also
contains customary indemnification provisions.
to the terms of a modified go-shop provision in the License
Agreement, until 11:59 p.m.New York City time on February19, 2017
(the Go-Shop Period), the Company has the right to continue
negotiating with a select number of parties that previously
expressed interest in licensing IMMU-132, and accept a superior
licensing proposal. SGEN has the right to match any such superior
licensing proposal and if it decides not to match, the Company
has the right to accept the superior licensing proposal and
terminate the License Agreement upon payment of a termination fee
to SGEN.
Following the expiration of the Go-Shop Period, the Company will
become subject to customary no shop restrictions on its and its
representatives ability to solicit, discuss or negotiate
alternative licensing proposals from third parties.
Stock Purchase Agreement
On February10, 2017, in connection with the execution of the
License Agreement, the Company entered into a Stock Purchase
Agreement (the SPA) with SGEN. Under the SPA, SGEN has purchased,
and the Company has sold, in the aggregate, 3,000,000 shares of
the Companys common stock, par value $0.01 per share (the Common
Shares), at a price of $4.90 per share, which represents a 10%
premium to the 15-day trading volume weighted average stock price
of $4.45 for the period ending at the close of trading on
February9, 2017, the last trading day prior to entering into the
License Agreement, for aggregate proceeds of $14.7 million.
Concurrently with the sale of the Common Shares, to the SPA, the
Company also agreed to issue a three-year warrant (the Warrant)
to purchase an aggregate of 8,655,804 shares of
common stock of the Company (the Common Stock). The Warrant
will be exercisable for cash only and only upon approval by the
Companys stockholders of an amendment to the Companys
certificate of incorporation, and filing thereof, increasing
such number of shares of Common Stock in an amount sufficient
to allow for the exercise of the shares being issued upon the
exercise of the Warrant, at an initial exercise price equal to
$4.90 per share of Common Stock. The Warrant was issued on
February16, 2017 and is exercisable until February10, 2020.
Registration Rights Agreement
In connection with the entrance by the Company into the SPA,
the Company entered into the Registration Rights Agreement, by
and between the Company and SGEN, dated February10, 2017, to
which the Company granted customary registration rights to SGEN
obligating the Company to register for resale under the
Securities Act on FormS-3 the Common Shares and the shares of
Common Stock into which the Warrant is exercisable (the Warrant
Shares).
The preceding summary descriptions are qualified in their
entirety by reference to the terms of each of the SPA and the
Registration Rights Agreement, each of which will be included
as an exhibit to the Companys next quarterly report on
Form10-Q, the Warrant, and the License Agreement, which,
subject to certain redactions requested to a request for
confidential treatment, will be included as an exhibit to the
Companys next quarterly report on Form10-Q, and the
transactions contemplated thereby.
Indemnification Agreement
The Board of Directors of the Company (the Board) approved a
form of indemnification agreement (the Indemnification
Agreement), effective as of February 10, 2017, and authorized
the Company to enter into the Indemnification Agreement with
each of its current directors and executive officers and
certain of its former directors and executive officers (each,
an Indemnitee).
The Indemnification Agreement clarifies and supplements the
indemnification rights and obligations of the Indemnitee and
Company already included in the Companys Amended and Restated
Certificate of Incorporation (the Certificate of Incorporation)
and Second Amended and Restated By-laws, as amended (the
By-laws). Under the terms of the Indemnification Agreement, the
Company, among other things, will indemnify, to the fullest
extent permitted by law and the Certificate of Incorporation
and By-laws, each director and officer for certain losses or
expenses including attorneys fees, judgments, fines and
settlement amounts incurred by any such person in any action or
proceeding (other than certain proceedings against the Company
or securities laws claims), including any action by or in the
Companys right, arising out of the persons services as the
Companys director or officer or any other company or
enterprise, including the Companys subsidiaries, to which the
person provides services at the Companys request. The
Indemnification Agreements will also provide for the
advancement or payment of all expenses to the Indemnitee and
for the reimbursement to the Company if it is found that such
Indemnitee is not entitled to such indemnification under
applicable law and the Companys Certificate of Incorporation
and By-laws.
