Form 8-K
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`Page 1 of 5
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`8-K 1 d8k.htm FORM 8-K
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`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`WASHINGTON, D.C. 20549
`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): April 4, 2008
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`Novacea, Inc.
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`(Exact name of Registrant as Specified in its Charter)
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`Delaware
`(State or other jurisdiction
`of incorporation)
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`000-51967
`(Commission
`File Number)
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`33-0960223
`(I.R.S. Employer
`Identification No.)
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`400 Oyster Point Boulevard, Suite 200
`South San Francisco, California 94080
`(Address of Principal Executive Offices)
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`(650) 228-1800
`(Registrant’s telephone number, including area code)
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`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 (see General Instruction A.2. below):
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`(cid:133) Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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`(cid:133) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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`(cid:133) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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`(cid:133) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/
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`JANSSEN EXHIBIT 2083
`Mylan v. Janssen IPR2016-01332
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`Form 8-K
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`Page 2 of 5
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`Item 1.02. Termination of a Material Definitive Agreement
`On April 4, 2008, Schering Corporation (“Schering”), a wholly-owned subsidiary of Schering-Plough Corporation,
`delivered written notice (the “Termination Letter”) of Schering’s termination of the exclusive License, Development and
`Commercialization Agreement between Novacea, Inc. (“Novacea” or the “Company”) and Schering, dated May 29, 2007,
`for the development and commercialization of AsentarTM (DN-101) for all diagnostic, therapeutic and prophylactic uses in
`humans and animals (the “Collaboration Agreement”). Schering elected to terminate the Collaboration Agreement
`pursuant to Section 16.4(b) based on Schering’s determination, related to the termination of the ASCENT-2 Phase 3
`clinical trial, that there had been a technical failure related to Asentar™. In November 2007, Novacea and Schering
`terminated the ASCENT-2 trial of Asentar™ due to an unexplained imbalance of deaths between the treatment and control
`arms of the trial.
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`According to the Termination Letter, the termination was effective immediately upon Novacea’s receipt of the
`Termination Letter. Upon termination of the Collaboration Agreement, the licenses and other rights granted by Novacea to
`Schering pursuant to the Collaboration Agreement terminated and Schering became responsible for conducting an orderly
`wind-down of all ongoing development activities with respect to Asentar™ and making all payments due to Novacea and
`any other third parties with respect to Asentar™, as per the terms of the Collaboration Agreement. Novacea anticipates
`that Schering will honor invoices for all costs incurred through the effective date of termination. However, Schering has
`indicated that they may dispute the costs associated with the currently ongoing wind-down activities with respect to
`Asentar™, which costs would be incurred by Novacea subsequent to the effective date of termination and subject to
`reimbursement by Schering. Any future development of Asentar™ would be at Novacea’s expense. Novacea does not
`anticipate incurring any early termination penalties as a result of the termination of the Collaboration Agreement.
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`As a result of the termination of the Collaboration Agreement, Novacea anticipates that it will recognize as revenue
`in 2008 the entire deferred revenue balance ($54.8 million as of December 31, 2007) related to the $60.0 million in
`upfront payments, which were being amortized previously over an approximately six-year period.
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`Novacea disclosed the material terms of the Collaboration Agreement and filed a copy of the Collaboration
`Agreement in its current report on Form 8-K filed with the Securities and Exchange Commission on June 1, 2007.
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`The foregoing description is qualified in its entirety by reference to the Company’s press release dated April 9, 2008,
`a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
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`Forward-Looking Statements. This report includes forward-looking statements within the meaning of Section 27A of
`the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements relate to future
`events or our future clinical or product development, financial performance, regulatory review of our products or product
`candidates, or commercialization efforts. In some cases, you can identify forward-looking statements by
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`* * * * *
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
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`Form 8-K
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`Page 3 of 5
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`terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,”
`“predicts,” “potential” or “continue” or the negative of those terms and other comparable terminology. These statements
`reflect only management’s current expectations. Important factors that could cause actual results to differ materially from
`the forward-looking statements we make or incorporate by reference in this report are set forth under the heading “Risk
`Factors” in our most recent Annual Report on Form 10-K, as may be updated from time to time by our future filings under
`the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying assumptions
`prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance
`or achievements expressed or implied by these forward-looking statements. We disclaim any intent or obligation to update
`these forward-looking statements.
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`Item 9.01. Financial Statements and Exhibits.
`(d) Exhibits.
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`Exhibit No.Description
`99.1
`Press Release dated April 9, 2008
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
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`Form 8-K
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`Page 4 of 5
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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.
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`SIGNATURES
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`Date: April 9, 2008
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`NOVACEA, INC.
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`/s/ Edward C. Albini
`By:
`Name: Edward C. Albini
`Title: Chief Financial Officer
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
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`Form 8-K
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`Page 5 of 5
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`Exhibit No.Description
`99.1
`Press Release dated April 9, 2008
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`EXHIBIT INDEX
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`http://www.sec.gov/Archives/edgar/data/1178711/000119312508077953/d8k.htm
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`4/20/2015
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