The foregoing description of the Indemnification Agreement does
not purport to be complete and is qualified in its entirety by
reference to the form of Indemnification Agreement, which is
filed as Exhibit10.1 to this Current Report on Form8-K and is
incorporated herein by reference.
Item 3.02 Unregistered Sales of Equity
Securities.
The information contained above in Item 1.01 related to the
Common Shares and the Warrant Shares is hereby incorporated by
reference into this Item 3.02.
The issuance by the Company of Common Shares, the Warrant and
the Warrant Shares is being made in reliance upon the exemption
from registration afforded by Section4(a)(2)of the U.S.
Securities Act of 1933, as amended (the Securities Act), and/or
Rule506(b)of Regulation D under the Securities Act as a
transaction not involving a public offering. SGEN is an
accredited investor as defined in Rule501 of Regulation D under
the Securities Act, and is acquiring the Common Shares and the
Warrant for investment only and not with a view toward, or for
resale in connection with, the public sale or distribution
thereof. Furthermore, the Companys securities are not being
offered or sold by any form of general solicitation or general
advertising.
Item 5.03 Amendments to Articles of Incorporation or
Bylaws; Change in Fiscal Year.
Second Amendment to Second Amended and Restated
By-Laws
Directors Election
On February10, 2017, the Company amended, upon approval by the
Board, Section3.3 of the By-laws in order to clarify that, in
any contested election of directors, the nominees receiving the
highest numbers of votes for such nominees election will be
elected.
Indemnification
The Company, also, amended, upon approval by the Board,
Section8.5 of the By-laws in order to ensure that expenses
incurred in defending any civil, criminal, administrative, or
investigative action, suit or proceeding will be paid by the
Company in advance of the final disposition of such action,
suit or proceeding upon receipt of an undertaking by or on
behalf of any person entitled to indemnification under the
terms of the By-Laws.
The preceding summaries of the amendment are qualified in their
entirety by reference to the full text of the Second Amendment
to the By-laws, which is attached hereto as Exhibit3.4 and
incorporated herein.
Item 8.01 Other Events.
On February10, 2017, the Company issued a press release
announcing its transactions with SGEN, including the Companys
entry into the License Agreement and the SPA. A copy of the
press release is filed as Exhibit99.1 hereto and is
incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form8-K, in addition to historical
information, may contain forward-looking statements about the
Company made to the Private Securities Litigation Reform Act of
1995. Such statements, including statements regarding clinical
trials, patent protection, out-licensing arrangements
(including the timing and amount of contingent payments to the
License Agreement with SGEN), forecasts of future operating
results, and capital raising activities, involve significant
risks and uncertainties and actual results could differ
materially from those expressed or implied herein. Factors that
could cause such differences include, but are not limited to,
risks associated with new product development (including
clinical trials outcome and regulatory requirements/actions),
any delays or failure to receive HSR approval of the License
Agreement, competitive risks to marketed products and
availability of required financing and other sources of funds
on acceptable terms, if at all, as well as the risks discussed
in the Companys filings with the Securities and Exchange
Commission. The Company is not under any obligation, and the
Company expressly disclaims any obligation, to update or alter
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
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Exhibit No. |
Description of Exhibits |
|
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3.3 |
Second Amendment to Second Amended and Restated By-Laws |
|
|
4.1 |
Warrant Agreement, dated as of February16, 2017, between |
|
|
10.1 |
Formof Indemnification Agreement |
|
|
99.1 |
Press Release of the Company, dated February10, 2017. |
About Immunomedics, Inc. (NASDAQ:IMMU)
Immunomedics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Its geographic segments include United States and Europe. Its technologies allow it to create humanized antibodies that can be used either alone in unlabeled or naked form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. It has a pipeline of eight clinical-stage product candidates. Its portfolio of investigational products includes antibody-drug conjugates (ADCs) that are designed to deliver a payload of a chemotherapeutic directly to the tumor, while the managing overall toxic effects that are found with conventional administration of these chemotherapy agents. Its ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase II trials. Immunomedics, Inc. (NASDAQ:IMMU) Recent Trading Information
Immunomedics, Inc. (NASDAQ:IMMU) closed its last trading session down -0.06 at 5.11 with 1,726,922 shares trading hands.
